On May 29, 2026 Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment, reported an expanded manufacturing collaboration with PharmaLogic Holdings Corp. (PharmaLogic), a leading contract development and manufacturing organization (CDMO) specialized in radiopharmaceuticals, to support the continued clinical development and future commercialization readiness of Ratio’s lead therapeutic candidate, [Ac-225]RTX-2358.

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Under the expanded agreement, PharmaLogic will increase manufacturing capacity for the clinical supply of Ratio’s fibroblast activation protein-alpha (FAP)-targeted therapeutic, [Ac-225]RTX-2358, by expanding manufacturing to PharmaLogic’s Idaho Falls therapeutics facility. The broadened collaboration will also include enhancements of production processes with the aim of providing larger scale multi-dose batch manufacturing. The partnership is designed to support ongoing and future clinical studies, including later-stage and potentially registrational trials evaluating [Ac-225]RTX-2358 in FAP-expressing tumors.

"This expanded collaboration with PharmaLogic represents an important step in advancing our manufacturing strategy as we continue to progress [Ac-225]RTX-2358 through clinical development," said Jack Hoppin, Chief Executive Officer of Ratio. "Reliable, redundant and scalable manufacturing infrastructure is critical to the successful development of radiopharmaceutical therapeutics, particularly Actinium-225-based therapies. PharmaLogic has been a strong and reliable partner in supporting our clinical programs, and this next phase of our collaboration is intended to support the progression of our clinical trials and achieve readiness for commercial supply."

"As a service provider to the radiopharmaceutical industry, PharmaLogic measures its success by the success of its partners," said Etienne Montagut, President and Chief Executive Officer of PharmaLogic. "The expansion of our collaboration with Ratio Therapeutics, including the addition of our Idaho Falls therapeutics facility and enhancements to enable larger multi-dose batch production will provide the capacity, redundancy, and scalability that the [Ac-225]-RTX-2358 program requires as it advances toward commercialization. Drawing on more than a decade of experience producing clinical and commercial radiopharmaceutical therapies, we are committed to supporting this program with the full depth of that capability. We thank the Ratio team for their continued trust and collaboration."

About [Ac-225]RTX-2358

[Ac-225]RTX-2358 is a FAP-targeted alpha particle emitting radiotherapeutic. [Ac-225]RTX-2358 is designed for high tumor uptake & long retention time: a trifunctional small molecule engineered for optimized plasma clearance, increased binding affinity, and prolonged tumor retention, radiolabeled with the potent alpha-emitting [Ac-225] radioactive payload. Ratio is currently evaluating [Ac-225]RTX-2358 to treat patients with relapsed or refractory soft tissue sarcomas in the ongoing Phase 1/2 ATLAS trial.

About the ATLAS Trial

Ratio is conducting the ATLAS, ‘Actinium Therapy for Late-stage Aggressive Sarcomas’, clinical study (clinicaltrials.gov: NCT07156565). ATLAS is an open-label, seamless, Phase 1/2 clinical trial to evaluate the safety, tolerability, dosimetry, biodistribution, pharmacokinetics (PK), and anti-tumor activity of [Ac-225]RTX-2358 to treat patients with relapsed or refractory soft tissue sarcoma.

The Phase 1 portion of the ATLAS trial uses a modified 3+3 with queue (IQ) dose escalation design with backfill. Cohorts of patients will assess increasing administered activity ‘dose’ levels and treatment schedules of [Ac-225]RTX-2358, to determine the maximum tolerated dose and establish a recommended dose and schedule for the Phase 2 Expansion. Backfill of Phase 1 cohorts will enable more patients to be treated and evaluated, to provide better characterization of safety and tolerability, as well as assessment of preliminary efficacy. The Phase 2 Expansion portion of the ATLAS study will evaluate the efficacy and safety of [Ac-225]RTX-2358 in up to 50 patients with soft tissue sarcoma.

(Press release, Ratio Therapeutics, MAY 29, 2026, View Source [SID1234666201])

On May 29, 2026 PanTher Therapeutics ("PanTher" or the "Company"), a clinical-stage company redefining early cancer treatment with therapeutic implants administered directly at the tumor site, reported that it has concluded the dose escalation portion of its Phase 1b clinical trial of PTM-101 in pancreatic ductal adenocarcinoma (PDAC). PanTher has identified the PTM-101 400mg paclitaxel-containing implant as the recommended Phase 2 dose (RP2D) in combination with neoadjuvant standard of care chemotherapy. In addition, PanTher announced the appointment of senior life sciences executive Dr. Tim Clackson to its Board of Directors. This news reflects a pivotal stage in the company’s development to achieve the promise of the PTM-101 technology.

