On August 12, 2026 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) reported that the REZILIENT3 trial, a global Phase 3 clinical trial evaluating the combination of zipalertinib and platinum-based chemotherapy compared with chemotherapy alone in the first-line treatment of adult patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations, met its primary endpoint of progression-free survival (PFS) at a planned interim analysis.

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In this analysis, the study demonstrated a statistically significant and clinically meaningful improvement in PFS in the zipalertinib containing arm. Observed safety for the zipalertinib containing arm was manageable. Based on these data, the Independent Data Monitoring Committee recommended unblinding the study. The trial will continue to monitor efficacy and safety.

Full results from REZILIENT3 will be submitted for presentation at an upcoming international medical conference. Based on these results, pending discussions with the U.S. Food and Drug Administration (FDA), Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics plan to pursue U.S. regulatory approval for this combination regimen in the first-line setting.

"The positive topline results from the planned interim analysis of REZILIENT3 further support the potential of zipalertinib to meet the high unmet medical need in patients with NSCLC harboring EGFR exon 20 insertion mutations," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We look forward to pursuing regulatory approval of zipalertinib in combination with chemotherapy in the first-line treatment setting with the goal of providing a new treatment option for this group of patients."

"Zipalertinib is a compound created through Taiho Pharmaceutical’s proprietary drug discovery technology," said Fabio Benedetti, MD, Global Chief Medical Officer, Taiho Pharmaceutical. "Achieving positive results in this Phase 3 trial in the first-line setting represents an important milestone for this program. We will continue to work closely with Taiho Oncology and Cullinan Therapeutics to bring zipalertinib in combination with chemotherapy to patients as soon as possible."

"Meeting the primary endpoint early at a planned interim analysis marks an important milestone for the REZILIENT3 study and supports the potential role of zipalertinib in the first-line treatment setting," said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. "These topline results give us confidence in the potential for zipalertinib to offer a first-line treatment option for patients with NSCLC with EGFR exon 20 insertion mutations."

About the REZILIENT3 Trial

This multicenter, randomized, controlled, open-label global trial enrolled 285 adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. The primary objective of this trial is to assess progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm.

About Zipalertinib

Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

About EGFR Exon 20 Insertion Mutations

NSCLC is a common form of lung cancer and up to 4% of all cases globally have EGFR ex20ins.1 In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations,1 with insertions at exon 20 accounting for up to 12% of these mutations.

(Press release, Taiho, AUG 12, 2026, View Source [SID1234670028])

On August 12, 2026 NMPA reported to have granted approval to Geneseeq’s PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for VELMARTO (Eratrectinib), a next‑generation highly selective TRK inhibitor independently developed by Vcare PharmaTech. The approval provides critical support for the precise identification and clinical medication of patients with NTRK fusion‑positive solid tumors.

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As the original companion diagnostic for Eratrectinib, PanTRKare addresses key testing challenges including the pan‑tumor distribution, low incidence and complex fusion patterns of NTRK1/2/3 fusions, enabling accurate detection of NTRK fusion variants across diverse cancer types. Following clinical accuracy validation, bridging study results demonstrated that patients tested positive by PanTRKare achieved objective response rates highly consistent with those observed in the drug’s clinical trials, in both treatment‑naïve and pre‑treated populations. This further validates the assay’s stability and consistency for companion diagnostic applications.

Eratrectinib marks Nanjing’s first innovative drug approval this year. Through innovative cyclic structural optimization, it delivers more potent and highly selective inhibition of TRK kinases, overcoming structural limitations and drug‑resistance drawbacks of first‑generation agents at the molecular‑mechanism level. The pivotal VC004‑101 clinical trial has comprehensively verified Eratrectinib’s clinical efficacy and long‑term patient benefits. Study data revealed an overall ORR of 68.5% for Eratrectinib. Among patients with follow‑up exceeding six months, the ORR rose further to 89.7%, representing clinically meaningful improvement superior to first‑generation TRK inhibitors.

