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EpimAb Biotherapeutics and QIMR Berghofer Medical Research Institute Announce Research Collaboration and License Agreement on Novel Bispecific Target Combinations

On April 23, 2020 EpimAb Biotherapeutics, an emerging Shanghai-based biopharmaceutical company specializing in bispecific antibodies, and the QIMR Berghofer Medical Research Institute (QIMR Berghofer), a non-profit research organization based in Brisbane, Australia, reported a research collaboration and license agreement to evaluate novel target combinations for their application using EpimAb’s bispecific antibody format, Fabs-In-Tandem Immunoglobulin (FIT-Ig) (Press release, EpimAb Biotherapeutics, APR 23, 2020, View Source [SID1234556509]). Under the terms of the agreement, EpimAb will be granted an exclusive license to QIMR Berghofer’s novel target combinations identified by Professors Bill Dougall and Mark Smyth to develop novel bispecific antibodies. During the collaboration, EpimAb’s novel bispecific antibodies will be tested in QIMR Berghofer’s pre-clinical models. Financial details were not disclosed.

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"QIMR Berghofer is one of the pioneering institutes in the discovery of immuno-oncology mechanisms which are playing an important role in today’s treatment of cancer. We are proud to collaborate with QIMR Berghofer to identify novel target combinations as EpimAb enters the next stage of growth," said Dr. Chengbin Wu, CEO and founder of EpimAb. "With our lead program in clinical trials and several to follow, we have shown the ability of our FIT-Ig technology to rapidly generate innovative bispecific antibodies. We look forward to using the technology to evaluate novel bispecific target pairs developed under our collaboration and select viable pairs to broaden our pipeline."

"The bispecifics field has opened up new potential avenues to treat cancer and EpimAb’s bispecific antibody format has unique capabilities and features. EpimAb’s proprietary platform technology and experienced team will allow us to further evaluate some of our most recent discoveries, hopefully bringing novel immunotherapies to future cancer patients," said Professor Mark Smyth, Senior Scientist and Immunology Department Coordinator at QIMR Berghofer.

Samsung Biologics and ImmuneOncia Therapeutics Inc. Development and Manufacturing Agreement Accomplishes IND Clearance of IMC-002 (anti-CD47 antibody)

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.

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.

Alkermes to Host Conference Call to Discuss First Quarter 2020 Financial Results

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.

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.

Cytokinetics to Announce First Quarter Results on May 6, 2020

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.

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.

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

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.

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.