Posterior Segment Company Showcase - Aura Biosciences at OIS@AAO 2016.
Presenter:
Elisabet de los Pinos, CEO
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Posterior Segment Company Showcase - Ohr pharmaceuticalHealthegy
Posterior Segment Company Showcase - Ohr pharmaceutical at OIS@AAO 2016.
Presenter:
Jason Slakter, CEO
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Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
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Posterior Segment Company Showcase - Clearside BiomedicalHealthegy
Posterior Segment Company Showcase - Clearside Biomedical at OIS@AAO 2016.
Presenter:
Daniel White, President & CEO
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Anterior Segment Company Showcase - Sensimed AGHealthegy
Anterior Segment Company Showcase - Sensimed AG at OIS@AAO 2016.
Presenter:
David Bailey, CEO
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Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
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Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuti...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals at OIS@AAO 2016.
Presenter:
David Southwell, President & CEO
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Anterior Segment Company Showcase - AvedroHealthegy
Anterior Segment Company Showcase - Avedro at OIS@AAO 2016.
Presenter:
Rajesh K. Rajpal, MD, Chief Medical Officer
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Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
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Posterior Segment Company Showcase - Ohr pharmaceuticalHealthegy
Posterior Segment Company Showcase - Ohr pharmaceutical at OIS@AAO 2016.
Presenter:
Jason Slakter, CEO
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Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
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Posterior Segment Company Showcase - Clearside BiomedicalHealthegy
Posterior Segment Company Showcase - Clearside Biomedical at OIS@AAO 2016.
Presenter:
Daniel White, President & CEO
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Anterior Segment Company Showcase - Sensimed AGHealthegy
Anterior Segment Company Showcase - Sensimed AG at OIS@AAO 2016.
Presenter:
David Bailey, CEO
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Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
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Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuti...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Inotek Pharmaceuticals at OIS@AAO 2016.
Presenter:
David Southwell, President & CEO
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Anterior Segment Company Showcase - AvedroHealthegy
Anterior Segment Company Showcase - Avedro at OIS@AAO 2016.
Presenter:
Rajesh K. Rajpal, MD, Chief Medical Officer
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Ophthalmic Innovation 2016 - "A View From The AAO"Healthegy
Ophthalmic Innovation 2016 - "A View From The AAO"
Presenter:
David Parke, II, MD, CEO
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Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
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Posterior Segment Company Showcase - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
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Posterior Segment Company Showcase - Alimera SciencesHealthegy
Posterior Segment Company Showcase - Alimera Sciences at OIS@AAO 2016.
Presenter:
Dan Myers, CEO
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Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
Ophthalmic Innovation 2016 - "A View From The NEI"Healthegy
The National Eye Institute (NEI) funds vision research through its $707 million annual budget. Its Audacious Goal Initiative aims to regenerate neurons in the eye and visual system by focusing on photoreceptor loss, ganglion cell injury, and optic nerve regeneration. The NEI supports translational research through grants such as the NEI Translational Research Program and Small Business Grants. It also conducts intramural research including stem cell therapy and gene therapy clinical trials. The NEI commits $50 million annually to support large clinical trials through organizations like the Diabetic Retinopathy Clinical Research Network. It also trains students and clinicians in vision research through fellowship programs.
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
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Public Device & Biopharma Ophthalmology Company Showcase - OmerosHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Omeros at OIS@AAO 2016.
Presenter:
Leonard M. Blum, Chief Business & Commercial Officer
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Public Device & Biopharma Ophthalmology Company Showcase - pSividaHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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Posterior Segment Company Showcase - Graybug VisionHealthegy
Posterior Segment Company Showcase - Graybug Vision at OIS@AAO 2016.
Presenter:
Jeffrey Cleland, PhD, President & CEO
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Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
Ocular Therapeutix is developing sustained-release drug therapies for ophthalmic conditions to improve patient outcomes and compliance. Their lead product, DEXTENZA, is an intracanalicular insert delivering dexamethasone for up to 30 days after cataract surgery to reduce pain and inflammation. Phase 3 trials showed DEXTENZA was well-tolerated and effective in meeting primary efficacy endpoints. If approved, DEXTENZA could become the new standard of care by replacing complex topical drop regimens. The company is also developing sustained-release therapies for glaucoma and posterior segment diseases in collaboration with Regeneron.
