On April 2, 2024 EpicentRx, Inc, a clinical-stage biotechnology drug and device company with two therapeutic platforms that address cancer and inflammatory diseases of unmet clinical need, reported that an abstract on its lead therapy, AdAPT-001, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held in San Diego, CA from April 5-10, 2024 (Press release, EpicentRx, APR 2, 2024, View Source;trap-program-in-checkpoint-inhibitor-resistant-patients-at-the-2024-aacr-meeting-302105991.html [SID1234641717]).

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AdAPT-001 constitutes a novel strategy to deliver a transforming growth factor-beta (TGF-β) trap to tumors. Importantly, data from a Phase 1/2 clinical trial demonstrate that administration of AdAPT-001 successfully converted immunologically cold tumors, such as sarcomas and triple negative breast cancer, into immunologically hot tumors. Furthermore, AdAPT-001 administration also demonstrates reversion of established resistance to checkpoint inhibitors.

"We’re excited to share groundbreaking clinical data with our lead therapy, AdAPT-001, against several treatment- and checkpoint inhibitor resistant solid tumors," said Tony R. Reid, MD, PhD, CEO of EpicentRx. "We’re also thrilled to be working with top-notch investigators like Dr. Anthony P. Conley from the MD Anderson Cancer Center and Dr. Lucy B. Kennedy from the Cleveland Clinic."

"Immune checkpoint inhibitors are largely ineffective against sarcomas. TGF-β is a soluble protein that suppresses immune responses," said treating study investigator and sarcoma oncologist, Dr. Conley from the MD Anderson Cancer Center. "Based on the several unprecedented responses that I have seen with AdAPT-001, which expresses a TGF-β trap, this TGF-β blockade from AdAPT-001 synergizes with PD-1/PD-L1 inhibition in checkpoint-resistant sarcoma."

Poster Presentation:
Title: Improved clinical outcomes in patients that received treatment beyond tumor progression with AdAPT-001 +/- a checkpoint inhibitor
Presenters: Dr. Anthony P. Conley of MD Anderson Cancer Center and Drs Tony Reid (CEO) and Chris Larson (VP) of EpicentRx.
Date and Time: Tuesday, April 9, 2024, 1:30 PM – 5:00 PM PDT
Location: Poster Section 48
Poster Number: 23

About AdAPT-001
AdAPT-001 is an investigational immunotherapy with a TGF-β receptor-immunoglobulin Fc fusion trap, designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and to sensitize resistant tumors to checkpoint blockade.

In the ongoing Phase 1/2 BETA PRIME trial, AdAPT-001 was administered as single-agent and in combination with checkpoint inhibitors to patients with treatment-refractory tumors.

Importantly, AdAPT-001 plus checkpoint inhibitors improved toxicity and AE profile over what is typically observed with checkpoint inhibitors. No dose limiting toxicities, AdAPT-001 related serious adverse events, or dose reductions have been observed to date.

On April 2, 2024 Convergent Therapeutics Inc., a clinical stage biotechnology company focused on developing next generation radiopharmaceutical therapies for the treatment of prostate cancer and other cancers, reported that the U.S. Food and Drug Administration ("FDA") has cleared the investigational new drug ("IND") application for CONV01-α, its lead candidate for the treatment of patients with advanced prostate cancer (Press release, Convergent Therapeutics, APR 2, 2024, View Source;a-best-in-class-radioantibody-targeting-prostate-specific-membrane-antigen-302106271.html [SID1234641716]).

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"Receiving clearance of our IND is a significant milestone for Convergent Therapeutics," said Convergent’s Co-founder and CEO, Philip Kantoff, MD. "While we have already treated well over 100 prostate cancer patients in the context of investigator INDs, this new IND will allow us to rapidly advance CONV01-α into Phase 3 studies and expand the scope of clinical development of CONV01-α as a monotherapy and in combination with other cancer therapies."

In a multi-dose, dose escalation study conducted in advanced prostate cancer patients, CONV01-α demonstrated a prostate-specific antigen decline of 50% (PSA50) in 67% of patients and a PSA decline of 90% (PSA90) in 27% of patients and was well tolerated.1 Ongoing studies suggest CONV01-α may be highly effective when used alone or in combination with other cancer therapies.

"Importantly, patients also showed minimal side effects in Phase 1/2 trials. CONV01-α’s ideal biodistribution delivers potent alpha particles while avoiding immediate and significant salivary gland toxicity as well as the potential delayed renal toxicity," said Neil Bander, MD, Convergent’s Co-founder and CSO. "CONV01-α’s design increases delivery of tumor-killing radiation to malignant cells while greatly reducing both off-tumor effects and the amount of radiation delivered per dose, thereby improving both treatment efficacy and safety."

About CONV01-α

CONV01-α, Convergent’s alpha emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA) which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called 225Ac, which releases alpha particles which kill cancer cells through DNA double strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful yet precise payload offers the ideal combination to treat many types of cancers.

