On October 14, 2026 Pilatus Biosciences, a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported that the first patient has been dosed in Hong Kong, in the hepatocellular carcinoma (HCC) biomarker backfill cohort of its ongoing Phase 1 clinical trial of PLT012.

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The dosing follows authorization from the Hong Kong Department of Health in July 2026 to conduct the PLT012 clinical study in Hong Kong. The Hong Kong site, based at the Phase I Clinical Trial Centre under the Department of Clinical Oncology of The Chinese University of Hong Kong, will support the HCC backfill and dose expansion cohorts as part of the broader PLT012 Phase 1 study.

The backfill cohorts are intended to evaluate preliminary clinical activity and generate biomarker data in patients with advanced HCC, including those with underlying liver dysfunction. By integrating clinical outcomes with biomarker findings from this cohort, the study aims to further inform PLT012’s future clinical development and support a deeper understanding of its potential role across the liver disease continuum, from chronic liver dysfunction to malignancy.

PLT012 is a first-in-class investigational monoclonal antibody targeting CD36, a key regulator of lipid metabolism within the tumor microenvironment. By blocking CD36-mediated lipid uptake, PLT012 is designed to reprogram the tumor microenvironment by reducing immunosuppressive cell populations while restoring the activity of antitumor immune cells.

"Dosing the first patient in Hong Kong represents an important milestone for the PLT012 program and for Pilatus as we continue expanding the global clinical development of our lead program," said Raven Lin, Ph.D., Chief Executive Officer and Co-Founder, Pilatus Biosciences. "By collecting clinical and biomarker data from patients with HCC, we aim to better understand PLT012’s broader anti-tumor activity, inform its next stage of development supported by FDA Fast Track Designation, and further explore mechanisms associated with response to immunotherapy in HCC. We appreciate the collaboration of our investigators in Hong Kong."

"There remains a significant need for new treatment approaches for patients with advanced Liver cancers, particularly those with underlying liver dysfunctions," said Stephen Chan, M.D., Principal Investigator and Clinical Professor at the Department of Clinical Oncology of The Chinese University of Hong Kong. "The HCC biomarker backfill cohort will help characterize clinical findings and selected biomarker profile of patients receiving PLT012 treatment. We are pleased to begin dosing patients from Asia in Hong Kong."

The current Hong Kong study cohort forms part of Pilatus’ broader clinical development program for PLT012. Pilatus established its Hong Kong subsidiary earlier this year as part of the Company’s expansion in Asia and is leveraging the region’s clinical research infrastructure to support the developments of PLT012, as well as further academic and metabolic chokepoints immunotherapies strategic collaborations.

About PLT012

PLT012 is a humanized monoclonal antibody designed to selectively block CD36-mediated lipid uptake, a key mechanism driving immunosuppression and immune exclusion within the tumor microenvironment. By targeting lipid metabolism, PLT012 exerts a unique mechanism of action: it depletes immunosuppressive cell populations, including Tregs and pro-tumor macrophages, while simultaneously enhancing antitumor activities of intratumoral NK cell and cytotoxic CD8+ T cell that are otherwise susceptible to lipid-induced exhaustion. In preclinical studies, PLT012 has demonstrated potent monotherapy efficacy in models of liver malignancies, with a favorable safety profile across species. Leveraging its distinct mechanism of action, PLT012 further acts as a potent sensitizer in combination with oncology therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

(Press release, Pilatus Biosciences, OCT 14, 2026, View Source [SID1234673468])

On October 14, 2026 Ironfist Therapeutics ("Ironfist"), a preclinical-stage company developing a nanomedicine radiopharmaceutical (Tamrada) that selectively targets tumor-associated macrophages without a targeting ligand, reported it will present positive preclinical proof-of-concept results for 177Lu-Tamrada at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM’26), taking place October 17–21, 2026, in Vienna, Austria. In an orthotopic syngeneic model of pancreatic cancer resistant to anti-PD-1 therapy, 177Lu-Tamrada in combination with anti-PD-1 therapy more than doubled survival compared to anti-PD-1 therapy alone.

