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 Amgen (NASDAQ:AMGN) reported that the European Commission (EC) has granted marketing authorization for IMDYLLTRA (tarlatamab) as a monotherapy to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy.

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The approval was based on results from DeLLphi-304, the first global Phase 3 trial to demonstrate a significant survival benefit over chemotherapy in this setting.1

"Small cell lung cancer is one of the most aggressive solid tumors, with high rates of relapse following first-line treatment and limited treatment options," said Jean-Charles Soria, senior vice president of Oncology at Amgen. "The European Commission’s approval of IMDYLLTRA, the first and only T-cell engager therapy approved to treat small cell lung cancer, marks an important step forward for patients in Europe and reflects our commitment to advancing innovative medicines that can meaningfully improve outcomes for people living with this devastating disease."

DeLLphi-304, the global Phase 3 clinical trial, demonstrated that IMDYLLTRA reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care (SOC) chemotherapy as a treatment for patients with ES-SCLC who progressed on or after one line of platinum-based chemotherapy (median OS: 13.6 vs. 8.3 months; hazard ratio (HR), 0.60; 95% confidence interval (CI): 0.47, 0.77; P < 0.001).1

"Patients with small cell lung cancer have historically faced a hard road when they progress after initial treatment, surviving only a few months," said Debra Montague, president, Lung Cancer Europe (LuCE). "Approval of a novel treatment option for people in Europe living with this challenging cancer represents meaningful progress and underscores the urgent need for innovation in lung cancer care."

The safety profile for IMDYLLTRA was consistent with its known profile. The most common adverse reactions were cytokine release syndrome (CRS) (56.7%), decreased appetite (36.4%), pyrexia (31.9%), dysgeusia (31.3%), constipation (30.4%), anaemia (30.0%), fatigue (29.8%), nausea (24.9%), asthenia (19.0%), neutropenia (16.9%), hyponatraemia (16.7%), headache (16.3%) and lymphopenia (15.6%). The most common serious adverse reactions were CRS (19.7%) and pyrexia (4.7%).

CRS primarily occurred after the first two doses. As reflected in the Summary of Product Characteristics (SmPC), patients should be monitored from the start of the IMDYLLTRA infusion for 6 to 8 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting.2

Amgen’s robust IMDYLLTRA clinical development program includes the DeLLphi clinical trials, which evaluate IMDYLLTRA as a monotherapy and as part of combination regimens, including in both earlier stages of SCLC and earlier lines of treatment.

About the Phase 3 DeLLphi-304 Study
DeLLphi-304 is a global Phase 3, randomized, controlled, open-label clinical trial evaluating the efficacy and safety of IMDYLLTRA as a treatment for patients living with SCLC who progressed on or after one platinum-based chemotherapy regimen. Five hundred and nine patients were randomized to receive either IMDYLLTRA or local standard of care chemotherapy (topotecan in all countries except Japan; lurbinectedin in the U.S., Canada, Australia, Singapore, South Korea; and amrubicin in Japan). The primary outcome measure of the trial is OS. Key secondary outcome measures include progression-free survival (PFS) and patient-reported outcomes (PROs) including disease-related symptoms, physical function, and quality of life.3 Results from DeLLphi-304 were reviewed as a late-breaking presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.1,4

About IMDELLTRA/IMDYLLTRA (tarlatamab)
IMDYLLTRA is a first-in-class targeted immunotherapy engineered by Amgen researchers to bind to both DLL3 on tumor cells and CD3 on T cells, thereby activating T cells to kill DLL3-expressing SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell. 5,6 DLL3 is a protein that is expressed on the surface of SCLC cells in up to 96% of patients with SCLC, but is minimally expressed on healthy cells, making it an exciting target.7,8

About Small Cell Lung Cancer (SCLC)  
SCLC is one of the most aggressive and devastating forms of solid tumor cancer. Each year, SCLC accounts for approximately 13-15% of more than 2.4 million cases of lung cancer diagnosed worldwide.9-11 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options.10

