On November 21, 2019 Immunitas Therapeutics ("Immunitas"), a single cell genomics-based drug discovery company founded by Longwood Fund, reported a $39 million Series A financing led by Leaps by Bayer and Novartis Venture Fund and joined by additional investors including Evotec, M Ventures, Alexandria Venture Investments, and other institutional investors (Press release, Immunitas Therapeutics, NOV 21, 2019, View Source [SID1234551570]). The company plans to use this funding to advance its first programs, monoclonal antibody therapeutics with single agent activity in preclinical models of oncology, to clinical studies.

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Underlying the company’s programs is the unique drug development platform crafted by the Immunitas team along with Aviv Regev (Professor of Biology and Core Member of the Broad Institute and Investigator at the Howard Hughes Medical Institute) that dissects the microenvironment of human tumors using single cell genomics-based approaches to identify novel immune targets. The Immunitas platform has generated fully humanized antibodies that act on these targets, advancing to human efficacy studies driven by specific clinical biomarkers, and a breadth of promising druggable cancer targets.

The scientific founders of Immunitas are pioneers in studying the immunobiology of human tumors, including the use of single cell genomics-based techniques and antibody-development techniques:

Kai Wucherpfennig M.D. Ph.D., Professor and Chair of the Department of Cancer Immunology and Virology at the Dana-Farber Cancer Institute and Professor of Neurology at Harvard Medical School,
Mario Suvà M.D., Ph.D., an Associate Professor in the Department of Pathology at Massachusetts General Hospital and at the Broad Institute of MIT and Harvard, and
Dane Wittrup, Ph.D., the Carbon P. Dubbs Professor of Chemical Engineering and Biological Engineering at the Massachusetts Institute of Technology.
"Single cell genomic sequencing has tremendous promise to help unravel the interactions between immune cells and cancer cells in tumors to advance cancer drug development but focusing it appropriately to discover meaningful new targets based on human biology has been challenging," said Dr. Wucherpfennig. "The Immunitas platform is designed to reveal novel and important adaptive and innate immune interactions with tumor cells, which may open up new possibilities in cancer therapy. My scientific co-founders and I look forward to continuing to work with the Immunitas team as they advance this powerful science."

"Our scientific founders are pioneers in the field of single cell sequencing and analysis. They have extensive expertise in deep computational biology, which has enabled us to discover novel therapeutic targets directly from human immunology," said Lea Hachigian, Ph.D., co-founder, director and President of Immunitas Therapeutics. "The data from this platform have also provided us with biomarkers for patient selection, which has potential to accelerate our development plans and provides improved chances for efficacy for individual patients."

Immunitas was founded to directly address the challenge of translating findings from laboratory research in model organisms to meaningful clinical advances in humans. Immunitas focuses on human samples, allowing the company to start with and stay closer to the most relevant and translatable biology for patients.

"One of today’s biggest challenges in oncology is how to efficiently and effectively move preclinical research into human therapies while avoiding the false signals often seen in animal models," said Dr. Jürgen Eckhardt, Head of Leaps by Bayer, Bayer AG’s strategic venture capital unit. "The scientific founders of Immunitas have elegantly solved this problem by dissecting the biology of immune cells in human tumors directly. We are excited to support this approach which has the potential to significantly improve cancer drug development."

Longwood-founded Immunitas also announced key senior management appointments as well as the Board of Directors of the company. Dr. Lea Hachigian is co-founder, director and President of Immunitas as well as a Principal at Longwood Fund. She is also a co-founder and director of TScan Therapeutics. Tarek Samad, Ph.D. is the Chief Scientific Officer at Immunitas Therapeutics. He has over two decades of experience in academia and industry leading small molecule and antibody biologic programs into the clinic. Amanda Wagner joins the company as Vice President of Strategy and Operations with over ten years of biotech experience in similar roles. The Board of Directors includes Dr. Laura Brass, Dr. Jürgen Eckhardt, Dr. Lea Hachigian, Dr. Lucio Iannone, Dr. Christoph Westphal, and Dr. Vincent Xiang.

