Anixa Biosciences Receives Notice of Allowance from USPTO for Ovarian Cancer Vaccine

On March 24, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a key patent application covering its ovarian cancer vaccine technology (Press release, Anixa Biosciences, MAR 24, 2025, View Source [SID1234651361]). The patent includes broad claims related to methods of eliciting an immune response targeting Anti-Mullerian Hormone Receptor, Type II (AMHR2), a promising target for ovarian cancer prevention and treatment.

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Anixa’s ovarian cancer vaccine, being developed in collaboration with Cleveland Clinic and the National Cancer Institute, represents a novel approach to preventing and treating ovarian cancer, particularly among high-risk populations such as those carrying BRCA mutations or with a family history of the disease.

The allowed claims include methods of administering an immunogenic composition comprising a nucleic acid encoding the AMHR2 polypeptide, specifically the extracellular domain of human AMHR2, to elicit an AMHR2-specific immune response.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "Receiving this Notice of Allowance from the USPTO is a significant milestone in our mission to develop a preventative and therapeutic ovarian cancer vaccine. The allowed claims provide broad protection for the various components and delivery mechanisms of our vaccine technology. This strengthens our intellectual property position and supports the continued advancement of our program."

Adagene Reports Full Year 2024 Financial Results and Provides Corporate Update

On March 24, 2025 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, reported financial results for the full year 2024 and provided corporate updates (Press release, Adagene, MAR 24, 2025, View Source [SID1234651360]).

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"The clinical data we generated in 2024 with ADG126 gives us great confidence in our ability to provide patients with colorectal cancer a tolerable, efficacious treatment option. These data also provide the basis for us to expand our study in microsatellite stable colorectal cancer (MSS CRC) to include earlier lines of therapy and patients with liver metastases, a patient subpopulation that has historically seen little to no benefit from checkpoint inhibitors," said Peter Luo, Ph.D., Chairman, CEO and President of R&D at Adagene. "Regulatory T cells, a primary mechanism of resistance, can be overcome through higher and more frequent dosing of a conditionally active anti-CTLA-4 antibody. We continue to believe that ADG126 can transform immunotherapy in combination with anti-PD-1 and other therapies. Our SAFEbody masking capability enables the best therapeutic index among all CTLA-4 programs, showing the potential to unlock therapeutic value with a target previously limited by safety concerns."

Dr. Luo continued, "In addition to ADG126, we have also utilized our SAFEbody masking technology to create T cell engagers (TCEs) that can link T cells to any number of antigens presented on tumor cells. These masked TCEs can recruit the immune system for conditional cytotoxicity, shrinking tumors and prolonging patient survival. The combination of TCEs with ADG126, which depletes CTLA-4 mediated regulatory T cells, is expected to enhance the response to TCE therapy. We look forward to sharing more on our TCE programs going forward."

PIPELINE HIGHLIGHTS

ADG126 – Phase 1b/2 data:

· 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab, Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), cohort achieved an improved ORR of 33%.

o All responders remain on treatment at a maintenance dose of 10 mg/kg Q3W or 10 mg/kg Q6W in combination with pembrolizumab

· Good tolerability with a manageable safety profile for ADG126 + pembrolizumab combo, with overall low discontinuation rate (6%) for the MSS CRC expansion cohort. No Grade 4/5 safety events were seen to date.

· Based on robust safety data of ADG126 at 20 mg/kg Q6W in combination with pembrolizumab, the efficacy of this dosing regimen is being evaluated in the cohort expansion stage of the Phase 1b/2 trial.

· Company also plans to evaluate a broader patient population, including patients with liver metastases, by combining with standard of care medicines, a combination that has been limited by safety concerns in the past.

· Investigator initiated Phase 2 trial of ADG126 in neoadjuvant colorectal cancer to begin enrolling patients in April at the National University Cancer Institute in Singapore

ADG138, a SAFEbody engineered T cell engager targeting HER2, has shown a wide therapeutic window and extended half-life for prolonged circulation in the tumor micro-environment in preclinical models. ADG138 is currently IND-ready.

