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.

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"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 enroll 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 [SID1234665883])

On May 19, 2026 Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML).

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"FDA Orphan Drug Designation for CLN-049 emphasizes both the urgent need for new therapies for people living with relapsed or refractory acute myeloid leukemia – including patients with TP53-mutated AML who currently face a particularly poor prognosis – and the potential of this FLT3-directed T cell engager to expand treatment options across the broadest population of AML patients," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "Coupled with promising results from our ongoing Phase 1 program, this designation by the FDA reinforces a shared goal to rapidly advance novel therapies for patients living with AML."

About Orphan Drug Designation

The U.S. FDA’s Orphan Drug Designation provides orphan status to drugs and biologics intended to prevent, diagnose, or treat rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies sponsors for certain development incentives, including tax credits for qualified clinical trials, exemption from certain FDA user fees, and the potential for seven years of market exclusivity in the United States following marketing approval.

About CLN-049

CLN-049 is a novel, investigational FLT3xCD3 T cell engager. CLN-049 is designed to target FLT3-expressing leukemia cells, offering a new immunotherapeutic approach for treating acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CLN-049 binds to both mutated and non-mutated FLT3, enabling targeted action regardless of FLT3 mutational status, making the investigational treatment widely applicable to a broad population.

CLN-049 is being studied in a Phase 1, open-label, multicenter, first-in-human, multiple ascending dose study evaluating safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of intravenously (IV) administered CLN-049 in patients with relapsed/refractory AML or MDS (NCT05143996) and in a parallel Phase 1, open-label, dose escalation and dose expansion study for the treatment of patients with AML with measurable residual disease (MRD) (EUCT 2023-506572-27-00).

CLN-049 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of relapsed/refractory AML.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow, and the most common form of acute leukemia in adults.1,2 It is characterized by the rapid growth of abnormal white blood cells that crowd out healthy cells, leading to infections, fatigue, and bleeding.3 Each year in the U.S., approximately 22,000 people are diagnosed with AML, and about half as many lives are lost to the disease.4 Globally, AML affects an estimated 144,000 people annually, with approximately 130,000 deaths.5

Despite recent advances, outcomes for patients with AML remain poor, particularly for those with relapsed or refractory disease, where five-year survival is 10% or less.4,6 Patients with high-risk genetic features, such as complex karyotype or TP53 mutations, face especially limited options.7,8 Intensive treatments like chemotherapy and stem cell transplantation may be inaccessible for many older patients due to severe side effects.8 Currently, there are no approved immunotherapies for AML, underscoring the urgent need for novel therapeutic approaches that can improve outcomes for patients and their families facing this life-threatening disease.

(Press release, Cullinan Oncology, MAY 19, 2026, View Source [SID1234665882])

On May 19, 2026 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, reported that dosimetry data from its Phase 3 COMPETE trial will be provided in a poster presentation at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting, held from May 30 – June 2, 2026 in Los Angeles, California. ITM will also host a satellite symposium on the evolution of SSTR-targeted radiopharmaceutical therapy.

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Poster Presentation Details
Title: Accurate single-time-point dosimetry of [177Lu]Lu-edotreotide using non-linear mixed-effects modeling: results from the COMPETE Phase 3 trial
Display Date and Location: May 31 – June 2 at the SNMMI Science Pavilion

Satellite Symposium Details
Title: ITM Dinner Symposium – The Evolution of SSTR‑Targeted Therapy – from Agonists to Antagonists and Emerging Radionuclides
Objective: Discuss the evolution of SSTR‑targeted radiopharmaceutical therapy; spanning early approaches, current ¹⁷⁷Lu agonist therapies to next‑generation ligand biology and emerging radionuclides – linking today’s clinical practice with future therapeutic directions
Speaker: Dr. Julia Fricke, MD, Clinic for Radiology and Nuclear Medicine at the University Hospital Basel, Switzerland
Date: May 31, 2026, 6:30 PM – 7:30 PM PT
Location: Petree Hall C, LA Convention Center, Los Angeles, CA

During the conference, ITM will exhibit its innovative isotope portfolio, including Lutetium-177, Actinium-225 and Terbium-161. Attendees will have the opportunity to learn more about the company’s innovative radiopharmaceutical pipeline and its capabilities in the manufacturing and supply of radioisotopes at booth #1523.

About the COMPETE Trial
The COMPETE trial (NCT03049189) evaluated 177Lu-edotreotide (ITM-11), a proprietary, synthetic, targeted radiotherapeutic investigational agent compared to everolimus, a targeted molecular therapy, in patients with inoperable, progressive Grade 1 or Grade 2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This trial met its primary endpoint, with 177Lu-edotreotide demonstrating clinically and statistically significant improvement in progression-free survival (PFS) compared to everolimus. 177Lu-edotreotide is an investigational product pending review by the U.S. Food and Drug Administration (FDA) and is not approved by any regulatory authority for the safety and/or efficacy of any intended use. It is also being evaluated in COMPOSE (NCT04919226), a Phase 3 study in patients with well-differentiated, aggressive Grade 2 or Grade 3, somatostatin receptor (SSTR)-positive GEP-NETs.

(Press release, ITM Isotopen Technologien Munchen, MAY 19, 2026, View Source [SID1234665881])

On May 19, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported the successful completion of an RMB 120 million (approximately USD 17.5 million) Series Pre-B financing. This round is co-led by an undisclosed fund and Fudan Capital, along with Changshu Guofa Venture, Kunsheng Relay Fund and other investors. Proceeds from the financing will be used to advance FL115, an IL-15 superagonist, into the pivotal clinical stage, and FL116, a PD-1/IL-18 bispecific, into clinic.