On November 21, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported its CEO Pnina Fishman Ph.D. will share insight into the Company’s recent developments during an investor webinar on Monday, November 25, 2019 at 11:00 a.m. ET (Press release, Can-Fite BioPharma, NOV 21, 2019, View Source [SID1234551589]). A live Q&A session with Dr. Fishman will follow her presentation.

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To join the Can-Fite webinar, please register via the following link: View Source

The webinar will be accessible through the News/Events section of Can-Fite’s website at www.canfite.com, where it will also be archived for a period of time.

Questions can be pre-submitted to [email protected] or during the event.

On November 21, 2019 FORMA Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported positive Phase 1b/2 results from an ongoing study in patients with IDH1-mutated gliomas (Press release, Forma Therapeutics, NOV 21, 2019, View Source [SID1234551571]). The data, presented at the 2019 Society for NeuroOncology Annual Meeting (SNO), demonstrate blood-brain barrier penetrance, as exhibited by cerebrospinal fluid exposure, and disease response to olutasidenib, a next-generation IDH1m inhibitor.

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"The safety profile and clinical activity observed to date with olutasidenib in patients with recurrent and often life-threatening gliomas are exciting," said Patrick Kelly, M.D., chief medical officer at FORMA Therapeutics. "In patients with a predominantly enhancing relapsed/refractory glioma, we achieved a clinical response with half of the patients still on study treatment at four months. Particularly for patients with late-stage gliomas where the disease progresses quickly, maintaining disease control holds promise."

FORMA is conducting a Phase 1b/2 study evaluating the safety, efficacy and pharmacokinetics/pharmacodynamics of olutasidenib for patients with advanced solid tumors and gliomas. The trial, 2102-ONC-102, is an open-label, single-agent dose-confirmation study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma and other IDH1 mutant solid tumors). Results announced today are based on continuous oral treatment for 24 patients with advanced IDH1 mutant glioma.

"These data create a compelling profile for olutasidenib as a next generation IDH1m inhibitor," said Frank Lee, chief executive officer of FORMA Therapeutics. "Our goal at FORMA is to offer patients first-in-class and best-in-class medicines, and the early results announced today bring us closer to this goal."

Phase 2 of FORMA’s study is ongoing, evaluating both olutasidenib monotherapy and olutasidenib in combination with azacitidine in patients with confirmed IDH1 gene-mutated advanced glioma. Full study results will be reported in 2020.

Presentation Overviews

Phase 1b/2 study of FT-2102, an inhibitor of mutant IDH1, in patients with relapsed/refractory IDH1 mutant gliomas: preliminary safety and clinical activity

E-talk Presentation by Macarena de la Fuente, M.D., Sylvester Cancer Center, University of Miami

Findings presented regarding olutasidenib monotherapy in the Phase 1 cohort of 24 patients with confirmed IDH1 gene-mutated advanced glioma, the majority of which were enhanced and high-grade glioma. Dr. de la Fuente discusses data that:

Demonstrate blood-brain barrier penetration as measured by cerebrospinal fluid exposure and disease control;
Confirm partial response in one patient and stable disease in 10 patients with enhancing glioma with a median duration of treatment of 3.7 months;
Indicate steady-state olutasidenib plasma concentrations in glioma patients within two weeks of initiation of dosing, which remained consistent over time;
Demonstrate acceptable safety profile in patients with relapsed/refractory IDH1-mutated glioma at 150 mg BID; and
Report no trial discontinuations due to treatment-emergent adverse events (TAEs). Grade 3-4 TAEs in greater than 10 percent of patients included increased ALT, increased AST, decreased platelet count, vomiting and hemiparesis. Transaminase elevations resolved without consequential impact in all patients.
FT-2102 – A Potent and Selective Brain Penetrant Inhibitor of Mutant Isocitrate Dehydrogenase