ADG152, a SAFEbody engineered T cell engager targeting CD20, is designed to conditionally bind to CD20 on tumor cells and show negligible interaction with healthy cells, yielding a 100-fold reduction in cytokine release syndrome in preclinical models. ADG152 is currently in the IND-enabling phase.

The Company is pursuing strategic partnerships to advance the SAFEbody T cell engager programs.

ONGOING COLLABORATIONS

Exelixis: In June 2023, Adagene received a US$3.0 million milestone payment from Exelixis for the successful nomination of lead SAFEbody candidates for the second collaboration program under a technology licensing agreement to develop novel masked antibody-drug conjugate candidates. Including upfront and other milestone payments, we have received over US$18 million in total from Exelixis to date.

Sanofi: Adagene and Sanofi are collaborating to develop both bispecific and monoclonal SAFEbody antibody candidates, preparing preclinical candidates using Adagene’s SAFEbody precision masking technology for future development and commercialization by Sanofi. The collaboration announced in March 2022 included an upfront payment of US$17.5 million for the initial two programs, an option fee for two additional programs, potential milestone payments of up to US$2.5 billion, and tiered royalties.

Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC). To date, the combination has been well tolerated. Adagene retains global development and commercialization rights to ADG126.

2025 MILESTONES & CASH RUNWAY

Consistent with ongoing initiatives to prudently manage its cash balance, Adagene expects its current cash balance to fund activities into late 2026, with the following milestones expected in 2025:

· Provide longer-term time-to-event data from the existing Ph 1b/2 study of ADG126 + pembrolizumab in 3L+ MSS CRC

· Update 20 mg/kg loading dose cohort for durability of response (DOR and other time-to-event endpoints)

· Conduct EOP1 meeting with FDA by Q3 to obtain their endorsement on the proposed dose regimens, trial design and patient population

· Initiate evaluation of ADG126 + pembrolizumab in combination with standard of care in MSS CRC patients including those with liver metastases, beginning Q2

· Provide initial clinical data from investigator initiated Phase 2 trial for neoadjuvant ADG126 in colorectal cancer

· Establish additional collaboration/licensing agreements

CORPORATE UPDATES

JC Xu, M.D., Ph.D., Adagene’s Chief Strategy Officer and Head of Regulatory Affairs, has recently transitioned from a full-time employee of Adagene to a consulting role. JC will continue to support the Company’s development while serving as a consultant.

Ms. Yumeng Wang, a member of Adagene’s Board of Directors and a Vice President at General Atlantic, will step down from the Board upon filing of the Company’s 2024 Annual Report on form 20-F due to personal reason. Ms. Wang has served on Adagene’s Board since 2023 and provided invaluable guidance as Adagene has developed ADG126 through first-in-human clinical trials.

Mervyn Turner, Ph.D., Independent Director of Adagene’s Board of Directors, will complete his term as Independent Director concurrent with the filing of the Company’s 2024 Annual Report on form 20-F, and transition to an advisory role. Mr. Turner has served on Adagene’s Board of Directors since April of 2023 and will continue to provide strategic guidance to the Company in this advisory capacity.

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents:

Cash and cash equivalents were US$85.2 million as of December 31, 2024, compared to US$109.9 million as of December 31, 2023. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$18.2 million as of December 31, 2024 from US$21.9 million as of December 31, 2023. The associated loan proceeds were primarily used to support the company’s R&D activities.

Net Revenue:

Net revenue was US$0.1 million for the year ended December 31, 2024, compared to US$18.1 million in 2023.

Research and Development (R&D) Expenses:

R&D expenses were US$28.8 million for the year ended December 31, 2024, compared to US$36.6 million in 2023. The decrease of approximately 21% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:

Administrative expenses were US$7.3 million for the year ended December 31, 2024, compared to US$8.7 million in 2023. The decrease was due to both a reduction in personnel and in office-related expenses as a result of cost-control measures.

Other Operating Income, Net:

Other operating income, net was nil for the year ended December 31, 2024 compared to US$3.5 million in 2023. The amount of US$3.5 million included a one-time compensation payment from a contract manufacturer for a preclinical-related outsourcing arrangement.