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"These preclinical results continue to support our strategy of treating the immune-suppressing microenvironment in cancers," said Jeffrey L. Cleland, PhD, Chief Executive Officer of Ironfist Therapeutics. "In Q1 2027, we plan to begin clinical studies with 64Cu-Tamrada PET imaging, followed by 177Lu-Tamrada treatment in patients whose tumors show Tamrada uptake on PET."

Oral Presentation Details:
Targeted Killing of Tumor Associated Macrophages with a Novel [177Lu]Lu-Nanomedicine Prolongs Survival and Unlocks Checkpoint Inhibition in an Orthotopic Pancreatic Cancer Model
Oral presentation OP-482 | Session 1104: M2M Track – TROP Session – Translational Molecular Imaging & Therapy Committee: Advances in Combination Therapies
Monday, October 19, 2026, 5:35 PM | Hall E2

Pancreatic ductal adenocarcinoma is a difficult-to-treat cancer resistant to checkpoint inhibition and generally considered protected from the immune system. Long-term survival is limited with current treatments. The pancreatic cancer results are consistent with previous positive single-agent results, including tumor inhibition in xenograft and orthotopic 4T1 triple-negative breast cancer models and in PSMA-negative prostate cancer models.

"By killing tumor-associated macrophages (TAMs) and suppressor cells, 177Lu-Tamrada exposes the tumor to the immune system to halt tumor growth and promote survival," said S. Sakura Minami, PhD, Vice President of Translational Medicine and Nonclinical Development. "The cytotoxic effects are confined to the tumor, as shown by localized double-strand DNA breaks, leaving other organs and healthy tissue intact. And unlike other radiopharmaceutical approaches, Tamrada is tumor agnostic because it directly targets the TAMs that protect the tumor from the immune system, stimulate angiogenesis, and generate metastases."

e-Poster Details:
Radiation Dosimetry, Chemistry and Formulation of a Novel [64Cu]Cu-Nanomedicine Radiotracer that Selectively Targets Tumor Associated Macrophages
e-Poster Number: EP-0072
Session: EP-05, During Congress, October 17–21, 2026
Session Title: A: Preclinical and Translational Studies › A1 Medical Preclinical › A15a Preclinical Dosimetry

The e-Poster reports that dosimetry for the imaging agent 64Cu-Tamrada identified red marrow as the dose-limiting organ, with a 240-fold safety factor above the highest proposed human dose of 200 MBq.

"Radiopharmaceuticals have drawn significant interest from large pharma, and Tamrada offers something different: a target-independent way to reach the tumor microenvironment across many cancer types," said Mukul Agarwal, Chief Business Officer of Ironfist Therapeutics. "With clinical studies starting in 2027 and a platform that can carry other isotopes, we look forward to meeting potential partners." To schedule a meeting at EANM’26 or the J.P. Morgan Healthcare Conference in January ’27, contact [email protected].

About Tamrada

Tamrada is designed from the novel nanomedicine technology of hydroxyl dendrimers invented at Johns Hopkins University. The nanomedicine component of Tamrada is comparable in size to an antibody fragment, does not leave the vasculature except in tumors, and has renal and biliary clearance without metabolism. 177Lu-Tamrada provides an additional benefit of a bystander effect by killing adjacent tumor cells. The nanomedicine in Tamrada is amenable to modifications to create a pipeline of radiopharmaceuticals with different radioisotopes beyond lutetium-177, such as actinium-225 or other alpha emitters.

(Press release, Ironfist Therapeutics, OCT 14, 2026, View Source [SID1234673467])

On October 14, 2026 Debiopharm (www.debiopharm.com), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, reported their latest research on antibody drug conjugate (ADC) research released at World ADC San Diego 2026. Results highlighted the pre-clinical performance of a selection of linker technology from Debiopharm’s MultiLINK Linker Technology suite (MLINK Select, MLINK Duo and MLINK HiSol), revealing positive implications for the development of next generation ADCs and for the future of cancer patients that require more innovative therapies to overcome their disease.

