On April 8, 2026 Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, reported the initiation of a first-in-human Phase 1/2a clinical trial of GLIX1 in patients with recurrent and progressive glioblastoma (GBM) and other high-grade gliomas (NCT07464925). The study is being conducted in collaboration with BioLineRx Ltd. (NASDAQ/TASE: BLRX).

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GLIX1 is an orally available, first-in-class small molecule designed to activate TET2 and drive tumor-selective DNA damage. By restoring TET2 activity, GLIX1 induces DNA damage selectively in cancer cells, representing a differentiated approach to targeting the DNA damage response with potential applicability across a broad range of tumors.

Glioblastoma was selected as the initial indication due to its highly suppressed TET2 activity and significant unmet medical need. Despite existing therapies, GBM remains one of the most aggressive and treatment-resistant cancers.

In extensive preclinical studies, including orthotopic in vivo GBM models, GLIX1 demonstrated:

Potent anti-tumor activity
Robust blood-brain barrier penetration
Favorable safety profile in toxicology studies
The trial will be conducted across three leading academic centers. The first site to initiate patient enrollment is NYU Langone Health, led by Dr. Alexandra Miller. Additional sites include Northwestern University, led by Dr. Roger Stupp and Dr. Ditte Primdahl, and Moffitt Cancer Center, led by Dr. Patrick Grogan.

"The initiation of this Phase 1/2a study marks a defining milestone for Hemispherian and represents the culmination of years of dedicated research and development work by our team and our collaboration partner, BioLineRx. GLIX1 has a compelling preclinical profile and a truly differentiated mechanism of action, and we look forward to bringing this innovative therapy to patients who urgently need new treatment options. We are proud to be advancing this program alongside world-leading glioblastoma investigators and anticipate initial data readout in the first half of 2027," said Zeno Albisser, Chief Executive Officer of Hemispherian AS.

"GLIX1 is built on a fundamentally new understanding of how to exploit DNA repair vulnerabilities in cancer. The strength and consistency of the preclinical data give us confidence as we now transition this mechanism into the clinic," remarks Adam Robertson, Chief Scientific Officer at Hemispherian.

Dr. Alexandra Miller, Chief of Neuro-Oncology and Co-Director of the Brain and Spine Tumor Center at the Perlmutter Cancer Center, NYU Langone Health, stated:

"I am pleased to be the first investigator able to enroll patients into this critical study, which brings new hope to patients who are in desperate need of innovative and novel treatment options."

Dr. Roger Stupp, Medical Director of the Malnati Brain Tumor Institute at Northwestern University in Chicago and lead investigator of the study, added:

"GLIX1 is a promising innovative molecule with impressive pre-clinical data, and I could not be more excited to participate in this study. The protocol will rigorously assess the safety of an agent with an entirely novel mechanism of action, with the potential to ultimately integrate well and synergize with the current treatments. We urgently need breakthrough innovations for our patients suffering from glioblastoma, one of the most aggressive and difficult malignancies to treat."

Clinical Trial Design (NCT07464925)

The Phase 1 portion of the study will enroll up to 30 patients with recurrent and progressive GBM and other high-grade gliomas. The primary objective is to establish the maximum tolerated dose (MTD) and/or a recommended dose based on safety, pharmacokinetics/pharmacodynamics (PK/PD), and preliminary efficacy. Data from Phase 1 are anticipated in the first half of 2027.

The Phase 2a expansion is expected to include multiple patient cohorts, including newly diagnosed and recurrent GBM, as well as additional tumor types. Combination approaches, including with PARP inhibitors, will also be evaluated. These cohorts are designed to generate early efficacy signals, inform dose optimization, and support subsequent clinical development.

(Press release, Hemispherian, APR 8, 2026, View Source [SID1234664254])

On April 8, 2026 Sidewinder Therapeutics, a biopharmaceutical company pioneering the development of next-generation bispecific ADCs (antibody-drug conjugates) for the treatment of cancer, reported the closing of an oversubscribed $137 million Series B financing. The round was co-led by Frazier Life Sciences and Novartis Venture Fund, with participation from the sole Series A investor OrbiMed as well as new investors including Life Sciences at Goldman Sachs Alternatives, DCVC Bio, Samsara BioCapital, Longwood Fund, Astellas Venture Management and Alexandria Venture Investments. Concurrent with the financing, Daniel Estes, Ph.D., from Frazier Life Sciences, Michal Silverberg from Novartis Venture Fund, Josh Richardson, M.D., from Life Sciences at Goldman Sachs Alternatives and John Hamer, Ph.D., from DCVC Bio were named to the Board of Directors.

