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ViroCell Biologics and AvenCell Therapeutics Announce Retroviral Vector Manufacturing Collaboration to Accelerate Development of Novel Allogeneic CAR-T Therapies for Blood Cancers

On July 29, 2025 ViroCell Biologics ("ViroCell"), a specialist viral vector Contract Development and Manufacturing Organisation ("CDMO") for cell and gene therapy (CGT) clinical trials, reported a manufacturing collaboration with and the successful delivery of a novel retroviral vector to AvenCell Therapeutics, Inc. ("AvenCell"), a leading clinical-stage cell therapy company focused on advancing allogeneic switchable CAR-T cell therapies (Press release, AvenCell Therapeutics, JUL 29, 2025, View Source [SID1234654620]). This first retroviral vector will be used to manufacture AVC-203, an investigational CD19/CD20 dual-targeted cell therapy for the treatment of B cell malignancies and autoimmune diseases.

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AvenCell’s AV203 is its second investigational cell therapy using its differentiated allogeneic engineering to provide an "off-the-shelf" product engineered to overcome graft-versus-host disease as well as graft rejection by host T and Natural Killer ("NK") cells. AVC-203 is designed to achieve superior efficacy compared to currently-approved CAR-Ts while enabling immediate treatment and greater patient access at much lower cost and complexity. The further inclusion of AvenCell’s RevCAR receptor in AVC203 allows for additional antigen targeting (with "off/on" capability in vivo) beyond CD19 and CD20.

AvenCell selected ViroCell as its partner to manufacture the retroviral vector for this program based on the CDMO’s expertise and track record in delivering high yield vectors at speed. Incorporating a cell line acquired by AvenCell into the GMP manufacturing process, ViroCell successfully delivered a high yield vector while meeting AvenCell’s accelerated timeline. This program evidences ViroCell’s ability to deliver a bespoke, complex manufacturing process in the allogeneic CAR-T cell therapy space, ultimately, enabling AvenCell’s timelines for clinical entry. AvenCell’s AVC-203 is expected to enter a first-in-human phase I study in patients with relapsed/refractory B cell lymphoma in H2/2025.

John W. Hadden II, CEO of ViroCell, commented: "We are thrilled to partner with AvenCell and support their innovative allogeneic CAR-T therapy platform. I am proud of Team ViroCell’s accomplishments on the successful end-to-end delivery of this retroviral vector and accelerating a novel therapy into clinical development in an area of high unmet need. We look forward to continuing our work with AvenCell on their exciting platform."

Andrew Schiermeier, Ph.D., CEO, AvenCell, added: "We are delighted with ViroCell’s performance in process development and GMP manufacture of this complex retroviral vector. We selected ViroCell to support our platform because we knew that they could execute reliably in areas where other CDMOs can’t. The delivery of this retroviral vector for AVC-203 is proof that our trust in ViroCell was well placed."

Natera Announces Launch of ABCSG 61 (“TEODOR”), a Randomized Controlled Trial of Signatera™ in Early-Stage Breast Cancer

On July 29, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the launch of the TEODOR trial (Neoadjuvant TrEatment Optimization driven by ctDNA and endOcrine Responsiveness) (Press release, Natera, JUL 29, 2025, View Source [SID1234654619]). TEODOR is a Phase II, multicenter, randomized controlled trial (RCT) that aims to replace chemotherapy with endocrine therapy prior to surgery for a subset of women with hormone receptor-positive (HR+), HER2-negative breast cancer, who are endocrine responsive and test negative with Signatera.

Sponsored by the Austrian Breast & Colorectal Cancer Study Group (ABCSG), TEODOR expects to enroll approximately 250 patients across 15 sites in Austria. Previous studies have demonstrated that patients who test Signatera-negative at diagnosis and then receive chemotherapy have excellent outcomes, with risk of recurrence at less than 5%. In an effort to reduce pre-operative chemotherapy, which can carry significant side effects, this study is designed to evaluate the efficacy of endocrine therapy compared to chemotherapy in patients who are Signatera-negative.

After a four-week course of endocrine therapy, patients who are Signatera-negative and show a favorable endocrine sensitivity as measured by the Ki-67 proliferation index will be randomized to receive either additional endocrine therapy or chemotherapy. The primary endpoint of the study is the rate of neoadjuvant therapy response, assessed via pathological complete response (pCR) and modified Preoperative Endocrine Prognostic Index (PEPI) score across the endocrine therapy and chemotherapy arms of the trial. Secondary endpoints include long-term outcomes such as breast cancer recurrence and overall survival.

"TEODOR is designed to examine whether we can use endocrine responsiveness and ctDNA status to optimize systemic therapy in the neoadjuvant setting," said ABCSG President, Michael Gnant, M.D., FACS, FEBS, who serves as professor of surgery, Comprehensive Cancer Center, Medical University of Vienna, and principal investigator of the TEODOR trial. "This study marks a critical step toward more personalized medicine, leveraging the latest technologies to improve patient care."

