On September 15, 2020 Obsidian Therapeutics, Inc., a biotechnology company pioneering controllable cell and gene therapies, reported that Bristol Myers Squibb (NYSE:BMY) has exercised its option to an exclusive worldwide license to a cell therapy candidate based on Obsidian’s cytoDRiVE technology for the controlled expression of the immunomodulatory factor CD40L (Press release, Obsidian Therapeutics, SEP 15, 2020, View Source [SID1234565149]). This announcement marks the first opt-in decision by Bristol Myers Squibb since the companies announced their collaboration to develop novel cell therapies in January 2019. Under the terms of the agreement, Obsidian is eligible to receive potential future milestone and royalty payments.

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"We are very interested in exploring innovative approaches to developing engineered cell therapies, including the cytoDRiVE platform," said Rupert Vessey, D. Phil., Executive Vice President, Research and Early Development, Bristol Myers Squibb. "By controlling the expression of armed payloads like CD40L, Obsidian’s cell therapy candidates may have the potential to overcome tumor microenvironment resistance and unlock the power of cell therapy in solid tumors and other malignancies."

"This announcement marks an important milestone validating Obsidian’s cytoDRiVE platform, and we look forward to continuing to work with Bristol Myers Squibb to bring powerful new immunotherapies to patients," said Paul K. Wotton, Ph.D., Chief Executive Officer of Obsidian Therapeutics. "We are also pleased with the pace with which our own pipeline programs are progressing as we continue to advance our lead controllable tumor infiltrating lymphocyte (TIL) therapy to the clinic."

On September 15, 2020 Physicians at the University of California, San Diego (UCSD) School of Medicine and Cofactor Genomics, the company bridging the precision medicine gap, reported a partnership aimed at improving a physician’s ability to predict tumor response to immunotherapy, specifically in recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC) (Press release, Cofactor Genomics, SEP 15, 2020, View Source [SID1234565148]). Guiding and prioritizing therapy selection is especially important given last year’s FDA approval of pembrolizumab as a first line treatment for RM-HNSCC. The partnership is championed by Ezra Cohen, MD, Chief of the Division of Hematology‐Oncology at the UCSD Moores Cancer Center, and leverages Cofactor’s recently-patented Predictive Immune Modeling technology.

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The current clinical care pathway for recurrent and metastatic head and neck cancer patients relies on using underpowered, antiquated technologies for treatment decisions. New tools that provide physicians with higher confidence in therapy selection are needed.

"Predicting tumor response prior to treatment is a necessary part of the precision medicine challenge," explained Dr. Cohen. "Working with immune checkpoint inhibitors, a class of therapies that are already approved and proven to work in a subset of patients, is a low-risk, high-reward approach."

The terms of the partnership include providing Cofactor Genomics with access to patient specimens and clinical metadata, a resource well-curated by the team at UCSD. The data generated in this collaboration will further expand clinical evidence presented earlier this year by Washington University physicians, where Cofactor’s technology showed superiority over the incumbent PD-L1 IHC assay in predicting responders to therapy.

"Cofactor is approaching diagnostic development in a number of ways that are unique. Integrating multiple immune signals into a single clinical decision simultaneously simplifies and expands how we leverage this information," noted Dr. Cohen.

Dr. Cohen is a global leader in this space, serving as Co-Director of the San Diego Center for Precision Immunotherapy, and leader of the Solid Tumor Therapeutics research program. He brings his expertise and an exceptional reputation in head and neck cancer research and patient care to solid tumor therapeutics. He has served as chair of the National Cancer Institute (NCI) Head and Neck Cancer Steering Committee (which oversees NCI-funded clinical research in this disease), currently chairs the SITC (Free SITC Whitepaper) Cancer Immunotherapy Guidelines Head and Neck Expert Panel, and previously served on the Board of the Head and Neck Cancer Alliance.

