On June 1, 2026 Foundation Medicine, Inc., a global, patient-focused precision medicine company, reported that it has received approvals from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx and FoundationOneLiquid CDx to be used as companion diagnostics for Pfizer’s TALZENNA (talazoparib) in combination with XTANDI (enzalutamide) to identify patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). TALZENNA is first and only PARP inhibitor approved for use with an existing standard of care (XTANDI) for adult patients with both BRCA mutated and non-BRCA HRR gene-mutated mCRPC.

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Prostate cancer is the second most common cancer in men, with approximately 1 in 8 diagnosed during their lifetime.2 mCRPC occurs when prostate cancer grows and spreads to other parts of the body despite hormone therapy that lowers testosterone. HRR gene mutations are present in approximately 20-30% of patients with mCRPC.3 While treatment options have expanded in recent years, patients with mCRPC often continue to face poor prognosis and limited treatment options.4

"Every patient deserves clear, personalized answers when it comes to their treatment plan, but one-size-fits all approaches do not work for everyone. As more targeted therapies become available to treat mCRPC, it is incredibly important to have high-quality tissue- and blood-based companion diagnostics available to best inform personalized treatment plans for each unique patient," said Todd Druley, M.D., Ph.D., Chief Medical Officer at Foundation Medicine. "These two approvals further strengthen Foundation Medicine’s leadership in companion diagnostics and underscore the critical role of comprehensive genomic profiling in connecting patients with targeted treatment options."

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests.5 With this most recent approval, Foundation Medicine has nine FDA-approved companion diagnostic indications for prostate cancer, and over 100 approved CDx indications in total, three times more than any other comprehensive genomic profiling company.1,6

"Too many prostate cancer patients still can’t access the biomarker tests that should guide their treatment, not because the tests don’t exist, but because access isn’t consistent or equitable," said Courtney Bugler, President and CEO of ZERO Prostate Cancer. "Biomarker testing gives patients and their families the clarity they need to understand their diagnosis and make informed decisions about care. Every person deserves access to personalized treatment information, regardless of their doctor, their diagnosis, or their ZIP code."

(Press release, Foundation Medicine, JUN 1, 2026, View Source [SID1234666346])

On June 1, 2026 Sumitomo Pharma America, Inc. (SMPA) reported clinical data from its ongoing first-in-human Phase 1/2 trial of SMP-3124LP (NCT06526819). SMP-3124LP is a structurally distinct, investigational, selective checkpoint kinase 1 (CHK1) inhibitor delivered via a PEGylated liposome formulation. Designed with the specific goal of treating malignancies characterized by high replication stress, these findings were presented as a poster at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"Historically, the development of CHK1 inhibitors has been hampered by significant low blood counts and a narrow therapeutic window, which has limited their clinical utility for patients," said Timothy A. Yap, MBBS, PhD, Professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and lead investigator of the study. "By using this liposomal delivery method, we are attempting to address the primary obstacles that have previously stalled the CHK1 inhibitor mechanism of action. For patients who have already navigated multiple lines of therapy, this approach may offer the potential for meaningful clinical benefit and disease control without the overwhelming burden of side effects common to older therapies."

Encouraging antitumor activity in heavily pretreated malignancies
The phase 1 part of the study enrolled 61 patients with selected advanced solid tumors across four intravenous (IV) doses: 20, 40, 60, and 90 mg/m2 given every two weeks. The study population was heavily pretreated, with 37.7% of participants treated with more than four prior lines of therapy. SMP-3124LP demonstrated promising signals of antitumor activity (as of April 03, 2026.)

Among the 56 efficacy-evaluable patients, the study reported a 48.2% disease control rate (DCR). This included five RECIST v1.1 partial responses (PR) and 22 patients with stable disease (SD). The clinical significance of these results is underscored by responses in difficult-to-treat cancers. Partial responses were observed in 2 patients with platinum-resistant ovarian cancer (PROC), 2 with squamous cell carcinoma of the anus (SCCA), and 1 with colorectal cancer harboring an FBXW7 mutation (this mutation is linked to poorer outcomes). Furthermore, 2 additional PROC patients achieved stable disease with tumor shrinkage of 20% or more, including one patient who experienced a -88% cancer antigen-125 (CA-125) response.