Oral presentation by Maria Ribadeneira, Ph.D., executive director of DMPK and clinical pharmacology at FORMA Therapeutics

Data demonstrate broad in vitro activity against the major IDH1-R132 mutations observed in glioma. Olutasidenib was observed to be more than 1000-fold selective in R132H, the more common mutation observed in glioma, as compared to IDH1 wild type, and showed potent in vivo suppression of tumor 2-HG in a mouse xenograft (cellular accumulation of 2-HG impairs cell differentiation and promotes tumorigenesis). Data also show olutasidenib to be highly brain penetrant in a rat model.

About Olutasidenib (FT-2102)

FORMA Therapeutics’ most advanced clinical asset, olutasidenib, is designed to be a potent and selective next generation inhibitor of mutated isocitrate dehydrogenase 1 (IDH1m) to treat patients with relapsed/refractory acute myeloid leukemia (R/R AML) or myelodysplastic syndrome (MDS), as well as patients with glioma and other solid tumors with an IDH1 mutation. IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 7-14% of patients with AML and more than 70% of patients with gliomas. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis, with a median survival ranging from five to seven years. Treatment options for relapsed glioma are limited.

On November 21, 2019 Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, reported that the first patient was dosed in a Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in Australia for the treatment of cancer patients with malignant pleural effusions (MPE) (Press release, Clover Biopharmaceuticals, NOV 21, 2019, View Source [SID1234551590]). There are now five clinical studies evaluating SCB-313 open to recruiting patients in China and Australia across three oncology indications (malignant ascites, peritoneal carcinomatosis, and malignant pleural effusions).

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"MPE has historically posed significant challenges for both patients and clinicians, and it remains a high unmet medical need for many cancer patients worldwide," said Dr. Y. C. Gary Lee, Director of Pleural Medicine at Sir Charles Gairdner Hospital, Perth, Australia.

The Phase I, open-label, dose escalation trial in Australia is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of intrapleural administered SCB-313 for the treatment of MPE. Several sites in Australia, including Dr. Lee’s unit, are participating in this study.

"We are excited to work with these world-class investigators and sites participating in this study," said Dr. Min Dong, Executive Vice President, Global Clinical Development at Clover. "Now that Clover has successfully initiated clinical studies evaluating SCB-313 in multiple countries, we hope to bring this novel and potentially first-in-class therapy to patients worldwide."

"TRAIL has long been considered a tantalizing target for cancer therapy because it can induce apoptosis in a tumor-specific manner across many different tumor types. SCB-313, which utilizes our proprietary Trimer-Tag© technology, is able to potently and uniquely target this trimerization-dependent pathway," said Dr. Peng Liang, co-founder, Chairman and President of Clover. "We believe that SCB-313 has the potential to be a best-in-class TRAIL-based therapy based on our R&D results to date, and in the months ahead, we look forward to initiating multiple new clinical studies for the treatment of intracavitary cancers."

On November 21, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will present at the NeoAg Summit US 2019 in Boston on November 21st at 9:15 AM EST (Press release, Personalis, NOV 21, 2019, View Source [SID1234551591]).

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The presentation, entitled "ImmunoID NeXT: A Comprehensive Platform for Improving Neoantigen Prediction, Tumor Escape Mechanism Reporting, TME Assessment, and Tumor Heterogeneity Profiling for Immuno-Oncology," will provide an overview of Personalis’ newly-launched cancer immunogenomics platform, specifically highlighting innovative machine learning-based methods for the comprehensive identification of neoantigens and the detection of emerging and novel biomarkers of response and resistance to immunotherapy.

ImmunoID NeXT is the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

The presentation will be delivered by Sean M. Boyle, PhD, Sr. Director, Bioinformatics Applications for Personalis.

Personalis will also be exhibiting during the conference (Exhibit #9). Representatives will be available to answer questions about the company’s cancer immunogenomics capabilities.