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Juniper Biosciences Announces Strategic Collaboration with leading global cancer center on F-MISO (JBS-003): A First-in-Class Precision Diagnostic Poised to Revolutionize Head and Neck Cancer Treatment

On April 28, 2026 Juniper Biosciences reported a strategic licensing agreement with Memorial Sloan Kettering Cancer Center (MSK) to accelerate the development of JBS-003 (18F-fluoromisonidazole, or FMISO). This first-in-class hypoxia tracer in the U.S. is the cornerstone of a new precision oncology paradigm designed to spare patients from the devastating side effects of high-dose radiation therapy.

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The Human Toll of "One-Size-Fits-All" Radiation

In the current standard of care for HPV-positive Oropharyngeal Carcinoma (OPC), patients are subjected to a "one-size-fits-all" aggressive radiation regimen regardless of their individual tumor biology. This maximum-dose approach often results in severe, permanent morbidity—including the risk of jawbone removal (osteoradionecrosis), significant weight loss requiring feeding tubes, and long-term quality-of-life impairment.

Redefining the Standard of Care: From 70 Gray to 30 Gray Radiation

JBS-003 utilizes precision molecular imaging to identify tumor hypoxia, a known marker of radioresistance. By mapping these oxygen-starved regions, clinicians can, for the first time, accurately risk-stratify patients. Research indicates that approximately 75-80% of these patients have non-hypoxic tumors and may safely undergo a 67% reduction in radiation, de-escalating from the standard 70 Gray (7 weeks) to 30 Gray (3 weeks) absorbed dose of ionizing radiation.

This transformation represents a significant opportunity for the healthcare system to improve clinical outcomes while reducing the high costs associated with managing long-term radiation toxicity and surgical interventions.

Expanding the Precision Radiopharmaceutical Platform

JBS-003 is a vital component of Juniper Biosciences’ expanding multi-indication precision platform. This partnership with MSK underscores Juniper’s commitment to building a high-value pipeline that addresses the most complex challenges in nuclear medicine.

"We are excited to announce our newest clinical pipeline asset and collaboration with MSK. Using F-MISO PET imaging, we can now visualize the specific hypoxic signatures of a tumor to maintain aggressive control where it’s needed, while safely reducing radiation doses for patients with well-oxygenated tissue. This effectively minimizes toxicity and preserves long-term quality of life. We aren’t just treating the cancer; we are preserving the patient’s future" said Alex Agnoletto, CEO.

"This collaboration is exciting because it combines our deeply validated clinical data with a partner positioned to efficiently translate it into a regulatory pathway toward FDA approval. Together, we can accelerate the impact of this work—moving from promising clinical evidence to a scalable solution that meaningfully improves patient outcomes," said Nancy Lee, MD, FASTRO, Vice Chair, Experimental Therapeutics, Department of Radiation Oncology; Service Chief, Head & Neck Radiation Oncology; and Service Chief, Proton Therapy, at MSK.

Unveiling at the MSK Innovation Summit

The strategic roadmap for JBS-003 will be officially unveiled by Alex Agnoletto during a featured presentation at the MSK Innovation with Lasting Impact Summit on May 11, 2026. This presentation will serve as a prelude to the upcoming clinical milestones as the program moves toward a target regulatory filing window in late 2029.

About the JBS-003 Phase 3 Clinical Trial (NCT06563479)

The ongoing Phase 3 trial is a randomized, double-blind study evaluating FMISO-selected de-escalated radiation therapy. Patients in the personalized arm receive a FMISO scan at week two; those with non-hypoxic scans are eligible for a reduced 30 Gray radiation dose, while those with positive scans continue with the standard 70 Gray regimen. The trial is expected to reach primary completion in early 2028.

(Press release, Juniper Biosciences, APR 28, 2026, View Source [SID1234664878])

Kestrel Therapeutics Announces First Patient Dosed in the Phase 1 Clinical Trial of KST-6051, a Potential Best-in-Class Pan-KRAS Inhibitor, in Patients with KRAS-driven Malignancies

On April 28, 2026 Kestrel Therapeutics Inc. ("Kestrel" or the "Company"), a clinical stage biotechnology company developing next-generation small-molecule inhibitors targeting mutant KRAS, reported that that the first patient has been dosed in its Phase 1 clinical trial evaluating KST-6051, its investigational, oral, small-molecule pan-KRAS inhibitor, in patients with advanced or metastatic solid tumors with KRAS mutations. In conjunction, the Company announced that it has entered into a strategic agreement with AbbVie, a leading global biopharmaceutical company. The deal is structured as a warrant agreement with an exclusive option for AbbVie to acquire Kestrel based on defined development milestones.

