On October 5, 2026 Medicovestor, Inc. reported FDA clearance of its Investigational New Drug (IND) application for MC001, the Company’s first-in-class dimeric chemoimmunotherapy ADC for pancreatic cancer, following completion of the FDA’s 30-day initial review period without a clinical hold.

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MC001 is the first clinical candidate developed from Medicovestor’s proprietary ADoBind platform, which combines a traditional cytotoxic payload with a dimeric IgG1 antibody scaffolding to mediate enhanced immunologic cytotoxic effector mechanisms that leverage the patient’s innate immune response. This differentiated approach is intended to complement the direct cytotoxic activity against actively proliferating tumor cells with immune-mediated antitumor mechanisms that may also affect quiescent tumor cells that are not actively dividing, including cells in the G0/G1 phase of the cell cycle.

With the IND now in effect, Medicovestor is rapidly advancing its international, industry-sponsored Phase 1 clinical study of MC001, which will evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MC001 in patients with advanced solid tumors, particularly pancreatic cancer.

"This milestone marks a significant transition for Medicovestor and MC001 as we advance from preclinical development toward clinical evaluation," said Seah H Lim MD PhD, Founder and Chief Executive Officer. "We look forward to evaluating MC001’s novel chemoimmunotherapy approach in patients with pancreatic cancer and other advanced solid tumors."

(Press release, Medicovestor, OCT 5, 2026, View Source [SID1234673204])

On October 5, 2026 OnCusp Therapeutics, Inc., a clinical-stage biopharmaceutical company developing differentiated therapies designed to translate cutting-edge innovation into clinically meaningful outcomes for patients, reported initial data from the Company’s Phase 1b open-label, multicenter dose-expansion study evaluating its Cadherin-6 (CDH6)-directed antibody-drug conjugate ("ADC"), CUSP06, for the treatment of platinum-resistant ovarian cancer ("PROC"). The Phase 1b data are being presented for the first time by Roisin E. O’Cearbhaill, M.D., Gynecological Medical Oncologist and Cellular Therapist, Memorial Sloan Kettering Cancer Center, at a plenary oral session of the International Gynecologic Cancer Society (IGCS) 2026 Annual Global Meeting, on October 3, 2026, at Palais des Congrès de Montréal in Montréal, Canada.

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"We are excited to report these initial data from our Phase 1b trial at this year’s IGCS Annual Meeting, which reflect the potential of CUSP06 to treat platinum-resistant ovarian cancer in patients who have experienced disease progression after multiple lines of prior therapy," said Dr. Bing Yuan, Co-Founder and CEO of OnCusp Therapeutics. "The 62% ORR observed in the 4.0 mg/kg cohort represents one of the highest response rates reported in PROC patients receiving an experimental TOP1-inhibitor ADC. CUSP06 also demonstrates robust activity in patients previously treated with mirvetuximab soravtansine. Importantly, CUSP06 continues to maintain an acceptable safety and tolerability profile in line with other TOP1 inhibitor ADCs currently in development. We believe these Phase 1b data provide us with strong clinical evidence that CUSP06 is a very active, differentiated and potentially best-in-class CDH6-targeting ADC in ovarian cancer and possibly other CDH6-expressing cancers."

"Despite advances in treatment, most patients with ovarian cancer will ultimately develop resistance to platinum-based chemotherapy, highlighting the need for new therapeutic approaches," said Dr. Roisin E. O’Cearbhaill. "The development of highly potent antibody-drug conjugates targeting CDH6, which is frequently overexpressed in ovarian cancer, represents a promising strategy for patients with recurrent and treatment-resistant disease. I am particularly encouraged not only by the response rates observed in this study, but also by the duration of response and the low incidence of pneumonitis, which may suggest a potential safety advantage compared with other TOP1 inhibitor-based ADCs. While these results remain early, the overall findings from this Phase 1b study support the continued development of CUSP06, and I look forward to seeing the program advance into pivotal-stage clinical testing."

The Phase 1b trial (NCT06234423) is an open-label multi-center, dose- expansion study evaluating CUSP06 in patients with platinum-refractory/resistant ovarian cancer (PROC), advanced renal cell carcinoma (RCC) and other CDH6-positive solid tumors. More specifically, the Phase 1b portion of the trial included data from 86 heavily pre-treated PROC patients with a median of 3 lines of prior therapy. Eligibility included patients with high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer which is platinum-resistant with 1-4 prior lines of therapy.

Four cohorts treated with CUSP06 were evaluated in the Phase 1b trial: 3.6 mg/kg (n=22), 4.0 mg/kg (n=21), 4.0 mg/kg + prophylactic G-CSF (n=20), and 4.4 mg/kg + prophylactic G-CSF (n=23).

