On August 18, 2025 Skyhawk Therapeutics, Inc., a leader in the discovery and development of small molecules that modulate RNA expression, reported a strategic research collaboration with Merck KGaA, Darmstadt, Germany, a leading science and technology company (Press release, Skyhawk Therapeutics, AUG 18, 2025, View Source [SID1234655356]). The collaboration will focus on the discovery of novel RNA-targeting small molecules in select neurological indications with high unmet medical need.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Skyhawk will use its proprietary SkySTAR (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) platform to identify small molecule candidates directed at specific RNA targets designated by Merck KGaA, Darmstadt, Germany. The collaboration aims to expand the potential of RNA modulation in diseases where traditional approaches have proven challenging, leveraging Skyhawk’s industry-leading capabilities in RNA splicing modulation and Merck KGaA, Darmstadt, Germany’s expertise in drug development and commercialization.

"Our collaboration with Skyhawk aligns with our strategic focus on innovative science and next-generation technologies that have the potential to deliver impactful medicines to patients with neurological conditions," said Amy Kao, Senior Vice President and Global Head of Neuroscience & Immunology Research Unit, Merck KGaA, Darmstadt, Germany. "We believe RNA splicing modulation represents an exciting frontier in drug discovery, and Skyhawk’s expertise positions them as an ideal partner in this space. It is also in line with our mission in bringing more medicines to more patients, faster."

"We are proud to partner with Merck KGaA, Darmstadt, Germany a company with a strong heritage of innovation and a commitment to advancing transformative science," said Bill Haney, Chief Executive Officer of Skyhawk Therapeutics. "This collaboration underscores the power of our SkySTAR platform to address challenging disease biology through precise RNA targeting, and we look forward to working closely with Merck KGaA, Darmstadt, Germany to bring potential first-in-class medicines forward."

Skyhawk will lead discovery and preclinical development efforts, after which Merck KGaA, Darmstadt, Germany will assume responsibility for further development and commercialization upon option exercise. The overall deal is valued at over $2 billion, with Skyhawk being eligible for milestone payments, as well as tiered royalties on commercial sales.

On August 18, 2025 Philochem AG ("Philochem"), a wholly-owned subsidiary of Philogen company (MIL: PHIL), and RayzeBio, Inc. ("RayzeBio"), a wholly-owned subsidiary of Bristol-Myers Squibb company (NYSE: BMY), reported the successful completion of U.S. antitrust review and the closing of the global licensing agreement for OncoACP3, a clinical-stage therapeutic and diagnostic agent targeting prostate cancer (Press release, Philogen, AUG 18, 2025, View Source [SID1234655354]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The transaction, initially announced on June 10, 2025, has now been finalized following clearance under the Hart–Scott–Rodino Antitrust Improvements Act of 1976 by the U.S. Federal Trade Commission (FTC). As part of the agreement, Philochem will receive an upfront payment of $350 million.

RayzeBio will be responsible for the development and any subsequent commercialization of OncoACP3. The license agreement also includes up to $1.0 billion in development, regulatory and commercial milestone payments, as well as mid-single to low double-digit royalties on global net sales.

"I am very pleased that we have received clearance, allowing us to proceed with this agreement with RayzeBio," said Dario Neri, CEO and CSO of Philogen. "They share our vision for revolutionizing the diagnosis and treatment of prostate cancer. We believe that OncoACP3 has all the credentials to become a breakthrough treatment for patients, translating scientific innovation into an important medical advance".

Ben Hickey, President, RayzeBio commented: "The closing of this agreement marks an important milestone for RayzeBio as we expand our leadership in the radiopharmaceuticals space. We look forward to advancing OncoACP3 for the benefit of patients, consistent with our strategy to bring forward best-in-class RPT candidates."

