On November 12, 2024 Alentis Therapeutics ("Alentis"), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, reported that it has raised $181.4 million in Series D financing, supported by a syndicate of top-tier biotech investors (Press release, Alentis Therapeutics, NOV 12, 2024, View Source [SID1234648155]). The financing will support Alentis to develop a deep pipeline of CLDN1 targeted medicines for solid tumors.

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The funding round was led by OrbiMed with co-leads Novo Holdings and Jeito Capital. New investors Frazier Life Sciences, Longitude Capital, Catalio Capital, Piper Heartland Healthcare Capital and Avego Bioscience Capital participated in the round. Significant backing was also received from existing investor RA Capital Management, along with support from Morningside Venture Investments, BB Pureos, Bpifrance through its InnoBio 2 fund, as well as other early institutional investors, all of whom have been instrumental to Alentis’ development path.

"This financing is a testament to the transformational potential of CLDN1 antibody-drug conjugates (ADCs) for the treatment of solid tumors," said Roberto Iacone, Chief Executive Officer of Alentis. "Let me take this opportunity to extend a warm welcome to our new investors." Dr. Iacone added, "We’re excited to execute our development strategy and deliver clinical data for our programs over the next 12-18 months."

The proceeds of the financing will be used to conduct Phase 1/2 clinical trials of two first-in-class ADCs targeting CLDN1, ALE.P02 and ALE.P03, further development of the pipeline, and general corporate purposes.

The FDA recently cleared an IND application for a Phase 1/2 clinical trial of ALE.P02 (with a tubulin inhibitor) in advanced or metastatic CLDN1+ squamous solid tumors. The clinical trial is expected to commence Q1 2025. For ALE.P03 (with a topoisomerase I inhibitor), a first-in-human trial in patients with CLDN1+ tumors is planned to start in 2025.

Luca Santarelli, Chairman of Alentis said, "I am excited about the future of Alentis, especially after this very significant financing, and would like to welcome the new Board Members that will join after the closing of the transaction."

OrbiMed Partner, Dina Chaya said, "With this financing, Alentis is now well positioned to advance its CLDN1 antibody-drug conjugates, which have the potential to be first and best-in-class therapies for the treatment of cancer."

"ADCs have shown their potential to be highly effective cancer treatments," said Naveed Siddiqi, Senior Partner at Novo Holdings, Venture Investments. "Alentis has an exciting pipeline of first-in-class ADCs and we are proud to have co-led this round. We are looking forward to seeing the data generated from the first clinical trials of ALE.P02 and ALE.P03."

Dr. Rafaèle Tordjman, Founder and CEO of Jeito Capital said, "We are excited to co-lead this major new financing round for Alentis that further validates the strength of its pipeline. We look forward to continuing to bring our expertise to support their development."

New Board of Directors Appointments
As part of the financing, three new Board Members will join the Alentis Board of Directors, further strengthening the business, science and drug development expertise at the Board level.

Dina Chaya, Partner at OrbiMed, has over 20 years of experience in healthcare investments, specializing in biopharma and medical technology.
Anna Chen, Principal at Frazier Life Sciences, where she has been involved with investing in and building many of Frazier Life Sciences’ biopharmaceutical portfolio companies over the past 7 years.
Brian Liu, Managing Director at Longitude Capital, brings more than 10 years of biopharma consulting and investing experience, focusing on transformative healthcare innovation.
About ALE.P02 and ALE.P03
ALE.P02 and ALE.P03 are first-in-class ADCs designed by linking a potent cancer drug (a tubulin and topoisomerase I inhibitor, respectively) to our antibody that specifically targets a unique CLDN1 epitope exposed on cancer cells. This combination creates a powerful new tool to fight cancer with less toxicity than traditional cancer drugs. The IND application for ALE.P02 to commence a Phase 1/2 clinical trial in advanced or metastatic CLDN1+ squamous solid tumors was recently cleared by the FDA.

