On June 27, 2025 Schrödinger, Inc. (Nasdaq: SDGR) reported that SGR-1505, its clinical stage MALT1 inhibitor, was designated as a Fast Track product by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with Waldenström macroglobulinemia that have failed at least two lines of therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor (Press release, Schrodinger, JUN 27, 2025, View Source [SID1234654163]).

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"We are excited to receive Fast Track designation for SGR-1505, which underscores the significant need in patients with Waldenström macroglobulinemia," said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. "Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients. This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens."

"We believe this Fast Track designation in Waldenström macroglobulinemia, combined with our encouraging Phase 1 data across a broad range of relapsed/refractory B-cell malignancies such as chronic lymphocytic leukemia, diffuse large B-cell lymphoma, and marginal zone lymphoma, reinforce the potential of SGR-1505 as a future therapeutic option for patients," said Margaret Dugan, chief medical officer at Schrödinger. "We look forward to discussing our Phase 1 study results and recommended Phase 2 dose with the FDA later this year."

The FDA Fast Track program is designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need. A drug granted Fast Track designation is eligible for multiple benefits, including more frequent meetings and written communications with the FDA, as well as eligibility for Accelerated Approval, Priority Review or Rolling Review, if relevant criteria are met.

SGR-1505 is currently being evaluated in a Phase 1 clinical study as a treatment for patients with relapsed/refractory B-cell malignancies. Initial data were recently presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress and International Conference on Malignant Lymphoma where SGR-1505 was observed to have a favorable safety profile and was well tolerated. Encouraging signs of preliminary efficacy were observed in multiple B-cell malignancy subtypes, including Waldenström macroglobulinemia patients, previously treated with a BTK inhibitor prior to starting SGR-1505.

On August 11, 2023, the FDA granted orphan drug designation to SGR-1505 for Mantle Cell Lymphoma (MCL) based on preclinical data.

About SGR-1505
SGR-1505 is an oral investigational MALT1 inhibitor being evaluated for the treatment of relapsed/refractory B-cell malignancies. MALT1 plays a central role in key signaling pathways that drive cancer cell survival and proliferation, making its location downstream of BTK in the NF-κB signaling pathway an attractive target for the development of novel therapeutics for a potentially broad range of B-cell malignancies. In preclinical studies, SGR-1505 was observed to be highly potent and selective, and has demonstrated anti-tumor activity in preclinical models both as a monotherapy and in combination with BTK and BCL-2 inhibitors. There is also emerging therapeutic rationale supporting MALT1 inhibition as a potential treatment for inflammatory and autoimmune disorders.

SGR-1505 was designed using Schrödinger’s computational platform at scale and was discovered approximately 10 months after the company started its MALT1 program. A Phase 1 study in patients with relapsed/refractory B-cell malignancies is ongoing (NCT05544019).

On June 26, 2025 Incyte (Nasdaq:INCY) reported that the Company’s Board of Directors has unanimously appointed Bill Meury as President and Chief Executive Officer (CEO) and a member of the Company’s Board of Directors, effective immediately (Press release, Incyte, JUN 26, 2025, View Source [SID1234654148]).

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Bill Meury succeeds Hervé Hoppenot who will retire from the Company after 11 years of service. Mr. Hoppenot will serve as an advisor to the CEO and will remain as a member of the Board through the end of the year to ensure a smooth transition. In addition, Lead Independent Director Julian Baker has been elected Chairman of the Board of Directors.

Mr. Meury is a proven enterprise leader with expertise in organizational strategy, pipeline and commercial execution and capital allocation. He most recently served as CEO of Anthos Therapeutics, where he successfully scaled the company for its next stage of growth. Prior to that, he was CEO of Karuna Therapeutics, leading its transition into a fully integrated R&D and commercial organization. Before Karuna, Mr. Meury spent more than two decades at Allergan, serving as Chief Commercial Officer, managing a global business with fifty products, $16 billion in revenue and approximately 8,000 employees across a range of therapeutic areas.

"I am honored to join Incyte at this pivotal moment and thank Hervé for his support during this transition," said Mr. Meury. "Incyte’s track record for discovering innovative treatments for complex problems in human health is outstanding. My priority is to build upon our exceptional R&D and commercial capabilities to accelerate new product flow, drive sustainable growth and create value for all stakeholders. I look forward to working with the Incyte team to continue to grow the company for enduring success."

