EpiBiologics Launches with $50 million Series A Financing to Advance Next-Generation Protein Degradation Platform

On March 22, 2023 EpiBiologics, a biotechnology company building a next-generation antibody-based protein degradation platform for membrane and extracellular drug targets, reported the company launched with $50 million in Series A funding (Press release, EpiBiologics, MAR 22, 2023, View Source [SID1234643975]). The funding was co-led by Mubadala Capital and Polaris Partners, with participation from Vivo Capital and GV. The company’s technology platform is based on the scientific work of EpiBiologics’ co-founder and renowned antibody engineer Dr. Jim Wells of the University of California, San Francisco (UCSF), and the platform intellectual property has been exclusively licensed from UCSF.

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Protein degradation technologies are of high interest to the medical community because of their potential to attack disease targets that have been historically difficult to drug. However, companies pursuing these approaches have focused primarily on intracellular proteins. EpiBiologics’ proprietary EpiTAC platform expands the targeted protein degradation landscape to the extracellular space, enabling the company to target both membrane proteins and secreted proteins through the use of genetically encoded bifunctional antibodies. As reported in Nature Biotechnology and the Journal of the American Chemical Society, the Wells Lab at UCSF demonstrated that membrane E3 ligases and cytokine receptors could be leveraged as cell surface ligands to internalize and degrade a number of membrane or extracellular drug targets. EpiBiologics has now expanded the platform and built an atlas of tissue-specific degrader antibodies to target proteins for new treatments for a range of diseases, including cancer, immunology and neuro-related conditions.

"Our vision has been to build EpiBiologics to be the leading company in the extracellular degradation space," said Dr. Rami Hannoush, co-founder, interim CEO and President of EpiBiologics, who has also served as Chief Scientific Officer of the company since its inception. "Since launching the company, the team at EpiBiologics has been able to further validate and industrialize the EpiTAC platform, creating a fit-for-purpose atlas of degraders. The current financing will enable us to expand and validate the platform, advance our pipeline of drug candidates, and further build our talented team of scientists and protein engineers."

To strengthen their leadership and support their expansion, EpiBiologics also announced the appointment of Shyra Gardai as its incoming Chief Scientific Officer. With over 20 years of scientific and pre-clinical drug development experience across multiple key therapeutic areas, Dr. Gardai has served in roles of increasing responsibilities in the biotechnology industry, including most recently as Vice President of Therapeutic Discovery Research at Seagen.

"I’m looking forward to working with the talented team at EpiBiologics to develop innovative therapeutics for hard-to-treat diseases," said Dr. Gardai, CSO of EpiBiologics. "Leveraging EpiBiologics’ technology platform we are taking a novel approach to degrade disease-causing targets that evade existing therapeutic approaches."

"EpiBiologics represents a key example of our company formation efforts, where we worked hand-in-hand with the founding scientists to build the company from the ground up. We have a strong conviction in the transformative potential of EpiBiologics to advance the field of protein degradation," said Alaa Halawa, Executive Director and Head of the U.S. Ventures business at Mubadala Capital.

"We believe EpiBiologics’ core technology has the potential to greatly expand the scope of therapeutically relevant targets that can be successfully drugged through degradation, and we are excited to support their growing team of talented scientists, drug developers and industry leaders," said Alexandra Cantley, Partner at Polaris Partners.

2022 Annual Results Announcement

On March 22, 2023 WuXi Biologics reported its 2022 annual results (Filing, 3 mnth, DEC 31, WuXi Biologics, 2022, MAR 22, 2023, View Source [SID1234630448]).

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Entry into a Material Definitive Agreement

On March 22, 2023 Werewolf Therapeutics, Inc. (the "Company") reported that it has entered into a First Amendment to Amended and Restated Loan and Security Agreement (the "First Amendment") with Pacific Western Bank ("PWB"), which amended that certain Amended and Restated Loan and Security Agreement dated as of April 12, 2022, by and between the Company and PWB (Filing, 8-K, Werewolf Therapeutics, MAR 22, 2023, View Source [SID1234629252]). The First Amendment permits the Company to maintain depository accounts in an aggregate amount not exceeding $5,000,000 outside PWB. Prior to maintaining any such accounts, the Company and PWB will enter into a deposit account control agreement with respect to any such accounts.

