On August 28, 2026 Alphamab Oncology (stock code: 9966.HK) reported interim financial results for the six months ended June 30, 2026 and highlighted recent business progress.

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Key Highlights

● KN026 (Anbenitamab) obtained approval for marketing for gastric cancer indication in May 2026, becoming the first domestically developed HER2 bispecific antibody commercialized in China. KN026 has achieved strong positive results in three consecutive Phase III studies in gastric cancer, neoadjuvant breast cancer, and first-line breast cancer. NDAs for both the neoadjuvant and first-line breast cancer indications have been accepted by the NMPA. Leveraging its outstanding efficacy and safety profile, KN026 has been granted two BTDs by the NMPA for gastric and breast cancer, as well as ODD by the FDA for gastric cancer.

● JSKN003 (Anbenitamab repodatecan) has completed patient enrollment in the Phase III clinical study for second-line HER2-positive breast cancer, while three additional Phase III studies in HER2-low breast cancer, PROC, and HER2-positive colorectal cancer are progressing steadily. Previously, JSKN003 has been granted two BTDs by the NMPA for PROC and colorectal cancer, as well as three international recognitions from the FDA, including BTD for PROC, ODD for gastric cancer, and FTD for PROC.

● JSKN016 is currently advancing through a Phase III clinical study for the treatment of TNBC, alongside multiple Phase II clinical studies of JSKN016 as monotherapy and in combination therapies for lung cancer, breast cancer, and other indications. Clinical studies for its high‑concentration subcutaneous formulation are ongoing, with a Phase Ib study in China and a Phase I study in Australia. The Company has entered into an exclusive licensing agreement with Pathos AI for global rights (excluding Greater China), with total deal value up to US$2.093 billion.

● JSKN033 has advanced its cervical cancer indication to Phase III clinical development. Concurrently, multiple Phase II studies are ongoing, including in combination with platinum‑based chemotherapy as first‑line treatment for advanced cervical cancer, as monotherapy for second‑line or above cervical cancer, and for second‑line or above endometrial cancer.

● Leveraging modular and iterative technology platforms, innovative molecules continue to be generated and efficiently advanced into clinical development. JSKN022 has entered the dose‑optimization phase, showing preliminary efficacy and a favorable safety profile. Both JSKN027 and JSKN021 received IND approval for Phase I clinical trials in 2026, with patient enrollment ongoing. As of the first half of 2026, the Company had six ADC candidates in clinical development, comprising bispecific ADCs and dual‑payload ADCs.

Financial Summary

● For the six months ended June 30, 2026, we recorded total revenue of RMB 271.24 million. Meanwhile, product revenue (attributed to the Company) amounted to RMB 74.11 million.

● For the six months ended June 30, 2026, our R&D expenditure amounted to RMB 255.04 million, basically unchanged as compared with the first half of 2025.

● For the six months ended June 30, 2026, we recorded loss for the period of RMB 40.46 million.

● We have a healthy financial position, with cash reserves of RMB 1,431.58 million as of June 30, 2026.

Business Highlights

Product Pipeline

Leveraging its proprietary core technology platforms, including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payload, dual-payload conjugation, and high-concentration subcutaneous formulation, the Company has built a product portfolio with differentiated innovation and global competitiveness, covering cutting-edge fields such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies. Two products have received market approval: Envafolimab (KN035, brand name: 恩维达), the world’s first subcutaneously injected PD-(L)1 inhibitor, offering greater convenience and accessibility in cancer treatment; and Anbenitamab (KN026, brand name: 恩尼妥), the first domestically developed HER2 bispecific antibody approved for marketing in China, redefining the standard of treatment for second‑line HER2‑positive gastric cancer. In addition, three bispecific ADC candidates are currently in phase III clinical trials, while several other bispecific ADCs and dual-payload ADCs are advancing rapidly in clinical development.

KN035 (Envafolimab)

Envafolimab is the first subcutaneously injectable PD-(L)1 inhibitor worldwide and single-domain antibody in oncology. Envafolimab offers significant advantages in convenience and compliance by avoiding intravenous infusion and can be administered in just 30 seconds, making it particularly suitable for frail, elderly, or IV-intolerant patients. Envafolimab has been granted Breakthrough Therapy Designation (BTD) by the NMPA for the treatment of unresectable or metastatic solid tumors with high tumor mutation burden (TMB-H); it has been granted three Orphan Drug Designations (ODDs) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced biliary tract cancer, soft tissue sarcoma and gastric cancer and gastroesophageal junction cancer (GC/GEJ).

Events during the Reporting Period

● In January 2026, the New Drug Application (NDA) for Envafolimab in combination with the Gemcitabine and Oxaliplatin (GEMOX) regimen as first-line treatment for unresectable or metastatic biliary tract cancer was accepted by NMPA.

