On July 15, 2026 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that new patients have been administered INT230-6 in the INVINCIBLE-4 Study in Switzerland. The trial (NCT06358573) analyzes INT230-6 given before administration of the standard-of-care neoadjuvant immuno-chemotherapy ("SOC") and the SOC alone by using a 2-cohort design. The study evaluates the pathological complete response ("pCR") rates of the two cohorts relative to a null hypothesis, which is a pCR rate of ≤ 0.6. The success of each cohort in rejecting the null hypotheses will be evaluated.

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The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer ("TNBC") who undergo SOC treatment and SOC alone. The primary endpoint is pCR in the primary tumor and affected lymph nodes. In the amended protocol, patients will be randomized to receive a regimen of one dose of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or to SOC alone. The INVINCIBLE-4 Study reopens following a pause in patient accrual to evaluate skin irritation issues seen in some patients. In March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a slightly lower drug-to-tumor volume ratio and a single injection of INT230-6. Prior to the pause, fourteen (14) patients were treated, seven (7) with the combination and (7) received the SOC alone. Patients receiving INT230-6 prior to the SOC reported a favorable trend towards much fewer overall grade 3 or higher adverse events and immune-related adverse events compared to those patients receiving the SOC alone. The INVINCIBLE-4 Study is expected to enroll an additional 47 patients in Switzerland and France.

"Many TNBC patients undergoing SOC treatment alone fail to achieve a pathological complete response at the time of surgery, especially in larger tumor sizes. Early data indicates that INT230-6 has the potential to fill this unmet need for aggressive subtypes, such as TNBC, through its anti-cancer mechanisms of action that cause tumor cell necrosis and ignite an anti-cancer immune-based response," said Markus Joerger, MD-PhD from the Department of Medical Oncology and Hematology at Health Ostschweiz, Professor of Medicine at the University of Basel, Co-Chair of the SCI’s Project Group for Developmental Therapeutics and coordinating investigator of the trial. "The ability for INT230-6 to induce necrosis and activate immune effects before a patient’s surgery with reduction in toxicity would be a major advance for the treatment of breast cancer and potentially many other cancers."

"We are excited to have restarted our Phase 2 study in presurgical triple-negative breast cancer. Triple-negative is a deadly and aggressive form of breast cancer, and patients having local disease currently undergo a harsh six-month regimen whereby a small percentage can die from the SOC before their surgery," said Intensity Therapeutics’ Founder, Chairman, and CEO, Lewis H. Bender. "We believe that the new dosing regimen can continue to show favorable overall safety, a meaningful improvement in the percentage of patients who achieve pCR, and ultimately an improved event-free survival."

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

About Triple Negative Breast Cancer in the Presurgical Setting

Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and excess human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, mainly because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are only 63%, with rates generally lower in the larger-sized T2 to T4 tumors. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.

(Press release, Intensity Therapeutics, JUL 15, 2026, View Source [SID1234669238])

On July 15, 2026 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, reported the closing of an oversubscribed and upsized US $315 million Series D financing.

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The financing was led by Ally Bridge Group and co-led by Alpha Wave, alongside new investors Bain Capital Life Sciences, Fidelity Management & Research Company, funds and accounts advised by T. Rowe Price Associates, Inc., a leading sovereign wealth fund, Eventide Asset Management, and Velosity Capital. Existing investors Morningside, Eli Lilly and Company, SV Health Investors, Sanofi Ventures, Abingworth, SymBiosis, Tenmile, Brandon Capital, Piper Heartland, Catalio Capital Management, Proto Axiom, Time BioVentures and other shareholders also participated in the round.

Targeted alpha therapy is entering a new era in oncology, but until now, broader adoption has been limited by isotope supply and manufacturing challenges. AdvanCell has built a vertically integrated platform centered on proprietary Lead-212 technology that combines secure isotope supply, automated manufacturing and scalable production to accelerate the development and commercial delivery of next-generation targeted alpha therapies.

