FibroGen and HiFiBiO Announce Transformative Partnership to Advance Next-Generation Therapies for Patients with Cancer and Autoimmune Disease

On June 17, 2021 FibroGen, Inc. (Nasdaq: FGEN) and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science reported a partnership covering three HiFiBiO programs(Filing, 8-K, FibroGen, JUN 17, 2021, View Source [SID1234584112]).

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"We are very pleased to add the HiFiBiO drug candidates to our pre-clinical development pipeline," said Enrique Conterno, Chief Executive Officer, FibroGen. "With the addition of up to three programs in the immuno-oncology and autoimmune space, we have the potential to transform our early development pipeline."

"The FibroGen partnership represents significant validation of our Drug Intelligent Science (DIS) approach and deep expertise in disease biology and translation science," said Liang Schweizer, Ph.D., Chief Executive Officer, HiFiBiO. "As another successful showcase of our open innovation approach, we look forward to working closely with FibroGen, an exciting, growing biopharmaceutical company."

Under the terms of the agreement, FibroGen will make a $25 million upfront payment to HiFiBiO, as well as payments upon option exercise. In addition, HiFiBiO may receive up to a total of an additional $1.1B in future option, clinical, regulatory, and commercial milestone payments across all three programs. HiFiBiO will also be eligible to receive royalties based upon worldwide net sales.

FibroGen exclusively licensed all products in the Galectin-9 program and will have sole right to develop them worldwide. The lead product candidate in the Galectin-9 program is expected to enter clinical development in the first quarter of 2023. FibroGen has also obtained exclusive options to license all product candidates in HiFiBiO’s CXCR5 and CCR8 programs. Each option may be independently exercised following delivery of program-specific data to be generated by HiFiBiO. If an option is exercised, FibroGen will have the sole right to develop products from that program worldwide. The lead product candidates from the CXCR5 and CCR8 programs are expected to enter clinical development by the middle of 2023.

We look forward to a productive partnership with HiFiBiO, a leader in the field of single-cell science for antibody discovery and translational medicine," said Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. "We are excited to bring the Galectin-9 antibody program into the FibroGen portfolio. As Galectin 9 plays a role in suppressing the anti-tumor immune response in both myeloid malignancies and solid tumors, we believe this antibody candidate from HiFiBiO can advance the treatment of cancer in combination with chemotherapy or other immuno-oncology agents. The exclusive option to access projects directed to CXCR5 and CCR8 provides additional opportunities to expand our therapeutic area focus on oncology and immunology. These are both important biological targets playing clear roles in autoimmune disease and cancer.

OncoNano Raises $50 Million from China Investor for pH-based Cancer Products

On June 17, 2021 OncoNano Medicine, located in a suburb of Dallas, Texas, reported that it raised $50 million for its novel pH-based cancer products in a B round led by Advantech Capital, a China cross border investor(Press release, OncoNano Medicine, JUN 17, 2021, View Source [SID1234584111]). Proceeds of the round will be used to support the Phase II US/EU clinical trials for pegsitacianine, a real-time imaging agent used in intraoperative surgical resection of solid tumors, and to accelerate development of ONM-501, a novel immunoncology molecule. OncoNano was founded by Jinming Gao, PhD, who received his BS from Peking University and PhD from Harvard.

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Eisai and Bristol Myers Squibb Enter Into Global Strategic Collaboration for Eisai’s MORAb-202 Antibody Drug Conjugate

On June 17, 2021 Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) reported that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC)(Press release, Bristol-Myers Squibb, JUN 17, 2021, View Source [SID1234584109]). MORAb-202 is Eisai’s first ADC and combines Eisai’s in house developed anti-folate receptor alpha (FRα) antibody, and Eisai’s anticancer agent eribulin, using an enzyme cleavable linker. It is a potential best-in-class FRα ADC with a favorable pharmacology profile and demonstrated single agent activity in patients with advanced solid tumors. Eisai is currently investigating MORAb-202 in FRα-positive solid tumors (inclusive of endometrial, ovarian, lung and breast cancers) in two studies: a Phase 1 clinical study in Japan and a Phase 1/2 clinical study in the United States. The companies are planning to move into the registrational stage of development for this asset as early as next year.