● In May 2026, patient enrollment was completed in a Phase III clinical study of Envafolimab in combination with platinum‑based doublet chemotherapy as neoadjuvant/adjuvant treatment for resectable non‑small cell lung cancer (NSCLC).

● In June 2026, data from a Phase III study (in combination with the GEMOX regimen) and a Phase II study (in combination with lenvatinib plus gemcitabine and cisplatin) of Envafolimab as first‑line treatment for advanced biliary tract cancer were presented as posters at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, with two additional studies published online.

KN026 (Anbenitamab)

Anbenitamab is the first domestically developed HER2 bispecific antibody approved for marketing in China, opening a new era in advanced gastric cancer treatment. It can simultaneously bind two non-overlapping epitopes of HER2, leading to HER2 signal blockade. Through antibody-induced receptor clustering, it enhances ADCC and CDC effects while promoting the down-regulation of HER2 receptors on the cell surface. Anbenitamab has been granted two BTDs by NMPA for the treatment of patients with HER2-positive GC/GEJ who have failed first-line standard treatment, and first-line treatment of patients with unresectable or metastatic HER2-positive breast cancer; it has been granted ODD by the FDA for the treatment of HER2-positive or low expressing GC.

Events during the Reporting Period

● In January 2026, the phase III clinical study results of Anbenitamab in patients with HER2-positive GC/GEJ were published in Annals of Oncology, a top-tier oncology journal.

● In March 2026, the first patient was dosed in the phase III clinical study of Anbenitamab in combination with albumin-bound docetaxel (HB1801) and chemotherapy as adjuvant treatment for HER2-positive breast cancer, and the study is currently progressing smoothly.

● In March 2026, the Phase III clinical study of Anbenitamab in combination with HB1801 as neoadjuvant treatment for HER2‑positive breast cancer met its pre‑specified primary endpoint of total pathological complete response (tpCR). Compared with the current standard of care (trastuzumab plus pertuzumab, docetaxel, with or without carboplatin, i.e., the TCbHP regimen), the Anbenitamab‑based combination significantly improved tpCR. This study is the first registrational trial globally to demonstrate in a head‑to‑head Phase III setting that a HER2 bispecific antibody surpasses the dual monoclonal antibody combination of "trastuzumab + pertuzumab," marking a historic breakthrough for bispecific antibodies in the neoadjuvant treatment of breast cancer.

● In May 2026, Anbenitamab obtained marketing approved in China through the NMPA priority review and approval procedure for use in combination with chemotherapy for the treatment of adult patients with locally advanced or metastatic HER2‑positive GC/GEJ who have previously received at least one trastuzumab‑containing regimen.

● In June 2026, the significant results from the Phase III study of Anbenitamab in combination with HB1801 as neoadjuvant treatment for HER2‑positive breast cancer were presented as a Late‑Breaking Abstract (LBA) oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. Results showed that neoadjuvant therapy with Anbenitamab plus HB1801 with or without carboplatin significantly improved tpCR compared with the current standard of care in patients with HER2‑positive early or locally advanced breast cancer. The tpCR assessed by the Blinded Independent Review Committee (BIRC) was 62.4% in the experimental arm versus 51.2% in the control arm (one‑sided p=0.0036), with a manageable overall safety profile.

● In June 2026, the Phase III clinical study of Anbenitamab in combination with HB1801 as first‑line treatment for HER2‑positive advanced breast cancer was assessed by an independent Data Monitoring Committee (IDMC) and successfully met its primary endpoint, demonstrating superior progression‑free survival (PFS) over the current standard of care (trastuzumab plus pertuzumab and docetaxel, i.e., the THP regimen), with the superiority being both statistically significant and clinically meaningful benefits, as well as a favorable overall survival (OS) trend and a manageable safety profile. This combination therapy is expected to become the preferred first-line treatment option for patients with HER2-positive advanced breast cancer.

● In June 2026, the first-batch commercial products of Anbenitamab were delivered nationwide for official clinical use.

● In June 2026, Anbenitamab was selected as one of the "2026 Suzhou Top Ten Industrial Scientific and Technological Achievements".

● The phase II clinical study of KN026 in combination with chemotherapy (with or without Enlonstobart) as first-line treatment for HER2-positive locally advanced or metastatic GC/GEJ is progressing smoothly.

Events after the Reporting Period

● In July 2026, Anbenitamab in combination with HB1801 as first‑line treatment for unresectable or metastatic HER2‑positive breast cancer was granted BTD by Center for Drug Evaluation (CDE) of the NMPA.

