A single dose of a PD-1 inhibitor before surgery predicts outcomes in melanoma patients

A single dose of a PD-1 inhibitor before surgery for melanoma can put patients in remission. Researchers from the Abramson Cancer Center at the University of Pennsylvania, who documented this finding in the largest cohort of patients to be treated with anti-PD-1 drugs before surgery, also showed that immune responses brought on by this therapy can peak as early as seven days after treatment—much earlier than previous studies have shown. Patients in this study completed up to a year of anti-PD-1 therapy after surgery, and those with complete responses after the initial dose have remained cancer free for more than two years—the longest follow-up data to date for a trial evaluating this treatment approach for patients with melanoma. Further, researchers also identified patterns in the way melanoma that comes back after surgery adapts to develop resistance to PD-1 inhibitors, potentially paving the way for greater understanding of how best to help these patients. The findings appear in Nature Medicine today. "Knowing so much earlier whether or not patients are responding to PD-1 inhibitors may give us the ability to guide them to the most appropriate therapy with the greatest chance for success," said the study's lead author Alexander C. Huang, MD, an instructor of Hematology-Oncology in Penn's Perelman School of Medicine and a Parker Bridge Scholar through the Parker Institute for Cancer Immunotherapy.

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Amicus Therapeutics and Blackstone Enter into $430 Million Strategic Financing Collaboration

GlobeNewswire | October 03, 2023

Amicus Therapeutics a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering novel medicines for rare diseases, today announced that it has entered into a definitive agreement for a $430 million financing collaboration with funds managed by Blackstone. As part of the collaboration, Blackstone Life Sciences and Blackstone Credit have agreed to provide Amicus with a $400 million senior secured term loan facilitating a refinancing of existing debt and a $30 million strategic investment in Amicus’s common stock. The financing collaboration allows Amicus to grow revenues and move toward profitability while delivering on its mission for patients and its vision of being one of the leading biotechnology companies focused on rare diseases. Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, stated: “This new financing with Blackstone strengthens our balance sheet and financial profile by reducing the interest rate versus our current debt, pushing out the amortization schedule and extending the amortization period. This strategic investment demonstrates Blackstone's commitment to Amicus’ future and belief in the strong growth potential of Galafold and Pombiliti™ + Opfolda™ as we continue on our mission to develop medicines for people living with rare diseases.” Key features of this transaction include $400M senior secured term loan facility; interest rate at adjusted Term SOFR plus 6.25%, subject to a 2.50% floor on Term SOFR $30M investment in Amicus common stock Requires interest-only payments until late 2026 and matures in October 2029 The full amount of the loan and equity purchase will be available and fully drawn at the initial funding The proceeds will be used to refinance Amicus’s existing debt and fund ongoing operations Commenting on the arrangement, Craig Shepherd, Senior Managing Director with Blackstone Life Sciences and Brad Colman, Senior Managing Director with Blackstone Credit said: "Blackstone aims to provide customized financing solutions for the world’s leading biotech and pharma companies across therapeutic areas to support mission critical scientific innovation. We are excited to collaborate with Amicus and provide capital to advance their mission of bringing important new medicines to people living with rare diseases around the world." Simon Harford, Amicus Chief Financial Officer, added: “Securing this financing with Blackstone as we launch Pombiliti™ + Opfolda™ around the world, allows us to better align our borrowing with anticipated cash flows while at the same time enhancing our ability to maximize access to our therapies for people living with rare diseases.” Subject to completion of customary conditions, the loan is expected to be funded and the equity investment is expected to close on October 5, 2023. About Amicus Therapeutics Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. About Blackstone Life Sciences Blackstone Life Sciences is an industry-leading private investment platform with capabilities to invest across the life cycle of companies and products within the key life science sectors. By combining scale investments and hands-on operational leadership, Blackstone Life Sciences helps bring to market promising new medicines and medical technologies that improve patients’ lives and currently has more than $8 billion in assets under management.

