Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors. Targovax’s focus is to activate the patient’s immune system to fight cancer, and to bring benefit to cancer patients with few available treatment alternatives. Targovax is developing its product candidates in different cancer indications, including melanoma, mesothelioma, and multiple myeloma, and has demonstrated a favorable safety and tolerability profile.
Targovax’s lead clinical candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect cancer cells and activate the immune system against the tumor. Following very encouraging clinical data in several indications, both as monotherapy and in combinations, ONCOS-102 is progressing into a randomized phase 2 trial in melanoma patients resistant to PD-1 checkpoint inhibitor treatment.
Building on successful clinical studies which have provided deep mechanistic insights into the tumor biology and the human immune systems, Targovax is researching circular RNA (circRNA) as novel cancer medicines. In addition, Targovax has a KRAS immunotherapy program, with lead cancer vaccine candidate, TG01, expected to enter the clinic in an enhanced format in the second half of 2022. Together this provides Targovax with a rich pipeline of innovative future immunotherapy product candidates to follow ONCOS-102.
This report discusses Targovax's oncolytic virus and neoantigen vaccine programs for cancer immunotherapy. ONCOS-102, an oncolytic virus, has shown signs of efficacy in early clinical trials and is being studied in combination with chemotherapy for mesothelioma. Targovax is also developing TG, a neoantigen vaccine targeting mutated RAS cancers which accounts for many pancreatic and colorectal cancer cases. Targovax has an ongoing clinical program and aims to become a frontline treatment for mesothelioma with ONCOS-102 based on positive early data.
Targovax is a biotechnology company developing oncolytic viruses and cancer vaccines to activate the immune system and fight cancer. The company has two clinical programs, ONCOS-102, an oncolytic virus, and TG, a neoantigen vaccine targeting mutated RAS cancers. Targovax is conducting clinical trials for both programs and has a strong cash position to complete its planned clinical trials into 2019.
Targovax is a biotechnology company developing oncolytic viruses and cancer vaccines to activate the immune system and fight cancer. The company has two clinical programs, ONCOS-102, an oncolytic virus, and TG, a neoantigen vaccine targeting mutated RAS cancers. Targovax is conducting clinical trials for both programs and has a strong cash position to complete its planned clinical trials into 2019.
Targovax provides a summary of their company presentation on activating the immune system to fight cancer. They have two clinical programs, ONCOS oncolytic virus and TG neoantigen vaccine. ONCOS has ongoing clinical trials in mesothelioma, melanoma, ovarian and colorectal cancers. Early results show immune activation and clinical activity. Their focus is developing ONCOS as the lead product, with mesothelioma as the potential initial indication due to its orphan drug designation. Financially, Targovax has sufficient cash into the second half of 2019 to complete their planned clinical program.
1706 ir deck full w_appendix v1_cmd_v12_netttargovax2017
The document discusses Targovax's TG01 peptide vaccine platform. TG01 primes the immune system to recognize and destroy cancer cells with RAS mutations through a cocktail of 7 peptides covering common RAS mutations. Earlier trials in pancreatic cancer showed encouraging median and 1-year survival rates compared to historical controls when TG01 was administered with GM-CSF adjuvant. Long-term survival data also correlated with immune responses detected following vaccination.
Arming the patient's immune system to fight cancertargovax2017
This document summarizes a presentation by Targovax CEO Øystein Soug at a healthcare conference on December 15, 2016. Targovax is developing immunotherapies to enable the immune system to kill cancer cells, including oncolytic viruses, peptide vaccines, cell therapies, and checkpoint inhibitors. The presentation outlines Targovax's clinical trial pipeline and strategy, including trials of ONCOS-102 in CPI-refractory melanoma and mesothelioma and TG01 in resected pancreatic and colorectal cancers. Near-term value drivers include TG01 two-year survival data in pancreatic cancer in 1H2017 and ONCOS-102 interim data in melanoma in 2H2017.
This document provides an overview of Targovax, a biotechnology company developing immunotherapy treatments for cancer. It summarizes Targovax's two platform technologies: ONCOS-102, an oncolytic virus that selectively infects and lyses cancer cells to trigger an immune response, and TG neoantigen vaccines that target specific cancer mutations to generate T-cells to kill cancer cells. The document outlines Targovax's clinical development plans and timelines across six clinical trials in several cancer indications. It also reviews the company's financial position and shareholder base, noting a strong cash runway into 2019 to complete the planned clinical program.
1706 ir deck full w_appendix v1_cmd_v6_uten appendixtargovax2017
The document summarizes a capital markets update presentation by Targovax. It discusses Targovax's two immunotherapy platforms - ONCOS-102, an oncolytic virus, and TG01, a peptide cancer vaccine. For ONCOS-102, the virus is injected into tumors where it stimulates an immune response by releasing cancer antigens. TG01 mimics antigens to stimulate "killer" T-cells. Early clinical trial results for ONCOS-102 showed increased tumor-infiltrating T-cells and systemic immune responses in cancer patients. Targovax is pursuing multiple clinical trials to combine its immunotherapies with other treatments.
