On April 22, 2020 Samsung Biologics (207940.KS) and ImmuneOncia Therapeutics Inc. reported the successful FDA IND approval of IMC-002 under a development and manufacturing agreement with Samsung Biologics since 2018 (Press release, Samsung BioLogics, APR 22, 2020, View Source [SID1234556602]). As a result, ImmuneOncia will begin Phase 1 clinical trials of the pipeline product.

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IMC-002 is an immune checkpoint inhibitor antibody, which blocks CD47-SIRP- α interaction between tumor cells and macrophages. According to ImmuneOncia, IMC-002 is expected to help patients with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.

Leveraging Samsung Biologics’ global CDO capabilities, IMC-002 IND was approved by the FDA without significant comments. Samsung Biologics provided ImmuneOncia with services in cell line development, process development, non-clinical and clinical material production.

Samsung Biologics is currently providing support to 51 CDO development projects and is distinctly able to help clients achieve the most optimal path to IND approval by providing Faster & Better services. Samsung’s presence as a CDO in the global biopharma market has demonstrated rapid growth, and the company has announced plans to expand geographically to support even more clients globally and domestically.

"We are very impressed with the outstanding service Samsung Biologics provided in the full development scope – from cell line development, process development, preclinical and clinical manufacturing, and IND filing support," said Yun Jeong Song, CEO of ImmuneOncia. "The two companies collaborated exceptionally well together during the whole development process including the IND evaluation period, allowing us to enter phase I clinical trials for IMC-002 much quicker."

"We are excited to join in ImmuneOncia’s success," said Dr. Tae Han Kim, CEO of Samsung Biologics. "This IND approval is the product of the strong collaboration between Samsung Biologics and ImmuneOncia. As a world-leading CMO, CDO and CRO partner, we will continue to support ImmuneOncia and ensure client satisfaction through Samsung’s competitive advantages: faster timeline, excellent quality, and outstanding capability."

About IMC-002

IMC-002 is a fully human IgG4 monoclonal antibody designed to block the CD47–SIRPα interaction in order to promote the phagocytosis of cancer cells by macrophages. It binds to human CD47 with an optimal affinity that maximizes efficacy without binding to RBCs or causing anemia which is often seen in other CD47 blocking agents under development. For more information about the upcoming Phase 1 clinical trial, visit clinicaltrials.gov, identifier number NCT04306224.

On April 22, 2020 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, April 29, 2020 to discuss the company’s first quarter 2020 financial results (Press release, Alkermes, APR 22, 2020, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-first-quarter-2020-financial-results-301044765.html [SID1234556542]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, April 29, 2020, through Wednesday, May 6, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13701480.

On April 22, 2020 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report first quarter results on May 6, 2020 at 4:00 PM Eastern Time (Press release, Cytokinetics, APR 22, 2020, View Source [SID1234556541]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 9063637.

An archived replay of the webcast will be available via Cytokinetics’ website until May 20, 2020. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 9063637 from May 6, 2020 at 7:30 PM Eastern Time until May 20, 2020.

On April 22, 2020 FoRx Therapeutics AG (FoRx), the biotechnology company developing a new generation of cancer drugs focusing on novel DNA Replication Stress (DRS) pathways, reported the closing of a EUR 10 million seed financing led by M Ventures (venture capital arm of Merck), Novartis Venture Fund and Omega Funds (Press release, FoRx Therapeutics, APR 22, 2020, https://www.prnewswire.com/news-releases/forx-therapeutics-ag-raises-eur-10-million-seed-round-and-becomes-first-company-to-develop-a-pipeline-of-drugs-targeting-dna-replication-stress-for-cancer-301044549.html [SID1234556517]). Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE) and LSP (Life Sciences Partners) also joined the seed financing. The company also announces the appointment of Colin Goddard as Executive Chairman.