About Tarlatamab Clinical Trials
Tarlatamab is being investigated in multiple studies including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with SOC therapies in first-line ES-SCLC; DeLLphi-305, a randomized Phase 3 study comparing tarlatamab in combination with durvalumab vs. durvalumab alone in first-line ES-SCLC in the maintenance setting; DeLLphi-306, a randomized placebo-controlled Phase 3 study of tarlatamab following concurrent chemoradiotherapy in limited-stage SCLC; DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab in second-line or later ES-SCLC; DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens with tarlatamab in second-line ES-SCLC; DeLLphi-310, a Phase 1b study of tarlatamab in combination with YL201, a B7-H3 targeting antibody drug conjugate, with or without anti-programmed death ligand 1 (PD-L1) in patients with ES-SCLC; DeLLphi-311, a Phase 1b study of tarlatamab in combination with etakafusp alfa (AB248), a novel CD8+ T-cell selective interleukin-2 (IL-2), in patients with ES-SCLC; DeLLphi-312, a randomized Phase 3 study evaluating tarlatamab in combination with carboplatin, etoposide and durvalumab as an induction and maintenance therapy in first-line treatment of ES-SCLC; and DeLLphi-313, a Phase 1b study of tarlatamab in combination with zocilurtatug pelitecan, a DLL3 targeting antibody drug conjugate, with and without a PD-L1 inhibitor in patients with ES-SCLC.12

For more information, please visit www.tarlatamabclinicaltrials.com.

(Press release, Amgen, JUN 1, 2026, View Source [SID1234666296])

On June 1, 2026 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies to treat cancer, and Simcere Zaiming Pharmaceutical Co., Ltd., (Simcere Zaiming) an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), reported the presentation of positive Phase 1 dose escalation data for SIM0505 at the American Society for Clinical Oncology (ASCO 2026) in Chicago, IL (poster #246). SIM0505 is an investigational antibody drug conjugate (ADC) targeting Cadherin-6 (CDH6) with a proprietary topoisomerase 1 inhibitor (TOPOi) payload. NextCure plans to host a virtual KOL Event on Tuesday, June 2, 2026 (register here) to review these data.

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Platinum-resistant ovarian cancer (PROC) and uterine serous carcinoma (USC) represent two of the most challenging gynecologic malignancies. In PROC, once platinum resistance develops, response rates to available therapies drop to as low as 10–25%, with a median overall survival of approximately 11 months. USC, while accounting for only 10% of uterine cancers, is responsible for about 40% of uterine cancer deaths, with 5-year survival falling to 33% in advanced-stage disease. Taken together, these two cancers represent a persistent and significant unmet need for more effective treatment options.1-3

The Phase 1 dose escalation study (NCT06792552) evaluated SIM0505 in 59 heavily pre-treated cancer patients, with a data cutoff of April 07, 2026. Patients in the U.S. (n=25) and China (n=34) received SIM0505 at doses ranging from 1.6 mg/kg to 9.6 mg/kg, regardless of CDH6 expression.

Positive efficacy data were observed, with an objective response rate (ORR) of:

● 55% (11/20) for gynecologic cancers (ovarian cancer and USC)
● 52.9% (9/17) for ovarian cancer
● 66.7% (2/3) for USC
● Responses were observed across a range of CDH6 expression
ORRs, above, are reported for patients within therapeutic dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with partial response (PR), there was one unconfirmed PR and one PR pending confirmation at next follow-up scan.

"Positive Phase 1 data presented at ASCO (Free ASCO Whitepaper) 2026 validate our conviction in SIM0505 as a potential best-in-class CDH6-directed therapy for gynecologic cancers. Meaningful response rates at 12 weeks, alongside a manageable safety profile, give us strong confidence in this program and reinforce our enthusiasm for the ongoing dose optimization study. We believe SIM0505 has broad potential in gynecologic cancers and beyond, and these data put us on a solid track toward pivotal studies and our goal of bringing this treatment to patients," said Michael Richman, President and CEO of NextCure.

"Data presented at ASCO (Free ASCO Whitepaper) 2026 underscore the promise of our ADC platform and SIM0505, purpose-designed to deliver better efficacy, safety and tolerability, combining a carefully selected EC1 CDH6 epitope with our proprietary CPT116 topoisomerase payload. These results validate the science behind the SIM0505 construct and the accelerating pace of the global development program. Together with our partner, we remain deeply committed to advancing innovative medicines for patients facing hard-to-treat cancers," said Renhong Tang, PhD, CEO of Simcere Zaiming.

