On April 30, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported its financial results and provides an update on clinical and operational progress for the first quarter ended March 31, 2026.

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Clinical & Operational Updates

Operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:

Since in-licensing ivonescimab, from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023, over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients have been treated in the commercial setting with ivonescimab in China, as noted and updated by Akeso. Summit has rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan, while Akeso retains development and commercialization rights for remaining territories, including China.
Summit is developing ivonescimab in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), specifically conducting multiregional Phase III clinical trials in the following proposed indications:
HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI)
HARMONi-3: Ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC, with two distinct cohorts to be analyzed separately for squamous tumors and non-squamous tumors
HARMONi-7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression
HARMONi-GI3: Ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC
HARMONi-6

Overall survival data from the Phase III HARMONi-6 trial, conducted in China and sponsored by Akeso, will be presented in the Plenary Session of the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. According to ASCO (Free ASCO Whitepaper), Late-breaking Abstracts are released at 8:00am ET on the day of the presentation, currently scheduled for Sunday, May 31, 2026.
The HARMONi-6 study evaluated ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. HARMONi-6 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso with all relevant data exclusively generated and analyzed by Akeso.
HARMONi-3 Squamous

Previously, Summit announced its intention to perform an interim PFS analysis for the squamous cohort of the HARMONi-3 study in the second quarter of 2026. As previously communicated, the purpose of this interim analysis was to provide a potential opportunity to speak with the regulatory authorities, including the US Food & Drug Administration, earlier than the timing of the preplanned final PFS analysis in the second half of 2026. To achieve statistical significance, there was a meaningfully higher bar than the upcoming planned final PFS analysis based on the minimal alpha spent on the interim analysis. At this early interim PFS analysis reviewed exclusively by the Independent Data Monitoring Committee (iDMC), the iDMC recommended that the study continue as planned. No safety concerns were noted, and the study continues to be double-blinded. There is no change to the previously guided timing of the preplanned final PFS analysis in the second half of 2026.
HARMONi-3 Non-Squamous

Enrollment in the non-squamous NSCLC cohort continues and enrollment is now expected to complete by the end of the second quarter of 2026. We expect to have PFS data for this cohort in the first half of 2027.
HARMONi

In January 2026, we announced that the U.S. Food & Drug Administration (FDA) accepted for filing Summit’s Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy. The BLA was submitted based on the overall results of the global Phase III HARMONi trial. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
Additional Ivonescimab Development Updates

Summit’s clinical trial collaborations continue to progress as planned.
In June 2025, we announced a clinical collaboration with Revolution Medicines, Inc. (RevMed) to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. As previously announced, the initial study under this collaboration, sponsored by RevMed, began enrolling patients in the first quarter of 2026.
In January 2026, we announced a clinical collaboration with GSK plc (GSK) to evaluate ivonescimab in combination with GSK’s novel B7-H3, risvutatug rezetecan, in multiple solid tumors. The initial study under this collaboration agreement is expected to begin dosing patients mid-2026.
In February 2026, we announced a clinical collaboration with GORTEC, a European Head and Neck Oncology and Radiotherapy Group based in France, to evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a randomized three-arm study. The Phase III study, GORTEC 2024-04 ILLUMINE (NCT07264075), is sponsored by GORTEC and is intended to be conducted in multiple countries in Europe and in China; Summit may consider the expansion of this study into the United States. The primary endpoint for the study is overall survival and is expected to enroll approximately 780 patients with PD-L1 positive, recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Patient enrollment is expected to begin in the second quarter of 2026.
Summit’s global Phase III trials, the non-squamous cohort of HARMONi-3, HARMONi-7, and HARMONi-GI3, continue to enroll. In addition to the multiregional studies conducted and sponsored by Summit, our partners at Akeso are enrolling several single-region Phase III studies exclusively in China in multiple indications, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, small cell lung cancer, colorectal cancer, and pancreatic cancer.
We plan to continue further expansion of the global Phase III clinical development program for ivonescimab in additional settings and tumor types. We intend to continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond NSCLC, CRC, and HNSCC.
Clinical trial collaborations and investigator sponsored trials (ISTs) with leading academic organizations, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumors. Summit is supporting more than 65 ISTs, of which 20 are actively enrolling.
Financial Highlights