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BenevolentAI Signs Strategic Collaboration with Merck

Business Wire | September 26, 2023

BenevolentAI a leader in the development of advanced AI that accelerates biopharma discovery, announces that it has signed a strategic collaboration with Merck, a leading science and technology company headquartered in Darmstadt, Germany. The collaboration will enable Merck to leverage BenevolentAI’s powerful end-to-end AI platform capabilities and gain access to an expert team of interdisciplinary drug discovery scientists with the aim of identifying and developing innovative compounds, through Hit Identification (Hit ID) to pre-clinical stage. BenevolentAI will leverage its suite of AI chemistry design tools, in combination with its fully equipped wet lab facility in Cambridge (UK), to deliver small molecule drug development candidates into the Merck pipeline, ready for onward pre-clinical and clinical development. Under the terms of the agreement, BenevolentAI will be eligible for payments of up to $594 million, consisting of a low double-digit million dollar upfront payment on signing and then potentially discovery, development and commercial milestones. Tiered royalties will also be payable on net sales of any commercialised products. Joanna Shields, Chief Executive Officer of BenevolentAI, said: “Our strategic collaboration with Merck exemplifies BenevolentAI’s unique capability to leverage AI to accelerate drug discovery. Our proprietary technology and extensively validated approach of combining AI, molecular biology, medicinal chemistry, and in vivo pharmacology supports the discovery of innovative drug candidates in fewer cycles. We look forward to working with the Merck team and are excited at the opportunities in our partnership.” Public disclosure of inside information in accordance with article 17(1) of the Regulation (EU) No 596/2014 on market abuse (Market Abuse Regulation) About BenevolentAI BenevolentAI is a leading developer of advanced artificial intelligence technologies that unlock the value of multimodal data, surface novel insights, and accelerate biomedical discovery. Through the combined capabilities of its AI platform, its scientific expertise, and wet-lab facilities, the Company is developing an in-house drug pipeline of high-value assets. The Company is headquartered in London, with a research facility in Cambridge (UK) and a further office in New York.

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Nurix Announces Strategic Collaboration with Seagen Combining Industry Leading Technologies of Targeted Protein Degradation and Antibody-Drug

globenewswire | September 12, 2023

Nurix Therapeutics, Inc. a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors, today announced that it has entered into a multi-year, multi-target strategic collaboration agreement with Seagen Inc. to advance a new class of medicines called Degrader-Antibody Conjugates (DACs) for use in cancer. The collaboration between the two companies will focus on an innovative approach to combine two powerful technologies to target cancer—antibody-drug conjugation (ADC) and targeted protein degradation (TPD)—with the goal of creating drugs with new mechanisms of action as well as improved specificity and anti-cancer activity. “By combining the tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins, we believe that DACs may represent a next generation of cancer medicine for a wide range of solid tumors and hematologic malignancies,” said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. “With Seagen, our strategic goal is to advance ADC technology to the next level to provide patients with new DAC drugs that deliver greater anti-tumor efficacy and safety compared to currently available agents.” “The targeted protein degrader modality provides unique advantages over payloads currently employed across the ADC field,” said Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix. “This collaboration is a new application of our DELigase technology, and we are delighted to work with Seagen, a pioneer in the development and commercialization of ADC therapeutics, to create a new generation of drugs to fight cancer.” Under the terms of the agreement, Nurix will receive an upfront payment of $60 million and has the potential to receive up to approximately $3.4 billion in research, development, regulatory and commercial milestone payments across multiple programs. In addition, Nurix will be eligible for mid-single to low double digit tiered royalties on future sales, and Nurix retains an option for U.S. profit sharing and co-promotion on two products arising from the collaboration. As part of the multi-year collaboration, Nurix will use its proprietary DELigase platform to develop a suite of targeted protein degraders against multiple targets nominated by Seagen that are suitable for antibody conjugation. Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization. Given the potential to conjugate multiple antibodies to unique degraders, several DAC drugs may be developed and commercialized within this collaboration. With the receipt of the $60 million upfront payment, Nurix expects that its existing cash, cash equivalents and marketable securities, excluding any future potential milestones from collaborations, will be sufficient to fund its operating activities into the second quarter of 2025. About Nurix Therapeutics, Inc. Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines based on the modulation of cellular protein levels as a novel treatment approach for cancer and other challenging diseases. Leveraging extensive expertise in E3 ligases together with proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform, to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin-proteasome system to selectively decrease or increase cellular protein levels. Nurix’s wholly owned, clinical stage pipeline includes targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B, an E3 ligase that regulates activation of multiple immune cell types including T cell and NK cells. Nurix is headquartered in San Francisco, California.

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