CHEMSAS is a drug discovery platform that uses machine learning and algorithms to accelerate drug development and identify compounds with a higher likelihood of clinical success. ROSALIND is a smart data platform that analyzes a tumor's genetic profile and identifies potential treatment combinations tailored to restore normal cell signaling. Critical Outcome Technologies (COTI) is a clinical-stage biotech company focusing on novel cancer therapeutics discovered using CHEMSAS. COTI's lead candidates COTI-2 and COTI-219 are currently in clinical trials.
A brief overview of ROSALIND - a smart data platform designed to provide better personalized treatment options to cancer patients based on their genetic profile.
This document discusses how in vivo imaging can be used to understand the distribution of candidate compounds in the body. It provides examples of how various imaging modalities such as positron emission tomography (PET), near infrared imaging, and mass spectrometry imaging can be used to track the accumulation of compounds in organs, penetration into tissues, and ability to cross barriers like the blood brain barrier. The document emphasizes how imaging can accelerate drug development by providing visualization of biological processes and quantifying pharmacokinetics, target engagement, and toxicity.
Get the right cancer drug, at right TimeSubin Suresh
Mitra Biotech is a Boston and Bengaluru-based startup that is developing personalized cancer therapies. It focuses on testing drugs on recreated tumor microenvironments in the lab before human trials. This approach has higher success rates and lower toxicity than conventional trials. Mitra Biotech has raised over $27 million to develop these personalized therapies and diagnostics. Major challenges include high costs, ensuring data quality, and coordinating information between different treatment centers.
di Pier Giuseppe Pelicci, MD-PhD, Istituto Europeo di Oncologia IEO, Università degli Studi di Milano.
Slide per l'intervento tenuto in Fondazione Giannino Bassetti in occasione del primo incontro del ciclo "La medicina di precisione", primo progetto dalla convenzione tra Università di Pavia e Fondazione Bassetti.
12 marzo 2018
Proteomics Modules designed to bring clinically relevant data, at any point, into the Drug Discovery Process. 1000s of proteins are plated from primary cells and are used to trap autoantibodies from diseased patients' blood sera. Results put a spotlight on highest probability targets.
The dream of any physician and consequently every patient is to receive the right treatment in the right time with cost effectiveness. To achieve this goal, the 3 pillars: evidence based medicine, clinical research innovation & resources utilization should be integrated efficiently.
In this presentation, I'll try to comprehensively review the following:
1- How are we used to perform clinical trials in Oncology?
2- Does it fits in today’s needs?
3- Integration of biology knowledge in shaping drug development
4- New Clinical trial designs “Can they offer solution for accelerating drug development?”
5- The supporting infrastructure role in clinical trial execution
CHEMSAS is a drug discovery platform that uses machine learning and algorithms to accelerate drug development and identify compounds with a higher likelihood of clinical success. ROSALIND is a smart data platform that analyzes a tumor's genetic profile and identifies potential treatment combinations tailored to restore normal cell signaling. Critical Outcome Technologies (COTI) is a clinical-stage biotech company focusing on novel cancer therapeutics discovered using CHEMSAS. COTI's lead candidates COTI-2 and COTI-219 are currently in clinical trials.
A brief overview of ROSALIND - a smart data platform designed to provide better personalized treatment options to cancer patients based on their genetic profile.
This document discusses how in vivo imaging can be used to understand the distribution of candidate compounds in the body. It provides examples of how various imaging modalities such as positron emission tomography (PET), near infrared imaging, and mass spectrometry imaging can be used to track the accumulation of compounds in organs, penetration into tissues, and ability to cross barriers like the blood brain barrier. The document emphasizes how imaging can accelerate drug development by providing visualization of biological processes and quantifying pharmacokinetics, target engagement, and toxicity.
Get the right cancer drug, at right TimeSubin Suresh
Mitra Biotech is a Boston and Bengaluru-based startup that is developing personalized cancer therapies. It focuses on testing drugs on recreated tumor microenvironments in the lab before human trials. This approach has higher success rates and lower toxicity than conventional trials. Mitra Biotech has raised over $27 million to develop these personalized therapies and diagnostics. Major challenges include high costs, ensuring data quality, and coordinating information between different treatment centers.
di Pier Giuseppe Pelicci, MD-PhD, Istituto Europeo di Oncologia IEO, Università degli Studi di Milano.
Slide per l'intervento tenuto in Fondazione Giannino Bassetti in occasione del primo incontro del ciclo "La medicina di precisione", primo progetto dalla convenzione tra Università di Pavia e Fondazione Bassetti.
12 marzo 2018
Proteomics Modules designed to bring clinically relevant data, at any point, into the Drug Discovery Process. 1000s of proteins are plated from primary cells and are used to trap autoantibodies from diseased patients' blood sera. Results put a spotlight on highest probability targets.
The dream of any physician and consequently every patient is to receive the right treatment in the right time with cost effectiveness. To achieve this goal, the 3 pillars: evidence based medicine, clinical research innovation & resources utilization should be integrated efficiently.
In this presentation, I'll try to comprehensively review the following:
1- How are we used to perform clinical trials in Oncology?
2- Does it fits in today’s needs?
3- Integration of biology knowledge in shaping drug development
4- New Clinical trial designs “Can they offer solution for accelerating drug development?”