"With the TEODOR trial, our goal is to identify patients who may be able to safely forgo chemotherapy," said Angel Rodriguez, M.D., medical director of oncology at Natera. "We are proud to collaborate with ABCSG on this important trial, and we hope this study will support the role of Signatera in guiding neoadjuvant therapy in breast cancer."

LTZ Therapeutics Announces Strategic Collaboration with Eli Lilly to Advance Development of its Myeloid Engager Platform for Autoimmune Diseases

On July 29, 2025 LTZ Therapeutics ("LTZ"), an immunotherapy-focused biotechnology company, reported a strategic research collaboration with Eli Lilly and Company ("Lilly") to develop novel myeloid engager therapeutics against selected targets for the treatment of diseases with high unmet need (Press release, LTZ Therapeutics, JUL 29, 2025, View Source [SID1234654618]).

Under the terms of the agreement, LTZ will receive a double-digit million USD upfront payment and an equity investment in the company. LTZ is also eligible to receive preclinical, clinical, regulatory and commercial milestone payments, in addition to tiered royalties on net sales of any resulting commercialized products.

"We are thrilled to enter into a strategic partnership with Lilly, a global leader in immunology and oncology," said Robert Li, Founder and CEO of LTZ. "This collaboration represents a pivotal step towards our mission in harnessing the potential of myeloid biology to address diseases with high unmet need. With Lilly’s expertise and global reach, we’re accelerating the development of our myeloid engager programs and we’re one step closer to bringing transformative therapies to the patients who need them most."

Hoth Therapeutics Announces Engagement with ICON and Expansion of Phase II Clinical Trial for HT-001 in Europe

On July 29, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, reported its engagement with ICON Clinical Research Limited ("ICON") to expand it’s Phase II Clinical Trial for cancer patients suffering from skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) (Press release, Hoth Therapeutics, JUL 29, 2025, View Source [SID1234654617]).

Additional regulatory approval for the Phase II clinical trial is expected from potentially three EU countries in the upcoming months. The EU approval is part of the Company’s international clinical development strategy for HT-001. The trial is currently enrolling patients in multiple sites in the United States. This Phase 2a dose- ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi. More information can be found at www.hoththerapeutics.com.

"We are delighted with the addition of clinical sites in the EU and for a strong partnership with ICON. ICON was selected based on their previous clinical trial management experience and their interest in novel therapies," said Robb Knie, CEO of Hoth Therapeutics. "Broadening the clinical presence in the EU serves dual purposes. First, it addresses the near-term objective of completing enrollment of the Phase II trial. Additionally, the initiation of sites in the EU establishes the groundwork for realizing our long-term goal of conducting a global Phase III trial."

ARTBIO Announces $132 Million Series B Financing to Advance Pipeline of Alpha Radioligand Therapies and Expand Manufacturing and Supply Chain Infrastructure

On July 29, 2025 ARTBIO, Inc. ("ARTBIO"), a clinical-stage radiopharmaceutical company developing a new class of alpha radioligand therapies (ARTs) to treat a range of cancers, reported the closing of a $132 million Series B financing co-led by new investors Sofinnova Investments and B Capital along with a life sciences dedicated investment fund that invested previously (Press release, ARTBIO, JUL 29, 2025, View Source [SID1234654616]). Further support came from existing investors F-Prime, Omega Funds, and Third Rock Ventures, and new investors Qatar Investment Authority and Alexandria Venture Investments. These proceeds will be used to advance the company’s development of ARTs.

"This sizable investment from both existing and new investors will enable ARTBIO to continue innovating therapies that treat a range of deadly cancers with power and precision," said Emanuele Ostuni, Ph.D., CEO of ARTBIO. "Our team is grateful for the investment and recognition of the need to build a supply chain that matches the properties of the therapies and the unique payload that we use."

This latest round of funding will support the advancement of ARTBIO’s pipeline, including its lead program, AB001, for metastatic castration-resistant prostate cancer, through Phase II clinical trials, and enable continued expansion of the company’s supply chain. The company plans to rapidly advance its manufacturing network infrastructure to supply global clinical trials, and ultimately, commercialization.

"ARTBIO’s approach to ART has the potential to positively change standards of care in cancer," said Robert Mittendorff, M.D., General Partner at B Capital. "ARTBIO’s lead asset, AB001, is designed to fully harness the unique power of lead-212. My team and I are excited for what’s to come."

A critical enabler of ARTBIO’s success is its patented AlphaDirect isotope isolation technology, which enables flexible production of clinical-grade lead-212 (212Pb) and therapeutic doses daily. This is achieved by a strategically distributed manufacturing network, improving access and de-risking common supply chain issues.

"With a differentiated ART portfolio and integrated manufacturing approach, ARTBIO represents the ideal company that we look to partner with," said Maha Katabi, Ph.D., General Partner at Sofinnova Investments. "Equally impressive is their proprietary generator technology which is a game-changer for navigating around supply and production challenges for radioisotopes in today’s complex environment."