Aerie Pharmaceuticals is developing Rhopressa and Roclatan as once-daily eye drops to lower intraocular pressure for glaucoma. Rhopressa demonstrated efficacy in Phase 3 trials and Aerie expects to file an NDA in Q3 2016. Roclatan achieved all endpoints in a Phase 2b trial and is now in Phase 3 trials. Preclinical research also shows Rhopressa may modify diseased tissue and increase blood flow in the eye. Aerie is exploring AR-13154 for wet AMD which showed lesion size reduction exceeding the leading product in studies. The company collaborates with other organizations on delivery technologies and product candidates for the front and back of the eye.
Vision Medicines is developing two drug candidates, VM100 and VM200, to treat retinal diseases with high unmet medical need and large market opportunities. VM100 is in Phase 2/3 development for geographic atrophy and intermediate AMD, with a combined $20B market. VM200 is in preclinical development for Stargardt disease, an orphan indication with no approved therapies and a $6B market opportunity. Both drugs address the underlying disease mechanisms and have demonstrated preclinical efficacy in preserving retinal structure and function. Vision Medicines aims to develop these assets and consolidate the fragmented ophthalmology space, which has fewer products per company than other therapeutic areas.
The document discusses an investigational ocular insert called the Helios Insert developed by ForSight VISION5 to treat glaucoma. Clinical trials showed the insert provided clinically significant IOP reduction for 6 months in a safe and comfortable manner. Patients and doctors preferred the insert to eye drops based on market research. ForSight VISION5 believes the insert could address the large problem of non-adherence to eye drops and fulfill an unmet need in the multibillion-dollar glaucoma market. The company is pursuing FDA approval and regulatory clearance for the insert.
Spark Therapeutics is developing gene therapies for genetic disorders including SPK-RPE65 for retinal diseases. SPK-RPE65 achieved highly statistically significant results in a pivotal Phase 3 trial, demonstrating long-lasting benefits on vision tests over 3 years. If approved, it could be the first gene therapy approved in the US for a genetic disease. Spark is applying its validated AAV gene therapy platform to expand its pipeline to additional retinal diseases and indications.
The document summarizes the development of an anti-VEGF eye drop called PAN-90806 being developed by PanOptica for the treatment of wet age-related macular degeneration and other retinal diseases. It describes positive preliminary results from a Phase 1/2 clinical trial in wet AMD patients showing biological activity with no systemic side effects. It also outlines plans to further study PAN-90806 using an advanced formulation in additional clinical trials for wet AMD and proliferative diabetic retinopathy. Developing an effective anti-VEGF eye drop could provide significant benefits over frequent eye injections.
This presentation discusses forward-looking statements and risks associated with them. It notes that while management believes expectations in forward-looking statements are reasonable, actual results could differ materially due to known and unknown risks and uncertainties. The presentation also notes that views expressed as of the date may change in the future.
This corporate presentation outlines Aura Biosciences' novel targeted therapy approach using viral-like particles to treat cancer. Their lead product, AU-011, is being developed for the treatment of ocular melanoma, an orphan disease with no approved therapies. Preclinical data shows AU-011 effectively targets and kills tumor cells through a unique mechanism of action. Aura plans to initiate clinical trials in Q1-2/2016 to obtain proof of concept data and accelerate approval. If approved, AU-011 could be the first FDA-approved treatment for the primary tumor in ocular melanoma patients.
Professor of Neurosurgery at Stanford University;
Inventor of MDNA55
Sam Denmeade, MD
Johns Hopkins University:
Chief Scientific Officer; Expert in Prostate Cancer Therapeutics
David M. Nanus, MD
Memorial Sloan Kettering Cancer Center:
Expert in Immunotherapy for Solid Tumors
David Spetzler, MD, PhD
CSO, Xencor:
Expert in Protein Engineering and Antibody Therapeutics
John Sampson, MD, PhD
Duke University:
Principal Investigator and Expert in Drug Delivery to the Brain
17
Posterior Segment Company Showcase - Notal visionHealthegy
Posterior Segment Company Showcase - Notal vision at OIS@AAO 2016.
Presenter:
Quinton Oswald, CEO
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Posterior Segment Company Showcase - AGTCHealthegy
Posterior Segment Company Showcase - AGTC at OIS@AAO 2016.
Presenter:
Sue Washer, President & CEO
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Posterior Segment Company Showcase - Alimera SciencesHealthegy
Posterior Segment Company Showcase - Alimera Sciences at OIS@AAO 2016.