5- The supporting infrastructure role in clinical trial execution
A biomarker strategy aims to answer key clinical questions to support drug development through identifying and testing biomarkers. Developing a robust biomarker strategy can mitigate risks and inform clinical study design by generating testable hypotheses to bridge pre-clinical and clinical research. Effective biomarker strategies consider assay suitability, study design, and sample availability to reliably detect biomarkers and provide statistically meaningful results. Emerging technologies allow deeper interrogation of drugs and disease through multiplexed readouts to enhance biomarker discovery and clinical development.
On Target Laboratories focuses on developing small molecule drugs that target and illuminate specific cancerous and diseased cells, avoiding healthy tissues. It is led by Dr. Sumith Kularatne, who has over 25 patents and has advanced 6 drug candidates into human clinical trials. The company's lead candidate, OTL38, has been shown safe in phase I trials and effective in phase II trials for ovarian cancer, with upcoming phase II trials for lung cancer. OTL38 and other candidates use targeted drug delivery with ligands to illuminate and treat diseases precisely while minimizing side effects.
On Target Laboratories (OTL) is developing novel optical imaging agents that target and illuminate cancerous cells. OTL's lead candidate, OTL38, is a near-infrared dye conjugated to a ligand that targets folate receptors, which are overexpressed in several types of cancer. OTL38 has undergone successful preclinical testing and a phase I clinical trial. Additional candidates target prostate-specific membrane antigen and receptors for ovarian, lung, renal, colon, liver, breast, head and neck, and pancreatic cancers. OTL's technology provides surgeons with real-time visualization of cancerous tissues during surgery to more precisely and completely remove tumors.
Cancer nanomedicine market & pipeline insight 2015KuicK Research
The document discusses cancer nanomedicine and nanoparticles for drug delivery. It notes that nanoparticles have advantages for drug delivery including longer circulation, improved pharmacokinetics, and reduced side effects. Nanoparticles can accumulate in tumor sites due to leaky vasculature and represent a promising approach for delivering multiple drugs using a single carrier. The future of cancer nanomedicine involves developing safer and more effective nanoparticle systems for targeting drugs to tumors, including protein-based nanoparticles. The report provides an overview of the cancer nanomedicine market and clinical pipeline.
Cancer nanomedicine market & pipeline insight 2015KuicK Research
“Cancer Nanomedicine Market & Pipeline Insight 2015” Report Highlight
Nanomedicine for Cancer Therapies
Cancer Nanoparticles Drug Delivery Systems Classification
Mechanism of Cancer Nanomedicine Therapy
Cancer Nanomedicine Clinical Pipeline Overview
Cancer Nanomedicine Clinical Pipeline by Company, Indication & Phase
Cancer Nanomedicine Clinical Pipeline: 79 Drugs
Marketed Cancer Nanomedicine: 8 Drugs
Global cancer stem cell therapy market outlook 2020KuicK Research
“Global Cancer Stem Cell Therapy Market Outlook 2020” Report Highlight:
Introduction & Classification of Stem Cells
Stem Cell Transplants Classification
Cancer Stem Cell Therapy Mechanism of Action
Global Cancer Stem Cell Market Analysis
Global Cancer Stem Cell Clinical Pipeline by Company & Phase
Global Cancer Stem Cell Clinical Pipeline: 32 Therapies
Global Cancer Stem Cell Market Dynamics: Challenges & Favorable Parameters
Global Cancer Stem Cell Market Future Outlook
Breakthrough Nanoparticle Drug Delivery Platform Enabling Lead Compound nanoFenretinide (ST-001): SciTech Development presentation with a focus on pediatric oncology (cancer) including Ewing’s Sarcoma Family of Tumours (ESFT), leukemia - acute lymphocytic leukemia (ALL), acute myelogenous leukemia (AML); and, neuroblastoma. The pitch deck also includes a company overview, proprietary technology, lead drug ST-001 nanoparticle fenretinide, patents, addressable market sizes, competiton, key personnel, advisory board, drug product characteristics, fenretinide history, other cancer indications, investment opportunity and drug mechanism of action (MOA).
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
Pharmacology Forever ! has been set as a meeting in recognition of Frits Peters tremendous involvement in pharmacology. This presentation discusses latest drug development methods and is illustrated by exemple of new drugs and target in oncology.
Immune-based Therapies: A Focus on Accessflasco_org
This document discusses immune-based cancer therapies and clinical trials. It outlines Keith Knutson's conflicts of interest with several cancer vaccine companies. It then summarizes different types of immune cells involved in the adaptive immune response and cancer immunology approaches like vaccines, monoclonal antibodies, and immune checkpoint blockade. The document discusses clinical trial design, phases of trials, randomization, and blinding. It provides examples of specific cancer vaccine clinical trials and limitations to patient access of advanced trials.
This document provides information about Dr. Paul Cornes and his work in oncology. It discloses that Dr. Cornes receives a salary from the UK National Health Service and has received honoraria from several pharmaceutical companies. The bulk of the document discusses the costs of cancer to individuals and societies and highlights both challenges and areas of progress in cancer treatment, including improved survival rates due to innovations in targeted therapies and monoclonal antibodies.
The Center for Comparative Effectiveness in Genomic Medicine (CCEGM) will conduct research on using genomics to improve cancer care and prevention by tailoring approaches to individuals. It will generate and synthesize evidence on translating genomic tools into cancer screening, diagnosis, treatment and survivorship. The CCEGM includes studies on pharmacogenomics for smoking cessation, breast and lung cancer genomic markers, and testing for a tumor suppressor gene. It will contribute findings on the clinical and economic outcomes of genomic approaches compared to standard care.