On August 18, 2025 Moleculin presented its corporate presentation (Presentation, Moleculin, AUG 18, 2025, View Source [SID1234655353]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 18, 2025 Jabez Biosciences, Inc., a clinical-stage biopharmaceutical company dedicated to ushering in the future of cancer therapy with their seamless, scalable, and synergistic approach, reported the opening of a second clinical site for its Phase 1 clinical study of JBZ-001, a next-generation small molecule inhibitor targeting dihydroorotate dehydrogenase (DHODH) (Press release, Jabez Biosciences, AUG 18, 2025, View Source [SID1234655352]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Phase 1 study is now enrolling patients at a second site, START Mountain Region (link) in West Valley City, UT, under the direction of William McKean, MD, PhD. The study initially opened in March 2025 and continues to enroll at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James), under the direction of Asrar Alhamadi, MBBS.

This Phase 1 study is evaluating the safety, tolerability, and preliminary efficacy of JBZ-001 in patients with advanced solid tumors and non-Hodgkin lymphoma (NHL). JBZ-001, designed to inhibit DHODH—an enzyme critical for nucleotide production and cancer cell proliferation—has demonstrated promising preclinical results, including significant tumor growth inhibition and a favorable safety profile in animal models. Preclinical data, published in JCI Insights (2024), highlight JBZ-001’s ability to induce myeloid cell differentiation and enhance anti-tumor activity, positioning it as a potential game-changer in oncology.

"We are excited to add a second center to our first-in-human trial, serving the Mountain Region and allowing more geographical access to patients," said Tamara Jovonovich, PhD, Chief Executive Officer of Jabez Biosciences. "We are currently enrolling our second dose cohort in the dose-escalation portion of the study. Opening the trial at a second site expands our reach and our hope of delivering best-in-class therapies that address the unmet needs of cancer patients. JBZ-001’s unique mechanism of action, which targets multiple pathways beyond nucleotide depletion, offers hope for a broad spectrum of oncological indications, and we are eager to see its potential unfold in this trial."

Founded in 2024 by industry veterans, Jabez Biosciences leverages decades of expertise to target key mechanistic drivers of cancer and tumor biology. JBZ-001 exemplifies the company’s innovative approach—"built for patients and guided by biology"—to ensure commercial viability while maintaining a focus on patient-centered outcomes.

"This milestone is one more step along the approval pathway as more sites will be added this year," added Dr. Jovonovich. "We are grateful to the patients and clinical investigators who are making this trial possible, and we look forward to building these relationships while advancing JBZ-001 through the clinic."

For more information about Jabez Biosciences and its pipeline, visit View Source

On August 18, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that the U.S. Patent and Trademark Office has issued a Notice of Allowance for a patent to Genprex that covers the use of the Company’s lead drug candidate, Reqorsa Gene Therapy, in combination with PD-L1 antibodies, such as Tecentriq (Press release, Genprex, AUG 18, 2025, View Source [SID1234655351]). Similarly, the European Patent Office has issued a Notice of Allowance to Genprex for a patent covering the use of REQORSA in combination with PD-1 antibodies. Both patents will expire in 2037 at the earliest.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very proud to continue building a fortress of intellectual property protection around our oncology program for REQORSA, and these newly granted patents strengthen and expand our intellectual property estate for REQORSA in combination with immune checkpoint inhibitors applicable to our Acclaim-3 clinical trial," said Thomas Gallagher, Esq., Senior Vice President of Intellectual Property and Licensing at Genprex.

Genprex has been granted patents for the use of REQORSA in combination with PD-L1 antibodies in Korea. Genprex is pursuing additional patent applications in Europe, Canada, Brazil, China and Israel. Should these applications grant, they would be applicable to Genprex’s Acclaim-3 clinical trial.

Genprex has been granted patents for the use of REQORSA in combination with PD-1 antibodies in the U.S., Japan, Mexico, Russia, Australia, Chile, China, Korea and Singapore.

PD-L1 and PD-1 antibodies are a type of targeted immunotherapy and a part of a group of checkpoint inhibitor anti-cancer drugs that block the activity of PD-L1 and PD-1 immune checkpoint proteins present on the surface of cells.The Acclaim-3 study is a Phase 1/2 clinical trial that uses a combination of REQORSA and Genentech’s Tecentriq as maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC) who are candidates for maintenance therapy after receiving Tecentriq and chemotherapy as initial standard treatment. The Acclaim-3 clinical trial has received U.S. Food and Drug Administration (FDA) Fast Track Designation for this patient population, and Acclaim-3 has received FDA Orphan Drug Designation.