Mundipharma Enters Partnership With Samsung Bioepis to Expand Biosimilars Into Hong Kong and Taiwan

On January 16, 2020 Mundipharma reported a partnership with Samsung Bioepis to commercialize Samsung Bioepis’ first-wave biosimilar candidates in Taiwan and Hong Kong (Press release, Mundipharma, JAN 16, 2020, View Source [SID1234553291]).

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The partnership covers Samsung Bioepis’ biosimilar candidates in the field of immunology and oncology, including SB5 (adalimumab), SB4 (etanercept), SB3 (trastuzumab), and SB8 (bevacizumab).

Through the partnership, Mundipharma will be the exclusive commercialization partner, while Samsung Bioepis will remain the Marketing Authorisation Holder (MAH), responsible for clinical development, regulatory registration, and manufacture of the biosimilars.

"This partnership brings together Samsung Bioepis’ proven biosimilar development platform with Mundipharma’s commercial acumen and market insight and ability to increase patient access to proven treatments," said Mundipharma CEO, Raman Singh. "This partnership will help to address the patient need in two important territories in Asia for immunology and oncology treatments," he added.

Bellicum Pharmaceuticals to Present New Translational Data for BPX-601 at ASCO 2020 Gastrointestinal Cancers Symposium

On January 16, 2020 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported that an abstract on new Phase 1 translational results for BPX-601, its lead GoCAR-T product candidate, has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) (Press release, Bellicum Pharmaceuticals, JAN 16, 2020, View Source [SID1234553311]). The meeting is being held January 23-25, 2020 in San Francisco.

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Details of the poster presentation are as follows:

Title: Tumor Infiltration and Cytokine Biomarkers of Prostate Stem Cell Antigen (PSCA)-Directed GoCAR-T Cells in Patients with Advanced Pancreatic Tumors
Poster Board: M1, Abstract 734
Presenter: Joanne Shaw, Ph.D.
Time/Location: Friday, January 24, 2020, 12 p.m. to 1:30 p.m., 4:30 p.m. to 5:30 p.m. PT, Level 1, West Hall

Physicians’ Education Resource® to Host 5th Annual School of Gastrointestinal Oncology®

On January 16, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will host the 5th Annual School of Gastrointestinal Oncology on Saturday, March 21, at the MGM National Harbor in Oxon Hill, Maryland (Press release, Physicians’ Education Resource, JAN 16, 2020, View Source [SID1234553292]). The program will be co-chaired by world-renowned experts John L. Marshall, M.D., chief, division of hematology/oncology, Medstar Georgetown University Hospital; professor of medicine and oncology, Lombardi Comprehensive Cancer Center; and director, The Ruesch Center for the Cure of Gastrointestinal Cancers; and Michael A. Choti, M.D., MBA, FACS, chief of surgery, Banner MD Anderson Cancer Center.

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"The gastrointestinal (GI) cancer landscape is constantly transforming, as is the growing number of therapies and treatment options," said Phil Talamo, president of PER. "This conference will educate attendees on how precision medicine has changed the treatment landscape and how to properly use precision medicine to optimize patient care and outcomes."

SOGO is a one-day, multidisciplinary educational conference, dedicated to exploring emerging therapies and evolving standards of care in the management of patients with GI tumors, with a focus on providing oncologists and gastroenterologists with the tools to individualize patient care. The program includes various modules that feature general presentations and workshops geared toward important concepts in the field. With separate tracks in medical oncology, surgical and radiation oncology, and case-based SOGO seminars, the program is designed to match the learning interests of everyone who attends.

This year’s symposium will once again feature the dynamic and interactive Medical Crossfire format, in which experts will engage in debate and answer questions about ongoing paradigm shifts. The program will also feature case-based lectures by expert faculty that explore the latest data and how it can affect decisions to improve outcomes for patients.

