On November 4, 2026 Step Pharma ("the Company"), the global leader in CTPS1 inhibition for targeted cancer treatment, reported that an oral presentation disclosing the first preliminary data from its ongoing, open-label phase 2 VECTRA trial of dencatistat for high risk essential thrombocythaemia (ET) will be delivered at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place in New Orleans, Louisiana from 12–15 December 2026.

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ET is a rare blood cancer characterised by the overproduction of platelets and increased risk of thrombosis that can lead to serious complications such as stroke or heart attack. The VECTRA trial is evaluating the safety, tolerability and efficacy of dencatistat, the Company’s first-in-class, highly selective, oral CTPS1 inhibitor, in up to 50 participants with high-risk ET across sites in the US, EU and UK. The trial’s primary endpoints are efficacy, safety, and tolerability. Secondary endpoints include durability of haematologic response and rates of thrombosis, haemorrhage, and disease transformation.

As of 21 July 2026, 10 out of 12 (83%) evaluable participants achieved platelet normalisation, and all achieved a platelet count of <600 ×10⁹/L, with a median maximal platelet reduction of 76% (22–86%) and no thromboembolic events occurring. A favourable tolerability profile was observed with nine participants (64%) having treatment related adverse events, predominantly anaemia and nausea. Further data will be presented at the meeting.

Oral Presentation Details:

Presentation title: A phase 2 study of dencatistat, an oral CTP synthase 1 inhibitor, for the treatment of high risk essential thrombocythemia; preliminary data from the VECTRA study.
Session: 634: Myeloproliferative Syndromes: Clinical and Epidemiological: Molecular Insights and New Approaches in MPNs
Date and time: Monday 14 December 2026, 4:00 PM to 4:15 PM CT
Presenter: Michael Loschi MD PhD
Location: Hall B, Ernest N. Morial Convention Center (MCCNO), New Orleans, Louisiana

Further details of the VECTRA trial can be found on ClinicalTrials.gov under the identifier NCT06786234.

(Press release, Step Pharma, NOV 4, 2026, View Source [SID1234674249])

On November 4, 2026 Boehringer Ingelheim, headquartered in Germany, and Sino Biopharmaceutical Limited (01177.HK; together with its subsidiaries, "SBP Group") reported a strategic multi-program option and license agreement to advance potential next-generation cancer treatments based on antibody-drug conjugate (ADC) and T-cell engager (TcE) technologies. Deepening the companies’ existing partnership in oncology, the new agreement combines SBP Group’s innovative platforms and early-development capabilities with Boehringer Ingelheim’s global oncology expertise to advance new treatment approaches for patients worldwide.

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Cancer remains one of the world’s greatest health challenges, with approximately 20.6 million new cases and close to 10 million deaths annually. ADCs are designed to deliver potent therapeutic agents more selectively to cancer cells, while T-cell engagers are designed to activate and direct immune cells to eradicate cancer cells, offering complementary approaches to treating cancer.

"Our partnership with SBP Group brings together complementary science to broaden our development portfolio of antibody-drug conjugates and T-cell engagers. It puts our China strategy into action by connecting innovation from China with our global research and development capabilities," said Paola Casarosa, Member of the Board of Managing Directors and Head of the Innovation Unit at Boehringer Ingelheim. "Together, we aim to accelerate promising therapeutic approaches and create new treatment possibilities for people living with difficult-to-treat cancers worldwide."

Boehringer Ingelheim is building a broad and differentiated oncology portfolio spanning cancer cell-directed therapies and immuno-oncology. This relationship adds to this foundation and provides opportunities to further the ADC and T-cell engager portfolio through multiple programs and technology approaches. It underscores the company’s strengthened commitment to the growing innovation ecosystem in China. Its recently opened China R&D Center in Shanghai expands early clinical development and external innovation capabilities, connecting innovation in China with its global R&D network.

"Our second partnership with Boehringer Ingelheim marks an important milestone in SBP Group’s international innovation strategy and further validates our scientific capabilities in next-generation oncology. By combining our innovative platforms and early-development capabilities with Boehringer Ingelheim’s global oncology expertise, we aim to maximize the potential of these programs and bring innovative treatment options to patients worldwide. We will continue to expand our global partner network and contribute high-quality innovation from China to global healthcare," said Theresa Tse, Chairwoman of SBP Group.

The collaboration covers six biologic pre-clinical programs. Five of these center on LaNova Medicines (Shanghai) Co., Ltd. ("LaNova Medicines"), a wholly owned SBP Group subsidiary. The remaining program comes from Beijing Tide Pharmaceutical Co., Ltd. ("Beijing Tide"), another SBP Group subsidiary.

Under the agreement, SBP Group will undertake early development. After agreed clinical milestones are reached, Boehringer Ingelheim may exercise options for exclusive development, manufacturing and commercialization rights: outside mainland China, Hong Kong and Macau for four programs, and worldwide for the remaining two programs.