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"We are pleased to receive the support of this exceptional group of investors and their shared enthusiasm in advancing Sidewinder’s mission to develop next-generation bispecific ADCs for difficult to treat cancers," said Eric Murphy, Ph.D., Co-Founder and CEO of Sidewinder Therapeutics. "The ADC field is at an inflection point driven by technological breakthroughs enabling next-generation bispecific ADCs, and Sidewinder is eager to lead this wave of innovation and advance promising therapies for patients with cancer."

Sidewinder’s mission focuses on developing bispecific ADCs designed to target receptor co-complexes that are highly expressed on certain solid tumors. The pipeline features bispecific antibodies engineered from internally discovered antibody sequences and finely tuned to target tumor-specific co-complexes consisting of an oncogenic driver receptor and an internalizing receptor. Precise targeting of these co-complexes enhances both tumor cell specificity and internalization, thereby improving the delivery of drugs to cancer cells while avoiding normal cells. Sidewinder’s programs are designed to address oncology indications that have limited treatment options and affect substantial patient populations such as squamous cell carcinomas in lung and head and neck cancers as well as gastrointestinal cancers including colorectal cancer. The company expects to advance its lead program into clinical development in 2027.

"Founded on compelling science and a differentiated approach, Sidewinder’s novel bispecific ADC pipeline has the potential to address key hurdles limiting safety and efficacy for this class of therapeutics," said Daniel Estes, Ph.D., General Partner at Frazier Life Sciences. "We believe that Sidewinder Therapeutics will significantly advance the ADC space and is well positioned to transform the treatment paradigm for cancer patients."

(Press release, Sidewinder Therapeutics, APR 8, 2026, View Source [SID1234664253])

On April 8, 2026 Pilatus Biosciences, Inc., a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for cancer and immune-related diseases, reported it will present new preclinical data as a poster session at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, taking place April 17-22 in San Diego, California.

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The poster presentation highlights a sex-specific therapeutic effect of its lead antibody, PLT012, in colorectal cancer (CRC), a finding that could inform more precise treatment strategies for a historically difficult-to-treat patient population.

Colorectal cancer remains the second leading cause of cancer-related deaths globally, with the majority of patients classified as mismatch repair-proficient (pMMR), a subtype that shows limited response to current standard therapies, including immune checkpoint inhibitors and anti-VEGF agents. The data presented at AACR (Free AACR Whitepaper) highlight CD36, a fatty acid transporter implicated in tumor metabolism and immune suppression, as a promising and differentiated therapeutic target in this setting.

In preclinical orthotopic models of pMMR CRC, PLT012, a humanized IgG4 antibody targeting CD36, demonstrated significant tumor growth inhibition in both male and female subjects. Notably, the therapeutic effect was more pronounced in female models, a difference that correlated with higher CD36 expression levels observed in female tumors. Additional analyses showed that CD36 was enriched in cancer-associated fibroblasts (CAFs), with a female-biased distribution, suggesting a potential mechanistic basis for the observed sex-specific response.

"These findings provide compelling evidence that CD36 plays a central role in shaping the tumor microenvironment in colorectal cancer, particularly in ways that may differ by sex," said Jingying Zhou, Assistant Professor, School of Biomedical Sciences, Faculty of Medicine, The Chinese University of Hong Kong. "The ability to target metabolic pathways like lipid uptake represents an important and emerging strategy in oncology, and the observed enrichment of CD36 in tumor-associated stroma further underscores its relevance as a therapeutic target."

PLT012 is designed to inhibit CD36-mediated lipid uptake, modulating tumor metabolism and reversing immunosuppressive features of the tumor microenvironment. The antibody has demonstrated activity in liver cancer models and a favorable safety profile in non-human primates, supporting its continued advancement. Given its distinct mechanism, PLT012 has the potential to function both as a monotherapy and as a sensitizing agent in combination with immune checkpoint inhibitors, with the ability to reprogram metabolically constrained tumors and convert immunologically "cold" tumors into more responsive states, addressing a key limitation of current therapies.