Cash and Cash Equivalents and Short-term Investments

Aggregate cash and cash equivalents and short-term investments were $598.7 million and $713.4 million at March 31, 2026 and December 31, 2025, respectively.
GAAP and Non-GAAP Operating Expenses

GAAP operating expenses were $195.2 million for the first quarter of 2026, compared to $66.8 million for the same period of the prior year. The increase in GAAP operating expenses was due to the increase in stock-based compensation expense of $61.7 million primarily related to the modification to our performance-based stock option awards during the second quarter of 2025.
Non-GAAP operating expenses were $122.4 million for the first quarter of 2026, compared to $55.7 million for the same period of the prior year. The increase in Non-GAAP operating expenses was primarily driven by the expansion of clinical studies and development costs related to ivonescimab.
GAAP and Non-GAAP Research and Development (R&D) Expenses

GAAP R&D expenses were $132.6 million for the first quarter of 2026, compared to $51.2 million for the same period of the prior year. The increase was due to the increase in stock-based compensation expense of $20.3 million primarily related to the modification to our performance-based stock option awards during the second quarter of 2025.
Non-GAAP R&D expenses were $108.2 million for the first quarter of 2026, compared to $47.1 million for the same period of the prior year. The increase was primarily driven by initiating new clinical trials and expanding current clinical trials from last year.
GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $62.6 million for the first quarter of 2026, compared to $15.6 million for the same period of the prior year. The increase was due to the increase in stock-based compensation expense of $41.4 million primarily related to the modification to our performance-based stock option awards during the second quarter of 2025.
Non-GAAP G&A expenses were $14.2 million for the first quarter of 2026, compared to $8.6 million for the same period of the prior year. The increase was primarily driven by the expansion of our infrastructure and management team to support the development of ivonescimab.
GAAP and Non-GAAP Net Loss

GAAP net loss in the first quarter of 2026 and 2025 was $189.4 million or $(0.24) per basic and diluted share, and $62.9 million or $(0.09) per basic and diluted share, respectively.
Non-GAAP net loss in the first quarter of 2026 and 2025 was $116.6 million or $(0.15) per basic and diluted share, and $51.8 million or $(0.07) per basic and diluted share, respectively.
Use of Non-GAAP Financial Measures

This release includes measures that are not in accordance with U.S. generally accepted accounting principles (Non-GAAP measures). These Non-GAAP measures should be viewed in addition to, and not as a substitute for, Summit’s reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these Non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results. For further information regarding these Non-GAAP measures, please refer to the tables presenting reconciliations of our Non-GAAP results to our U.S. GAAP results and the "Notes on our Non-GAAP Financial Information" that accompany this press release.

(Press release, Summit Therapeutics, APR 30, 2026, View Source [SID1234664986])

On April 30, 2026 The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) reported that it has recognized a favorable benefit risk profile for AstraZeneca’s TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for the treatment of patients with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC), based on the CAPItello-281 Phase III trial. The Committee voted 7 to 1, with 1 abstaining.

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In August 2025, the FDA accepted the supplemental New Drug Application (sNDA) for TRUQAP in combination with abiraterone and ADT based on positive results from the CAPItello-281 Phase III trial, presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and simultaneously published in Annals of Oncology.1

Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the trial, said: "Patients identified to have PTEN-deficient metastatic hormone-sensitive prostate cancer have an aggressive form of the disease and currently experience poor outcomes. Their disease significantly impacts their quality of life and inevitably progresses to more advanced stages that are associated with high mortality rates. In addition to this poor prognosis, patients currently have limited treatment options, which is why today’s recommendation of the capivasertib combination is welcome news for both patients and clinicians to address an urgent need for new treatments that delay progression."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "CAPItello-281 is the first pivotal trial to prospectively define PTEN-deficient metastatic hormone-sensitive prostate cancer and its severe course of disease. The Committee’s recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the TRUQAP combination verifies its potential to address this significant need and optimize outcomes for patients. We are committed to working closely with the FDA to bring the first and only targeted treatment option to the one in four patients with this form of metastatic hormone-sensitive prostate cancer."