Just – Evotec Biologics announces product development and manufacturing agreement with OncoResponse

On January 16, 2020 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that its wholly-owned Seattle-based subsidiary company Just – Evotec Biologics, Inc. has established a collaborative relationship with OncoResponse, Inc., a biotech company developing human antibodies as product candidates for multiple high value targets associated with immunosuppressive myeloid biology (Press release, Evotec, JAN 16, 2020, View Source;announcements/press-releases/p/just—evotec-biologics-announces-product-development-and-manufacturing-agreement-with-oncoresponse-5899 [SID1234553255]). OncoResponse’s lead antibody product candidate, OR2805, is a fully human antibody derived from an elite responder that reverses immunosuppression in the tumour microenvironment and promotes greater cancer killing that will lead to higher response rates and more cures.

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Under the agreement, Just – Evotec Biologics will leverage its integrated technology platform, J.DESIGN, to provide OncoResponse with services to accelerate OR2805 into the clinic. The services include cell line development, process development, and Phase I/II cGMP clinical manufacturing of a selected drug candidate for use in human clinical trials.

Clifford Stocks, Chief Executive Officer of OncoResponse, commented: "We are thrilled to have Just – Evotec Biologics develop and manufacture our lead therapeutic antibody. Just – Evotec Biologics’ background, expertise and guidance combined with their track record and unique technology platform will play a critical role in the successful production of our molecule for clinical studies."

Dr James Thomas, EVP Global Head Biotherapeutics, President U.S. Operations at Just – Evotec Biologics, commented: "We are delighted to be working with the experienced and dynamic team at OncoResponse on the development and manufacturing of this exciting immunotherapy approach to cancer."

BioNTech to acquire Neon to strengthen global leadership position in T cell therapies

On January 16, 2020 BioNTech and Neon Therapeutics reported that they have entered into a definitive merger agreement under which BioNTech will acquire Neon in an all-stock transaction valued at approximately $67.0 million (Press release, BioNTech, JAN 16, 2020, View Source [SID1234553275]). Neon is a biotechnology company developing novel neoantigen-based T cell therapies. Upon closing, it will operate as a subsidiary of BioNTech, a global clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases. The transaction will combine two organizations with a common culture of pioneering translational science and a shared vision for the future of cancer immunotherapy.
Neon has deep expertise in the development of neoantigen therapies, with both vaccine and T-cell capabilities. Neon’s most advanced program is NEO-PTC-01, a personalized neoantigen-targeted T cell therapy candidate consisting of multiple T cell populations targeting the most therapeutically relevant neoantigens from each patient’s tumor. Neon is also advancing a precision T cell therapy program targeting shared neoantigens in genetically defined patient populations. The lead program from this approach, NEO-STC-01, is a T cell therapy candidate targeting shared RAS neoantigens. In addition, Neon has assembled libraries of high-quality TCRs against various shared neoantigens across common HLAs.

Neon’s pipeline is underpinned by its platform technologies including RECON, its machine-learning bioinformatics platform, and NEO-STIM, its proprietary process to directly prime, activate and expand neoantigen-targeting T cells ex vivo.

Transaction Details

Under the terms of the definitive agreement, Neon will, following consummation of the acquisition, merge with Endor Lights, Inc., a Delaware corporation and a direct, wholly-owned subsidiary of BioNTech and become a wholly-owned subsidiary of BioNTech. At closing, BioNTech will issue, and Neon shareholders will receive 0.063 American Depositary Shares (ADS) (each ADS representing one ordinary share of BioNTech) in exchange for each of their shares of Neon. The exchange ratio implies a deal value of $67 million, or $2.18 per share of Neon, based on the closing price of BioNTech’s ADSs of $34.55 on Wednesday, January 15th, 2020.

The transaction was unanimously approved by both BioNTech’s and Neon’s boards of directors. The transaction, which is expected to close during the second quarter of 2020, is subject to approval of Neon’s shareholders and the satisfaction of customary closing conditions. Certain stockholders of Neon owning approximately 36% of the outstanding Neon shares have entered into voting agreements, pursuant to which they have agreed, among other things, and subject to the terms and conditions of the agreements, to vote in favor of the Neon acquisition.

Ondra Partners is acting as the exclusive financial advisor to Neon and Goodwin Procter LLP is acting as legal counsel to Neon. Duff & Phelps LLC provided a fairness opinion to Neon’s board of directors in connection with the transaction. Covington & Burling LLP is acting as legal counsel to BioNTech.