KST-6051 is an investigational pan-KRAS inhibitor designed to offer a differentiated mechanism of action. Its novel binding mode is designed to enable a durable target pathway suppression, which may confer a clinical efficacy advantage over other pathway inhibitors. KST-6051 is designed to bind directly to KRAS in both its active and inactive states, thereby providing broad coverage of oncogenic signaling while selectively sparing HRAS and NRAS. This selectivity profile may reduce the toxicity risks associated with non-selective pan-RAS inhibition.

"This strategic agreement represents a major validation of our lead pan-KRAS program," said Dr. Frank Haluska, Chief Executive Officer of Kestrel Therapeutics. "AbbVie’s commitment underscores the potential of our approach to address one of the most important targets in oncology. And dosing the first patient in our Phase 1 trial marks an important step forward in the clinical development of KST-6051. We believe KST-6051 has the potential to address significant unmet medical needs in patients with KRAS-driven cancers, and look forward to advancing this study and generating initial clinical data with AbbVie."

"KRAS mutations drive tumor growth and survival among many cancers. While earlier KRAS inhibitors targeted specific mutations, a new wave of pan-KRAS inhibitors are exploring the potential for broader patient impact," said Eleni Lagkadinou, M.D., Vice President, Oncology Early Development, AbbVie. "We’re looking forward to exploring how these advances can help complement our pipeline of antibody-drug conjugates and immunotherapies to accelerate innovation for patients."

The deal with AbbVie is structured as a warrant agreement with an exclusive option for AbbVie to acquire the Company. Under the terms of the agreement AbbVie will support funding of the KST-6051 program and based on the completion of development and regulatory milestones will have the exclusive option to acquire Kestrel. Including the upfront payment, future exercise payments and downstream development and regulatory milestones, the value of the deal could reach up to $1.45 billion.

About KST-6051

KST-6051 is a potential best-in-class, oral pan-KRAS inhibitor, developed for the treatment of KRAS-driven cancers. KST-6051 is a potent and selective inhibitor of KRAS with activity against KRAS in both its active (GTP-bound) and inactive (GDP-bound) states, while selectively sparing HRAS and NRAS. Preclinical data demonstrate robust on-target pathway modulation, anti-proliferative activity, and efficacy at well-tolerated doses in multiple human KRAS mutant tumor models. The clinical development program will ultimately address pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and other KRAS-driven malignancies.

About Phase 1 Trial KST-6051-101 (FALCON)

The Phase 1 study, KST-6051-101 (FALCON), is an open-label, multicenter, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of KST-6051 in patients with advanced solid tumors harboring KRAS mutations, including pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), and other KRAS-driven malignancies

The trial will enroll patients with advanced metastatic solid tumors who have progressed following standard therapies. The study consists of a dose-escalation phase which will be followed by expansion cohorts in selected tumor types.

Primary objectives include evaluation of safety and tolerability, and determination of the recommended dose for expansion (RDE). Secondary and exploratory objectives include preliminary assessments of antitumor activity, pharmacokinetics, and pharmacodynamics.

Additional information about the trial is available at ClinicalTrials.gov [NCT07458347]

(Press release, Kestrel Therapeutics, APR 28, 2026, View Source [SID1234664877])

Silexion Therapeutics Announces Successful Submission of Phase 2/3 Clinical Trial Application to Germany’s BfArM for SIL204 in KRAS-Driven Locally Advanced Pancreatic Cancer

On April 28, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported the recent successful submission of a Clinical Trial Application (CTA) to Germany for its planned Phase 2/3 clinical trial of its lead, small interfering RNA (siRNA) product candidate, SIL204, in patients with locally advanced pancreatic cancer (LAPC). The CTA was submitted through the EU Clinical Trials Information System (CTIS), with Germany serving as the Reporting Member State – the country that will lead the scientific assessment of the trial across the European Union.

