On July 15, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported compelling new preclinical data independently validating the anti-tumor activity of its lead cell therapy candidate, ERNA-101, in combination with PD-1 checkpoint inhibition.

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The independently conducted study successfully reproduced earlier findings generated at The University of Texas Anderson Cancer Center, demonstrating complete tumor clearance and durable long-term survival in a substantially larger study. The results further strengthen confidence in ERNA-101’s mechanism of action and provide important third-party validation as the Company advances toward its planned Investigational New Drug (IND) submission in the third quarter of 2026 and anticipated first-in-human Phase 1 clinical trial in the fourth quarter.

In the study, ERNA-101 combined with anti-PD-1 therapy achieved complete tumor clearance and long-term survival in 10 of 15 treated animals (67%). Remarkably, no complete tumor clearance or durable survival was observed in any of the remaining 45 animals treated with ERNA-101 alone, anti-PD-1 alone, or left untreated, demonstrating the unique anti-tumor activity of the combination therapy.

"This independent study represents an important milestone as we transition from a preclinical company to a clinical-stage oncology company," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics. "Independent reproduction of these findings in a larger, statistically robust study substantially increases our confidence in ERNA-101 and meaningfully strengthens the scientific foundation supporting our upcoming IND submission. Perhaps most importantly, complete tumor eradication and long-term survival were observed only with the ERNA-101 combination therapy, reinforcing our belief that ERNA-101 has the potential to unlock the full therapeutic benefit of checkpoint inhibitors in ovarian cancer and potentially many other immunologically ‘cold’ solid tumors. With IND submission planned this quarter and our first clinical study expected later this year, we believe Ernexa is entering one of the most important value-creating periods in the Company’s history."

Earlier studies performed by The University of Texas Anderson Cancer Center demonstrated that ERNA-101 selectively homes to ovarian tumors and delivers its engineered IL-7/IL-15 fusion cytokine directly into the tumor microenvironment. This localized immune activation increased infiltration of cancer-fighting T cells into tumors that typically evade immune detection, providing the biological rationale for combining ERNA-101 with PD-1 checkpoint inhibitors.

The newly completed independent study reproduced those findings and further demonstrated that this strategy generates durable anti-tumor responses that were not achieved with either therapy alone.

"One of the greatest challenges in immuno-oncology is that many solid tumors remain effectively invisible to the immune system," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "These independently generated results provide compelling validation that ERNA-101 may successfully remodel the tumor microenvironment, recruit and activate T cells, and dramatically enhance the activity of PD-1 checkpoint inhibitors. Independent confirmation of these findings is particularly meaningful because reproducibility is one of the strongest indicators supporting successful clinical translation. We believe ERNA-101 has the potential to become an important combination immunotherapy platform for ovarian cancer and potentially numerous other immunologically ‘cold’ solid tumors where today’s checkpoint inhibitors have produced limited clinical benefit."

The study was conducted by an independent contract research organization using expanded treatment groups in an immunocompetent ID8luc-ova syngeneic ovarian cancer model. Tumor burden was monitored longitudinally through bioluminescence imaging to evaluate treatment response and confirm complete tumor clearance.

The study included four treatment arms:

ERNA-101 plus anti-PD-1
ERNA-101 monotherapy
Anti-PD-1 monotherapy
Untreated control

Complete tumor clearance and durable long-term survival were observed exclusively in the combination therapy group, further validating the synergistic mechanism between ERNA-101 and PD-1 blockade.

With completion of this independent validation study, Ernexa remains on track to submit its IND application during the third quarter of 2026 and initiate its first-in-human Phase 1 clinical trial during the fourth quarter of 2026.