"The data presented at AACR (Free AACR Whitepaper) reinforce our conviction that CD36 is a highly actionable target in cancer biology," said Raven Lin, CEO & Founder, Pilatus Biosciences. "What is particularly exciting is the potential to incorporate sex as a biological variable in treatment selection, enabling more tailored, effective therapies for patients with pMMR colorectal cancer, where patients urgently need new therapies."

These findings significantly broaden the therapeutic scope of PLT012, demonstrating activity beyond tumor-associated immune cells to encompass the critical tumor-associated stromal population. By simultaneously targeting the immune and stromal compartments of the microenvironment, PLT012 is designed to overcome key barriers of tumor progression and may have utility both as a monotherapy and in combination with existing therapies, to improve outcomes in underserved CRC populations.

PLT102 is currently in an ongoing Phase 1 clinical trial (NCT07337525) in patients with advanced solid tumors, including colorectal cancer. The study is designed to assess safety, pharmacokinetics, and early clinical evidence of target engagement and biological activity in CD36-driven tumors. Translational endpoints include the evaluation of CD36 expression, stromal composition, and immune cell reprogramming, with the goal of establishing a biomarker framework to guide patient selection and combination strategies in future trials. PLT102 has received both FDA Fast Track and Orphan Drug Designation.

AACR 2026 Poster Presentation Details:

Title: A Sex-Specific Role of CD36 Targeting Therapy in Colorectal Cancer
Date/Time: Tuesday, April 21, 2026, 9:00 am – 12:00 pm PT
Poster Number: 4351

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it depletes immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing antitumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

(Press release, Pilatus Biosciences, APR 8, 2026, View Source [SID1234664252])

On April 8, 2026 TAE Life Sciences (TLS), a leader in Boron Neutron Capture Therapy (BNCT), reported the publication of new research in ACS Pharmacology & Translational Science (an ACS journal), demonstrating that its next-generation boron delivery platform may enable both enhanced tumor control and systemic immune activation.

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The study introduces a novel class of proprietary BPA-based dipeptides designed to overcome key limitations of conventional BPA (boronophenylalanine) for BNCT, particularly solubility and dosing constraints. By enabling substantially higher boron delivery to tumors, these compounds significantly improved therapeutic outcomes across multiple preclinical models.

The dipeptides achieved 12- to 77-fold higher solubility than standard BPA, allowing for increased dosing within clinically relevant administration parameters. In vivo, this translated into complete and durable tumor regressions, including 100% complete response rates (5/5) in a human head and neck cancer xenograft model using dipeptides, i.e. 10B l-BPA-BPA.

Beyond local tumor control, the study demonstrates that BNCT can activate a systemic anti-tumor immune response in mouse models. The mice that achieved complete responses were able to reject tumor rechallenge, indicating the development of durable immune memory. Additionally, suppression of untreated tumors in contralateral sites demonstrates an abscopal effect, supporting the potential for BNCT to function as an in situ tumor vaccine in the clinic.

These findings position BNCT as a dual-mechanism modality, combining highly localized, high-linear energy transfer radiation with immune activation. This profile may create meaningful opportunities for combination strategies with immune checkpoint inhibitors, targeted therapies, and other systemic treatments, particularly in tumors with limited treatment options or resistance to conventional therapies.

"Our studies highlight the potential for BNCT to evolve into a platform that not only delivers precise tumor-targeted radiation, but also engages the immune system to enhance tumor control," said Kendall Morrison, Chief Scientific Officer, at TAE Life Sciences. "These findings support the continued advancement of BNCT across clinical pathways with the goal of expanding treatment options for patients."

TAE Life Sciences is the only company with an integrated BNCT platform that combines its Alphabeam accelerator-based neutron system with a pipeline of proprietary boron drug candidates. The company is actively exploring strategic collaborations to further evaluate BNCT in combination settings and expand its clinical applications.

The full study is available in ACS Pharmacology & Translational Science (DOI: 10.1021/acsptsci.5c00613).