New science is redefining cancer as a large number of narrowly defined diseases and bringing therapeutic options to an expanded number of patients. With the rapid growth in the oncology treatment landscape, health systems are struggling to adapt and embrace the evolution—including regulatory systems, diagnostic infrastructure, treatment providers and financing mechanisms. These challenges will require urgent attention in light of the strong near-term pipeline of clinically distinctive therapies and new programs that are galvanizing research efforts to change the trajectory for cancer.
Read the full report >> http://imsh.co/2axszmt
The Potential for Individualization of Neoadjuvant Chemotherapy in Breast Can...CrimsonpublishersCancer
The preoperative, or, as it is often called, neoadjuvant chemotherapy (NAPCT) of operable breast cancer (the breast cancer) with affected regional lymph nodes has in its time replaced preoperative radiotherapy, as it has a number of significant advantages over the latter. The most important advantage of NAPCT is its systemic action, which allows to “catching up” with probable distant micro-metastases or circulating tumor cells, while pre-operative radiotherapy has a local effect, and on the systemic level the tumor continues to develop. Despite of the fact that with operative breast cancer the time of NAPCT (before or after the operation) does not affect to the long-term results of treatment, the latter becomes applicable even for operable breast cancer without affected regional lymph nodes.According to the literature, NAPCT with primary-operative breast cancer allows: 1) make organ saving operations; 2) improve the prognosis in cases of complete morphological regression in patients with triple negative and Her2 / neu positive (non-luminal) subtypes; 3) evaluate the effect of chemotherapy and, in the absence of effect, stop it on time [1].
This document discusses using data from the Veterans Affairs (VA) healthcare system to conduct precision oncology research. It describes extracting data from the VA Corporate Data Warehouse, including clinical records from cancer registries and records of patients who received tumor sequencing and immunotherapy. The author builds a cohort of 330 non-small cell lung cancer patients who received immunotherapy before 2018 and had their cancer verified in the registry to study outcomes like the impact of PD-L1 expression on response to treatment. Challenges include lag times in cancer registry reporting and building a large enough cohort to draw powerful conclusions from retrospective analyses.
2014 02-24 Oxford Global biomarker congress, ManchesterAlain van Gool
This document summarizes a presentation given by Alain van Gool on biomarkers in a changing world. It discusses the shift from personalized medicine to personalized healthcare, which takes a more holistic systems view of an individual. It also notes disruptive technologies that can accelerate biomarker development and the need to translate biomarkers into useful tools. Throughout, it provides examples of challenges like tumor heterogeneity and factors beyond genetics that influence disease and response to treatment.
Next Generation Companion Diagnostics; Adoption, Drivers, and Moderators of N...Andrew Aijian
Analysis and synthesis of a pulse survey conducted across >140 oncologists, pathologists, and lab directors regarding current adoption and trends associated with emerging oncology biomarkers and companion diagnostics (CDx), with an emphasis on next-generation sequencing (NGS)-based CDx.
Trends in the Adoption of Robotic Surgery for Common Surgical ProceduresΔρ. Γιώργος K. Κασάπης
Given concerns that robotic surgery is increasing for common surgical procedures with limited evidence and unclear clinical benefit, how is the use of robotic surgery changing over time?Given concerns that robotic surgery is increasing for common surgical procedures with limited evidence and unclear clinical benefit, how is the use of robotic surgery changing over time?
In this JAMA study of 169 404 patients in 73 hospitals, the use of robotic surgery for all general surgery procedures increased from 1.8% to 15.1% from 2012 to 2018. Hospitals that launched robotic surgery programs had a broad and immediate increase in the use of robotic surgery, which was associated with a decrease in traditional laparoscopic minimally invasive surgery.
These findings highlight a need to continually monitor the adoption of robotic surgery to ensure that enthusiasm for new technology does not outpace the evidence needed to use it in the most effective clinical contexts.
This presentation contains an overview of the scientific and business update provided by management during Critical Outcome Technologies' 2017 Annual General and Special Meeting of Shareholders on December 20, 2017.
A biomarker strategy aims to answer key clinical questions to support drug development through identifying and testing biomarkers. Developing a robust biomarker strategy can mitigate risks and inform clinical study design by generating testable hypotheses to bridge pre-clinical and clinical research. Effective biomarker strategies consider assay suitability, study design, and sample availability to reliably detect biomarkers and provide statistically meaningful results. Emerging technologies allow deeper interrogation of drugs and disease through multiplexed readouts to enhance biomarker discovery and clinical development.
On Target Laboratories focuses on developing small molecule drugs that target and illuminate specific cancerous and diseased cells, avoiding healthy tissues. It is led by Dr. Sumith Kularatne, who has over 25 patents and has advanced 6 drug candidates into human clinical trials. The company's lead candidate, OTL38, has been shown safe in phase I trials and effective in phase II trials for ovarian cancer, with upcoming phase II trials for lung cancer. OTL38 and other candidates use targeted drug delivery with ligands to illuminate and treat diseases precisely while minimizing side effects.
On Target Laboratories (OTL) is developing novel optical imaging agents that target and illuminate cancerous cells. OTL's lead candidate, OTL38, is a near-infrared dye conjugated to a ligand that targets folate receptors, which are overexpressed in several types of cancer. OTL38 has undergone successful preclinical testing and a phase I clinical trial. Additional candidates target prostate-specific membrane antigen and receptors for ovarian, lung, renal, colon, liver, breast, head and neck, and pancreatic cancers. OTL's technology provides surgeons with real-time visualization of cancerous tissues during surgery to more precisely and completely remove tumors.
