On December 20, 2021 FibroGen, Inc. (Nasdaq: FGEN), a leading biopharmaceutical company discovering, developing, and commercializing first-in-class therapeutics, and HiFiBiO Therapeutics, a private, multinational clinical-stage biotherapeutics company with expertise in immune modulation and single cell science, reported an extension of their partnership with FibroGen’s exercise of an exclusive license option for HiFiBiO’s anti-CCR8 monoclonal antibody program (HFB1011) (Press release, HiFiBiO Therapeutics, DEC 20, 2021, View Source [SID1234597440]).

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"We are pleased to add the HiFiBiO CCR8 program and the HFB101110 molecule to our preclinical development pipeline," said John Hunter, Chief Scientific Officer, FibroGen. "With this addition in the immuno-oncology space, we have the exciting opportunity to further expand our early development pipeline."

"We are excited to strengthen our FibroGen partnership with the license of HFB1011, a unique program targeting CCR8, a GPCR majorly expressed on regulatory T cells in the tumor microenvironment. Our antibody, identified by using our single B cell cloning platform, is another demonstration of our Drug Intelligent Science (DIS) approach for novel drug discovery and development. Together with the Galectin-9 program (HFB2009), we expand our collaboration with FibroGen to develop transformative medicines in immuno-oncology", said Liang Schweizer, Ph.D., Chief Executive Officer, HiFiBiO.

Under the terms of the agreement, HiFiBiO will receive a $35 million upfront payment from FibroGen in addition to potential clinical, regulatory, and commercial milestones. HiFiBiO will also be eligible to receive royalties based upon net sales.

FibroGen will have the sole right to develop all products in the CCR8 program worldwide. The development candidate is expected to enter clinical development in 2023.

About CCR8

CCR8 is a GPCR with prevalent and highly specific expression on immunosuppressive tumor infiltrating regulatory T cells (Tregs) across different tumor types. Stimulation of CCR8 by its ligand results in proliferation of Tregs and immune-suppression in the tumor microenvironment. Targeting CCR8 with an antibody able to mediate cell killing through antibody-dependent cellular cytotoxicity (ADCC) offers the potential to selectively deplete highly immunosuppressive Tregs in the tumor microenvironment and promote anti-tumor immunity.

On December 20, 2021 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that mOS of 25.0 months for treatment with ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in malignant pleural mesothelioma (MPM) in the subgroup of patients receiving therapy in the first-line setting (Press release, Targovax, DEC 20, 2021, View Source [SID1234597439]).

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The study is an open-label, exploratory phase 1/2 trial adding ONCOS-102 to SoC chemotherapy (pemetrexed/cisplatin) in first and later line MPM to assess safety, immune activation and clinical efficacy compared with SoC alone. A total of 31 patients were enrolled in the trial, with 20 patients in the treatment group receiving ONCOS-102 plus SoC chemotherapy, and 11 patients in the control group receiving SoC only. The 30-month follow-up has now been completed.

At the 30-month follow-up, mOS was 25.0 months for the subgroup of randomized, first-line ONCOS-102-treated patients (n=8). This is a clear improvement over the mOS of 13.5 months observed in the first-line SoC-only control group (n=6). Previous phase 3 clinical trials in MPM have reported mOS in the range of 12-16 months for patients receiving the same SoC chemotherapy treatment in the first-line setting1. The combination of Opdivo/Yervoy double checkpoint inhibition was recently approved as a first-line treatment option for MPM based on a phase 3 trial showing 18.1 months mOS2.

Objective response rate (ORR), progression free survival (PFS) and mOS have been previously reported, and remain unchanged. The 30-month follow-up analysis completes the mOS data set for all subgroups in the trial.

Immune activation was assessed in tumor biopsies pre- and post-ONCOS-102 treatment (Day 0 and Day 36). The tumor tissue analyses revealed powerful and consistent ONCOS-102-induced remodeling of the tumor microenvironment with increased T-cell infiltration and a shift towards pro-inflammatory immune cells, far beyond what was observed for the SoC-only control group. This immune activation is associated with tumor responses and is most pronounced in patients with better survival outcomes, indicating that the immune activating capacity of ONCOS-102 is driving the clinical benefit for patients.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, commented: "This excellent survival outcome suggests a great promise for ONCOS-102 to benefit mesothelioma patients. The results complement the class-leading ORR and immune activation ONCOS-102 has demonstrated in anti-PD1 resistant melanoma by showing that ONCOS-102 can be used in combination with both chemotherapy and anti-PD1 checkpoint inhibition. Importantly, we have confirmed that ONCOS-102 is active and effective in highly different types of solid tumors in both early and late lines of therapy. Based on the encouraging patient outcomes and deep mechanistic analysis from the phase 1/2 program, we are currently designing and preparing for the next phase in ONCOS-102 clinical development."

