On April 7, 2026 Pluristyx, a leader in advanced induced pluripotent stem cell (iPSC)-based solutions, reported expansion of its intellectual property portfolio with a U.S. patent allowance for claims covering cells expressing autoimmune-associated self-antigens coupled with its exclusive induced Allogeneic Cell Tolerance (iACT Stealth) technology for "cell cloaking".

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The newly allowed patent claims are specifically drawn to the use of iACT in the treatment of autoimmune diseases. With this technology Pluristyx can combine a genetic engineering package integrating iACT Stealth with self-antigen technology, and "train" a patient’s own immune system. This innovative approach allows for a precise, desired immune response to a self-antigen without dangerous "off-target" effects or using traditional debilitating systemic immune suppression.

This patent marks a pivotal shift in the use of cell therapy beyond oncology. By pairing iACT Stealth cloaking with specific self-antigens, Pluristyx is enabling development of "tolerogenic" cell therapies. Unlike traditional methods that broadly suppress the immune system, leaving patients vulnerable to infections, this technology allows engineered cells to persist in the body and specifically retrain the immune system to stop attacking itself. This represents a new frontier in "living medicine," where engineered iPSC-derived cells act as a localized, intelligent platform for long-term autoimmune remission.

iACT Stealth is designed to work in tandem with Pluristyx’s FailSafe technology. FailSafe’s drug-inducible safety feature acts as a genetic "kill switch," allowing for the selective removal of any proliferating cells to ensure patient safety and is the only commercially-available safety switch technology.

"This addition to our patent portfolio furthers our commitment to advancing regenerative, living-medicine therapies, now in the autoimmune field," said Kaye Reiter, PhD, JD, Pluristyx Chief Legal Officer. "We continue to expand our exclusive intellectual property portfolio of combined iPSC, FailSafe, and iACT Stealth technologies that are setting the standard for functionality, safety, and scalability".

Pluristyx’s full suite of technologies, including iACT Stealth, FailSafe, and proprietary mRNA-based iPSC reprogramming technology, is available for immediate adoption through a streamlined research evaluation and commercial licensing model. This provides partners today with a powerful, clinical-grade foundation to bring tomorrow’s next-generation living medicines to market.

(Press release, Pluristyx, APR 7, 2026, View Source [SID1234664225])

On April 7, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported it will present new data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting in Boston, Massachusetts on May 14, 2026. The Company will present data on its RedTail platform.

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RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetic payloads directly at the tumor site while limiting peripheral exposure. Data presented at the ASGCT (Free ASGCT Whitepaper) meeting by Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations for Calidi, will showcase the ability of the RedTail extracellular enveloped and CD55-overexpressing virus (EEV) to avoid immune clearance, replicate only in target cells, and deliver high concentrations of genetic medicine to sites of disease.

CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist (IL-15 SA), a known T- and NK-cell activator, in the TME. The Company expects to file an IND for CLD-401 by the end of 2026. Additionally, Calidi is expanding the RedTail platform to enable in situ expression of T-cell engagers (TCEs) in solid tumors, including in combination with T-cell activating payloads such as IL15 SA. This strategy is intended to support localized T-cell- engagement within the tumor microenvironment following systemic administration.

"The data we will present at ASGCT (Free ASGCT Whitepaper) highlight the advances we have made with our novel approach to the targeted, systemic delivery of genetic medicines" said Dr. Santidrian. "In our preclinical and syngeneic models, we are seeing profound biology driven by targeted genetic expression with RedTail candidates."

"We continue to advance the RedTail platform with an IND filing expected this year for CLD-401" said Eric Poma, PhD, Chief Executive Officer of Calidi. "We continue to expand what the RedTail platform can do with new payload, a novel approach to in situ T-cell engagers, and ongoing lead discovery in indications outside of oncology."

The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

(Press release, Calidi Biotherapeutics, APR 7, 2026, View Source [SID1234664224])

On April 7, 2026 Recursion (Nasdaq: RXRX), a leading clinical-stage TechBio company decoding biology to radically improve lives, reported its participation in the following upcoming investor conferences:

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25th Annual Needham Virtual Healthcare Conference – Monday, April 13, 2026
Bank of America Health Care Conference 2026 – Tuesday, May 12, 2026

Webcasts may be found in the events section of the Recursion Investor Relations website at ir.recursion.com.

(Press release, Recursion Pharmaceuticals, APR 7, 2026, View Source [SID1234664223])

On April 7, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, reported that the U.S. Food And Drug Administration (FDA) has granted Fast Track Designation for SIM0505 for the treatment of platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload.

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"Securing Fast Track designation for SIM0505 validates the urgent, unmet need for new treatments for platinum resistant ovarian cancer and enables us to work more closely with FDA to accelerate development. We believe this designation will help to streamline and de-risk development through proactive and ongoing engagement with FDA," said Michael Richman, President and CEO of NextCure. "We are committed to bringing SIM0505 to patients as quickly as possible and we plan to initiate dose optimization in ovarian cancer patients in the second quarter of 2026. In addition, we look forward to presenting Phase 1 data on the program at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference."