● In August 2026, the NDA for Anbenitamab in combination with HB1801 as neoadjuvant treatment for HER2‑positive early or locally advanced breast cancer was accepted by the NMPA and granted priority review.

● In August 2026, the NDA for Anbenitamab in combination with HB1801 as first‑line treatment for unresectable or metastatic HER2‑positive breast cancer was accepted by the NMPA and granted priority review.

Expected Milestones in 2026 (September 2026 and Beyond)

● Data release from the Phase III clinical study of Anbenitamab as first‑line treatment for HER2‑positive breast cancer.

● IND submission in the U.S. and China for Anbenitamab‑based combination therapy in patients with breast cancer previously treated with T‑DXd.

● End‑of‑Phase II (EOP2) communication with the FDA for Anbenitamab as first‑line treatment for HER2‑positive breast cancer.

JSKN003 (Anbenitamab repodatecan)

JSKN003 is developed by site-specific conjugation to the Fc glycans of KN026, resulting in a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. JSKN003 binds to two HER2 epitopes on tumor cells and release topoisomerase I inhibitors upon internalization, exerting anti-tumor effects. Compared to most of ADCs, JSKN003 demonstrates better serum stability, reduced hematological toxicity, and stronger tumor inhibition and bystander effect, resulting in significantly wider therapeutic window. JSKN003 has been granted two BTDs by the NMPA for all-comer platinum-resistant ovarian cancer (PROC) and HER2-positive advanced colorectal cancer; It has also been granted BTD by the FDA for HER2-expressing PROC that has received prior treatment with bevacizumab, has been granted ODD by the FDA for GC/GEJ, has been granted Fast Track Designation (FTD) for all-comer PROC.

Events during the Reporting Period

● In February 2026, the first patient was dosed in the Phase III clinical study of JSKN003versus investigator’s choice of regimen (regorafenib/fruquintinib/trifluridine tipiracil) for the treatment of HER2‑positive advanced colorectal cancer in patients who have failed prior therapy with oxaliplatin, fluorouracil, and irinotecan. The study is currently progressing smoothly.

● Enrollment of all patients was completed in the phase III clinical study of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced breast cancer. Two additional Phase III studies of JSKN003 are ongoing: one versus investigator’s choice of chemotherapy for the treatment of PROC, and the other for the treatment of unresectable locally advanced or metastatic HER2‑low breast cancer.

Events after the Reporting Period

● In July 2026, an updated overall survival (OS) pooled analysis from the Australian Phase I study and the Chinese Phase I/II study of JSKN003 as monotherapy in patients with PROC, with a median follow‑up of 20.5 months, was accepted by the 2026 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and will be presented as a poster during the conference in October.

● In July 2026, data from a Phase II clinical study of JSKN003 in combination with KN026, immunotherapy (IO), and chemotherapy as first‑line treatment for HER2‑positive advanced or metastatic GC/GEJ were accepted by the 2026 ESMO (Free ESMO Whitepaper) Congress and will be presented as a poster during the conference in October.

● In July 2026, JSKN003 received approval from the CDE to conduct a pivotal Phase II clinical study of JSKN003 as monotherapy for second‑line or above treatment of HER2‑overexpressing (IHC 3+) pan‑solid tumors.

Expected Milestones in 2026 (September 2026 and Beyond)

● Data readout from the Phase III clinical study of JSKN003 as second‑line or above treatment for HER2‑positive breast cancer, and submission of a pre‑BLA.

● Completion of patient enrollmlent in the Phase III clinical study of JSKN003 for the treatment of PROC.

● Completion of patient enrollment in the Phase III clinical study of JSKN003 as later‑line treatment for HER2‑low breast cancer.

● EOP2 communication with the FDA for JSKN003 in HER2‑overexpressing colorectal cancer.

JSKN016

JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a DAR of 4. JSKN016 binds to TROP2 and/or HER3 on tumor cells and release topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects.

Events during the Reporting Period

● In March 2026, JSKN016 received approval from the CDE to conduct a Phase III clinical study versus investigator’s choice of regimen for the treatment of unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer (TNBC) in patients who have failed at least two prior lines of systemic therapy. The first patient was dosed in the same month, and the study is currently progressing smoothly.

● In March 2026, the subcutaneous formulation of JSKN016 received approval from the Bellberry Human Research Ethics Committee in Australia to conduct a Phase I clinical study for the treatment of advanced solid tumors. Three patients have been enrolled to date.

● In June 2026, the subcutaneous formulation of JSKN016 was approved via the NMPA "30‑day review channel" for innovative drug clinical trials to conduct a Phase Ib clinical study in China for the treatment of advanced solid tumors. Five patients have been enrolled to date.