Results from the primary analysis of the CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death and a clinically meaningful improvement in median radiographic progression-free survival (rPFS) of 7.5 months with the TRUQAP combination versus treatment with abiraterone and ADT with placebo (based on a hazard ratio [HR] of 0.81; 95% confidence interval [CI] 0.66-0.98; P=0.034). Median rPFS was 33.2 months for the TRUQAP combination versus 25.7 months for the comparator arm.1

A consistent benefit was observed with the TRUQAP combination versus treatment with abiraterone and ADT with placebo in key secondary endpoints of the trial, including prolonged time to castration resistance (29.5 vs. 22.0 months [HR 0.77; 95% CI: 0.63-0.94]) and prostate-specific antigen (PSA) progression (HR 0.73; 95% CI: 0.52-1.01), and fewer and delayed events in terms of symptomatic skeletal event-free survival (SSE-FS) (42.5 vs. 37.3 months [HR 0.82, 95% CI: 0.66-1.02]).1

Overall survival (OS) data were immature at the time of primary analysis; however, subsequent interim results for OS numerically favored the TRUQAP combination versus the comparator arm. The trial will continue as planned to further assess OS as a key secondary endpoint.

The safety profile of TRUQAP in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine. Consistent with the addition of a targeted treatment to background therapy, Grade 3 or higher adverse events occurred in 67% of patients treated with the TRUQAP combination versus 40.4% of patients treated with abiraterone and ADT with placebo. The most common Grade 3 or higher adverse events in the TRUQAP arm were rash (12.3%), hyperglycemia (10.3%), hypokalemia (8.7%), diarrhea (6.2%), hypertension (5.8%) and anemia (5.2%).1

The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the feedback as it reviews the submission and is not bound by the Committee’s recommendation.

A regulatory application for TRUQAP in combination with abiraterone and ADT for the treatment of PTEN-deficient mHSPC is under review in the EU based on the CAPItello-281 Phase III trial.

IMPORTANT SAFETY INFORMATION ABOUT TRUQAP (capivasertib) tablets

TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components.

Hyperglycemia

Severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes, can occur in patients treated with TRUQAP (n=355).

Increased fasting glucose (FG) from baseline occurred in 37% of patients treated with TRUQAP, including 11% of patients with Grade 2 (FG >160 to 250 mg/dL), 2% with Grade 3 (FG >250 to 500 mg/dL), and 1.1% with Grade 4 (FG >500 mg/dL) events. The median time to first occurrence of hyperglycemia was 15 days (range: 1 to 367). Dose reduction for hyperglycemia was required in 0.6% of patients and permanent discontinuation was required in 0.6% of patients. Diabetic ketoacidosis occurred in 0.3% of patients and diabetic metabolic decompensation in 0.6% of patients.

In CAPItello-291, 12% (43/355) of patients who received TRUQAP had an anti-hyperglycemic medication either initiated or changed during the study, including treatment with insulin in 4.8% (17/355) of patients.

The safety of TRUQAP has not been established in patients with Type I diabetes or diabetes requiring insulin. Patients with insulin-dependent diabetes were excluded from CAPItello-291.

Before initiating treatment with TRUQAP, test fasting glucose levels (fasting plasma glucose or fasting blood glucose), hemoglobin A1C (HbA1C) levels, and optimize fasting glucose. After initiating treatment with TRUQAP, monitor or self-monitor FG levels on Day 3 or 4 of the dosing week during weeks 1, 2, 4, 6, and 8; then monthly while on treatment with TRUQAP; and as clinically indicated. Monitor HbA1C levels every 3 months during treatment with TRUQAP and as clinically indicated. Patients with a history of well-controlled Type 2 diabetes mellitus may require intensified anti-hyperglycemic treatment and close monitoring of FG levels.