Presenter:
Dan Myers, CEO
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Presentation from OIS@ASCRS 2016
James Brandt, MD, Principal Investigator
Video Presentation:
https://www.youtube.com/watch?v=jvIozhPMSQ8&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=30
Ophthalmic Innovation 2016 - "A View From The NEI"Healthegy
The National Eye Institute (NEI) funds vision research through its $707 million annual budget. Its Audacious Goal Initiative aims to regenerate neurons in the eye and visual system by focusing on photoreceptor loss, ganglion cell injury, and optic nerve regeneration. The NEI supports translational research through grants such as the NEI Translational Research Program and Small Business Grants. It also conducts intramural research including stem cell therapy and gene therapy clinical trials. The NEI commits $50 million annually to support large clinical trials through organizations like the Diabetic Retinopathy Clinical Research Network. It also trains students and clinicians in vision research through fellowship programs.
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
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Public Device & Biopharma Ophthalmology Company Showcase - OmerosHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Omeros at OIS@AAO 2016.
Presenter:
Leonard M. Blum, Chief Business & Commercial Officer
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Public Device & Biopharma Ophthalmology Company Showcase - pSividaHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - pSivida at OIS@AAO 2016.
Presenter:
Nancy Lurker, President & CEO
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Posterior Segment Company Showcase - Graybug VisionHealthegy
Posterior Segment Company Showcase - Graybug Vision at OIS@AAO 2016.
Presenter:
Jeffrey Cleland, PhD, President & CEO
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Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
Ocular Therapeutix is developing sustained-release drug therapies for ophthalmic conditions to improve patient outcomes and compliance. Their lead product, DEXTENZA, is an intracanalicular insert delivering dexamethasone for up to 30 days after cataract surgery to reduce pain and inflammation. Phase 3 trials showed DEXTENZA was well-tolerated and effective in meeting primary efficacy endpoints. If approved, DEXTENZA could become the new standard of care by replacing complex topical drop regimens. The company is also developing sustained-release therapies for glaucoma and posterior segment diseases in collaboration with Regeneron.
Aerie Pharmaceuticals is developing Rhopressa and Roclatan as once-daily eye drops to lower intraocular pressure for glaucoma. Rhopressa demonstrated efficacy in Phase 3 trials and Aerie expects to file an NDA in Q3 2016. Roclatan achieved all endpoints in a Phase 2b trial and is now in Phase 3 trials. Preclinical research also shows Rhopressa may modify diseased tissue and increase blood flow in the eye. Aerie is exploring AR-13154 for wet AMD which showed lesion size reduction exceeding the leading product in studies. The company collaborates with other organizations on delivery technologies and product candidates for the front and back of the eye.
Vision Medicines is developing two drug candidates, VM100 and VM200, to treat retinal diseases with high unmet medical need and large market opportunities. VM100 is in Phase 2/3 development for geographic atrophy and intermediate AMD, with a combined $20B market. VM200 is in preclinical development for Stargardt disease, an orphan indication with no approved therapies and a $6B market opportunity. Both drugs address the underlying disease mechanisms and have demonstrated preclinical efficacy in preserving retinal structure and function. Vision Medicines aims to develop these assets and consolidate the fragmented ophthalmology space, which has fewer products per company than other therapeutic areas.
The document discusses an investigational ocular insert called the Helios Insert developed by ForSight VISION5 to treat glaucoma. Clinical trials showed the insert provided clinically significant IOP reduction for 6 months in a safe and comfortable manner. Patients and doctors preferred the insert to eye drops based on market research. ForSight VISION5 believes the insert could address the large problem of non-adherence to eye drops and fulfill an unmet need in the multibillion-dollar glaucoma market. The company is pursuing FDA approval and regulatory clearance for the insert.
Spark Therapeutics is developing gene therapies for genetic disorders including SPK-RPE65 for retinal diseases. SPK-RPE65 achieved highly statistically significant results in a pivotal Phase 3 trial, demonstrating long-lasting benefits on vision tests over 3 years. If approved, it could be the first gene therapy approved in the US for a genetic disease. Spark is applying its validated AAV gene therapy platform to expand its pipeline to additional retinal diseases and indications.
The document summarizes the development of an anti-VEGF eye drop called PAN-90806 being developed by PanOptica for the treatment of wet age-related macular degeneration and other retinal diseases. It describes positive preliminary results from a Phase 1/2 clinical trial in wet AMD patients showing biological activity with no systemic side effects. It also outlines plans to further study PAN-90806 using an advanced formulation in additional clinical trials for wet AMD and proliferative diabetic retinopathy. Developing an effective anti-VEGF eye drop could provide significant benefits over frequent eye injections.
This presentation discusses forward-looking statements and risks associated with them. It notes that while management believes expectations in forward-looking statements are reasonable, actual results could differ materially due to known and unknown risks and uncertainties. The presentation also notes that views expressed as of the date may change in the future.