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Under the agreement, Eisai and Bristol Myers Squibb will jointly develop and commercialize MORAb-202 in the following collaboration territories: Japan; China; countries in the Asia-Pacific region*; the United States; Canada; Europe, including the European Union and the United Kingdom; and Russia. Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories. Eisai will remain responsible for the manufacturing and supply of MORAb-202 globally.

Under the financial terms of the agreement, Bristol Myers Squibb will pay $650 million U.S. dollars to Eisai including $200 million U.S. dollars as payment toward Eisai research and development expenses. Eisai is also entitled to receive up to $2.45 billion U.S. dollars in potential future development, regulatory, and commercial milestones. The parties will share profits, research and development and commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories. Eisai is expected to book sales of MORAb-202 in Japan, China, countries in the Asia-Pacific region, Europe and Russia. Bristol Myers Squibb is expected to book sales of MORAb-202 in the United States and Canada.

"MORAb-202 combines Eisai’s in-house discovered antibody and payload using the company’s advanced chemistry capabilities." said Haruo Naito, Chief Executive Officer at Eisai. "It is characterized by its payload of eribulin, which is a product of our modern synthetic organic chemistry that has already made contributions to patients with breast cancer and soft tissue sarcoma. Our collaboration with Bristol Myers Squibb will accelerate the development of MORAb-202 with the goal of bringing a potentially impactful treatment option to patients globally."

"This global collaboration with Eisai is an important strategic fit for Bristol Myers Squibb as it extends our leading position in oncology with a differentiated asset that complements our broad solid tumor portfolio and leverages our deep internal development expertise." said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. "We look forward to collaborating with Eisai as we work to bring this potential treatment option to patients in need as soon as possible.

Bristol Myers Squibb Announces Dividend

On June 17, 2021 Bristol Myers Squibb (NYSE: BMY) reported that its Board of Directors has declared a quarterly dividend of forty-nine cents ($0.49) per share on the $.10 par value common stock of the company(Press release, Bristol-Myers Squibb, JUN 17, 2021, View Source [SID1234584108]). The dividend is payable on August 2, 2021 to stockholders of record at the close of business on July 2, 2021.

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In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable September 1, 2021 to stockholders of record at the close of business on August 10, 2021.

Biodesix Announces Presentation on Novel Proteomic Techniques in Partnership with Seer

On June 17, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company, reported in partnership with Seer, Inc. (NASDAQ: SEER), a life sciences company commercializing a disruptive new platform for proteomics, a webinar to present the newest trends in proteomics for biomarker discovery and translational research(Press release, Biodesix, JUN 17, 2021, View Source [SID1234584107]). The webinar entitled "A New Era in Precision Medicine – Uncovering the Depth & Breadth of the Plasma Proteome with Novel Proteomic Technologies" will be presented by Robert Georgantas, III, PhD, Senior Vice President, Research and Translational Science at Biodesix and Daniel Hornburg, PhD, Principal Scientist from Seer. The webinar is scheduled at 11:00 am ET, Tuesday June 22, 2021 and participants are encouraged to REGISTER HERE.

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Proteomics is the next frontier in biomarker and translational research with new emerging technologies that are enabling researchers to see deeper and broader into the plasma proteome than ever before. Biodesix is a recognized leader in profiling patients’ immune response to all cancer types using blood-based solutions that combine proteomic and genomic insights with a proprietary AI analytics platform.

The webinar will include an overview of Seer’s Proteograph Product Suite, which uses proprietary engineered nanoparticles to survey plasma proteins, allowing researchers to identify and quantitate proteins across the dynamic range of the proteome. Additionally, learnings will be shared on how the Seer Proteograph Product Suite will help define the biological underpinnings of tests created by Biodesix and how it is being integrated into the Biodesix mass spectrometry-based workflows for biopharmaceutical and academic research.