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])

On October 5, 2026 Alliance Foundation Trials, LLC (AFT), a national leader in conducting innovative, practice-changing cancer clinical trials, and Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported the launch of AFT-70 NAVIGATE, a randomized phase III trial evaluating a novel molecular residual disease (MRD)-guided treatment strategy for patients with intermediate and high-risk ER-positive/HER2-negative early breast cancer. The trial is sponsored and led by AFT, with collaboration and co-funding from Natera and Genentech, a member of the Roche Group.

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AFT-70 NAVIGATE is designed to test whether patients can maintain excellent outcomes while more selectively using CDK4/6 inhibitors, rather than exposing all patients to prolonged combination therapy. The strategy pairs giredestrant, an investigational highly active next-generation oral selective estrogen receptor degrader (SERD), with longitudinal Signatera Genome MRD monitoring, to identify patients who may benefit from treatment escalation with a CDK4/6 inhibitor.

Giredestrant was selected as the endocrine therapy backbone for the investigational arm based on results from the phase III lidERA trial, which showed giredestrant achieved a statistically significant and clinically meaningful improvement in invasive disease-free survival compared with standard endocrine monotherapy in patients with ER-positive/HER2-negative early breast cancer. These findings support the potential for giredestrant to provide an endocrine therapy backbone on which an MRD-guided treatment strategy can be built.

Signatera was selected as the MRD test for this trial based on its extensive clinical evidence in ER-positive, HER2-negative early breast cancer, including from the AFT-05 PALLAS and MonarchE trials, and because of its new ultrasensitive Genome-based technology with Phased and Structural Variants reporting analytical sensitivity below 1 ppm (parts per million).

AFT expects to enroll more than 2,000 patients with stage II-III ER-positive/HER2-negative breast cancer who are eligible for endocrine therapy at approximately 200 sites across the U.S. and internationally. Patients with no detectable MRD by Signatera after completing standard-of-care treatment, including surgery, radiotherapy, and chemotherapy when indicated, will be randomly assigned to one of two approaches: (1) a control arm receiving standard-of-care endocrine therapy plus upfront CDK4/6 inhibition; or (2) an investigational arm receiving giredestrant monotherapy, with CDK4/6 inhibition added only if Signatera becomes positive. The primary endpoint is non-inferiority in 4-year distant recurrence-free survival.

"This collaboration brings together leading expertise in breast cancer research, clinical care, and molecular testing to address an important question for patients: How can we make treatment more precise while avoiding unnecessary toxicity?" said Evanthia Galanis, M.D., D.Sc., president of Alliance Foundation Trials, LLC. "By using MRD technology to guide treatment decisions, this trial has the potential to transform care for eligible breast cancer patients and individualize treatment intensity."

"We know that patients with ER-positive, HER2-negative breast cancer do not all face the same risk of recurrence, yet adjuvant treatment decisions are still largely based on clinical and pathological features measured at diagnosis," said Komal Jhaveri, M.D., FACP, FASCO study chair, breast medical oncologist and early drug development specialist at Memorial Sloan Kettering Cancer Center. "The AFT-70 NAVIGATE trial combines two important advances: an endocrine therapy backbone with giredestrant and longitudinal MRD testing with Signatera that can provide a dynamic measure of recurrence risk. The trial will determine whether MRD-guided monitoring can distinguish patients most likely to benefit from adding a CDK4/6 inhibitor from those in whom it can be safely omitted. It’s an important step forward using biology—not just baseline risk—to guide adjuvant therapy."

"More treatment is not always better treatment," said Gaorav Gupta, M.D., Ph.D., study co-chair, breast radiation oncologist, and co-leader of the Breast Cancer Research Program at UNC Lineberger Comprehensive Cancer Center. "CDK4/6 inhibitors can be an important part of care for some patients, but they can also add side effects, monitoring, and treatment burden. If highly sensitive blood-based MRD testing can identify patients who can safely defer additional therapy, we may be able to spare many patients from the burdens of more treatment while maintaining excellent cancer control. That is the promise we hope to explore through this study."