Preliminary results show liposomal delivery widened the therapeutic window with a manageable safety profile
The Phase 1/2 results show that SMP-3124LP was generally well tolerated with a manageable safety profile. No dose-limiting toxicities (DLTs) were observed at the lower dose levels of 20 or 40 mg/m2. While DLTs including Grade 4 thrombocytopenia and Grade 3 febrile neutropenia were noted at higher doses (60 and 90 mg/m2), the blood-related side effects (low blood counts) were generally transient and did not lead to any treatment discontinuations.

These findings suggest the liposomal delivery system may minimize drug exposure to healthy tissues while optimizing delivery to tumors. Infusion-related reactions (IRR), reported in 41% of patients, were all Grade 1/2 and manageable through standard supportive care or adjusted infusion rates. Additionally, pharmacokinetic data validated the therapeutic approach, long half-life (24-28 hr), and low volume of distribution (2.00-2.67 L) are consistent with liposomal formulation. Dose-proportional increases in exposure were observed across all levels tested.

"We are proud to present our first-in-human data for SMP-3124LP at ASCO (Free ASCO Whitepaper)—where the most rigorous advancements in oncology are shared—as it reinforces our focus on addressing some of the most persistent challenges in cancer treatment," said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA.

"With SMP-3124LP, we are developing a technology platform at SMPA based on liposomal delivery of targeted therapies in an effort to maximize the therapeutic window and minimize toxicities," said Jatin Shah, M.D., Chief Medical Officer, Oncology, SMPA. "These are the first data in this first-in-human study of SMP-3124 where we have demonstrated the potential ability to deliver selective CHK1 inhibition with less myelosuppression, which has been the major AE limiting the ability to target CHK1 directly to the tumor while sparing the patient’s healthy cells. These data are a reflection of our efforts toward realizing sustainable and effective therapeutic options for those facing the complexities of difficult-to-treat cancers, including advanced solid tumors."

CHK1 is an essential enzyme in the DNA damage response pathway that helps cancer cells repair their DNA to survive under high replication stress. While blocking CHK1 has long been a goal for oncologists, prior inhibitors were often toxic to healthy bone marrow, limiting their clinical utility. SMP-3124LP seeks to overcome this hurdle by using liposomal technology to widen the therapeutic window (the gap between an effective dose and a toxic one). This advancement may potentially unlock CHK1 inhibition for patients with few remaining treatment options.

Presentation Details

Abstract Number: 3081
Abstract title: First data disclosure from the first-in-human phase 1/2 trial of SMP-3124LP, the first investigational pegylated liposome CHK1 inhibitor, in patients with selected advanced solid tumors
Session title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
About SMP-3124LP
SMP-3124LP is a structurally distinct, investigational, selective checkpoint kinase 1 (CHK1) inhibitor delivered via a PEGylated liposome formulation. CHK1 is a key regulator of the DNA damage response; SMP-3124LP is designed with the goal of inhibiting this protein to induce DNA damage and promote apoptosis (cell death) in cancer cells with high replication stress. The use of liposomal technology may potentially widen the therapeutic window by maximizing drug delivery to tumors while minimizing exposure to healthy tissues, potentially reducing treatment emergent adverse events (TEAEs).

(Press release, Sumitomo Pharmaceuticals, JUN 1, 2026, View Source [SID1234666345])

On June 1, 2026 Qurient Co., Ltd. (KRX: 115180) reported that the first patient has been dosed in a Phase 2 clinical study evaluating mocaciclib (Q901) in combination with fulvestrant for treatment of hormone receptor-positive (HR+) breast cancer. The trial specifically targets patients who have stopped responding to prior treatments containing CDK4/6 inhibitors. Mocaciclib is a highly selective and potent covalent inhibitor of cyclin-dependent kinase 7 (CDK7), developed to address significant unmet medical needs in advanced solid tumors, including treatment-resistant breast cancer.

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The dosing of the first patient with CDK4/6 inhibitor-resistant HR+ breast cancer marks a significant milestone in development of mocaciclib as a new therapeutic option. While CDK4/6 inhibitors combined with endocrine therapy have proven highly effective for treatment of HR-positive, HER2-negative metastatic breast cancer, many patients eventually experience disease progression due to innate non-responsiveness or acquired resistance. Mocaciclib is being investigated as a targeted solution to overcome the refractory conditions through cell cycle control and transcriptional regulation of key refractory mechanisms, such as PTEN-PI3K/AKT pathway activation.