The financing will advance ADVC001 toward Phase 3 clinical development in metastatic prostate cancer, expand AdvanCell’s proprietary Lead-212 platform, strengthening isotope supply and expanding U.S. manufacturing infrastructure to support Phase 3 development and future commercial demand, and accelerate AdvanCell’s growing pipeline of targeted alpha therapies.

"This financing marks a transformational milestone for AdvanCell and reflects the conviction of an exceptional investor syndicate in the potential of ADVC001 and the innovation behind our vertically integrated Lead-212 platform," said Philina Lee, Ph.D., Chief Executive Officer, AdvanCell. "Building on our recent leadership appointments and U.S. expansion, this financing puts us in a strong position to enter our next stage of growth and execution, advancing our lead therapy ADVC001 toward registrational development, expanding isotope supply and manufacturing infrastructure to support Phase 3 and future commercial demand, and progressing our Lead-212 pipeline into the clinic. Together, these priorities establish a clear path towards a diversified clinical pipeline with the goal of bringing the promise of targeted alpha therapy to more patients with cancer."

"The companies poised to lead the next generation of targeted alpha therapies will be those that combine differentiated clinical assets with end-to-end control over supply and manufacturing," said Andrew Lam, PharmD, Managing Director, Head of Biotech Private Equity at Ally Bridge Group. "AdvanCell has assembled that foundation through its de-risked lead program, vertically integrated platform and experienced leadership team, uniquely positioning the company to execute at scale and emerge as a potential category leader."

"The most enduring healthcare companies combine breakthrough science with the infrastructure and expertise to repeatedly develop new medicines," said Nik Economopoulos, Director, Life Sciences Investments, Alpha Wave. "We believe AdvanCell is building that kind of generational company, with the platform, manufacturing capabilities and pipeline to unlock the full potential of targeted alpha therapies."

Concurrent with the financing round, Andrew Lam of Ally Bridge Group and Nik Economopoulos of Alpha Wave will join AdvanCell’s Board of Directors.

AdvanCell’s lead program, ADVC001, is an investigational Lead-212 PSMA-targeted alpha therapy for metastatic prostate cancer currently in Phase 2 clinical development (NCT05720130). Designed to selectively deliver potent alpha radiation to tumor cells while minimizing radiation exposure to healthy tissue, ADVC001 has the potential to address key limitations of PSMA radioligand therapy, including treatment resistance, tolerability challenges and the need for dose optimization. ADVC001 has demonstrated encouraging Phase 1b anti-tumor activity and favorable tolerability in patients with prostate cancer. These results support the continued advancement of ADVC001 while validating AdvanCell’s Lead-212 platform and its broader pipeline of next-generation targeted alpha therapies across additional cancer indications.

(Press release, Advancell, JUL 15, 2026, View Source [SID1234669239])

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])

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 Alpha Tau Medical Ltd. (Nasdaq: DRTS, DRTSW) ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the successful treatment of the first patient in the ADMIRE (Alpha DaRT Management for Immunocompromised patients with REcurrent cSCC) study – a clinical trial evaluating intratumoral Alpha DaRT for immunocompromised patients with recurrent cutaneous squamous cell carcinoma (cSCC). The procedure was performed at Banner MD Anderson Cancer Center in Gilbert, Arizona, by Michael Samuels, MD, Chief of Multidisciplinary Programs at Banner MD Anderson Cancer Center and Principal Investigator of the ADMIRE study at this site, along with Thomas Shellenberger, MD, Head and Neck Cancer Surgical Oncologist.

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Immunosuppression is one of the strongest known risk factors for cSCC, whether it results from organ transplantation, hematologic malignancies such as chronic lymphocytic leukemia (CLL), or long-term treatment for autoimmune disease. An estimated 17 million U.S. adults are living with immunosuppression. These immunosuppressed patients face a much higher chance of developing cSCC; organ transplant recipients, for example, face a 65- to 100-fold higher incidence than the general population. Further, standard local treatments for these patients become progressively harder to repeat: surgical excision carries cumulative morbidity, and repeated procedures bring a growing degree of surgical fatigue and diminishing healthy tissue to work with, while radiation therapy is constrained by cumulative dose limits that frequently preclude re-treating the same field. This underscores the need for a localized treatment for this population that can be delivered in a single procedure and be repeated at the same site if the disease returns.

