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])

On June 1, 2026 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; "Ono") reported the results of the phase 2 clinical study (ONO-4578-08 study) of the EP4 antagonist ONO-4578 in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer). The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting.

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In this study, patients received ONO-4578 in combination with the anti–PD-1 antibody nivolumab (OPDIVO) and chemotherapy or placebo in combination with OPDIVO and chemotherapy. The ONO-4578 group demonstrated a statistically significant improvement of PFS compared to the placebo with a median PFS of 9.0 months in the ONO-4578 group and 6.9 months in the placebo group (HR, 0.67; 90% CI, 0.48–0.92; P = 0.040). The ONO-4578 group also showed improvements in overall survival (OS) and objective response rate (ORR). Median OS was not reached in the ONO-4578 combination group and 12.7 months in the placebo combination group (HR, 0.60; 95% CI, 0.37–0.96). ORR was 62.0% and 48.7%, respectively (odds ratio, 1.72; 95% CI, 0.98–3.00).

Clinical benefit was more pronounced in patients with PD-L1 CPS ≥1. In this subgroup, the median PFS was 9.9 months in the ONO-4578 combination group versus 5.7 months in the placebo combination group (HR, 0.52; 95% CI, 0.34–0.79), median OS was not reached versus 12.7 months (HR, 0.44; 95% CI, 0.26–0.77), and ORR was 70.9% versus 50.9% (odds ratio, 2.36; 95% CI, 1.22–4.54), respectively. No new safety signals were identified. These results suggest that ONO-4578 may provide additional clinical benefit when added to standard therapy with an anti–PD-1 antibody and chemotherapy in this previously untreated patient population.

Based on these findings, Ono and its affiliate company, Deciphera, plan to initiate a pivotal phase 3 clinical study.

About ONO-4578-08 study

ONO-4578-08 study is a multicenter, randomized phase 2 clinical trial conducted in Japan, South Korea, and Taiwan in patients with previously untreated, HER2-negative unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer. ONO-4578 in combination with OPDIVO and chemotherapy (S-1 + oxaliplatin or capecitabine + oxaliplatin) was compared with placebo in combination with OPDIVO and chemotherapy. Patients received 40 mg of ONO-4578 once daily and 360 mg of OPDIVO every 3 weeks in combination with chemotherapy until disease progression or unacceptable toxicity occurred. The primary endpoint was PFS.

About Gastric cancer

Approximately 126,000 new cases of gastric cancer are diagnosed annually in Japan1 and 968,000 worldwide,2 with approximately 43,000 deaths in Japan1 and 660,000 worldwide.2 Gastric cancer is the third most common type of cancer following colorectal cancer and lung cancer in Japan. Combination therapies with anti–PD-1 antibody and chemotherapy is a standard first-line treatment for HER2-negative unresectable advanced or recurrent gastric cancer. However, gastric cancer remains incurable, and a new treatment option is needed.

About ONO-4578

ONO-4578 is a selective, oral antagonist of EP4, a receptor for prostaglandin E2 (PGE2), developed by Ono. PGE2, produced by cancer cells, suppresses the action of cancer immunity through EP4 receptors expressed on various immune cells.3-5 ONO-4578 is designed to exert antitumor effect by suppressing EP4-mediated effect of PGE2 and by restoring cancer immunity.6 In a phase 1 clinical study in patients with unresectable advanced or recurrent gastric cancer (including gastroesophageal junction cancer) after the third- or later-line treatment, a combination therapy with ONO-4578 and OPDIVO showed antitumor effect and a manageable safety profile.7 Currently, Ono is conducting several clinical studies of ONO-4578, including a global phase 2 clinical study in patients with colorectal cancer.

(Press release, Ono, JUN 1, 2026, View Source [SID1234666341])

On June 1, 2026 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with established laboratory services and therapeutic development businesses, reported it presented updated data in the Head and Neck Cancer Track during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting Rapid Oral Abstract Session, scheduled from 4:30 p.m. to 6:00 p.m. CDT in Hall D1 at McCormick Place in Chicago.

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The abstract, entitled "FID-007 in combination with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), Abstract #6020," will present updated preliminary data from the Company’s open-label, randomized Phase 2 study (NCT06332092). The study is evaluating the efficacy of two dosing regimens and characterizing the pharmacokinetics, safety, and tolerability of FID-007 in combination with cetuximab in patients whose disease progressed following PD-1 based immune checkpoint inhibitor therapy. As of the April 16, 2026, data cutoff, FID-007 demonstrated meaningful clinical activity and a manageable safety profile in combination with cetuximab in this target patient population.

The presentation slides with updated data will be available on Fulgent’s investor relations website at the conclusion of the presentation on June 1, 2026.

Dr. Guilherme Rabinowits, one of the study’s Principal Investigators and a Senior Member in the Department of Head and Neck-Endocrine Oncology at Moffitt Cancer Center, said: "Patients with R/M HNSCC who progress after anti PD-1 based therapy lack an established, best second-line standard of care. In this setting, preliminary data showed encouraging clinical activity and a manageable safety profile for FID-007 in combination with cetuximab. The objective response rate was 61.9%, median progression-free survival was 6.7 months, median duration of response was 7.4 months, and one-year overall survival was 63.4%. Additionally, this combination showed activity in both human papilloma virus-related and -unrelated head and neck squamous cell carcinoma." A Phase 3 study is planned.

(Press release, Fulgent Genetics, JUN 1, 2026, View Source [SID1234666340])