On February 22, 2019 Affibody Medical AB ("Affibody"), a clinical stage biopharmaceutical company developing a pipeline of innovative drug projects, reported the decision to carry out a capitalization of approximately SEK 150 million through a fully guaranteed rights issue (Press release, Affibody, FEB 22, 2019, View Source [SID1234575702]).

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The Board of Directors of Affibody Medical AB has called an Extraordinary General Meeting (EGM) with the intention to carry out a fully guaranteed rights issue which would bring approximately SEK 150 million to the company. The EGM will take place Monday March 11, 2019 at 11:00 am at the company’s premises on Gunnar Asplunds allé 24, Solna. The proceeds will be used to fund the company’s continued expansion.

Shareholders representing more than 70% of the ownership have committed to vote in favor of the proposed rights issue.

"Since inception, Affibody has been backed by Investor AB, now through Patricia Industries. As a long term owner we see attractive potential in the company with multiple studies showing encouraging results." says Christian Cederholm, Co-head of Patricia Industries. "We are therefore guaranteeing this rights issue in order to make sure that the company is well capitalized to continue its development."

Investor meetings will be held during the subscription period. Invitation to the investor meetings will be distributed to shareholders.

"Affibody has completed the transition from a technology platform company to a clinical stage drug development company with a broad pipeline", said David Bejker, CEO of Affibody. "This financing will provide the foundation for continued growth of our company and will enable value generating strategic initiatives".

Further details on the rights issue can be found in the formal notice which has been published on the company’s website.

On February 2019, Oncoceutics, Inc., reported the expansion of its diverse collaborations across the National Institutes of Health (NIH) involving its imipridone family of anti-cancer compounds (Press release, Oncoceutics, FEB 22, 2019, View Source [SID1234553818]).

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ONC206 has been studied extensively for several years in models of central nervous system cancers, including high grade gliomas as evaluated by the laboratory of Mark Gilbert, MD, Chief of the Neuro-Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI). These studies convincingly demonstrate that ONC206 exerts significant therapeutic effects on preclinical models of brain cancers that are commonly recognized as incurable. The properties of ONC206 that include penetrance of the blood brain barrier, feasibility of oral administration, demonstration of a benign safety profile in preclinical studies, and selective antagonization of dopamine receptor D2 (DRD2) further demonstrate the potential therapeutic value of the new class of imipridone compounds. While DRD2 is targeted by ONC206, as well as the first clinical-stage imipridone ONC201, the receptor pharmacology of ONC206 is unique, offering therapeutic options beyond ONC201.

Based upon NCI’s positive data from preclinical studies of ONC206, Dr. Mark Gilbert and his team in the Neuro-Oncology Branch, CCR, NCI in Bethesda, MD, are interested in conducting the first-in-human trial of ONC206 following Oncoceutics’ completion of IND-enabling studies and the execution of an appropriate agreement. This clinical trial will incorporate biomarker information derived from the molecular mechanism of ONC206 to select patients and to profile its activity in patients with central nervous system malignancies.

"I am excited to see ONC206, as the second imipridone, on the verge of entering the clinic," Minesh Mehta, MD, Deputy Director And Chief Of Radiation Oncology, Miami Cancer Institute and member of the board of directors of Oncoceutics. "This translational effort will introduce ONC206 as an impactful new therapy for patients with untreatable brain tumors and broadens the clinical utility of imipridones beyond its founding member, ONC201, which is already helping patients."

On February 22, 2019 Elpiscience Biopharma, Ltd. reported that the bispecific antibody ES101 has been approved by the Center for Drug Evaluation (CDE) for clinical trials in China (Press release, Elpiscience, FEB 22, 2019, View Source;id=1311 [SID1234536920]). ES101 is a first-in-class, bispecific antibody targeting both PD-L1 and 4-1BB, where 4-1BB-induced T cell activation is dependent on the binding to PD-L1 in the tumor microenvironment. The combination of "de-brake" and "add-gas" ideas not only greatly improved the efficacy of the drug, but also avoided the toxicity that 4-1BB single agent may have. This would solve the problem that 4-1BB monoclonal antibodies have encountered in clinical development. In the mean time, on February 19th, Inhibrx, Elpiscience’s US partner of ES101, announced the dosing of first patient of ES101 in the US. With ES101 being tested in clinical trials both in China and the US, it is expected to benefit cancer patients worldwide.

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Dr. Darren Ji, CEO of Elpiscience, said: "ES101 represents the arrival of the next generation of cancer immunotherapy beyond PD-1/PD-L1. As a first-in-class bispecific antibody, ES101 is expected to bring a transformative treatment to cancer patients on top of the existing therapies. We are delighted to witness this historical moment, which would have marked a small step for Elpiscience and its partner, and a giant leap for patients."

About ES101

ES101 is a tetravalent bispecific antibody that contains four binding domains, two targeting PD-L1 and two targeting 4-1BB, with a molecular weight being only two-thirds of that of an conventional antibody. Based on the high expression of PD-L1 in the tumor microenvironment and an unique antibody engineering, ES101 can conditionally activate 4-1BB upon binding to PD-L1. This would allow for a more efficient tumor killing by immune cells.

On February 22, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that Susan Molineaux, Ph.D, the company’s founder, president and chief executive officer, will participate in a fireside chat at the SVB Leerink Global Healthcare Conference at 3:30 p.m. ET on Thursday, February 28, 2019 in New York City (Press release, Calithera Biosciences, FEB 22, 2019, View Source [SID1234535229]). The presentation will be webcast live and available for replay for up to 30 days at www.calithera.com in the Investor Relations section.

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On February 22, 2019 Polaris Group reported that Shaw Chen, M.D., Ph.D. has been appointed as the Interim Chief Executive Officer (Press release, Polaris Pharmaceuticals, FEB 22, 2019, View Source [SID1234534439]).

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After more than 26 years with the FDA where he was the Deputy Director in the Office of Drug Evaluation, Center for Drug Evaluation and Research, Dr. Chen brings a wealth of expertise and institutional knowledge to Polaris Group. With his experience in FDA regulatory processes, Dr. Chen will be an invaluable asset as Polaris Group works to streamline the clinical development of its lead anti-cancer compound, ADI-PEG 20.

"The insight into the FDA that Dr. Chen has will be extremely valuable as we move forward with clinical investigations of ADI-PEG 20," said John Bomalaski, Executive Vice President of Medical Affairs at Polaris. "We are thrilled to work with him while we continue to search for a permanent CEO."

About ADI‑PEG 20

ADI‑PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI‑PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed. Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI‑PEG 20.