On April 14, 2026 Renaissance Pharma Limited, an Essential Pharma company focused on development stage assets, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation for Daretabart (hu1418K322A), a novel anti-GD2 monoclonal antibody in development for the treatment of high-risk neuroblastoma (HRNB), a rare paediatric cancer. The designation recognises the significant unmet medical need in HRNB and will support more frequent interactions with the FDA throughout development, as well as eligibility for accelerated and rolling review.

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The company also confirms it has received IND clearance from the FDA, enabling initiation of the SHINE Phase II/III clinical trial in relapse or refractory children with HRNB in the United States. The first commercial-scale Good Manufacturing Practice (GMP) batch of Daretabart (hu1418K322A) has also been successfully manufactured for use in the SHINE trial.

Daretabart (hu1418K322A) is being developed by Renaissance Pharma under an exclusive license agreement with St. Jude Children’s Research Hospital, a global leader in pediatric cancer research and treatment. The antibody targets GD2, a cell surface antigen highly expressed on neuroblastoma cells. By binding to GD2, Daretabart (hu1418K322A) is designed to enhance immune-mediated tumour cell killing, while incorporating novel structural modifications intended to improve tolerability profile.

The programme builds on encouraging Phase II data evaluating Daretabart (hu1418K322A) as part of first-line therapy and in the post-consolidation setting for patients with HRNB. The study demonstrated a three-year event-free survival (EFS) rate of 73.7% and an overall survival (OS) rate of 86.0%. These results were published in the Journal of Clinical Oncology in December 2021.

The successful manufacture of the first commercial-scale GMP batch marks a key operational milestone and underscores Renaissance Pharma’s commitment to ensuring reliable, high-quality supply as the programme advances. This achievement supports ongoing clinical development and represents an important step towards future commercial readiness.

Simon Ball, Interim CEO of Essential Pharma and Director of Renaissance Pharma Limited said: "Daretabart has the potential to make a real difference for children with high-risk neuroblastoma, a disease where outcomes remain deeply inadequate despite intensive treatment. FDA Fast Track Designation is an important external validation of that potential, and together with IND clearance and our ability to manufacture at commercial scale, reflects the strength and maturity of this programme. Having worked exceptionally hard behind the scenes for a number of months, it is with great excitement that we announce this update today. We are executing at pace, and look forward to sharing data from the SHINE trial as it progresses. Today’s news brings us another step closer to delivering Daretabart as a meaningful new treatment option for children facing this aggressive cancer."

(Press release, Essential Pharma, APR 14, 2026, View Source [SID1234664353])

(Press release, Essential Pharma, APR 14, 2026, View Source [SID1234664353])

On April 14, 2026 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a clinical-stage oncology company advancing leronlimab, a first-in-class humanized monoclonal antibody targeting the CCR5 receptor with therapeutic potential across multiple indications, including metastatic triple-negative breast cancer ("mTNBC") and colorectal cancer ("mCRC"), reported that it will be presenting two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, taking place April 17–22, 2026, in San Diego, California.

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Details of the poster presentations are as follows:

Abstract title:
Leronlimab induces PD-L1 expression and is associated with long term survival with an ICI in PD-L1 low metastatic TNBC
Presenter: Richard Pestell, M.D., Ph.D., FRCP AO, Lead Consultant in Preclinical and Clinical Oncology at CytoDyn
Date and Time: April 19, 2026, from 2:00 p.m. – 5:00 p.m. PST.
Poster ID: 1033
Location:
Section 41, Board 1


Abstract title:
Preliminary results of a phase 2 study of leronlimab in combination with TAS-102 and bevacizumab in previously treated metastatic colorectal cancer
Presenter: Pashtoon M. Kasi, M.D., M.S., Medical Director at City of Hope
Date and Time: April 21, 2026, from 2:00 p.m. – 5:00 p.m. PST.
Poster ID: 6466
Location:
Section 41, Board 14

"We are encouraged by the continued progress being made as we advance leronlimab and explore its potential applications across solid tumors," said Jacob Lalezari, M.D., CEO of CytoDyn. "The research being presented at AACR (Free AACR Whitepaper) reflects the growing body of scientific work examining CCR5 biology and its role in the tumor microenvironment. Together, these studies help deepen our understanding of how leronlimab may enhance immune responses and inform our broader strategy to develop new treatment approaches for patients with difficult-to-treat cancers."

A copy of the presentations will be made available on CytoDyn’s website under the Publications & Posters section after it is presented at the symposium.

(Press release, CytoDyn, APR 14, 2026, View Source [SID1234664352])

On April 14, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported that the first patient has been enrolled in the Phase 1b trial of CLR 121125 (CLR 125) for the potential treatment of triple negative breast cancer (TNBC).

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CLR 125 is Cellectar’s proprietary Auger-emitting radioconjugate incorporating iodine-125 to achieve intracellular delivery and direct DNA-level damage in tumor cells. The molecular structure of CLR 125 is identical to that of iopofosine I 131 (CLR 131) and the demonstrated clinical activity, safety, and tumor-targeting characteristics of iopofosine I 131 provide important validation of the platform and support translational relevance. However, these radioconjugates differ in their radiobiologic behavior at the tumor level, resulting in distinct mechanisms of action and therapeutic profiles. In preclinical studies, CLR 125 showed selective tumor uptake and statistically significant activity in vivo models of TNBC with no observed end-organ or hematologic toxicity at evaluated doses.