For patients who experience hyperglycemia during treatment with TRUQAP, monitor FG at least twice weekly, on days on and off TRUQAP, until FG decreases to baseline levels. During treatment with anti-diabetic medications, monitor FG at least once a week for 2 months, followed by once every 2 weeks, or as clinically indicated. Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia and initiation of FG monitoring at home for patients who have risk factors for hyperglycemia or who experience hyperglycemia. Advise patients on the signs and symptoms of hyperglycemia and counsel patients on lifestyle changes.

Withhold TRUQAP immediately when ketoacidosis is suspected. If ketoacidosis is confirmed, permanently discontinue TRUQAP. Based on the severity of hyperglycemia, withhold, reduce dose, or permanently discontinue TRUQAP.

Diarrhea

Severe diarrhea associated with dehydration occurred in patients who received TRUQAP (n=355).

Diarrhea occurred in 72% of patients. Grade 3 or 4 diarrhea occurred in 9% of patients. The median time to first occurrence was 8 days (range: 1 to 519). In the 257 patients with diarrhea, 59% required antidiarrheal medications to manage symptoms. Dose reductions were required in 8% of patients and 2% of patients permanently discontinued TRUQAP due to diarrhea. In patients with Grade ≥2 diarrhea (n=93) with at least 1 grade improvement (n=89), median time to improvement from the first event was 4 days (range: 1 to 154).

Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start antidiarrheal treatment at the first sign of diarrhea while taking TRUQAP. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.

Cutaneous Adverse Reactions

Cutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia, and drug reaction with eosinophilia and systemic symptoms (DRESS), occurred in patients who received TRUQAP (n=355).

Cutaneous adverse reactions occurred in 58% of patients. Grade 3 or 4 cutaneous adverse reactions occurred in 17% of patients receiving TRUQAP. EM occurred in 1.7% of patients and DRESS occurred in 0.3% of patients. Dose reduction was required in 7% of patients and 7% of patients permanently discontinued TRUQAP due to cutaneous adverse reactions.

Monitor patients for signs and symptoms of cutaneous adverse reactions. Early consultation with a dermatologist is recommended. Withhold, dose reduce, or permanently discontinue TRUQAP based on severity.

Embryo-Fetal Toxicity

Based on findings from animals and mechanism of action, TRUQAP can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRUQAP and for 1 month after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRUQAP and for 4 months after the last dose.

TRUQAP is used in combination with fulvestrant. Refer to the full Prescribing Information of fulvestrant for pregnancy and contraception information.

ADVERSE REACTIONS

Among the 355 patients who received TRUQAP in CAPItello-291, the most common (≥20%) adverse reactions, including laboratory abnormalities, were diarrhea (72%), cutaneous adverse reactions (58%), increased random glucose (57%), decreased lymphocytes (47%), decreased hemoglobin (45%), increased fasting glucose (37%), nausea and fatigue (35% each), decreased leukocytes (32%), increased triglycerides (27%), decreased neutrophils (23%), increased creatinine (22%), vomiting (21%), and stomatitis (20%).

In the 155 patients with PIK3CA/AKT1/PTEN alterations treated with TRUQAP + fulvestrant, dose reductions due to adverse reactions were reported in 21% of patients. Permanent TRUQAP discontinuation due to an adverse reaction occurred in 10% of patients. Dose interruptions of TRUQAP occurred in 39% of patients.

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid concomitant use with a strong CYP3A inhibitor. If concomitant use cannot be avoided, reduce the dose of TRUQAP and monitor patients for adverse reactions.

Moderate CYP3A Inhibitors: When concomitantly used with a moderate CYP3A inhibitor, reduce the dose of TRUQAP and monitor patients for adverse reactions.

Strong or Moderate CYP3A Inducers: Avoid concomitant use of TRUQAP with strong or moderate CYP3A inducers.

INDICATION AND USAGE

TRUQAP in combination with fulvestrant is indicated for the treatment of adult patients with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alteration as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Please see full Prescribing Information, including Patient Information for TRUQAP.