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The ongoing Phase 1b study builds on PanTher’s first-in-human trial that demonstrated the safety of PTM-101 at 100 mg and reported promising tumor shrinkage, with reduction in overall tumor volume of up to 70%. The current trial is an open-label, multicenter, single-arm study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PTM-101 in patients with newly diagnosed, treatment naïve, non-metastatic pancreatic cancer. In the dose-finding phase, subjects were treated at higher doses of paclitaxel (200 mg and 400 mg) with no systemic paclitaxel detected, no evidence of significant implant-related toxicities, and no additive toxicities with standard of care chemotherapy. Plasma pharmacokinetic data show no evidence of systemic exposure to paclitaxel with levels below quantifiable limits. Based on these data from a total of 12 patients, the Study Safety Committee endorsed the 400mg dose as the RP2D for further evaluation. This dose represents 4x the Maximum Tolerable Dose (MTD) of paclitaxel when delivered systemically, underscoring the potential benefit of localized therapy.

Approximately 50% of PDAC patients present with non-metastatic disease at diagnosis, when timely anti-tumor treatment and surgery still offer the potential for cure. Yet multi-agent systemic chemotherapy is often limited by toxicity. PTM-101 is a proprietary paclitaxel implant administered at the tumor surface during a standard tumor staging laparoscopy, immediately after diagnosis, providing ~6 weeks of sustained high-dose therapy directly to the tumor, with no systemic exposure. As an add-on therapy, PTM-101 integrates seamlessly with neoadjuvant standard of care FOLFIRINOX by adding a fourth chemotherapy agent while creating a new window for early intervention and improved outcomes.

The ongoing Phase 1b study (NCT06673017) is assessing safety, tolerability, and anti-tumor activity of PTM-101 when combined with standard of care neoadjuvant chemotherapy (FOLFIRINOX) in subjects with borderline resectable or locally advanced PDAC. PanTher is now enrolling patients in the dose expansion phase, which will enroll approximately 15 additional patients at sites across the United States to further characterize the safety and efficacy of PTM-101. For more information on the trial, please visit View Source

PanTher also announced today the appointment of Dr. Tim Clackson to its Board of Directors. Dr. Clackson brings more than three decades of experience building oncology companies to PanTher’s board, and his appointment reflects PanTher’s commitment to assembling a world-class team to support the advancement of PTM-101 and the Company’s broader pipeline.

"We are thrilled to welcome Tim to PanTher’s Board of Directors," said Laura Indolfi, Ph.D., Chief Executive Officer and Co-founder of PanTher Therapeutics. "His experience in developing and commercializing oncology therapies will be invaluable as we continue to build on the momentum of our Phase 1b clinical program and work to bring PTM-101 to patients in need."

Laura continued, "For patients with localized pancreatic cancer, every treatment decision made at diagnosis can impact the future of that patient and the development of their diagnosis. PTM-101 offers the potential to integrate directly into the neoadjuvant standard treatment paradigm from the outset, delivering additional anti-tumor activity without compounding systemic side effects. It is our aim with PTM-101 to meaningfully improve clinical outcomes for patients, alongside the current standard of care, to drive deeper and longer treatment responses before a tumor has the opportunity to become metastatic."

"PanTher is taking a highly differentiated and promising approach to tackling one of the most challenging cancers. By intervening right after diagnosis, with localized, high dose and sustained therapy, PTM-101 has the potential to transform PDAC outcomes before metastasis," said Tim Clackson, Ph.D. "As a simple add-on therapy that integrates seamlessly with existing workflows and therapies, it has the potential for wide adoption. I look forward to working with Laura and the PanTher team to help bring PTM-101, and a broader pipeline of localized medicines, to patients in need."

PTM-101 is the lead product candidate within PanTher’s pipeline of implantable medicines designed to directly address hard-to-treat solid tumors. PanTher is additionally developing polymeric drug formulations for the treatment of a range of other solid tumor types.

The company expects to share topline data from the Phase 1b study of PTM-101 in the first half of 2027.

About PTM-101

PanTher’s most advanced investigational product candidate, PTM-101, is an absorbable thin film formulation of paclitaxel for non-metastatic pancreatic cancer. PTM-101 is designed to deliver continuous, long-lasting, high-dose chemotherapy to the tumor with little to no systemic exposure. The product, laparoscopically implanted at the tumor site, easily integrates with common minimally invasive procedures used in staging pancreatic cancer. PTM-101 is currently being evaluated in a Phase 1b clinical trial (NCT06673017) with support from the Cancer Prevention & Research Institute of Texas (CPRIT) DP220066.

