On March 12, 2026 Pilatus Biosciences, Inc., a clinical-stage biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, reported the first patient has been dosed in its Phase 1 clinical trial evaluating PLT012, a first-in-class anti-CD36 monoclonal antibody for the treatment of advanced solid tumors. The first patient was treated at Next Oncology in Houston, Texas.

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PLT012 recently received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration. The antibody target, CD36, is a key regulator of lipid uptake and metabolic adaptation within the tumor microenvironment (TME). By blocking CD36-mediated fatty acid uptake, PLT012 aims to invigorate innate and adaptive effector cells, reduce immunosuppressive cell populations, and elicit durable tumoricidal immune responses.

"Dosing our first patient is an important milestone for Pilatus and validates our work advancing a new immuno-metabolic approach to cancer therapy," said Raven Lin, CEO and Co-Founder, Pilatus Biosciences. "Many solid tumors create a metabolically hostile microenvironment that drives immune exhaustion and resistance to existing therapies. PLT012 is designed to directly address this metabolic suppression, with the goal of restoring effective antitumor immunity for patients with limited treatment options."

"Many advanced solid tumors suppress immune responses through metabolic mechanisms, limiting the effectiveness of current immunotherapies," said Anthony B. El-Khoueiry, MD, principal investigator of the trial, who also serves as chief of section of developmental therapeutics and associate director for clinical research at the USC Norris Comprehensive Cancer Center, part of Keck Medicine of USC. "CD36 is a key regulator of lipid uptake and immune dysfunction in the tumor microenvironment, making it a compelling target. This Phase 1 study will evaluate the safety of PLT012 and help determine whether targeting metabolic checkpoints can restore immune activity for patients with difficult-to-treat cancers."

The open-label, multi-center Phase 1 study is evaluating PLT012 in patients with advanced solid tumors, with expansion cohorts planned in tumor types characterized by lipid-driven metabolic dysregulation, including, but not limited to, liver cancers and tumors with liver metastases. The primary objectives of the study are to assess safety and tolerability, and to determine the maximum tolerated dose and the recommended Phase 2 dose of PLT012.

Additional endpoints will look at pharmacokinetics/pharmacodynamics, biomarkers, and early signs of clinical response. In addition to pharmacokinetics and immunogenicity, a comprehensive biomarker strategy centered on CD36 biology has been designed to support translational insights and guide future clinical development. This approach is intended to enable more precise patient stratification in expansion cohorts and subsequent trials, with the goal of enriching for lipid-enriched tumor types and CD36-high patient populations.

"There is a significant unmet need for patients whose tumors do not respond adequately to current immunotherapies," said George E. Peoples, MD, Chief Medical Officer, Pilatus Biosciences. "Targeting CD36 represents a differentiated approach to reshape the tumor microenvironment by addressing lipid-driven immune dysfunction. The comprehensive clinical and biomarker assessments incorporated into this study will be essential to understanding how PLT012 reprograms the TME and to guiding further development."

Preclinical studies demonstrated that PLT012 blocked CD36-mediated metabolic reprogramming in regulatory T cells (Tregs) and CD8+ tumor-infiltrating lymphocytes, resulting in enhanced antitumor immune activity. In murine models of liver metastasis, PLT012 significantly reduced tumor growth in both hepatic and subcutaneous tumors. These effects were associated with favorable remodeling of the TME, including reduced M2 macrophages and Treg populations, and increased CD8+ T cell infiltration.

Additionally, PLT012 mitigated liver metastasis–associated resistance to immune checkpoint inhibitors and resensitized tumors to anti-PD-1 therapy in preclinical models. Together, these findings support the potential of CD36-targeted immunometabolic therapy as a complementary strategy to existing checkpoint blockade treatments.

Building on previously reported preclinical data demonstrating PLT012’s robust anti-tumor activity in both inflamed and immune-cold HCC murine models, PLT012 received Orphan Drug Designation from the FDA in December 2024 for the treatment of hepatocellular carcinoma (HCC) and intrahepatic bile duct cancers, underscoring the significant unmet medical need in these indications. Pilatus also received FDA Fast Track Designation for PLT012 for the treatment of HCC on February 14, 2026.

This announcement is intended to share information about this study and is not soliciting participants.