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The foregoing description of the First Amendment is qualified by reference to the complete text of the First Amendment, a copy of which is attached hereto as Exhibit 10.1 and is incorporated into this Item 1.01 by this reference.

Clinical-Stage targeted Radiopharmaceuticals for treatment of cancer

On March 22, 2023 QSAM Biosciences presented its corporate presentation (Presentation, QSAM Biosciences, MAR 22, 2023, View Source [SID1234629249]).

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DEBIOPHARM ANNOUNCES LAUNCH OF THE PHASE 1/2 GaLuCi™ STUDY FOR ITS CA IX-TARGETED RADIOPHARMACEUTICAL PROGRAM

On March 22, 2023 Debiopharm (www.debiopharm.com), a Swiss-based, global biopharmaceutical company, aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, reported the first patient dosed of their first-in-human, phase 1/2 study, GaLuCi (Press release, Debiopharm, MAR 22, 2023, View Source [SID1234629179]). The first patient was screened and dosed at the Australian-based Peter MacCallum Cancer Centre. This multicenter international trial, evaluating a radioligand theranostic pair will be carried out in three stages: Part A to confirm the safety and reliability of Debio 0328 in detecting CA IX-expressing solid tumors, Part B to assess escalating doses of the therapeutic agent, Debio 0228 in patients, whose tumors show high uptake of Debio 0328 and finally, based on the recommended dose from part B, Part C will further assess safety and preliminary efficacy in selected tumor types.

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Currently, Debio 0228/0328 is the only peptide-based theranostic pair targeting CA IX in clinical development, with pan-tumor potential, and developed first for patients with advanced cancers such as renal, pancreatic, and colorectal. It leverages a theranostic approach to identify and deliver radiation to diseased tissues, allowing the imaging-based pre-identification of patients who have the target proteins necessary to respond to the targeted radioligand.

"The results of the GaLuCi trial are highly anticipated considering the therapeutic potential of Debio 0228 as observed in preclinical models. Using this theranostic pair could pave the way for personalized nuclear medicine, enabling administration of the lutetium coupled radioligand only to patients who are more likely to respond to the therapy." explained Angela Zubel, Chief Development Officer at Debiopharm.

"We always have immense gratitude for our patients who participate in first time in human trials, but in this case, we are particularly thankful for our patient who agreed to be the first person in the world to have their kidney cancer imaged with Debio 0328 on the GaLuCi trial. We hope this is the beginning of the theranostics era in kidney cancer!" expressed Dr. Ben Tran, Lead Genito-urinary medical oncologist, Peter MacCallum Cancer Centre.

"We are excited about this first-in-human study as it is a novel approach for advanced kidney cancer patients," said Darren R. Feldman, MD, Associate Attending Physician, Genitourinary Oncology Service at Memorial Sloan Kettering Cancer Center. "Precision nuclear medicine applied to CA9 could benefit advanced cancer patients who still experience a high unmet medical need. This theranostic pair allows targeted radiation delivery to the cancer cells bearing CA IX, which is largely expressed, over 85%, in clear cell renal cell carcinoma."

The theranostic approach with Debio 0228/0328
Debio 0228 ([177Lu]Lu-DPI-4452) and 0328 ([68Ga]Ga-DPI-4452) is an investigational theranostic pair originally discovered by 3B Pharmaceuticals GmbH and exclusively licensed to Debiopharm. ([68Ga]Ga-DPI-4452 is a PET imaging agent, (Debio 0328) used to identify patients whose cancers overexpress CA IX. Once identified, these patients can be treated with the lutetium-labelled radioligand, Debio 0228, which delivers targeted radiation to the tumor, destroying it from the inside.