MEDICAL

Hillstream BioPharma to Announce Collaborating with Sapien Biosciences

Hillstream | June 30, 2022

Hillstream_Bio_Pharma
Hillstream BioPharma, Inc., a U.S.-based biotechnology company developing novel therapeutic candidates targeting ferroptosis for cancer treatment, announced a collaboration with an Indian pioneer biobank and peonalized medicine company that leverages Saarum Innovation's global life sciences research expertise, Sapien Biosciences. The collaboration is aimed at assessing the compatibility of HSB-1216 with immune checkpoint inhibitors.

HSB-1216, Hillstream’s most advanced candidate, is an IMCD modulator that targets various types of solid tumors. In an exhaustive study in Germany, the active drug in HSB-1216 was found to be efficacious in a clinical pilot for devastating cancers, including epithelial carcinomas and triple-negative breast cancer.

Hillstream aims to build an early clinical proof-of-concept by beginning a clinical investigation with HSB-1216 in 2022. With this collaboration, Hillstream will be able to use Sapien’s patient samples and rich datasets to validate its HSB-1216 for the development of novel cancer therapeutics.

We are initiating studies, in collaboration with Sapien Biosciences, to determine the synergy between HSB-1216, our ferroptosis inducer and nivolumab, an anti-PD1 antibody.” He stated, “In addition, we will also study the potential synergistic effects of HSB-1216 with the recently approved Bristol Myers Squibb drug Opdualag® (nivolumab + relatlimab), a fixed dose combination of an anti-PD1 MAb + anti-LAG3 MAb, to demonstrate that targeting a ferroptosis-associated metabolism in tumors may improve the efficacy of cancer immunotherapy.”

Randy Milby, Hillstream’s Chief Executive Officer.

We are excited to extend our collaboration with Hillstream Biopharma to evaluate potential synergy between their HSB-1216 molecule and ICIs using our expertise in establishing patient tissue-derived cell models in oncology, immunology and Immune-oncology Previously, Sapien demonstrated potent anti-cancer activity of HSB-1216 in primary triple negative breast cancer cells which were presented at AACR 2020.”

Dr. Jugnu Jain, CEO, Sapien Biosciences.

Spotlight

Within the drug development process, there are several steps that occur between the laboratory and final manufacture of the drug product.

Spotlight

Within the drug development process, there are several steps that occur between the laboratory and final manufacture of the drug product.

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INDUSTRIAL IMPACT

Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Corp. | November 24, 2022

Sirona Biochem Corp. announces that, subsequent to the LOI, Sirona and Wanbang Biopharmaceuticals have signed an expanded, international partnership agreement to collaborate on licencing Sirona’s SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence. Wanbang and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes. Together, Sirona and Wanbang share extensive knowledge and scientific results of TFC-039. Partnering will significantly increase the speed to third-party partnerships and commercialization. The shared data spans over 12 years of research and development, and includes in vitro and in vivo preclinical work, multiple clinical studies, advanced manufacturing process development and the ability to commercially manufacture TFC-039. “We have a long-standing relationship with Wanbang and are excited to combine our two companies’ expertise to license TFC-039. Wanbang has invested millions of dollars into the clinical stage research and development of the manufacturing processes for TFC-039. These pieces of data are critical to large organizations and will greatly increase the opportunities to move forward. The probability of a successful licensing agreement has been made much stronger by leveraging our alliance with Wanbang. We have had a successful year building Sirona’s pipeline, with positive movement on all projects and we’re looking forward to continuing this success with our SGLT2 inhibitor as well as our antiviral and anti-aging projects in 2023.” Dr. Howard Verrico, CEO About Wanbang Biopharmaceuticals and Fosun Pharmaceuticals Wanbang Biopharmaceuticals develops, manufactures, and markets drugs with indications for chronic disease treatment, antibiotics, and other endocrine diseases in China. Founded in 1981, the company is headquartered in Xuzhou, China, and is a subsidiary of Shanghai Fosun Pharmaceutical Group. Fosun is a leader in the pharmaceutical industry and is regarded as one of the top five domestic pharmaceutical companies in China. About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants.