Cancer nanomedicine market & pipeline insight 2015KuicK Research
The document discusses cancer nanomedicine and nanoparticles for drug delivery. It notes that nanoparticles have advantages for drug delivery including longer circulation, improved pharmacokinetics, and reduced side effects. Nanoparticles can accumulate in tumor sites due to leaky vasculature and represent a promising approach for delivering multiple drugs using a single carrier. The future of cancer nanomedicine involves developing safer and more effective nanoparticle systems for targeting drugs to tumors, including protein-based nanoparticles. The report provides an overview of the cancer nanomedicine market and clinical pipeline.
Cancer nanomedicine market & pipeline insight 2015KuicK Research
“Cancer Nanomedicine Market & Pipeline Insight 2015” Report Highlight
Nanomedicine for Cancer Therapies
Cancer Nanoparticles Drug Delivery Systems Classification
Mechanism of Cancer Nanomedicine Therapy
Cancer Nanomedicine Clinical Pipeline Overview
Cancer Nanomedicine Clinical Pipeline by Company, Indication & Phase
Cancer Nanomedicine Clinical Pipeline: 79 Drugs
Marketed Cancer Nanomedicine: 8 Drugs
Global cancer stem cell therapy market outlook 2020KuicK Research
“Global Cancer Stem Cell Therapy Market Outlook 2020” Report Highlight:
Introduction & Classification of Stem Cells
Stem Cell Transplants Classification
Cancer Stem Cell Therapy Mechanism of Action
Global Cancer Stem Cell Market Analysis
Global Cancer Stem Cell Clinical Pipeline by Company & Phase
Global Cancer Stem Cell Clinical Pipeline: 32 Therapies
Global Cancer Stem Cell Market Dynamics: Challenges & Favorable Parameters
Global Cancer Stem Cell Market Future Outlook
Breakthrough Nanoparticle Drug Delivery Platform Enabling Lead Compound nanoFenretinide (ST-001): SciTech Development presentation with a focus on pediatric oncology (cancer) including Ewing’s Sarcoma Family of Tumours (ESFT), leukemia - acute lymphocytic leukemia (ALL), acute myelogenous leukemia (AML); and, neuroblastoma. The pitch deck also includes a company overview, proprietary technology, lead drug ST-001 nanoparticle fenretinide, patents, addressable market sizes, competiton, key personnel, advisory board, drug product characteristics, fenretinide history, other cancer indications, investment opportunity and drug mechanism of action (MOA).
The document discusses the increasing need for companion diagnostics to accompany targeted cancer therapies. It outlines three categories of diagnostic development: 1) Co-development of the drug and diagnostic from an early stage; 2) Development of a diagnostic after a drug is approved to identify patients who will benefit; and 3) Development of a diagnostic for one indication that is later repurposed for another. It also discusses the regulatory environment, noting that regulatory agencies like the FDA are increasingly requiring companion diagnostics and biomarkers to guide patient selection and drug approval. Developing diagnostics poses challenges for drug companies who must partner with diagnostic firms and navigate regulatory requirements.
Pharmacology Forever ! has been set as a meeting in recognition of Frits Peters tremendous involvement in pharmacology. This presentation discusses latest drug development methods and is illustrated by exemple of new drugs and target in oncology.
Immune-based Therapies: A Focus on Accessflasco_org
This document discusses immune-based cancer therapies and clinical trials. It outlines Keith Knutson's conflicts of interest with several cancer vaccine companies. It then summarizes different types of immune cells involved in the adaptive immune response and cancer immunology approaches like vaccines, monoclonal antibodies, and immune checkpoint blockade. The document discusses clinical trial design, phases of trials, randomization, and blinding. It provides examples of specific cancer vaccine clinical trials and limitations to patient access of advanced trials.
This document provides information about Dr. Paul Cornes and his work in oncology. It discloses that Dr. Cornes receives a salary from the UK National Health Service and has received honoraria from several pharmaceutical companies. The bulk of the document discusses the costs of cancer to individuals and societies and highlights both challenges and areas of progress in cancer treatment, including improved survival rates due to innovations in targeted therapies and monoclonal antibodies.
The Center for Comparative Effectiveness in Genomic Medicine (CCEGM) will conduct research on using genomics to improve cancer care and prevention by tailoring approaches to individuals. It will generate and synthesize evidence on translating genomic tools into cancer screening, diagnosis, treatment and survivorship. The CCEGM includes studies on pharmacogenomics for smoking cessation, breast and lung cancer genomic markers, and testing for a tumor suppressor gene. It will contribute findings on the clinical and economic outcomes of genomic approaches compared to standard care.
New science is redefining cancer as a large number of narrowly defined diseases and bringing therapeutic options to an expanded number of patients. With the rapid growth in the oncology treatment landscape, health systems are struggling to adapt and embrace the evolution—including regulatory systems, diagnostic infrastructure, treatment providers and financing mechanisms. These challenges will require urgent attention in light of the strong near-term pipeline of clinically distinctive therapies and new programs that are galvanizing research efforts to change the trajectory for cancer.