"The UCSD Moores Cancer Center is well-recognized as both a leader in clinical research, and perhaps more importantly, patient care," noted Natalie LaFranzo, PhD, Vice President of Market Development for Cofactor. "As Cofactor’s technology moves into clinical practice, partnerships with leaders in cancer care, such as Dr. Cohen, are an integral part of adoption."

Multidimensional biomarkers have been described by many, including the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Immune Biomarkers Task Force, as the ideal approach to obtaining a complete view of the tumor microenvironment, necessary for predicting immunotherapy response. Cofactor’s RM-HNSCC diagnostic development is the outcome of Predictive Immune Modeling, which leverages immune-specific multidimensional biomarkers. These biomarkers integrate the distinct differences in the tumor profile between the tumors of responders and non-responders to immunotherapy. RM-HNSCC is one of 16 indications approved for treatment with immune checkpoint inhibitors, the sum of which represents 50% of U.S. cancer cases annually. Predictive diagnostics are an integral part of achieving UCSD’s precision medicine goals, as supported by the Center for Personalized Cancer Therapy.

On September 15, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Michael Nally, executive vice president and chief marketing officer, is scheduled to participate in a virtual fireside chat at the Cantor Fitzgerald Virtual Global Healthcare Conference on Sept. 17, 2020, at 10:00 a.m. EDT (Press release, Merck & Co, SEP 15, 2020, View Source [SID1234565147]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

On September 15, 2020 GlaxoSmithKline plc reported that it will present new data at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, underscoring its commitment to advancing its growing oncology portfolio, which includes the recent European Commission (EC) and US Food and Drug Administration (FDA) approvals of BLENREP (belantamab mafodotin) for patients with relapsed/refractory multiple myeloma, and the FDA approval of a new indication in first-line ovarian cancer for ZEJULA (niraparib) (Press release, GlaxoSmithKline, SEP 15, 2020, View Source [SID1234565139]).

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Reflecting the increasing depth and breadth of GSK’s innovative research in oncology, investigators will present 13 abstracts covering a range of approved and investigational therapies, focused on science related to the immune system, the use of human genetics and other research platforms.

GSK presentations at ESMO (Free ESMO Whitepaper) will focus on research intended to improve outcomes for women with high unmet medical needs, including data related to the safety and efficacy of ZEJULA in patients with advanced, recurrent or resistant ovarian cancer. Investigators also will present a late-breaking presentation: "Safety and Antitumor Activity of Dostarlimab in Patients (Pts) with Advanced or Recurrent DNA Mismatch Repair Deficient (dMMR) or Proficient (MMRp) Endometrial Cancer (EC): Results from GARNET."

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "This year we have achieved strong momentum for our oncology pipeline, with 14 assets in clinical development across four key research areas. Recent approvals for BLENREP in multiple myeloma and a new indication for ZEJULA in first-line ovarian cancer have delivered new treatment options for patients with unmet needs, and we look forward to sharing new data from our oncology pipeline at ESMO (Free ESMO Whitepaper)."

A list of additional presentations focused on GSK therapies at ESMO (Free ESMO Whitepaper) can be found below:

Synthetic Lethality

Abstract Name

Presenter

Presentation Details

Patient-Reported Outcomes (PRO) in Patients (Pts) Receiving Niraparib in the PRIMA/ENGOT-OV26/GOG-3012 Trial

Pothuri, B.

810MO

Efficacy and Safety of Niraparib in Older Patients (Pts) with Advanced Ovarian Cancer (OC): Results from the PRIMA/ENGOT-OV26/GOG-3012 Trial

Valabrega, G.

819P

MOONSTONE/GOG-3032: A Phase II, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Niraparib + Dostarlimab in Patients with Platinum-Resistant Ovarian Cancer

Randall, L.M.

883TiP

JASPER: Efficacy and Safety of First-Line (1L) Niraparib Plus a Programmed Death Receptor 1 Inhibitor (PD-1i) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Ramalingam, S.S.

