Radiopharm Theranostics Announces Positive Data from the Phase 1 Imaging Trial of RAD301 in Patients with Pancreatic Ductal Adenocarcinoma

On September 9, 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 positive data from the Phase 1 imaging trial designed to evaluate the safety, biodistribution and dosimetry of RAD 301 in healthy volunteers and subjects with Pancreatic Ductal Adenocarcinoma (PDAC).

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RAD301 is a peptide-based molecule bound to Gallium-68 (Ga-68) that targets αvβ6-integrin, a cellular marker for tumor invasion and metastatic growth, the expression of which correlates with decreased survival in several carcinomas. The αvβ6-integrin receptor is found in high density on most pancreatic carcinoma cells, making it an attractive diagnostic and therapeutic target. RAD 301 has previously received Orphan Drug Designation (ODD) from the FDA.

"These data are an important step forward for patients suffering from advanced pancreatic cancer, as RAD301 has demonstrated significant and selective tumor uptake in metastatic lesions," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "Given the limited imaging and treatment options available for patients with PDAC, these findings highlight the potential role of RAD301 in improving disease detection, patient selection, and future theranostic applications. Pancreatic cancer remains a challenging disease to image, and conventional approaches such as FDG PET are limited by variable tumor biology and non-specific uptake. The results from this Phase 1 study support the potential of αvβ6-integrin-targeted imaging to provide a more tumor-specific approach to detecting pancreatic cancer, further supporting the advancement of RAD 301 into Phase 2 development."

Data from the Phase 1 trial of RAD301 demonstrated a favorable safety profile in all evaluable participants. Additionally, RAD301 had favorable biodistribution along with significant tumor uptake in pancreatic cancer metastases, consistent with initial results from the first five patients evaluated. The results showed significant and selective tumor uptake in pancreatic cancer metastases, which supports the potential of αvβ6-integrin as a target for future therapeutic development and potentially as a theranostic pair. Importantly, the low background uptake observed in liver, lung and bowel — the sites where pancreatic cancer most often spreads — supports the potential of RAD301 to distinguish metastatic lesions from surrounding normal tissue. The unmet medical need in the earlier stages of disease and the high mortality of the disease provide a rationale for a future Phase 2 imaging trial of RAD301.

(Press release, Radiopharm Theranostics, SEP 9, 2026, View Source [SID1234670705])

Actuate Announces Promising Preclinical Data Showing Synergistic Activity of Elraglusib in Combination with RAS Inhibitors Zoldonrasib and Daraxonrasib

On September 9, 2026 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company, focused on developing novel therapies for high-impact, difficult-to-treat cancers, reported new preclinical data evaluating elraglusib in combination with zoldonrasib (RMC-9805), an investigational RAS(ON) G12D-selective inhibitor, and daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor, in pancreatic ductal adenocarcinoma (PDAC), including models resistant to FOLFIRINOX chemotherapy. The studies were conducted in collaboration with investigators at Northwestern University and the Mayo Clinic.

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Across a panel of murine KPC pancreatic cancer cell lines, the addition of elraglusib to zoldonrasib resulted in greater inhibition of tumor-cell growth compared with zoldonrasib alone. Synergistic combination activity was also observed across human patient-derived xenograft (PDX)-derived pancreatic cancer cell lines, demonstrating the effect across multiple independent pancreatic cancer models. Studies of elraglusib in combination with daraxonrasib were also conducted, demonstrating synergistic anti-cancer activity compared with either agent alone. Together, the findings with two distinct RAS-targeted agents provide evidence that the combination effect of elraglusib extends beyond a single RAS inhibitor.