On November 12, 2024 Agenus Inc. ("Agenus" or the "Company") (Nasdaq: AGEN), an immuno-oncology company focused on innovation, reported a corporate update and reported financial results for the third quarter of 2024 (Filing, 3 mnth, SEP 30, Agenus, 2024, NOV 12, 2024, View Source [SID1234648154]).

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"BOT/BAL represents one of the most significant advancements in cancer immunotherapy, showing remarkable results in MSS colorectal cancer where previous treatments have fallen short," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "Its potential extends beyond this challenging cancer type, with promising efficacy seen in the neoadjuvant setting and other hard-to-treat cancers. While we are excited by these achievements, we remain mindful of the financial challenges that come with advancing such breakthrough therapies. We are focused on strategic initiatives, including asset monetization and operational efficiencies, to strengthen our financial position and continue driving forward. We are confident in our path and unwavering in our commitment to deliver innovative treatments that redefine patient care and create long-term value for our patients and shareholders."

Key Highlights from Q3 2024

Breakthrough Clinical Progress – Botensilimab (BOT) and balstilimab (BAL) continues to deliver unprecedented outcomes across multiple cancer settings.

•Neoadjuvant MSS Colorectal Cancer (CRC): BOT/BAL is advancing in 3 ISTs with consistent clinical activity in MSS CRC, a tumor historically resistant to immunotherapy. Initial results from Cornell study (ESMO GI 2024) show groundbreaking potential; results from additional trials in Italy and the Netherlands expected to be presented at prestigious oncology conferences in early 2025.
•Broad and Durable Responses in Sarcoma and other cancers: Presentations at ESMO (Free ESMO Whitepaper)2024 highlighted BOT/BAL’s clinical activity advanced sarcomas and other difficult-to-treat cancers, reinforcing its potential to redefine cancer treatment. Additional data updates are expected to be shared at key oncology conferences in the coming months.

Expanding Patient Access Globally – Agenus is committed to expanding patient access to BOT/BAL through Compassionate Use and Named Patient Programs, providing innovative treatment options for patients with limited alternatives. These programs empower

physicians to deliver advanced care as regulatory frameworks evolve to support broader patient access.

Strategic Financial Initiatives – Agenus is actively pursuing a disciplined approach to strengthen its financial foundation:

•Operational Efficiencies: Cash outflows have been significantly reduced through focused measures.
•Asset Monetization: Discussions to monetize real estate assets are progressing, reflecting increased interest and opportunities following the recent U.S. elections, which have positively impacted financial markets. These monetization efforts are expected to provide near-term cash infusions to support operations.
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Near-Term Transaction: Agenus is also advancing discussions on a strategic transaction designed to deliver substantial resources. The company views its current financial initiatives as a bridge to this transformative step, which is expected to position Agenus for long-term growth while maximizing value for shareholders.

Regulatory Alignment – Ongoing discussions with the European Medicines Agency (EMA) have progressed to agreement on dose selection and trial design for the pivotal Phase 3 study in MSS CRC, marking significant progress in BOT/BAL’s development. These achievements reflect a collaborative effort to enable access to this transformative combination to patients worldwide.

On November 12, 2024 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation to elraglusib, a novel GSK-3β inhibitor for treatment of Ewing sarcoma (EWS) (Filing, Actuate Therapeutics, NOV 12, 2024, View Source [SID1234648153]).

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"Receiving rare pediatric disease designation from the FDA underscores the urgent need for new treatment options for patients with EWS and recognizes elraglusib’s transformative potential," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "Early clinical data from our ongoing Phase 1/2 trial show promising anti-tumor activity with objective tumor responses, including two ongoing durable Complete Responses (CRs) in the first six patients treated with relapsed/refractory EWS, reinforcing our confidence in elraglusib’s potential impact in this challenging disease setting. We are committed to advancing elraglusib’s clinical development with the ultimate goal of providing new therapeutic options where current approaches are unsatisfactory."