"Treating the first patient in this Phase 1b trial is a significant milestone for Cellectar and for those impacted by triple negative breast cancer, a condition still defined by a profound lack of targeted therapies," said James Caruso, president and chief executive officer of Cellectar. "CLR 125 embodies our commitment to optimize our proprietary PDC delivery platform to develop highly selective radioconjugates capable of delivering precise cytotoxic radiation while minimizing systemic toxicity. With additional study sites being activated in Q2, we are poised to rapidly advance this program and plan to provide dosimetry, safety, and efficacy updates throughout 2026."

The Phase 1b clinical trial is an open-label, dose-escalation study in patients with relapsed or refractory TNBC, designed to evaluate three dose levels and dosing regimens of CLR 125 (32.75 mCi administered over 4 cycles, 62.5 mCi over 3 cycles, and 95 mCi over 2 cycles), with approximately 15 patients enrolled per treatment arm. The study incorporates imaging-based assessments to characterize tumor uptake and biodistribution, supporting prediction of safety and therapeutic activity. Clinical endpoints include safety and tolerability, as well as preliminary efficacy measures, including tumor response per RECIST criteria and progression-free survival.

About Triple Negative Breast Cancer
Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer characterized by the absence of estrogen receptors, progesterone receptors, and HER2 protein expression. This lack of common therapeutic targets makes TNBC particularly challenging to treat, with limited options beyond chemotherapy. TNBC tends to grow and spread more quickly than other breast cancer types and disproportionately affects younger women and those of African descent. In the U.S., approximately 12% of breast cancer diagnoses are TNBC. Studies suggest that approximately 25% of TNBC cases relapse after standard treatments like surgery, chemotherapy, and radiation. Due to its high recurrence rate and poor prognosis, there is a critical need for innovative, targeted therapies to improve outcomes for patients facing this difficult diagnosis.

(Press release, Cellectar Biosciences, APR 14, 2026, View Source [SID1234664351])

On April 14, 2026 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology company using artificial intelligence ("AI") and machine learning to turn complex biomedical data into actionable insights, reported its participation as an exhibitor at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. The AACR (Free AACR Whitepaper) Annual Meeting will be held from April 17-22 at the San Diego Convention Center in San Diego, California.

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Companies, researchers, and other conference attendees who are interested in meeting with the BullFrog AI team should visit booth 2957 or contact Steven Seegers at [email protected].

The AACR (Free AACR Whitepaper) Annual Meeting is the premier gathering for the global cancer community, uniting researchers, clinicians, patients, and advocates to share cutting-edge breakthroughs in oncology. Showcasing top-tier research from around the world, the event covers the entire spectrum of cancer care, from basic biology and prevention to clinical trials and patient advocacy. With a theme this year of "Precision, Partnership, Purpose: Advancing Cancer Science to Save Lives Globally," the meeting will highlight the work of the best minds in cancer science and medicine from institutions all over the world.

(Press release, Bullfrog AI, APR 14, 2026, View Source [SID1234664350])

On April 14, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, reported a new clinical case study illustrating how CyPath Lung, the Company’s noninvasive sputum-based diagnostic test, helped determine next steps for a high-risk patient with a suspicious pulmonary nodule where imaging and risk models suggested a high likelihood of cancer, but the physician suspected possible inflammation.

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The patient, a 70-year-old female with a 50 pack-year smoking history and smoking-related emphysema, presented with increased symptoms including cough, sputum production and shortness of breath. A low-dose CT scan identified a suspicious 30-millimeter (mm) lesion in the lower right lung with nearby enlarged lymph nodes, findings that can be associated with lung cancer. PET imaging suggested a high likelihood of malignancy. Lung cancer risk calculators estimated the probability of cancer as high on the Mayo and Herder models and intermediate on the Brock model.

"In this case, imaging findings and risk calculators suggested a very high probability of lung cancer, and we scheduled her for biopsy," said Daya Nadarajah, MD, the treating pulmonologist. "I routinely use CyPath Lung in my practice and ordered the test for her. She received a negative result, ‘Unlikely Malignancy,’ which prompted another scan before we moved forward with the biopsy."

A follow-up CT scan showed that the concerning 30-mm nodule had completely resolved, confirming the physician’s acumen that the abnormality was due to a reversible inflammatory process rather than lung cancer.

"In patients with underlying lung disease, like emphysema, or other comorbidities like cardiovascular disease, biopsy can carry significant risks. Physicians must weigh the risks against the potential benefits," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "Adding CyPath Lung to the diagnostic pathway for indeterminate nodules provides additional objective data that can be very valuable when assessing patients with complicating health conditions. In this patient’s case, CyPath Lung supported additional imaging before biopsy which resulted in saving the patient from a risky, costly and unnecessary procedure."

This case highlights how CyPath Lung can assist physicians with pulmonary nodule management by helping physicians confidently defer unnecessary – and often risky – invasive procedures. This case study is illustrative of a single patient experience and does not establish generalized clinical utility.

About CyPath Lung

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. CyPath Lung is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

(Press release, BioAffinity Technologies, APR 14, 2026, View Source [SID1234664349])