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Evaxion expands and refocuses R&D pipeline with EVX-05, an AI-designed off-the-shelf brain cancer vaccine program

On August 17, 2026 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology platform, reported to expand its pipeline of cancer vaccine programs with EVX-05 against the deadly brain cancer glioblastoma.

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We are collaborating with experts from Duke University School of Medicine to develop EVX-05. This program targets endogenous retrovirus (ERV)-derived antigens shared between glioblastoma patients, which AI-Immunology has unique capabilities in identifying. These ERV-antigens constitute a novel source of highly attractive targets for off-the-shelf cancer vaccines.

With its new therapeutic concept, EVX-05 is being developed as a novel therapeutic approach for glioblastoma. Current therapies are often inadequate, meaning glioblastoma remains one of the most aggressive and deadly cancers.

"We are delighted to transform our discoveries in glioblastoma into a promising new vaccine program with EVX-05, which could hold a significant therapeutic potential in area of massive unmet medical need. We have an outstanding collaboration with Duke University and now see the huge benefits of combining their extensive disease understanding and clinical expertise with the unique target discovery capabilities of AI-Immunology," says Birgitte Rønø, CSO and COO of Evaxion.

"Patients with glioblastoma continue to face limited treatment options and poor outcomes," said Mustafa Khasraw, M.D., professor at Duke University School of Medicine. "The potential of ERVs as therapeutic targets has long been acknowledged, if we can unlock this potential, it would be a significant advancement towards improving care."

World-leading expertise
Evaxion is currently undertaking optimization of a lead vaccine candidate for the EVX-05 program as part of advancing it towards initial clinical testing. This is expected to be carried out by Professor Khasraw and his team, allowing for world-leading clinical expertise and knowledge of patient needs to help guide clinical development. The collaboration also potentially allows a cost-efficient way for Evaxion to study EVX-05 in a clinical phase 1 trial.

EVX-05 builds on the same ground-breaking ERV-targeting concept as EVX-04, Evaxion’s vaccine candidate against acute myeloid leukemia. This confirms the broad applicability of the concept across cancers where immunotherapies remain inadequate and conserved immunogenic antigens can be identified.

Both programs draw on learnings from the EVX-03 program, which has now been discontinued and removed from our R&D pipeline as a matter of portfolio management. The costs related to EVX-05 are captured within Evaxion’s existing budgets and hence does not impact on our cash runway, which continues to stretch into second half of 2027.

Conference call and webcast
This coming Thursday, August 20, Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting our Q2 2026 business update and financial results as well as taking questions. EVX-05 will be one of the topics discussed.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

About glioblastoma
Glioblastoma is the most aggressive malignant primary brain tumor. It has an incidence rate of 3.19 per 100,000 persons in the United States and a median age of 64 years (National Institute of Health).

No cure exists for glioblastoma, and treatment outcomes remain poor: 50% of patients die approximately one year from diagnosis (New England Journal of Medicine, 2005).

(Press release, Evaxion, AUG 17, 2026, View Source [SID1234670197])

Artelo Biosciences Receives a Notice of Allowance from the U.S. Patent and Trademark Office for its Lead Investigational Drug Currently in Two Phase 2 Studies

On August 17, 2026 Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signalling pathways to develop treatments for people living with cancer, pain, dermatologic, or neurological conditions, reported that the United States Patent and Trademark Office has issued a Notice of Allowance for a U.S. patent application covering the intended commercial formulation of ART27.13, the Company’s peripherally selective cannabinoid agonist currently being evaluated in the Phase 2 CAReS trial for cancer-related anorexia and the Phase 2 DREAM study in patients with glaucoma or ocular hypertension.

The allowed claims protect compositions of ART27.13 dispersed in polyethylene glycol, including the Company’s intended commercial formulation. This development marks a major milestone in Artelo’s global intellectual property strategy and positions the Company for long-term value creation.

"This U.S. Notice of Allowance and near-term expectation of the issuance of the patent further strengthens the intellectual property foundation supporting ART27.13 and its long-term development potential," said Gregory D. Gorgas, President and Chief Executive Officer of Artelo Biosciences. "As ART27.13 advances in multiple Phase 2 studies, we believe protecting the intended commercial formulation is an important step in building value around the program and preserving opportunities across multiple indications."