Ewing sarcoma (EWS) is a highly metastatic form of sarcoma, originating in bone with a peak incidence at the age of 15, that ranks as the second most prevalent primary malignant tumor of childhood and adolescence. Approximately 25% of new EWS patients have metastatic disease when first diagnosed, which is the most significant predictor of poor survival. The ongoing Phase 1/2 Trial (NCT 04239092), also referred to as Actuate-1902, is an open-label, multicenter study evaluating the safety and efficacy of elraglusib in pediatric patients with relapsed/refractory malignancies, including EWS and EWS-related pediatric small round cell sarcomas. To date, the study has enrolled 8 patients with relapsed/refractory EWS (>1 remission) treated with the combination of elraglusib and topotecan/cyclophosphamide.

Rare Pediatric Disease Designation is granted by the FDA for serious or life-threatening diseases that affect fewer than 200,000 people in the United States and in which the serious or life-threatening manifestations primarily affect individuals less than 18 years of age. If, in the future, a New Drug Application (NDA) for elraglusib for the treatment of Ewing sarcoma is approved by the FDA, Actuate will be eligible to receive a Priority Review Voucher (PRV) that could be utilized by the Company or potentially sold to another company for its use.

On November 12, 2024 Zetagen Therapeutics, Inc., a private, clinical stage, biopharmaceutical company focused on developing breakthrough therapies, via local administration, for metastatic breast cancer to bone and soft tissues, announced today that the first two patients have enrolled in the phase 2a study, which will evaluate ZetaMet (Zeta-BC-003) in the treatment of spinal metastatic lytic breast cancer lesions (ClinicalTrials.gov #NCT05280067) (Press release, Zetagen Therapeutics, NOV 12, 2024, View Source [SID1234648152]).

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"Our discovery is the first of its kind with the potential to be a curative therapy for this high unmet need," stated Joe C. Loy, CEO of Zetagen. "Our vision is to deliver breakthrough therapies to all individuals affected by metastatic breast cancer, offering them pain relief, a higher quality of life, while increasing survival rates. The commencement of this study represents a major milestone in the development of ZetaMet(Zeta-BC-003) and brings us closer to turning our vision into reality."

The 26-week study, conducted at the University of British Columbia, (UBC) Vancouver, BC, Canada, will evaluate the safety and efficacy of ZetaMet (Zeta-BC-003) in treating vertebral bone defects created by lytic metastatic breast cancer. The study will measure the reduction of skeletal related events (SRE), pain, change in vertebral body defect size, and postoperative prescription opioid use.

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ZetaMet (Zeta-BC-003)
ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, delivered via a proprietary controlled- release carrier intended to resolve metastatic breast cancer bone lesions, inhibit pain while regenerating bone, with the potential to increase survival rates.

ZetaMet’s (Zeta-BC-003) small molecule mechanism of action (MOA) via a novel molecular pathway initiates a circuit which results in tumor cell death.

The US Food & Drug Administration (FDA) has recognized Zetagen’s discoveries with multiple Breakthrough Designations including ZetaMet (Zeta-BC-003).

Zetagen with FDA approval via the Expanded Access (Compassionate Use) program has treated several patients with ZetaMet (Zeta-BC-003) with results published in multiple peer-reviewed journals.

Peer-reviewed 2-year follow up clinical data published in 2023 on ZetaMet (Zeta-BC-003) demonstrated resolution of 7 lytic lesions (radiated and non-radiated), reduction in pain, significant attrition of opioid pain medication (4-fold), prevention of vertebral fracture, and increased survival rate in a patient living with Stage 4 breast cancer.i To view this publication via open access, go to: View Source

On November 12, 2024 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a collaboration with the McGill University Centre for Microbiome Research to support microbiome research activities and outcomes (Press release, Qiagen, NOV 12, 2024, View Source [SID1234648130]).

