On April 24, 2025 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, reported it will present new data from Cohort 1 of the GOBLET study at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago May 30-June 3, 2025 demonstrating pelareorep’s anti-tumor activity in pancreatic ductal adenocarcinoma (PDAC) – the most common form of pancreatic cancer characterized by its poor prognosis and limited treatment options (Press release, Oncolytics Biotech, APR 24, 2025, View Source [SID1234652107]).

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"Pelareorep continues to deliver encouraging results in pancreatic cancer, where few effective treatments exist," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer for Oncolytics Biotech. "In multiple studies, pelareorep has repeatedly demonstrated its ability to engage the immune system to attack pancreatic cancer tumors, which has the potential to improve outcomes for patients battling this difficult-to-treat cancer."

Abstract Number: 2562
Title: Role of pelareorep in activating anti-tumor immunity in PDAC.
Presentation Type: Poster
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: June 2, 2025, 1:30 – 4:30 p.m. CT

Abstracts will be published on the ASCO (Free ASCO Whitepaper) website at 5:00 p.m. ET on May 22, 2025.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in Germany and is being managed by AIO-Studien-gGmbH. The primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers. The study comprises five treatment groups:

1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients

4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

5.Pelareorep in combination with modified FOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

On April 24, 2025 Mosaic Therapeutics, Ltd (‘Mosaic’, or ‘the Company’) a targeted oncology therapeutics company dedicated to resolving cancer’s complexity with new combination therapies for patients, reported the in-licensing of two clinical-stage oncology programs from Astex Pharmaceuticals (‘Astex’), a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd (Press release, Mosaic Therapeutics, APR 24, 2025, View Source [SID1234652123]). Mosaic has identified proprietary combinations incorporating the licensed products and their targets and this agreement gives Mosaic the exclusive rights to develop those combination products for patients for whom there are no, or limited, treatment options.

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As part of the agreement, Astex has taken an equity stake in Mosaic equating to a fully-diluted ownership stake of 19% equity upfront and a further 3% dependent on clinical milestones, which will consolidate the partnership between these two innovation-driven businesses. Astex will also receive potential future revenue shares. Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex, will also take an observer role on the Mosaic Board. Other financial details have not been disclosed.

Mosaic’s platform identifies combinations of pairs of oncology drugs predicted to have synergistic activity in biomarker-defined patient populations and expected to lead to greater efficacy and durability of response than achieved as monotherapy. The development strategy for each combination product is to seek a broad, biomarker-defined label across multiple tumour types. The two small molecule assets from Astex are ASTX029, an ERK1/2 inhibitor discovered by Astex that has completed a Phase 2 clinical study and ASTX295 an MDM2 antagonist discovered by Astex in collaboration with the Cancer Research UK Drug Discovery Unit at Newcastle University, that has completed a Phase 1 clinical study. Each of the two licensed compounds has been studied in more than 100 patients and demonstrated differentiated safety profiles within their target class and single-agent activity as monotherapies, enabling use in combination therapies.

"Mosaic’s mission is to bring novel targeted combination medicines to patients who need them," said Dr. Edward Hodgkin, Managing Partner of Syncona Investment Management Limited and Chair of Mosaic. "The in licensing of these two clinical-stage assets provides a step change in our development pipeline, allowing Mosaic to progress targeted drug combinations in novel biomarker-defined settings and enabling the delivery of precision medicines for patients who currently have few therapeutic options. Excitingly the deal significantly accelerates Mosaic’s development path, with the first clinical combination study expected to commence in 2026."

"We recognise the significance of Mosaic’s platform, which has identified these two assets as anchor components of a pipeline of potential combination products," said Dr. Harren Jhoti, co-founder, president and chief executive officer of Astex. "Both drug targets are well-characterised drivers of many cancers, and we are excited to be working with the experienced team at Mosaic to expand the Company’s pipeline in combination therapies with high unmet medical need."

On April 24, 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 MAPK pathway driven indications, reported the acceptance of an abstract for a poster prenstation at the Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) taking place May 30 – June 3, 2025, in Chicago, Illinois (Press release, Pasithea Therapeutics, APR 24, 2025, View Source [SID1234652108]).

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The Company will present updated interim clinical data from its onging Phase 1 clinical trial of PAS-004 in patients with MAPK pathway driven advanced solid tumors.

"We are pleased to present interim clinical data of PAS-004 through cohort 4A and 4B, that to date has demonstrated clinical activity, target engagement, and a favorable safety profile," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. "We believe PAS-004’s emerging profile may achieve the sweet spot between PK, PD and tolerability and may make PAS-004 an ideal candidate for the treatment of NF1 related cutaneous and plexiform neurofibromas as well as a potential candidate for treatment of various cancers and MAPK pathway driven diseases."

Presentation and poster details

Title: Phase 1 dose-escalation study of the safety and pharmacokinetics of PAS-004, a macrocyclic MEK inhibitor, for the treatment of patients with MAPK pathway–driven advanced solid tumors
Session: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 440
Date and Time: 6/2/2025, 1:30 – 4:30 PM CDT

The full abstract will be available on the ASCO (Free ASCO Whitepaper) website on May 22, 2025, at 5:00 p.m. ET.

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 24, 2025 Debiopharm Research & Manufacturing S.A. (Debiopharm, www.debiopharm.com), a Swiss-based global biopharmaceutical company aiming to cure cancer and infectious diseases, and Oncodesign Services (www.oncodesign-services.com), a leading CRO specialized in drug discovery and preclinical services, reported the execution of a license agreement for the use of the AbYlink technology for preclinical services (Press release, Debiopharm, APR 24, 2025, View Source [SID1234652124]).

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AbYlink is a regio-selective bioconjugation technology ideally suited for preparing conjugates for use in therapeutic and non-invasive diagnostic applications. Oncodesign Services will use this cutting-edge technology to prepare antibody chelator conjugates for use in preclinical studies to gain insights into the predictive effectiveness of novel treatment approaches in Molecular Radiotherapy, and particularly Radioimmunotherapy in the context of cancer. A joint poster will be presented at the AACR (Free AACR Whitepaper) Annual Meeting 2025 to demonstrate the use of the non-invasive technology in Radioimmunotherapy, targeting animal models bearing HER2+ tumors.

"We have demonstrated the effectiveness of this powerful technology to rapidly and covalently conjugate any off-the-shelf antibody in a single step with an imaging agent. Our strategic collaboration with Oncodesign Services allows broader access to and usage of non-invasive imaging applications and provides an innovative solution to biotech and pharma partners to integrate imagery in the development of new antibody- and ADC-based therapeutics," commented Frédéric Lévy, Chief Scientific Officer at Debiopharm.

Aidan Synnott, CEO of Oncodesign Services, said, "We are pleased to integrate this cutting-edge technology into our portfolio for our clients. The AbYlink technology gives the advantage of generating reproducible batches of bioconjugated antibodies and ADCs that secure specificity and efficacy of targeted radiotherapy."

About AbYlink

AbYlink is a versatile and rapid regio-selective chemical conjugation technology for use to prepare diagnostic or therapeutic conjugates. This one-step method results in stable conjugation at defined and invariable sites on the Fc domain of an antibody or the like, with no impact on antigen-binding regions. It enables a seamless and reproducible conjugation of payloads (e.g., a chelator for radiolabeling, a fluorescent dye or a drug) to antibodies or ADCs. The universal applicability of the technology has been demonstrated for various antibody isotypes and payloads.

On April 24, 2025 Merck & Co reported its First-Quarter 2025 Financial Results (Presentation, Merck & Co, APR 24, 2025, View Source [SID1234653383]).

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