"Dosing the first HR-positive breast cancer patient with mocaciclib is an important step forward in our mission to provide new therapeutic options for patients who have exhausted standard-of-care treatments," said Kiyean Nam, Ph.D., Chief Executive Officer of Qurient. "Because of its unique mechanism of action in cell cycle control and transcriptional regulation, mocaciclib holds promise for patients whose tumors have developed bypass mechanisms to evade CDK4/6 inhibition. We are highly encouraged by our latest findings in CDK7 biology and look forward to translating this science into meaningful clinical outcomes."

Mechanism of Action Rationale in HR+ Breast Cancer

Mocaciclib (Q901) provides a novel therapeutic strategy for HR+ breast cancer by targeting CDK7, a dual-function kinase essential for both cell cycle progression and transcriptional regulation:

Master Regulation of the Cell Cycle (CAK Inhibition): CDK7 acts as the CDK-activating kinase (CAK), responsible for phosphorylating the T-loop of other key cell cycle kinases, including CDK1, CDK2, CDK4, and CDK6. In HR+ breast cancer, resistance to CDK4/6 inhibitors frequently occurs through the loss of retinoblastoma (RB) protein function or the over-activation of the Cyclin E-CDK2 axis. This allows cancer cells to bypass the CDK4/6 blockade and re-enter the S-phase of division. By potently inhibiting CDK7, mocaciclib suppresses the activation of CDK2 and other downstream kinases, effectively shutting down these alternative escape routes and halting tumor proliferation.
Targeted Transcriptional Repression: Beyond cell cycle control, CDK7 is a core component of the transcription factor II H (TFIIH) complex. Mocaciclib selectively disrupts the transcription of heavily relied-upon oncogenic transcription factors (such as MYC and E2F) and suppresses the expression of genes that are activated by the PTEN-PI3K/AKT pathway, effectively neutralizing another mechanism of CDK4/6 inhibitor resistance.
About Mocaciclib (Q901)

Mocaciclib (Q901) is an intravenously administered, highly selective covalent CDK7 inhibitor currently advancing through Phase 1/2 clinical trials (NCT05394103). In addition to its potential as a monotherapy in HR+ breast cancer and other advanced solid tumors, mocaciclib has demonstrated profound synergy in preclinical models when used in combination with Topoisomerase 1 inhibitor-based antibody-drug conjugates (TOP1i-ADCs) and immune checkpoint inhibitors.

(Press release, Qurient Therapeutics, JUN 1, 2026, View Source [SID1234666344])

On June 1, 2026 Foundation Medicine, Inc., a global, patient-focused precision medicine company, and SWOG Clinical Trials Partnerships (SWOG CTP) reported a strategic partnership to advance biomarker-driven research and clinical trials, marking the first collaboration of this nature with a diagnostic company. This partnership builds upon Foundation Medicine’s decade-long collaboration with SWOG Cancer Research Network through the Lung Cancer Master Protocol (Lung-MAP) trial, a multi-drug, multi-arm, biomarker-driven clinical trial for patients with lung cancer.

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Foundation Medicine will bring its genomic testing capabilities and extensive expertise as a global leader in companion diagnostic (CDx) approvals, with 100 approved CDx indications, the most of any comprehensive genomic profiling company.1 SWOG CTP’s network of investigators and committees at over 1,300 sites in 47 states, including community hospitals, academic medical centers and National Cancer Institute-designated clinical cancer centers, can collaborate with Foundation Medicine on initiatives including multi-arm platform trials and registrational studies that may lead to future CDx applications. Trials can leverage Foundation Medicine’s robust portfolio of high-quality tests and robust solutions designed for biopharmaceutical partners to support protocol design and uncover multi-omic insights in oncology.

