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])

On August 28, 2026 Kazia Therapeutics Limited (NASDAQ: KZIA) ("Kazia" or the "Company"), an oncology-focused biotechnology company developing therapies that selectively reprogram cancer biology, restore anti-tumor immunity and overcome treatment resistance, reported the pricing of its previously announced tranched registered public offering (the "Offering") of (i) 2,580,000 American Depositary Shares ("ADSs"), each representing five hundred (500) ordinary shares of the Company, no par value per share, or in lieu of ADSs to certain investors, pre-funded warrants to purchase ADSs, (ii) accompanying Series A Warrants to purchase up to 2,243,478 ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at a purchase price of $17.825 per ADS and will expire upon the earlier of 30 days following the Company’s Stage IV triple-negative breast cancer (TNBC) data readout, expected in the second half of 2027, or the five-year anniversary of issuance, and (iii) accompanying Series B Warrants to purchase up to 2,064,000 ADSs (or pre-funded warrants in lieu thereof), which are exercisable immediately at a purchase price of $19.375 per ADS and will expire upon the earlier of 30 days following the Company’s HR+/HER2- data readout, expected in the first half of 2028, or the five-year anniversary of issuance. All of the securities in the Offering are being sold by Kazia. The combined public offering price for each ADS and accompanying warrants is $15.50, and the combined public offering price for each pre-funded warrant and accompanying warrants is $15.4999 (equal to the combined public offering price per ADS and accompanying warrants less $0.0001), for expected gross proceeds to Kazia of approximately $40 million, before deducting underwriting discounts and commissions and offering expenses. If all of the Series A Warrants and Series B Warrants are exercised in full, the Company would receive additional gross proceeds of approximately $80 million, before deducting applicable expenses.

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Leerink Partners and Guggenheim Securities are acting as joint bookrunning managers for the Offering. BTIG and Needham & Company are acting as lead managers for the Offering. Laidlaw & Company (UK) Ltd. is acting as co-manager for the Offering.

The Offering is expected to close on or about August 31, 2026, subject to satisfaction of customary closing conditions.

Kazia intends to use the net proceeds from the Offering primarily to fund clinical development of paxalisib, including ongoing and planned studies in triple-negative breast cancer and HR+/HER2- breast cancer and other oncology indications, and for working capital and general corporate purposes.

The ADSs and warrants are being offered pursuant to a registration statement on Form F-3 (File No. 333-294392), which was previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC"). The Offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the Offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, electronic copies of the preliminary prospectus supplement and the accompanying base prospectus may be obtained from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected], or from Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, telephone: (212) 518-9544, email: [email protected].

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

(Press release, Kazia Therapeutics, AUG 28, 2026, View Source [SID1234670417])