On March 31, 2026 Pheast Therapeutics, a clinical-stage biotechnology company advancing macrophage-directed immunotherapies for cancer, reported that the first patient has been dosed in the Phase 1b portion of its ongoing Phase 1 study of PHST001, an IgG4 anti-CD24 macrophage checkpoint inhibitor.

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"The initiation of the Phase 1b combination cohorts marks an important step forward for PHST001 and reflects the progress of our Phase 1 program," said Roy Maute, Ph.D., Co-founder and Chief Executive Officer of Pheast Therapeutics. "The safety and biological signals we have seen to-date support advancing PHST001 into combination cohorts with established therapies. Together with the preliminary data we will be presenting at AACR (Free AACR Whitepaper), we are building a strong foundation as we work toward our goal of bringing new options to patients facing cancers with significant unmet need."

The Phase 1b portion of the study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of PHST001 in combination with established chemotherapy regimens using a suitable dose identified by the Phase 1a portion. To date, the observed safety profile supports continued monotherapy escalation and advancement into combination regimens. Preliminary clinical and translational findings from the Phase 1a portion of the study, along with supporting preclinical data, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22 in San Diego (see company announcement dated March 17, 2026).

Initial expansion cohorts are actively enrolling patients with advanced ovarian cancer, endometrial cancer, and cholangiocarcinoma. Additional tumor types and combination strategies may be explored as the study progresses.

"Advancing into combination therapy allows us to explore how macrophage activation may enhance the activity of existing treatment approaches," said Raphaël Rousseau, M.D., Ph.D., Chief Medical Officer of Pheast Therapeutics. "With a dose established for combination evaluation, Phase 1b enables us to further define the potential role of PHST001 across multiple tumor settings."

PHST001 is designed to block CD24, a macrophage checkpoint that enables tumor cells to evade innate immune clearance through engagement of Siglec-10. By targeting this pathway, PHST001 is intended to promote macrophage-mediated phagocytosis of cancer cells and support anti-tumor immune responses.

About CD24

CD24 is a cell surface protein that plays a key role in tumor immune evasion by engaging Siglec-10, an inhibitory receptor on macrophages. This interaction suppresses macrophage-mediated clearance of cancer cells, allowing tumors to escape destruction by the innate immune system. CD24 was identified as a novel macrophage checkpoint through foundational work by Dr. Amira Barkal, principal founder of Pheast. Along with other co-founders, Drs. Irving Weissman, Ravi Majeti, and Roy Maute, Pheast’s research opened the door to therapeutic strategies targeting CD24 to drive innate immune responses against cancer.

About PHST001

PHST001 is an anti-CD24 macrophage checkpoint inhibitor designed to overcome immune suppression in the tumor microenvironment. CD24 is highly expressed by many human cancers, and high expression of CD24 is a negative prognostic factor in multiple cancer indications. Pheast has engineered PHST001 to be a potential best-in-class antibody designed to induce macrophages to phagocytose cancer cells and initiate a powerful immune response. PHST001-101 is an open-label, multicenter Phase 1 study in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT06840886). Primary objectives include safety, tolerability, and dose optimization, with secondary objectives evaluating pharmacokinetics and preliminary anti-tumor activity. PHST001 received FDA Fast Track Designation for the treatment of ovarian cancer in June 2025.

(Press release, Pheast Therapeutics, MAR 31, 2026, View Source [SID1234664105])

On March 31, 2026 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported upcoming presentations for NXP900 at the upcoming 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting (2026 AACR (Free AACR Whitepaper)), taking place from April 17th to April 22nd in San Diego, CA.

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Abstract Title Poster Presentation Details
NXP900, a Phase 1b, first-in-class YES1/SRC inhibitor demonstrates potent synergy with KRAS inhibitors in KRASi sensitive and resistant NSCLC models Session Title
Combination Targeted Therapy

Session Date / Time
April 21st, 2:00 PM – 5:00 PM PT
Resistance to the SFK inhibitor NXP900 in cholangiocarcinoma is characterized by IL13RA2-AKT signaling and can be overcome by combination therapy Session Title
Novel Strategies to Reverse Drug Resistance

Session Date / Time
April 22nd, 9:00 AM – 12:00 PM PT
Targeting myeloid-derived suppressor cells (MDSCs) to restore antitumor immunity in non-small cell lung cancer (NSCLC) via SRC family kinase Inhibition with NXP900 Session Title
Tyrosine Kinase, Phosphatase, and Other Inhibitors

Session Date / Time
April 21st, 2:00 PM – 5:00 PM PT

(Press release, Nuvectis Pharma, MAR 31, 2026, View Source [SID1234664104])

On March 31, 2026 Adcytherix, a biopharmaceutical company pioneering next-generation antibody-drug conjugates (ADCs), reported the dosing of the first patient in the Phase 1 clinical trial of ADCX-020, its most advanced product candidate derived from the ADCX Engine.