(Press release, PanTher Therapeutics, MAY 29, 2026, View Source [SID1234666232])

On May 29, 2026 Replimune Group, Inc. (NASDAQ: REPL), a clinical-stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.

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The company will resubmit the RP1 BLA in the coming days. The FDA has indicated it will treat the BLA resubmission as an urgent matter upon receipt and will prioritize its review in recognition of the significant unmet need for patients in the advanced melanoma community. This constructive dialogue represents an important step forward for the thousands of patients living with advanced melanoma who have progressed on prior anti-PD-1 based therapy and have limited treatment options available to them.

"We are grateful to the FDA leadership for their willingness to engage in a collaborative dialogue towards finding a meaningful path forward for RP1," said Sushil Patel, Ph.D., Chief Executive Officer of Replimune. "We are encouraged by the agency’s commitment to supporting patients and U.S. innovation and look forward to working closely with the FDA to bring this important therapy to the advanced melanoma community as swiftly as possible."

The BLA is supported by data from the IGNYTE clinical trial, which evaluated RP1 combined with nivolumab in patients with confirmed progression on an anti-PD-1 containing regimen. Approximately 8,500 Americans with advanced melanoma die each year, and standard of care checkpoint inhibitor therapy fails approximately half of all patients who receive it, underscoring the urgent need for new treatment options.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate, based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R⁻) and GM-CSF. RP1 is designed to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About Advanced Melanoma
Melanoma is the fifth most common cancer in the United States, with approximately 112,000 new cases estimated in 2026 and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Melanoma is considered advanced when the cancer has spread beyond the primary tumor. Standard of care therapy includes immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment, leaving a significant population in need of effective therapeutic alternatives.

(Press release, Replimune, MAY 29, 2026, View Source [SID1234666202])

On May 29, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported a new collaboration with Diakonos Oncology Corp., a clinical-stage biotechnology company developing immunotherapies to treat challenging and aggressive cancers. As part of the collaboration, Signatera will be used to longitudinally assess molecular response in patients with refractory melanoma enrolled in Diakonos’ DOC-RM Phase I/II investigational immunotherapy trial.

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The DOC-RM trial, which began enrollment in May, is evaluating DOC1021 (dubodencel), a first-in-class, personalized dendritic cell investigational therapy that recently received Fast Track designation by the U.S. Food and Drug Administration (FDA) in unresectable or metastatic cutaneous melanoma. With Signatera, Natera will conduct analyses of circulating tumor DNA (ctDNA) at multiple timepoints during and following treatment.

Refractory melanoma is an area of significant unmet need. Although immunotherapy has transformed the treatment landscape for advanced melanoma, many patients either do not respond or eventually develop resistance, underscoring the need for novel therapeutic approaches. Because radiographic response assessment can be challenging in immunotherapy-treated patients, serial ctDNA monitoring may provide earlier insight into molecular response and disease dynamics during treatment.1

"With an FDA Fast Track designation in hand, DOC1021’s path forward in refractory melanoma will benefit from early, high-quality evidence of activity," said Jay Hartenbach, president and COO of Diakonos Oncology. "Natera’s Signatera test is the most trusted tumor-informed MRD platform in oncology, making them a natural partner to help evaluate molecular response in a population where imaging often lags the biology."

"Signatera is uniquely positioned to help biopharma partners evaluate molecular response throughout the course of therapy, and we are thrilled to partner with Diakonos on this exciting program," said Eric Matthews, general manager, BioPharma, Natera. "By assessing MRD status across multiple timepoints, this collaboration has the potential to provide deep insight into treatment response dynamics and support future development efforts for patients with difficult-to-treat cancers."

(Press release, Diakonos Oncology, MAY 29, 2026, View Source [SID1234666233])

On May 28, 2026 NETRIS Pharma, a clinical-stage oncology company targeting the netrin-1 / epithelial-to-mesenchymal transition (EMT) axis, reported that it has secured €7.25 million in funding under the European Union’s Horizon Europe programme to conduct a Phase 2b randomized clinical trial of NP137 in head and neck squamous cell carcinoma (HNSCC). The trial will be led by Principal Investigator Dr. Jérôme Fayette, MD, PhD, a medical oncologist at Centre Léon Bérard (Lyon, France), and conducted in partnership with GORTEC (Groupe Oncologie Radiothérapie Tête Et Cou), the leading French cooperative oncology group in HNSCC led by Professor Jean Bourhis and TTCC group, the Spanish group for the treatment of head and neck tumors, chaired by Dr. Ricard Mesia.

