On April 10, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported it was discussed by field-leading key opinion leaders (KOLs) during a recent event hosted by H.C. Wainwright (Press release, Oncolytics Biotech, APR 10, 2025, View Source [SID1234651871]).

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Martine Piccart, M.D., Ph.D., an Honorary Professor of Oncology at the Université Libre de Bruxelles (ULB) and Scientific Director of Oncology at the Institut Jules Bordet, in Brussels, Belgium, offered a detailed overview of the HR+/HER2- metastatic breast cancer landscape and emphasized the need for new treatment innovations, such as pelareorep, that work to activate the immune system to recognize and kill cancer.

Alexander Eggermont, M.D., Ph.D., Professor of Clinical & Translational Immunotherapy at the University Medical Center Utrecht in the Netherlands and Board Member of the Comprehensive Cancer Center Munich of the Technical University Munich and the Ludwig Maximilians University, Munich, Germany, provided insights on the current standards for treating pancreatic ductal adenocarcinoma (PDAC), a cancer type known for its resistance to treatment, and the potential impacts that an immunotherapy such as pelareorep might have on the field.

On April 10, 2025 Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, for the treatment of neurofibromatosis type 1 (NF1) and other cancer indications, reported that the external Safety Review Committee recommended that the Company’s Phase 1 clinical trial of PAS-004 in advanced cancer should proceed to Cohort 6, 30mg capsule, without modification (Press release, Pasithea Therapeutics, APR 10, 2025, View Source [SID1234651872]). This recommendation was based on the review of the safety data from three patients from Cohort 5 and the absence of any dose limiting toxicities (DLT’s). In addition, no rash has been observed to date during the DLT period in any of the first 19 patients in either capsule (15 patients) or tablet (four patients) formulation of PAS-004. Rash is a common adverse event (AE) that is observed at low doses with competitor MEK inhibitors and may lead to the discontinuation rate in real world practice.

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"We are seeing substantial enrollment demand and have already identified Cohort 6 patients. In addition, we continue to observe substantial exposure levels of PAS-004, and remain excited about the possibility of delivering relevant pERK inhibition below the no observed adverse effect levels (NOAEL) as we modeled and observed during our previously conducted nine-month chronic toxicity studies. The on label rash rate for both approved MEKi for NF1 exceeds 80% which leads to patients discontinuing who otherwise should remain on treatment for longer periods of time", stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "We will provide additional safety, pharmacokinetic (PK) and pharmacodynamic (PD) data over the next several weeks."

The ongoing Phase 1 clinical trial is a multi-center, open-label, dose escalation 3+3 study design to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in patients with MAPK pathway driven advanced solid tumors with a documented RAS, NF1 or RAF mutation or patients who have failed BRAF/MEK inhibition (NCT06299839).

On April 9, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, reported that the company plans to explore a full range of strategic alternatives to advance its promising clinical stage programs and maximize stockholder value (Press release, Tempest Therapeutics, APR 9, 2025, View Source [SID1234651856]). Strategic alternatives under consideration may include, but are not limited to, mergers, acquisition, partnerships, joint ventures, licensing arrangements or other strategic transactions. The company has retained MTS Health Partners, L.P., an internationally recognized financial advisor with substantial experience in the biotechnology industry, to support it with the strategic evaluation process.

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"Notwithstanding the positive randomized data set from the amezalpat Phase 2 and its blockbuster potential in first-line HCC, as well as the potential of TPST-1495 as it moves towards a Phase 2 in FAP, the capital markets have been unavailable to support the next stage of advancement," said Stephen Brady, president and chief executive officer of Tempest. "We are initiating a process to explore alternatives available to the company to maximize stockholder value, which include finding a strategic partner with the resources to develop what we believe are potentially life-saving therapies for patients in need. Given the positive data and commercial potential with this pipeline, as well as the clearance from FDA on the lead program’s pivotal study, we believe this is a rare opportunity for a partner."

The company has not set a timetable for completion of the process for evaluating strategic alternatives and does not intend to disclose further developments or guidance on the status of its programs or the process for evaluating strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary. No agreement providing for any transaction has been reached and there can be no assurances that any transaction will result from the process for evaluating strategic alternatives. If the process for evaluating strategic alternatives results in an agreement regarding a transaction, there can be no assurances that any transaction will be completed.