"Natera and AFT have a longstanding partnership and shared commitment to cutting-edge trials across many cancer types," said Minetta Liu, M.D., chief medical officer, oncology and early cancer detection, Natera. "AFT-70 NAVIGATE creates enormous potential to enhance treatment options for patients with intermediate and high-risk, hormone receptor positive breast cancer."

(Press release, Genentech, OCT 5, 2026, View Source [SID1234673198])

On October 5, 2026 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported Cancer Research Communications, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), has published results from the COSMOS-MEL01 study (UMIN000042040). The study is the first published prospective, multicenter evaluation of the tissue-free, epigenomic Guardant Reveal blood test for molecular residual disease (MRD) detection and recurrence monitoring in patients with resected stage II–III melanoma.

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The COSMOS (COnquer Solid Malignancies by blOod Screening) program is a large prospective initiative evaluating MRD detection with the Guardant Reveal test across six cancer types. This report presents findings from COSMOS-MEL01, in which 280 longitudinal surveillance samples from 48 patients with clinical stage II–III melanoma treated with surgery were analyzed. The study found that detection of circulating tumor DNA (ctDNA) following surgery was strongly associated with recurrence and melanoma-related death. During longitudinal surveillance, Guardant Reveal detected 81% of distant recurrences, with 100% specificity in post-treatment samples from patients who remained recurrence-free. ctDNA detection preceded clinical identification of recurrence by a median of 70.5 days. These findings support the use of Guardant Reveal as a rapid, noninvasive approach for earlier identification of patients at high risk for recurrence, enabling refined treatment and surveillance strategies.

"Patients with resected, high-risk melanoma need more precise tools to assess how their risk changes after surgery and throughout surveillance," said Yoshiaki Nakamura, M.D., Ph.D., former Chief, International Research Promotion Office at National Cancer Center Hospital East in Chiba, Japan, and a co-lead author of the study. "These results show that ctDNA detection using a tissue-free assay was associated with a substantially increased risk of recurrence and melanoma-related death and often preceded clinical detection of disease. Fast, broadly accessible testing would be valuable in helping to inform therapy for patients with substantially higher risk of melanoma recurrence and poorer survival than those who remained ctDNA-negative."

"Predicting melanoma recurrence after surgery remains difficult at the individual-patient level, and conventional clinicopathologic staging provides only a static estimate of risk," said Kenjiro Namikawa, M.D., Ph.D., Chief, Department of Dermatologic Oncology at National Cancer Center Hospital in Tokyo, Japan. "Our findings suggest that serial ctDNA testing may provide a dynamic view of recurrence risk and potentially complement routine imaging, particularly in identifying patients at increased risk of distant relapse. Further studies will be important to determine whether and how ctDNA results could be incorporated into postoperative treatment and surveillance decisions."

Key study findings include:

100% specificity in samples from patients without recurrence
81% longitudinal sensitivity for distant recurrence detection
Up to 273-day lead from ctDNA detection to recurrence
"COSMOS-MEL01 extends the growing body of evidence supporting Guardant Reveal into melanoma and demonstrates the power of epigenomic MRD detection across a diverse set of melanoma subtypes," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "The ability to identify patients at very high risk shortly after surgery, and to detect molecular recurrence before it appears clinically, could help inform more personalized surveillance and clinical trial strategies. These findings also illustrate the advantages of a tissue-free approach that can deliver molecular insights without the logistical complexity of obtaining and analyzing a tumor specimen."

The incidence of melanoma is steadily rising, with annual cases projected to increase by more than 50% between 2020 and 2040. The COSMOS study provides strong evidence for the use of Guardant Reveal to improve recurrence risk stratification to inform management decisions for this significantly large patient population.

The study was published today at 10 a.m. EDT in Cancer Research Communications.

About Guardant Reveal

Guardant Reveal is a tissue-free liquid biopsy test that detects MRD and monitors recurrence in early-stage colorectal, breast, and lung cancers, helping oncologists guide treatment decisions. In addition to MRD detection, Reveal can be used for late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights.

The first clinical-validation study of pan-cancer chemotherapy monitoring published in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures.

(Press release, Guardant Health, OCT 5, 2026, View Source [SID1234673197])