(Press release, Ernexa Therapeutics, JUL 15, 2026, View Source [SID1234669245])

On July 15, 2026 Cardiff Oncology, Inc. (Nasdaq: CRDF) (the "Company"), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 8,571,429 shares of its common stock and accompanying warrants to purchase up to an aggregate of 8,571,429 shares of its common stock, at a purchase price of $1.05 per share and accompanying warrant in a registered direct offering. In addition, certain members of the Company’s officers and directors are participating in the offering and have entered into definitive agreements for the purchase and sale of an aggregate of 731,707 shares of the Company’s common stock and accompanying warrants to purchase up to an aggregate of 731,707 shares of the Company’s common stock, at a purchase price of $1.435 per share and accompanying warrant. The warrants will have an exercise price of $1.31 per share, will be exercisable beginning on the later of (i) six months after issuance and (ii) the effective date of the increase of the Company’s authorized shares of common stock following stockholder approval, and will expire five and one-half years from the initial exercise date. The closing of the offering is expected to occur on or about July 16, 2026, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $10 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-285327) filed with the Securities and Exchange Commission ("SEC") on February 27, 2025 and declared effective on May 13, 2025. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or 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 jurisdiction.

(Press release, Cardiff Oncology, JUL 15, 2026, View Source [SID1234669243])

On July 15, 2026 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported the publication of complete Phase 1 data from the TRAVERSE study of ALLO-316 in advanced or metastatic renal cell carcinoma (RCC) in the Journal of Clinical Oncology. TRAVERSE is being conducted as part of a strategic five-year collaboration with The University of Texas MD Anderson Cancer Center. ALLO-316, Allogene’s CD70-targeting AlloCAR T investigational therapy incorporating the Dagger technology, achieved robust expansion, tumor infiltration, and durable antitumor activity in a solid tumor setting.

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"TRAVERSE represents a potential breakthrough for both Allogene and the broader CAR T field," said Zachary Roberts, M.D., Ph.D., President and Chief Executive Officer of Allogene. "CAR T has transformed hematologic malignancies while solid tumors have remained one of the field’s most difficult challenges. When we designed ALLO-316 with the Dagger technology, our goal was to address two of the most persistent barriers in solid tumors – achieving robust CAR T expansion with standard lymphodepletion and translating that biology into durable responses. These results show that a well-designed allogeneic CAR T product, developed for a defined population, can expand, persist, and produce durable responses in metastatic, treatment refractory solid tumors. Importantly, the robust CAR T expansion and durable persistence in this trial provides clinical validation of our Dagger technology platform and has direct read-through to our broader clinical and preclinical pipeline of next-generation AlloCAR T candidates."

Across the full Phase 1 TRAVERSE trial, 51 patients with Stage IV disease were enrolled, of whom 46 received ALLO-316 and had a median follow-up time of 28.8 months. The Phase 1b expansion cohort evaluated the safety and efficacy of the recommended Phase 2 regimen – ALLO-316 at a dose of 80M CAR T cells following a standard FC lymphodepletion regimen (fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) for 3 days). The 22 patients in the Phase 1b safety population all had RCC resistant to immune checkpoint blockers and at least one tyrosine kinase inhibitor (TKI), 82% had received ≥2 prior TKIs, and 41% had received prior belzutifan. Twenty of these patients received ALLO-316. Sixteen of the ALLO-316-treated patients in Phase 1b had a high CD70 Tumor Proportion Score (TPS ≥50%). The median time from enrollment to the start of therapy was four days.

"Most patients in TRAVERSE had exhausted available therapies and faced a poor prognosis, with survival often measured in months," said Samer A. Srour, MB ChB, MS, of The University of Texas MD Anderson Cancer Center. "In that context, the depth and durability of responses observed with a one-time ALLO-316 infusion are very promising, particularly in patients with high CD70-expressing tumors where all responders remained progression-free at the time of the published analysis. Taken together, these findings strongly support the continued clinical development of ALLO-316 and its evaluation as a potential new treatment approach for patients with advanced RCC."

A single dose of ALLO-316 produced disease control in half of patients in the Phase 1b cohort, with an overall confirmed response rate of 25% and a confirmed response rate of 31% in patients with CD70 TPS ≥50%. The median duration of response (mDOR) had not been reached (95% CI: 6.9 months to not estimable), with the longest ongoing response exceeding 18 months. Median overall survival in the Phase 1b population was 15.2 months (95% CI: 4.6 months to not estimable) and was not estimable in the CD70-high group (95% CI: 3.2 months to not estimable).