● In June 2026, data from the Phase I clinical study of JSKN016 for the treatment of HER2‑negative locally advanced or metastatic breast cancer were presented as a poster at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting. In the TNBC patient subgroup, the objective response rate (ORR) was 64.5%, the disease control rate (DCR) was 83.9%, and the median progression‑free survival (mPFS) was 8.5 months. In the HR+/HER2‑ breast cancer patient subgroup, the ORR was 51.7%, the DCR was 100%, mPFS was not yet mature, and the 12‑month PFS rate was 61.7%.

● The clinical study of JSKN016 monotherapy as later‑line treatment for HR‑positive breast cancer has completed efficacy confirmation, and in June 2026, JSKN016 received approval from the CDE to proceed with a Phase III clinical study.

● The Phase II clinical study of JSKN016 in combination with capecitabine for the treatment of patients with HR‑positive, HER2‑negative breast cancer who have been pretreated with CDK4/6 but not received prior chemotherapy is undergoing smoothly.

● The Phase II clinical study of JSKN016 monotherapy as later‑line treatment of driver gene‑positive (EGFR mutation/rare mutation) NSCLC has completed efficacy confirmation.

● The phase II clinical study of JSKN016 in combination with furmonertinib as first‑line and second‑line treatment for EGFR‑mutant NSCLC is progressing smoothly.

● The phase II clinical study of JSKN016 in combination with ivonescimab and carboplatin as first‑line treatment for driver gene‑negative NSCLC is progressing smoothly.

Events after the Reporting Period

● In August 2026, Jiangsu Alphamab entered into a license agreement with Pathos AI in respect of JSKN016, pursuant to which, Jiangsu Alphamab granted Pathos AI an exclusive license to research, develop, manufacture and commercialize JSKN016 in territories outside the Chinese Mainland, Hong Kong, Macau and Taiwan. Under the terms of the agreement, Jiangsu Alphamab is entitled to receive a non-refundable upfront payment of US$125 million and milestone payments based on certain development and commercialization progress, with a total aggregate consideration of up to US$2,093 million, as well as royalties at high-single digit to low-double digit percentage rates according to aggregate annual net sales in the Licensed Territory. In addition, as part of the overall transaction, Pathos AI granted Alphamab a warrant to subscribe for shares of Pathos AI’s preferred stock, with an aggregate subscription of US$62.5 million (subject to adjustment in accordance with the terms of the overall transaction).

Expected Milestones in 2026 (September 2026 and Beyond)

● Initiation of the Phase II/III clinical study of JSKN016 in the U.S.

● Data release from the clinical studies of JSKN016 as monotherapy and in combination for NSCLC.

JSKN033

JSKN033 is a high-concentration subcutaneous formulation, combining the ADC (JSKN003) with PD-L1(Envafolimab). JSKN033 has synergistic benefits of targeted therapy and immunotherapy while allowing administration in tens of seconds, significantly improving convenience, treatment adherence and patient quality of life.

Events during the Reporting Period

● In March 2026, JSKN033 was approved by the CDE to conduct a Phase II clinical study in combination with platinum‑based chemotherapy (with or without bevacizumab) as first‑line treatment for advanced cervical cancer, and the first patient was dosed in May 2026.

● The POC cohort of JSKN033 as monotherapy for second‑line or above treatment of endometrial cancer has completed patient enrollment.

Events after the Reporting Period

● In July 2026, efficacy and safety data from the Chinese Phase I/II clinical study of JSKN033 in patients with cervical cancer who had failed standard of care were accepted by the 2026 ESMO (Free ESMO Whitepaper) Congress and will be delivered as a rapid oral presentation during the conference in October.

● In August 2026, JSKN033 received approval from the CDE to conduct a Phase III clinical study of JSKN033 monotherapy versus physician choice chemotherapy for the treatment of patients with recurrent or metastatic cervical cancer whose disease has progressed on or after platinum-based chemotherapy and IO therapy, irrespective of HER2 expression status.

JSKN022

JSKN022 is a bispecific single-domain antibody targeting both PD-L1 and integrin αvβ6, developed through antibody-directed evolution. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a DAR of 4. Upon binding to PD-L1 and/or integrin αvβ6 on the surface of tumor cells, JSKN022 can release topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects. Additionally, JSKN022 blocks the binding of PD-L1 and PD-1, thereby activating antitumor immune responses. Simultaneously, by blocking integrin αvβ6, it inhibits the production of TGFB 1/3 and modulates the tumor immune microenvironment.

Events during the Reporting Period

● The Phase I clinical study of JSKN022 in patients with advanced malignant solid tumors is ongoing, with 70 patients enrolled and dose escalation reaching 5 mg/kg, showing preliminary efficacy and a favorable safety profile. The study has now entered the dose‑optimization phase.