"The emergence of direct RAS inhibitors represents a major advance in pancreatic cancer and creates an opportunity to identify combinations capable of further enhancing RAS-directed activity," said Tanios "Tony" Bekaii-Saab, MD, FASCO – Chair for the Division of Hematology/Medical Oncology, Mayo Clinic in Arizona. "Importantly, the enhanced activity observed when elraglusib was combined with either zoldonrasib or daraxonrasib, two distinct RAS-targeted agents, highlights the potential for elraglusib to synergize with diverse RAS-directed therapies. Based on the unique and complementary mechanisms of action of elraglusib with these new RAS inhibition therapies, we are eager to evaluate the potential of combining elraglusib with RAS inhibition therapies in a clinical setting to expand treatment opportunities across RAS-driven diseases, including pancreatic cancer."

Separate studies evaluated the combination of elraglusib with zoldonrasib in FOLFIRINOX-resistant murine and human pancreatic cancer models. Both murine and human models demonstrated that the combination of elraglusib with zoldonrasib in vitro resulted in enhanced anti-tumor activity of the combination and greater reductions in tumor cell viability compared with either agent alone.

"Resistance to frontline chemotherapy remains a major challenge in pancreatic cancer, underscoring the need for new therapeutic strategies to be used after patients progress on FOLFIRINOX," said Dr. Deva Mahalingam, Professor of Medicine, Robert H. Lurie Comprehensive Cancer Center, Northwestern University. "Across multiple FOLFIRINOX-resistant pancreatic cancer models, we observed greater antitumor activity when elraglusib was combined with zoldonrasib than with either agent alone, with quantitative analysis supporting enhanced anti-tumor activity and potential synergistic interactions of the combination in the models evaluated. These findings provide a compelling rationale to further investigate whether combining GSK-3β (elraglusib) and RAS G12D inhibition can enhance therapeutic activity in treatment-resistant pancreatic cancer. We look forward to participating in advancing the development of elraglusib in upcoming clinical trials, including combination trials with these most promising RAS inhibitors."

Key preclinical findings

Across murine KPC and human PDX-derived pancreatic cancer cell lines, the addition of elraglusib to zoldonrasib reduced cell growth beyond that observed with zoldonrasib alone across all models tested.
Elraglusib in combination with daraxonrasib demonstrated enhanced activity across multiple murine/human PDAC models compared with daraxonrasib alone.
In independent cell line models of FOLFIRINOX-resistant PDAC, both murine and human models of elraglusib plus zoldonrasib produced greater reductions in tumor-cell viability than either agent alone

Additional studies are ongoing, with results planned for presentation at upcoming medical conferences.

"RAS-targeted therapies are rapidly reshaping the treatment landscape for pancreatic cancer, highlighted by the recent FDA approval of daraxonrasib, the first broad RAS-targeted therapy approved for metastatic pancreatic cancer," said Daniel Schmitt, President and Chief Executive Officer of Actuate Therapeutics. "What is particularly compelling about the synergy data with elraglusib is the breadth and consistency of these findings. Elraglusib enhanced RAS-targeted activity across multiple murine and human models, with two distinct RAS inhibitors, and in models resistant to FOLFIRINOX. We believe these independent findings strengthen the potential for elraglusib to work synergistically with RAS-directed therapies and establish an important new combination approach in pancreatic and potentially other RAS-driven cancers."

(Press release, Actuate Therapeutics, SEP 9, 2026, View Source [SID1234670704])

Crossbow Therapeutics Doses First Patient in Phase 1 Trial of CBX-663 for Treatment of Multiple Hematologic and Solid Malignancies

On September 9, 2026 Crossbow Therapeutics, Inc., a biotechnology company focused on developing a novel class of potent and precise antibody therapies to treat a broad range of cancers, reported dosing of the first participant in its TelOscope-001 Phase 1 clinical trial of CBX-663, a first-in-class T-cell engager (TCE) for the treatment of multiple hematologic and solid tumors.