(Press release, TAE Life Sciences, APR 8, 2026, View Source [SID1234664251])

On April 8, 2026 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), reported a definitive agreement (the "Garda Agreement") to be acquired by Garda Therapeutics ("Garda" or the "Buyer") for $18 per share in cash, or a total cash consideration of $125.1 million, (the "Garda Transaction"), plus a contingent value right (the "CVR"). In connection with the Garda Transaction, the Company today also announced that it has signed and closed an agreement ("Cosette Agreement") to sell all non-Rolvedon assets to Cosette Pharmaceuticals ("Cosette").

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The Garda Transaction represents a 34.6% premium to the Company’s unaffected stock price on March 20, 2026 – the day before a significant share price and trading volume movement – a 46.6% premium to the 30-day unaffected volume-weighted average price ("VWAP") and a 62.2% premium to the 60-day unaffected VWAP as of March 20. The Garda Transaction has been unanimously approved by the Boards of Directors of both companies.

Heather Mason, Chair of the Assertio Board of Directors, stated: "Over the course of this extensive multi-month process, the Board, management, and our advisors have conducted a disciplined and wide-ranging review of our business. We evaluated multiple strategic pathways – including a potential sale of the Company, merger opportunities, monetization of Rolvedon, and continuing as a standalone entity. The Company and its advisors engaged more than 35 counterparties, including both strategic and financial buyers. Following this thorough process – and with the addition under the agreement for an incremental shop period to ensure maximum value – the Board has determined that these transactions with Cosette and Garda provide the best outcome for our shareholders."

Assertio will file a Schedule 14D-9 with respect to the tender offer in approximately 10 business days, which will include additional detailed information on the strategic review process.

Mark Reisenauer, CEO and a Director of Assertio, added: "These transactions provide our shareholders with a certain path to value realization amid a rapidly evolving regulatory, reimbursement, and macroeconomic environment. I would like to sincerely thank everyone involved for the hard work that helped the Company to achieve this outcome."

Transaction Details

Under the terms of the Garda Agreement, Garda will promptly commence a tender offer to acquire all outstanding shares of Assertio Holdings at an upfront price of $18 per share in cash, or a total cash consideration of $125.1 million, plus a non-tradeable CVR related to potential future milestones for Sprix. The Company’s Board of Directors unanimously recommends that Assertio stockholders tender their shares in the tender offer.

In connection with the Garda Agreement, Assertio divested the assets, properties, rights, title and interest in and to the Indocin products, Sympazan, Sprix, Cambia, Zipsor, and the recently decommercialized Otrexup to Cosette for an up-front payment of $35 million plus earnouts related to certain product milestones, all of which are included in the total consideration of the Garda Transaction. Other than the Sprix-related milestones, which would be passed through to the Assertio shareholders through the CVR, the economics of the Cosette transaction will not further impact the $125.1 million purchase price.

The Garda Agreement includes a 20-day "window-shop" period. Under the terms of the window-shop provision, Assertio is free to engage with other parties who may provide superior value to our shareholders. In the event the Board terminates the Garda Agreement in favor of a superior bid during the window-shop period, a reduced breakup fee would apply.

The closing of the Garda Transaction is expected to occur in the second quarter of 2026 and is subject to customary closing conditions, including the tender of a majority of the outstanding shares of Assertio’s common stock. The Company does not expect any regulatory approvals to be required for closing. Following the successful closing of the tender offer, Garda will acquire all remaining shares of Assertio Holdings’ common stock that are not tendered in the tender offer through a second-step merger at the same price as the tender offer of $18 per share, plus the CVR.

Following the completion of the tender offer, Assertio’s common stock will no longer be listed for trading on Nasdaq.

Assertio will file a current report on Form 8-K with the U.S. Securities and Exchange Commission containing a summary of terms and conditions of the Garda Transaction.

Moelis & Company LLC acted as exclusive financial advisor, and Gibson, Dunn & Crutcher LLP served as legal counsel to Assertio on the sale to Garda and on the divestiture to Cosette. Longacre Square Partners serves as strategy and communications advisor to Assertio.

(Press release, Assertio Holdings, APR 8, 2026, View Source [SID1234664250])