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Despite remarkable progress in the ADC field, many cancers remain difficult to treat due to biological complexities that challenge current-generation therapies. Tumor heterogeneity can enable cancer cells with low or absent target expression to escape treatment, while acquired resistance to single-payload ADCs may emerge over time and compromise durable responses. Furthermore, premature linker cleavage can lead to systemic payload release and off-target toxicities, restricting the therapeutic index of ADCs. These limitations underscore the urgent need for next-generation ADC technologies, including innovative linker-payload systems and dual-payload linker approaches, designed to address resistance, broaden anti-tumor activity while remaining tolerable, and ultimately improve outcomes for patients facing cancer.

MLINK Select MMAE: Novel Linker-Payload Research

Research results presented at World ADC demonstrated that novel linker MLINK Select releases controlled intracellular MMAE and substantially widens the therapeutic index of vedotin-based MMAE ADCs in preclinical models, while maintaining high-level anti-tumor activity. Notably, efficacy was demonstrated in specific models resistant to approved ADC therapies. Data presented reveal that MLINK Select MMAE achieves: more selective intracellular cleavage, stepwise/controlled MMAE release, higher plasma stability, minimal circulation of free MMAE, improved therapeutic index, and maintenance of anti-tumor activity.

"We recognize the remarkable progress made by ADCs, but many patients, however, continue to face disease progression due to treatment resistance, tumor heterogeneity, and dose-limiting toxicities. We believe that next generation ADC innovation can make a difference by focusing not only on what is delivered to cancer cells, but also on how it is delivered, particularly regarding linker selection," explained Noemie Luong, Associate Principal Scientist, Debiopharm. "Our preclinical findings demonstrate that precise control of payload release through innovative linker engineering has the potential to expand the therapeutic window while maintaining anti-tumor activity."

MLINK DUO: Synergystic activity with Dual-Payload linker

Strong proof-of-concept data was released for Debiopharm’s next-generation dual-payload ADC, MLINK Duo, a linker technology that allows conjugation of two payloads to the same antibody. Results revealed that our dual-payload ADCs produced synergistic antitumor activity, including in models with low sensitivity to individual payloads, demonstrating the potential to synergistically overcome resistance and tumor heterogeneity. Enhanced efficacy was achieved while preserving critical ADC properties, including plasma stability, antibody pharmacokinetics and a favorable preclinical safety profile.

"With MLINK Duo, we observed the potential to exploit payload synergy while reducing resistance mechanisms," expressed Viktoriia Postupalenko, Senior Scientist/ Project Manager, Drug Research and Development, Debiopharm. "As dual-payload conjugation did not compromise antibody pharmacokinetics, we confirmed that increased payload complexity can be achieved without sacrificing desired ADC properties. By advancing smart dual-payload designs such as with MLINK Duo, we aim to help unlock more effective and better tolerated treatment options for patients fighting cancer."

MLINK HiSol: Unlocking new ADC therapeutic strategies

Further research showcased modular cathepsin B-cleavable MLINK HiSol linkers designed to overcome common ADC development challenges, including payload solubility, stability, aggregation, and efficient intracellular release. The versatility of this linker type was particularly highlighted showing that it is not limited to conventional ADC payloads such as MMAE and exatecan, but can potentially unlock new ADC therapeutic strategies based on targeted pathway inhibition with precision oncology payloads such as ATR inhibitors, CHK1 inhibitors, and NAMPT inhibitors.

"Targeted small-molecule inhibitors are traditionally difficult to use as ADC payloads," Noemie Luong added, "We’re excited that the results with MLINK HiSol are opening the door towards more payload possibilities to help patients fight cancer. Now that we’ve seen early evidence that MLINK HiSol can enable delivery of targeted small-molecule inhibitors, we can explore ADCs beyond conventional cytotoxic mechanisms."