This report discusses Targovax's oncolytic virus and neoantigen vaccine programs for cancer immunotherapy. ONCOS-102, an oncolytic virus, has shown signs of efficacy in early clinical trials and is being studied in combination with chemotherapy for mesothelioma. Targovax is also developing TG, a neoantigen vaccine targeting mutated RAS cancers which accounts for many pancreatic and colorectal cancer cases. Targovax has an ongoing clinical program and aims to become a frontline treatment for mesothelioma with ONCOS-102 based on positive early data.
Targovax is a biotechnology company developing oncolytic viruses and cancer vaccines to activate the immune system and fight cancer. The company has two clinical programs, ONCOS-102, an oncolytic virus, and TG, a neoantigen vaccine targeting mutated RAS cancers. Targovax is conducting clinical trials for both programs and has a strong cash position to complete its planned clinical trials into 2019.
Targovax is a biotechnology company developing oncolytic viruses and cancer vaccines to activate the immune system and fight cancer. The company has two clinical programs, ONCOS-102, an oncolytic virus, and TG, a neoantigen vaccine targeting mutated RAS cancers. Targovax is conducting clinical trials for both programs and has a strong cash position to complete its planned clinical trials into 2019.
Targovax provides a summary of their company presentation on activating the immune system to fight cancer. They have two clinical programs, ONCOS oncolytic virus and TG neoantigen vaccine. ONCOS has ongoing clinical trials in mesothelioma, melanoma, ovarian and colorectal cancers. Early results show immune activation and clinical activity. Their focus is developing ONCOS as the lead product, with mesothelioma as the potential initial indication due to its orphan drug designation. Financially, Targovax has sufficient cash into the second half of 2019 to complete their planned clinical program.
1706 ir deck full w_appendix v1_cmd_v12_netttargovax2017
The document discusses Targovax's TG01 peptide vaccine platform. TG01 primes the immune system to recognize and destroy cancer cells with RAS mutations through a cocktail of 7 peptides covering common RAS mutations. Earlier trials in pancreatic cancer showed encouraging median and 1-year survival rates compared to historical controls when TG01 was administered with GM-CSF adjuvant. Long-term survival data also correlated with immune responses detected following vaccination.
Arming the patient's immune system to fight cancertargovax2017
This document summarizes a presentation by Targovax CEO Øystein Soug at a healthcare conference on December 15, 2016. Targovax is developing immunotherapies to enable the immune system to kill cancer cells, including oncolytic viruses, peptide vaccines, cell therapies, and checkpoint inhibitors. The presentation outlines Targovax's clinical trial pipeline and strategy, including trials of ONCOS-102 in CPI-refractory melanoma and mesothelioma and TG01 in resected pancreatic and colorectal cancers. Near-term value drivers include TG01 two-year survival data in pancreatic cancer in 1H2017 and ONCOS-102 interim data in melanoma in 2H2017.
This document provides an overview of Targovax, a biotechnology company developing immunotherapy treatments for cancer. It summarizes Targovax's two platform technologies: ONCOS-102, an oncolytic virus that selectively infects and lyses cancer cells to trigger an immune response, and TG neoantigen vaccines that target specific cancer mutations to generate T-cells to kill cancer cells. The document outlines Targovax's clinical development plans and timelines across six clinical trials in several cancer indications. It also reviews the company's financial position and shareholder base, noting a strong cash runway into 2019 to complete the planned clinical program.
1706 ir deck full w_appendix v1_cmd_v6_uten appendixtargovax2017
The document summarizes a capital markets update presentation by Targovax. It discusses Targovax's two immunotherapy platforms - ONCOS-102, an oncolytic virus, and TG01, a peptide cancer vaccine. For ONCOS-102, the virus is injected into tumors where it stimulates an immune response by releasing cancer antigens. TG01 mimics antigens to stimulate "killer" T-cells. Early clinical trial results for ONCOS-102 showed increased tumor-infiltrating T-cells and systemic immune responses in cancer patients. Targovax is pursuing multiple clinical trials to combine its immunotherapies with other treatments.
1708 2 q presentation v6 uten back-upstargovax2017
This document provides a 3-sentence summary of a presentation by Targovax, a biotech company developing immunotherapies to treat cancer:
Targovax is developing two immunotherapy platforms, ONCOS-102 oncolytic virus and TG01 RAS peptide vaccine, to boost immune responses against cancer and has clinical trials ongoing or planned in several cancer types including pancreatic, melanoma, mesothelioma and others.
The presentation highlights interim clinical data from TG01 showing improved survival outcomes compared to historical controls in resected pancreatic cancer patients and outlines the company's clinical development plans and timelines over the next two years with multiple data readouts expected.
Targovax has sufficient cash runway into
Targovax is developing two cancer immunotherapy drugs - ONCOS-102, an oncolytic virus, and TG01, a neoantigen vaccine. Data from clinical trials of ONCOS-102 showed it activated patients' immune systems against their tumors. Targovax has an ongoing clinical program testing ONCOS-102 in various cancer types and combinations. TG01 targets RAS mutations in pancreatic cancer and showed encouraging long-term survival rates in previous trials. A recent trial combining TG01 with chemotherapy showed improved median and 2-year survival over historical controls. Targovax is seeking a partner to advance TG01 into a late-stage trial aimed at registration.