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CBX-663 is the second candidate developed through Crossbow’s T-Bolt platform, a portfolio of novel TCE molecules that uniquely target peptide human leukocyte antigen (pHLA) complexes on tumor cells, using antibodies that mimic T-cell receptors (TCR-mimetics). The wholly owned TCE is a potent bispecific antibody that targets telomerase reverse transcriptase (TERT), a protein that drives tumor growth and is overexpressed in approximately 90% of all cancers.1,2

"TERT is a priority target for anticancer therapy due to its widespread overexpression, which allows cancer cells to bypass cellular aging, promotes uncontrolled tumor proliferation, and correlates with disease severity," said Briggs Morrison, M.D., Chief Executive Officer of Crossbow Therapeutics. "CBX-663 selectively targets a TERT-derived pHLA complex expressed across a broad range of hematologic and solid malignancies, making it a promising therapeutic candidate in an area of heightened unmet medical need."

The Phase 1, open-label, dose-escalation TelOscope-001 study is evaluating the safety, tolerability, and clinical activity of CBX-663 in patients with relapsed or refractory myeloid malignancies, advanced solid tumors, or recurrent or progressive glioblastoma multiforme (GBM).

CBX-663 binds to TERT-derived pHLA complexes on the surface of tumor cells and activates T cells through a CD3-binding arm, one half of an engineered bispecific antibody designed to grab onto the CD3 protein on T cells. The molecule includes two binding domains for TERT, which increase its ability to engage tumor cells and boost immune activation.

In preclinical studies, CBX-663 drove potent, antigen-specific tumor killing across multiple TERT-positive cancer models, with minimal activity against TERT-negative or HLA-mismatched cells. CBX-663 also demonstrated a favorable safety profile and pharmacokinetics comparable to conventional antibody therapies.

Crossbow discovered and developed CBX-663 through its proprietary T-Bolt platform, which uses optimized antibody libraries and precision screening to find high-affinity, specific binders to intracellular tumor antigens displayed as pHLA complexes. Crossbow designed and is conducting the TelOscope-001 clinical study, which is investigating CBX-663 on a fixed step-up dosing schedule. The company expects initial clinical data from TelOscope-001 around the end of 2027.

For additional trial details, visit the TelOscope-001 (NCT07779798) study page on ClinicalTrials.gov.

(Press release, Crossbow Therapeutics, SEP 9, 2026, View Source [SID1234670702])

InduPro Announces Publication in Nature Establishing Spatial Protein Proximity as a New Framework for Therapeutic Discovery

On September 9, 2026 InduPro, Inc., a biotechnology company harnessing protein proximity to create novel therapeutics for cancer and autoimmune diseases, reported the publication in Nature of research establishing the spatial organization of cell-surface proteins as a new and therapeutically actionable dimension of disease biology.

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The study, Proximity-Guided Graph Learning Reveals Tumor-Associated Proximity Antigens, describes an integrated approach developed by InduPro to systematically map the nanoscale neighborhoods surrounding proteins on the surface of tumor cells, identify unique disease-associated spatial relationships, and translate those relationships into novel therapeutic strategies. The work defines Tumor-Associated Proximity Antigens, or TAPAs, a new class of co-targets distinguished not simply by protein co-expression, but by their disease-associated spatial proximity to another therapeutically relevant cell-surface antigen.

"By industrializing high-resolution proximity mapping and combining it with computational approaches that allow us to understand protein neighborhoods at scale, we can uncover biology that is invisible to expression-based approaches alone. TAPAs give us a new class of targets and, importantly, a new framework for designing medicines around relationships that are enriched in disease context," said Scott Lesley, Ph.D., President and Chief Scientific Officer of InduPro. "IDP-001, our lead clinical program in squamous and non-squamous solid tumors, is a powerful example of that translation, taking a newly uncovered protein pair and translating it into a highly differentiated therapeutic."

Mapping a previously hidden layer of cell-surface biology

Proteins on the surface of cells exist within organized, dynamic neighborhoods that influence signaling, trafficking and therapeutic response. Yet conventional target-discovery approaches have largely focused on which proteins are present and how they are expressed, leaving this spatial dimension of biology relatively unexplored.