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FoRx is developing a new generation of drugs against a unique target class for the treatment of cancer. The company’s scientific foundations are built on the pioneering work of Professor Thanos Halazonetis, from the University of Geneva. Professor Halazonetis discovered novel DNA repair pathways, such as Break Induced Replication (BIR) that enable cancer cells to overcome DNA Replication Stress, a prevalent feature in human cancers but absent in normal, healthy cells. These repair pathways constitute a vulnerability that can be exploited for targeted intervention using synthetic lethality. The work of Professor Halazonetis describing oncogene-induced replication stress has been published in renowned scientific journals including Nature[1]. The Company’s validated BIR targets furthermore appear to have potential for both therapy and maintenance treatment as shown in preclinical knock-out models.

Newly appointed Executive Chairman, Dr. Colin Goddard, said: "I am excited to join the Board of FoRx as we embark upon this new approach for therapeutic intervention in cancer. With strong scientific foundations and a high quality investor syndicate, the Company has the potential to materially improve the options available to oncologists around the world."

Dr. Colin Goddard has a long track record of leadership and success in the industry. He works as an investor and board member in a number of early stage and public biotechnology companies, leveraging over 30 years of experience in the industry. He is Chairman of Mission Therapeutics and BlinkBio. He was previously a non-executive director of Endocyte Inc. which was acquired by Novartis in 2018 for US$ 2.1 billion. From October 1998 until its US$4 billion acquisition by Astellas Pharmaceuticals Inc. in June of 2010, Dr. Goddard was CEO of OSI Pharmaceuticals Inc. Dr. Goddard holds a PhD in Cancer Pharmacology.

Therese Maria Liechtenstein from M Ventures, Florian Muellershausen from Novartis Venture Fund, Vincent Ossipow from Omega Funds, Vincent Brichard from LSP, and Denis Patrick from Pfizer Ventures joined the FoRx board along with Professor Halazonetis.

Andreas Goutopoulos, current Senior Scientific Director at EMD Serono and Chief Scientific Officer at Metabomed, is supporting FoRx Therapeutics as interim Chief Executive Officer, as part of his role as Entrepreneur-in-Residence at M Ventures.

On April 22, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses and cancer vaccines to target hard-to-treat solid tumors, and Valo Therapeutics (Valo Tx) reported that they have entered into a collaboration agreement to evaluate PeptiCRAd technology as a tool to coat ONCOS oncolytic adenoviruses with Targovax’s TG mutant RAS peptides (Press release, Targovax, APR 22, 2020, View Source [SID1234556516]).

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Valo Tx’s PeptiCRAd technology has been developed to coat oncolytic viruses with tumor antigen peptides for enhanced immune activation and local delivery of antigens directly into the tumor site. With this collaboration, Targovax and Valo Tx will test whether PeptiCRAd coating of ONCOS-102 adenovirus with TG mutant RAS peptides can generate enhanced systemic CD4+ and CD8+ T-cell responses against mutant RAS, and specifically direct these T-cells to the tumor site.

The technical feasibility, in vitro activity and in vivo immune activation potential of the concept will be evaluated in the first phase of the collaboration. If successful, the parties will jointly determine how to further expand and develop the collaboration to establish a first-in-class oncolytic virus engineered to induce mutant RAS immune responses.

Dr. Anne-Sophie Møller, Head of Clinical Science of Targovax, said: "We are excited to initiate this collaboration with Valo Therapeutics. We continue to view mutant RAS as a very compelling immunotherapeutic target. The innovative PeptiCRAd technology enables us to merge our peptide vaccine and oncolytic virus platforms to generate a truly novel RAS-targeting ONCOS vaccine. The combination of these promising technologies could become a new platform supporting our aspiration to develop novel therapies for hard-to-treat solid tumors."

Dr. Sari Pesonen, Head of R&D at Valo Tx, commented, "We are delighted that Targovax has chosen to partner with us in the solid tumor space, providing further endorsement of our PeptiCRAd technology. By enabling the coating of ONCOS-102 adenovirus with TG mutant RAS peptides, we have a unique opportunity to take full advantage of the clinically proven immune activation potency of ONCOS-102 by directing the immune responses towards mutant RAS neoantigens, driving enhanced tumor-specific T-cell responses in cancer patients."