"Bill is a decisive and collaborative leader who possesses the strategic planning and executional skills necessary to accelerate Incyte’s growth and maximize the tremendous opportunities we have in oncology and immunology," said Mr. Baker. "During our thoughtful succession process, Bill’s leadership experience stood out, including his ability to effectively translate scientific breakthroughs into business results. Bill is a great listener, a tireless learner and a direct and open communicator. I believe that he embraces Incyte’s values of hard work, commitment to excellence in science and business and dedication to bringing novel, innovative and life changing medicines to patients in need. In my new role as Chairman, I look forward to working closely with Bill to create long-term value for our shareholders."

"On behalf of the entire Board of Directors, I want to thank Hervé for his unwavering service as Chairman and CEO of Incyte," continued Baker. "It was at Hervé’s request last Fall that the Board of Directors engaged in a thorough succession planning process that led us to today’s transition. Hervé’s leadership and vision have been invaluable over the past decade, growing Incyte into a leading, diversified company. Hervé joined Incyte in 2014 when it was a single product, U.S.-only company. During Hervé’s tenure, Incyte launched six novel medicines plus two new indications for Jakafi, expanded commercial operations into Europe, Japan and Canada and grew revenues from $355 million dollars in 2013 to $4.2 billion today. Hervé fostered a culture of innovation and collaboration that will carry on at Incyte. I would like to thank him for his hard work and dedication to the Company, which I expect will continue through the coming years, and wish him the best in his retirement."

"It has been a privilege to lead Incyte over the past eleven years," said Mr. Hoppenot. "Guided by our mission to Solve On. and relying on great science, together we have achieved remarkable success in our effort to address unmet medical needs. I am proud to retire at a time when Incyte has the strongest management team, internal R&D pipeline and commercial portfolio ever. With Bill’s leadership, I am confident that the Company will continue its legacy of delivering transformative solutions to patients for many years to come."

About Bill Meury

Bill Meury was formerly CEO of Anthos Therapeutic, a Blackstone Life Sciences portfolio company, which was acquired by Novartis in April 2025. Mr. Meury joined Anthos after leading Karuna Therapeutics, a biopharmaceutical company focused on neuroscience, until its merger with Bristol Meyers Squibb in March 2024. Prior to Karuna, he served as a Partner at Hildred Capital Management, a private equity firm focusing on healthcare products and services. Prior to Hildred Capital Management, he was Executive Vice President and Chief Commercial Officer at Allergan, until the time of its acquisition by AbbVie, where he had responsibility for over 50 products with $16 billion in revenue and over $3 billion in operating investment. In this role, he led multiple global divisions totaling approximately 8,000 employees, including marketing, sales, business development, marketing analytics, managed care and customer service. Mr. Meury has experience across a broad range of therapeutics areas and has been involved with over 20 U.S. Food and Drug Administration (FDA) approvals and new product launches. He also served as Allergan’s President, Branded Pharma and Executive Vice President, Commercial, North American Brands, and as Executive Vice President Commercial Operations, at Forest Laboratories prior to its acquisition by Allergan.

Mr. Meury currently serves on the board of directors of the Jed Foundation. He received his B.A. in Economics from the University of Maryland.

About Julian Baker

Julian Baker is Managing Partner of Baker Bros. Advisors LP ("BBA") a biotechnology-focused, long-term investment adviser. Mr. Baker founded BBA, together with his brother and Co-Managing Partner Dr. Felix Baker, in 2000. Prior to BBA, Mr. Baker and his brother were portfolio managers of a biotech-focused investment partnership at Tisch Financial Management from 1994 to 1999. Previously, Mr. Baker was employed from 1988 to 1993 by the private equity investment arm of Credit Suisse First Boston Corporation.

In addition to Incyte, Mr. Baker serves as Chairman of Madrigal Pharmaceuticals, Chairman of Denali Therapeutics and as a Director of Acadia Pharmaceuticals. Mr. Baker holds an A.B. Magna Cum Laude from Harvard University.

On June 26, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma (Press release, Bristol-Myers Squibb, JUN 26, 2025, View Source;Food-and-Drug-Administration-Approves-Streamlined-Patient-Monitoring-Requirements-and-Removal-of-REMS-Programs-within-Bristol-Myers-Squibbs-Cell-Therapy-Labels/default.aspx [SID1234654133]). These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved.