About Fast Track Designation

Fast Track Designation is an FDA process designed to facilitate the development of new therapies to treat serious conditions and fulfill an unmet medical need. Drug candidates that receive Fast Track Designation are eligible for more frequent meetings and written interactions with the FDA, rolling review and priority review.

About SIM0505

SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on platinum resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.

(Press release, NextCure, APR 7, 2026, View Source [SID1234664222])

On April 7, 2026 CatalYm reported that the first patient has been dosed in the GDFATHER-HCC-01 trial (NCT07219459). The trial evaluates the company’s lead anti-GDF-15 antibody visugromab in combination with chemoimmunotherapy as a second-line (2L) treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The Phase 2b trial targets patients who have progressed following 1L treatment with an anti-PD-(L)1-based therapy.

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The trial will assess a treatment strategy combining visugromab with the PD-1 inhibitor nivolumab and the multi-target tyrosine kinase inhibitor (TKI) lenvatinib. The study consists of an open-label safety run-in to confirm the recommended dose for expansion, followed by a randomized, double-blind phase evaluating visugromab plus nivolumab plus lenvatinib versus double placebo plus lenvatinib.

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), an immunosuppressive cytokine exploited by tumor cells to promote immune evasion and resistance to anti-PD-(L)1 therapies. By neutralizing GDF-15, visugromab aims to restore anti-tumor immune responses to improve outcomes in a setting where 5-year overall survival remains as low as 18%.1 In the exploratory Phase 1/2a GDFATHER trial (NCT04725474), visugromab demonstrated encouraging anti-tumor activity when combined with an anti-PD-1 antibody in advanced-stage, anti-PD-(L)1 relapsed/refractory HCC patients, demonstrating deep and durable responses, with a median duration of response of 21.4 months and a favorable safety profile.

"HCC is the third leading cause of cancer-related deaths globally and continues to present immense clinical challenges, especially in patients who progress on immunotherapy," said Sujata Rao, MD, Chief Medical Officer at CatalYm. "This new trial is designed to combine the immune-restoring properties of visugromab with a checkpoint inhibitor and the standard of care tyrosine kinase inhibitor. With this approach we aim to improve clinical outcomes for HCC patients with limited treatment options."

"Expanding into HCC represents a pivotal step in our strategy to bring visugromab to additional high-need tumor types," said Scott Clarke, Chief Executive Officer at CatalYm. "Visugromab’s dual potential to restore immune sensitivity and address cancer cachexia, which affects nearly one in four patients with HCC at diagnosis, underpins our approach in this study. By combining our antibody with proven standards of care, we aim to shift the treatment paradigm and ultimately improve survival and quality of life for patients who have few options today."

The GDFATHER-HCC-01 trial is a global, randomized, blinded Phase 2b study enrolling approximately 104 participants across 40 sites in North America, Europe and Asia-Pacific. It consists of two parts:

Part 1: An open-label safety run-in assessing the combination of visugromab with nivolumab and lenvatinib to determine the Recommended Dose for Expansion (RDE).
Part 2: A randomized and double-blind evaluation of the triple combination versus double placebo plus lenvatinib.
The primary endpoint is progression-free survival (PFS) assessed by local investigators. Key secondary endpoints include overall survival (OS), independently assessed PFS, and objective response rate (ORR). The study will also explore visugromab’s potential to mitigate cancer cachexia using the Functional Assessment of the Anorexia and Cachexia Therapy questionnaire (FAACT-ACS), as muscle wasting and weight loss are common in HCC and known to negatively affect treatment tolerance and clinical outcomes.

About Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the most common primary liver cancer and the third leading cause of cancer-related death worldwide. The five-year survival rate for HCC is only 18%, second lowest among common cancers1. While checkpoint inhibitors have become a first-line standard of care, most patients with advanced-stage HCC ultimately experience disease progression or relapse. Treatment options in the second-line setting remain limited, underscoring the urgent need for more effective and well-tolerated therapies.

About Visugromab

Visugromab is a monoclonal antibody that neutralizes Growth Differentiation Factor-15 (GDF-15), a locally acting immunosuppressant produced by tumors which fosters immunotherapy resistance and drives cachexia in people with cancer. Neutralizing GDF-15 with visugromab reverses key cancer resistance mechanisms to reinstate an efficient anti-tumor response by re-enabling immune cell activation, proliferation and induction of interferon-γ. In addition, visugromab also mitigates cancer cachexia, a severe condition affecting a significant number of advanced cancer patients by inhibiting the activation of the GFRAL pathway in the brainstem, a key driver of weight loss and appetite suppression in cancer patients.

(Press release, Catalym, APR 7, 2026, View Source [SID1234664221])