Read the full report >> http://imsh.co/2axszmt
The Potential for Individualization of Neoadjuvant Chemotherapy in Breast Can...CrimsonpublishersCancer
The preoperative, or, as it is often called, neoadjuvant chemotherapy (NAPCT) of operable breast cancer (the breast cancer) with affected regional lymph nodes has in its time replaced preoperative radiotherapy, as it has a number of significant advantages over the latter. The most important advantage of NAPCT is its systemic action, which allows to “catching up” with probable distant micro-metastases or circulating tumor cells, while pre-operative radiotherapy has a local effect, and on the systemic level the tumor continues to develop. Despite of the fact that with operative breast cancer the time of NAPCT (before or after the operation) does not affect to the long-term results of treatment, the latter becomes applicable even for operable breast cancer without affected regional lymph nodes.According to the literature, NAPCT with primary-operative breast cancer allows: 1) make organ saving operations; 2) improve the prognosis in cases of complete morphological regression in patients with triple negative and Her2 / neu positive (non-luminal) subtypes; 3) evaluate the effect of chemotherapy and, in the absence of effect, stop it on time [1].
This document discusses using data from the Veterans Affairs (VA) healthcare system to conduct precision oncology research. It describes extracting data from the VA Corporate Data Warehouse, including clinical records from cancer registries and records of patients who received tumor sequencing and immunotherapy. The author builds a cohort of 330 non-small cell lung cancer patients who received immunotherapy before 2018 and had their cancer verified in the registry to study outcomes like the impact of PD-L1 expression on response to treatment. Challenges include lag times in cancer registry reporting and building a large enough cohort to draw powerful conclusions from retrospective analyses.
2014 02-24 Oxford Global biomarker congress, ManchesterAlain van Gool
This document summarizes a presentation given by Alain van Gool on biomarkers in a changing world. It discusses the shift from personalized medicine to personalized healthcare, which takes a more holistic systems view of an individual. It also notes disruptive technologies that can accelerate biomarker development and the need to translate biomarkers into useful tools. Throughout, it provides examples of challenges like tumor heterogeneity and factors beyond genetics that influence disease and response to treatment.
Next Generation Companion Diagnostics; Adoption, Drivers, and Moderators of N...Andrew Aijian
Analysis and synthesis of a pulse survey conducted across >140 oncologists, pathologists, and lab directors regarding current adoption and trends associated with emerging oncology biomarkers and companion diagnostics (CDx), with an emphasis on next-generation sequencing (NGS)-based CDx.
Trends in the Adoption of Robotic Surgery for Common Surgical ProceduresΔρ. Γιώργος K. Κασάπης
Given concerns that robotic surgery is increasing for common surgical procedures with limited evidence and unclear clinical benefit, how is the use of robotic surgery changing over time?Given concerns that robotic surgery is increasing for common surgical procedures with limited evidence and unclear clinical benefit, how is the use of robotic surgery changing over time?
In this JAMA study of 169 404 patients in 73 hospitals, the use of robotic surgery for all general surgery procedures increased from 1.8% to 15.1% from 2012 to 2018. Hospitals that launched robotic surgery programs had a broad and immediate increase in the use of robotic surgery, which was associated with a decrease in traditional laparoscopic minimally invasive surgery.
These findings highlight a need to continually monitor the adoption of robotic surgery to ensure that enthusiasm for new technology does not outpace the evidence needed to use it in the most effective clinical contexts.
This presentation contains an overview of the scientific and business update provided by management during Critical Outcome Technologies' 2017 Annual General and Special Meeting of Shareholders on December 20, 2017.
1) TapImmune is developing T-cell immunotherapies focused on breast and ovarian cancers. Their lead candidate, TPIV 200, is in four Phase 2 clinical trials.
2) They are also developing TPIV 110 for HER2-positive breast cancer and plan to file an IND in 2017. Additionally, their PolyStart technology aims to enhance DNA vaccines and is being evaluated preclinically.
3) TapImmune's strategy in 2017 is to complete ongoing Phase 2 trials, seek partners for late-stage development and commercialization, explore combination regimens, and seek opportunities to monetize PolyStart.
Slide deck used by Dr. Wayne Danter, President and CEO of Critical Outcome Technologies, at the Equities.com Small-Cap Stars investor conference in New York City on June 10, 2015.
COTI-2 is a small molecule drug discovered by Critical Outcome Technologies Inc. that shows promise for treating many cancers. It is effective against cancers with a p53 gene mutation and has received Orphan Drug Designation from the FDA for ovarian cancer. Experiments by MD Anderson Cancer Center independently confirmed COTI-2's novel mechanism of action and identified an effective lower dosage. Critical Outcome Technologies plans to file for FDA approval and begin a Phase 1 clinical trial at MD Anderson in early 2015 to further test the safety and efficacy of COTI-2.
An overview of Critical Outcome Technologies' lead cancer drug candidate, COTI-2, which represents a potential breakthrough treatment for many types of cancer. Critical Outcome Technologies is listed on the TSX Venture Exchange under the symbol COT.
Senesco Technologies is developing a gene regulation technology to treat cancer. They are running a Phase 1b/2a clinical trial of their lead product, SNS01-T, to treat B-cell cancers like multiple myeloma and lymphoma. Preclinical studies show SNS01-T significantly inhibits tumor growth and improves survival in mouse models of these cancers. The presentation provides an overview of Senesco's technology, clinical trial status, financial information, and development plans to advance SNS01-T and expand to additional cancer indications.
This document provides an overview of Oncolytics Biotech and their lead product, REOLYSIN.
It discusses three clinical development pathways for REOLYSIN: 1) Combinations with chemotherapy to directly lyse tumor cells, 2) Combinations with immunotherapy to activate immune responses, and 3) Combinations with targeted therapies to modulate innate immunity.
For pathway 1, a phase 2 trial showed REOLYSIN in combination with paclitaxel significantly improved overall survival over paclitaxel alone in metastatic breast cancer patients. This provides the basis for a planned 400-patient phase 3 registration study in this indication.