This corporate presentation outlines Aura Biosciences' novel targeted therapy approach using viral-like particles to treat cancer. Their lead product, AU-011, is being developed for the treatment of ocular melanoma, an orphan disease with no approved therapies. Preclinical data shows AU-011 effectively targets and kills tumor cells through a unique mechanism of action. Aura plans to initiate clinical trials in Q1-2/2016 to obtain proof of concept data and accelerate approval. If approved, AU-011 could be the first FDA-approved treatment for the primary tumor in ocular melanoma patients.
Professor of Neurosurgery at Stanford University;
Inventor of MDNA55
Sam Denmeade, MD
Johns Hopkins University:
Chief Scientific Officer; Expert in Prostate Cancer Therapeutics
David M. Nanus, MD
Memorial Sloan Kettering Cancer Center:
Expert in Immunotherapy for Solid Tumors
David Spetzler, MD, PhD
CSO, Xencor:
Expert in Protein Engineering and Antibody Therapeutics
John Sampson, MD, PhD
Duke University:
Principal Investigator and Expert in Drug Delivery to the Brain
17
Immuron provided a company update for the first half of 2016. Key developments included reaching 50% recruitment milestones in its Phase 2 NASH trial, initiating a pediatric NASH study, and reporting highly successful pre-clinical data for IMM-529 in treating C. difficile that demonstrated efficacy without antibiotics. The company also started pre-clinical programs in colitis and collaborated with the US Army on a Shigella vaccine. In its OTC business, Immuron expanded its US customer and retail footprint and launched products in China through an e-commerce partnership. Upcoming milestones include reporting interim NASH results in 4Q2016 and initiating the Phase 1 C. difficile trial.
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.
Medicenna is a clinical-stage biotech company developing MDNA55, a targeted immunotherapy for the treatment of glioblastoma and other IL4R-expressing cancers. MDNA55 has shown promising efficacy and safety results in Phase 2 clinical trials for recurrent glioblastoma. Medicenna is currently enrolling patients in a Phase 2b clinical trial evaluating MDNA55 for recurrent glioblastoma and plans to initiate additional clinical trials in brain and other cancers in 2018. The company has a deep pipeline of IL-2 and IL-4 superkines and is well funded through non-dilutive grants and an equity financing to advance its programs over the next two years.
1) Imugene is developing B-cell peptide cancer immunotherapy vaccines targeting the HER-2 receptor, which is the target of Roche's $6.4 billion breast cancer drug Herceptin.
2) Imugene has completed a Phase 1 clinical trial of its lead HER-Vaxx vaccine in HER-2 positive breast cancer patients, and plans to begin a Phase 1b/2 gastric cancer trial in early 2016.
3) HER-Vaxx induces polyclonal antibody responses against HER-2, unlike monoclonal antibodies, and has the potential to provide long-lasting immunity through immune memory activation.
Oncolytics Biotech presented their investor presentation which included the following key points:
1) Oncolytics is developing REOLYSIN, a novel immuno-oncology viral agent for systemic administration that exploits cancer cell lysis and anti-tumor immunity.
2) Additional randomized phase 2 clinical trials in 2017 are expected to generate overall survival data in breast cancer, ovarian cancer, non-small cell lung cancer, and colorectal cancer.
3) The clinical development plan focuses on combining REOLYSIN with chemotherapy for late-stage development and establishing it as a backbone agent combined with immunotherapy.
4) Over 900 patients have been treated with REOLYSIN intravenously with no drug
This investor presentation summarizes Oncolytics Biotech's REOLYSIN viral therapy program. It highlights statistically significant increases in overall survival seen in phase 2 trials in metastatic breast cancer and pancreatic cancer. The clinical development plan focuses on three pathways: chemotherapy combinations as the first registration pathway, immunotherapy combinations with agents like pembrolizumab, and targeted therapy combinations using agents like pomalidomide. Safety data from over 1,100 patients shows a good toxicity profile. Manufacturing is established at commercial scale and the company has a strong patent portfolio. The leadership team has extensive experience in oncology drug development.
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.
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).
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
This corporate presentation by Medicenna outlines their lead candidate MDNA55 for the treatment of glioblastoma and other IL4R-expressing cancers. MDNA55 is a targeted immunotherapy currently in Phase 2 clinical trials for recurrent glioblastoma. The presentation highlights compelling efficacy data from previous studies of MDNA55 and outlines plans to improve outcomes through second generation convection enhanced delivery. It also discusses Medicenna's pipeline of IL-2 and IL-4 superkines and preclinical programs, as well as upcoming clinical milestones and financial position.
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.
