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.

On April 2, 2024 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, reported that on March 6, 2024, the European Patent Office (EPO) issued EP patent 3,823,617 (‘617 patent) covering the pharmaceutical composition of matter for the company’s lead compound, LNS8801 (Press release, Linnaeus Therapeutics, APR 2, 2024, View Source [SID1234641712]).

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Linnaeus’s patent disclosure is directed toward the pharmaceutical composition of matter of LNS8801 and embodies (1) an enantiomerically purified compound SRR G-1, or a derivative thereof, including specific crystal forms, salts, and co-crystals, that modulates G protein-coupled estrogen receptor activity; (2) pharmaceutical and cosmetic compositions comprising an enantiomerically purified SRR G-1, or a derivative thereof; and (3) methods of treating or preventing disease states and conditions and cosmetic conditions mediated through these receptors and related methods thereof in humans and animals.

"We are extremely pleased that the EPO has issued this composition of matter patent," commented Patrick Mooney, MD, CEO of Linnaeus. "We are thrilled to have these issued claims in both the US and Europe, and we believe that they will provide critical market protection for LNS8801 into the 2040s. As we continue to collect very promising data from our clinical trials with LNS8001, we will continue to prosecute the claims in this patent worldwide."

Linnaeus is currently conducting an open-label phase 1/2 study assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced cancer, including cutaneous melanoma.

Based on promising data from the phase 1/2 study, Linnaeus plans to initiate a potentially pivotal, randomized controlled trial in patients with metastatic cutaneous melanoma who have had confirmed progression on immune checkpoint inhibitors. The study will enroll 135 patients who will be selected based on a predictive biomarker and then randomized to receive LNS8801 alone, LNS8801 and pembrolizumab, or physician’s choice therapy. Key endpoints will include an analysis of progression-free survival and overall survival between the treatment groups. Over 25 comprehensive cancer centers in the United States are eager to participate in this study.

About LNS8801

LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory.

In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and durable clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified.

About Metastatic Cutaneous Melanoma
Although there has been progress in the treatment of metastatic cutaneous melanoma, most patients will progress on standard-of-care therapies and need further treatment. According to the American Cancer Society, almost 8000 patients die each year in the United States, highlighting the need for safe and effective therapies in the treatment-refractory setting.