Net Loss:

Net loss attributable to Adagene Inc.’s shareholders was US$33.4 million for the year ended December 31, 2024, compared to US$18.9 million in 2023.

Ordinary Shares Outstanding:

As of December 31, 2024, there were 58,886,944 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

Non-GAAP Net Loss:

Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding share-based compensation expenses, was US$28.5 million for the year ended December 31, 2024, compared to US$11.7 million in 2023. Please refer to the section in this press release titled "Reconciliation of GAAP and Non-GAAP Results" for details.

TransCode Therapeutics, Inc. Announces Registered Direct Offering Priced At-the-Market Under Nasdaq Rules

On March 23, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that it has agreed to sell an aggregate of 10,250,000 shares of its common stock and warrants to purchase up to 10,250,000 shares of common stock priced at-the-market under Nasdaq rules, at a purchase price of $0.98 per share and associated warrant (Press release, TransCode Therapeutics, MAR 23, 2025, View Source [SID1234651355]). The warrants will have an exercise price of $0.86 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. All of the shares of common stock and associated warrants are being offered by the Company. The offering is expected to close on March 25, 2025, subject to satisfaction of customary closing conditions.

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The gross proceeds to the Company from the offering are expected to be approximately $10 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for product development activities, including one or more clinical trials with TTX-MC138, its lead therapeutic candidate, including related IND-enabling studies, and for working capital and other general corporate purposes.

ThinkEquity is acting as the exclusive placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333- 268764), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on December 13, 2022, and declared effective on December 16, 2022. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Everest Medicines Announces FDA Clearance of IND Application for Tumor-Associated Antigen Vaccine EVM14

On March 23, 2025 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine (Press release, Everest Medicines, MAR 23, 2025, View Source [SID1234651354]). EVM14 is Everest’s first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company’s efforts to develop innovative mRNA therapeutics in oncology.

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EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. It utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response. The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens.

In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. EVM14 promoted T cell infiltration into tumor tissues, increased T cell activation and cytotoxic function, decreased the Treg population and cytotoxic T lymphocyte (CTL) exhaustion – all well correlated with its anti-tumor activity. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with ICIs greatly enhanced the anti-tumor activity, supporting clinical exploration of combination therapies.

"With FDA IND approval, EVM14 has become the Everest’s first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our ‘dual-engine’ strategy, evolving from a license-in model to a balanced integration of both license-in and in-house R&D innovation." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our ‘AI-powered’ pipeline, underscoring Everest’s leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalized cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China’s mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to the clinical trials. Over the past four years, Everest has utilized its AI- and big data-powered mRNA platform to accelerate target identification, sequence design, and delivery optimization. Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modeling."

Luo added: "This approach has enabled key breakthroughs in mRNA technology, expanded our global pipeline, and unlocked potential new opportunities for international collaboration. We look forward to advancing EVM14 into clinical trials and providing new treatment options for cancer patients. Additionally, we will submit the IND application for EVM14 to the China National Medical Products Administration (NMPA) in the near future."

According to Globocan 2022 statistics, nearly 20 million new cancer cases were diagnosed worldwide, with approximately 9.7million cancer-related deaths1. Lung cancer remains the most prevalent cancer globally, responsible for almost 2.5 million new cases. Lung cancer was also the leading cause of cancer death, with an estimated 1.8 million deaths. Non-small cell lung cancer (NSCLC) accounts for 85%–90% of all lung cancers2, with squamous NSCLC (sq-NSCLC) comprising 25%–30%3. However, targetable genetic alterations, such as EGFR mutations, ALK, and ROS1 rearrangements occur in fewer than 10% of sq-NSCLC cases4, underscoring the urgent need for new treatment options.

Additionally, Global Cancer Statistics 2022 reports that head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer, accounting for an estimated 890,000 new cases and 450,000 deaths annually5. more than 50% of patients with locally advanced HNSCC who have completed definitive treatment ultimately experience recurrence or metastasis6, leading to poor prognosis, high mortality rates, and diminished quality of life.

Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. EVM14’s unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and delaying disease recurrence, aligning with current trends in oncology drug development.