(Press release, Debiopharm, OCT 14, 2026, View Source [SID1234673466])

On October 14, 2026 Akamis Bio, a clinical-stage oncology company working to advance the standard of care in colorectal cancer, reported that it has completed enrollment of the Phase 1b FORTRESS study of NG-350A, an oncolytic immunotherapy for the treatment of mismatch repair-proficient (pMMR) locally advanced rectal cancer (LARC). The FORTRESS study enrolled 33 participants with pMMR LARC across seven sites in the United States and the United Kingdom to evaluate the efficacy and safety profile of NG-350A in combination with chemoradiotherapy (CRT).

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Topline results from the FORTRESS study are anticipated in the first half of 2027, and subject to discussions with regulators, the company expects to initiate a Phase 2 randomized controlled trial of NG-350A in combination with CRT in pMMR LARC in the second half of 2027.

The Phase 1b FORTRESS study (NCT06459869) is assessing the anti-tumor effects of NG-350A combined with CRT following a 12-week active treatment period to establish whether NG-350A can improve composite response rates in pMMR LARC patients relative to expected outcomes from CRT alone. The primary endpoint of the FORTRESS study is the composite response rate defined as the proportion of patients achieving a clinical complete response (cCR) or a near clinical complete response (ncCR) at 12 weeks. The benchmark composite response rate (cCR + ncCR) for CRT alone at 12 weeks is approximately 25 percent.

"Completion of enrollment of the FORTRESS study marks an important milestone as we evaluate the potential of NG-350A plus chemoradiotherapy to advance the standard of care for patients living with mismatch repair proficient locally advanced rectal cancer," said Oliver Rosen, MD, Chief Medical Officer of Akamis Bio. "Preliminary results from the FORTRESS study indicate that NG-350A combined with chemoradiotherapy has the potential to improve tumor response rates relative to expected rates for chemoradiotherapy alone. We look forward to reporting topline data across the full 33 enrolled FORTRESS participants in the first half of 2027 in preparation for the initiation of a randomized controlled Phase 2 study of NG-350A plus chemoradiotherapy in a pMMR LARC patient population."

In data shared earlier this year at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, NG-350A combined with CRT demonstrated a composite response rate of 50 percent across the first 10 patients who completed the 12-week active treatment period, with no serious adverse events or new safety signals identified related to NG-350A. The company previously announced that NG-350A has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of pMMR LARC.

About NG-350A

NG-350A is a clinical-stage, intravenously delivered oncolytic immunotherapy designed to drive intratumoral expression of a CD40 agonist monoclonal antibody triggering the activation of antigen-presenting cells (APCs) resident in solid tumors and their draining lymph nodes. Once activated, APCs recruit T cells into the vicinity of the tumor to deliver a potent anti-tumor immune response. Akamis Bio has evaluated NG-350A’s safety, tolerability, and preliminary efficacy as a monotherapy (FORTITUDE study) and in combination with pembrolizumab (FORTIFY study) in patients with metastatic or advanced epithelial tumors. Across these studies, NG-350A has demonstrated a consistent safety and tolerability profile, as well as strong evidence of tumor-selective delivery, replication and transgene expression.

