On September 26, 2023 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, reported positive data in a preclinical study investigating the anti-cancer activity of a novel prodrug of mebendazole for the treatment of glioblastoma (Press release, Bullfrog AI, SEP 26, 2023, View Source [SID1234635403]). The study assessed the relative efficacy of BF-222, a novel formulation of mebendazole that has been evaluated in clinical trials, and BF-223, a novel prodrug of mebendazole with improved solubility and bioavailability relative to BF-222, compared with placebo in mice that had been implanted with tumor cells as a model for human glioblastoma.

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Animals treated with BF-223 had an average survival time of 27.9 days compared with 27.3 days for mice treated with BF-222 and 23.4 days for mice given placebo. Mice treated with BF-223 were administered 80% of the dose that mice treated with BF-222 received, and improved outcomes for both treatment groups were statistically significant compared to placebo. In addition, animals treated with equivalent doses of BF-222 and BF-223 showed comparable and significant reduction in tumor growth compared to control animals during the study.

"This is the first study to demonstrate that BF-223, a novel mebendazole prodrug, has anti-cancer activity in animals," said Vin Singh, Chairman and CEO of BullFrog AI. "The data from this study, combined with BF-223’s improved properties, gives us confidence that BF-223 has potential to be an effective treatment in the fight against glioblastoma, a form of cancer for which there are few good treatment options. We are currently pursuing partnering opportunities for BF-222 and BF-223 with pharmaceutical companies and are confident that these data will assist in that effort."

About Glioblastoma
Glioblastoma is a fast-growing and aggressive type of cancer that occurs in the brain or spinal cord. It is the most common malignant tumor of the central nervous system (CNS), accounting for nearly 50% of primary malignant tumors occurring in the CNS. Treatment options include surgery, radiation and chemotherapy with the drug temozolomide, but the prognosis for survival in patients diagnosed with glioblastoma remains poor, with a five-year survival rate of less than 10%. The global glioblastoma multiforme treatment market is projected to increase from $ 5.1 billion in 2020 to an estimated $ 10.2 billion by 2030, growing at a compound annual growth rate of 12.8% during the forecast period, according to a report by Vision Research Reports.

On September 26, 2023 Bristol Myers Squibb (NYSE: BMY) reported that it will announce results for the third quarter of 2023 on Thursday, October 26, 2023 (Press release, Bristol-Myers Squibb, SEP 26, 2023, View Source [SID1234635402]). Company executives will review financial results and address inquiries from investors and analysts during a conference call beginning at 8:00 a.m. ET on the same date.

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Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source Investors and the public can register for the live conference call here. Those unable to register can access the live conference call by dialing in the U.S. toll free 1-833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at View Source prior to the start of the conference call.

A replay of the webcast will be available at View Source approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on October 26, 2023, through 11:30 a.m. ET on November 9, 2023, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, conference code: 3515954.

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 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.