Everest has built end-to-end capabilities within its proprietary mRNA platform. The Company is advancing multiple mRNA therapies targeting cancer and autoimmune diseases, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) cancer vaccines, immunomodulatory cancer vaccines, and in vivo CAR-T therapies. Additionally, the Company is working on next-generation LNP delivery systems to further boost cell-mediated immune responses. The Company’s first internally developed personalized mRNA cancer vaccine, EVM16, has completed its first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025.

Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China, is designed to comply with global cGMP standards and to produce at clinical- and commercial-scale.

About EVM14

EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding multiple tumor-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens. These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. The activated T cells can migrate to tumor tissues, recognize, and kill the tumor cells expressing the target antigens.

Innovent Dosed First Participant in Phase 3 Clinical Study of IBI354 (Novel HER2 ADC) for Platinum-resistant Ovarian Cancer

On March 23, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the first participant has been successfully dosed with IBI354 (HER2 Monoclonal Antibody-Camptothecin Derivative Conjugate, HER2 ADC) in a randomized, controlled, multicenter Phase 3 clinical trial (HeriCare-Ovarian01), for platinum-resistant ovarian cancer (PROC) with HER2 expression (Press release, Innovent Biologics, MAR 23, 2025, View Source [SID1234651353]).

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HeriCare-Ovarian01 is the first Phase 3 clinical trial (NCT06834672) in China to investigate PROC with HER2 expression (IHC 1+, 2+ or 3+). The study will evaluate the safety and efficacy of IBI354, compared with investigator’s choice of chemotherapy for PROC with HER2 expression. The primary endpoints are progression-free survival (PFS) and overall survival (OS).

Previously, in a multicenter Phase 1/2 study in participants with advanced solid tumors, a total of 87 participants with platinum-resistant ovarian cancer were enrolled and were treated with 6-12 mg/kg doses of IBI354. 67 (77.0%) participants had previously received at least 3 anti-tumor regimens.

As of July 24, 2024, the overall objective response rate (ORR) was 40.2% and the disease control rate (DCR) was 81.6%.
Among them, ORR reached 52.5% and DCR reached 90.0% in 40 ovarian cancer participants treated with 12mg/kg Q3W
ORR reached 55.6% and DCR reached 88.9% in 27 subjects with HER2 IHC 1+ (12mg/kg Q3W dose group).
The median follow-up time of 12mg/kg Q3W dose group was 6.5 months as of the cut-off date, and progression-free survival (PFS) and duration of response (DoR) were not mature. The data was presented at the ESMO (Free ESMO Whitepaper) conference.
In the phase 1/2 clinical study (n=368), IBI354 demonstrated an excellent safety profile.

No DLT was occurred up to 18mg/kg dose group.
The overall incidence of grade 3 or higher treatment-related adverse events (TRAEs) was 21.5%, the incidence of TRAEs leading to dose interruption was 12.2%, the incidence of TRAEs leading to dose reduction was 2.4%, the overall incidence of TRAEs leading to discontinuation was 1.6%, and no TRAE leading to death reported.
The most common TRAEs are nausea, white blood cell count decreased, and anemia. The incidence of interstitial lung disease was only 1.6%, all were grade 1.
The Principal Investigator of the HeriCare-Ovarian01 study, Prof. Qi Zhou from Chongqing University Cancer Hospital, stated, "Prolonging PFS and OS of PROC is an urgent unmet medical need. Ovarian cancer is characterized by a pattern of frequent recurrence, which ultimately leads to platinum resistance. Non-platinum monotherapy chemotherapy remains the primary treatment option at this stage, but its limited efficacy is a major contributor to the high mortality rate associated with ovarian cancer. As a fully-validated target, HER2-targeted therapy has proven effective in breast and gastric cancers. IBI354, as a innovative conjugate of anti-HER2 monoclonal antibody and camptothecin derivative, has shown good anti-tumor activity in PROC with HER2 expression in the previous study. Especially in the population with low HER2 expression (IHC 1+), the efficacy of IBI354 is comparable to that in the population with higher HER2 expression. At the same time, IBI354 has an excellent safety profile, showing a very low risk of common or concerned toxicities of other antibody-drug conjugates (ADCs), such as interstitial lung disease, fatigue, diarrhea, hair loss, eye toxicity, etc. I look forward to positive results from the HeriCare-Ovarian01 study. It is hoped that IBI354 may provide survival benefits to the PROC patients with varying levels of HER2 expression."

