On September 26, 2023 Biogen Inc. (Nasdaq: BIIB) reported that it has completed the acquisition of Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a company focused on developing therapeutics that regulate cellular metabolism and inflammation in serious neurologic diseases (Press release, Biogen, SEP 26, 2023, View Source [SID1234635401]). As a result of the transaction, Biogen has now acquired SKYCLARYS (omaveloxolone), as well as other clinical and preclinical pipeline programs.

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SKYCLARYS, Reata Pharmaceuticals’ lead asset, was approved for the treatment of Friedreich’s ataxia (FA), a rare neuromuscular disorder, in the United States earlier this year. FA is genetic, progressive, life-shortening, debilitating, and degenerative, affecting an estimated 5,000 diagnosed patients within the United States1. The commercial launch of SKYCLARYS is underway in the United States and European regulatory review is ongoing. As of the closing date, over 1,000 patient start forms for SKYCLARYS have been submitted in the United States.

"By adding a highly complementary product in an area of significant unmet medical need to our portfolio, we believe the acquisition of Reata aligns with our strategy to serve patients, drive sustainable growth and create significant shareholder value," said Christopher A. Viehbacher, President and Chief Executive Officer at Biogen. "With the transaction now complete, we look forward to leveraging Biogen’s rare disease expertise and capabilities to work together with our Reata colleagues as one team to bring SKYCLARYS to patients living with this devastating disease."

Biogen anticipates significant synergies with its existing rare disease portfolio and plans to update its Full Year 2023 Financial Guidance in conjunction with its third quarter 2023 earnings release. The acquisition of Reata is expected to be slightly dilutive to Biogen’s Non-GAAP diluted Earnings Per Share (EPS) in 2023, roughly neutral in 2024, and significantly accretive beginning in 2025, inclusive of associated transaction costs. As a result of the transaction closing, Reata’s Class A common stock will no longer be listed for trading on the Nasdaq Global Market.

About SKYCLARYS (omaveloxolone)

SKYCLARYS (omaveloxolone) is an oral, 150 mg once-daily medication indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older in the United States Additionally, the company’s Marketing Authorization Application for omaveloxolone is under review in Europe by the European Medicines Agency (EMA). The European Commission has granted Orphan Drug designation in Europe to omaveloxolone for the treatment of Friedreich’s ataxia.

On September 26, 2023 Amphista Therapeutics ("the Company" or "Amphista"), a leader in next generation targeted protein degradation (TPD) approaches, reported that it has achieved the first milestone in the second active discovery programme under its strategic collaboration and license agreement with Bristol Myers Squibb (NYSE: BMY), triggering a payment for achieving the milestone (Press release, Amphista Therapeutics, SEP 26, 2023, View Source [SID1234635400]).

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This follows the announcement of the first milestone achieved in the first discovery programme on May 4, 2023. Both programmes are part of the original agreement with Bristol Myers Squibb, which was announced in May 4, 2022 and included a $30 million upfront payment and the potential for up to $1.25 billion in performance-based milestone payments and payment for a limited expansion of the collaboration, as well as royalties on global net sales of products.

Louise Modis, Chief Scientific Officer of Amphista Therapeutics said: "The achievement of this first milestone in the second discovery programme under Amphista’s strategic collaboration with Bristol Myers Squibb is a testament to our innovative science and ability to discover and progress at pace differentiated, novel therapeutic molecules for our pharmaceutical partners. We have now delivered milestones on both active discovery programmes in our ongoing collaboration with the company and we look forward to continuing this strong momentum. Such collaborations further validate our unique approach and ambition to overcome challenges faced by other target protein degradation modalities. With potential for CNS penetration, we continue to expand the range of potential applications for Amphista’s therapeutic modality."

Under the agreement, Amphista is responsible for the discovery and development of small molecule protein degraders using EclipsysTM, its next-generation TPD platform. Bristol Myers Squibb is granted a global exclusive license to the resulting degraders and will be responsible for further development and commercialization activities.

On September 25, 2023 The board of directors (the "Board") of Hansoh Pharmaceutical Group Company Limited
(the "Company" and together with its subsidiaries, the "Group") reported that "HS-20105", a Category 1 therapeutic biological product self-developed by Shanghai Hansoh Biomedical Technology Company Limited* (上海翰森生物醫藥科技有限公司) and Changzhou Hansoh Pharmaceutical Company Limited* (常州恒邦藥業有限公司), both being subsidiaries of the Company, has been granted a clinical trial notice issued by the National Medical Products Administration of the People’s Republic of China, and is intended to be used for the treatment of advanced solid tumors (Press release, Jiangsu Hansoh Pharmaceutical, SEP 25, 2023, View Source [SID1234654211]). The specific indication will be determined after the completion of clinical research.