In terms of long‑term therapeutic benefit, Eratrectinib exhibited favorable PFS and DOR, with a 2‑year PFS rate of 75.7% and a 2‑year DOR rate of 85.5%. These findings confirm its capacity to deliver durable disease control and sustained remission for patients. It also demonstrates prominent advantages in long‑term survival outcomes by effectively prolonging overall survival; the median OS reached 40.7 months, bringing substantial long‑term survival benefits to patients.

Both Vcare PharmaTech and Geneseeq are enterprises located in the Life Science & Health Industry Office of Nanjing Jiangbei New Area, with a solid long‑term collaborative foundation. Eratrectinib gained marketing approval in June this year, and merely two months later, PanTRKare obtained approval for its companion diagnostic use. This completes a key link in the diagnosis‑treatment workflow for NTRK‑fusion solid tumors, creating favorable conditions for post‑launch patient identification, clinical implementation and market adoption, and enabling eligible NTRK‑positive patients to access Eratrectinib targeted therapy at an earlier time point. Such expedited dual approvals fully illustrate the synergistic value brought by the strong partnership between the two parties. It also underscores the industrial ecosystem strengths of Life Science & Health Industry Office of Nanjing Jiangbei New Area in connecting upstream‑downstream industrial chains and empowering collaborative innovation among resident enterprises.

(Press release, Jiangsu Vcare PharmaTech, AUG 12, 2026, View Source [SID1234670027])

On August 12, 2026 Senhwa Biosciences, Inc. (TPEx: 6492) reported a significant research advance involving its investigational drug Pidnarulex (CX-5461). A multinational research team comprising investigators from Poland, Slovakia, France and Senhwa Biosciences in Taiwan found that, under specific cell-based experimental conditions, controlled light activation increased the cancer-cell-killing activity of CX-5461 by up to 96-fold and induced immunogenic cell death (ICD). The findings, published in the peer-reviewed journal Nucleic Acids Research, reveal that CX-5461 may have potential applications in photodynamic therapy and photoimmunotherapy in addition to its established research profile involving G-quadruplex (G4) targeting and DNA-damage-related mechanisms. The study opens a potential new development path for this clinical-stage asset.

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Turning Photosensitivity into a Controlled Therapeutic Mechanism
Photosensitivity observed during the clinical development of CX-5461 has generally been viewed as a drug characteristic requiring risk management. In the new study, researchers reframed this property as a potentially controllable and spatially targeted therapeutic mechanism. By applying light of an appropriate wavelength to the tumor area, CX-5461 may be activated at the intended site, increasing local tumor-cell killing while limiting activity in non-illuminated tissue.

This light-switch concept could extend CX-5461 from a systemically administered anticancer agent into a photosensitizer with temporal and spatial control. The approach may warrant further investigation in tumors that are accessible to external light, endoscopy or fiber-optic delivery, including selected skin, oral and esophageal tumors.

Light Activation Triggers Tumor-Cell Killing and Immunogenic Cell Death
The study further showed that light-activated CX-5461 not only directly damaged cancer cells but also induced ICD. When cancer cells die through an immunogenic process, they release or expose danger-associated signals, including cell-surface calreticulin, extracellular ATP and high-mobility group box 1 (HMGB1). These signals can help dendritic cells recognize and take up tumor antigens, potentially initiating a T-cell-mediated antitumor immune response.

The therapeutic objective may therefore extend beyond destroying an illuminated local tumor. By making antigens from dying cancer cells more visible to the immune system, the treatment could provide a biological basis for using localized therapy to stimulate a broader antitumor immune response.

Preclinical Findings Support an In Situ Cancer Vaccine Concept
In preclinical mouse studies, animals whose tumors regressed after treatment with CX-5461 and light exposure showed suppressed tumor growth when subsequently challenged with the same cancer cells. The observation suggests that treatment may establish tumor-specific immune memory and supports further investigation of an in situ cancer vaccine concept. Under this approach, the patient’s own tumor could serve as the source of tumor antigens, allowing an immune response to be initiated at the treatment site without the need to manufacture an external vaccine in advance.

If validated through additional studies, this mechanism could also be explored in combination with immune checkpoint inhibitors targeting PD-1 or PD-L1, with the goal of broadening or prolonging antitumor immune activity. These findings are preclinical and require confirmation in additional animal studies and human clinical trials.