CD70+ patients Phase 1b (N=20)
n (%)
ORR (confirmed CR or PR per RECIST v1.1) 5/20 (25%)
CD70 TPS ≥50% 5/16 (31%)
CD70 TPS <50% 0/4 (0)
RECIST v1.1, Response Evaluation Criteria in Solid Tumors, version 1.1; TPS, tumor proportion score

The safety profile of ALLO-316 was manageable and consistent with lymphodepletion and an active CAR T product across the full Phase 1 trial. The most frequent Grade ≥3 events were hematologic. Three previously reported treatment related Grade 5 adverse events occurred in the Phase 1a portion (cardiogenic shock, failure to thrive and sepsis). There were no Grade 5 adverse events in Phase 1b. A higher incidence of IEC-HS was reported in Phase 1b relative to Phase 1a, likely due in part to improved diagnosis and coding implemented during Phase 1b. Most IEC-HS events were mild to moderate and were successfully managed utilizing a protocol-defined diagnostic and management algorithm.

TEAEs ≥20% incidence Phase 1b (N=22*)
n (%)
Any Grades Grade ≥3
Neutropenia 18 (82%) 18 (82%)
White blood cell count decreased 16 (73%) 16 (73%)
Anemia 13 (59%) 9 (41%)
Fatigue 5 (23%) 0
Nausea 8 (36%) 0
Thrombocytopenia 13 (59%) 7 (32%)
Pyrexia 8 (36%) 0
Peripheral edema 8 (36%) 0
ALT increased 7 (32%) 2 (9%)
Headache 5 (23%) 0
Arthralgia 8 (36%) 0
AST increased 6 (27%) 2 (9%)
Lymphopenia 5 (23%) 5 (23%)
AEs of Special Interest Any Grade Grade ≥3
CRS 15 (68%) 0
Infection 11 (50%) 9 (41%)
IEC-HS 8 (36%) 2 (9%)ᵃ
ICANS 4 (18%) 0
Graft-versus-host disease 0 0
* Two patients received lymphodepletion but did not receive ALLO-316: one due to progression of disease (altered mental status during lymphodepletion found to be brain metastases on imaging), and one due to liver and kidney failure during lymphodepletion. IEC-HS includes the preferred terms immune effector cell-associated HLH-like syndrome and Hemophagocytic lymphohistiocytosis.
ᵃ One patient experienced Grade 4 IEC-HS based on gastrointestinal bleeding with subsequent improvement; one patient experienced Grade 3 IEC-HS based on hypotension managed without vasopressors with subsequent improvement.

The findings also underscore the broader strategic potential of the Dagger technology, which addresses rejection by the patient’s immune system. By targeting CD70-expressing tumor cells as well as CD70-positive alloreactive host T cells, ALLO-316 is designed to support CAR T-cell expansion and persistence without requiring intensified lymphodepletion. In TRAVERSE, this design translated into robust expansion, durable persistence, and evidence of tumor infiltration – core attributes Allogene believes may be applicable across its next-generation clinical and pre-clinical allogeneic CAR T pipeline.

About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced an award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.

(Press release, Allogene, JUL 15, 2026, View Source [SID1234669242])

On July 15, 2026 NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) ("NeOnc" or the "Company"), a clinical-stage life sciences company focused on the development of treatments for central nervous system cancers, reported that it has received written feedback from the U.S. Food and Drug Administration ("FDA") regarding the chemistry, manufacturing and controls ("CMC") development program for NEO212, the Company’s novel temozolomide-perillyl alcohol conjugate.

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The written feedback was provided in advance of a Type B End-of-Phase 1 meeting scheduled for July 9, 2026. FDA’s preliminary comments expressly provided NeOnc the option to cancel the meeting if the written responses were sufficiently clear, in which case the written responses would constitute the official record of the meeting. After reviewing the detailed responses, the Company determined that an additional meeting discussion was not required at this stage and canceled the July 9 meeting.