The DESTINY-Breast04 trial is a Phase III randomized trial evaluating Enhertu compared to chemotherapy for previously treated HER2-low metastatic breast cancer. The trial randomized over 550 patients 2:1 to receive either Enhertu or one of several standard chemotherapy options. The primary endpoint is progression-free survival in the hormone receptor positive subgroup. Key secondary endpoints include overall survival in both the hormone receptor positive and total patient populations. Baseline characteristics were well balanced between the two arms. Results from this trial could establish Enhertu as a new treatment option for HER2-low breast cancer.
The document summarizes recent news and events in oncology, including:
1) Daiichi Sankyo's acquisition of Plexxikon for its promising drug PLX4032 that targets the BRAF mutation in melanoma.
2) Positive results from Roche's phase 2 trial of its hedgehog pathway inhibitor vismodegib for advanced basal cell carcinoma.
3) How next-generation sequencing is enabling more personalized cancer treatment by matching drugs to patients based on their tumor's molecular profile.
This presentation summarizes Advanced Cell Technology's (ACT) business and therapeutic programs. ACT is developing stem cell therapies for retinal diseases, heart disease, and blood disorders. Their retinal pigment epithelium program is in Phase I/II clinical trials for Stargardt's disease. Their myoblast program for heart disease has completed Phase I and is initiating a Phase II trial. ACT also has preclinical programs in blastomere stem cells and hemangioblasts (blood cell precursors). They have a portfolio of intellectual property and collaborations with major research institutions.
Glaukos investor presentation for q2 2017 for website and 8_kglaukos
This document discusses Glaukos Corporation and its glaucoma treatment technologies. It contains the following key points:
- Glaukos is transforming glaucoma therapy with micro-scale injectable treatments that restore eye's natural drainage and reduce intraocular pressure, the only proven treatment for glaucoma.
- Their flagship product, iStent, is a single-use micro-bypass stent that has demonstrated long-term IOP reduction and medication reduction when used with cataract surgery based on multiple clinical studies.
- New products in development include iStent Inject for combination cataract/glaucoma procedures, iStent Supra to access a secondary drainage pathway, and iDose for targeted
Similar to Posterior Segment Company Showcase - Aura Biosciences (20)
This document provides an overview of a company called Aerie Pharmaceuticals and their glaucoma products. It summarizes clinical trial results for Rhopressa and Roclatan, which are novel glaucoma drugs. Rhopressa achieved non-inferiority compared to timolol in lowering eye pressure over 6 months in multiple trials. A pilot study found Rhopressa to be effective at lowering pressure during both day and night. Roclatan was statistically superior to its individual components latanoprost and Rhopressa in lowering pressure at all timepoints in a phase 3 trial. Both drugs were generally well tolerated with conjunctival hyperemia as the most common side effect.
This document provides an overview of a company called Aerie Pharmaceuticals and their glaucoma products. It summarizes results from clinical trials of their two leading investigational drug candidates, Rhopressa and Roclatan. Rhopressa achieved non-inferiority compared to timolol in lowering eye pressure over 6 months in phase 3 trials. A pilot study also found Rhopressa to be effective at lowering pressure during nighttime hours. Roclatan was found to be statistically superior to its individual components, latanoprost and Rhopressa, in lowering pressure at all timepoints in a phase 3 trial. Both drugs demonstrated favorable safety profiles in clinical testing.
This document discusses small aperture optics for improving vision, including the KAMRA corneal inlay and IC-8 intraocular lens. It summarizes clinical studies that show the KAMRA inlay and IC-8 IOL provide an extended depth of focus, improving intermediate and near vision while maintaining good distance vision. The document also notes that these technologies are capturing more market share and have the potential to address a significant segment of patients with aberrated corneas.
This document provides an overview of Avedro, the world leader in corneal remodeling. Key points include:
- Avedro has developed the first and only FDA-approved corneal cross-linking platform for treating keratoconus and corneal ectasia. They have installed 1500 systems and performed 250,000 treatments.
- Their 2017 plans are to expand into keratoconus and refractive markets, drive toward reimbursement, and conduct 14 clinical studies on epi-on procedures and refractive applications.
- They have a proven cross-linking mechanism of action that strengthens the cornea to stabilize keratoconus and ectasia. Their PiXL technique allows for non-invasive zonal strengthening to induce corneal
The document discusses Cassini, a corneal imaging system that provides comprehensive analysis of the anterior and posterior cornea to reduce refractive surprises. It has 6 key features: 1) total corneal analysis, 2) ocular surface diagnostics, 3) iris registration, 4) integrated surgical workflow, 5) data mining, and 6) proactive solutions. Cassini provides valuable pre-op information and seamlessly integrates with other technologies. It uses multi-colored LEDs and 2nd Purkinje imaging to map total corneal astigmatism. Cassini has been used in over 300,000 cataract patients to date. It can drive premium procedures and adoption of premium IOLs while also streamlining surgical workflows.