The work builds on protein proximity-based mapping technology invented by Rob Oslund, Ph.D., Vice President of Platform Technology, and Niyi Fadeyi, Ph.D., Vice President of Chemical Sciences, both members of InduPro’s founding team. The technology was subsequently industrialized and expanded at InduPro into a scalable discovery platform.

In the Nature study, researchers applied this approach at scale across diverse tumor systems, creating a rich dataset of cell-surface protein neighborhoods and demonstrating that proximity reveals biological information beyond expression alone.

InduPro subsequently developed MetaMap to move beyond individual proximity maps and extract recurring spatial relationships across large datasets. By integrating proximity signatures across targets and biological contexts, MetaMap reveals protein communities and predicts spatial relationships even when proteins have not been directly mapped against one another. Graph-based machine learning further enables these relationships to be prioritized for therapeutic discovery.

"What began as a technology for labeling proteins within defined nanoscale environments has become something much broader: a way to systematically interrogate the spatial organization of the cell surface," said Rob Oslund, Ph.D., Vice President of Platform Technology at InduPro. "The critical step was industrializing the technology so we could generate these datasets at scale. MetaMap takes that evolution further by allowing us to learn across the collective dataset, moving beyond individual experiments toward a predictive understanding of protein relationships and creating an increasingly powerful foundation for therapeutic discovery."

TAPAs create a new class of therapeutic targets

A central advance described in the publication is the definition of Tumor-Associated Proximity Antigens, or TAPAs.

Rather than defining targets solely by differential expression, TAPAs are identified through disease-associated spatial relationships between proteins on the cell surface. These relationships create opportunities to design multispecific medicines that recognize a disease-associated protein neighborhood rather than relying on either antigen independently.

This approach has the potential to expand the universe of therapeutically actionable targets, including proteins that may not be sufficiently tumor-selective on their own, while creating new opportunities to improve selectivity, internalization and therapeutic activity through proximity-driven drug design.

"TAPAs represent a fundamentally different way to think about therapeutic targets," said Niyi Fadeyi, Ph.D., Vice President of Chemical Sciences at InduPro. "Rather than only asking which proteins are expressed in disease, we can also ask which proteins come together in a disease-specific context and whether that relationship creates a therapeutic opportunity. We believe this opens an important new dimension of target space and provides a foundation for designing medicines with differentiated selectivity and activity. Seeing this concept progress from the original science to therapeutic programs in the clinic provides validation of the approach and what we believe proximity biology can unlock."

Translating Proximity Biology into Medicines

The study demonstrates that proximity-defined relationships can be translated directly into therapeutic design. Using spatial relationships identified through the platform together with biological and translational data, InduPro demonstrated that co-targeting proximity-defined antigen pairs can produce differentiated tumor cell internalization and killing across therapeutic modalities.

These discoveries established the scientific foundation for InduPro’s proximity-guided therapeutic pipeline, including IDP-001, the Company’s lead bispecific antibody-drug conjugate, which has advanced into Phase 1 clinical development.

The progression from proximity-labeling technology, to industrialized spatial datasets, to MetaMap and computational prediction, to TAPAs and ultimately therapeutic candidates represents the broader vision of InduPro’s platform: transforming spatial relationships between proteins into a systematic source of new targets and differentiated medicines.

The article is available in Nature at View Source
(Press release, InduPro, SEP 9, 2026, View Source [SID1234670701])

Puma Biotechnology to Present at H.C. Wainwright’s 28th Annual Global Investment Conference

On September 9, 2026 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder, will provide an overview of Puma at 3:30 p.m. ET on Monday, September 14, at the H.C. Wainwright 28th Annual Global Investment Conference. The conference will be held September 14-16, 2026 at the Lotte New York Palace Hotel in New York City.

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A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source The presentation will be archived on the website and available for 30 days.

(Press release, Puma Biotechnology, SEP 9, 2026, View Source [SID1234670700])