About the FORTRESS Study

The Phase 1b FORTRESS study (NCT06459869) is an open-label, single-arm, multicenter trial of NG-350A in combination with CRT in adult patients with pMMR LARC and at least one risk factor for local or distant recurrence or with oligometastatic disease. The FORTRESS study builds upon the Akamis Bio-supported CEDAR study, which showed a significantly greater composite response rate in LARC patients treated with a combination of Akamis Bio’s first-generation oncolytic immunotherapy (EnAd) and chemoradiotherapy (CRT), relative to expected outcomes using standard-of-care CRT alone. The FORTRESS study enrolled 33 patients aged eighteen and older with histologically confirmed, locally advanced adenocarcinoma of the rectum (clinical stage II-III based on pelvic MRI). During the 12-week active treatment period, patients receive NG-350A plus CRT (oral capecitabine plus long-course intensity-modulated radiotherapy). The primary endpoint of the FORTRESS study is the composite response rate, defined as the proportion of patients achieving a clinical complete response (cCR) or a near clinical complete response (ncCR) at 12 weeks. Key secondary endpoints include the incidence and severity of adverse events, characterization of the anti-tumor effects of NG-350A in combination with CRT (including clinical response outcome and magnetic resonance tumor regression grade [mrTRG]), and assessment of circulating tumor DNA (ctDNA) clearance.

About Locally Advanced Rectal Cancer (LARC)

Colorectal cancer (CRC) is the second leading cause of cancer-related death in the United States, and it has recently emerged as the leading cause in patients under 50 years of age. Approximately 159,000 people are newly diagnosed with CRC each year, including about 53,000 with rectal cancer of which approximately 30,000 are diagnosed with LARC. In patients with LARC, the rectal cancer has spread to the lymph nodes and/or through the muscle and into the outermost layers of the rectum. In more severe cases, the rectal cancer may extend through the wall of the rectum where it can attach to other organs or structures. Approximately 95 percent of LARC patients have mismatch repair-proficient (pMMR) tumors which have a functional DNA mismatch repair system.

(Press release, Akamis Bio, OCT 14, 2026, View Source [SID1234673465])

On October 14, 2026 Vir Biotechnology, Inc. (Nasdaq: VIR), reported a collaboration and license agreement with Gilead to discover and engineer three novel PRO-XTEN dual-masked T-cell engager (TCE) development candidates targeting selected solid tumor-associated antigens. Gilead will have an exclusive license to develop and commercialize the novel TCEs.

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Through this collaboration, Vir Biotechnology will apply its deep expertise in TCE discovery and protein engineering, its proprietary dAIsY (data AI structure and antibodY) platform for rapid, multiparameter optimization of high-quality TCEs and the universal PRO-XTEN masking technology to develop next-generation TCEs, each with potent anti-tumor activity and a wide therapeutic index across solid tumor targets addressing areas of high unmet need.

"We believe TCEs have a powerful role to play in the future of immunotherapy to treat cancer. This collaboration with Gilead provides an opportunity to generate multiple differentiated candidates aimed at difficult-to-address solid tumors and to expand the potential impact of our science, while also advancing our own clinical oncology portfolio," said Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology. "This transaction provides further external validation of Vir Biotechnology’s integrated discovery capabilities and the broad potential of the PRO-XTEN platform."

"We look forward to combining Gilead’s established and growing oncology capabilities, including our extensive development expertise and focus on next-generation immunotherapies, with Vir Biotechnology’s innovative discovery capabilities," stated Flavius Martin, MD, Executive Vice President, Research, Gilead Sciences. "Together with Vir Biotechnology, we seek to bring meaningful innovative therapeutics to patients."

Under the terms of the agreement, Vir Biotechnology will be responsible for discovery, design and optimization of three novel PRO-XTEN dual-masked TCE development candidates targeting selected solid tumor-associated antigens. Gilead will have an exclusive license to nominate and advance candidates generated under the collaboration and will be responsible for subsequent development, manufacturing and commercialization activities. Vir Biotechnology will be eligible to receive up to $135 million in total upfront and near-term preclinical milestone payments, consisting of $90 million in upfront consideration, which includes $65 million in cash and a $25 million equity investment at a 30% premium, and up to $45 million in potential near-term preclinical milestones. In addition, Vir Biotechnology has the potential to receive up to $1.74 billion in further development, regulatory and commercial milestones, along with tiered high single-digit to low double-digit royalties on net sales.

(Press release, Vir Biotechnology, OCT 14, 2026, View Source [SID1234673464])