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]).

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 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."

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]).

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!

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.

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]).

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 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

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.

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 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.

On June 10, 2025 The European Organisation for Research and Treatment of Cancer (EORTC) and Syreon Research Institute reported the official start of DE-ESCALATE, a pragmatic Phase III clinical trial focusing on metastatic prostate cancer (Press release, EORTC, JUN 10, 2025, View Source [SID1234653791]).

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!

DE-ESCALATE is one of three research projects coordinated by EORTC, alongside LEGATO and STREXIT-2, which are also funded by the Horizon Europe Programme.

About metastatic prostate cancer
Prostate cancer is the most frequently occurring cancer in men and the third leading cause of cancer death in men.¹ Despite dramatic improvements in early diagnosis and local treatment, one out of five prostate cancer patients will die from their disease.² While data about the rates of metastasis are limited, about 22% of prostate cancer cases metastasize.3 Advanced metastatic prostate cancer is a heterogeneous disease, for which androgen deprivation therapy combined with an androgen receptor pathway inhibitor (ARPI) is the mainstay of treatment.

Metastatic prostate cancer patients suffer from low quality of life and very burdensome symptoms, including treatment-related side effects.

About DE-ESCALATE
The study will evaluate whether intermittent intensified androgen deprivation treatment (iADT) in metastatic prostate cancer is not inferior to continuous treatment in terms of oncological benefit, while minimizing side effects and resource utilization and improving patient quality of life. It is also designed to detect early if iADT has a negative impact on overall survival compared to continuous therapy.

Up to 1,600 patients are expected to be enrolled in this study across Europe. The clinical trial will be opened in 80 sites in the following 8 countries within the EORTC network (Belgium, Croatia, Czechia, Denmark, Italy, Portugal, Romania, Slovenia) and 30 sites across national networks in Ireland, France, and Spain.4
The study is designed with a strong focus on patient centricity, employing a patient-developed health questionnaire to better assess quality of life improvements.

DE-ESCALATE is managed by a multidisciplinary and multistakeholder consortium involving clinical oncologists, surgeons, health economists, and patient representatives.

To compare the effectiveness of the health interventions tested within the study, Syreon Research Institute will deliver a cost-effectiveness analysis and will also oversee the health policy aspects of the dissemination of the study findings.

The DE-ESCALATE study may lead to improved patient survival and quality of life while also improve health system sustainability.