On March 22, 2023 EpiBiologics, a biotechnology company building a next-generation antibody-based protein degradation platform for membrane and extracellular drug targets, reported with $50 million in Series A funding (Press release, EpiBiologics, MAR 22, 2023, View Source [SID1234629202]). 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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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.

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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.

On March 22, 2023 Morphimmune, Inc., a preclinical biotechnology company focused on developing targeted oncology therapeutics, reported the appointment of Clay Siegall, Ph.D. as its CEO and President (Press release, MorphImmune, MAR 22, 2023, View Source [SID1234629201]).

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"Clay is a highly passionate and effective leader with a demonstrated ability to build significant value for an emerging biotechnology company," said Isaac Barchas, Morphimmune’s Founding Board Chairman, co-founder and CEO of Research Bridge Partners, which made seed capital and follow-on investments in the company in 2020. "His emphasis on scientific and clinical excellence will drive Morphimmune’s development of novel targeted therapeutics with the goal to deliver significant benefit to cancer patients."

"I am pleased to join Morphimmune as CEO," said Dr. Siegall. "Morphimmune’s targeted effector platform has the potential to deliver the next generation of oncology therapeutics. I look forward to advancing the company’s pipeline into the clinic while expanding its technology suite."

"Clay immediately understood the vision for Morphimmune and is the right leader to advance our goal of saving patient lives," said Dr. Philip Low, Morphimmune co-founder.

Dr. Siegall previously served as the CEO and President of Seagen, Inc., which he co-founded in July 1997. Under his nearly 25 years of leadership, Seagen became the world leader in ADC therapeutics, earned FDA approvals for four cancer therapies, and grew to over $2 billion in annual revenue. During his tenure, he raised well over $1 billion of financing for Seagen from public and private markets and oversaw the company’s acquisition of Cascadian Therapeutics. Earlier this month, Pfizer, Inc. agreed to purchase Seagen for $43 billion.

Prior to Seagen, Dr. Siegall worked in positions of increasing responsibilities at Bristol Myers Squibb and the National Cancer Institute. He earned a Ph.D. in Genetics at George Washington University and a B.S. in Zoology at the University of Maryland.

Morphimmune was founded on the research of the company’s scientific co-founder Dr. Low, the Presidential Scholar for Drug Discovery and Ralph C. Corley Distinguished Professor of Chemistry at Purdue University. Dr. Low previously founded Endocyte, which Novartis acquired for $2.1 billion in 2018. He has published more than 500 articles and has over 700 patents/patents pending, in addition to being the founder of seven companies to commercialize these discoveries.

On March 22, 2023 InvoX Pharma Limited ("invoX"), a U.K.-based wholly-owned subsidiary of Sino Biopharmaceutical Limited ("Sino Biopharm") (HKEX 1177 HK) with an advancing pipeline of innovative products, reported that F-star, an invoX company, has entered into a second licence agreement with Takeda for a novel next-generation immuno-oncology bispecific antibody (Press release, , MAR 22, 2023, View Source [SID1234629199]).

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Under the terms of the licence agreement, F-star will grant Takeda a worldwide, exclusive royalty-bearing licence to research, develop, and commercialize a bispecific antibody directed towards an undisclosed immuno-oncology target using F-star’s proprietary Fcab and mAb2 platforms. Takeda will be responsible for all research, development and commercialisation activities under the agreement. F-star will receive an undisclosed upfront licence fee and is eligible to receive potential future development and commercialization milestone payments, plus royalties on annual net sales.

This licence agreement represents the second option that Takeda has exercised under an evaluation and licence agreement with F-star that was entered into in July 2021. F-star and Takeda entered into a licence agreement for a different bispecific antibody in July 2022.

Neil Brewis, Ph.D., Chief Executive Officer of F-star said: "This second licence agreement with Takeda provides further validation of the enormous potential of F-star’s mAb2 platform to produce multiple next-generation bispecific antibody therapeutics. We look forward to our continued partnership with Takeda who share our vision of developing pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives."

"Takeda is committed to developing novel therapies that harness the innate immune system to fight cancer," said Kathy Seidl, Ph.D., head of the Oncology Drug Discovery Unit at Takeda. "This second license agreement with F-star allows us to apply the mAb2 platform to generate novel bispecific antibodies leveraging innate immune mechanisms to eliminate tumor cells creating value for the patients we serve."

On March 22, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported a new study published in Cancer showing the prognostic and predictive utility of Natera’s personalized and tumor-informed molecular residual disease (MRD) test, Signatera, to inform adjuvant treatment decisions and monitor for recurrence and therapy response in patients with stages III-IV melanoma (Press release, Natera, MAR 22, 2023, View Source [SID1234629196]). The full study can be found here.