Presentation providing an overview of the recent milestones and next steps for getting Critical Outcome's p53-dependent cancer treatment, COTI-2, into clinical trials. This presentation was first given by Dr. Wayne Danter at Critical Outcome Technologies' annual shareholders meeting on October 21, 2014.
Critical Outcome Technologies Inc. is listed on the Toronto Venture Exchange under the trading symbol COT.
Presentation delivered during Critical Outcome Technologies' Annual General and Special Meeting of Shareholders on October 15, 2015. The presentation highlights significant milestones reached for the company's lead cancer drug, COTI-2, and outlines next steps and strategic goals going forward.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
This presentation provides an overview of Oncolytics Biotech and its lead product candidate REOLYSIN. Key points include:
- REOLYSIN is a first-in-class immuno-oncolytic virus being developed for solid tumors and blood cancers. It has a dual mechanism of action selectively killing cancer cells while activating the immune system.
- In a phase 2 trial in metastatic breast cancer, REOLYSIN combined with paclitaxel more than doubled overall survival compared to paclitaxel alone in ER+/PR+/HER2- patients.
- The clinical development plan is pursuing combinations with chemotherapy, immunotherapy agents like Keytruda, and targeted therapies. This includes an ongoing myel
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
- PTX has a deep clinical pipeline with 3 ongoing or planned clinical trials, including Phase Ib/II trials of PTX-200 in breast cancer and ovarian cancer, and a planned Phase Ib trial of PTX-100 in AML.
- PTX-200 and PTX-100 are novel cancer drugs targeting the Akt and Ras pathways that have potential to overcome chemotherapy resistance.
- The clinical trials are being conducted at prestigious cancer centers in the US including Moffitt Cancer Center and Albert Einstein College of Medicine.
Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE), a diversified molecular diagnostics company. GTG offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead products GeneType for Breast Cancer and GeneType for Colorectal Cancer are clinically validated risk assessment tests and are first in class. Genetic Technologies is developing a pipeline of risk assessment products. Learn more at GENETechinfo.com.
This document discusses issues with early-phase oncology drug development and proposes approaches to improve decision making. Currently, high costs, long timelines, and high failure rates mean few drugs progress to approval. While targeted therapies held promise, biomarkers have not been effectively utilized. Improving preclinical understanding and using molecular profiling to select patients and biomarkers could optimize go/no-go decisions and increase efficiency. Biomarker-driven and dose escalation approaches may better indicate drug viability and facilitate decisions.
This document summarizes an investor presentation by Oncolytics Biotech regarding their immuno-oncology agent REOLYSIN. It discusses 3 key points:
1. REOLYSIN's dual mechanism of action turns "cold" tumors "hot" by selectively lysing cancer cells and activating the innate and adaptive immune system.
2. Clinical trials showed REOLYSIN in combination with chemotherapy significantly improved overall survival in patients with metastatic breast cancer and doubled 2-year survival in pancreatic cancer.
3. The company's development plan focuses on combination trials with chemotherapy, immunotherapy agents like Keytruda, and targeted therapies through collaborations with Celgene to advance their lead program in registration trials for metastatic breast cancer
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
OneMedForum New York 2010 - Company Presentation. Access Pharmaceuticals, Inc., a emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development.
Similar to COTI Corporate Presentation at Cantech 2017 (20)
COTI-2 is a novel small molecule discovered by Critical Outcome Technologies Inc. that restores the function of mutant p53 proteins and negatively modulates the PI3K/AKT/mTOR cancer-related signaling pathway. It shows promise as an oral cancer therapy for cancers with p53 mutations or abnormalities in the PI3K/AKT/mTOR pathway, which include a broad range of common cancers. Preclinical studies demonstrate its safety and effectiveness against several cancer types. A Phase I clinical trial is currently underway for gynecological cancers.
Investor presentation for Critical Outcome Technologies Inc. (TSX-V: COT; OTC: COTQF). This presentation provides the latest overview of the company's lead cancer drug, COTI-2, as well as other revenue opportunities being pursued by Critical Outcome Technologies.
ROSALIND is a computer simulation program that uses a patient's tumor gene profile to evaluate all available cancer therapy options and predict the most effective treatments. It can simulate over 10,000 drug combinations in under 2 hours, allowing for a comprehensive and fast analysis. ROSALIND's predictions aim to personalize cancer treatment for each patient and help guide them to therapies with the highest chance of remission or available clinical trials when standard options are unlikely to work. The company envisions ROSALIND being widely adopted to achieve higher remission rates and lower healthcare costs through more personalized cancer care.
COTI-2 is a small molecule discovered by Critical Outcome Technologies to reactivate mutant p53 through zinc chelation. It demonstrates strong efficacy against a wide range of p53 mutations in vitro and significant tumor growth inhibition in vivo without inducing resistance. Further studies confirmed COTI-2's p53-dependent mechanism of action and ability to modulate the PI3K/AKT pathway. An IND filing is planned in mid-2014 to study COTI-2 in gynecological cancers.
Investor presentation for Critical Outcome Technologies (TSXV: COT), highlighting the Company's lead cancer drug candidate and its small molecule profiling and investment due diligence tool, CHEMFirm.
Critical Outcome Technologies Inc. is a bioinformatics company that uses its proprietary CHEMSAS platform to reduce the time and cost of drug discovery. Its lead compound, COTI-2, shows promise for treating cancers with p53 mutations and is nearly ready for Phase 1 clinical trials. If successful, COTI-2 could generate hundreds of millions in licensing deals. The company also has additional compounds in development and collaborations that could produce milestone payments in the coming years. Critical Outcome Technologies aims to revolutionize drug discovery through computational simulation and reduce the traditional multi-billion dollar and decade-long process.