1) The document discusses Targovax's clinical programs targeting cancer through immune activation, including their ONCOS oncolytic virus and TG RAS neoantigen vaccine.
2) Early clinical trials of ONCOS-102 demonstrated immune activation and clinical activity in patients with various solid tumors.
3) Targovax is conducting additional trials of ONCOS-102 in combination with checkpoint inhibitors in indications like mesothelioma and peritoneal cancers.
4) The TG vaccine targets mutated RAS neoantigens, which are present in many cancer types, and aims to induce T-cell responses against patient-specific tumors.
Targovax presented its 3Q 2017 results, highlighting ongoing clinical trials with its two platforms: ONCOS-102, an oncolytic virus in Phase I/II trials in combination with other therapies, and TG01, a neoantigen vaccine showing encouraging survival data in a Phase I/II trial in pancreatic cancer. Targovax has a cash runway into 2019 to fund its clinical programs and is listed on the Oslo Stock Exchange with a market capitalization of around NOK 930 million.
The document provides an overview of Targovax's clinical programs for ONCOS-102 and TG01. For ONCOS-102, a Phase I/II trial in ovarian and colorectal cancer in combination with durvalumab was initiated in Q3 2017. Encouraging survival and immune response data was reported from the ongoing Phase I/II trial of TG01 in resected pancreatic cancer. Targovax is developing these programs to boost the effectiveness of immunotherapy and has clinical readouts expected in 2017-2019.
This document provides an overview of Targovax, a biotech company developing immunotherapies for cancer. It summarizes their two platforms: ONCOS-102, an oncolytic virus, and TG, a neoantigen cancer vaccine targeting RAS mutations. For ONCOS-102, phase 1 data showed it can activate the immune system against tumors. Targovax is conducting multiple clinical trials of ONCOS-102 in combination with other therapies. For TG, earlier phase 1 trials showed a 20% 10-year survival rate in pancreatic cancer patients. A recent phase 1/2 trial in pancreatic cancer showed encouraging survival and safety data. Targovax is seeking a partner to advance TG into a
Targovax is developing two immunotherapy platforms - ONCOS-102, an oncolytic virus, and TG01, a peptide vaccine targeting RAS mutations. Early phase clinical trial data shows promise for both platforms. ONCOS-102 increased tumor-infiltrating CD8+ T-cells in 11 of 12 cancer patients and induced systemic anti-tumor immune responses. TG01 shows a median survival of 33.1 months in a phase I/II pancreatic cancer trial compared to historical controls of 27.6 months. Targovax has initiated six new clinical trials to further evaluate these platforms alone and in combination with other therapies.
Targovax presentation december 2017 carnegietargovax2017
Targovax provided an overview of its clinical programs for its two immuno-oncology platforms: ONCOS oncolytic virus and TG mutRAS neoantigen vaccine. For ONCOS, interim data from ongoing phase I/II trials in several solid tumors was highlighted. For TG, encouraging survival data from a phase I/II trial in resected pancreatic cancer was summarized. Upcoming clinical readouts and trial initiations in 2017-2018 were outlined for both platforms.
1) The document discusses Targovax's clinical programs using oncolytic viruses and neoantigen vaccines to activate a patient's immune system to fight cancer.
2) Targovax has two lead programs - ONCOS, an oncolytic virus, and TG, a neoantigen vaccine. ONCOS has several ongoing clinical trials and TG has one ongoing trial in colorectal cancer.
3) Preliminary data from a TG trial in pancreatic cancer showed increased median overall and disease-free survival compared to historical controls, suggesting efficacy.
Targovax has two immuno-oncology programs - ONCOS, an oncolytic virus, and TG, a RAS neoantigen vaccine. TG has shown promising results in pancreatic cancer trials, with 20% 10-year survival in previous trials. An ongoing phase I/II trial is validating these results with adjuvant chemotherapy. ONCOS has demonstrated the ability to increase tumor-infiltrating T-cells in early trials. Targovax has a broad clinical program with several upcoming data readouts in 2017-2018 from trials in melanoma, mesothelioma, ovarian/colorectal, prostate, and pancreatic/colorectal cancers.
Targovax is developing immunotherapies to enable the immune system to kill cancer cells. They have two platforms: oncolytic viruses and peptide vaccines. Their peptide vaccine TG01 showed encouraging 2-year survival data in a Phase I/II trial in pancreatic cancer patients, with a survival rate higher than historical controls. Their oncolytic virus ONCOS-102 is in a Phase I trial in CPI-refractory melanoma patients to see if it can activate the immune system and make those patients responsive to checkpoint inhibitors again. Targovax has multiple clinical readouts expected in 2017 and 2018 that could be value inflection points.
The document provides an overview and highlights from Targovax's first quarter 2018 presentation. Some key points:
- Targovax has two immuno-oncology programs in clinical development, ONCOS-102 and ONCOS TG.