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Despite the transformative potential of cell therapy, only about 2 in 10 eligible patients receive it, due to the confluence of complex logistical and geographic barriers affecting patients and providers. BMS is committed to a long-term goal of expanding access to cell therapy and supports today’s class-wide label updates that will help ease known barriers to treatment and administration while maintaining patient safety.

Across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. These prolonged requirements posed burdens on healthcare delivery systems and for certain patients and their care partners, particularly those who live far from certified cell therapy treatment centers. The changes include:

Driving restrictions reduced from 8 weeks to 2 weeks post treatment
Requirement to stay within proximity of a healthcare facility following infusion reduced from 4 weeks to 2 weeks
"CAR T cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions and barriers that limit access," said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. "Today’s FDA-approved label updates reinforce BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy."

The FDA has also approved removal of the REMS requirement from each product label. A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies. The FDA has since determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies. This change is likely to help further accelerate cell therapy into the community center setting.

Together, these label updates reflect the growing body of clinical and real-world evidence underpinning the favorable efficacy and safety profile of CAR T cell therapy. To date, more than 30,000 patients have been treated with a CAR T cell therapy, with recent studies, including an analysis BMS presented earlier this month at the ASCO (Free ASCO Whitepaper) Annual Meeting, showing that the vast majority of serious adverse events (CRS and NTs) occur within the first two weeks of infusion.

Following this announcement, BMS will work closely with the more than 150 treatment centers currently approved to administer Breyanzi and Abecma to remove the REMS programs. In parallel, BMS is focused on rapidly expanding the geographic footprint of cell therapy, with a renewed effort to add community cancer centers nationwide to administer Breyanzi and Abecma closer to patients, helping further reduce travel time and duration of stay away from home, family and work.

"Living with blood cancer is challenging, but patients and their loved ones still need to maintain jobs, take care of families, and plan for the future," said Sally Werner, chief executive officer, Cancer Support Community. "Today’s announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy. We applaud any and all efforts to continue to break down barriers, reduce time burden on patients and caregivers, and increase uptake of this life-saving therapy."

As BMS continues to bring cell therapy to more patients, we are committed to working across the healthcare ecosystem to implement these label updates and continue to design and implement measurable programs to increase uptake and equitable access to cell therapy. For a list of programs and services currently offered to support patients through their BMS cell therapy journey, visit celltherapy360.com.

On June 26, 2025 CDR-Life Inc., a biotechnology company developing highly selective T cell engagers (TCEs) to treat cancer and autoimmune diseases, reported CDR609 as its next clinical candidate. CDR609 is a novel TCE targeting LGR5, a surface antigen that presents a compelling opportunity for broad, tumor-specific therapeutic intervention in solid tumors (Press release, CDR-Life, JUN 26, 2025, View Source [SID1234654149]).

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LGR5 is a challenging and largely underexploited target in cancer immunotherapy. Unlike most other highly cancer-specific targets, LGR5 is not HLA-restricted, allowing CDR609 to potentially reach a broad patient population. Its high tumor specificity, a critical requirement for the successful use of TCEs, and broad expression across multiple high-prevalence tumor types, including colorectal, gastric, liver and pancreatic cancers, position CDR609 as a differentiated and scalable therapeutic approach.

"CDR609 embodies the key elements of our T cell engager platform: precision, potency and safety," said Christian Leisner, Ph.D., CEO of CDR-Life. "By targeting LGR5, we’re advancing a first-in-class molecule that could unlock significant value for patients with tumors that are currently underserved by immunotherapy."

CDR609 is built on CDR-Life’s proprietary M-gager platform, which enables the development of TCEs that address highly challenging but clean tumor targets and thus designed to minimize off-tumor effects. The company plans to initiate IND-enabling studies in the second half of 2025. The M-gager format and platform are currently being validated in the clinic in the CDR404 Phase 1 program, which is recruiting patients whose tumors express the intracellular target MAGE-A4.