Expanding the Potential Value of an Existing Clinical-Stage Asset
In drug development, a molecule can gain a second life when its existing properties and mechanisms are understood in a new way. CX-5461 has already generated a body of development data across chemistry, manufacturing and controls, toxicology, pharmacology and human clinical safety. The new research reframes photosensitivity as a potentially useful therapeutic mechanism and extends the molecule’s research potential beyond G4 targeting and DNA-damage response into photodynamic therapy, photoimmunotherapy and immune-combination strategies.

Compared with developing an entirely new molecule from the outset, identifying a new mechanism and potential indications for an existing clinical-stage asset may support development continuity and broaden its potential product lifecycle, subject to successful preclinical, regulatory and clinical evaluation.

Next Steps
Senhwa views these findings as an important starting point for repositioning the value of CX-5461. Based on further validation, the Company plans to evaluate suitable tumor types, dosing and illumination conditions, light-delivery technologies and potential combination strategies. Senhwa will also seek multinational academic and industry collaborations to support the clinical translation of this photoimmunotherapy approach.

Additional preclinical and regulatory work will be required before clinical development can proceed. The safety and efficacy of CX-5461 as a photodynamic or photoimmunotherapy treatment have not been established in human clinical trials, and CX-5461 has not been approved for commercial use in these applications.

(Press release, Senhwa Biosciences, AUG 12, 2026, View Source [SID1234670026])

On August 12, 2026 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the China National Medical Products Administration (NMPA) has approved the supplemental New Drug Application (sNDA) for ivonescimab injection in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC).

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The approval of ivonescimab combination therapy as a first-line treatment for squamous NSCLC marks the third lung cancer indication for ivonescimab. In a randomized, double-blind Phase III trial, this regimen demonstrated statistically significant improvements in both progression-free survival (PFS) and overall survival (OS) compared with a PD-1 inhibitor plus chemotherapy. These results establish a new first-line standard of care for squamous NSCLC and mark a major milestone in the treatment of lung cancer worldwide.

This latest approval is supported by the breakthrough results from the Phase III HARMONi-6/AK112-306 study. The positive OS data were presented in a Plenary Session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the first time a China-originated novel therapy has been featured in an ASCO (Free ASCO Whitepaper) Plenary Session. The full results were simultaneously published in The Lancet. The positive PFS results were previously presented in a Presidential Symposium at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, with the full paper concurrently published in The Lancet as well.

The HARMONi-6 study enrolled a total of 532 patients. Approximately 63% had centrally located squamous tumors, 39.0% had PD-L1 TPS <1%, and 33.8% had multi-site metastases, liver metastases, or brain metastases. The study met all primary and secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in both PFS and OS, with a favorable safety profile.

Key findings from the HARMONi-6 study:

Ivonescimab plus chemotherapy significantly prolonged OS. Ivonescimab plus chemotherapy reduced the risk of death by 34% versus tislelizumab plus chemotherapy (HR=0.66 [95% CI: 0.50-0.87], P=0.0017). Median OS was 27.9 months in the ivonescimab arm versus 23.7 months in the control arm. The 12-month OS rate was 78.9% with ivonescimab plus chemotherapy versus 72.2% in the control arm, and the 24-month OS rate was 64.7% versus 48.6%, respectively. The survival benefit continued to widen over time, reflecting a more durable and clinically meaningful long-term survival advantage compared with PD-1 inhibitor plus chemotherapy.
At the prespecified interim analysis for PFS, ivonescimab plus chemotherapy had already demonstrated a clinically meaningful and statistically significant improvement in PFS compared with tislelizumab plus chemotherapy, with a median PFS of 11.1 months versus 6.9 months (HR=0.60 [95% CI: 0.46-0.78], P<0.0001).
Consistent and substantial OS benefit was observed across all prespecified subgroups, regardless of PD-L1 expression levels or metastatic burden.
The overall safety profile of the ivonescimab combination was favorable and comparable to that of the control arm.
Professor Shun Lu, Principal Investigator of HARMONi-6, Director of the Oncology Department, Shanghai Chest Hospital:

"We are highly encouraged by the dual-positive PFS and OS results from HARMONi-6 and proud to see the approval of ivonescimab plus chemotherapy for first-line sq-NSCLC. By outperforming PD-1 plus chemotherapy, this regimen has rewritten the gold standard of care and represents a landmark advance in the treatment of lung cancer.