SBP Group will receive upfront and near-term payments of US$358million and is eligible to receive potential option-exercise, development, regulatory and commercial milestone payments of US$7 billion as well as tiered royalties on potential future product sales.

(Press release, Boehringer Ingelheim, NOV 4, 2026, View Source [SID1234674248])

On November 4, 2026 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA, OTCQB: MDNAF), a clinical-stage immunotherapy company developing Superkines for cancer and autoimmune diseases, reported that it has completed enrollment in its global Phase 1/2 ABILITY-1 study of MDNA11. The Company will host a live key opinion leaders (KOL) webinar on November 10, 2026 from 9:00 a.m. to 10:00 a.m. Eastern Standard Time, to discuss updated data from the study.

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As previously announced on October 5, 2026, updated data from ABILITY-1 will be presented by Prof. Paolo Ascierto, during an oral session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2026 Annual Meeting on November 7th, 2026. The abstract was selected as one of the meeting’s Top 150 Abstracts.

MDNA11 is an investigational, long-acting IL-2 Superkine designed to activate and expand cancer-fighting immune cells. ABILITY-1 is evaluating MDNA11 both as a monotherapy and in combination with Merck’s KEYTRUDA (pembrolizumab). Overall, a total of 152 patients from Canada, US, Australia, Europe and South Korea were enrolled in this global study.

"Achieving our target enrollment in ABILITY-1 is an important milestone for the development of MDNA11 as we demonstrate the potential benefits of an engineered beta-enhanced IL-2 Superkine," said Fahar Merchant, PhD, President and Chief Executive Officer of Medicenna. "We believe MDNA11 has the potential to expand treatment options for patients with advanced cancers where significant unmet needs remain. ABILITY-1 is helping us define its potential role both as a standalone therapy and in combination with checkpoint inhibitors, and guide the next stage of clinical development. We are grateful to the patients, their families, physicians and clinical teams for their enthusiasm to achieve our target enrollment. We look forward to presenting the updated data at SITC (Free SITC Whitepaper) 2026 on November 7th and discussing the findings during our KOL webinar on November 10 th."

The webinar will feature Medicenna’s management team, Dr. Hussein A. Tawbi, MD, PhD, Professor of Melanoma Medical Oncology and Director of Personalized Cancer Therapy at The University of Texas MD Anderson Cancer Center, and Dr. André Mansinho, MD, MSc, a principal investigator in the Phase 1/2 ABILITY-1 study. Dr. Mansinho is the Director of Clinical Research at START Lisbon, Portugal, and a clinical researcher at the Gulbenkian Institute for Molecular Medicine (GIMM).

Medicenna KOL Webinar – Event Details

Date: November 10, 2026
Time: 9:00 a.m. – 10:00 a.m. EST
Format: Live Webinar with Q&A

Registration: Participants can register using this link: View Source A replay will be available on Medicenna’s website following the event.

About Dr. Hussein A. Tawbi, MD, PhD

Dr. Hussein A. Tawbi is a Professor of Melanoma Medical Oncology and Director of Personalized Cancer Therapy at The University of Texas MD Anderson Cancer Center in Houston, Texas. He also serves as Director of the Immuno-Oncology Clinical Drug Development Program and Co-Leader of MD Anderson’s Melanoma Moon Shot. He also co-founded and co-directs the Andrew M. McDougall Brain Metastasis Clinic and Research Program. Dr. Tawbi specializes in melanoma, immuno-oncology and the clinical development of innovative cancer therapeutics, with particular expertise in immune checkpoint inhibitors, treatment resistance and melanoma brain metastases. He has served as principal investigator on numerous clinical trials evaluating novel immunotherapies and combination treatment strategies and has made significant contributions to advancing personalized approaches to cancer treatment. Dr Tawbi has been a recipient of numerous honors, including Irwin H. Krakoff Award for Excellence in Clinical Research, The Otis W. and Pearl L. Walters Faculty Achievement Award in Clinical Research and MD Anderson President’s Award for Faculty Excellence. Dr. Tawbi has over 180 publications in high impact journals including the New England Journal of Medicine, Lancet Oncology, Journal of Clinical Oncology, Nature, Science, Nature Medicine among others. He is Co-Chair of the SITC (Free SITC Whitepaper) PD-1 Resistance Committee and in 2020 he was appointed to the President’s Council of Advisors on Science and Technology.

Dr. Tawbi obtained his MD in 2001 from the American University of Beirut, Beirut, Lebanon and completed his training in Internal Medicine and Hematology/Oncology at the University of Pittsburgh His clinical training was coupled with a PhD degree in Clinical and Translational Science.