1268P

Immuno-oncology

Abstract Name

Presenter

Presentation Details

Safety and Efficacy of Dostarlimab in Patients (Pts) with Recurrent/Advanced Non-Small Cell Lung Cancer (NSCLC)

Subramanian, J.

1399P

Patient-Reported Outcomes (PROs) in the GARNET Trial in Patients (Pts) with Advanced or Recurrent Mismatch Repair Deficient/Microsatelite Instability-High (dMMR/MSI-H) Endometrial Cancer (EC) Treated with Dostarlimab

Kristeleit, R.

858P

The Relationship Between Overall Survival (OS), Progression-Free Survival (PFS), and Objective Response Rate (ORR) in Immune Checkpoint Inhibitor Clinical Trials of Head and Neck Squamous Cell Carcinoma (HNSCC): A Systematic Review and Meta-analysis

Wang, X.

951P

Matching-Adjusted Indirect Comparisons (MAIC) of Safety Between Single-Agent Belantamab Mafodotin Versus Selinexor Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM)

· Suvannasankha, A.

901P

A Phase II/III, Randomized, Placebo-Controlled Study of Bintrafusp Alfa with Gemcitabine Plus Cisplatin as First-Line Treatment of Biliary Tract Cancer

Oh, D-Y.

79TiP

Long-Term Follow-Up of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Patients with Pretreated Biliary Tract Cancer

Yoo, C.

73P

Three-Year Follow-up of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, for Second-Line (2L) Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Paz-Ares, L.

1272P

Phase 2 Study of Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Platinum-Experienced Advanced Cervical Cancer

Birrer, M.

879TiP

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody-drug conjugates and cell therapy, either alone or in combination.

On September 15, 2020 Carina Biotech and Sydney-based immuno-oncology company Glytherix reported a co-development agreement that could result in a promising new CAR-T therapy that is effective in killing a range of cancers (Press release, Carina Biotech, SEP 15, 2020, View Source [SID1234565138]).

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Glytherix is developing its proprietary antibody Miltuximab for the targeted treatment of a number of cancers. Miltuximab is specific for GPC-1, a protein found in solid tumours such as prostate, bladder, pancreatic, glioblastoma, oesophageal and ovarian cancers, and is not present in healthy tissue.

The agreement with Glytherix will see Carina use its CAR-T development platform to create and optimise a library of CAR-T cells targeted at GPC-1, creating jointly owned IP.

This is the second recent commercial deal for Carina, after it sold the IP rights to its first successful CAR-T cell to UK-based biopharmaceutical company Biosceptre in July 2020.

Deborah Rathjen, PhD, CEO of Carina Biotech says: "We are delighted to have partnered with Glytherix, a company that shares our vision of defeating cancer. Carina Biotech has substantial experience in creating potent, targeted CAR-T cell-based therapies. Combining our knowledge and expertise, we believe will lead to the identification of a GPC-1-targeted CAR-T cell that is effective in killing a range of cancers."

Brad Walsh, PhD, CEO of GlyTherix Ltd, commented: "We are excited to commence our CAR-T development program with Carina Biotech, whose expertise, track record and experienced management made it an easy choice. We are looking forward to working together on this unique target with a view to making a difference in the lives of cancer patients, particularly those with currently limited treatment options."

ABOUT GLYTHERIX Glytherix, is an Australian immuno-oncology company specialising in therapeutics for solid tumours expressing Glypican-1 (GPC-1), the basis for its proprietary antibody Miltuximab. Glytherix are investigating multiple mechanisms of action including radioimmunotherapy, bi-specific antibodies and immune cell engagement and activation. They have completed a ‘first-in-human’ clinical trial of 12 patients with advanced prostate, bladder and pancreatic cancer using Miltuximab, with no drug-related adverse events observed. Glytherix are based in Sydney, adjacent to Macquarie University and the Macquarie University Hospital, one of their key collaborators.