The Principal Collaborating Investigator of the study from Zhejiang Cancer Hospital, Prof. Tao Zhu, stated: "We are pleased to complete the first patient enrollment for the HeriCare-Ovarian01 study at our site. Although ovarian cancer ranks third among gynecologic malignancies in incidence, behind cervical and endometrial cancers, its mortality rate exceeds the combined total of the latter two, making it the deadliest gynecologic cancer and a severe threat to women’s health. As an anti-HER2 ADC, preliminary findings from IBI354 have demonstrated encouraging objective response rates (ORR) and disease control rates (DCR) in PROC. Furthermore, IBI354 exhibits a superior clinical safety profile and treatment tolerability compared to other ADCs. Current clinical data suggest promising development prospects for IBI354 in PROC. We are hopeful that IBI354 will achieve success in the HeriCare-Ovarian01 study, offering new therapeutic options for this patient population."

Dr. Zhou Hui, Senior Vice President of Innovent, stated, "I’m pleased that the Phase III clinical study of IBI354 in HER2-expressing PROC has completed the first participant dosing. I look forward to positive results for IBI354 to provide a better treatment option for patients with HER2-expressing PROC. ADC is one of the core technology areas of Innovent’s strategic layout. We combine the world’s leading antibody engineering and multiple sets of differentiated linker-payload technologies to create a highly competitive and innovative TOPO1i ADC technology platform SoloTx. IBI354 has demonstrated excellent safety and efficacy data in the previous study, which fully proves the value and the development strength of Innovent ADC platform. We will deeply layout the ADC and immunotherapy areas, focusing on the next generation of innovation, committed to bring better benefits to cancer patients."

About Ovarian Cancer

OC is one of the leading causes of death among gynecological cancers. According to the International Agency for Research on Cancer, there will be about 324,000 new cases of ovarian cancer worldwide in 2022, and about 206,000 deaths[1]. About 61,000 new cases and 33,000 deaths were reported in China[2]. A higher mortality/morbidity ratio suggests a shorter survival time. Platinum-containing chemotherapy is the first choice for systemic treatment of advanced ovarian cancer. About 70% of patients with platinum-sensitive ovarian cancer will relapse after receiving platinum-containing chemotherapy and eventually develop platinum resistance[3]. There is a lack of effective treatment for platinum-resistant cancer patients. The existing evidence is non-platinum-single drug chemotherapy with or without anti-angiogenic therapy, with ORR only about 4-13.2% and median overall survival (OS) only about 10.9-14 months[4-8]. There is a urgent unmet medical need for PROC, and it is recommended that these patients participate in clinical trials in Chinese and foreign guidelines.It has been reported that about 38% of ovarian cancer patients have HER2 expression[9]. There are currently no anti-HER2 treatments approved for HER2-overexpressed ovarian cancer in China.

About IBI354

IBI354 is an innovative HER2-targeted antibody–drug conjugate developed using Innovent’s proprietary novel topoisomerase inhibitor platform. Based on this platform, Innovent is promoting clinical trial studies multiple self-developed ADC molecules, which have shown promising safety and efficacy signals.

With a drug-to-antibody ratio (DAR) of 8, IBI354 delivers a high payload of effective drugs to tumors. The highly hydrophilic linker design contributes to its excellent biophysical and pharmacokinetic (PK) properties, while the hydrophobic payload enhances its bystander effect, targeting adjacent antigen-low or negative tumor cells. IBI354 exhibits extremely low exposure of free toxin in circulation and has an ideal safety profile based on pre-clinical and clinical studies. IBI354 has demonstrated remarkable anti-tumor activity in various tumor-bearing mice models, particularly in those resistant to HER2-targeted therapies and in metastatic tumors.

Starting from the urgent clinical needs, in addition to the phase III study (HeriCare-Ovarian01) already initiated in PROC, Innovent will develop IBI354 in multiple solid tumor indications.