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XL-protein grants worldwide license to Grifols to develop a biopharmaceutical using PASylation® technology

On June 10, 2025 XL-protein GmbH, a pioneer in the area of biopolymers for pharmacokinetic optimization, reported that it has entered into a worldwide License, Development and Commercialization Agreement with Grifols, a global healthcare company and leading manufacturer of plasma-derived medicines, for a novel, long-acting biopharmaceutical product (Press release, XL-protein, JUN 10, 2025, View Source [SID1234653796]).

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Under this collaboration, XL-protein will leverage its proprietary, clinical-stage PASylation technology to extend the circulation of Grifols therapeutics, paving the way for a more effective and long-lasting treatment. XL-protein will actively support preclinical development activities while Grifols will be entitled to further developing as well as, manufacturing and marketing the PASylated-enhanced biologic.

Under the terms of the agreement, XL-protein will receive an upfront payment as well as payments for achievement of preclinical, clinical, regulatory and commercial milestones. Furthermore, XL-protein will receive tiered royalties on sales from marketed therapeutics resulting from the collaboration. Grifols will have worldwide exclusive marketing rights under the agreement. Further financial terms have not been disclosed.

"Grifols continues to innovate across its therapeutic portfolio to develop new treatments and enhancing existing ones for patients", said Dr. Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer. "We look forward to collaborating with XL-protein and combining our advanced scientific efforts in this leading initiative".

"We are excited to work with Grifols to enhance the pharmacological properties of their therapeutics", said Dr. Michaela Gebauer, Managing Director of XL-protein. "This partnership leverages the potential of our PASylation technology, together with other PASylated drugs currently under development, and creates added value for Grifols", commented Uli Binder, Managing Director of XL-protein.

Quest Diagnostics to Develop Multi-cancer Stratification (MCaST) Blood Test Based on MD Anderson Technology

On June 10, 2025 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported a collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) designed to improve the assessment of elevated risk of cancer in individuals who would benefit from medically appropriate cancer screenings (Press release, Quest Diagnostics, JUN 10, 2025, View Source [SID1234653795]).

Under terms of the agreement, Quest will develop and validate a laboratory-developed blood test based on circulating protein biomarkers associated with high risk for one or more cancers, including colorectal, lung, breast, pancreatic, ovarian, liver, prostate, esophageal and stomach. Quest will base the test on a developmental license to technology and intellectual property associated with the Multi-Cancer Stratification Test (MCaST), a cohesive risk model developed by the laboratory of Samir Hanash, M.D., Ph.D., at MD Anderson. Dr. Hanash and his team identified a set of biomarkers that inform the model through extensive clinical research conducted on screening study cohorts involving tens of thousands of individuals. Quest plans to refine and further develop and validate the MCaST technology for its own lab-developed test.

Assuming successful test validation, the parties may agree for Quest to exercise rights to commercialize the test, with the goal to make it available to providers in North America in 2026.

Quest expects the future test will supplement, not replace, conventional screening methods, by providing insights to help providers identify patients that would benefit from medically appropriate screening or other forms of evaluation. Conventional screening methods target a limited number of cancers and only one at a time, often with invasive or costly procedures that patients resist. While multi-cancer early detection (MCED) liquid biopsy tests that detect cancer DNA in circulating blood are convenient, they are comparatively expensive, not intended to personalize risk, and may lack well-established protocols for clinical follow-up.

Only 51% of U.S. adults say they have had a routine medical appointment or routine cancer screening in the last year.

"One of the biggest problems in cancer care today is patients skipping preventive screenings because the methods are too invasive, inconvenient or unaffordable," said Mark Gardner, senior vice president, Oncology, Genomics and R&D, Quest Diagnostics. "Another huge problem is a lack of tests for infrequent, but often deadly cancers, like pancreatic cancer. Building on proteomics discoveries from Dr. Hanash and his team, Quest intends to create a simple blood test anyone can conveniently access and reasonably afford to identify risk of a range of cancers. A patient identified with elevated risk may be more inclined to pursue preventive cancer screening or other medical assessments that could identify cancer in early, more treatable stages of disease."

Philochem AG Announces the Licensing of Worldwide Rights to OncoACP3, a novel Radiopharmaceutical Therapeutic and Diagnostic Agent targeting Prostate Cancer, to RayzeBio, a Bristol-Myers Squibb Company, for a potential value of up to $1.35bn plus royalties.

On June 10, 2025 Philochem AG ("Philochem"), a wholly-owned subsidiary of the Philogen Group (MIL:PHIL), and RayzeBio, Inc. ("RayzeBio"), a wholly-owned subsidiary of Bristol-Myers Squibb company (NYSE: BMY), reported a definitive agreement under which Philochem will license the exclusive worldwide rights to develop, manufacture, and commercialise OncoACP3, a clinical stage therapeutic and diagnostic agent targeting prostate cancer, to RayzeBio (Press release, Philogen, JUN 10, 2025, View Source [SID1234653794]).

OncoACP3 is a small molecule ligand with high affinity and specificity for Acid Phosphatase 3 (ACP3), a novel target in prostate cancer. The compound is currently under evaluation in a company-sponsored Phase I trial (NCT06840535). Initial data from the first cohort of patients evaluated with the OncoACP3 diagnostic has been promising, displaying selective tumour uptake and long residence time with minimal healthy tissue uptake. IND-enabling activities to support the application for a Phase I therapeutic study with 225Ac-OncoACP3 are ongoing.

