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Mestag Therapeutics Announces the First Patient Dosed with MST-0312 in the Phase I STARLYS Trial

On May 19, 2026 Mestag Therapeutics, a clinical-stage biotech company harnessing fibroblast immunology for the benefit of patients with inflammatory disease and cancer, reported the dosing of the first patient in a Phase 1 clinical trial evaluating MST-0312 in patients with selected advanced solid tumors. The first in human trial, named the STARLYS trial, is an adaptive, modular multi-part, multi-arm open-label study designed to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics and anti-tumor activity of MST-0312 alone and in combination with pembrolizumab.

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MST-0312 is a bispecific antibody designed to activate lymphotoxin-beta receptor (LTBR) in the tumor microenvironment to induce the formation of tertiary lymphoid structures (TLS) and associated high endothelial venules (HEV) in tumor tissue. TLS are a hallmark of effective anti-tumor immunity consisting of aggregates of T, B and dendritic cells, associated with the recruitment, education, and activation of immune cells to drive anti-tumor immune responsesi,ii. Patients with TLS and HEV in their tumors show significantly improved response to treatment and extended survival outcomes compared to patients whose tumors lack these structuresiii,iv,v,vi. The STARLYS trial will initially evaluate MST-0312 in tumors formed in barrier organs (lung, gut, bladder, breast and skin), which are believed to be particularly sensitive to TLS formation.

"Dosing the first patient with MST-0312 is a significant milestone in developing this potential new therapeutic class," said Dr. Lindsey Rolfe, MBChB, Chief Medical Officer of Mestag. "Our carefully designed study evaluates monotherapy and combination therapy in immunologically ‘cold’ and ‘warm’ tumors, generating multiple mechanistic and clinical insights to inform future development. This important step reflects the scientific rigor and dedication of the Mestag team, as we advance novel therapies for patients."

Dr. Emiliano Calvo MD PhD, a Principal Investigator of the study and Director of Clinical Research at START Madrid-CIOCC (Centro Integral Oncológico Clara Campal) Hospital in Madrid, Spain where the first patient was dosed, said "MST-0312 is an exciting new investigative approach for the treatment of solid tumors and we are thrilled to have dosed the first patient in the STARLYS trial."

Dr. Elena Garralda MD PhD, Co-Director of the Clinical Research Program and Head of Early Drug Development at Vall d’Hebron Institute of Oncology in Barcelona, Spain, and coordinating Principal Investigator of the STARLYS trial, added, "Published data show that the presence of TLS is associated with significantly improved outcomes for patients. Despite recent therapeutic advances, many patients with solid tumors derive limited benefit from current therapies. MST-0312 is designed to address this unmet need by inducing TLS and reshaping anti-tumor immunity. I look forward to working with the STARLYS investigators to evaluate MST-0312 in the clinic."

(Press release, Mestag Therapeutics, MAY 19, 2026, View Source [SID1234665844])

Amplia Launches First Stage of Pivotal Narmafotinib Trial

On May 19, 2026 Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), ("Amplia" or the "Company"), reported that it is initiating a Phase 2b study of narmafotinib in pancreatic cancer exploring a new dosing regimen. Designed in alignment with FDA feedback, the study will form the basis – and first stage – of a registrational study in this indication given the high existing unmet need for innovative treatments. Narmafotinib is a best-in-class FAK inhibitor that has received orphan drug designation and fast track designation from the U.S. FDA as a potential treatment in pancreatic cancer.

To-date narmafotinib has shown no significant tolerability burden over chemotherapy alone, and we have observed a range of compelling efficacy signals across responses and survival. This has been achieved with only an intermittent dosing schedule, giving us confidence that moving into daily dosing may further enhance the therapeutic potential of narmafotinib", said Dr Chris Burns, CEO and Managing Director of Amplia. "We have been able to accelerate this phase of the narmafotinib program with redeployed resources, including drug product, following the wind-down of recruitment in the AMPLICITY trial. We believe our registrational study submission to the FDA will be stronger for the inclusion of this portion of the Phase 2b study and we look forward to further engagement with regulators."

The study will investigate, for the first time, a daily dosing schedule for narmafotinib, at two dosing levels, with the chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients. In this first stage, each dosing cohort will have 6 patients (12 patients in total), which will be combined with gemcitabine and Abraxane given on their conventional schedule. In addition to safety and tolerability, pharmacokinetics (PK) and efficacy will be assessed. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis, a key indicator of FAK activity. The study will enrol patients across 3-4 sites in Australia. The Company anticipates patient enrolment will begin by the fourth quarter of this year with the safety, tolerability and PK assessment for the 12 patients completed in the second quarter of 2027.

(Press release, Amplia Therapeutics, MAY 19, 2026, View Source [SID1234665832])

Parabilis Medicines Announces Strategic Collaboration with Regeneron Pharmaceuticals to Advance Novel Antibody-Helicon™ Conjugates Across Multiple Therapeutic Areas

On May 18, 2026 Parabilis Medicines reported a strategic research collaboration with Regeneron Pharmaceuticals, Inc. to discover and develop multiple therapeutic candidates based on Parabilis’s Helicon peptide platform, with a particular focus on Antibody-Helicon Conjugates (AHCs), a novel class of therapeutics designed to target challenging and historically "undruggable" targets.

Helicons are stabilized, cell-penetrant alpha-helical peptides designed to engage intracellular protein targets, including flat surfaces not well suited to traditional small molecule binding. The collaboration is designed to explore the use of Helicons both as stand-alone therapies and as part of AHCs.