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 anti–PD-L1 therapies, effectively overcoming drug resistance in immune "cold" tumors and liver metastases.

(Press release, Pilatus Biosciences, MAR 12, 2026, View Source [SID1234663520])

On March 12, 2026 PRISM BioLab Co., Ltd. ("PRISM") and Receptor.AI Inc. reported that they have entered into a drug discovery collaboration agreement (the "Collaboration") to develop an integrated, AI-navigated, physics-guided platform for the discovery of orally available small molecules targeting intracellular protein–protein interactions (PPIs), membrane proteins, and complex receptor systems.

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The Collaboration unites PRISM’s PepMetics chemistry — conformationally rigid, three-dimensional small molecules engineered to mimic α-helix and β-turn motifs — with Receptor.AI’s physics-informed, multi-objective AI navigation engine. By integrating their technologies, the companies aim to generate innovative hit, lead and clinical candidate compounds against PPI and membrane-protein targets that have proven challenging for conventional small molecule drug discovery, with an initial focus on metabolic diseases, including obesity.

The Collaboration will initially focus on one selected receptor target for metabolic disease. Receptor.AI will carry out molecular design using the combination of PRISM’s chemical space and Receptor.AI’s design algorithms. In parallel, the companies will jointly engage pharmaceutical partners interested in utilizing the combined capabilities of both technologies.

The Collaboration aims not only to generate clinical candidates—typically the goal of joint research — but also to showcase the power of combined technologies and to acquire specialized know‑how, which will be the basis for proposals to potential partner companies, enabling the expansion of future collaborative opportunities.

"We are very pleased to partner with Receptor.AI on this exciting project," said Dai Takehara, President & CEO of PRISM BioLab. "We have developed PepMetics Technology, a highly effective drug discovery platform targeting PPIs, and possess a unique peptide‑mimetic small‑molecule library, the PepMetics Library. We believe this library can be applied not only for intracellular PPI drug discovery but also for membrane proteins, which are not easily targeted by small molecules. With Receptor.AI’s AI‑based molecular design technologies ranging from peptides to small molecules, we expect the potential of the PepMetics Library to expand even further."

"We’re excited to partner with PRISM BioLab to move intracellular and receptor-driven discovery from ‘screening harder’ to navigating smarter," said Dr. Alan Nafiiev, Founder & CEO of Receptor.AI. "PRISM contributes a high-quality, structurally constrained virtual chemical space designed for practical progression. We’re bringing QuorumMap — our chemical space navigation engine — together with structure- and physics-informed modeling and multi-objective optimization to continuously reallocate compute and experimental focus toward the compounds most likely to translate: not just binders, but candidates that balance selectivity with the permeability and stability needed for oral exposure. The goal is a repeatable, decision-driven loop that turns difficult intracellular biology into actionable chemical hypotheses and ranked molecules ready for synthesis and testing."

PRISM and Receptor.AI share a common philosophy of "pursuing new approaches to drug discovery"—creating innovative therapeutics more rapidly, rationally, and with scientific rigor. Through this Collaboration, the companies aim to create synergies by mutually adopting state‑of‑the‑art drug discovery methods.

(Press release, PRISM BioLab, MAR 12, 2026, View Source [SID1234663519])

On March 12, 2026 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, reported an update on the INVINCIBLE-4 Study. In September 2025, enrollment was paused by the Company due to skin irritations observed in Cohort A. In early March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a lower drug volume per tumor volume ratio and a single injection of INT230-6.

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The SOC in the INVINCIBLE-4 Study is the Keynote-522 study regimen, a 6-month presurgical treatment consisting of pembrolizumab every three weeks, then paclitaxel, followed by carboplatin and 4 doxorubicin or epirubicin with cyclophosphamide. The INVINCIBLE-4 Study enrollment criteria is limited to patients with tumors sizes ≥ 1.5 cm, whereas the Keynote-522 study enrolled tumors > 1.0 cm. As a result, patients in the INVINCIBLE-4 Study, on average, have larger tumors than patients in the Keynote-522 study. Patients undergo the Keynote-522 regimen in an attempt to obtain a pCR, which has been shown to significantly reduce the risk of disease recurrence. pCR is an endpoint that the U.S Food and Drug Administration ("FDA") and the European Medicines Agency could allow for an accelerated or conditional marketing approval.