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ABOUT "HS-20105"
HS-20105 is an antibody-drug conjugate formed by coupling humanized anti-Trop-2 monoclonal antibody of IgG1 subtype with cytotoxic payload (DNA topoisomerase I inhibitor) by the cleavable linker.

By Order of the Board
Hansoh Pharmaceutical Group Company Limited
Zhong Huijuan
Chairlady

On September 25, 2023 BioCity Biopharma and AstraZeneca reported to have signed an agreement to collaborate on a Phase Ib/II clinical study to evaluate the safety and efficacy of BioCity’s BC3402, a monoclonal antibody (mAb) targeting the T cell immunoglobulin and mucin domain-containing protein 3, also known as TIM-3, in combination with AstraZeneca’s anti-PD-L1 mAb IMFINZI (durvalumab) for the treatment of advanced hepatocellular carcinoma (HCC）in China (Press release, AstraZeneca, SEP 25, 2023, View Source [SID1234635471]). BioCity will lead the trial, which has received IND approval by the National Medical Products Administration (NMPA). The study will be conducted at Zhongshan Hospital with Prof. Jia Fan who is a renowned liver cancer surgeon, member of the Chinese Academy of Sciences, president of Zhongshan Hospital, and will serve as the principal investigator of the study.

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BC3402 is a potential best-in-class anti-TIM-3 mAb that binds to multiple TIM-3 epitopes and has a higher binding affinity than other anti-TIM-3 mAbs in development. BC3402 has also been demonstrated to efficiently block the binding of CEACAM1, PtdSer and Gal-9 to TIM-3, alleviate the inhibitory effects of Tregs, and restore IL-2 production by T cells. Moreover, BC3402 has shown synergistic anti-cancer activity with mAbs targeting PD-1 and CTLA-4, which are important clinical targets for liver cancer. TIM-3, PD-1, and CTLA-4 are immune checkpoint inhibitors.

The unmet medical needs are significant for HCC treatments in China with the 5-year survival rate of patients with advanced disease being about 7%. The collaboration between BioCity and AstraZeneca will evaluate the potential for the combination of BC3402 with durvalumab to improve the clinical outcome of subjects with HCC. Both companies may be expected to explore further collaboration opportunities to boost innovation in China in HCC and possibly other types of cancer.

On September 25, 2023 Chime Biologics, a leading CDMO that enables its partners’ success in biologics, announced a strategic cooperation with Kings Pharm (Press release, Chime Biologics, SEP 25, 2023, View Source [SID1234635395]).

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According to the agreement, Chime Biologics will leverage its rich experience in biosimilar projects to provide cell line development, early process development, global clinical and commercial manufacturing, and registration services to Kings Pharm. Chime Biologics will be the exclusive CDMO service provider and will help Kings Pharm to bring the asset to global markets.

The signing ceremony was accompanied by delegates of the Consulate General of the Republic of Korea in Wuhan, Foreign Affairs Office of Wuhan Municipal People’s Government, Wuhan East Lake High-tech Development Zone, and Wuhan National Bio-Industry Base Construction Management Office as this agreement underlines the strong collaboration between both countries.

Jaehee Lee, Advisor of Kings Pharm, commented, "Kings Pharm is committed to developing new drugs for oncology and metabolic diseases for aging. We believe that life must be respected and that human life goes on. This anti-tumor biosimilar is the first collaboration project between Kings Pharm and Chime Biologics, and we are very pleased to enter into a strategic partnership with Chime for such an important project. Chime Biologics has a proven track record of quality systems with international quality standards, rich experience in biologics marketing and filing, and a flexible business model to ensure the global development and production of this project. We are willing to authorize the exclusive cooperation with Chime Biologics and look forward to further expanding the cooperation in the future for the benefit of patients."

Dr. Jimmy Wei, President of Chime Biologics, said, "We are pleased to establish a strong partnership with Kings Pharm to accelerate the development and commercialization of this anti-tumor biosimilar. The biosimilar program is Chime Bio’s strength, our team has successful experience in developing several biosimilars and has a proprietary platform for high-expression cell line development, which allows us to provide low-cost biosimilar development services to clients all over the world. This collaboration is the beginning of our one-stop solution for biosimilars, we are proud to make every effort to support Kings Pharm to promote its biosimilars to market and increase the accessibility of biologics to patients globally."

Chime Biologics is launching a global one-stop solution for biosimilars. Clients start a project with a product idea, then Chime will leverage its rich experience in biosimilar development to support the client’s biosimilar IND-filing, clinical sampling, commercial manufacturing and regulatory service.