A-Alpha Bio Collaborates with Amgen to Identify and Validate Ligase-Target Pairs for Molecular Glue Discovery

On September 26, 2023 A-Alpha Bio (A-Alpha), a synthetic biology and machine learning company that measures and engineers protein-protein interactions, reported the expansion of their collaboration with Amgen’s Induced Proximity Platform to characterize interactions between ligases and molecular glue targets for protein degradation (Press release, A-Alpha Bio, SEP 26, 2023, View Source [SID1234636945]).

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As part of a research collaboration initiated in 2022 with Amgen, a leading biotechnology company, A-Alpha discovered several weakly interacting ligase-target pairs between a list of Amgen’s targets and A-Alpha’s proprietary library of E3 ubiquitin ligases. Following review of the results from the initial collaboration and additional work carried out by Amgen, A-Alpha and Amgen have agreed to an expanded collaboration. Under the expanded collaboration agreement, A-Alpha will further interrogate selected pairs to evaluate glueability and provide structural insights expected to enable rational design of molecular glue degraders. A-Alpha Bio will receive an upfront payment and will be eligible for milestones and a royalty on product sales resulting from licensed ligase-target pairs.

"Our work with Amgen over the past six months has been exciting and fruitful. We have enjoyed collaborating with an incredible industry-leading team on this major area of interest," said David Younger, CEO and Co-Founder of A-Alpha Bio. "We look forward to expanding our collaboration and moving into the validation of glueability and the generation of data to inform rational molecular glue discovery. Combining our technology and expertise with Amgen’s has the potential to generate high-impact therapeutics and advance our mission to improve human health."

Entry into a Material Definitive Agreement

On September 26, 2023, Roivant Sciences Ltd. (the "Company") reported to have entered into common share purchase and sale agreements (collectively, the "Purchase and Sale Agreements") with certain institutional investors, pursuant to which the Company agreed to issue and sell an aggregate of 19,600,685 of the Company’s common shares, par value $0.0000000341740141 per share (the "Common Shares"), at purchase price of $10.21 for each Common Share for aggregate gross proceeds of approximately $200.1 million (the "Registered Direct Offering") (Filing, 8-K, Roivant Sciences, SEP 26, 2023, View Source [SID1234635548]).

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The Registered Direct Offering was made pursuant to a prospectus supplement to the Company’s effective shelf registration statement on Form S-3 (Registration No. 333-267503) (the "Shelf Registration Statement"). The Company expects to use the net proceeds from the Registered Direct Offering to make an investment into its subsidiary, Immunovant, Inc., and for working capital and other general corporate purposes.

The legal opinion of Conyers Dill & Pearman Limited relating to the legality of the issuance and sale of the Common Shares in the Registered Direct Offering is attached as Exhibit 5.1 to this Current Report on Form 8-K.

The foregoing summary of the Purchase and Sale Agreements is qualified in its entirety by reference to the Form of Common Share Purchase and Sale Agreement, which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Rocket Pharmaceuticals to Participate in the Chardan 7th Annual Genetic Medicines Conference

On September 26, 2023 Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, reported that Gaurav Shah, M.D., Chief Executive Officer, is scheduled to participate in a fireside chat at the Chardan 7th Annual Genetic Medicines Conference in New York City on Tuesday, October 3, at 1:00 p.m. ET (Press release, Rocket Pharmaceuticals, SEP 26, 2023, View Source [SID1234635436]).

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A webcast of the fireside chat will be available under "Events" in the Investors section of the Company’s website at View Source

OS Therapies Announces Full Enrollment in PhIIb Clinical Trial AOST-2121 in Recurred, Resected Osteosarcoma with OST-HER2 (Listeria monocytogenes) for Delay or Prevention of Recurrence

On September 26, 2023 OS Therapies, a research and clinical stage biopharmaceutical company, reported Full Enrollment for its lead OST-HER2 (OST31-164) program in its ongoing clinical trial AOST-2121 (NCT04974008) (Press release, OS Therapies, SEP 26, 2023, View Source [SID1234635435]). The trial is being conducted at 21 Children’s Oncology Group (COG) sites across the country for patients with Osteosarcoma that had metastasized to the lungs requiring surgical removal. Historically, 80-90% of these patients would develop additional metastasis within the period of the trial. The planned number of patients have now received treatment and the few remaining slots will be allocated to patients that have already been identified. Patients continue OST-HER2 treatment for 48 weeks and then are followed for survival 2 additional years. The primary endpoints of the trial are Event Free Survival and Overall Survival.

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"Several patients have completed the treatment phase of the trial and many more are undergoing treatment with OST-HER2. We hope that this treatment will reduce additional recurrences and extend the lives of all osteosarcoma patients and look forward to the outcome once all patients have completed treatment," said Dr. Robert Petit, CMO/CSO of OS Therapies. Osteosarcoma is a rare but challenging disease for patients and their physicians, occurring primarily in teens and young adults. "Reaching thirty-nine patients enrolled is a major milestone in this trial, occurring more quickly than projected. A sincere thank you to the patients, families and healthcare providers – the Children’s Oncology Group, and the outstanding leadership of Principle Investigators Damon Reed, MD, and Kelly Bailey, MD," said Paul Romness, CEO of OS Therapies.

About Osteosarcoma

Osteosarcoma is a solid tumor of the bone that predominantly occurs in adolescents and young adults (AYA). Standard treatment includes surgery and chemotherapy. For patients with metastatic osteosarcoma or have recurrence after chemotherapy, the prognosis is poor.

Elpiscience Announces First Patient Dosed for Phase 1 Clinical Trial of Anti-LILRB2 Antibody ES009 in Australia

On September 26, 2023 Elpiscience Biopharmaceuticals ("Elpiscience"), a clinical-stage biopharmaceutical company dedicated to discovering and developing next-generation cancer immunotherapies, reported that the first patient has been dosed in a Phase 1 clinical trial of its anti-LILRB2 monoclonal antibody ES009 in Australia (Press release, Elpiscience, SEP 26, 2023, View Source [SID1234635434]). The objective of the trial is to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.

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LILRB2, also known as ILT4, is an inhibitory receptor widely expressed on the surface of myeloid cells that also contributes significantly to immune suppression in the tumor microenvironment (TME). ES009 specifically binds to a unique epitope on human LILRB2 and potently blocks LILRB2 binding to multiple ligands. By blocking LILRB2-mediated inhibitory signaling, ES009 can reprogram myeloid cells from anti-inflammatory phenotype into pro-inflammatory phenotype, and reinvigorate T cell functionalities. ES009 has demonstrated exceptional potential to reverse immune suppression in the TME and promote anti-tumor immunity in preclinical studies.

"LILRB2 is a key immune checkpoint for tumor immunotherapy whose suppression of immune response is proved as one mechanism of anti-PD(L)1 resistance. With a keen interest in revolutionizing therapies for cancer patients non-responsive or resistant to PD(L)1 treatment, we developed ES009 which has shown best-in-class potential. We believe in the power of enhanced innate immunity in treating cancer and have developed a highly differentiated myeloid cell focused therapeutics portfolio. We will work relentlessly to bring these highly promising therapies to cancer patients with unmet medical needs," said Dr. Hongtao Lu, Co-founder and CSO of Elpiscience.