- In the mesothelioma trial, the safety lead-in cohort of 6 patients was completed without safety concerns and showed signs of immune activation and early clinical responses in 3 patients.
- Targovax has a sound financial position with cash to fund its planned clinical program into 2019 and is listed on the Oslo Stock Exchange.
Targovax is developing two complementary and highly targeted approaches to cancer immunotherapy: a peptide-based targeted immunotherapy platform for patients with RAS-mutated cancers and a virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors.
Targovax is developing immunotherapies to help the immune system fight cancer. They have six ongoing clinical trials combining their oncolytic adenovirus or peptide vaccines with checkpoint inhibitors or chemotherapy. They expect readouts from four of these trials in 2017-2018, which will be important value inflection points. Encouraging survival data was seen in a Phase I/II trial of their peptide vaccine TG01 in resected pancreatic cancer patients.
Dr. Hager 2016 Presentation The Challenges of Achieving Early Efficacy in Cli...Dr. Martin Hager, MBA
This document summarizes information about the development of DS-6051, a ROS1/NTRK dual kinase inhibitor being developed by Daiichi-Sankyo for the treatment of cancers. It discusses challenges in early drug development including predicting phase II success. It provides details on DS-6051's mechanism of action, differentiation from other drugs, ongoing clinical trial design incorporating screening approaches, safety and efficacy results from the phase I trial, and plans for phase I expansion. The document covers multiple topics relating to DS-6051's development path and strategies to incorporate early efficacy data.
Targovax presented highlights from Q1 2017, including encouraging survival data from a phase I/II trial of TG01 in pancreatic cancer. 68% of patients were still alive after 2 years, compared to historical rates of 30-53%. Targovax will present further clinical data on TG01 at ASCO in June. The company initiated an exploratory trial of TG01 in colorectal cancer and has six clinical trials ongoing or planned in 2017-2018 across cancer indications. Financially, Targovax has cash of NOK 147M and an operating expenses run rate of NOK 104M annually based on the last four quarters.
This corporate presentation summarizes PharmaMar's pipeline and strategy:
- PharmaMar is a biotech company focused on developing marine-derived oncology drugs. It has a fully integrated platform from discovery to commercialization.
- The pipeline includes Yondelis® for soft tissue sarcoma and ovarian cancer, Aplidin® for multiple myeloma, and PM1183 which is being studied in small cell lung cancer, platinum-resistant ovarian cancer, and BRCA breast cancer.
- PM1183 has shown promising results in early clinical trials, achieving a 67% response rate in small cell lung cancer. Phase III trials are ongoing in platinum-resistant ovarian cancer.
SciTech Development pitch deck including company overview, proprietary technology, lead drug ST-001 nanoFenretinide, patents, addressable market sizes, competiton, key personnel, advisory board, drug product characteristics, fenretinide history, cancer indications and drug mechanism of action (MOA).
Merck presented at the 2016 ASCO conference on their oncology strategy and KEYTRUDA program. Key points include:
1) Merck's strategy is to identify patients most likely to benefit from KEYTRUDA, establish KEYTRUDA as a foundation for cancer treatment in monotherapy and combinations, and improve long-term disease control and survival across cancers.
2) KEYTRUDA has shown clinical activity in over 20 tumor types and has over 30 ongoing registration-enabling studies and 100 combination trials. Data at ASCO 2016 showed further progress in combinations and predictive biomarkers.
3) Merck is pursuing a combination strategy with KEYTRUDA and targeted therapies, immunomodulators
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET). Phase 1 and 2 trials show it has a favorable safety profile compared to immediate release anagrelide with fewer adverse events. A pivotal Phase 3 trial is planned for Q2 to initiate comparing GALE-401 to best available therapies in patients who failed or were intolerant to hydroxyurea.
NeuVax is an investigational immunotherapy targeting HER2-positive breast cancer. It contains an immunodominant HER2 peptide that stimulates CD8+ T-cells to destroy tumor cells. Phase 2 trials are ongoing in various breast cancer populations in combination with Hercept
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
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The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
DECLARATION OF HELSINKI - History and principlesanaghabharat01
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
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Similar to Targovax Next generation immune activators for solid tumors
1708 2 q presentation v6 uten back-upstargovax2017
This document provides a 3-sentence summary of a presentation by Targovax, a biotech company developing immunotherapies to treat cancer:
Targovax is developing two immunotherapy platforms, ONCOS-102 oncolytic virus and TG01 RAS peptide vaccine, to boost immune responses against cancer and has clinical trials ongoing or planned in several cancer types including pancreatic, melanoma, mesothelioma and others.
The presentation highlights interim clinical data from TG01 showing improved survival outcomes compared to historical controls in resected pancreatic cancer patients and outlines the company's clinical development plans and timelines over the next two years with multiple data readouts expected.