The submission represents a pivotal regulatory milestone in Silexion’s clinical development program and marks the Company’s entry into the European regulatory process for its next-generation siRNA therapy targeting mutated KRAS. The filing was informed by the positive Scientific Advice received from Germany’s Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) announced in December 2025, and follows the recent approval from the Israeli Ministry of Health to initiate the same Phase 2/3 trial in Israel.

The application is supported by a comprehensive regulatory package, including completed two-species toxicology studies confirming no systemic organ toxicity, and extensive preclinical data. Upon approval, Silexion plans to conduct the trial at leading oncology centers in Germany and across additional EU member states, in parallel with its previously announced Israeli sites led by Sheba Medical Center. Overall Phase 2/3 trial initiation remains planned for the second quarter of 2026.

"The successful submission of our Phase 2/3 clinical trial application to Germany is a defining milestone that extends SIL204’s development into Europe and positions Silexion to advance one of the most innovative RNAi programs in KRAS-driven cancer across multiple major jurisdictions," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Germany is widely regarded as one of the most rigorous and respected regulatory environments in the world, and its role as our Reporting Member State under the EU Clinical Trials Regulation provides a strong foundation for our broader European Phase 2/3 program. With the recent Israeli Ministry of Health approval in hand and now our European filing successfully in place, we are executing against every pillar of our 2026 regulatory roadmap as we prepare to initiate the Phase 2/3 trial in the second quarter of this year."

The planned Phase 2/3 trial will evaluate SIL204 in combination with standard-of-care chemotherapy in patients with LAPC, using Silexion’s innovative dual-route administration strategy – combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The study is structured as a safety run-in followed by a randomized cohort. Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate below 13% and more than 80% of pancreatic cancer mortality driven by metastatic disease. KRAS mutations are present in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 30-35% of lung adenocarcinomas, representing one of the largest and most persistent unmet needs in oncology.

(Press release, Silexion Therapeutics, APR 28, 2026, View Source [SID1234664876])

Genexine’s First-in-Class SOX2 Degrader GX-BP1 Demonstrates Up to 96% TGI and Eliminates Tumor Regrowth in Preclinical Models

On April 28, 2026 Genexine, Inc. (KOSDAQ: 095700), a clinical-stage biotechnology company, reported new preclinical data for its SOX2-targeting bioPROTAC candidate, GX-BP1, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego.

GX-BP1 is a first-in-class bioPROTAC drug candidate designed to selectively degrade SOX2, a transcription factor widely recognized as a key driver of tumor progression, cancer stemness, and therapeutic resistance, yet historically considered undruggable. By directly eliminating SOX2 via the ubiquitin-proteasome system, GX-BP1 targets a central driver of tumor relapse, metastasis, and resistance to standard therapies.

Preclinical data demonstrated strong anti-tumor activity across multiple models. GX-BP1 monotherapy achieved approximately 70% tumor growth inhibition (TGI), confirming meaningful standalone efficacy.

In combination settings, GX-BP1 restored sensitivity in chemotherapy-resistant models and enhanced the efficacy of EGFR-targeted therapies, including osimertinib, by suppressing SOX2-driven resistance mechanisms.

Notably, the combination of GX-BP1 with carboplatin and paclitaxel showed a clear dose-dependent response, achieving 87% to 96% TGI, with near-complete tumor growth suppression at higher doses. In addition, while tumor regrowth was observed in the osimertinib monotherapy group, the combination of GX-BP1 with osimertinib completely prevented tumor relapse, accompanied by effective elimination of cancer stem cell populations.

These findings position GX-BP1 as a potential backbone therapy for combination strategies, with broad applicability across chemotherapy, targeted therapy, and immunotherapy settings, particularly in resistant or refractory disease.

Genexine has also established a clinically relevant delivery approach using a lung-targeted lipid nanoparticle (LNP) system, enabling efficient systemic delivery of over 70% GX-BP1 mRNA to lung tissues within 24 hours.

GX-BP1 has demonstrated a comprehensive preclinical profile, including in vivo efficacy, pharmacokinetics, biodistribution, and safety, supporting advancement into IND-enabling studies. Genexine is actively pursuing global licensing and strategic partnership opportunities for GX-BP1 and its bioPROTAC platform-based pipelines.

"GX-BP1 represents a differentiated therapeutic approach that directly targets a central driver of cancer resistance," said Jaehyun Choi, Ph.D., Chief Executive Officer and Head of R&D at Genexine. "We believe its strong combination potential, and GX-BP1’s robust preclinical profile position it as a promising next-generation therapeutic candidate, and we are advancing discussions with global partners."