Notes

Prostate cancer
Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with an incidence of more than 1.4 million and approximately 397,000 deaths in 2022.2 In the US, prostate cancer is the most common cancer in men, with more than 300,000 new cases of the disease diagnosed annually, and more than 36,000 deaths.3

Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis.4 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.5

Metastatic hormone-sensitive prostate cancer
In patients with mHSPC, also known as metastatic castration-sensitive prostate cancer (mCSPC), prostate cancer cells need high levels of androgens to drive cancer growth.5,6 Hormone therapies, such as ADT, are widely used to block the action of male sex hormones and lower the levels of androgens in the body.6,7 However, resistance to these therapies is common and there is a need to extend their use to delay disease progression and castration resistance, where the prostate cancer grows and spreads to other parts of the body despite the use of these therapies.6-8

Newly diagnosed mHSPC is an aggressive form of the disease associated with poor outcomes and survival.6,8 Globally, approximately 200,000 patients are diagnosed with mHSPC each year, with 35,000 patients diagnosed with the disease in the US.9 One in four of these patients have PTEN-deficient tumors.9

PTEN-loss or deficiency fuels the growth of cancer cells, leading to dysregulation of the PI3K/AKT pathway, and is associated with poor outcomes in patients with prostate cancer.10,11

CAPItello-281
CAPItello-281 is a Phase III, double-blind, randomized trial evaluating the efficacy and safety of TRUQAP in combination with abiraterone and ADT versus abiraterone and ADT in combination with placebo in the treatment of patients with PTEN-deficient de novo mHSPC.

The global trial enrolled 1,012 adult patients with histologically confirmed de novo hormone-sensitive prostate adenocarcinoma and PTEN deficiency as confirmed by central testing. The primary endpoint of the CAPItello-281 trial is rPFS as assessed by investigator, with OS as a secondary endpoint.

TRUQAP (capivasertib)
TRUQAP (capivasertib) is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). TRUQAP 400 mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition.

TRUQAP in combination with fulvestrant is approved in the US, EU, Japan, China and a number of other countries for the treatment of adult patients with HR-positive (or estrogen receptor-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. TRUQAP is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results.

TRUQAP is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-281) in combination with established treatments.

TRUQAP was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited).

(Press release, AstraZeneca, APR 30, 2026, View Source [SID1234664985])

On April 30, 2026 Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, reported that two latest clinical study results of its novel Nectin‑4 targeting ADC (R&D code: 9MW2821) in cervical cancer will be presented respectively as an oral presentation and a poster presentation, at the 2026 European Society for Medical Oncology Gynaecological Cancers (ESMO GC) Annual Congress in Copenhagen, Denmark, June 17–19, 2026.

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Oral Presentation

Title:
Bulumtatug Fuvedotin (BFv, 9MW2821), a nectin-4 antibody-drug conjugate, in patients with recurrent or metastatic cervical cancer: Updated results from a phase I/II study.
Abstract No.: 28RO
Presenter: Prof. Yang Huijuan, Fudan University Shanghai Cancer Center
Session Date and Time: 6/17/2026 2:45PM-4:10PM (local time)

Poster Presentation

Title:
Preliminary results of Bulumtatug Fuvedotin (BFv, 9MW2821) in combined with Toripalimab in patients with recurrent or metastatic cervical cancer: A cohort from a Phase Ib/II Clinical Study.

Abstract No.: 36P
Principal Investigator:
Prof. Lou Hanmei, Zhejiang Cancer Hospital
Prof. Wang Yudong, International Peace Maternity and Child Health Hospital of China Welfare Institute
Session Date and Time: 6/18/2026 12:45PM-1:30PM (local time)

(Press release, Mabwell Biotech, APR 30, 2026, View Source;mabwell-to-present-latest-clinical-data-on-9mw2821-for-cervical-cancer-in-oral-and-poster-presentations-302758286.html [SID1234664984])

On April 30, 2026 Factor Bioscience Inc., a Cambridge-based biotechnology company focused on using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported its participation in the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting to be held in Dublin, Ireland from May 6-9, 2026. Factor will deliver an oral presentation on FACT-112, Factor’s IL12-expressing iMacrophage program for solid tumors.

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"We are excited to share the latest pre-clinical data from our FACT-112 program at ISCT," said Dr. Matt Angel, Co-Founder, Chairman and CEO of Factor. "The striking anti-tumor activity of our engineered iMacrophages, demonstrated in vivo, represents a major milestone for the company, underscoring our commitment to translating cutting-edge science into clinically meaningful therapies."