Overall, fourteen (14) patients have been treated to date in the INVINCIBLE-4 Study, with seven (7) in each cohort. The expected total enrollment is up to sixty-one (61) patients. Preliminary observations for the fourteen patients treated to date are as follows:

pCR Data Observations

Cohort A: A pCR was achieved in five (5) out of seven (7) patients (71.4%) who received injections of INT230-6 prior to SOC. Six (6) patients received two (2) injections and one patient, who achieved a pCR, received one (1) injection.

Cohort B: A pCR was achieved in two (2) out of six (6) patients (33%) who received the SOC alone, with one patient still to be evaluated.
The pCR analysis is ongoing, and results are preliminary and early.

Safety Data Observations (through March 2, 2026)

Cohort A: There has been a total of fourteen (14) grade 3 or higher AEs, only one (1) of which is considered a common immune-related side effect of checkpoint immunotherapy.

Cohort B: There has been a total of twenty-five (25) SOC-related grade 3 AEs, of which four (4) are considered common or rare side effects of immune checkpoint inhibitors (three grade 3 and one grade 4).
The safety data for patients who received INT230-6 plus SOC remain favorable compared with SOC alone.

In the Company’s first presurgical Breast Cancer study completed in 2023 (the "INVINCIBLE-2 Study"), fifty-eight (58) women received one (1) to three (3) injections of only INT230-6. Additionally, skin issues were rare, and surgery was performed without complications.

The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference.

Lewis H. Bender, Founder, President & CEO, said, "The pCR data observations to date in the INVINCIBLE-4 study are promising, though preliminary and early. We are also pleased to see fewer total grade 3 or higher adverse events and fewer adverse events associated with checkpoint inhibitors when our drug is combined with immunochemotherapy in Cohort A than seen in Cohort B. The safety observed to date is consistent with our prior results using our drug with immunotherapy in mice1 and humans, which have been presented at oncology conferences or published in peer-reviewed journals."2

Mr. Bender continued, "Triple-negative breast cancer is one of the most aggressive and difficult to treat subtypes. As reported in the Keynote-5223 study, 77% of patients using the current SOC immunochemotherapy regimen alone have grade 3 or higher systemic adverse events, and 0.5% of patients died from the regimen. Reducing the total number of grade 3 or higher adverse events by 44%, especially immune-related adverse events, and the potential for a higher pCR rate with INT230-6 prior to SOC, could be life-saving for patients. With the amendment now filed with Swissmedic, we look forward to dosing the next patient."

About Triple Negative Breast Cancer in the Presurgical Setting

Women with aggressive forms of breast cancer, such as Triple Negative Breast Cancer ("TNBC"), are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of disease recurrence from 50% to 16% at 5 years. Approximately 11 to 17% of breast cancers test negative for estrogen receptors ("ER"), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 ("HER2") protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 worldwide diagnosed each year, 85% of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immunochemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates range from 50 to 65%, depending on tumor size. Rates are generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 77% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

About a Potential INT230-6 Approval Pathway in the Presurgical Setting

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint. pCR is an accepted FDA accelerated approval criterion for approval in high-risk breast cancer, such as TNBC subtype. Pathological complete response is defined as the absence of residual invasive and in situ cancer after evaluation of the completely resected breast specimen and lymph nodes following completion of neoadjuvant systemic therapy. If a product is approved using pCR, companies must still seek full approval using event-free survival as an endpoint.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About the INVINCIBLE-4 Study

The INVINCIBLE-4 study is a Phase 2 non-comparative, hypothesis-driven randomized open-label, two-cohort multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC immunochemotherapy treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the pathological complete response rate for the combination and the SOC alone. pCR is the absence of cancer at the time of surgery in the tumor and nodes. pCR is an FDA accelerated approval endpoint. Clinical evidence is strong that the risk of a patient’s cancer returning is significantly reduced when there is a pCR at the time of surgery. The Swiss Medic and the European Medicines Agency authorized the initiation of the INVINCIBLE-4 Study in Switzerland and France. The SCI led study is also being done in collaboration with Unicancer (UCBG), the French referent cooperative group in breast cancer accredited by the French National Cancer Institute. The expected total enrollment is up to sixty-one (61) patients.