"Treatment of gynecologic cancers has advanced meaningfully in recent years, yet the need for safer and more effective treatments remains real. CDH6 is an attractive target given its expression across ovarian, uterine, and other solid tumors. ADCs directed at this target have the potential to deliver the deeper, more durable responses these patients need. The early response rates observed for SIM0505 at ASCO (Free ASCO Whitepaper) 2026 are encouraging, and I believe the safety profile is manageable in routine clinical practice. I am enthusiastic about this program and its potential to advance the standard of care in gynecologic cancers," said Udayan Guha, MD, PhD, Chief Medical Officer of NextCure.

ASCO Poster Overview: "Phase 1, multicenter, first-in-human (FIH) global study of SIM0505, an anti-CDH6 (CDH6) antibody-drug-conjugate (ADC) in patients with advanced solid tumors"

Table 1: Study Subject Overview:

All Patients

Baseline Characteristics

(n=59)

Age, years: median (range)

58 (42-78)

Sex, %: Male/Female

3.4%/96.6%

Race, n (%)

Asian

34 (57.6%)

Black or African American

3 (5.1%)

White

20 (33.9%)

Other

2 (3.4%)

Tumor Type, n (%)

Ovarian

46 (78.0%)

USC/other endometrial

10 (16.9%)

Renal cell carcinoma (RCC)

3 (5.1%)

ECOG performance status, n (%)

0

16 (27.1%)

1

43 (72.9%)

Prior systemic anti-cancer regimen: median (range)

5 (1-12)

Table 2: Efficacy Overview:

Patient Group

ORR*

All gynecologic patients (n=20)

55% (11/20)

• Ovarian cancer (n=17)

52.9% (9/17)

• USC (n=3)

66.7% (2/3)

*Reported for patients within therapeutic SIM0505 dose cohorts of 4.8 – 8.0 mg/kg who had a minimum 12 weeks of follow-up at the April 7, 2026 data cut-off, and were determined by best response according to RECIST 1.1 criteria. Of the nine (9) ovarian patients with PR, there was one unconfirmed PR and one PR pending confirmation at next follow-up scan.

Overall safety: Favorable overall data, potentially manageable in routine practice setting (n=59):

● Grade 1 and 2 treatment emergent adverse events (TEAEs) predominantly hematological, nausea and vomiting
● Grade 3 and 4 TEAEs predominantly hematological and manageable without primary prophylaxis for hematological toxicities
● Treatment related adverse events (TRAEs) requiring dose discontinuation: n=3
A full copy of the poster will be available on the NextCure website under the Investor Relations "Events & Presentations" tab following the presentation.

Virtual KOL Event

NextCure will host a virtual KOL Event to discuss the ASCO (Free ASCO Whitepaper) 2026 data.

● Date: June 2, 2026
● Time: 8:00 AM ET
● Registration Link: Click here
A replay of the webinar will be accessible on the Events page of the NextCure website for 90 days.

About SIM0505

SIM0505 is a novel ADC directed to CDH6, featuring a proprietary TOPOi payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer, with an emphasis on PROC. The U.S. Food and Drug Administration granted Fast Track Designation to SIM0505 for the treatment of PROC. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming.

About the Phase 1 Trial of SIM0505

SIM0505 is being evaluated in a global Phase 1 open-label, multicenter study (NCT06792552) with sites in the U.S. and China. The Phase 1 dose escalation segment has evaluated SIM0505, at dose levels from 1.6 mg/kg to 9.6 mg/kg, in heavily pre-treated cancer patients with solid tumors including gynecologic cancers and renal cell carcinoma. As of the April 7, 2026 data cutoff, 59 patients were enrolled without preselection for CDH6 expression. Follow-up is ongoing.

In May 2026, NextCure initiated a Phase 1 dose optimization segment in gynecologic cancers, initially focusing on patients with PROC. The global study is expected to enroll up to 120 patients, with initial doses of 5.6, 6.4 and 7.2 mg/kg, at sites in the U.S., Canada, the EU and China.

