On November 30, 2020 Transition Bio, Inc. ("Transition Bio" or the "Company") reported forming, funding, and launching with the focused objective to build the best and first-in-class technological capabilities required to evaluate and advance the novel area of cell biology known as condensates (Press release, Transition Bio, NOV 30, 2020, View Source [SID1234648797]).

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The initial closing of the Company’s Series Seed financing occurred at the end of September and was led by Lifeforce Capital.

Transition Bio brings together the unique fundamental knowledge and experience of Professor David Weitz of Harvard University’s John A. Paulson School of Engineering and Applied Sciences and Department of Physics, and Professor Tuomas Knowles of the University of Cambridge’s Departments of Chemistry and Physics.

"After nearly 15 years of supporting each other’s work from an academic point of view, it is extremely exciting to combine the distinctive capabilities of our respective labs," commented Professor Weitz. "It is our strong belief that this area of liquid-liquid phase separation offers an amazing opportunity in human health care advancement."

Professor Knowles added, "David and I have long discussed how we could merge our knowledge and technologies to create something substantial that could genuinely change the world." Knowles continued, "The combination of unique physical science methods with microfluidics and "big data" allows for disruptive advances in the world of drug discovery and diagnostics."

Professors Weitz and Knowles branded the analysis of condensates cell biology based on the Company’s proprietary technology as Condensomics. Transition Bio aims to make the Company the world leader in the field. When fully built, Transition Bio’s condensomics approach will replace the industry’s current reliance on inadequate conventional technologies to study biomolecular condensates.

Leading the Company’s research efforts is Assaf Rotem, Ph.D., who joined as Head of Research and Development based in Cambridge, MA. Assaf was most recently Director and Group Leader of Platform Technology at Repertoire Immune Medicine and was a Postdoctoral Research Fellow in Biomicrofluidics at Harvard University under the direction of Professor Weitz. Assaf will lead a team of scientists based in Cambridge, MA, the Company’s headquarters, and Cambridge, UK, together with William Arter, Ph.D., and Georg Krainer, Ph.D., members of the Knowles Lab who are responsible for the Company’s UK-based scientific operations.

Transition Bio further announced that its Board of Directors will include Professor Weitz, Professor Knowles, Dr. Samuel Cohen (UK), David Zimble, Esq. (Israel), and Executive Chairman, Kelly Martin (U.S.). Owen Hughes (U.S.) will serve as an advisor to the Company.

On November 30, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that management will host a virtual event entitled "The Power of hnCD16" on Friday, December 4, 2020 at 4:30 PM EDT (Press release, Fate Therapeutics, NOV 30, 2020, View Source [SID1234571948]).

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The event will highlight the unique therapeutic features and functionality of the Company’s proprietary high-affinity, non-cleavable CD16 (hnCD16) Fc receptor, a core component incorporated in its iPSC-derived NK cell product candidates. The Company’s hnCD16 Fc receptor is designed to maximize antibody-dependent cellular cytotoxicity, a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells.

The live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event. The event is not an official program of the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Company’s platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

On November 30, 2020 NuCana plc (NASDAQ: NCNA) reported that the final results of the Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer (ABC-08) have been published online ahead of print in The Oncologist (Press release, Nucana BioPharmaceuticals, NOV 30, 2020, View Source [SID1234571982]). Encouraging interim data had previously been reported and the final data confirm the high objective response rate and favorable safety profile of Acelarin plus cisplatin in this patient population.

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In the efficacy-evaluable patient population, the Objective Response Rate was 44%. By comparison, in the ABC-02 study, which led to gemcitabine plus cisplatin becoming the current standard of care for the first-line treatment of patients with advanced biliary tract cancer, an Objective Response Rate of 26% was achieved in the efficacy-evaluable population.