The document discusses Critical Outcome Technologies Inc. (COTI), a bioinformatics company that uses its proprietary CHEMSAS platform to accelerate drug discovery and reduce costs. The CHEMSAS platform uses artificial intelligence and computational modeling to simulate the drug discovery process in silico, identifying promising compounds faster and cheaper than traditional wet-lab approaches. COTI has multiple collaborations utilizing the platform and an oncology drug candidate, COTI-2, that shows promise for cancers with p53 mutations and is nearing phase 1 clinical trials. The platform also positions COTI for numerous potential licensing deals and revenue streams from drug development milestones and royalties.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
Critical Outcome Technologies Inc. streamlines drug discovery - dramatically reducing the time and cost to bring new drugs to market. The Company is listed on the TSX Venture Exchange (ticker symbol: COT).
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2. 2
When used anywhere in this presentation, whether oral or written, the words expects,
believes, anticipates, estimates and similar expressions are intended to identify forward-
looking statements. Forward-looking statements may include statements addressing
future financial and operating results of Critical Outcome Technologies Inc. (COTI).
COTI bases these forward-looking statements on its current expectations about future
events. Such statements are subject to risks and uncertainties including, but not limited
to, the successful implementation of COTI’s strategic plans, the acceptance of new
products, the obsolescence of existing products, the resolution of potential patent
issues, competition, changes in economic conditions, and other risks described in COTI’s
public documents such as press releases and filings with the Toronto Stock Exchange and
the Ontario Securities Commission.
All forward-looking statements are qualified in their entirety by the cautionary
statements included in this document and such filings. These risks and uncertainties
could cause actual results to differ materially from results expressed or implied by
forward-looking statements contained in this presentation. These forward-looking
statements speak only as of the date of this presentation.
Disclaimer
3. 3
• Clinical stage biotech company focused
on the development of novel
therapeutics for the treatment of
cancers and other unmet medical needs
• Pipeline of internally developed
compounds
• CHEMSAS platform – in silico high
throughput screening for molecule
identification
• ROSALIND technology – genomics
profiling for personalized oncology care
• Offices in London, ON and Boston, MA
TSX-V: COT
OTCQB: COTQF
Company and Pipeline Synopsis
4. • In response to cellular stress, wild-type p53 induces cell cycle arrest and/or
apoptotic cell death
• Mutant p53 promotes tumor formation (loss of tumor suppressor function)
– Mutant p53: single most important cancer-causing gene mutation known
– >50% of all human cancers
– Most frequently mutated gene in human cancer with frequencies ranging from
38% to 96%
• COTI-2 induces a wild-type-like conformational change in the p53 mutant
protein that restores sequence-specific p53 transcription
– Oral small molecule
– Low preclinical toxicity
– Active as a mono or combination therapy
– Currently in a Phase I trial in gynecological malignancies
4
COTI-2 Mechanism of Action & Synopsis
mutp53
mutp53
Sequence-specific
transactivation defective
Conformational change to a
wild-type configuration
Restoration of sequence-specific
transcriptional activity
Apoptosis,
growth arrest,
senescence
mutp53
Drug Drug
5. 5
0
50
100
150
200
0 5 9 16 23 30 37 44 51 61
TumorVolume(mm3)
Study Day
Effect of IV Treatment on OVCAR-3 Tumor Volume
Group 1 = Vehicle IV
Group 2 = COTI-2 20mg/kg IV
Group 3 = COTI-2 40mg/kg IV
0
50
100
150
200
250
0 5 9 16 23 30 37 44 51 61
TumorVolume(mm3)
Study Day
Effect of PO Treatment on OVCAR-3 Tumor Volume
Group 4 = Vehicle PO
Group 5 = COTI-2 75mg/kg PO
Group 6 = COTI-2 100mg/kg PO
* *
* * * *
* *
* * * * * * * * *
*
* * * *
*
*
* * * * * * * *
James Koropatnick, LRCC, London, ON.
Significant Tumor Growth Inhibition as a Single Agent
• COTI-2 administered IV and PO produced a significant tumor growth inhibition
as a single agent in an OVCAR-3 ovarian cancer xenograft model
6. 6
• COTI-2 as a single agent and in combination with cisplatin produced significant
tumor growth inhibition relative to untreated controls in the PCI13 pG245D head
and neck cancer xenograft models
• Cisplatin treatment alone did not yield significant tumor growth inhibition
* * * * *
* * * * *
* * *
Jeffrey Myers, U of Texas, MDACC, Houston, TX.
Significant Tumor Growth Inhibition in Combination
with Cisplatin
7. 7
Protocol
Title
A PHASE 1 STUDY OF COTI-2 FOR THE TREATMENT OF ADVANCED OR RECURRENT GYNECOLOGIC MALIGNANCIES
Study Sites MD Anderson Cancer Center, Houston, TX Northwestern University Memorial Hospital, Chicago, IL
Principal
Investigators
Dr. Shannon Westin Dr. Wilberto Neives-Niera
Study Phase Phase 1
Objective Primary
• To evaluate the safety and tolerability of COTI-2 in patients with advanced or recurrent gynecologic malignancies.
• To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of COTI-2 for the
treatment of patients with advanced or recurrent gynecologic malignancies.
Secondary
• To evaluate the pharmacokinetics of COTI-2 at all dose levels in patients with advanced or recurrent gynecologic
malignancies.