(Press release, Intensity Therapeutics, MAR 12, 2026, View Source [SID1234663518])

On March 12, 2026 Pierre Fabre Pharmaceuticals, Inc., reported that the U.S. Food and Drug Administration (FDA) has agreed to Type A meeting for the biologic license application for tabelecleucel, an allogeneic T-cell therapy with a proposed indication for relapsed/refractory (R/R) Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD).

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"We look forward to a collaborative and productive discussion with the FDA on a timely path forward to achieving accelerated approval of tabelecleucel in R/R EBV+ PTLD, an acute disease with no FDA-approved treatment options," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals Inc., the Pierre Fabre Laboratories pharmaceutical subsidiary in the United States. "It is essential to agree upon a timely approach to resubmission as the lifespan of patients with R/R EBV+ PTLD in the U.S. is often measured in weeks to months following failure of standard treatment."

The meeting will address the Complete Response Letter received by PFP from the agency on January 9, 2026. The company anticipates providing a regulatory update on the outcome of the meeting in the second quarter.

(Press release, Pierre Fabre, MAR 12, 2026, View Source [SID1234663517])

On March 12, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported financial results for the fourth quarter and full-year ended December 31, 2025, and provided recent corporate highlights.

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"Last year marked our evolution into Whitehawk Therapeutics, a boldly pragmatic company developing the next generation of ADC cancer treatments. We progressed three programs through IND-enabling work in tandem, while building the capabilities required to execute efficiently in the clinic as we enter 2026," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "Whitehawk combines established but underexploited tumor targets with a differentiated ADC platform. With two active Phase 1 studies for HWK-007 and HWK-016, and a third IND submission for HWK-206 planned mid-year, we are energized by the opportunity to translate our strategy into clinical data with the potential to have a meaningful impact for patients."

Q4 2025 and Recent Operational Highlights:

Advanced development of PTK7-targeted HWK-007 and MUC16-targeted HWK-016 into Phase 1. In January, Whitehawk announced regulatory progress for these programs, which are both now actively recruiting Phase 1 trials.
The HWK-007 Phase 1 trial will initially evaluate activity in lung and ovarian cancers, two PTK7-expressing tumor types with established precedent data, as well as endometrial cancer, one of the highest PTK7-expressing tumor types.
The HWK-016 Phase 1 trial will initially evaluate activity in two high MUC16-expressing gynecologic cancers, ovarian and endometrial.

Strengthened management with new CMO. In December 2025, Whitehawk appointed Margaret Dugan, MD, as Chief Medical Officer (CMO). Dr. Dugan brings more than 30 years of global oncology drug development experience, with extensive expertise in early-stage clinical development and regulatory strategy.

Presented real-world analysis confirming PTK7 as a broadly expressed, clinically relevant target across solid tumors. Whitehawk presented data at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting that established PTK7 as the third most highly expressed tumor marker among clinically validated and emerging ADC targets, present in ~70% of tumors. We believe these findings support the potential of PTK7 as a pan-tumor target.
Fourth Quarter and Full Year 2025 Financial Results:

Cash, cash equivalents and short-term investments as of December 31, 2025, were $145.7 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

Net loss for the three months ended December 31, 2025, was $23.3 million as compared to $18.3 million for the three months ended December 31, 2024. Net loss for the full-year ended December 31, 2025, was $20.6 million, as compared to $63.7 million for the same period in 2024. The full-year net loss includes an $87.3 million gain on the divestiture of AADI Subsidiary.
Anticipated Milestones:

Preclinical data – expect to present preclinical data across the portfolio at an upcoming medical congress in Spring 2026.

HWK-206 – plan to submit an Investigational New Drug application to the U.S. Food and Drug Administration in mid-2026 for HWK-206 in small-cell lung cancer and neuroendocrine tumors; Phase 1 recruitment planned to start in Q3 2026.

HWK-007 and HWK-016 – ongoing recruitment into Phase 1 trials, with initial results expected in 1H 2027.

(Press release, Whitehawk Therapeutics, MAR 12, 2026, View Source [SID1234663516])