Antibody–drug conjugates traditionally use antibodies to selectively deliver drug payloads into target cells to drive cell death from within. The AHCs envisioned by this collaboration are underpinned by the same delivery principle: pairing antibody-targeted cell access with Helicon payloads designed to selectively modulate specific intracellular proteins, including some long considered undruggable.

"Through our own pipeline, we have demonstrated the potential of Helicon peptides to directly inhibit or degrade several disease-driving proteins in oncology that have long been considered out of reach," said Mathai Mammen, M.D., Ph.D., Chairman, CEO and President of Parabilis Medicines. "We are thrilled to enter into a collaboration with Regeneron that builds on this foundation, combining the intracellular access and binding capabilities of our Helicons against challenging targets with antibodies from Regeneron."

Under the terms of the agreement, Parabilis is to receive $125 million from Regeneron in the form of a $50 million upfront payment and a commitment to invest $75 million in Parabilis’s next equity financing, subject to certain conditions. Parabilis is also eligible to receive milestone payments for development, regulatory, and commercial milestones, as well as tiered royalties up to the low double digits on future net sales of any approved medicines resulting from the collaboration. With five initial targets, the agreement provides the potential for up to approximately $2.2 billion in total milestone payments to Parabilis. Under the terms of the agreement, additional targets may be pursued upon additional option payments from Regeneron.

The agreement provides for the parties to collaborate to discover new Helicons and AHCs, which Regeneron will then be responsible for advancing through development, manufacturing and worldwide commercialization.

(Press release, Parabilis Medicines, MAY 18, 2026, View Source [SID1234666534])

Fortress Biotech to Participate in A.G.P.’s Annual Virtual Healthcare Conference

On May 18, 2026 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in a fireside chat at A.G.P.’s Annual Virtual Healthcare Conference, taking place on Wednesday, May 20, 2026. The fireside chat is scheduled to begin at 12:20pm ET.

To register for the conference, visit the A.G.P. Registration Link.

(Press release, Fortress Biotech, MAY 18, 2026, View Source [SID1234665854])

Perspective Therapeutics Announces First Patients Dosed in New Cohorts of Two Ongoing Phase 1/2a Studies

On May 18, 2026 Perspective Therapeutics, Inc. ("Perspective," the "Company," "we," "us," and "our") (NYSE AMERICAN: CATX), a radiopharmaceutical development company pioneering advanced treatments for cancers throughout the body, reported that the first patients were dosed with [212Pb]VMT-α-NET and [212Pb]PSV359 in two new cohorts of Phase 1/2a studies in neuroendocrine tumors and solid tumors, respectively.

The first patient was treated with [212Pb]VMT-α-NET in a fourth cohort of the Company’s ongoing Phase 1/2a clinical trial of [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor type 2 (SSTR2) expressing neuroendocrine tumors (NETs). This cohort explores optimizing a 20 mCi cumulative dose by front-loading, with 6.0 mCi in the first dose, 5.0 mCi in the second dose, 5.0 mCi in the third dose, and 4.0 mCi in the fourth dose. The design of this dosing regimen will help determine whether front-loading could change response kinetics and further improve response rate and tolerability at the same cumulative administered dose.

Additionally, the first patient was treated with [212Pb]PSV359 in a third cohort of the Company’s Phase 1/2a dose-finding trial to determine safety and preliminary anti-tumor activity of the radiopharmaceutical [212Pb]PSV359 in patients with solid tumors that express fibroblast activation protein alpha (FAP-α). Cohort 3 was cleared to open following a safety monitoring committee review of safety data from Cohort 2. Patients in Cohort 3 are receiving up to four fixed administered doses of PSV359 at 6.0 mCi every eight weeks.

About [212Pb]VMT-α-NET

Perspective designed [212Pb]VMT-α-NET to target and deliver 212Pb to tumor sites expressing somatostatin receptor type 2 (SSTR2). The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study (clinicaltrials.gov identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received prior radiopharmaceutical therapies (RPT).

Interim analysis with a data cut-off date of March 4, 2026 was previously presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 (AACR 2026) in April 2026, including efficacy data on half of the patients in Cohort 2 and both patients in Cohort 1. Initial efficacy data for the remaining patients in Cohort 2 and eight patients in Cohort 3 are pending, and submissions for presentations at additional medical conferences during 2026 are planned.

About PSV359

PSV359 was designed to target and deliver 212Pb to tumor sites expressing FAP-α, associated with multiple highly prevalent solid tumors, with patients in need of additional treatment options. The targeting moiety may also be radiolabeled with 203Pb or 68Ga (known as PSV377) to detect FAP-α expression in individual patients. Preclinical imaging and therapy as well as human imaging results suggest Perspective’s proprietary targeting ligand has improved levels of target engagement and uptake in tumors, as well as reduced retention in healthy tissues, which may result in a desirable therapeutic index.

Perspective is conducting a multi-center, open-label, dose-finding and dose-expansion study (clinicaltrials.gov identifier NCT06710756) of [212Pb]PSV359 in patients with advanced solid tumors that express FAP-α as determined by imaging with [203Pb]PSV359. The primary objective of the dose finding phase of the study is to assess the safety and tolerability of various doses of [212Pb]PSV359 in order to determine the recommended Phase 2 dose to be used in the expansion phase of the study, where anti-tumor activities may be an additional primary outcome measure.

(Press release, Perspective Therapeutics, MAY 18, 2026, View Source [SID1234665853])