About Dr. André Mansinho, MD, MSc

Dr. André Mansinho is Director of Clinical Research at START Lisbon, Portugal, and a clinical researcher at the Gulbenkian Institute for Molecular Medicine (GIMM). He earned his Integrated Master’s Degree in Medicine from NOVA Medical School – Faculdade de Ciências Médicas, Universidade NOVA de Lisboa, in 2011. Following his medical studies, he completed his general medical residency at Centro Hospitalar Lisboa Ocidental and his residency in Medical Oncology at Centro Hospitalar Lisboa Norte. He is also an invited Assistant Professor at the Faculty of Medicine, University of Lisbon, where he has been involved in teaching and academic activities in oncology.

Dr. Mansinho specializes in the clinical development of innovative cancer therapies, with particular expertise in early-phase clinical trials, precision medicine and the treatment of genitourinary, gastrointestinal and skin cancers. He completed a clinical research fellowship at START in 2017 and has participated in numerous international clinical trials evaluating novel oncology treatments, including immunotherapies and targeted therapies. He is a member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), and has contributed to peer-reviewed scientific publications and oncology research.

About ABILITY-1

ABILITY-1 (NCT05086692) is an open-label, multicenter Phase 1/2 dose-escalation and expansion study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MDNA11 both alone and in combination with pembrolizumab, in patients with advanced solid tumors. Previously disclosed ABILITY-1 results showed an objective response rate (ORR) of 36% with MDNA11 monotherapy (n=14) and 43% with MDNA11 in combination with pembrolizumab (n=14), in patients treated in the second or third line or following resistance to checkpoint inhibitors for melanoma, endometrial and gastrointestinal cancers, as disclosed on February 13, 2026.

(Press release, Medicenna Therapeutics, NOV 4, 2026, View Source [SID1234674247])

On November 4, 2026 Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported receipt of the final meeting minutes following its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), at which the Company reached alignment with the FDA on the design of a pivotal Phase 3 trial to evaluate RAD101 in patients with indeterminate brain metastases following radiotherapy. The pivotal, multicenter single Phase 3 imaging clinical trial is expected to enroll approximately 280 patients with indeterminate brain metastases from various solid tumor types after previous radiotherapy. The co-primary endpoints of the study will be sensitivity and specificity of RAD101 PET against a defined reference standard.

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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 brain metastases 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.

Regulators reviewed the data from the Company’s Phase 2b trial of RAD101, which demonstrated 93% concordance between MRI and PET imaging of brain metastases in a patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101, with PET demonstrating tracer uptake in lesions that were equivocal on MRI.

"Accurately distinguishing recurrent tumor from treatment-related necrosis is one of the most important challenges physicians face when managing patients with brain metastases. This determination has profound implications for patient care, helping clinicians decide whether a patient requires additional intervention and treatment or can be managed with continued observation and surveillance. Existing imaging modalities often leave uncertainty, creating difficult clinical decisions for both physicians and patients. RAD101 has shown the potential to resolve diagnostic uncertainty in lesions that are equivocal on MRI, potentially offering a clearer assessment of active disease," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We are grateful to the FDA for its constructive review of our clinical data and for aligning with us on a single, multicenter pivotal study design. Importantly, the approximately 280-patient trial is substantially smaller than many historical registrational imaging studies (i.e. prostate cancer imaging agents required two Phase 3 trials and more than 700 patients combined.) We believe this reflects the significant unmet medical need faced by patients with brain metastases from solid tumors. We look forward to advancing RAD101 into this pivotal study as we work to provide physicians and patients with a more reliable tool to guide critical treatment decisions."

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 has also announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support the upcoming Phase 3 registrational trial in the U.S.

In the U.S. alone, there are more than 300,000 patients diagnosed annually with brain 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 tumors outside of the central nervous system. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise 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 brain metastases 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, NOV 4, 2026, View Source [SID1234674246])

On November 4, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported that updated results from the pivotal Phase 2 portion of the PYNNACLE clinical trial of rezatapopt will be featured in a late-breaking oral presentation at the 38th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2026). The presentation will include updated data from all PYNNACLE trial cohorts.

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Presentation details:

Title: Efficacy, molecular activity and safety from the pivotal PYNNACLE Phase 2 trial assessing rezatapopt, a p53 reactivator, in TP53 Y220C-positive advanced solid tumors

Session Date and Time: November 20, 2026 at 15:00 CET

Session Title: Plenary Session 7 – Proffered Papers: Novel Agents and Targets

Presenter: Alison M. Schram, M.D., Memorial Sloan Kettering Cancer Center

Abstract Number: 12LBA

Location: International Barcelona Convention Center, Rooms 111 and 112

About Rezatapopt

Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

About the PYNNACLE Clinical Trial

The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics, and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C advanced solid tumors, conducted across approximately 70 sites.

For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).

(Press release, PMV Pharma, NOV 4, 2026, View Source [SID1234674245])