On December 20, 2021 IMMUNOPRECISE ANTIBODIES LTD. ("IPA" or the "Company") (NASDAQ: IPA) (TSX VENTURE: IPA) and ChemPartner Biologics Co. Ltd. ("ChemPartner") reported their global antibody manufacturing collaboration under which ChemPartner will manufacture and supply to IPA’s specifications IPA’s proprietary PolyTope TATX-03 Therapy, a rationally designed four monoclonal antibody cocktail developed for use in human clinical trial for the potential prevention and treatment of infection with current and future variants of SARS-CoV-2 (Press release, ImmunoPrecise Antibodies, DEC 20, 2021, View Source [SID1234597438]). The goal of this collaboration is to secure the ability to quickly develop and manufacture in parallel the individual cocktail antibodies in IPA’s PolyTope TATX-03 up to large scale required for use in clinical development and using ChemPartner’s state-of-the-art manufacturing facilities, with the potential for additional capacity to manufacture ‘plug-and-play’ antibodies addressing novel variants of concern in the event this is desired.

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"In light of the recent events as it pertains to concerns about vaccines and therapeutic antibodies losing efficacy against novel variants of concern, we believe that, if the preclinical data that we have to date is confirmed through human clinical studies, IPA is in a strong position to potentially address a worldwide need for alternative SARS-CoV-2 therapies using our Polytope cocktail. Our relationship with ChemPartner is one further step in that direction. Based on the work we have done to date with ChemPartner, and the positive interactions between our two teams, we believe that ChemPartner has the experience and global capabilities to meet our currently anticipated manufacturing needs for PolyTope TATX-03 cocktail," stated Dr. Jennifer Bath, President and Chief Executive Officer at IPA.

"We are impressed by the innovative approaches of ImmunoPrecise Antibodies and excited to help advance their TATX-03 PolyTope antibody cocktail program against SARS-CoV-2," said Livia Legg, Chief Commercial Officer at ChemPartner. "ChemPartner Biologics is strategically positioned to join forces in the battle against Covid-19 disease by utilizing our extensive capabilities and expertise in developing, scaling and manufacturing of complex biologics."

On December 20, 2021 Avecho Biotechnology Limited (ASX:AVE) has reported it has entered into a licensing and supply agreement with Medterra Pharma – one of the most successful CBD companies in the United States – to develop and commercialise Avecho’s soft-gel CBD capsule for the treatment of arthritis (Press release, Phosphagenics, DEC 20, 2021, View Source [SID1234597431]).

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Arthritis represents a promising opportunity for development, with the osteoarthritis therapeutics market projected to reach US$11 billion by 2025. Medterra scientists have already demonstrated the therapeutic potential of CBD for arthritis in preclinical models, and a six-week human study using the soft-gel for pain reduction in patients with osteoarthritis of the knee is scheduled for early next year.

This partnership is a strategic move for our Company. We know that our product has wide-ranging potential for a number of indications, and our ambition is to secure FDA approval for our proprietary CBD soft-gel product. By working in partnership with a reputable, well-resourced partner, this allows us to pursue regulatory approval in the US in parallel to our current efforts to register our product for sleep indications with the TGA in Australia.

On December 20, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported it has entered into an agreement with Gilead Sciences, Inc. (Headquarters: Foster City, California, "Gilead") for the commercialization and distribution of filgotinib (generic name, product name: Jyseleca ), an oral, JAK1 preferential inhibitor for indications of rheumatoid arthritis (RA), ulcerative colitis, and Crohn’s disease in Asia (South Korea, Taiwan, Hong Kong and Singapore) (Press release, Eisai, DEC 20, 2021, View Source [SID1234597411]). In December 2019, Eisai signed a partnership agreement with Gilead Sciences K.K. (Headquarters: Tokyo), a Japanese subsidiary of Gilead, for the distribution and co-promotion of filgotinib in Japan.

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Under the terms of the new agreement, Eisai will obtain an exclusive marketing right for filgotinib in South Korea, Taiwan, Hong Kong and Singapore from Gilead. Gilead has received approval for the treatment of RA in Taiwan and has applied for approval of filgotinib for the treatment of RA in South Korea. Following approvals, Eisai will take over the manufacturing and marketing licenses for filgotinib from Gilead in South Korea and Taiwan. In Hong Kong and Singapore, Eisai will apply for approval for filgotinib. With this agreement, Eisai will pay Gilead a contractual up-front payment, as well as regulatory milestones and sales milestones.

Filgotinib is a once-daily, oral, JAK1 preferential inhibitor. In Japan, filgotinib has been approved for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. In April 2021, Gilead Sciences K.K. applied for an additional indication of filgotinib as a treatment for patients with moderate to severe active ulcerative colitis.

Eisai will leverage its strong business foundation throughout Asia, provide new treatment options for patients with rheumatoid arthritis and inflammatory bowel disease, and contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients their families, and healthcare providers.

1. About filgotinib

Filgotinib is a once-daily, oral, JAK1 preferential inhibitor. In Japan, filgotinib has been approved for the treatment of RA (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. In April 2021, Gilead Sciences K.K. applied for an additional indication of filgotinib as a treatment for patients with moderate to severe active ulcerative colitis.

In addition, filgotinib has been approved in the European Union and Great Britain for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib has also been approved in the European Union for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Applications have been submitted to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with moderately to severely active ulcerative colitis and are currently under review.

2. About the market for biological products South Korea, Taiwan, Hong Kong and Singapore

The market of biological products in 2020 in South Korea, Taiwan, Hong Kong and Singapore is approximately US $ 400 million, accounting for approximately more than 80% of the total market for biological products in Asia (Hong Kong, India, Indonesia, South Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand and Vietnam).1 Many of biological products are adapted in the treatments for rheumatoid arthritis and inflammatory bowel disease.

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