About Ovarian Cancer4-8

Ovarian cancer is the fifth leading cause of cancer-related death among women. It is characterized by vague, easily overlooked symptoms like bloating, pelvic pain, and frequent urination that often go undetected until late stage. Risk factors include age, family history, BRCA1/2 mutations, and hormone therapy use. The median age at diagnosis is 63, and the overall 5-year relative survival rate is 51.6% — though early-stage diagnosis carries a 5-year survival rate of 91.7%. As of 2022, an estimated 244,000 women were living with ovarian cancer in the United States.

About Uterine Serous Cancer2

Uterine serous carcinoma is a rare but highly aggressive subtype of endometrial cancer, accounting for approximately 10% of uterine cancers and about 40% of uterine cancer deaths. It typically arises in postmenopausal women, with abnormal or postmenopausal bleeding as the most common presenting symptom. Risk factors include advancing age, a history of breast cancer, tamoxifen use, and hereditary breast-ovarian cancer syndrome. More than half of patients present with stage III or IV disease at diagnosis, contributing to its disproportionate mortality burden.

(Press release, NextCure, JUN 1, 2026, View Source [SID1234666312])

On June 1, 2026 Servier reported promising new Phase 1 clinical data for Emi-Le, an investigational antibody drug conjugate (ADC) directed against B7-H4, during an oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago, Illinois.

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Emi-Le is an advanced engineered ADC that is directed against B7-H4, an immune checkpoint protein that is highly expressed in ACC along with several other cancers. As part of an ongoing Phase 1 trial, a dose escalation and backfill cohort enrolled adult patients with advanced or metastatic solid tumors (n=180), including those with ACC (n=48) defined by an aggressive clinicopathologic phenotype and/or molecular features consistent with poor prognosis.

"Emi-Le represents a novel, targeted therapeutic approach for patients who suffer from recurrent, advanced or metastatic ACC. The recent FDA Breakthrough Designation further validates the critical unmet need for a targeted systemic therapy to address the challenging effects of this disease for affected individuals," said Elly Barry, MD, Chief Medical Officer, Day One Biopharmaceuticals, now part of Servier Group. "These encouraging data at ASCO (Free ASCO Whitepaper) indicate strong promise to support a population distinctly in need of effective therapies and will help inform the pivotal Phase 2 study we will undertake in a larger set of participants."

The analysis presented at ASCO (Free ASCO Whitepaper) found:

Emi-Le was well-tolerated demonstrating a distinct and potentially differentiated emerging safety profile:
Most treatment-related adverse events (TRAEs) were transient laboratory-based and/or low-grade. The most common TRAEs were transient AST increase (56%) generally asymptomatic and reversible proteinuria (54%), predominantly low-grade fatigue (42%) and nausea (33%).
The only Grade 3 TRAEs in ≥10% of pts were transient AST increase (20%) and proteinuria (23%). No Grade 4 or 5 TRAEs reported.
TRAEs leading to treatment discontinuation occurred in 3.9% of patients and no treatment-related deaths were reported.
Promising signals of efficacy among 45 evaluable participants with ACC.
Objective response rate (ORR) was 35.6%, including one complete response.
Disease control rate was 82.2%.
Further, a post-hoc analysis was conducted in a more clearly defined aggressive ACC subtype reflecting clinical features used in practice by clinicians and pathologists, including solid histology or high-grade transformation. This analysis (n=32 evaluable participants) reported promising signals:
Consistent tumor shrinkage, with an ORR of 46.9%, DCR of 81.3% and median PFS of 7.8 months.
"These data provide important insights into the use of a targeted ADC for the difficult-to-treat rare cancer ACC, most notably demonstrating favorable tolerability and a potentially differentiated safety profile," said Glenn J. Hanna, M.D., study investigator and Director, Center for Cancer Therapeutic Innovation at Dana Farber Cancer Institute. "The encouraging anti-tumor activity observed to date supports continued investigation of this program, particularly given the poor prognosis for patients with ACC and the lack of approved or preferred systemic therapies in the advanced or metastatic setting. If confirmed in further studies, this profile could potentially represent a paradigm shift in treatment."

(Press release, Servier, JUN 1, 2026, View Source [SID1234666328])

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])