HARMONi-6 provides clear evidence that compared to PD-1 plus chemotherapy, the ivonescimab treatment significantly prolongs both OS and PFS, reduces the risks of death and disease progression, delivers consistent benefit across subgroups, and helps patients maintain better quality of life for longer. These findings fully demonstrate the breakthrough clinical value of the PD-1/VEGF bispecific mechanism and the strengths of this next-generation immuno-oncology therapy. The regimen also overcomes the previous limitation that anti-angiogenic agents could not be used in sq-NSCLC, filling an important clinical gap.

Ivonescimab combination therapy offers patients a new, more effective and safer treatment option, bringing particular hope to those with squamous cell carcinoma who have had limited choices. This is what we as clinicians and patients have long been waiting for. We look forward to seeing ivonescimab continue to deliver strong results globally and help reshape cancer treatment worldwide."

Dr. Xia Yu, Founder, Chairwoman, President and CEO of Akeso:

"We are incredibly pleased by the approval of ivonescimab plus chemotherapy for first-line advanced squamous NSCLC. This approval marks a critical milestone in the development of next-generation immuno-oncology therapies worldwide. We sincerely thank all the investigators, patients, and regulatory authorities who made this possible. Since its inception, ivonescimab’s every advance has drawn significant global attention and is recognized as a benchmark therapy poised to shape the pharmaceutical landscape from 2026 onward and redefine treatment paradigms. With robust dual-positive PFS and OS data, it has successfully challenged PD-1 plus chemotherapy, rewritten the first-line standard of care for squamous NSCLC, and established a new benchmark for clinical benefit.

Currently, ivonescimab stands as the cornerstone of Akeso’s IO2.0 + ADC2.0 strategy. We are advancing a portfolio of highly differentiated therapies that continue to elevate and reshape the global treatment landscape in major cancers such as lung and breast cancer. This work includes extensive combination studies with our proprietary next-generation ADCs and bispecific ADCs, as well as partnerships with multiple high-potential ADC candidates from collaborators around the world. The breakthrough results from HARMONi-6 further strengthen our confidence in ivonescimab’s transformative clinical value and its potential for even greater success worldwide. Together with Summit, we are committed to bringing the full value of ivonescimab to patients worldwide."

Previously, in patients with advanced non-squamous NSCLC who had progressed on EGFR-TKI therapy, the HARMONi-A study of ivonescimab became the first immunotherapy trial to demonstrate clinically meaningful and statistically significant improvements in both PFS and OS. In the Phase III HARMONi-2 study, first-line ivonescimab delivered a median PFS of 11.14 months in PD-L1-positive NSCLC, compared with 5.8 months for pembrolizumab, making it the first drug to demonstrate a positive Phase III result against the leading PD-1 therapy.

These results position ivonescimab as a cornerstone of the immuno-oncology 2.0 era. Across comparisons with PD-1 monotherapy, PD-1 plus chemotherapy (the current optimal standard of care in many tumors), and VEGF-targeted therapies, ivonescimab has shown clear clinical advances and a strong capacity to improve upon existing treatment options.

(Press release, Akeso Biopharma, AUG 12, 2026, View Source [SID1234670025])

On August 12, 2026 Azitra, Inc. ("Azitra" or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides, reported financial results for the quarter ended June 30, 2026, and provided a business update.