Targovax has sufficient cash runway into
Targovax is developing two cancer immunotherapy drugs - ONCOS-102, an oncolytic virus, and TG01, a neoantigen vaccine. Data from clinical trials of ONCOS-102 showed it activated patients' immune systems against their tumors. Targovax has an ongoing clinical program testing ONCOS-102 in various cancer types and combinations. TG01 targets RAS mutations in pancreatic cancer and showed encouraging long-term survival rates in previous trials. A recent trial combining TG01 with chemotherapy showed improved median and 2-year survival over historical controls. Targovax is seeking a partner to advance TG01 into a late-stage trial aimed at registration.
1) The document discusses Targovax's clinical programs targeting cancer through immune activation, including their ONCOS oncolytic virus and TG RAS neoantigen vaccine.
2) Early clinical trials of ONCOS-102 demonstrated immune activation and clinical activity in patients with various solid tumors.
3) Targovax is conducting additional trials of ONCOS-102 in combination with checkpoint inhibitors in indications like mesothelioma and peritoneal cancers.
4) The TG vaccine targets mutated RAS neoantigens, which are present in many cancer types, and aims to induce T-cell responses against patient-specific tumors.
Targovax presented its 3Q 2017 results, highlighting ongoing clinical trials with its two platforms: ONCOS-102, an oncolytic virus in Phase I/II trials in combination with other therapies, and TG01, a neoantigen vaccine showing encouraging survival data in a Phase I/II trial in pancreatic cancer. Targovax has a cash runway into 2019 to fund its clinical programs and is listed on the Oslo Stock Exchange with a market capitalization of around NOK 930 million.
The document provides an overview of Targovax's clinical programs for ONCOS-102 and TG01. For ONCOS-102, a Phase I/II trial in ovarian and colorectal cancer in combination with durvalumab was initiated in Q3 2017. Encouraging survival and immune response data was reported from the ongoing Phase I/II trial of TG01 in resected pancreatic cancer. Targovax is developing these programs to boost the effectiveness of immunotherapy and has clinical readouts expected in 2017-2019.
This document provides an overview of Targovax, a biotech company developing immunotherapies for cancer. It summarizes their two platforms: ONCOS-102, an oncolytic virus, and TG, a neoantigen cancer vaccine targeting RAS mutations. For ONCOS-102, phase 1 data showed it can activate the immune system against tumors. Targovax is conducting multiple clinical trials of ONCOS-102 in combination with other therapies. For TG, earlier phase 1 trials showed a 20% 10-year survival rate in pancreatic cancer patients. A recent phase 1/2 trial in pancreatic cancer showed encouraging survival and safety data. Targovax is seeking a partner to advance TG into a
Targovax is developing two immunotherapy platforms - ONCOS-102, an oncolytic virus, and TG01, a peptide vaccine targeting RAS mutations. Early phase clinical trial data shows promise for both platforms. ONCOS-102 increased tumor-infiltrating CD8+ T-cells in 11 of 12 cancer patients and induced systemic anti-tumor immune responses. TG01 shows a median survival of 33.1 months in a phase I/II pancreatic cancer trial compared to historical controls of 27.6 months. Targovax has initiated six new clinical trials to further evaluate these platforms alone and in combination with other therapies.
Targovax presentation december 2017 carnegietargovax2017
Targovax provided an overview of its clinical programs for its two immuno-oncology platforms: ONCOS oncolytic virus and TG mutRAS neoantigen vaccine. For ONCOS, interim data from ongoing phase I/II trials in several solid tumors was highlighted. For TG, encouraging survival data from a phase I/II trial in resected pancreatic cancer was summarized. Upcoming clinical readouts and trial initiations in 2017-2018 were outlined for both platforms.
1) The document discusses Targovax's clinical programs using oncolytic viruses and neoantigen vaccines to activate a patient's immune system to fight cancer.
2) Targovax has two lead programs - ONCOS, an oncolytic virus, and TG, a neoantigen vaccine. ONCOS has several ongoing clinical trials and TG has one ongoing trial in colorectal cancer.
3) Preliminary data from a TG trial in pancreatic cancer showed increased median overall and disease-free survival compared to historical controls, suggesting efficacy.
Targovax has two immuno-oncology programs - ONCOS, an oncolytic virus, and TG, a RAS neoantigen vaccine. TG has shown promising results in pancreatic cancer trials, with 20% 10-year survival in previous trials. An ongoing phase I/II trial is validating these results with adjuvant chemotherapy. ONCOS has demonstrated the ability to increase tumor-infiltrating T-cells in early trials. Targovax has a broad clinical program with several upcoming data readouts in 2017-2018 from trials in melanoma, mesothelioma, ovarian/colorectal, prostate, and pancreatic/colorectal cancers.
Targovax is developing immunotherapies to enable the immune system to kill cancer cells. They have two platforms: oncolytic viruses and peptide vaccines. Their peptide vaccine TG01 showed encouraging 2-year survival data in a Phase I/II trial in pancreatic cancer patients, with a survival rate higher than historical controls. Their oncolytic virus ONCOS-102 is in a Phase I trial in CPI-refractory melanoma patients to see if it can activate the immune system and make those patients responsive to checkpoint inhibitors again. Targovax has multiple clinical readouts expected in 2017 and 2018 that could be value inflection points.