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The trial is an open-label study designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ADCX-020 in patients with advanced solid tumors. It includes a dose-escalation phase followed by dose-optimization and selected cohort expansion in patients with relapsed or refractory diseases.

This milestone marks the transition of Adcytherix to a clinical-stage company. ADCX-020 has been designed to address key limitations of earlier ADC products through an optimized molecular design, combining a stable linker with a clinically validated payload class to support an improved therapeutic index and broader applicability across multiple tumor types.

Clinical perspective: translating science into patient impact

"The entry of ADCX-020 into the clinic reflects the strength of our scientific approach and the speed and discipline of our development execution," said Jan Schellens, Chief Medical Officer of Adcytherix. "Our Phase 1a/b study is designed to characterize its safety and pharmacokinetic profile while generating the data required to advance development, with the ultimate goal of delivering meaningful new treatment options for patients with high unmet need."

ADCX-020 incorporates a stable linker and an exatecan-derived topoisomerase I inhibitor. Dosing of the first patient in its Phase 1a/b trial, achieved less than two years after the company’s inception, highlights Adcytherix’s disciplined execution and capital-efficient development model, and represents the first clinical validation of its strategy.

In parallel, the company is advancing several additional programs targeting clinically validated antigens and leveraging payloads with novel mechanisms of action, selected from approved cancer treatments, with the ambition to build a diversified ADC franchise.

"Administering ADCX-020 to the first patient is a defining milestone for Adcytherix," said Jack Elands, Founder and Chief Executive Officer. "It reflects our ability to translate strong scientific vision into a clinical program and confirms our readiness to operate as a clinical-stage company."

Strengthened leadership to support the next phase of development

The company has further strengthened its leadership team with the appointment of Paul Jackson as Chief Operating Officer and Magali Gibou as Chief Regulatory & Quality Officer.

Paul Jackson brings deep expertise in ADC technologies, development strategy and operational scale-up. An experienced biotech entrepreneur, he has built and led innovative payload platforms and structured development programs from preclinical stages through clinical readiness.

Magali Gibou brings extensive experience in global regulatory strategy and quality systems for innovative biopharmaceutical products, having supported multiple programs through key regulatory interactions and clinical-stage transitions.

In their respective roles, they will play a key role in advancing the pipeline of Adcytherix, strengthen its operational and regulatory foundation, and enable the broader deployment of the ADCX Engine.

In parallel, Adcytherix recently appointed Simon Sturge as Independent Chairman of the Board, further reinforcing the company’s governance as it enters its clinical growth phase. Mr. Sturge brings more than four decades of international leadership experience across biotechnology and pharmaceuticals, including senior executive roles, CEO positions, and board chairmanships at leading life sciences companies.

Positioned for the next phase of growth

With the first patient now dosed in its inaugural clinical trial, a strengthened leadership and governance structure, and a solid financial foundation following its €105 million Series A financing, Adcytherix is advancing ADCX-020 through clinical development while building a differentiated ADC franchise across multiple clinically validated targets and payload classes to address a broad range of oncology indications. The company’s ambition is to become a global leader in next-generation ADC therapeutics.

(Press release, Adcytherix, MAR 31, 2026, View Source [SID1234664103])

On March 31, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported a business update highlighting the Company’s accelerating transition toward clinical development and a series of upcoming milestones expected to serve as key value-inflection points over the next 12-18 months.

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Following significant scientific, regulatory and operational progress, Ernexa is entering a pivotal execution phase as it advances its lead program, ERNA-101, toward a first-in-human clinical trial expected to begin in Q4 2026 for the treatment of platinum-resistant ovarian cancer. The Company is currently completing the final steps required to support an Investigational New Drug (IND) submission in Q3 2026.

ERNA-101 is an engineered synthetic induced-mesenchymal stem cell (iMSC) therapy designed to deliver immune-activating cytokines directly to the tumor microenvironment, with the goal of converting immunologically "cold" tumors into immune-responsive tumors. Recent preclinical data further strengthen the rationale for ERNA-101 as a potential treatment for ovarian cancer. In a syngeneic ovarian cancer model, the combination of an anti-PD-1 mAb plus ERNA-101 demonstrated durable antitumor activity, including high rates of complete tumor regressions, significantly prolonged survival. When combined with PD-1 blockade, ERNA-101 produced markedly enhanced responses compared with either agent alone, supporting its potential to convert immunologically "cold" tumors into responsive tumors and reinforcing the Company’s confidence as the program advances toward first-in-human clinical studies.

