F. Hoffmann-La Roche Announces Third Quarter Sales 2021

On October 20, 2021 F. Hoffmann-La Roche Ltd. (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan] reported its third quarter sales 2021 (January 1 – September 30, 2021) (Press release, Chugai, OCT 20, 2021, View Source [SID1234591568]).

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Roche owns 59.89% of Chugai’s outstanding shares (61.16% of the total number of shares issued excluding treasury stock) as of the end of September 2021.

Its investor updates and presentation materials can be found on its website (View Source).
Chugai’s performance for the period of January 1 to September 30, 2021 is included in the announced Roche Group’s results.

F-star Therapeutics Announces License Agreement with Janssen to Develop and Commercialize Multiple Next Generation Bispecific Antibody Therapeutics

On October 20, 2021 F-star Therapeutics, Ltd. (NASDAQ: FSTX) ("F-star" or the "Company"), a clinical-stage biopharmaceutical company dedicated to developing next generation immunotherapies to transform the lives of patients with cancer, reported that it has entered into a license and collaboration agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Press release, F-star, OCT 20, 2021, View Source [SID1234591585]). The agreement was facilitated by Johnson & Johnson Innovation.

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Under the terms of the agreement, F-star will grant Janssen a worldwide, exclusive royalty-bearing license to research, develop, and commercialize up to five novel bispecific antibodies directed to Janssen therapeutic targets using F-star’s proprietary Fcab and mAb2 platforms. Janssen will be responsible for all research, development, and commercialization activities under the agreement.

Neil Brewis, Ph.D., Chief Scientific Officer of F-star said, "We are pleased to collaborate with Janssen and leverage the science of F-star’s proprietary tetravalent bispecific technology. Beyond our proprietary pipeline, we believe there is broad potential for our mAb2 platform to produce multiple next-generation bispecific antibody therapeutics."

Under the terms of the agreement F-star is entitled to receive upfront fees of $17.5 million, near-term fees and potential further milestones of up to $1.35 billion. F-star is also eligible to receive potential tiered mid-single digit royalties on annual net sales.

About F-star’s Fcab and mAb2 Platforms

F-star’s proprietary platform allows substitutions in the Fc region of a natural antibody, creating two additional distinct antigen binding sites. The resulting Fcab (Fc with antigen binding) building blocks can be rapidly inserted into a natural IgG antibody format to create tetravalent mAb2 bispecific antibodies that bind, simultaneously, to two different antigens.

F-star’s mAb2 bispecific antibodies are designed to conserve the natural human antibody format, with greater than 95% identity, providing minimal systemic toxicity, low immunogenicity risk, and ease of manufacturability.

Fcab building blocks can be used to generate not only bispecific antibodies but also tri-specific antibodies and fusion proteins.

F-star has 230 granted patents and over 150 pending applications covering its Fcab and mAb2 technology and associated product pipeline.

Crescendo Biologics Announces Prestigious New Collaboration With the Institute of Cancer Research, London

On October 20, 2021 Crescendo Biologics Ltd (Crescendo), a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, reported a new translational science collaboration with The Institute of Cancer Research, London, one of the world’s most influential cancer research organisations (Press release, Crescendo Biologics, OCT 20, 2021, View Source [SID1234591605]). Working together, Crescendo and The Institute of Cancer Research (ICR) will further characterise the non-clinical pharmacology of CB307, Crescendo’s first-in-class lead programme.

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CB307 is a novel, half-life extended PSMA x CD137 bispecific currently in a Phase 1 clinical study. It is designed for the conditional and durable activation and expansion of tumour-specific T cell populations, exclusively within the tumour microenvironment. The alliance with the ICR will drive valuable mechanistic insights into the pharmacology of CB307 in both in vitro and in vivo settings. It will include studies on patient-derived prostate cancer tissues to extend the understanding of PSMA and CD137 co-localisation and their influence on CB307-mediated T cell enhancement.

Professor Johann de Bono, Regius Professor of Cancer Research and Head of the Division of Clinical Studies at the ICR, commented: "We are very pleased to have initiated this important work with the team at Crescendo. Next generation immunotherapies could offer much-needed new treatment options to patients with castration-resistant prostate cancer, as well as other cancer types with high prevalence. We expect this collaboration to provide meaningful additional insights into the mechanisms and activity of CB307 in a variety of relevant settings."

Dr Andrew Pierce, VP Translational Biology at Crescendo, added: "The ICR is a world-renowned research institution, and we are very excited to have the opportunity to collaborate with Professor de Bono and his team to further explore the immunobiology of PSMA and CD137, including their co-localisation in tumour tissue. The results of these translational studies will be of great importance in understanding the profile of CB307, especially when placed alongside the clinical results as they continue to emerge from our ongoing clinical programme."

Alligator Announces First Patient Dosed in Phase II Clinical Trial with Shanghai Henlius Biotech, Inc. & AbClon, Inc.

On October 20, 2021 Alligator Bioscience AB ("Alligator" or the "Company") reported that the Company was notified that the first patient has been dosed in its Phase II clinical trial collaboration with Shanghai Henlius Biotech, Inc. and AbClon, Inc (Press release, Alligator Bioscience, OCT 20, 2021, View Source [SID1234591628]). Alligator out-licensed AC101 to AbClon, Inc. in October 2016. Abclon, Inc. subsequently sub-licensed AC101 in China for clinical development by Shanghai Henlius Biotech Inc. (November 7, 2018 press release).

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"We are happy to see that Henlius Biotech has dosed the first patient dosed with AC101 (HLX22). Previously, the phase I clinical trial demonstrated that HLX22 is well tolerated and has good safety profiles. Phase II will reinforce safety and compare the clinical efficacy in AC101 (HLX22) and placebo group," said Søren Bregenholt, CEO of Alligator Bioscience. "The commencement of dosing in the Phase II study with AC101 (HLX22) is an important step forward for our best-in-class antibodies technologies and partner collaborations."

Decibel Therapeutics to Present at the Jefferies Gene Therapy/Editing Summit

On October 20, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Laurence Reid, Ph.D., Chief Executive Officer of Decibel, will participate in a fireside chat at the Jefferies Gene Therapy/Editing Summit on Wednesday, October 27, 2021 at 10:30 am ET (Press release, Decibel Therapeutics, OCT 20, 2021, View Source [SID1234591569]).

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A live webcast of the fireside chat may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the fireside chat.