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Fudan Capital Stated: "We are confident in Forlong Biotechnology’s leadership position in the cytokine therapeutics space. The company has established globally leading technology platforms including Fbody and Syntokine, validated through R&D collaborations with top-tier pharmaceutical companies such as Innovent and Henlius. Its lead asset, FL115, has demonstrated global best-in-class potential in Phase I clinical trials, with the bladder cancer indication already advancing into Phase II, underscoring a high probability of successful commercialization. We believe FL115 will emerge as a benchmark in tumor immunotherapy in the post-PD-1 era."

Forlong last raised 110 million RMB (~$16.2 million) in February 2023. Since then, it has advanced FL115 into clinics and dosed 95 patients with advanced solid tumors or NMIBC, demonstrating best-in-class potential. In addition, it has developed a robust portfolio of interleukin-18 (IL-18) variants that fully escape IL-18BP neutralization, and FL116, a PD-1/IL-18 bispecific antibody, which has demonstrated potent tumor-killing efficacy in multiple in vivo tumor models with safety profile supported by pilot toxicology study in non-human primates. Furthermore, early research efforts are ongoing to engineer other cytokines.

"We welcome the new investors and appreciate the continuing support of existing investors." Said Dong Wei, Ph.D., CEO of Forlong Biotechnology, "Exciting progress in the past 3 years have validated our cytokine-based portfolio strategy, R&D capability and efficiency. This round of financing will enable us to strengthen operational readiness and accelerate clinical development momentum to advance FL115 into Phase 3 pivotal study for BCG-unresponsive NMIBC, and FL115 as well as FL116 into Phase 2a definitive studies for solid tumors in 2027."

"We are grateful to our new and existing investors for their confidence in the Forlong team, our technology platforms, and our product pipeline." Said Mr. En Ji, Co-founder of Forlong Biotechnology, "Cytokine therapeutics have demonstrated breakthrough potential across multiple areas of significant unmet medical needs. Over the years, we are committed to synthetic immunology-driven original innovation, successfully building globally leading platforms including Fbody and Syntokine, and now advancing our lead asset FL115 into clinical validation. This financing will accelerate our core pipeline toward pivotal clinical stage. Looking ahead, we will continue to focus on unmet medical needs, advance novel products , and strive to bring safer and more effective cytokine therapies to patients."

(Press release, Forlong Biotechnology, MAY 19, 2026, View Source [SID1234665880])

On May 19, 2026 Forlong Biotechnology, a clinical-stage biotech company focusing on developing transformative cytokine therapies for patients with severe unmet needs, reported the successful completion of an RMB 120 million (approximately USD 17.5 million) Series Pre-B financing. This round is co-led by an undisclosed fund and Fudan Capital, along with Changshu Guofa Venture, Kunsheng Relay Fund and other investors. Proceeds from the financing will be used to advance FL115, an IL-15 superagonist, into the pivotal clinical stage, and FL116, a PD-1/IL-18 bispecific, into clinic.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Fudan Capital Stated: "We are confident in Forlong Biotechnology’s leadership position in the cytokine therapeutics space. The company has established globally leading technology platforms including Fbody and Syntokine, validated through R&D collaborations with top-tier pharmaceutical companies such as Innovent and Henlius. Its lead asset, FL115, has demonstrated global best-in-class potential in Phase I clinical trials, with the bladder cancer indication already advancing into Phase II, underscoring a high probability of successful commercialization. We believe FL115 will emerge as a benchmark in tumor immunotherapy in the post-PD-1 era."

Forlong last raised 110 million RMB (~$16.2 million) in February 2023. Since then, it has advanced FL115 into clinics and dosed 95 patients with advanced solid tumors or NMIBC, demonstrating best-in-class potential. In addition, it has developed a robust portfolio of interleukin-18 (IL-18) variants that fully escape IL-18BP neutralization, and FL116, a PD-1/IL-18 bispecific antibody, which has demonstrated potent tumor-killing efficacy in multiple in vivo tumor models with safety profile supported by pilot toxicology study in non-human primates. Furthermore, early research efforts are ongoing to engineer other cytokines.

"We welcome the new investors and appreciate the continuing support of existing investors." Said Dong Wei, Ph.D., CEO of Forlong Biotechnology, "Exciting progress in the past 3 years have validated our cytokine-based portfolio strategy, R&D capability and efficiency. This round of financing will enable us to strengthen operational readiness and accelerate clinical development momentum to advance FL115 into Phase 3 pivotal study for BCG-unresponsive NMIBC, and FL115 as well as FL116 into Phase 2a definitive studies for solid tumors in 2027."

"We are grateful to our new and existing investors for their confidence in the Forlong team, our technology platforms, and our product pipeline." Said Mr. En Ji, Co-founder of Forlong Biotechnology, "Cytokine therapeutics have demonstrated breakthrough potential across multiple areas of significant unmet medical needs. Over the years, we are committed to synthetic immunology-driven original innovation, successfully building globally leading platforms including Fbody and Syntokine, and now advancing our lead asset FL115 into clinical validation. This financing will accelerate our core pipeline toward pivotal clinical stage. Looking ahead, we will continue to focus on unmet medical needs, advance novel products , and strive to bring safer and more effective cytokine therapies to patients."

(Press release, Forlong Biotechnology, MAY 19, 2026, View Source [SID1234665880])