Program Milestones and Status

Amezalpat (TPST-1120) (clinical PPARα antagonist):

Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC.
Received a "Study May Proceed" letter from the FDA to evaluate amezalpat in combination with atezolizumab (TECENTRIQ) and bevacizumab (Avastin), the current standard of care for unresectable or metastatic HCC, in a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC.
Announced an agreement with F. Hoffmann-La Roche Ltd. (Roche) to advance the evaluation of amezalpat in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC.
Announced positive feedback from the end-of-Phase 2 meeting with the FDA for amezalpat in combination with atezolizumab and bevacizumab to treat first-line unresectable or metastatic HCC.
Reported new positive survival data from the ongoing global randomized Phase 1b/2 clinical study demonstrating that amezalpat delivered a six-month improvement in median overall survival (OS) when combined with atezolizumab and bevacizumab in comparison to atezolizumab and bevacizumab alone, the standard of care, in the first-line treatment of patients with unresectable or metastatic HCC.
Published positive data from the Phase 1 trial of amezalpat in patients with advanced solid tumors in the Journal of Cancer Research Communications. Data showed that amezalpat demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor-refractory and immune-compromised cancers. These data complement the positive Phase 1b/2 data reported in October 2023 and June 2024 from a global randomized study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC.
Reported new preclinical data at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that amezalpat reduced kidney cancer growth as a monotherapy, while also showing increased inhibition when combined with frontline chemotherapy and immunotherapy.
TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist):

Granted Orphan Drug designation by the FDA for TPST-1495 for the treatment of patients with FAP.
Received a "Study May Proceed" letter from the FDA to evaluate TPST-1495 in a Phase 2 trial for the treatment of FAP.
About Amezalpat (TPST-1120)

Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In an ongoing global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by additional positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors, including renal cell carcinoma and cholangiocarcinoma.

About TPST-1495

TPST-1495 is a novel, highly selective and potent EP2-EP4 dual antagonist designed to block the cancer-promoting EP2 and EP4 receptors in the prostaglandin (PGE2) pathway, while sparing the homologous but differentially active EP1 and EP3 receptors. PGE2 signaling through EP2 and EP4 has been observed to enhance tumor progression through the stimulation of tumor proliferation, enhanced angiogenesis and suppression of immune function in the tumor microenvironment. The Phase 2 study of TPST-1495 in patients with FAP is expected to begin in 2025 under the auspices of the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (NCI) Division of Cancer Prevention.

On April 9, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval for an indication extension of DARZALEX (daratumumab) subcutaneous (SC) co-formulated with ENHANZE in the frontline setting (Press release, Halozyme, APR 9, 2025, View Source [SID1234651857]). The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma.1

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"The continued expansion of DARZALEX delivered subcutaneously with ENHANZE into additional settings highlights its status as a cornerstone of therapy for multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "This approval means that newly diagnosed patients can receive daratumumab subcutaneous plus VRd and avoid the need for lengthy IV infusions."

This approval follows the indication extension approval for daratumumab-VRd in October 2024, for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant, based on the results from the Phase 3 PERSEUS (NCT03652064) study. The study evaluated this daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide maintenance.2,3

1 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. April 2025.

2 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology Annual Meeting. June 3, 2024.

3 Johnson & Johnson Innovative Medicine EMEA. DARZALEX (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: View Source Last accessed: April 2025.

On April 9, 2025 Engine Biosciences (Engine), a Singapore- and Silicon Valley-based biotechnology company pioneering precision medicine for cancer, reported a new partnership with the Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development hosted by the Agency for Science, Technology and Research (A*STAR) (Press release, Experimental Drug Development Centre, APR 9, 2025, View Source [SID1234654013]).

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This first-of-its-kind collaboration unites Engine’s NetMAPPR platform and proprietary oncology intellectual property with EDDC’s drug discovery and development expertise to create first-in-class precision cancer treatments.

The first project under this partnership focuses on ENB-871, a novel pairing of a drug target and patient selection biomarkers discovered through Engine’s NetMAPPR platform. This platform combines AI, computation, biology, and chemistry to identify, validate, and prioritise drug targets with strong clinical and commercial potential, driving the development of new therapies that exploit specific vulnerabilities in tumours.

This programme shows significant promise for treating tumours with particular genetic mutations that predict sensitivity to the ENB-871 targeted therapy, including breast, liver, kidney and prostate cancers – diseases afflicting large and growing patient populations in Singapore and worldwide. In total, the potential addressable population exceeds 500,000 patients per year.

The teams will collaborate to develop small molecule degraders targeting ENB-871, including demonstration of in vivo efficacy. By bringing together Engine’s proprietary technology and deep translational insights with EDDC’s strengths in designing and developing therapies, this partnership aims to create targeted cancer treatments tailored to patients’ specific profiles, improving treatment effectiveness and outcomes. Engine and EDDC may also identify additional drug targets and research programmes for collaboration during the partnership.

"We’re excited by the synergies created by bringing together our two platforms, leveraging first-in-class Singapore research and innovation to advance transformative cancer therapies. This marks another key step in Engine’s mission to develop more effective, targeted and safer drugs for cancer patients." said Jeffrey Lu, CEO and Co-Founder of Engine Biosciences.

"The future of drug development lies in precision-driven innovation. Our partnership with Engine enables us to develop therapies tailored to specific patient populations through Engine’s biomarker-driven patient selection approaches. We are particularly excited to launch our first collaborative project around monovalent small molecule degraders, building on EDDC’s expanding capabilities in this field. Beyond this, we look forward to strengthening our partnership by advancing more precision therapies that have the potential to transform the lives of cancer patients in need," shared Damian O’Connell, CEO of EDDC.