The document provides an overview and highlights from Targovax's first quarter 2018 presentation. Some key points:
- Targovax has two immuno-oncology programs in clinical development, ONCOS-102 and ONCOS TG.
- In the mesothelioma trial, the safety lead-in cohort of 6 patients was completed without safety concerns and showed signs of immune activation and early clinical responses in 3 patients.
- Targovax has a sound financial position with cash to fund its planned clinical program into 2019 and is listed on the Oslo Stock Exchange.
Targovax is developing two complementary and highly targeted approaches to cancer immunotherapy: a peptide-based targeted immunotherapy platform for patients with RAS-mutated cancers and a virus-based oncolytic immunotherapy platform based on engineered oncolytic viruses armed with potent immune-stimulating transgenes for patients with solid tumors.
Targovax is developing immunotherapies to help the immune system fight cancer. They have six ongoing clinical trials combining their oncolytic adenovirus or peptide vaccines with checkpoint inhibitors or chemotherapy. They expect readouts from four of these trials in 2017-2018, which will be important value inflection points. Encouraging survival data was seen in a Phase I/II trial of their peptide vaccine TG01 in resected pancreatic cancer patients.
Dr. Hager 2016 Presentation The Challenges of Achieving Early Efficacy in Cli...Dr. Martin Hager, MBA
This document summarizes information about the development of DS-6051, a ROS1/NTRK dual kinase inhibitor being developed by Daiichi-Sankyo for the treatment of cancers. It discusses challenges in early drug development including predicting phase II success. It provides details on DS-6051's mechanism of action, differentiation from other drugs, ongoing clinical trial design incorporating screening approaches, safety and efficacy results from the phase I trial, and plans for phase I expansion. The document covers multiple topics relating to DS-6051's development path and strategies to incorporate early efficacy data.
Targovax presented highlights from Q1 2017, including encouraging survival data from a phase I/II trial of TG01 in pancreatic cancer. 68% of patients were still alive after 2 years, compared to historical rates of 30-53%. Targovax will present further clinical data on TG01 at ASCO in June. The company initiated an exploratory trial of TG01 in colorectal cancer and has six clinical trials ongoing or planned in 2017-2018 across cancer indications. Financially, Targovax has cash of NOK 147M and an operating expenses run rate of NOK 104M annually based on the last four quarters.
This corporate presentation summarizes PharmaMar's pipeline and strategy:
- PharmaMar is a biotech company focused on developing marine-derived oncology drugs. It has a fully integrated platform from discovery to commercialization.
- The pipeline includes Yondelis® for soft tissue sarcoma and ovarian cancer, Aplidin® for multiple myeloma, and PM1183 which is being studied in small cell lung cancer, platinum-resistant ovarian cancer, and BRCA breast cancer.
- PM1183 has shown promising results in early clinical trials, achieving a 67% response rate in small cell lung cancer. Phase III trials are ongoing in platinum-resistant ovarian cancer.
SciTech Development pitch deck including company overview, proprietary technology, lead drug ST-001 nanoFenretinide, patents, addressable market sizes, competiton, key personnel, advisory board, drug product characteristics, fenretinide history, cancer indications and drug mechanism of action (MOA).
Merck presented at the 2016 ASCO conference on their oncology strategy and KEYTRUDA program. Key points include:
1) Merck's strategy is to identify patients most likely to benefit from KEYTRUDA, establish KEYTRUDA as a foundation for cancer treatment in monotherapy and combinations, and improve long-term disease control and survival across cancers.
2) KEYTRUDA has shown clinical activity in over 20 tumor types and has over 30 ongoing registration-enabling studies and 100 combination trials. Data at ASCO 2016 showed further progress in combinations and predictive biomarkers.
3) Merck is pursuing a combination strategy with KEYTRUDA and targeted therapies, immunomodulators
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET). Phase 1 and 2 trials show it has a favorable safety profile compared to immediate release anagrelide with fewer adverse events. A pivotal Phase 3 trial is planned for Q2 to initiate comparing GALE-401 to best available therapies in patients who failed or were intolerant to hydroxyurea.
NeuVax is an investigational immunotherapy targeting HER2-positive breast cancer. It contains an immunodominant HER2 peptide that stimulates CD8+ T-cells to destroy tumor cells. Phase 2 trials are ongoing in various breast cancer populations in combination with Hercept
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The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
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5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
Combination Therapies
Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
2. Important notice and disclaimer
2
This report contains certain forward-looking statements based on uncertainty, since they relate to events and depend on circumstances
that will occur in the future and which, by their nature, will have an impact on the results of operations and the financial condition of
Targovax and the Targovax Group. Such forward-looking statements reflect the current views of Targovax and are based on the
information currently available to the company. Targovax cannot give any assurance as to the correctness of such statements.