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« Head and neck squamous cell carcinoma remains a disease with significant unmet need, particularly with a large portion of patients relapsing under immunotherapy. The scientific rationale for targeting netrin-1 in HNSCC to alleviate resistance to immunotherapy and thus extend the survival of patients is compelling,and the clinical outcomes from the Phase2 ImmunoNET study confirms the potential of NP137 to deliver meaningful clinical benefit for our patients » said Dr. Jérôme Fayette, MD, PhD, Principal Investigator and Medical Oncologist at Centre Léon Bérard.

Patrick Mehlen, PhD, Chief Executive Officer of NETRIS Pharma, said: « We are delighted to receive this Horizon Europe grant, which is a further validation of both our scientific approach and our development strategy in head and neck cancer. NP137 is the only clinical-stage anti-netrin1 therapy, and HNSCC is a key indications given the resistance to current treatment. Conducting this Phase 2b study in partnership with GORTEC, the most experienced cooperative group in this field, and under the leadership of Dr. Fayette, provides the ideal framework to generate the high-quality clinical evidence needed to advance NP137 toward regulatory discussions. This funding reinforces our commitment to bringing truly differentiated therapies to patients with limited options ».

« GORTEC is proud to partner with NETRIS Pharma on this innovative Phase 2b programme. Head and neck cancer is a field where new mechanistic approaches are urgently needed. The netrin-1 / EMT axis represents a clinically actionable target, and we look forward to generating robust data in the context of this well-designed Horizon Europe-funded trial » said Professor Jean Bourhis, Chief Executive Officer and Chief Medical Officer of GORTEC.

The Horizon Europe programme is the European Union’s key funding mechanism for research and innovation. « Following the positive outcome of the immunonet study, this funding reflects the high value of NP137 in oncology », said Christophe Guichard, Chief Financial Officer of NETRIS Pharma. The funding will support the design, conduct and analysis of the Phase 2b randomized trial in HNSCC, building on the clinical evidence supporting the role of netrin-1 in driving treatment resistance in this indication. The project will be conducted through a consortium led by NETRIS Pharma with GORTEC, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello – TTCC and Université Libre de Bruxelles.

About the Phase 2b HNSCC Trial

The Phase 2b trial is a randomized, multi-center study evaluating NP137 in patients with head and neck squamous cell carcinoma. The study will be conducted across multiple centers in France and Spain under the sponsorship of GORTEC, with Dr. Jérôme Fayette of Centre Léon Bérard serving as Principal Investigator. The trial design will incorporate translational endpoints aimed at further characterizing the role of netrin-1 and its receptors as predictive biomarkers of response to NP137, consistent with NETRIS Pharma’s precision oncology development strategy.

Full details of the trial design, including patient population, primary and secondary endpoints, and treatment schedule, will be disclosed at the time of trial initiation.

About Head and Neck Squamous Cell Carcinoma (HNSCC)

Head and neck squamous cell carcinoma (HNSCC) encompasses cancers of the oral cavity, pharynx, larynx, and other structures of the upper aerodigestive tract. It represents the sixth most common cancer worldwide, with approximately 900,000 new cases and 450,000 deaths annually. Despite advances in surgery, radiotherapy, and systemic therapy including checkpoint inhibitor immunotherapy, outcomes for patients with recurrent and/or metastatic HNSCC remain poor, with median overall survival of approximately 14–15 months with current standard-of-care regimens.

NETRIS Pharma has established a scientific rationale for netrin-1 blockade in HNSCC based on the role of netrin-1 in driving epithelial-to-mesenchymal transition (EMT) and acquired resistance to treatment, mechanisms that are highly relevant in this tumor type. NP137 is currently in clinical development in HNSCC as part of NETRIS Pharma’s broader multi-indication development strategy.

About GORTEC

GORTEC (Groupe Oncologie Radiothérapie Tête Et Cou) is the leading French cooperative oncology group dedicated to the clinical development of innovative treatments for head and neck cancers. GORTEC has conducted numerous landmark clinical trials in HNSCC and is widely recognized as one of the most prolific and scientifically rigorous cooperative groups in this field in Europe. The group is led by Professor Jean Bourhis, a world-leading expert in head and neck oncology and radiation oncology.

(Press release, Netris Pharma, MAY 28, 2026, View Source [SID1234666150])