Expected Milestones in 2026 (September 2026 and Beyond)

● Completion of dose optimization for JSKN022.

● Initiation of a Phase II clinical study of JSKN022 in combination therapy as first‑line treatment for advanced head and neck squamous cell carcinoma.

● IND submission in the U.S. for JSKN022.

JSKN027

JSKN027 is a first-in-class bispecific ADC designed to co-engage PD-L1 and VEGFR2. By leveraging glycan-specific conjugation technology, it precisely links its cleavable linker and topoisomerase I inhibitor payload to the antibody’s Fc region – maintaining a strong safety profile while unlocking potent anti-tumor activity. JSKN027’s efficacy stems from a unique three-fold synergistic mechanism. Beyond the standard ADC effects of targeted cell killing and bystander activity, it also inhibits tumor angiogenesis by blocking VEGF/VEGFR2 signaling and reverses immune suppression by disrupting the PD-1/PD-L1 checkpoint. This integrated attack enhances overall anti-tumor power and is anticipated to help overcome therapeutic resistance.

Events during the Reporting Period

● The Phase I clinical study of JSKN027 in patients with advanced malignant solid tumors is ongoing, with 18 patients enrolled and dose escalation reaching 12.5 mg/kg, showing preliminary efficacy and a favorable safety profile.

Expected Milestones in 2026 (September 2026 and Beyond)

● Completion of dose escalation and dose expansion for JSKN027.

JSKN021

JSKN021 is a first-in-class dual payload ADC consisting of an EGFR/HER3 bispecific antibody conjugated with novel topoisomerase I inhibitor (T01) and Monomethyl auristatin E (MMAE). Engineered with finely tuned binding avidity in both arms to address tumor heterogeneity while minimizing on-target, off-tumor toxicity, JSKN021 was designed for enhanced stability and improved homogeneity. It combines T01 (DAR 4) and MMAE (DAR 2) payloads to overcome non-response and resistance observed with single-payload treatment strategies.

Events during the Reporting Period

● The Phase I clinical study of JSKN021 in patients with advanced malignant solid tumors is ongoing, with 9 patients enrolled and dose escalation reaching 2 mg/kg.

Expected Milestones in 2026 (September 2026 and Beyond)

● Completion of dose escalation for JSKN021.

● IND submission in the U.S. for JSKN021.

Manufacturing Facilities

The Company’s manufacturing facility has a total floor area of 71,000 square meters, comprising three antibody drug substance (DS) production workshops, two ADC DS production workshops, one pilot DS production workshop, and two drug product (DP) production workshops. The facility is built in compliance with GMP standards of the NMPA (China), FDA (U.S.), and EMA (Europe), and has passed GMP compliance inspections conducted by the NMPA, TGA (Australia, a PIC/S member), and MCAZ (Zimbabwe).

For more information, please refer to the Company’s Interim Results Announcement for the Six Months Ended June 30, 2026 published on the Hong Kong Stock Exchange and the Company’s official website.

(Press release, Alphamab, AUG 28, 2026, View Source [SID1234670915])

On August 28, 2026 NeOnc Technologies Holdings (NASDAQ: NTHI), reported the most important part of the NEO100 story may no longer be whether the company can produce a meaningful signal in recurrent brain cancer. After its latest Phase 2a readout, the bigger move is whether those results can support a credible path toward registration.

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On August 12, NeOnc reported positive topline results from the NEO100-01 Phase 2a study in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The company reported 48.9% six-month progression-free survival, substantially above the prespecified 20% benchmark, with a reported p-value of 0.0047. Median overall survival was reported at 26.09 months, while 86.7% of patients were alive at six months. Five of the 24 patients remained on treatment, including one patient with a partial response continuing beyond 114 days.

Those figures are still clinical-stage evidence, not proof of efficacy sufficient for approval, and the open-label Phase 2a design creates important limitations. Yet, they represent a significant change in the information available to investors. NeOnc now has a defined clinical dataset, survival information and, importantly, a specific regulatory objective: the company plans to request a Type B meeting with the FDA to discuss a potential registrational pathway for NEO100.

That meeting could become the next major catalyst because it may help determine what the FDA would require to move the program forward. In other words, the investment question could be shifting from "Does NEO100 work?" to "What would it take to get NEO100 to a potential approval?"

The science behind the program gives that question additional weight. NEO100 is an intranasal formulation of purified perillyl alcohol being developed for CNS cancers. NeOnc’s strategy is designed around delivering therapy through the nasal route while addressing the challenges associated with treating tumors in the brain. The company is also developing NEO212, which has completed Phase 1 and established a recommended Phase 2 dose of 610 mg.