"SWOG CTP shares our commitment to advancing precision oncology by pursuing scientifically rigorous, cutting-edge biomarker-driven research," said Todd Druley, M.D, Ph.D., chief medical officer at Foundation Medicine. "By bringing Foundation Medicine’s deep scientific, regulatory and genomic expertise to SWOG CTP and its broad investigator community, we can help accelerate new breakthroughs in biomarker-driven medicine, moving from discovery to impacting patient care in the clinic with speed and clarity."

"SWOG CTP offers access to an extensive network of sites nationwide and the opportunity to move biomarker-driven science closer to the people who need it most," said Kathy S. Albain, M.D., SWOG vice chair for Clinical Trials Partnerships. "This formalized partnership marks an exciting step forward – one we believe will drive the translation of promising research into meaningful options for patients."

(Press release, Foundation Medicine, JUN 1, 2026, View Source [SID1234666343])

On June 1, 2026 Waypoint Bio, an AI-native biotech company using spatial biology to design next-generation CAR T therapies for solid tumors, reported that it closed a $20M Series A financing round.

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The financing was led by Amplify Partners and Elliot Hershberg will join the board of directors. General Catalyst, Time BioVentures, Mitsui Global Investments, and Lux Capital participated in the round, alongside existing investors including Hummingbird Ventures.

The Series A will fund advancement of Waypoint’s WAY-103 program into an investigator-initiated trial beginning in late 2026. Additionally, Waypoint will expand its AI and spatial biology platform and the buildout of its clinical development capabilities. Dr. Patrick Kaifosh, previously co-founder and Chief Scientific Officer of the neuro-AI startup CTRL-Labs and Senior Director at Meta’s Reality Labs, has joined as CTO, strengthening Waypoint’s leadership in AI and automation. Dr. Kristen Hege, formerly Senior Vice President, Early Clinical Development, Hematology/Oncology & Cell Therapy at Bristol-Myers Squibb, has joined the Scientific Advisory Board.

Waypoint Bio is developing next-generation in vivo CAR T therapeutics using a platform that integrates AI, computer vision, and spatial pooled screening. WAY-103, its lead program for gastric & pancreatic solid tumors, demonstrates greater than 15-fold improved potency in animal models compared to multiple clinical benchmarks, alongside reduced on-target/off-tumor toxicity. The construct was discovered and optimized through pooled head-to-head screens with spatially resolved readouts measuring how each candidate interacts with the tumor microenvironment. This creates a rich data layer for identifying first-in-class and best-in-class programs before committing to costly clinical development, while also generating the feedback needed to improve the next generation of AI models.

Waypoint is pairing its discovery engine with a clinical development strategy designed to rapidly validate their programs in clinical studies. "AI is incredibly powerful at exploring complicated search spaces, but predictions are easy, actual rigorous validation is limiting. What matters now is knowing which ideas translate to human biology and clinical success," said Xinchen Wang, co-founder and CEO of Waypoint Bio. "We built Waypoint to design therapeutic candidates with AI, evaluate them with spatially informed screening, and advance multiple of the strongest programs rapidly into the clinic. Our goal is not to produce more preclinical hits that look good in mice. It’s to also leverage capital efficient first-in-human studies to produce differentiated medicines that can lead their categories."

"Spatial biology has really picked up over the past few years because you can finally measure how your therapeutic candidates affect different local environments and cell-cell interactions," said David Phizicky, co-founder and CSO of Waypoint Bio. "This is critical for most complex diseases and especially solid tumors, where immunosuppressive signaling and infiltration barriers can’t be captured by simple readouts like tumor size – and we have a way to screen at-scale for these spatial phenotypes. We’re solving not only for the T cell biology, but also interactions within the tumor microenvironment, and how the in vivo delivery vector affects all of this."

Waypoint is also advancing their WAY-200 for colorectal cancer into the clinic with this round of funding, alongside preclinical development of a deeper pipeline of in vivo CAR T constructs for other solid tumors. The platform is also being used to build proprietary next-generation lentiviral vectors engineered to be superior to current in vivo delivery systems.

"As AI models become better at generating ideas, the scarce resource is experimental systems that tell you which designs actually matter," said Elliot Hershberg, Partner at Amplify Partners. "Waypoint combines AI-generated assets with spatially resolved in vivo evaluation and a path to rapid clinical readouts. We think that combination compounds over time."

(Press release, Waypoint Bio, JUN 1, 2026, View Source [SID1234666342])