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INDUSTRIAL IMPACT

Envisagenics Announces Research Collaboration with Bristol Myers Squibb

Envisagenics | December 05, 2022

Envisagenics, an Artificial Intelligence driven biotechnology company that delivers therapies for RNA splicing diseases, today announced a research collaboration agreement with Bristol Myers Squibb. The multi-year collaboration will leverage Envisagenics' SpliceCore® AI platform to identify alternative splicing derived targets for therapeutic development to expand Bristol Myers Squibb's vast oncology pipeline. Envisagenics will receive an upfront payment and milestone payments based on development, regulatory, and commercial achievements. SpliceCore, a cloud-based, AI-powered platform, can identify disease-specific splicing-derived targets by using RNA-sequencing data. Envisagenics will integrate data from thousands of patients to identify mRNAs encoding for tumor-specific cell surface antigens, thereby fostering the discovery of novel targets to enable development of therapeutics. "It is exciting to see how quickly significant scientific breakthroughs in the biopharma industry can be achieved with the assistance of AI. Our SpliceCore platform, coupled with Bristol Myers Squibb's expertise, has the potential to accelerate target identification, transform modern drug development, and improve patient outcomes." Maria Luisa Pineda, Ph.D., Envisagenics' CEO and Co-founder The SpliceCore platform applies an ensemble of proprietary algorithms to RNA-sequencing data, creating a sequence search space of approximately 7 million splicing events, thus maximizing the odds of drug target discovery. SpliceCore prioritizes drug targets based on their disease-specificity, biological roles, and druggability through a variety of drug modalities. Thanks to its scalable and cost-effective cloud architecture, the platform can process massive amounts of RNA-seq data efficiently and at high speed. SpliceCore helps to identify drug targets quickly and, in turn, predicts drug-responding alternative splicing events for therapeutic development. Martin Akerman, Ph.D., Envisagenics' CTO and Co-founder, added, "novel therapeutic targets are urgently needed for patients, and Envisagenics is thrilled to be collaborating with BMS as part of our quest for innovation." About Envisagenics Envisagenics is an Artificial Intelligence-driven biotechnology company that focuses on the discovery of novel RNA splicing variants that cause cancer and other genetic diseases. Its principal technology is the SpliceCore® discovery platform. The platform re-envisions the human genome with a validated exon-centric approach, combined with machine learning algorithms and high-performance computing. It is up to 250 times more likely to discover novel targets than gene-centric discovery tools. Using innovative technology and RNA analysis expertise, Envisagenics accelerates the development of highly specific therapeutics that modulate RNA splicing events that drive pathogenesis of oncology, neurodegenerative, and metabolic disorders. Envisagenics partners with biopharmaceutical companies and academic institutions to advance their drug discovery capabilities. Envisagenics also has its own internally developed RNA therapeutic programs. Envisagenics is a spin-out of Cold Spring Harbor Laboratory and a proud woman- and minority-led recipient of several grants from the National Institute of General Medical Sciences and the National Cancer Institute.

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MEDTECH, INDUSTRIAL IMPACT

Puma Biotechnology Presents Updated Findings from the TBCRC-022 Trial at the 2022 San Antonio Breast Cancer Symposium

Puma Biotechnology | December 08, 2022

Puma Biotechnology, Inc. a biopharmaceutical company, presented updated findings from the Translational Breast Cancer Research Consortium Trial 022 at the ongoing 2022 San Antonio Breast Cancer Symposium in San Antonio, Texas. The poster entitled “Neratinib and ado-Trastuzumab-Emtansine for HER2+ Breast Cancer Brain Metastases Translational Breast Cancer Research Consortium Trial 022,” was presented by Rachel A Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women's Cancers, Dana Farber Cancer Institute, at Spotlight Poster Session 7 on December 7 from 5:00 p.m. – 6:15 p.m. CT. TBCRC-022 is a prospective, multicenter, Phase II study to evaluate the effect of neratinib plus T-DM1 in patients with HER2-positive breast cancer brain metastases. This presentation outlined updates from three cohorts: 4A – patients with previously untreated BCBM; 4B – patients with BCBM progressing after prior local CNS-directed therapy without prior T-DM1 exposure; and 4C – patients with BCBM progressing after prior local CNS-directed therapy with previous T-DM1 exposure. Data from previous cohorts from this study were reported at the 2017 ASCO Annual Meeting. Patients with measurable HER2-positive BCBM received neratinib 160 mg orally once daily plus T-DM1 3.6 mg/kg intravenously every 21 days in the three parallel-enrolling cohorts. Diarrhea prophylaxis with colestipol and loperamide was required during cycle 1. All enrolled patients underwent a brain MRI plus CT scan of the chest/abdomen/pelvis every 6 weeks for 18 weeks, followed by every 9 weeks thereafter. The primary endpoint, Response Assessment in Neuro-Oncology-Brain Metastases was evaluated in each cohort separately. The efficacy results from the trial showed that CNS Objective Response Rate by RANO-BM was 33.3% of patients in cohort 4A, 29.4% in cohort 4B, and 28.6% in cohort 4C. Rates of response + stable disease greater than or equal to 6 months were 50% in cohort 4A, 35.3% in cohort 4B, and 33.3% in cohort 4C. Intracranial activity was observed for the combination of neratinib plus T-DM1 in all three cohorts, including in patients with prior T-DM1 exposure, suggesting a reversal of resistance to T-DM1. Overall, the most frequently observed adverse event was diarrhea, grade 2 and grade 3. These data provide additional evidence for the consideration of neratinib-based combinations in patients with HER2-positive BCBM. “Neratinib given in combination with T-DM1 showed promising activity in patients with heavily pre-treated HER2-positive disease metastatic to the CNS including patients with prior T-DM1 exposure, which may suggest that neratinib is playing a role in reversing resistance to T-DM1. Despite the introduction of several new treatments for patients with HER2-positive metastatic breast cancer, CNS progression events remain a major source of patient morbidity and mortality. The data from this study provide additional evidence for consideration of neratinib- based combinations in patients with HER2-positive breast cancer brain metastases.” Rachel A. Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute Alan H. Auerbach, CEO and President of Puma Biotechnology, added, “We are pleased with the results from the TBCRC-022 trial on the combination of neratinib and T-DM1. As a small molecule that can cross the blood brain barrier, neratinib potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option. This data adds to the existing body of data that we have from the other previously presented arms from the TBCRC-022 trial that continue to demonstrate that neratinib is active in patients with HER2-positive breast cancer brain metastases.” About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 PB272 and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® tablets. 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