NeOnc had already described the August clinical readout as "one of the most important clinical milestones in NeOnc’s history." The subsequent data provide context for that statement, while the upcoming FDA interaction could determine whether the milestone becomes a foundation for the next stage of development.

There are other signals worth watching. In June, NeOnc announced UAE IND approvals for NEO100 and NEO212, covering adult and pediatric development programs. The company said the NEO100 authorization encompasses three clinical programs ranging from Phase 1 through Phase 2. Meanwhile, CEO Amir Heshmatpour has continued reporting open-market purchases of NTHI shares, following earlier buying and more than $500,000 in previously disclosed purchases. Director Thomas Chen, M.D., Ph.D. also reported purchasing 33,787 shares at $3.8477 on August 14 and another 2,472 shares at $4.0445 on August 17, according to the provided SEC filing information.

That creates interesting market dynamics, but the fundamental catalyst remains the company’s ability to translate clinical results into regulatory progress and that is ultimately what makes the current setup different.

NeOnc remains a clinical-stage biotechnology company, with substantial risks involving additional trials, regulatory review, financing, manufacturing, competition and eventual commercialization. Phase 2a results do not guarantee a successful registrational study or FDA approval.

However, NEO100 has now crossed an important threshold, by reporting that its primary endpoint was achieved, six-month PFS substantially exceeded its prespecified benchmark, median overall survival reached 26.09 months, and management is preparing to engage the FDA about a potential registrational strategy.

For NTHI, the next headline may matter more than the last one. The clinical question produced a meaningful answer. Now the regulatory question takes center stage.

(Press release, Neonc, AUG 28, 2026, View Source [SID1234670421])

On August 28, 2026 Pinion Immunotherapeutics reported it has published preclinical data supporting ARV-2001, its lead RNA immunotherapy, in the peer-reviewed journal Vaccines. With an Investigational New Drug application cleared by the FDA, Pinion is ready to begin clinical development for women with HPV-16-positive high-grade cervical precancer (CIN2/3).

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ARV-2001 is designed to clear precancerous lesions without surgery while preserving the cervix and addressing the underlying HPV infection. Pinion’s RNA immunotherapy platform combines optimized RNA design, a proprietary lipid formulation, intradermal delivery and a therapeutic regimen designed to generate a targeted T-cell response at the site of disease.

Women with CIN2/3, the immediate precursor to cervical cancer, are typically treated with LEEP, a procedure that removes cervical tissue. LEEP can carry reproductive risks and may not clear the underlying HPV infection. CIN2/3 is also well suited to an immune-based therapy: the disease is localized, the viral targets are defined, and response can be measured directly in cervical tissue.

ARV-2001 targets E6 and E7, two well characterized viral proteins that allow HPV-related precancer to persist. In the study, ARV-2001 encoded modified, non-oncogenic forms of E6 and E7 in Pinion’s proprietary lipid formulation. Intradermal administration outperformed intramuscular injection on tumor control, survival and E6/E7-specific T-cell responses while limiting systemic exposure. The findings established the formulation, delivery method and regimen Pinion will take into the clinic.

"This publication marks an important transition for Pinion from preclinical validation to a clinical-ready program with an FDA-cleared IND," said Gregory Glenn, MD, Chief Executive Officer. "We believe the combination of our platform, formulation and therapeutic regimen gives ARV-2001 a strong foundation as we move into patients."

Pinion’s first-in-human study, PIN-001, will evaluate ARV-2001 in women with HPV-16-positive CIN2/3, with histopathologic clearance of the cervical lesion as the primary endpoint.

The study was published in Vaccines (2026;14(8):714): View Source

(Press release, Pinion Immunotherapeutics, AUG 28, 2026, View Source [SID1234670420])

On August 28, 2026 CREATE Medicines, Inc. ("CREATE"), a clinical-stage biotechnology company pioneering in vivo immune programming, reported a strategic research and development collaboration and license agreement with WestGene Biopharma, a Chengdu, China-based biotechnology company developing targeted lipid nanoparticle (LNP) delivery technology and next-generation mRNA therapeutics.

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The collaboration expands CREATE’s access to cutting edge targeted LNP technologies, combining CREATE’s leading in vivo CAR platform with WestGene’s proprietary tLNP delivery platform. It will evaluate their synergistic potential across three product candidates, providing research, development, and early clinical evaluation of initial programs, and further development activities to advance candidate products.