• To estimate the clinical activity of COTI-2 at all dose levels and the RP2D in patients with advanced or recurrent
gynecologic malignancies by response rate (Response Evaluation Criteria In Solid Tumors [RECIST] v1.1 criteria) and
the progression-free survival (PFS) rate at 6 months.
• To estimate the response duration for COTI-2 at all dose levels and the RP2D in patients with advanced or recurrent
gynecologic malignancies.
Exploratory
• To determine if baseline molecular aberrations, including p53 mutation, correlate with activity of COTI-2 in advanced
or recurrent gynecologic malignancies.
• To evaluate pharmacodynamic markers of COTI-2 activity at all dose levels and at the RP2D in patients with advanced
or recurrent gynecologic malignancies.
Patient
Population
• Females with ovarian, fallopian tube, primary peritoneal, endometrial or cervical cancer that is recurrent, metastatic,
or unresectable and for which no effective or curative measures exist
Sample Size • Maximum 46 patients • Dose Escalation Phase: up to 36
patients (up to 6 cohorts)
• Dose Expansion Phase: 10 patients
with ovarian cancer (one cohort)
COTI2-101 Study Summary
8. • Regular updates will be provided as each cohort commences dosing, with
Cohort 4 announced in January 2017
– Announcement of dose escalation is the only “releasable” information during
this clinical phase
• June 2017 – preliminary results on the safety and clinical activity of COTI-2
• Other trials planned in 2017 – additional multi center clinical trial programs:
– Recurrent Head and Neck Squamous Cell cancer (HNSCC)
– Soft tissue sarcoma (STS)
– Combination trials with other chemo/radiotherapies
• Final trial results and conclusions
– Mid 2017 - gynecological phase
– Late 2017 - expansion phase
8
Anticipated COTI2-101 Clinical Trial News Flow
9. • Novel and specific p53-dependent mechanism of action
• Orally bio-available and effective at low dose
• Low toxicity in preclinical development
• Opportunity for single agent and combination therapy
• No drug resistance observed
• Sensitization to radiation therapy
• Strong IP protection in place
- 8 U.S. patents issued
- 1 Japanese, 1 Canadian and 1 EU patent issued
- Additional patents pending
9
COTI-2 Best-in-Class Potential
10. 10
CORPORATE
Appointed experienced Scientific Advisory Board
(SAB)
Opened US office (Boston, MA) in Aug 2016
Designated next preclinical candidate for clinical
development
COTI-2
Granted FDA orphan drug status for ovarian cancer
Received IND granting
Filed for FDA orphan drug status for Li-Fraumeni
syndrome
Published first scientific article in Oncotargets
Commenced patient dosing of Phase 1 clinical trial
at MDACC
Activated second clinical trial site at NWU
Initiated fourth patient cohort of Phase 1 clinical
trial
COMPLETED UPCOMING
CORPORATE
• Strengthen the balancesheet to execute on
corporate strategies
• Establish collaborations/partnershipsfor
COTI-2, pipelineprograms and other
technologies
COTI-2
• Broaden the potential for COTI-2 in
multiple additional clinical indications and
combination therapies
• Obtain additional orphan drug
designations
COTI-219
• Continue IND-enabling studies
• File an IND by the end of 2017
Corporate Objectives
11. 11
Management Team Directors
Alison Silva, MSc
• President & CEO
• Co-founder, former EVP & COO, Synlogic
• Co-founder & Principal, The Orphan Group
Wayne Danter, MD, FRCPC
• Co-founder & CSO
• Former Associate Professor of Medicine at
Western University
Gene Kelly
• Chief Financial Officer
• Former VP Finance, Cuddy Farms
Debi Sanderson, MBA
• Director, Resourcing and Operations
Kowthar Salim, PhD, MBA
• Program Director and Senior Scientist
John Drake, LLB, Chairman
• Chairman, Whippoorwill Holdings Limited
Alison Silva, MSc, President & CEO
Wayne Danter, MD, FRCPC, Co-founder & CSO
Douglas Alexander, CPA, CA
• Chairman, Hydrogenics Corporation
Bruno Maruzzo, MASc, MBA
• President, TechnoVenture Inc.
Dave Sanderson, LLB
• President & CEO, KFL Investment
Management Inc.
John Yoo, MD FRCPC
• Professor, Chairman and City-wide Chief of
Otolaryngology – Head and Neck Surgery at
Western University
Bharatt Chowrira, PhD, JD
• President, Synlogic
Committed Leadership
12. 12
Key Company Facts
Trading
TSX Venture (2) COT
Recent Closing Price (3) $0.475
52 Week Range (3) $0.21 - 0.90
Market Capitalization (3) $70,850,257
Capital
Cash (4) $3.56 M
Basic Shares Outstanding (3) 149,158,435
Options Outstanding (3) 11,197,435
Warrants Outstanding (3) 22,163,113
Fully Diluted Shares Outstanding (3) 182,518,983
Board & management control (3) (5) 16.3%
(1) All $ amounts in CAD
(2) COTI also trades on the OTCQB as COTQF but amounts
are for the TSXV only
(3) As of the close of business Dec 31, 2016
(4) As at Dec 31, 2016 consisting of cash, cash equivalents and investments
(5) On a fully diluted basis
13. Contact:
Alison Silva
President & CEO
Office: (519) 858-5157
Mobile: (860) 798-0816
asilva@criticaloutcome.com
www.criticaloutcome.com
www.criticaloutcomeblog.com
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