On June 26, 2025 The Australasian Gastro-Intestinal Trials Group ("AGITG"), the NHMRC Clinical Trials Centre at the University of Sydney, and Lisata Therapeutics, Inc ("Lisata", Nasdaq: LSTA), reported promising positive preliminary Cohort B data from the ASCEND Phase 2b trial (NCT05042128) in metastatic pancreatic cancer, with AGITG sponsoring the study and Lisata providing funding (Press release, Lisata Therapeutics, JUN 26, 2025, View Source [SID1234654134]). Dr. Andrew Dean, Study Chair, is scheduled to present these findings at the European Society for Medical Oncology ("ESMO") Gastrointestinal Cancers Congress in Barcelona, Spain, on 2 July, 2025.

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The ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial evaluating standard-of-care ("SoC") gemcitabine and nab-paclitaxel vs SoC plus certepetide or placebo in patients with metastatic pancreatic ductal adenocarcinoma ("mPDAC"). Participants were enrolled from 24 sites across Australia and Aotearoa New Zealand from May 2022 to December 2023. The study comprises two sequentially enrolled dosing regimens of either certepetide or placebo in combination with SoC. Cohort A employed one 3.2 mg/kg dose of certepetide administered as an IV push over 1 minute immediately after the infusion of gemcitabine and before the infusion of nab-paclitaxel. Cohort B mimicked the dosing regimen of Cohort A; however, it employed an additional dose of certepetide or placebo administered 4 hours after the initial dose.

As announced in January of this year, preliminary Cohort A data was presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. Those data showed a positive trend in overall survival, including four complete responses in the certepetide-treated group compared to none in the placebo-treated group.

The preliminary data from Cohort B demonstrate a six-month progression-free survival ("6MPFS") of 60.8% for the certepetide-treated group, whereas the 6MPFS in the placebo-treated group was 25%. Median progression-free survival ("mPFS") was 7.5 months for the certepetide-treated group and 4.7 months for the placebo-treated group. Objective response rate ("ORR") was 45.2% for the certepetide-treated group and 19% for the placebo-treated group. Median overall survival ("mOS") was 10.32 months for the certepetide-treated group compared to 9.23 months for the placebo-treated group.

A comparison of data from Cohort A and Cohort B indicates that the addition of two doses of certepetide (Cohort B regimen) to SoC chemotherapy resulted in a clinically meaningful improvement in both PFS and ORR for patients with mPDAC. These clinically significant findings provide compelling support for the continued and expedited investigation of certepetide as a novel therapeutic agent for the treatment of metastatic pancreatic cancer.

Final data and key findings from both cohorts of the ASCEND study are anticipated to be available later this year, with more information to follow as it becomes available.

"We are pleased with the promising Cohort B data of the ASCEND trial. These data, taken with those previously reported for Cohort A, reinforce our confidence in the therapeutic promise of certepetide. Along with its attractive safety profile, we continue to believe that certepetide has the potential to transform the treatment landscape for mPDAC and many other devastating solid tumors", stated David J. Mazzo, PhD, President and Chief Executive Officer of Lisata.

Pancreatic cancer has one of the poorest prognoses among cancers, ranking as the 6th leading cause of cancer mortality worldwide1. In Australia, pancreatic cancer is the 3rd leading cause of cancer-related deaths2. With a five-year survival rate of just 13%, there is a considerable need for new treatment options.

Dr. Dean commented, "The data from ASCEND provides us with critical new knowledge that will significantly enhance our understanding of how to optimally treat patients battling pancreatic cancer. We are excited by the evidence of certepetide’s therapeutic effect and encourage the continued development of this potentially treatment paradigm-changing compound."

We thank the Gut Cancer Foundation for providing funding for trial sites in Aotearoa New Zealand.

1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229–63.
2. Australian Institute of Health and Welfare (2024) Cancer data in Australia, AIHW, Australian Government, accessed 13 May 2025.

About Certepetide
Certepetide (formerly LSTA1), an internalizing RGD (arginylglycylaspartic acid or iRGD), cyclic peptide product candidate, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Certepetide actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. Certepetide also has been shown to modify the tumor microenvironment resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, certepetide has also demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Lisata is exploring the potential of certepetide to enable a variety of treatment modalities to treat a range of solid tumors more effectively. Certepetide has been awarded Fast Track designation (U.S.) and Orphan Drug Designation for pancreatic cancer (U.S. and E.U.) as well as Orphan Drug Designation for glioma (U.S.) and osteosarcoma (U.S.). Additionally, certepetide has received Rare Pediatric Disease Designation for osteosarcoma (U.S.).