Prof. Dr. Dario Neri, CEO and CSO of Philogen, commented: "We are delighted to enter into this new collaboration with RayzeBio, a leader in the field of radiopharmaceutical medicines. This partnership will focus on the development and commercialization of OncoACP3 for both diagnostic and therapeutic applications in prostate cancer. OncoACP3 is a best-in-class targeting agent with the potential to become a breakthrough treatment in this field. This collaboration reflects our shared commitment to translating scientific innovation into meaningful clinical solutions, making OncoACP3 therapies widely available to patients in need."

Ben Hickey, President, RayzeBio commented: "This collaboration with Philochem enhances our leadership in the rapidly advancing radiopharmaceuticals space, consistent with our strategy to bring forward best-in-class RPT candidates. OncoACP3, with its initial encouraging safety profile, provides a differentiated entry for Bristol Myers Squibb and RayzeBio into the prostate cancer arena, building on our leadership in actinium-based RPT development. This agreement is a significant milestone for RayzeBio and our goal to deliver radiopharmaceuticals to patients."

Under the terms of the agreement, Philochem will receive an up-front payment of $350m and up to $1.0bn in development, regulatory and commercial milestones. The company will also receive mid-single to low double-digit royalties payable on Global Net Sales of both Therapeutic and Diagnostic agents of OncoACP3.

The closing of the transaction is subject to regulatory approvals and other customary closing conditions. The parties expect that the agreement will close in the third quarter of 2025.

For Philochem, Centerview Partners UK LLP is acting as exclusive financial advisor and Cooley LLP is acting as exclusive legal counsel.

FDA Grants Priority Review for Zepzelca® (lurbinectedin) and atezolizumab (Tecentriq®) combination in Extensive Stage Small Cell Lung Cancer

On June 10, 2025 PharmaMar (MSE:PHM) reported that the U.S Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for Zepzelca (lurbinectedin) in combination with atezolizumab (Tecentriq) as a first-line maintenance treatment for people with extensive-stage small cell lung cancer (ES-SCLC), following induction therapy with carboplatin, etoposide and atezolizumab (Press release, PharmaMar, JUN 10, 2025, View Sourcefda-grants-priority-review-for-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-in-extensive-stage-small-cell-lung-cancer/" target="_blank" title="View Sourcefda-grants-priority-review-for-zepzelca-lurbinectedin-and-atezolizumab-tecentriq-combination-in-extensive-stage-small-cell-lung-cancer/" rel="nofollow">View Source [SID1234653793]).

The FDA’s Priority Review designation is assigned to applications for drugs that would offer a significant improvement in the safety or effectiveness of the treatment of a serious condition and means FDA’s goal is to take action on the NDA within six months (compared to ten months under standard review). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 7, 2025.

Jazz Pharmaceuticals plc (Nasdaq: JAZZ), PharmaMar’s partner in the U.S., submitted the sNDA to the FDA in April based on data from the Phase 3 IMforte trial, which evaluated lurbinectedin plus atezolizumab as a first-line maintenance therapy in patients with ES-SCLC. 483 patients were randomized after completion of 4 cycles of induction therapy with atezolizumab plus carboplatin and etoposide. From the point of randomization, the median OS for the lurbinectedin plus atezolizumab regimen was 13.2 months versus 10.6 months for atezolizumab alone. From the point of randomization, the median PFS by independent assessment was 5.4 months versus 2.1 months, respectively.

Data from the trial served as the basis, also, for the recent submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) by PharmaMar.

PharmaMar informs that Slingshot will host a Key Opinion Leader webcast on June 12th at 17:00h CEST / 11:00 EDT to review the Phase 3 IMforte data for lurbinectedin + atezolizumab in extensive-stage small cell lung cancer, which were presented at ASCO (Free ASCO Whitepaper), as well as the treatment landscape. The webcast will include a discussion panel of Dr. Martin Wermke from TU Dresden and Dr. Nicolas Girard from Institut Curie. The webcast may be accessed from the Investors section at View Source

MacroGenics and Sagard Healthcare Partners Enter into ZYNYZ® Royalty Purchase Agreement

On June 10, 2025 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, reported that it has entered into a royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ (retifanlimab-dlwr) (Press release, MacroGenics, JUN 10, 2025, View Source [SID1234653792]). ZYNYZ is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to ZYNYZ, including future potential development, regulatory and commercial milestones. MacroGenics will also continue to support a portion of global commercial manufacturing needs for ZYNYZ.

Under the terms of the royalty purchase agreement, MacroGenics received a $70 million upfront payment for the sale of its royalty rights on global net sales of ZYNYZ. Following Sagard’s receipt of aggregate royalty payments totaling $140 million (or 2.0x), MacroGenics will resume collecting all future royalties on global net sales.

Additional information regarding the royalty purchase agreement is provided in a Current Report on Form 8-K filed by MacroGenics with the U.S. Securities and Exchange Commission.

As of March 31, 2025, MacroGenics had $154.1 million in cash, cash equivalents and marketable securities. This balance, combined with the $70 million upfront payment from Sagard, projected and anticipated future payments from partners, and anticipated savings from the Company’s ongoing cost-reduction initiatives, is expected to support its cash runway through the first half of 2027. MacroGenics’ expected funding needs reflect planned investments in ongoing clinical and preclinical programs.

About ZYNYZ

ZYNYZ (retifanlimab-dlwr) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

ZYNYZ is also indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

ZYNYZ is marketed by Incyte in the United States.

ZYNYZ is a registered trademark of Incyte.