The HARMONI Modular IOL System provides a stable foundation through a reliable base and optimized rotational stability. Its modular design allows for versatile control through safe and easy optic exchangeability and upgradeability to provide refractive care for a patient's lifetime. Clinical trials show the HARMONI IOL has best-in-class stability and visual performance that rivals traditional IOLs, while offering the ability to fine tune outcomes through optic exchange. The system aims to provide complete confidence in surgical outcomes without added costs or changes to routines.
EyeGate Pharmaceuticals is developing two drug delivery platforms - a crosslinked hyaluronic acid eye drop called Ocular Bandage Gel to promote wound healing after corneal surgery or injuries, and an iontophoresis delivery system to administer the corticosteroid dexamethasone phosphate (EGP-437) after cataract surgery or for anterior uveitis. Positive pilot clinical trial data was announced for Ocular Bandage Gel in accelerating wound healing after photorefractive keratectomy. Later stage clinical trials are underway or planned for EGP-437 to reduce inflammation for cataract surgery and uveitis, with FDA filings targeted for 2018. EyeGate licensed worldwide commercial rights for EGP-
Ophthalmology Innovation Showcase 1 - InnFocus (A Santen Company)Healthegy
The InnFocus MicroShunt is designed to be the first FDA-approved standalone procedure to treat mild, moderate, and severe open-angle glaucoma by lowering intraocular pressure under 15 mmHg without eye drops in most patients. It uses a unique SIBS material that has been proven biocompatible and shown not to degrade or provoke scarring over 15 years of use in over 1 million patients. Clinical trials have demonstrated the MicroShunt's ability to successfully lower IOP long-term while maintaining an acceptable safety profile. The MicroShunt offers surgeons a potential replacement for trabeculectomy and tubes with advantages in both safety and operating time.
The document discusses the Hydrus Microstent, a minimally invasive glaucoma surgery (MIGS) device that provides a tri-modal mechanism of action to lower intraocular pressure. Over 3,200 patients have been treated globally using the Hydrus Microstent. Clinical studies and a large global registry have shown the Hydrus Microstent to provide superior outcomes compared to other MIGS devices, with a 20% reduction in diurnal intraocular pressure and increased treatment response rates. The Hydrus Microstent expands treatment opportunities for both standalone glaucoma procedures and combined cataract/glaucoma surgeries.
The LacriPen is a handheld portable device that can measure osmolality and biomarkers from tears in 1 second using surface plasmon resonance. It has achieved a goal of ±2 mOsms/L for osmolality measurements and can detect MMP-9 concentrations from 1-200 ng/ml with precision of ±5 ng/ml. Clinical testing of the LacriPen's ability to measure osmolality and detect smart diagnostics has been approved and initial testing has been completed. The portable design allows for point-of-care diagnostics without the need for anesthesia or eyelid scraping.
Ophthalmology Innovation Showcase 1 - Mati TherapeuticsHealthegy
This document discusses a punctal plug drug delivery system called Evolute. It can deliver drugs to treat various ocular diseases like glaucoma, allergies, inflammation, and dry eye. Clinical trials showed excellent plug retention rates over 12 weeks. The system offers benefits like a flexible drug delivery profile, non-invasive application, steady drug elution unlike eye drops, and comfort. It is developing formulations of nepafenac, difluprednate, travoprost, olopatadine, and cyclosporine to treat conditions like post-cataract pain/inflammation and glaucoma. The company has a strong intellectual property position and plans upcoming clinical trials.
ZeptoTM is a device that uses the Purkinje image to anchor cataract surgery on the visual axis. It completed a US clinical trial in 80 days and was submitted to the FDA for 510(k) clearance in March 2017. The device has launched in India, Germany, and is planned for the US summer 2017. Development is also underway for an automated ZeptoTM for posterior capsulotomy. ZeptoTM aims to increase practice efficiency, allow for difficult cases to be performed easily and safely, and has the potential to redefine cataract surgery.
The document expresses gratitude but does not provide any further details. It is a very short document consisting of only two words with no other context provided.
The document discusses an artificial intraocular lens (AIOL) called the FluidVision that mimics the eye's natural accommodative process. It is the first true shape changing, fluid-driven IOL. Early results from a 23 patient pilot study show promising results with a straightforward surgical technique. Bench testing shows the FluidVision provides excellent image quality over a range of powers as it continuously varies between far and near focal points by inflating and deflating the lens using fluid movements. PowerVision is developing additional innovations like a toric version and post-implant adjustment capabilities.