The primary endpoint of the Phase 1b study was Objective Response Rate (ORR) based on RECIST v1.1, safety parameters (incidence/severity of AEs and SAEs, frequency and duration of dose modifications). Secondary endpoints included Clinical Benefit Rate (CBR), Disease Control Rate (DCR), Duration of Response (DOR), Time to Progression (TTP), Progression Free Survival (PFS) as measured by RECIST v1.1, and Pharmacokinetic (PK) parameters.

As of September 23, 2026, there were 81 Ph1B PROC patients evaluable for efficacy in the trial.

Summary of efficacy data

CUSP06 demonstrated meaningful responses across dose levels in the four patient cohorts, including complete responses (CR):

50% ORR (10/20) in the 3.6 mg/kg cohort; including 1 CR
62% ORR (13/21) in the 4.0 mg/kg cohort; including 3 CR
45% ORR (9/20) in the 4.0 mg/kg + G-CSF cohort
40% ORR (8/20) in the 4.4 mg/kg + G-CSF cohort; including 1 CR

53% ORR (16/30) in post-mirvetuximab treated patients; including 1 CR
mDOR from the Phase 1a part of the study HGSOC was 10.5 months, with longest response > 23 months (ongoing)
Data from the ongoing Phase 1b study continues to mature, which could provide additional evidence in support of CUSP06 as a potential best-in-class TOP1 ADC therapy for the treatment of PROC.

Summary of safety and tolerability data

Most common TRAEs were hematologic (anemia, neutropenia, thrombocytopenia), GI (nausea, vomiting, diarrhea), and fatigue, consistent with TOP1 inhibitor ADC class effects
Dose modifications were primarily driven by hematologic AEs, consistent with mechanism, and were manageable
No ocular toxicity reported
Pneumonitis rate remains rare with only 1 case in 86 patients
Presentation Details:
Title: Dose-Optimization, Efficacy, and Safety of CUSP06, a Cadherin-6 Directed Antibody-Drug Conjugate, in Platinum-Resistant Ovarian Cancer
Session Title: Plenary Oral 2
Abstract Number: 503

CUSP06 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with platinum-resistant ovarian cancer.

About CUSP06

CUSP06 is a Cadherin-6 (CDH6)-targeting antibody-drug conjugate (ADC) now in the Phase 1b portion of a Phase 1 study in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors. CUSP06 has shown promising efficacy in heavily pretreated ovarian cancer, with both Phase 1a and Phase 1b results supporting potential best-in-class activity. CUSP06 is composed of a proprietary antibody with high CDH6 binding affinity, a protease-cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is designed to complement the exatecan payload, enabling a stable and homogeneous ADC. The payload is a weak substrate for BCRP/P-gp, drug efflux pumps that drive chemoresistance to many therapies. In preclinical data, CUSP06’s linker-payload has been shown to have an increased "bystander effect" compared with competitor ADCs. CUSP06 has a drug-to-antibody ratio of eight. OnCusp obtained the exclusive global rights (outside of China) to lead the development and commercialization of CUSP06 from Multitude Therapeutics in 2022. Additional information on the CUSP06-1001 (NCT06234423) trial can be found at ClinicalTrials.gov.

(Press release, OnCusp Therapeutics, OCT 5, 2026, View Source [SID1234673203])

On October 5, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQX: MDNAF), a clinical-stage immunotherapy company developing Superkines for targeting cancer and autoimmune disease, reported that an abstract reporting topline data from the Phase 1/2 study of MDNA11 has been selected for oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting.

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Details of the oral presentation are as follows:
Abstract Number: 517
Presentation Type: Oral Presentation
Presentation Date: Saturday, November 7, 2026
Presentation Time: 4:30-4:45 p.m. MST
Session: Oral Session 3, 3:30-4:50 p.m. MST
Location: Phoenix Convention Center, Room 301D, Phoenix, Arizona

Title: "MDNA11 Demonstrates Clinical Activity as Monotherapy and in Combination with Pembrolizumab in Biomarker-Enriched Gastrointestinal Malignancies, Including ICI-Refractory Disease."

(Press release, Medicenna Therapeutics, OCT 5, 2026, View Source [SID1234673202])

On October 5, 2026 Radiopharm Theranostics Limited (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage radiopharmaceutical company, reported the successful completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA or the Agency) regarding RAD101, the Company’s investigational radiopharmaceutical imaging agent for the detection of brain metastases.

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RAD101 is the Company’s novel Fluorine-18-labeled small-molecule imaging agent that targets fatty acid synthase (FASN) and is being developed to diagnose suspected recurrent brain metastases arising from a range of solid tumors. Previously reported data from the Phase 2b clinical trial showed that RAD101 demonstrated 93% concordance with MRI across all evaluable lesions, meeting the Phase 2 trial’s primary endpoint.