"Pioneering a new therapeutic class requires us to be fast, smart, and global," said Daniel Getts, Ph.D., Chief Executive Officer and Co-founder of CREATE Medicines. "We are excited to collaborate with WestGene and gain new exposure to its exceptional targeted-LNP expertise and technology. WestGene brings a highly productive translational organization and the ability to advance innovative programs rapidly through clinical studies, which will support CREATE’s efforts to develop the deepest pipeline and most informative human dataset in in vivo cell therapy. By combining these capabilities, we can accelerate the speed of clinical breakthroughs as we continue building the most integrated in vivo immune programming company in the world."

The collaboration will initially advance three programs spanning autoimmune disease, solid tumors, and durable gene delivery:

CRT-403, a dual-target CD19 × BCMA in vivo CAR-T therapy for autoimmune disease that targets both B cells and antibody-producing plasma cells.
CRT-401, a dual-component HER2 × TROP2 multi-immune in vivo CAR program for solid tumors.
A CD19 × BCMA RetroT-enabled in vivo CAR program, combining CREATE’s proprietary site-specific RNA gene integration platform with WestGene’s targeted delivery technology to evaluate durable CAR expression following a single administration.
"We are pleased to collaborate with CREATE Medicines to explore the potential of targeted LNP delivery in next-generation in vivo CAR therapies," said Xiangrong Song, Ph.D., Chairman and Chief Executive Officer of WestGene. "CREATE brings a broad clinical and technology platform spanning multiple immune-cell populations and RNA expression strategies, while WestGene brings targeted delivery technology and extensive experience in translating mRNA innovation in the clinic. Together, we aim to move differentiated programs into patients efficiently and generate data with global relevance."

The collaboration, which may be expanded by mutual agreement, builds on CREATE’s existing autoimmune pipeline, led by CRT-402, its CD19-directed, transient and repeat-dose in vivo CAR-T program, currently in a first-in-human Phase 1/2 clinical study (NCT07778446). CRT-402 establishes the foundation of CREATE’s CD19 development strategy, which the company is expanding through dual-target CD19 × BCMA immune programming with CRT-403 and potentially durable CAR expression through its RetroT platform.

CREATE’s growing global footprint now includes three targeted-delivery partnerships across three continents: WestGene in China, a research collaboration with Monash University in Australia, and a strategic collaboration with Acuitas Therapeutics in Canada. Partnerships are built on CREATE’s clinical dataset, which is the largest in the in vivo CAR field, with more than 60 patients dosed across its in vivo CAR clinical programs. Data generated across its candidates inform each of its subsequent programs, leveraging insights across targets, immune-cell populations, delivery systems, CAR architectures, expression profiles, dosing strategies, and disease settings.

(Press release, Create Medicines, AUG 28, 2026, View Source [SID1234670419])

On August 28, 2026 InxMed Co., Ltd ("InxMed"), a clinical-stage biotechnology company dedicated to developing innovative therapies targeting cancer treatment resistance and metastasis, reported that the clinical results of ifebemtinib (IN10018), a highly selective focal adhesion kinase (FAK) inhibitor, in combination with garsorasib (D-1553), a potent KRAS G12C inhibitor, in previously treated KRAS G12C-mutant metastatic colorectal cancer (CRC), have been published online in The Lancet Oncology.

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The data were derived from a phase Ib/II trial (NCT06166836/NCT05379946) evaluating the efficacy and safety of ifebemtinib plus garsorasib in KRAS G12C-mutant solid tumors, where ifebemtinib plus garsorasib, as an all-oral, chemotherapy-free regimen, demonstrated encouraging antitumor activity in patients with previously treated KRAS G12C-mutant metastatic CRC. This is the first clinical study, to our knowledge, to evaluate the efficacy and safety of FAK inhibitors in combination with KRAS G12C inhibitors in KRAS G12C-mutant solid tumors.

Encouraging Antitumor Efficacy and Manageable Safety Profile

The CRC cohort of this trial contains two parts: Part 1-single-arm study and Part 2-randomized study. In Part 1-single-arm study, 15 previously-treated KRAS G12C-mutant metastatic CRC patients were enrolled and received ifebemtinib (100mg once a day) plus garsorasib (600mg twice a day) orally. And in Part 2-randomized study, 36 previously-treated KRAS G12C-mutant metastatic CRC patients were enrolled and randomly assigned (1:1) to receive ifebemtinib plus garsorasib or garsorasib alone (600mg twice a day) orally. By the data cutoff on June 30, 2025, the median follow-up was 23.8 months in the single-arm study, and in the randomized study the median follow-up was 10•3 months for the combination group and 10•9 months for the monotherapy group. Key findings published in this paper were summarized below:

Objective Response Rate (ORR): In the single-arm study, 15 patients were enrolled with 14 patients evaluable, and the confirmed ORR was 46.7% (95% CI: 21.3–73.4) in the full population and 50.0% (95% CI: 23.0–77.0) in the evaluable population. In the randomized study, the confirmed ORR was 38.9% (95% CI: 17.3–64.3) in the ifebemtinib plus garsorasib group versus 16.7% (95% CI: 3.6–41.4) in the garsorasib monotherapy group, representing an absolute improvement of 22.2% in the combination group.