(Press release, Genexine, APR 28, 2026, View Source [SID1234664875])

U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

On April 28, 2026 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) reported that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.

The NDA is supported by data from the Phase 2b part of the REZILIENT1 clinical trial of zipalertinib monotherapy in patients with NSCLC harboring EGFR ex20ins mutations who have received prior therapy. The study met its primary endpoint of objective response rate. Study results from REZILIENT1 were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in the Journal of Clinical Oncology.

"Zipalertinib was discovered at Taiho Pharmaceutical Co., Ltd., and has been developed with a focus on addressing the unmet needs of patients with EGFR exon 20 insertion-mutated non-small cell lung cancer," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "The FDA’s acceptance of the NDA for zipalertinib is an important milestone for this program, and we look forward to working with FDA during the review process."

"Zipalertinib is a compound created using Taiho Pharmaceutical’s proprietary drug discovery and development technologies, Cysteinomix, with the aim of delivering a new treatment option to address high unmet medical needs," said Takeshi Sagara, PhD, Executive Director, Board Member, Medical Affairs, Translational Development, Clinical Development, Discovery and Preclinical Research at Taiho Pharmaceutical. "The FDA’s acceptance of the NDA represents an important milestone, reflecting the scientific and clinical data accumulated to date. We will continue to work closely with Taiho Oncology, Cullinan Therapeutics and the FDA throughout the review process, with the shared goal of ultimately delivering a new treatment option to patients with non-small cell lung cancer EGFR exon 20 insertion mutations."

"FDA acceptance of the zipalertinib NDA is an important step toward making zipalertinib available for people living with non-small cell lung cancer with EGFR exon 20 insertion mutations, who continue to face limited treatment options," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "We are deeply grateful to the patients and families who have participated in the REZILIENT program, and to the investigators, study teams, and advocates whose collaboration made achievement of this milestone possible. We believe zipalertinib has the potential to help address a significant unmet need, and we look forward to working with our partners at Taiho with the goal of bringing zipalertinib to patients waiting for new treatment options."

Summary of Primary Study Results:

Zipalertinib demonstrated clinically meaningful efficacy in the primary efficacy population (n=176), including 51 patients who had received prior amivantamab.
The confirmed objective response rate (ORR) was 35%. Median duration of response (mDOR) was 8.8 months.
In patients treated after prior platinum-based chemotherapy only (n=125), ORR was 40% with a mDOR of 8.8 months.
In exploratory subgroup analyses:
Patients who had received prior amivantamab without other ex20ins-targeted therapy (n=30) showed a confirmed ORR of 30% and mDOR of 14.7 months.

Patients with brain metastases (n=68) showed a confirmed ORR of 31% and a mDOR of 8.3 months.
The safety profile of zipalertinib was manageable and consistent with previously reported data.¹ The most common treatment-emergent adverse events were paronychia, rash, anemia, dermatitis acneiform, diarrhea, dry skin, nausea and stomatitis. Most treatment-emergent adverse events were grade 1 or 2 per NCI-Common Terminology Criteria for Adverse Events (CTCAE v5.0).
Zipalertinib is an oral EGFR tyrosine kinase inhibitor. Zipalertinib received Breakthrough Therapy Designation in 2021 for the treatment of patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations who have previously received platinum‑based systemic chemotherapy.

About REZILIENT1

REZILIENT1 (Researching Zipalertinib in EGFR Non-Small Cell Lung Cancer Tumors) is a Phase 1/2 clinical trial (NCT04036682) to evaluate efficacy and safety of zipalertinib in adult patients with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations who have received prior therapy. Patients were treated with oral zipalertinib 100 mg twice daily. The primary endpoints were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Adverse events were characterized and graded according to the NCI-Common Terminology Criteria for Adverse Events (CTCAE v5.0).

About Zipalertinib

Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with ex20ins mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA for the treatment of patients with locally advanced or metastatic NSCLC harboring epidermal growth factor EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., and its parent company, Taiho Pharmaceutical Co., Ltd. worldwide, and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins, which makes them the third most common EGFR mutation subtype.2 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,2 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Taiho, APR 28, 2026, View Source [SID1234664874])