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Q2 2026 and Recent Business Highlights

Reported the first preclinical data from ATR-COSF demonstrating breakthrough repeat-dose distribution, controlled delivery into targeted skin layers and anti-wrinkle activity in ex vivo human skin, supporting advancement toward a planned proof-of-concept clinical study.
Continued enrollment of the first cohort in the Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash.
Continued advancement of recombinant protein initiatives, including Tobacco Etch Virus (TEV) Protease and T7 RNA Polymerase, expanding the Company’s platform into biotechnology research and manufacturing applications.
Issued CEO Letter to Shareholders detailing Azitra’s expanded strategy to leverage its proprietary microbial genetic engineering platform across therapeutics, cosmetic ingredients and biotechnology products.
"The second quarter has marked an exciting evolution for Azitra with the first data from our ATR-COSF program, which provided validation of our strategy to leverage our microbial genetic engineering platform beyond traditional therapeutics," said Francisco Salva, Chief Executive Officer of Azitra. "Combined with the continued advancement of ATR-04 and our recombinant protein initiatives, these accomplishments reflect the breadth of opportunities we are creating in multiple billion dollar markets, including therapeutics, cosmetic ingredients and biotechnology applications."

Salva continued: "Our ATR-COSF program continues to excite our team, as it represents one of the first to demonstrate the wrinkle reducing potential of recombinant filaggrin ingredient in ex vivo human skin. It shows Azitra’s ability to translate our cutting edge science into observable benefits for consumers. The ATR-COSF program represents our first step in unlocking meaningful value for shareholders while positioning Azitra at the intersection of synthetic biology, artificial intelligence and next-generation biological manufacturing.

"During the quarter, we also continued enrollment of the first cohort in our Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash. With six active clinical sites, including MD Anderson Cancer Center, we remain on track to report topline data from the first cohort around year end. Additionally, we are in the process to open eligibility criteria to other cancer treatment related rashes driven by inhibitors along the same EGFR/KRAS/MEK/ERK pathway. EGFR inhibitor-associated rash remains a significant unmet medical need, affecting an estimated 50% to 90% of patients receiving EGFR-targeted cancer therapies and frequently leading to dose reductions, treatment interruptions or discontinuation."

Salva concluded: "Looking ahead, we remain focused on implementing the strategy outlined in our recent shareholder letter. That includes advancing ATR-COSF toward a planned proof-of-concept clinical study, continuing development of our recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase, and progressing ATR-04 as our lead clinical therapeutic program. We believe these initiatives position Azitra to unlock the full potential of our platform while creating multiple avenues for long-term growth and shareholder value."

Pipeline Achievements and Upcoming Milestones

ATR-COSF – New Consumer Initiative to Improve the Appearance of Fine Lines and Wrinkles

Results from synthesized filaggrin ingredients, repeat application study on explanted cosmetic surgery skin.
Announced positive preclinical data demonstrating breakthrough repeat-dose delivery and distribution together with anti-wrinkle activity in ex vivo human skin, supporting advancement toward a planned proof-of-concept cosmetic study evaluating the safety and efficacy of ATR-COSF.
Human cosmetic application study planned to start in Q3 2026.
ATR-04 – Addressing an Unmet Need for Cancer Patients in a Billion Dollar Market Opportunity

Continued enrollment of the first cohort of the ongoing Phase 1/2 clinical trial evaluating ATR-04 for the treatment of EGFRi-associated rash.
Topline data from first cohort of Phase 1/2 trial expected in Q4-2026.
Recombinant Protein Platform

Announced plans to advance development of its recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase.
Platform provides opportunity to develop high-quality recombinant proteins for biotechnology research and manufacturing applications, representing potential opportunities to leverage its microbial genetic engineering expertise while broadening its long-term commercial potential.
ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome

Consistent with the priorities outlined in the Company’s recent shareholder letter, Azitra plans to strategically pause further enrollment in the ongoing Phase 1b study evaluating ATR-12 for Netherton syndrome.
This decision reflects the Company’s disciplined approach to capital allocation and its focus on advancing programs with the greatest near-term opportunities for clinical, commercial and shareholder value creation.
Financial Results for the Quarter Ended June 30, 2026

Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2026, were $1.4 million compared to $1.4 million for the comparable period in 2025.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2026, were $2.1 million compared to $1.5 million for the comparable period in 2025.
Net Loss was $3.3 million for the quarter ended June 30, 2026, compared to $2.9 million for the comparable period in 2025.
Cash and cash equivalents: As of June 30, 2026, Azitra had cash and cash equivalents of $6.7 million.

(Press release, Azitra, AUG 12, 2026, View Source [SID1234670024])