There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in
these forward-looking statements. These factors include, among other things, risks or uncertainties associated with the success of
future clinical trials; risks relating to personal injury or death in connection with clinical trials or following commercialization of the
company’s products, and liability in connection therewith; risks relating to the company’s freedom to operate (competitors patents) in
respect of the products it develops; risks of non-approval of patents not yet granted and the company’s ability to adequately protect its
intellectual property and know-how; risks relating to obtaining regulatory approval and other regulatory risks relating to the development
and future commercialization of the company’s products; risks that research and development will not yield new products that achieve
commercial success; risks relating to the company’s ability to successfully commercialize and gain market acceptance for Targovax’s
products; risks relating to the future development of the pricing environment and/or regulations for pharmaceutical products; risks
relating to the company’s ability to secure additional financing in the future, which may not be available on favorable terms or at all; risks
relating to currency fluctuations; risks associated with technological development, growth management, general economic and business
conditions; risks relating to the company’s ability to retain key personnel; and risks relating to the impact of competition.
4. 4
Cornerstone of current
cancer treatment
Deep and durable responses
$30b annual sales globally
8 products approved to date,
many more in development
First generation immunotherapy: Checkpoint inhibitors
5. 5
0-40%
1
>50%
of treated patients
respond
PD-1 checkpoint inhibitor
monotherapy not sufficient
of responding patients
relapse
THE CHALLENGE:
Make checkpoint
inhibitors work for
more patients
6. 6
ONCOS-102 is an oncolytic immunotherapy based
on a genetically modified adenovirus
Reverses immuno-suppressive
defence mechanisms in the tumor
Primes anti-cancer T-cell
responses
Delivers immune stimulatory
payloads
7. 7
Targovax development pipeline
Mesothelioma
Combination w/Standard-of-Care (SoC)
Product candidate
Preclinical Clinical
Milestones
ONCOS-102
circular RNA
1H 2023
Publication in oncology journal
2H 2022
Initiation of trial (Norway)
2H 2022
Initiation of trial (USA)
Pancreatic cancer
TG01 / QS-21 +/- anti-PD-1
Mutant KRAS
2H 2022
Technical proof-of-
concept data
Multiple Myeloma
TG01 / QS-21
Discovery IND-
enabling
Phase 1 Phase 2 Phase 3 /
pivotal
1H 2023
Initiation of phase 2 trial (USA)
PD-1 Resistant Melanoma
Re-challenge combination w/anti PD-1
Trials run and financed by collaboration partners
8. 8
TG program update 15 December 2022:
New collaborative trial in pancreatic cancer announced
Mesothelioma
Combination w/Standard-of-Care (SoC)
Product candidate
Preclinical Clinical
Milestones
ONCOS-102
circular RNA
1H 2023
Publication in oncology journal
2H 2022
Initiation of trial (Norway)
Pancreatic cancer
TG01 / QS-21 +/- anti-PD-1
Mutant KRAS
2H 2022
Technical proof-of-
concept data
Multiple Myeloma
TG01 / QS-21
Discovery IND-
enabling
Phase 1 Phase 2 Phase 3 /
pivotal
1H 2023
Initiation of phase 2 trial (USA)
PD-1 Resistant Melanoma
Re-challenge combination w/anti PD-1
Trials run and financed by collaboration partners
2H 2022
Initiation of trial (USA)
9. 9
ONCOS-102 program: PD-1 resistant melanoma
Mesothelioma
Combination w/Standard-of-Care (SoC)
Product candidate
Preclinical Clinical
Milestones
ONCOS-102
circular RNA
1H 2023
Publication in oncology journal
2H 2022
Initiation of trial (Norway)
2H 2022
Initiation of trial (USA)
Pancreatic cancer
TG01 / QS-21 +/- anti-PD-1
Mutant KRAS
2H 2022
Technical proof-of-
concept data
Multiple Myeloma
TG01 / QS-21
Discovery IND-
enabling
Phase 1 Phase 2 Phase 3 /
pivotal
1H 2023
Initiation of phase 2 trial (USA)
PD-1 Resistant Melanoma
Re-challenge combination w/anti PD-1
Trials run and financed by collaboration partners
10. 10
Targovax assessment
There is a major and growing unmet medical need
in PD-1 resistant melanoma
Total ~50,000 patients per year diagnosed with
unresectable advanced malignant melanoma globally
~50% of cases become PD-1 resistant
Total ~25,000 patients per year
Estimated 10,000 – 20,000 patients per year addressable
with intra-tumoral therapies
Incidence
PD-1 resistance
Addressable
Other PD-1 resistance >100,000 patients per year lung cancer
>50,000 patients per year head and neck
12. 12
1: 8 patients had non-injected target lesions only, incl 2 patients with PR
Multiple examples of systemic (abscopal) effect,
including complete regression in non-injected lesions
o 12 of 36 (33%) non-injected
target lesions reduced in
size
o 8 of 15 (53%) patients had
reduction in non-injected
target lesions
o 6 of 15 patients (40%) with
abscopal objective
response (PR) according to
RECIST 1.1 30% tumor
shrinkage criteria
Response in individual tumors