The Company expects to receive the FDA’s official meeting minutes within approximately 30 days. The minutes will provide the formal record of the meeting and the Agency’s feedback on the proposed pivotal clinical development program. RAD intends to provide a further update following receipt and review of the official minutes.

"The successful completion of our End-of-Phase 2 meeting with the FDA marks a pivotal milestone for RAD101 and an important inflection point in the evolution of our company," said Riccardo Canevari, Chief Executive Officer of Radiopharm. "The discussion was highly constructive and provided meaningful clarity on the regulatory pathway for RAD101, reinforcing our confidence in the program’s potential to address a significant unmet need in brain metastases imaging. We are encouraged by the collaborative dialogue with the Agency and believe this interaction positions us well as we finalize our pivotal development strategy and take the next critical steps toward a potential registration program."

Building on the momentum from the meeting, RAD is moving immediately to advance Phase 3 readiness activities, including clinical and operational planning, in order that the program is positioned to progress efficiently once the Agency’s formal feedback is received.

"RAD101 represents a differentiated imaging approach targeting fatty acid synthase, a compelling biological mechanism that has demonstrated promising clinical potential in brain metastases," continued Mr. Canevari. "As we prepare for pivotal development, we are also evaluating opportunities to engage with potential strategic partners who recognize the value of this program and share our vision for bringing this innovation to patients and clinicians worldwide. Given the scale of the opportunity and the maturity of the asset, we believe now is the appropriate time to explore pathways that could maximize both clinical impact and long-term value creation."

RAD101 has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 registrational trial in the U.S.

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimize patient care.1

About RAD101

RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

(Press release, Radiopharm Theranostics, OCT 5, 2026, View Source [SID1234673201])

On October 5, 2026 Iambic Therapeutics, Inc. (Iambic), a clinical-stage life science and technology company developing novel medicines using its AI-driven platform, reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2 clinical trial evaluating IAM217, a brain-penetrant, differentiated inhibitor of KIF18A for the potential treatment of triple-negative breast cancer, ovarian cancer, and other solid tumor indications with chromosomal instability (CIN). In a preclinical brain metastasis model, IAM217 produced approximately 90% regression of established intracranial tumors.

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"Iambic’s mission is to make better technology for better medicines, and today marks another important milestone for the company," said Tom Miller, PhD, Co-Founder and CEO, Iambic. "With IAM217 poised to enter clinical trials, IAM1363 well underway in clinical trials, and our CDK2/4 dual inhibitor program advancing toward IND submission, we believe that we are seeing meaningful productivity from our molecular superintelligence platform."

KIF18A is a mitotic motor protein (kinesin) that governs chromosome alignment during cell division. Cancer cells with CIN — a hallmark of many of the most aggressive and treatment-refractory cancers — depend on KIF18A to complete cell division, while normal cells tolerate its inhibition, creating a potential therapeutic window distinct from broadly cytotoxic antimitotic agents. There is emerging clinical evidence that potentially validates KIF18A as an important target for high-grade serous ovarian cancer and preclinical evidence for a variety of other malignancies, including triple-negative breast cancer.

IAM217 is a product of Iambic’s AI-driven, molecular superintelligence platform. Iambic designed IAM217 without access to a high-resolution co-crystal structure of KIF18A bound to an inhibitor. NeuralPLexer was instead leveraged to supply structural insights. The allosteric binding mode confers mechanistic selectivity over other kinesin family members and avoids the cytotoxic liabilities associated with tubulin-targeting mitotic agents. Enchant and earlier Iambic property-prediction AI tools were then deployed for large-scale multi-parameter optimization. From an initial set of 100 nM-class hits identified in 24 high-throughput experimentation plates, AI-guided design drove potency improvement to multiple 10 nM-class compounds while simultaneously optimizing oral bioavailability, reducing CYP-mediated drug-drug interaction liabilities, and engineering CNS penetrance. At the stage of lead identification, brain penetrance was achieved within approximately six months.

"We believe IAM217 has the potential to be a differentiated inhibitor for cancers that rely on KIF18A to proliferate," said Pete Olson, PhD, Chief Scientific Officer, Iambic. "With IAM217, we see the opportunity for strong anti-tumor activity in patients with brain metastases, supported by a biomarker-informed development strategy. This investigational medicine could not have been nominated without our AI-driven platform, allowing us to optimize for key properties and quickly move through IND-enabling studies."

Subject to FDA clearance of the IND, IAM217 will become Iambic’s second program to enter clinical trials. Iambic is also advancing IAM1363, a highly selective and brain-penetrant HER2 inhibitor, in an ongoing Phase 1/1b clinical trial, and anticipates submitting an IND for IAM-C1, its CDK2/4 dual inhibitor, later in the fourth quarter of 2026, and subject to FDA clearance of the IND, to initiate a Phase 1/2 trial.

(Press release, Iambic Therapeutics, OCT 5, 2026, View Source [SID1234673199])