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This study analyzed 555 prospectively collected plasma samples from 69 patients with stages III-IV melanoma, analyzed in three cohorts. Key takeaways include:

Cohort A: Resectable stage III patients receiving immunotherapy or observation in the adjuvant setting:
MRD positivity post-resection was associated with significantly shorter distant metastasis-free survival (HR=10.77; p=0.01), and identified patients most likely to benefit from adjuvant therapy. Signatera detected recurrence with an average lead time of 3 months over standard imaging.
Cohort B: Unresectable stage III/IV patients receiving immunotherapy:
An increase in ctDNA levels 3-11 weeks after starting immune checkpoint inhibitor therapy was associated with significantly shorter progression-free survival (HR=22; p=0.006). All patients with increasing ctDNA experienced disease progression (4/4), while all patients with decreasing ctDNA achieved complete or partial response (15/15). In two patients, Signatera also correctly differentiated between true progression vs. pseudo-progression.
Cohort C: Stage III/IV patients in surveillance after completion of immunotherapy:
100% (7/7) of patients who were ctDNA-negative during surveillance remained progression-free until the last follow up (median 14.67 months), while all ctDNA-positive patients (3/3) experienced disease progression.
"ctDNA is emerging as a potential biomarker for informing adjuvant treatment decisions and assessing treatment response in metastatic disease in real-time," said Zeynep Eroglu, M.D., medical oncologist in the department of cutaneous oncology at Moffitt Cancer Center and lead author of the study. "Our study shows the potential for a personalized, tumor-informed ctDNA assay to help with making informed and timely treatment decisions for patients with advanced melanoma across treatment settings. We hope that this will be explored further in prospective clinical trials."

This new study builds upon prior literature supporting the validity and utility of Signatera for pan-cancer immunotherapy monitoring,1 which was the basis for Medicare’s local coverage determination issued in 2021. Although the use of immune checkpoint inhibitors has led to significant improvements in overall survival rates for patients with advanced melanoma,2-6 response can be difficult to assess and treatment related toxicity remains a problem. Current guidelines recommend periodic imaging and clinical assessment to determine therapeutic efficacy;7 however, imaging-based surveillance has limitations. This illustrates the unmet need for diagnostic tools, like Signatera, to help predict immunotherapy benefit in the adjuvant and metastatic settings and to identify patients early who have resistance to therapy.

"This collaborative analysis of real-world data supports the prognostic and predictive value of Signatera in the clinical management of melanoma patients after surgery, and those receiving an immune checkpoint inhibitor," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "It is critical to balance treatment-related benefit with toxicity, and ctDNA assessment by Signatera provides a means by which to predict and evaluate benefit from immunotherapy in melanoma, the deadliest of all skin cancers."

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

On March 22, 2023 BostonGene reported a collaboration with Little Warrior Foundation to drive the discovery, validation, and implementation of novel liquid biopsy solutions into sarcoma clinical practice (Press release, , MAR 22, 2023, View Source [SID1234629195]).

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Little Warrior Foundation was founded in 2020 with a simple mission to fund and find a lasting cure for childhood cancer, specifically focusing on Ewing Sarcoma. Funds the foundation raises are granted to researchers and institutions developing high-potential therapies and novel solutions for pediatric applications.

Sarcomas are malignant tumors originating in connective and supportive tissue and are incredibly diverse at the histological and molecular levels. Thus, in sarcomas, clinical decision-making often relies on the molecular features of each unique tumor. Further, sarcomas are fusion-rich, with various fusions as known drivers of myriad sarcomas, highlighting the importance of RNA-based analysis in sarcomas. Broad liquid biopsy panels have limited applicability for individual cancer types due to the unique molecular landscape of each cancer type; therefore, Little Warrior Foundation has partnered with BostonGene to develop sarcoma-specific cfDNA and cfRNA liquid biopsy assays to increase the sensitivity and accuracy of detecting sarcoma-related molecular alterations and fusions. In this collaboration, BostonGene will develop sarcoma-specific cfDNA and cfRNA liquid biopsy assays, aiming at implementing them into clinical practice for both pediatric and adult sarcomas.

"Our partnership with BostonGene enables us to accelerate research and development efforts by identifying novel solutions for patients with Ewing Sarcoma and related sarcomas," said Piero Spada, President and Co-Founder, Little Warrior Foundation. "We expect this collaboration to provide physicians with the necessary tools to monitor for relapse and reoccurrence in a more efficient manner, ultimately impacting integral clinical decisions for patients."

"We share a commitment with Little Warrior Foundation to develop and implement breakthrough solutions for patients with myriad sarcomas," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "BostonGene’s advanced sequencing and analytics will propel the development of more effective treatment strategies, ultimately positively impacting pediatric and adult patients."