Dr. Mairéad McNamara, Co-Chief Investigator of the ABC-08 study and Senior Lecturer and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust remarked: "Acelarin combined with cisplatin demonstrated a favorable safety profile and achieved good tumor control. Responses were seen across all five biliary tract cancer sub-types, including a Complete Response in one patient, a very rare occurrence in this patient population. In ABC-02, only one out of 161 efficacy-evaluable patients who received gemcitabine plus cisplatin achieved a Complete Response. Additionally, one patient with Stable Disease, whose tumor had initially been considered unsuitable for surgical resection, was able to have complete surgical removal of the tumor following treatment with Acelarin plus cisplatin. Four patients were still alive at the end of follow-up, having survived between 16 and 36 months."

"We are very encouraged by the final efficacy and safety data from ABC-08", said Hugh S. Griffith, NuCana’s founder and CEO. "We are committed to developing Acelarin plus cisplatin as the first approved front-line treatment for patients with advanced biliary tract cancer. We continue to drive recruitment in the ongoing Phase III NuTide:121 Study where we believe we have the potential opportunity to apply for accelerated approval based on Objective Response Rate. We remain on track to enroll the required number of patients in NuTide:121 by the end of 2021 in order to conduct the first interim analysis in 2022."

Professor Juan Valle, Co-Chief Investigator of the ABC-02, ABC-08 and NuTide:121 studies and Professor and Honorary Consultant in Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust said: "Biliary tract cancer is a devastating disease for which more effective treatments are desperately needed. While targeted therapies and immunotherapies may play a role in the treatment of biliary tract cancer in the future, chemotherapy will remain the backbone of treatment. Medicines like Acelarin, with the potential for improved efficacy and safety, would be welcome additions to the treatment options for patients with biliary tract cancer."

About NuTide:121

NuTide:121 is a global, multi-center, randomized Phase III study that is enrolling up to 828 patients in approximately 130 sites across North America, Europe, Asia and Australia. Patients are being randomized 1:1 and treated with either a combination of Acelarin (725 mg/m2) plus cisplatin (25 mg/m2) or the current standard of care regimen, gemcitabine (1,000 mg/m2) plus cisplatin (25 mg/m2). The primary objectives of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR). Three interim analyses, including two designed to support accelerated approval, are planned as part of the Phase III study protocol, in addition to the final analysis. Based on discussions with the FDA and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, supported by positive trends in other endpoints, could potentially allow for an accelerated approval of a new drug application (NDA) for Acelarin. Accelerated approval requires a confirmatory clinical study to verify the drug’s clinical benefit. If accelerated approval were to occur, NuTide:121 would continue and the Company anticipates that data from subsequent analyses could provide the confirmatory data to support full (regular) approval.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, is cancer originating in the bile duct, a vessel that transports bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the treatment of biliary tract cancer; however, the worldwide standard of care in the first-line setting for patients with advanced biliary tract cancer is the combination of gemcitabine and cisplatin.

On November 30, 2020 Medtronic plc (NYSE:MDT), the global leader in medical technology, reported it will participate virtually in the Piper Sandler 32nd Annual Healthcare Conference on Wednesday, December 2, 2020 (Press release, Medtronic, NOV 30, 2020, View Source;president-of-cardiovascular-portfolio-mike-coyle-to-speak-at-piper-sandler-healthcare-conference-301181942.html [SID1234572000]).

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Mike Coyle, executive vice president and president of the Cardiovascular Portfolio for Medtronic, will answer questions about the company beginning at 10:30 a.m. EST (9:30 a.m. CST).

A live audio webcast of the session will be available on December 2, 2020, by clicking on the Investors Events link at View Source An archived audio file will be available for replay on the same webpage later in the day.

On November 30, 2020 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that the Company will host a conference call and live audio webcast on Saturday, December 5, 2020, at 2:00 p.m. ET (Press release, IGM Biosciences, NOV 30, 2020, https://igmbio.com/2020/11/30/igm-biosciences-to-host-conference-call-and-webcast-to-review-igm-2323-data-presented-at-the-62nd-annual-ash-meeting/ [SID1234571949]). The event will take place following a poster presentation featuring the first clinical data from the Company’s Phase 1 trial evaluating IGM-2323 at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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The conference call may be accessed by dialing (866) 649-1996 (domestic) or (409) 217-8769 (international) and referring to conference ID 1141638. A live webcast of the presentation will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.