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The three-year partnership will further drive microbiome sciences – the study of a community of microorganisms that can be found living together in any environment, including the human body. It will focus on key areas such as DNA extraction from low microbial biomass samples and anaerobic culturing protocols.

The collaboration is expected to strengthen QIAGEN’s presence in microbiome research across North America which represents a $1.8 billion market. It also will help to gain a deeper understanding of the needs of the scientific community for studying the function of vast microbial ecosystems and how they can be shaped to improve health and mitigate disease. QIAGEN will support the McGill Centre for Microbiome Research with reagents for research across a variety of microbiology and genomic processing workflows and contribute to joint research projects demonstrating the suitability of QIAGEN products for microbiome science. The collaboration will also enable the McGill Centre for Microbiome Research to better train the next generation of scientists and to make microbiome research accessible to a wider range of scientific domains.

"Partnering with McGill University, a leading institution known for its outstanding research and educational programs, underscores our commitment to advancing microbiome research," said Nitin Sood, Senior Vice President and Head of the Life Sciences Business Area at QIAGEN. "This collaboration will enhance our ability to develop new microbiome solutions based on customer feedback and support the scientific community in uncovering new insights into the microbiome’s impact on health and disease."

"Microbial communities are central to the functioning of every known ecosystem, including the human body. Yet, we are only scratching the surface in understanding how these abundant, incredibly diverse and dynamic communities impact human health and ecosystems at large. This exciting partnership with QIAGEN will help us provide the tools and approaches to microbiome researchers at McGill University and from all around the province of Quebec to keep pushing the boundaries of our knowledge," said Corinne Maurice, PhD, co-director of the McGill Centre for Microbiome Research and Canada Research Chair in Gut Microbial Interactions.

Microbiome research aims to explore the relationships between microorganisms such as bacteria, fungi and viruses, and their hosts. It can help to better understand the microbiome’s impact on health, disease, and microbial ecological processes to develop novel diagnostic and therapeutic strategies. QIAGEN products will be used in the experimental platforms of the McGill Centre for Microbiome Research, and the Centre will also function as a beta-testing site for the development of new QIAGEN products for microbiome applications and to refine and optimize these for broader applications in the scientific community.

The partnership further drives QIAGEN’s strategy to advance microbiome research. At the beginning of 2024, the company announced a partnership with Penn State University in the United States to create a shared research and education facility for the fast-developing microbiome sciences. It aims to investigate research opportunities that address challenges and research gaps facing the microbiome.

McGill University is one of the top research universities globally. The McGill Centre for Microbiome Research provides McGill investigators and their partners with infrastructure and resources to generate evidence-based knowledge for the benefit of medicine and public health. The Centre aims to integrate and synergize microbiome research activities by offering services through two distinct, yet complementary experimental platforms housed at the Research Institute of the McGill University Health Centre (Gnotobiotic Animal Research platform) and downtown campus (Microbial Services Platform).

The Gnotobiotic Animal Research Platform investigates the effects of specific microbial taxa and communities on health and how microbial communities can be modified for improved health. The Microbial Services Platform provides experimental design services and specializes in sample processing for sequencing, as well as culturomics under anaerobic conditions, key steps to assess microbial content and identify key microbes, including pathogens, associated with health and disease.

The McGill Centre for Microbiome Research is dedicated to understanding the complex interactions between microbial communities and their hosts and is committed to make microbiome research accessible to a wide range of scientific domains in Montreal.

QIAGEN’s comprehensive microbiome portfolio encompasses tools for every aspect of the scientific workflow, including reliable sample preparation kits optimized for investigating challenging samples from environmental and human microbiomes. To ensure reproducibility, QIAGEN offers sample preparation automation for standardization and reliability. The extensive range of microbiome solutions also includes downstream processing technologies such as NGS, digital PCR (dPCR), or quantitative PCR (qPCR), all complemented by robust bioinformatics tools for seamless digital analysis.

Learn more about QIAGEN’s solutions for microbiome research at View Source