% change from baseline; injected and non-injected target lesions Observed
systemic
effect:
Complete regression in
25% of injected lesions
Complete regression in two
non-injected lesions
Injected (n=16)1
Non-injected (n=36)
13. 13
ONCOS-102 drives strong and consistent T-cell
infiltration in responding patients
CD8+ T-cell tumor infiltration
Tumor biopsy IHC, patient case example
CD8+ T-cell infiltration increased over time
in patients with clinical benefit (CR+PR+SD)
Progression on
pembrolizumab
3x ONCOS-102 only
monotherapy
6x ONCOS-102
2x pembrolizumab
p = 0.01
Prior therapies: T-vec (oncolytic virus) Disease stage: T4a-M1
Ipilimumab (aCTLA-4) Outcome PR RECIST 1.1
Pembrolizumab (aPD-1) Week 9 - EoS
14. 14
Next step ONCOS-102: multi-cohort Phase 2 trial with
PD-1 and CTLA-4 checkpoint inhibitor combination
ONCOS-102
monotherapy
high dose1
1
ONCOS-102 +
balstilimab
low2 high dose
2
Randomize
Part 1 – higher dose exploration run-in
Confirm safety
Select dose for
expansion
ONCOS-102 +
balstilimab
2
Part 2 – multi-cohort extension
ONCOS-102 +
botensilimab
3
ONCOS-102 +
balstilimab +
botensilimab
4
Expand to n=37
Initially n=18
Expand to n =37
Collaboration partner: Balstilimab: anti-PD-1
Botensilimab: Fc-enhanced anti-CTLA-4
Initially n=18
Expand to n =37
15. 15
Opportunity to achieve best-in-class data in PD-1 resistant
melanoma setting
Differentiated combinations vs. competitors, with strong
scientific and strategic rationale
Design and size to enable licensing decisions for big pharma
partners
Confirm ONCOS-102 high dose and address FDA requirements
for contribution of components
Support future expansion of combinations into earlier lines of
melanoma
The phase 2 trial is designed to enable future out-
licensing and address regulatory requirements
16. 16
Pipeline development : Targovax is a pioneer in the
emerging field of circular RNA (circRNA)
Dr Thomas Hansen
The circRNA
discoverers work
for Targovax
Dr Erik D Wiklund
17. 17
circRNA provides a toolbox to create a novel class
of medicines
Circular RNA is resistant to exonuclease
degradation, leading to vastly increased half-life
TLR
Onco-microRNA sponging
Extra-cellular trafficking
Immune response booster
Maximize payload expression
PRR
18. circAde – Targovax´s in-house vector system for
circRNA delivery to solid tumors
18
circAde vectors
Circular
RNA
Gene therapy /
protein translation
Encode tumor
antigens
Immunological
activation
Onco-microRNA
sponge
Highly versatile – Multi-modal MoA – Excellent stability
2022 objectives for the Targovax
circAde program:
o Establish technical proof-of-
concept (PoC) for circAde
approach
o Optimize vector expression
constructs and circRNA
structural design
o Explore and validate advantages
of circRNA vs. mRNA delivery
19. 19
Initial focus on oncology applications, with plans to expand
platform into vaccines and rare disease
Oncology
Solid tumors
Vaccines
Infectious diseases
Enzyme
replacement
Rare diseases
circAde
vector I
Combine key benefits of proprietary vector with
circRNA-based vaccine approach
Improved shelf-life and stability over mRNA
Delivery
Delivery of immuno-stimulatory payloads against
validated targets that face systemic toxicity issues
High-potency neoantigen immunization
Long-lasting supply of payloads that target key cancer
signalling and metabolic pathways
circAde
vector II
circAde
vector III
Application – leveraging circRNA to enhance existing medical toolbox
1
2
3
Novel delivery tool for enzyme replacement therapy at
reduced cost and complexity over gene therapy
Expand into non-immunogenic circRNA applications
Core initial
focus for
in-house
development
Expansion
and
partnering
opportunities
20. World-leading experts in-house with over 10 years circRNA experience
Led by circRNA pionéer Dr. Thomas Hansen
Unique circAde vector system for circRNA delivery to solid tumors
Technical PoC established, vector turns cancer cells into circRNA factory
GMP manufacturing at scale using commercially available equipment
circRNA GMP manufacturing at scale faces unresolved issues
No known competitors active in circRNA therapeutics for solid tumors
Efficient delivery of synthetic RNA to solid tumors is an unresolved challenge
Targovax has a unique edge in the emerging circRNA field
20
21. Targovax executive summary
21
Building
next generation
immune
activator therapies
for solid tumors
ONCOS-102: oncolytic immunotherapy with demonstrated clinical efficacy and
excellent safety profile in multiple solid tumors and treatment combinations
Highly competitive response rate: 35% ORR in anti-pd-1 resistant
melanoma, responses in non-injected lesions and deep mechanistic analyses
KRAS immunotherapy: Clinical-stage polyvalent mutant KRAS vaccine with
high-profile collaboration network and KRAS IO concepts in discovery phase
Circular RNA: Emerging pipeline in novel RNA biology leveraging 10 years of
academic research, unique delivery approach for solid tumors
Company Financials: OSE listed since 2016, raised >USD 100M in total, cash runway
until mid-2023