On April 2, 2024 Marengo Therapeutics, Inc, a clinical-stage biotech company pioneering a new way to activate T cells that target the Vβ chain of the T cell receptor (TCR) and select the right T cell subsets against cancer, reported that Ipsen (Euronext: IPN; ADR: IPSEY) has nominated the first clinical drug candidate (DC) of two from its multi-year strategic partnership in oncology (Press release, Marengo Therapeutics, APR 2, 2024, View Source [SID1234641715]).

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This clinical candidate reflects a productive collaboration since the strategic partnership was signed in August 2022. Marengo and Ipsen plan to advance the program through IND-enabling studies and into clinical development. This nomination represents the first of two selective T cell activation repertoire (STAR) T cell bi-functional activator programs that Marengo and Ipsen will advance as part of the collaboration.

"The DC nomination is a testament to our close partnership with Ipsen and to the expertise and dedication of Marengo’s R&D team," said Zhen Su, M.D., MBA, Chief Executive Officer of Marengo. "It underscores the potential of our STAR TCR Vb T cell activator platform to deliver a range of first-in-class precision T cell bispecific antibodies for the treatment of refractory solid tumors. We look forward to the next phase of the collaboration as we work to advance treatment options for patients living with cancer."

Under the terms of the agreement, Marengo will receive a milestone payment for this pre-defined pre-clinical milestone. Marengo is leading the research and preclinical development efforts while Ipsen will assume responsibilities for regulatory submissions, clinical development and commercialization.

On April 2, 2024 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a clinical-stage immunotherapeutics company focused on oncology, reported that President and Chief Executive Officer Dr. Matt Coffey will participate in the Viral Approaches in Oncology panel at Canaccord Genuity’s Horizons in Oncology Virtual Conference, which is taking place on April 15, 2024. Additional details on the panel presentation can be found below (Press release, Oncolytics Biotech, APR 2, 2024, View Source [SID1234641714]).

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Date: Monday, April 15, 2024
Time: 9:00 a.m. ET
Panel Title: Viral Approaches in Oncology

A live webcast of the panel presentation will be available to registered attendees of the conference through the conference website. Company management will also be participating in virtual one-on-one investor meetings at the conference. To schedule a meeting, contact your Canaccord representative or email [email protected].

On April 2, 2024 Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, reported the acquisition of Modulus Therapeutics’ cell therapy platform assets, including their chimeric antigen receptor (CAR) and switch receptor libraries (Press release, Ginkgo Bioworks, APR 2, 2024, View Source [SID1234641713]).

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Modulus Therapeutics is a cell engineering company focused on the design of next-generation cell therapies for autoimmune diseases. In contrast to legacy cell therapy design, the company uses a combinatorial approach to build and screen cell therapy components that work in concert with one another to yield novel cell behaviors.

Modulus has used its platform to develop and screen libraries of novel NK-specific and T-cell specific CAR and switch receptor designs, which enable improved control and performance of immune cell-based therapies. This technology has the potential to improve the safety and efficacy of cell therapies by allowing for more precise control over activation and targeting. Modulus’ CAR-NK and CAR-T components are designed to enhance proliferation and cytotoxicity, even in inhospitable cellular environments, providing a deeper and more durable response against target cells.

Modulus’ assets complement Ginkgo’s extensive cell therapy capabilities. With this addition, Ginkgo looks forward to supporting its customers who are improving the performance of T-cell and NK-cell based CAR therapies to treat solid tumors, autoimmune, and other diseases.

Jason Kelly, CEO and co-founder of Ginkgo Bioworks: "Modulus Therapeutics has built an array of incredible cell therapy assets that we are excited to add into the significant cell therapy capabilities Ginkgo has developed to date. Modulus’ CAR and switch receptor designs and libraries seamlessly integrate into our existing infrastructure and offerings. We are excited to put these new assets to work for our customers and contribute to the transformative advancements in CAR and cell therapies."

Max Darnell, CEO and co-founder of Modulus Therapeutics: "At Modulus, we have always been motivated by enhancing access to cutting-edge cell therapy innovation. We’re very pleased that Ginkgo Bioworks shares this commitment and can leverage our technology to help transform oncology and autoimmune cell therapies. We are thrilled to contribute our innovative designs to the Ginkgo ecosystem, and look forward to seeing these tools deployed across a range of Ginkgo-partnered programs."

Ginkgo’s platform works to enable its partners to sample CAR domains with a variety of functional roles and structural positions, sourced from diverse immune cell types. This approach to cell therapy discovery allows partners to thoroughly sample the breadth of therapeutic activities a CAR can produce. Last year, Ginkgo entered a partnership with the Wisconsin Alumni Research Foundation (WARF) to discover and develop next-generation CAR-T cell therapies. Ginkgo also presented new data on its high throughput pooled screening method to discover novel CAR-T designs for solid tumors at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in 2022, as well as data on its high-throughput screening platform for chimeric antigen receptor (CAR) libraries at the 26th American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting in 2023. The poster highlighted Ginkgo’s Foundry-enabled methods for large-scale, combinatorial library design and screening of CAR domains for improved persistence. Ginkgo expects Modulus’ cell therapy assets to help Ginkgo continue to strengthen its CAR-T research & development offerings.