Progression-Free Survival (PFS): In the single-arm study, the median PFS was 6.9 months (95% CI: 2.8–12.0). In the randomized study, ifebemtinib plus garsorasib achieved a median PFS of 7.7 months (95% CI: 3.0–NE) versus 4.0 months (95% CI: 2.0–5.6) with garsorasib monotherapy group (HR 0.48, 95% CI: 0.22–1.04), pointing to a favorable PFS trend in favor of the combination.

Overall Survival (OS): In the single-arm study, the median OS was 14.3 months (95% CI: 4.7–NE). In the randomized study, the median OS was not estimable (95% CI: 10.2–NE) in ifebemtinib plus garsorasib group versus 7.5 months (95% CI: 5.3–NE) in garsorasib monotherapy group (HR 0.34, 95% CI: 0.11–1.12), suggesting a favorable OS trend in the combination group.

Manageable safety profile: Across all 33 patients receiving ifebemtinib plus garsorasib, 32 patients (97%) reported treatment-related adverse events (TRAE) with most of them reported as grade 1-2 and grade 3 TRAEs reported in 30% of patients. No grade 4 TRAEs, treatment-related deaths or TRAEs leading to study drug discontinuation were reported across all cohorts. The most common TRAEs occurring in all 33 patients receiving ifebemtinib plus garsorasib were diarrhoea, proteinuria, and nausea.

Overcoming Resistance by FAK Inhibition When Targeting KRAS

KRAS G12C mutations occur in approximately 3–4% of patients with metastatic colorectal cancer. Currently, KRAS G12C inhibitor monotherapy shows limited efficacy in this patient population, and two KRAS G12C inhibitors plus anti-EGFR antibody regimens demonstrated synergistic activity and have been approved by FDA for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. However, anti-EGFR antibody requires intravenous administration and are commonly associated with dermatological toxicities. How to further enhance the efficacy of KRAS G12C-targeted therapy while providing a more convenient and tolerable treatment option has become a clinical imperative.

InxMed’s translational research found out that KRAS G12C inhibition alone triggers adaptive hyperactivation of the FAK–YAP signaling pathway, promotes fibrogenesis in the tumor microenvironment, and thereby enhances tumor cell survival. FAK inhibition by ifebemtinib disrupts this resistance mechanism, sensitizing tumor cells to KRAS G12C inhibition and prolonging the duration of treatment response. The clinical data reported herein provide further support for ifebemtinib in combination with KRAS G12C inhibitors in the treatment of previously treated KRAS G12C-mutant metastatic CRC.

Advancing the Clinical Development

The study demonstrates that the dual-oral, chemotherapy-free regimen of ifebemtinib plus garsorasib has shown encouraging antitumor activity and a manageable safety profile in patients with previously treated KRAS G12C-mutant metastatic CRC. These findings warrant a pivotal trial of this combination regimen to further establish its clinical benefit. The company has submitted an IND application in China, for a phase III trial evaluating the efficacy and safety of ifebemtinib plus garsorasib versus investigators’ choice of standard therapy for treatment of previously treated metastatic colorectal cancer harboring KRAS G12C mutation.

Based on a robust translational medicine foundation and compelling clinical evidence, Ifebemtinib is poised to become a revolutionary therapeutic that could fundamentally reshape the RAS-targeted treatment paradigm. InxMed is strategically driving a comprehensive development program for Ifebemtinib across RAS-mutant tumors, with combination regimens already initiated or in preparation not only with KRAS G12C inhibitors, but also with KRAS G12D inhibitors and multi-RAS inhibitors, among other novel classes, underscoring the company’s commitment to transforming the future of RAS-addicted cancers.

About Ifebemtinib (IN10018)

Ifebemtinib (IN10018) is an orally available, highly potent, and selective small-molecule inhibitor of focal adhesion kinase (FAK). InxMed holds exclusive global development and commercialization rights. Clinically, ifebemtinib has demonstrated excellent safety and tolerability in over 700 subjects globally, showing vast potential as a "backbone" combination partner across multiple modalities, including RAS inhibitors, immune checkpoint blockades, and antibody-drug conjugates (ADCs). It has received multiple Breakthrough Therapy Designations from the NMPA and Fast Track Designation from the U.S. FDA.

(Press release, InxMed, AUG 28, 2026, View Source [SID1234670418])