On March 3, 2026 T-knife Therapeutics, Inc., a biopharmaceutical company developing next-generation T cell therapies to fight cancer, reported the authorization of its Clinical Trial Application (CTA) to begin the Phase 1 ATLAS trial of TK-6302 in Europe. TK-6302 is a multi-armored PRAME-targeted T cell therapy specifically engineered to overcome the challenges associated with treating solid tumor cancers. The ATLAS trial, which is poised to begin this year, is an adaptive, first-in-human, open-label, Phase 1 trial of TK-6302 in patients with advanced PRAME-positive solid tumors.

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"We are proud to achieve this important milestone, which enables the initiation of the Phase 1 ATLAS clinical trial and our transition to becoming a clinical-stage company," stated Thomas M. Soloway, President and Chief Executive Officer of T-knife. "TK-6302 is a highly differentiated therapy, engineered for greater potency against PRAME, a clinically validated target with attractive commercial potential. PRAME is highly prevalent across multiple high unmet-need solid tumor indications, including squamous non-small cell lung, ovarian, endometrial, skin, and triple-negative breast cancers. Today’s announcement reflects the dedication, expertise, and urgency our team brings to transforming innovative science into life-changing therapies."

Peggy Sotiropoulou, Ph.D., Chief Scientific Officer of T-knife, added, "The CTA was supported by a comprehensive and compelling preclinical data package demonstrating TK-6302’s best-in-class anti-tumor efficacy. By bolstering T-cell fitness and persistence while overcoming challenging tumor mediated immune barriers, TK-6302 has the potential to deliver meaningful clinical benefit, including deep, durable responses across a range of solid tumor cancers. Bringing a first-of-its-kind multi-armored, CRISPR gene-edited T cell therapy into the clinic underscores our commitment to pushing scientific boundaries in the service of delivering transformative therapies to patients."

About TK-6302
TK-6302 is a PRAME-targeted T cell therapy that has been "supercharged" by the inclusion of multiple armoring innovations: a high affinity PRAME targeting receptor to enhance cytotoxicity; a costimulatory CD8 coreceptor to engage CD4 T cells and enhance T cell fitness and persistence; and a FAS-based checkpoint converter designed to boost engraftment and promote T cell survival in the hostile tumor micro-environment. Preclinical data with TK-6302 demonstrated sustained serial killing and cytokine secretion in a model mirroring the inhibitory ligand expression in PRAME-expressing tumors. In a complex 3-dimensional (3D) spheroid tumor model, TK-6302 eliminated multiple rounds of tumors and demonstrated superior anti-tumor activity compared to controls. TK-6302 is manufactured with a non-viral gene editing process for improved T cell receptor expression, and it has been successfully manufactured at-scale using the clinical process.

(Press release, T-Knife, MAR 3, 2026, View Source [SID1234663274])

On March 3, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that its partner Pierre Fabre Pharmaceuticals (PFP) has submitted a request to the FDA for a Type A meeting.

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Pierre Fabre Pharmaceuticals, in partnership with Atara, submitted a briefing book to the FDA addressing the points from the Complete Response Letter dated January 9, 2026, providing additional context and clarification that the ALLELE study was adequate, well-controlled, and sufficient to support the tabelecleucel (tab-cel) Biologics License Application. In addition, the briefing book includes summaries of updated, longer-term efficacy data from ALLELE, additional supportive data from the tab-cel development program and post-marketing data in Europe that will be included in a potential resubmission.

"With our partners at Pierre Fabre Pharmaceuticals, we are eager to engage in a constructive discussion with the FDA to reach a path forward for tabelecleucel," said Cokey Nguyen, President and Chief Executive Officer of Atara. "The PTLD community, including physicians and patient advocacy groups have emphasized the urgent need for tabelecleucel and its ability to address a dire unmet medical need in this ultra-rare disease."

(Press release, Atara Biotherapeutics, MAR 3, 2026, View Source [SID1234663219])

On March 3, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported its Simcyp Simulator enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application (NDA) for asciminib (Scemblix). PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in "Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib" (Loisios-Konstantinidis et al.), highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making.

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Asciminib is the first-in-class allosteric inhibitor that specifically binds the BCR::ABL1 myristoyl pocket used to treat patients with Chronic Myeloid Leukemia (CML). The global incidence rate of CML was close to one case in 100,000 population in 2018,1 and it accounts for approximately 15% of newly diagnosed cases of leukemia in adults. Given its potential for drug-drug interactions and the need to evaluate multiple dosing regimens, PBPK modeling with the Simcyp Simulator enabled a mechanistic assessment of asciminib’s pharmacokinetics across diverse patient populations, dosing regimens and clinical scenarios. These simulations provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA.

"As a member of the Simcyp Consortium, we have firsthand experience with Simcyp’s capabilities and value its leading scientific rigor essential for enabling regulatory acceptance of PBPK models," said Ioannis Loisios-Konstantinidis, Senior Principal Scientist, PK Sciences, Novartis Biomedical Research.

Key results from the PBPK modeling included:

Bridging between clinically tested and untested scenarios
Replacement of at least ten dedicated clinical pharmacology studies
Accurate characterization of asciminib pharmacokinetics across healthy volunteers and cancer patients
Predicting how medicines work in real-life patients taking other medications
"This collaboration exemplifies the scientific partnership that the Simcyp Simulator enables," said Rob Aspbury, President, Certara Predictive Technologies. "The modeling work for asciminib evolved over a decade and contributed to richer understanding its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval and an important new treatment for patients with CML."

(Press release, Certara, MAR 3, 2026, View Source [SID1234663220])

On March 3, 2026 Persevere Therapeutics, Inc. ("Persevere"), a Delaware-incorporated, clinical-stage oncology biotechnology company, reported its official launch following a period of stealth operations. The company is emerging with a Phase 1b/2a-ready clinical asset and the first close of its Seed financing.