The document discusses Presbia Flexivue Microlens, an investigational intracorneal inlay to treat presbyopia. It notes that there are 1.8 billion presbyopes worldwide and ophthalmologists are motivated to treat this large market. The technology involves implanting a small hydrophilic acrylic lens in the cornea using existing femtosecond lasers. The author's clinical experience found the procedure had a short learning curve, excellent uncorrected near vision, and distance vision was unaffected. The inlay shows potential for treating presbyopia, improving vision after cataracts or LASIK.
Presbyopia Therapies is developing LiquidVision Eye Drops to treat presbyopia, a large global market affecting most people over age 50. The drops aim to improve near vision without distance vision blur for 5+ hours after a single daily dose. Currently, the main treatment options are reading glasses or contact lenses. A phase 2a trial in 2016 showed the drops improved uncorrected near vision versus placebo. A phase 2b trial beginning in Q2 2017 aims to demonstrate a 30 minute onset and 5+ hour duration with a 3-line improvement in near vision. The company hopes to create a new global market category for the daily treatment of presbyopia.
This document summarizes information about the VisAbility Micro-Insert System, an investigational device for treating presbyopia. It provides details on the clinical trial results showing the device improved near vision without compromising distance vision. Over multiple time periods, a high percentage of patients achieved good near vision both with and without glasses. The device also showed stability in refractive error and high patient satisfaction rates. The summary concludes with benefits of the VisAbility procedure compared to other presbyopia surgeries, such as preserving full range of focus and stereopsis while having a superior safety profile.
The document discusses market research data on the presbyopic market in the US and patient outcomes and satisfaction rates for Raindrop vision correction surgery. It finds that there are over 28 million potential patients in the US, with 71% seeking an ophthalmologist for the procedure. Real-world data shows 99% of patients achieving less than 20/20 distance vision and 78% less than J3 near vision, with a low 2.5% explant rate. Surgeon, patient, and reorder satisfaction rates are over 90% based on recent surveys.
SightGlass Vision has developed lenses that can safely and effectively reduce myopia progression in children. Myopia is a growing global problem, with hundreds of millions expected to suffer vision impairment due to complications if left untreated. Current solutions are only marginally effective and carry safety risks. SightGlass lenses work by providing peripheral blur and reducing peripheral hyperopia based on clinical trials, demonstrating over a 90% reduction in axial eye growth. The company is seeking funding to conduct a pivotal study and launch the lenses globally to address this major public health issue.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive functioning. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
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10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
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3. Disclaimers and forward-looking statements
This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this
presentation, including statements regarding our short-term and long-term strategies, efforts to develop and commercialize our
products, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and
expected market growth are forward-looking statements. These statements involve known and unknown risks, uncertainties and other
important factors that may cause our actual results, performance or achievements to be materially different from any future results,
performance or achievements expressed or implied by the forward-looking statements. The words “anticipate,” “believe,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are
intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We
expressly disclaim any obligation to release any updates or revisions to any forward-looking statements to reflect any change in our
expectations or projections or any changes in events, conditions or circumstances on which any such statements are based for any
reason, except as required by law, even as new information becomes available. All forward-looking statements in this presentation are
qualified in their entirety by this cautionary statement.
Certain information contained in this presentation and statements made orally during this presentation relates to or is based on
information from industry publications and research, surveys and studies conducted by third parties. Industry publications and third
party research, survey and studies generally indicate that their information has been obtained from sources believed to be reliable,
although they do not guarantee the accuracy or completeness of such information. While we believe these industry publications and
third party research, surveys and studies are reliable, we have not independently verified such data.
This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of
any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification
under the securities laws of any such state or jurisdiction.
4. Working to transform the treatment of patients with
choroidal melanoma
4
Targeted therapy with unique
mechanism of action
Orphan Drug Designation granted
May 2015
Potential for early clinical readout and
accelerated regulatory path forward
Platform technology for non-ocular
cancers
Management team with expertise
in orphan drug development and
market launch
5. 1 Based on epidemiology estimates by Health Advances (US) and Company (Europe and rest of world)
2 COMS_2005. Collaborative Ocular Melanoma Study Group Report No. 26. Development of metastatic disease after enrollment into the COMS trials for treatment of choroidal
melanoma. Arch Ophthalmol 2005;123(12):1639-43
High unmet medical need with no FDA-approved
therapies
5
Choroidal melanoma is a rare disease.
Diagnosed and treated by
ocular oncologists (retina
specialists)
54
ocular oncologist in the U.S.