Beyond the physical toll of repeated procedures, these patients face a second barrier: For transplant recipients, physicians must often reduce immunosuppressive therapy once cancer is diagnosed, which raises the risk of organ rejection, and checkpoint inhibitor immunotherapy, a standard option for recurrent or advanced cSCC in the general population, is therefore typically avoided in these patients. Patients with CLL and other hematologic malignancies, and those on chronic immunosuppressive therapy for autoimmune disease, face a related but distinct problem: cSCC clinical trials have historically excluded immunocompromised patients as a category, regardless of the specific cause, leaving many without access to newer treatment options at all. The ADMIRE study was designed specifically to evaluate whether Alpha DaRT, delivered locally and directly into the tumor, can offer a meaningful alternative across this historically excluded and particularly vulnerable population.

Uzi Sofer, CEO of Alpha Tau, stated: "This milestone matters to us for a reason that goes beyond any one patient. There are many different reasons someone can become immunocompromised, but across nearly all of them, the same pattern holds: their cSCC comes back more often, and leaves them with far fewer treatment options than for others. This trial actually started with our physicians. Since we began enrolling ReSTART, our pivotal trial for recurrent cSCC, investigators at site after site have asked the same question on their own, right up to recently: could Alpha DaRT help their immunocompromised patients too, the ones ReSTART couldn’t enroll? That’s exactly the kind of trial our strategy is built around: treating patients whose tumors recur after surgery or radiation therapy, who are left with limited treatment options, and who need new solutions the most."

Dr. Michael Samuels, Chief of Multidisciplinary Programs at Banner MD Anderson Cancer Center, commented: "Our team has treated multiple patients under Alpha Tau’s ReSTART trial for recurrent cSCC, and that experience is exactly what gave us the confidence to bring Alpha DaRT to our immunocompromised patients through ADMIRE. Banner sees a significant number of transplant patients and patients with other causes of immunosuppression across across our network, many of whom go on to develop skin cancers that recur despite prior surgery or radiation, and who have very few good options left. Today’s patient came to us in exactly that situation, and I’m glad to say the treatment went smoothly, with the kind of single-session, localized procedure our patients need. I’m looking forward to seeing how this patient, and the others who will follow, respond over the coming months."

Dr. Robert Den, Chief Medical Officer of Alpha Tau, added: "ADMIRE is a natural extension of everything we’ve learned through ReSTART and, before that, through our original skin cancer feasibility study, which showed strong local tumor control in a population where nearly two-thirds already had recurrent disease. Bringing this treatment to a system like Banner, which already has both the transplant and oncology expertise this population requires, is exactly how we intend to build out this program. We’re grateful to Dr. Samuels and his team, and we look forward to following this patient’s progress."

About the ADMIRE Study

ADMIRE (Protocol CTP-SCC-04) is a prospective, multicenter, open-label, single-arm clinical study evaluating intratumoral Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma in immunocompromised patients. The study was initially announced in September 2024 as an investigator-initiated trial and is now conducted as a company-sponsored study. The study is designed to enroll up to 28 patients at up to 8 sites across the United States. Eligible patients must have histologically confirmed, recurrent cSCC with a single lesion up to 7 cm, and must be immunocompromised due to any primary or secondary immunodeficiency, including solid organ transplantation, hematologic malignancy, or chronic immunosuppressive therapy for autoimmune disease; diabetes alone does not qualify. The primary endpoint is objective response rate (ORR) based on best overall response per RECIST v1.1; secondary endpoints include progression-free survival, overall survival, and local control, each assessed over twelve months. Additional information about the study is available at View Source

(Press release, Alpha Tau Medical, JUL 15, 2026, View Source [SID1234669226])