Factor’s Associate Director of Cell Engineering, Ian Hay, who will deliver the presentation, added, "these data illustrate the intrinsic capacity of IL12-expressing iMacrophages to repolarize the immunosuppressive ovarian tumor microenvironment and elicit immune-mediated tumor rejection. We are excited about the potential to develop FACT-112 into a safe, effective option to patients with solid tumors."

Details of the oral presentation are below:

"iPSC-Derived Macrophages Engineered to Express IL-12 Modulate the Tumor Microenvironment and Support T Cell Lysis of Ovarian Cancer Models" -to be presented by Ian Hay on Wednesday, May 6 from 1:00-2:00 pm GMT, in the Immunotherapy Oral Presentation Session.

For more information about the International Society for Cell & Gene Therapy (ISCT) 2026 Annual Meeting, visit www.isctglobal.org/annual-meeting.

(Press release, Factor Bioscience, APR 30, 2026, View Source [SID1234664983])

On April 30, 2026 Huahui Health reported that it has entered into a global exclusive option, license and collaboration agreement with BeOne Medicines for HH160, a novel trispecific antibody in oncology immunotherapy. Under the agreement, BeOne Medicines is granted an exclusive option covering the development, manufacturing, and commercialization of HH160 worldwide.

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Pursuant to the agreement, BeOne Medicines will pay Huahui Health an upfront payment of USD 20 million. Upon exercise of the option by BeOne Medicines, Huahui Health will be entitled to receive an additional USD 100 million option exercise payment. Subject to the achievement of development, regulatory and sales milestones, Huahui Health is eligible to receive milestone payments of up to USD 1.9 billion in milestone payments, as well as tiered royalties on net sales. The parties have also agreed to maintain discussions regarding BeOne Medicines’ potential participation in Huahui Health’s future financing activities, with specific transaction terms and details to be negotiated separately.

Dr. Chen Bin, CEO of Huahui Health, stated, "Huahui Health has established an integrated research and development engine covering the full drug development value chain, enabling the independent identification of novel targets and development of proprietary drug candidates. Our pipeline includes one marketed product and several clinical-stage programs in Phase II, reflecting strong industry recognition of our R&D capabilities. BeOne Medicines is distinguished by its outstanding innovation capacity and global development expertise. We are delighted to deepen our collaboration with BeOne Medicines to advance HH160, a novel trispecific antibody for cancer immunotherapy, and to bring innovative immuno-oncology treatments to patients worldwide as early as possible."

In January 2026, China’s NMPA granted conditional approval to Libevitug injection, Huahui Health’s first commercial product, for chronic hepatitis D infection in adults with or without compensated cirrhosis. As a human monoclonal antibody targeting the PreS1 domain of HBV and HDV envelope protein, it blocks viral entry into hepatocytes. A pioneering first-in-class antibody for viral hepatitis and China’s first approved HDV therapy, Libevitug fills a critical unmet clinical gap. It received Breakthrough Therapy Designation from both NMPA and FDA, with its global Phase III trial now underway.

Going forward, Huahui Health will leverage its robust in-house innovation platforms and full-chain R&D strengths to advance first-in-class and best-in-class candidates across liver diseases and oncology. Backed by a rich layered pipeline spanning preclinical to clinical stages, the company demonstrates outstanding independent innovation and sustainable capacity to deliver original novel drugs worldwide.

About HH160

HH160 is a novel trispecific antibody developed by Huahui Health using its proprietary PolyBoost multispecific antibody platform. HH160 simultaneously targets PD-1, CTLA-4, and VEGF-A, three clinically validated targets in cancer immunotherapy and anti-angiogenesis. Through its "three-in-one" synergistic mechanism of action, HH160 is expected to enhance therapeutic efficacy, achieve tumor-specific drug distribution, and reduce treatment-related adverse effects. Positive preclinical results for HH160 were presented at the 2025 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) held in Chicago, United States.

(Press release, Huahui Health, APR 30, 2026, View Source [SID1234664982])