Key elements of the FDA’s written feedback include:

FDA stated that NeOnc’s proposed approach to CMC development appears reasonable, while identifying additional comparative assessments that may be required if the drug-substance manufacturing process or physical characteristics change during development.
FDA stated that the general drug-product development plan may proceed in parallel with the Company’s planned late-stage clinical program, subject to the development and submission of appropriate supporting data.
FDA indicated that a staged stability program supporting clinical development, followed by registration stability studies, is a commonly accepted approach.
FDA advised that the transition from the current capsule formulation to a tablet formulation should be supported by an in vivo relative bioavailability study.
FDA identified CMC work to be completed before representative tablet material is used in a confirmatory clinical phase, including finalization of the tablet formulation and manufacturing process, manufacture of at least one GMP batch, establishment of appropriate in-process controls, solid-state and particle-size characterization, and development of an appropriate dissolution method.
NeOnc is incorporating the FDA’s feedback into its NEO212 development plan and is evaluating the associated study design, manufacturing activities, timelines and costs. The Company expects to provide an updated development plan after completing this assessment.

"The FDA’s written feedback is detailed, constructive and actionable," said Amir Heshmatpour, Chief Executive Officer, Executive Chairman and President of NeOnc. "It provides greater clarity regarding the manufacturing, formulation and bioavailability work required to support the transition of NEO212 from the current capsule formulation to a tablet intended for late-stage clinical development. We are now integrating these requirements into a disciplined development plan and will continue working with the FDA as the program advances."

The FDA feedback relates principally to the CMC development of NEO212 and the capsule-to-tablet transition. The written responses do not constitute FDA approval of NEO212 or agreement on the design or adequacy of any future registrational clinical trial. Any future clinical study remains subject to applicable regulatory requirements and continued FDA review.

About NEO212
NEO212 is a novel covalently conjugated compound combining the chemotherapeutic agent temozolomide with perillyl alcohol. NeOnc is developing NEO212 as a potential treatment for malignant brain tumors and other central nervous system cancers.

(Press release, Neonc, JUL 15, 2026, View Source [SID1234669241])

On July 15, 2026 Anova Enterprises, Inc. (Anova), a technology enabled CRO dedicated to accelerating promising treatments, reported its partnership with Nouveau Biosciences, Inc. to conduct cancer focused clinical trials for their lead asset Kromastat. Nouveau Biosciences is a biotechnology company pioneering novel targeted nanomedicines to improve cancer therapy.

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Nouveau Biosciences has developed a proprietary drug discovery technology coupled to a polymer-based nanochemistry capability that enhances drug targeting, tolerability and efficacy. The platform enables the creation of novel anticancer agents that are now emerging as first-in-class and best-in-disease.

Kromastat (formerly known as NBS-M001) is a novel polymeric nanoparticle (PNP) of a highly potent epigenetic drug. Based on preclinical studies Kromastat is among one of the most potent drugs developed for pancreatic cancer, challenging T-cell malignancies and aggressive leukemia. The First-in-Human study will be conducted at leading academic medical centers in Australia, with a goal to rapidly move the drug into Phase 2 studies in the U.S. where the company will pursue a 505(b)2 regulatory strategy.

This collaboration underscores the commitment of both organizations to address significant unmet medical needs across cancer and accelerate the delivery of innovative therapies to patients worldwide.

Under this partnership, Anova will leverage its AnovaOS platform and comprehensive approach to accelerate clinical development of Kromastat. The partnership is poised to ensure the trial’s successful execution and bring new hope to patients globally.

"Anova is proud to collaborate with Nouveau Biosciences on this novel targeted nanomedicine," said Chris Beardmore, CEO of Anova. "We are proud to partner with Nouveau Biosciences to advance a highly differentiated nanomedicine pipeline with the potential to redefine treatment paradigms in oncology. By combining their cutting-edge science with Anova’s technology-enabled clinical delivery platform, we are uniquely positioned to accelerate development timelines, enhance execution certainty, and bring innovative therapies to patients with greater speed and precision."

"Nouveau Biosciences is deeply committed to accelerating the advancement of our pipeline through smart, execution-focused partnerships," said Owen A. O’Connor, M.D., Ph.D., Chief Executive Officer and Chairman of Nouveau Biosciences. "By working with Anova, we are integrating our innovative nanomedicine platform into a proven clinical development engine—enabling us to move more rapidly, de-risk our programs, and bring transformative therapies to patients with greater urgency."

(Press release, Nouveau Biosciences, JUL 15, 2026, View Source [SID1234669240])