Key Highlights
Combination drives high rates of complete tumor regressions and significantly extended survival in aggressive ovarian cancer model, supporting ERNA-101 as a potential foundational immunotherapy platform
Company on track to commence first-in-human clinical trials of ERNA-101 in ovarian cancer in Q4 2026

"The coming year represents a transformative period for Ernexa as we transition from a preclinical organization into a clinical-stage biotechnology company," commented Sanjeev Luther, President and CEO of Ernexa Therapeutics. "With an IND submission for ERNA-101 and our first-in-human study anticipated this year, we are approaching multiple important inflection points that we believe can unlock significant value while advancing a novel cell therapy platform designed to address cancers and autoimmune diseases with high unmet medical need."

In parallel with the advancement of ERNA-101, Ernexa continues to develop ERNA-201, an engineered anti-inflammatory iMSC therapy designed to deliver IL-10 directly to inflamed tissues for the treatment of autoimmune diseases, including rheumatoid arthritis.

Recent Achievements

2025 – Completed
Streamlined operations to reduce general and administrative expenses by approximately 61% year over year, while maintaining focus on advancing core programs
Completed Proof of Principle (PoP) studies for ERNA-101 and ERNA-201
Successfully completed Pre-IND meeting with the FDA for ERNA-101
Near-Term Milestones Expected to Drive Value

Ernexa expects the following operational, regulatory and clinical milestones to serve as key catalysts as the Company advances toward clinical development. Supported by a recent $10.5 million financing, the Company is well-positioned to achieve several key value inflection points.

Upcoming Milestones
Q2/Q3 2026: Completion of ERNA-101 clinical manufacturing process development in Q2 2026, followed by release of the first product batch in Q3 2026
Q3 2026: Completion of required IND-enabling preclinical studies for ERNA-101
Q3 2026: Submission of Investigational New Drug (IND) application for ERNA-101
Q4 2026: Initiation of first-in-human Phase 1 clinical study of ERNA-101 for treatment of platinum-resistant ovarian cancer
Q4 2026: Pre-IND meeting with the FDA for ERNA-201
1H 2027: Initial clinical data readout from ERNA-101
2H 2027: Advancement into Phase 2 trials with a potential co-development partner
Continue to present data at upcoming leading scientific conferences

"These upcoming milestones represent a clear pathway toward clinical validation of our platform and the potential expansion of our programs into broader oncology and autoimmune indications," Luther added. "We believe our engineered iMSC platform has the potential to deliver targeted cytokine therapies directly to sites of disease, opening the door to a new class of cell-based therapeutics."

(Press release, Ernexa Therapeutics, MAR 31, 2026, View Source [SID1234664102])

On March 31, 2026 MAIA Biotechnology, Inc. (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported highlights from a poster presented on March 27, 2026, at the European Lung Cancer Congress 2026 (ELCC), a premier thoracic oncology forum held March 25-28, 2026, in Copenhagen, Denmark.

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MAIA reports overall survival (OS) beyond two years for eight patients treated with ateganosine sequenced with cemiplimab in Parts A and B of its ongoing Phase 2 THIO-101 clinical trial in non-small cell lung cancer (NSCLC). The patients did not receive subsequent lines of therapy.

The eight patients featured in the poster include:

1 patient in third-line (3L) therapy with survival of 33 months. Expected survival in this heavily pre-treated population is 5.8 months.2
4 patients in 2L therapy with survival over 30 months. Documented OS for standard of care treatment (chemotherapy or checkpoint inhibitors alone) in second-line (2L) therapy is 10.5 months.3
All patients have failed previous treatment (prior to THIO-101) with a checkpoint inhibitor (CPI) alone.
All patients completed 29-34 cycles of therapy, except for 1 patient who completed 2 cycles of therapy with survival follow-up of 725 off therapy.
5 of the 8 patients have survival follow-up ongoing.

"It’s very encouraging to see such outstanding survival from these patients extending beyond our 24-month trial protocol and without any subsequent treatment. OS surpassing two-years bodes well as we continue to monitor patients in our ongoing Phase 3 pivotal trial and in THIO-101 Part C," said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. "These results illuminate ateganosine’s valuable role in targeting telomeres to eliminate NSCLC tumor cells and support this treatment—ateganosine sequenced by a CPI—as a potential breakthrough therapeutic option for NSCLC."

THIO-101 treated 79 patients in Parts A and B of the trial. The Part C expansion is currently enrolling up to 48 participants in Asia and Europe. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population.

MAIA’s ELCC poster is available on MAIA’s website at maiabiotech.com/publications.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

(Press release, MAIA Biotechnology, MAR 31, 2026, View Source [SID1234664101])