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As part of its launch, Persevere has acquired the clinical-stage program and related assets for misetionamide (GP-2250) from Geistlich Pharma AG. Misetionamide is a novel, first-in-class dual inhibitor of c-MYC and NFκB with clinical activity in a Phase 1 trial.

Persevere has closed on a first tranche of a Seed round and is actively engaging prospective investors for the remaining allocation. The company is prepared to share equity round terms with qualified investors.

The Seed financing proceeds will be used to complete a Phase 1b/2a proof-of-concept clinical trial evaluating misetionamide in patients with platinum-resistant ovarian cancer (PROC), an area of significant unmet medical need.

"We named the company Persevere as an enduring reminder that we must ‘Never Give Up’ on behalf of cancer patients, who persevere every day," said Greg Bosch, Founder and CEO. "Persevere Therapeutics’ mission is the unwavering pursuit of improved clinical outcomes for cancer patients with our novel therapeutic, misetionamide."

Persevere benefits from the solid foundation already established by the significant effort and investment to-date in the development of misetionamide. These advancements include a broad preclinical program and the completion of a successful Phase 1 clinical trial where 56 cancer patients were treated. Persevere’s investors have a unique opportunity to leverage this prior investment as the company now advances the program into its next stage of clinical development. In addition to the multi-center Phase 1 which demonstrated excellent safety and encouraging efficacy profile of misetionamide, significant milestones have already been achieved including all CMC, toxicology and regulatory hurdles with two open INDs as well as 16 scientific publications and an extensive patent estate.

"Platinum resistant ovarian cancer remains one of the most challenging and underserved areas in gynecologic oncology, leaving patients with limited effective options and a poor prognosis," noted Dr. Robert Coleman, MD, gynecologic oncologist with Texas Oncology and Chief Medical Officer at Vaniam Group. "Persevere’s misetionamide offers a much-needed therapeutic innovation, not only as a differentiated alternative to the growing number of antibody drug conjugates [ADCs] in development, but also as a potential option for patients whose disease has been exposed to, and/or progressed on prior ADC therapy."

(Press release, Persevere Therapeutics, MAR 3, 2026, View Source [SID1234663276])

On March 3, 2026 Delcath Systems, Inc. (Nasdaq: DCTH), ("Delcath" or the "Company") an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported the publication of the full results from the investigator-initiated CHOPIN randomized Phase 2 clinical trial, led by Principal Investigator Professor Ellen Kapiteijn, MD, from Leiden University Medical Center’s Department of Medical Oncology. The publication, titled "Percutaneous hepatic perfusion combined with ipilimumab and nivolumab for metastatic uveal melanoma (CHOPIN): a single-centre, open-label, randomised, phase 2 trial" is published in The Lancet Oncology and presents detailed analyses from the trial, building on the positive topline results previously presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October 2025. The link to the article can be found at: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00720-X/abstract.

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"The detailed analyses in this publication reinforce the synergistic potential of combining PHP with immunotherapy, showing not only superior PFS and OS but also enhanced hepatic control and deeper, more durable responses. This approach represents a significant advancement for patients with this challenging disease, where liver-dominant metastases drive poor outcomes," said Professor Ellen Kapiteijn, MD, Principal Investigator and Lead Author from Leiden University Medical Center’s Department of Medical Oncology.

"The full publication in The Lancet Oncology validates the impressive efficacy of combining our liver-directed PHP therapy with immune checkpoint inhibition," said Gerard Michel, Chief Executive Officer of Delcath Systems. "By more than tripling the 1-year progression-free survival rate and nearly doubling the 2-year overall survival, these results strongly underscore the clinical value of this combination and give us even greater confidence in adoption by treating physicians and patients. We are also encouraged by the potential to explore this paradigm in other liver-dominant cancers."

The CHOPIN trial randomized 76 patients with metastatic uveal melanoma (mUM; n=38 per arm) to percutaneous hepatic perfusion (PHP) with melphalan using Delcath’s CHEMOSAT Hepatic Delivery System (HDS) alone or in combination with ipilimumab plus nivolumab. In both arms patients received two PHP treatments (weeks 1 and 7). In the combination arm patients also received ipilimumab (1 mg/kg) plus nivolumab (3 mg/kg) in weeks 0, 3, 6, and 9, with no maintenance therapy.

Key results (intention-to-treat population):

Primary endpoint – 1-year progression-free survival (PFS): 54.7% vs 15.8% (adjusted HR 0.34 [95% CI 0.19–0.60]; p=0.0002), Median PFS: 12.8 months vs 8.3 months
Overall Survival (OS): Median 23.1 months vs 19.6 months (HR 0.39 [95% CI 0.20–0.77]; p=0.0065) 2-year OS: 49.6% vs 22.1%
Objective Response Rate (ORR): 76.3% vs 39.5% Complete response (CR) rate: 13% vs 3%
Safety

Grade 3 or higher treatment-related adverse events occurred significantly more frequently in the combination arm (82%) than in the PHP-alone arm (41%); p=0.0006. The rate in the combination arm was similar to that reported in the FOCUS trial (81%). The most common grade 3/4 events were thrombocytopenia (34% vs 14%), leukopenia (26% vs 14%), γ-glutamyl transferase increase (18% vs 8%), and anemia (13% vs 3%). Most events were self-limiting or manageable with standard supportive care; no new safety signals were identified. One treatment-related death (immune-related triple M syndrome) occurred in the combination arm.

Overall, the authors conclude that the combination of PHP with ipilimumab and nivolumab offers a promising new approach for patients with metastatic uveal melanoma.

(Press release, Delcath Systems, MAR 3, 2026, View Source [SID1234663222])