52
ocular oncologist in Europe
10,000
patients worldwide1
Early diagnosis of
primary tumor
High unmet medical need for
the treatment of disease with
vision preservation
25%
of patients develop
metastatic disease after
five years2
6. Current radioactive treatment options with high
association of comorbidities
1. Medium melanomas: Plaque
brachytherapy and proton
beam radiotherapy
- Requires multiple surgeries
- Causes severe vision loss (>5 lines)1
- Does not prevent metastases2
- Cost of treatment: $50,0003
2. Large melanomas: Enucleation
6
1 Shields CL et al. Arch Ophthalmol. 2000 Sep;118(9):1219-28
2 COMS Report No. 18. Arch Ophthalmol 119: 969-982, 2001.
3 Harbour et al. Investigative Ophthalmology & Visual Science March 2012, Vol.53, 3400
7. AU-011: A first-in-class targeted therapy
Targeted cytotoxicity upon light activation
7
Small molecule is conjugated to
the primary amines in the surface
of the viral nanoparticle. The drug
is inactive without irradiation.
Viral nanoparticle conjugates
(VNC) are delivered by intra-
vitreal injection and target tumor
cells in the choroid.
VNCs bind specifically to
HSPGs on the tumor cell
surface (multivalent binding).
Ophthalmic laser 689nm activates
the drug. The light-activated drug
disrupts the tumor cell membrane,
leading to necrosis.
8. Efficient outpatient treatment protocol
8
Routine administration by
intra-vitreal injection – same
as Avastin®, Eylea®, Lucentis®
Activated by ophthalmic laser
within six hours in standard
outpatient setting
689nm laser activation –
same wavelength and light
fluence as used for Visudyne®
9. Significant response to AU-011 in tumor model with
high correlation to human disease
9
Rabbit orthotopic tumor model with
human choroidal melanoma cells1
Administration schedule: once a week for
two or three weeks
All animals with small tumors had
complete responses to the therapy2
Small number of incomplete responders
had large tumors that extended beyond
the treatment field of the laser
Data replicated in multiple academic labs3
AU-011 Dose Response
% Complete ResponseDose
0%Control
0%5 ug
20%20 ug
50 ug 80%
1 Grossniklaus et al. Investigative Ophthalmology & Visual Science June 2013, Vol.54, 4229
2 Complete Responses defined by >90% tumor necrosis or absence of tumor cells after treatment
3 Dr. Grossniklaus/Emory University; Dr. Burnier/McGill University; BRM with oversight from Dr. Vavvas/ MEEI
10. Efficacy results validated by histopathology
10
Complete responses after intra-vitreal injections of AU-011 once a week for
two weeks in medium-large tumors
Original location of
treated posterior tumor
Data: Fundoscopy and Histopathology images provided by Ora Clinical-BRM. Tumor implants performed by Dr. Vavvas Harvard Medical School. Data reviewed by Dr. Grossniklaus
(Certified Ocular Pathologist at Emory University)
Histopathology (H&E):
Posterior choroidal
tumor with extra-ocular
extension (untreated
control)
Histopathology (H&E):
No signs of posterior
tumor after administration
of AU-011 once a week
for two weeks and light
activation
A B
11. Near-term clinical milestones
11
AU-011 could be the first FDA-approved therapy for primary choroidal melanoma.
Phase II/III Clinical TrialPhase I Clinical Trial
PIND agreement on
clinical endpoints:
- Safety / vision
- Tumor response
IND
NDA
Robust preclinical data
with complete
responses in multiple
independent animal
model studies
Preclinical IND-Enabling Studies
Safety
Preliminary
efficacy
Registration trial
Phase II/III
2014 2015 2016 2017 2018
Fast Track /
Breakthrough
Designations
Clinical operations
underway:
- Multiple U.S. sites
qualified
- Laser system setup
and training complete
at a number of sites
2019
12. 12
Carol Shields, M.D.
Sara Selig, M.D.
A strong rare disease community of patients,
foundations and ocular oncologists
13. Rare disease with large market potential
13
Choroidal melanoma represents
a unique rare disease
commercial opportunity.
Unmet medical need with no
FDA-approved therapies
Orphan drug market access and
reimbursement value
Focused call points enable efficient
commercialization opportunity
Initiating corporate and financing
discussions to develop drug
through approval
15. Working to transform the lives of patients with
choroidal melanoma
15
First-in-class targeted cancer therapy
Strong preclinical data in animal model
with high correlation to human disease
Granted FDA Orphan Drug
Designation
Phase I 2017
Rare disease with potential
accelerated regulatory path forward