ART27.13 is being evaluated in the Phase 2 portion of CAReS trial targeting cancer-related anorexia. The investigational drug was well tolerated in the Phase 1 stage and showed early signs of stabilizing or reversing weight loss in more than 60% of participants. Interim results from the Phase 2 portion of CAReS demonstrated the ability of the drug to reverse cancer-related anorexia in all patients taking the highest dose whereas the all the participants on placebo continued to lose weight throughout the study.

ART27.13 is also being evaluated in the DREAM study, a Phase 2 in patients with glaucoma or ocular hypertension. The investigator-led study, funded by Glaucoma UK and the HSC R&D Division, is evaluating ART27.13’s potential as a once-daily, orally administered treatment to reduce intraocular pressure, with initial results anticipated in the fourth quarter of this year.

About ART27.13
ART27.13 is a novel benzimidazole derivative and dual cannabinoid agonist. Initially developed by AstraZeneca plc, ART27.13 has been in seven clinical studies with over 280 participants. It is being developed as a once-daily, orally administered agent selectively targeting peripheral CB1 and CB2 receptors, with the potential to reduce muscle degeneration while improving body weight, appetite, and quality of life in cancer patients. A statistically significant and dose-dependent increase in body weight was observed in people with back pain who were otherwise healthy. Importantly, the drug enables systemic metabolic effects while minimizing central nervous system-mediated toxicity. Artelo is conducting a Phase 2 named the Cancer Appetite Recovery Study (CAReS) evaluating ART27.13 as a supportive care therapy for cancer patients suffering from anorexia and weight loss. Interim Phase 2 data revealed patients who had lost at least 5% of body weight to be included in CAReS and titrated to the highest ART27.13 dose (1300 µg) achieved an average +6% weight gain over 12 weeks, while patients on placebo lost an additional ~5%. Currently, there is no FDA approved treatment for cancer anorexia cachexia syndrome. In addition to CAReS, ART27.13 is also being evaluated in a Phase 2 study in people with glaucoma at a daily dose of 650 µg.

(Press release, Artelo Biosciences, AUG 17, 2026, View Source [SID1234670196])

Radiopharm Theranostics To Meet with U.S. FDA to Align on Pivotal Phase 3 Trial Design for RAD 101 in Diagnosis of Brain Metastases

On August 17, 2026 Radiopharm Theranostics (ASX:RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, reported that it has scheduled an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for October 1st , 2026, to align on the design of a pivotal Phase 3 trial to evaluate RAD101 in patients with suspected recurrence of brain metastases following radiotherapy. RAD101 is the Company’s novel Fluorine-18-labeled small-molecule imaging agent that targets fatty acid synthase (FASN) and is being developed to diagnose suspected recurrent brain metastases arising from a range of solid tumors.

The focus of the meeting will be to align on the pivotal Phase 3 clinical trial design criteria, including the number of patients to be enrolled along with primary and secondary endpoints. The regulators will also be reviewing the data from the Phase 2b trial of RAD 101, which demonstrated 93% concordance between MRI and PET imaging of brain metastases in this patient population with suspected recurrence. The results showed substantial and selective tumor uptake of RAD101, with images confirming metabolic activity in PET compared to equivocal MRI findings.

"We are pleased to have secured an End-of-Phase 2 meeting with the FDA for RAD101, an important milestone that brings us closer to advancing this promising imaging agent into a pivotal Phase 3 program," said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. "We believe the upcoming discussion will provide important alignment on the clinical and regulatory pathway forward, enabling us to finalize plans for a registrational study and remain on track to be Phase 3-ready by year-end. Supported by the strong Phase 2b data demonstrating 93% concordance with MRI, we believe RAD101 has the potential to address a meaningful unmet need in the diagnosis of recurrent brain metastases and create significant value for patients, clinicians, and shareholders."

RAD 101 has received FDA Fast Track Designation to distinguish between recurrent disease and treatment effect of brain metastases originating from solid tumors of different origin including leptomeningeal disease. The company also recently announced a partnership with Siemens Healthineers, who will manufacture and distribute doses of 18F-labeled RAD101 to support Radiopharm’s upcoming Phase 3 registrational trial in the U.S.

In the U.S. alone, there are more than 300,000 patients diagnosed annually with cerebral metastases. The incidence of Intracranial Metastatic Disease (IMD) continues to increase, in part, due to improvements in systemic therapy resulting in a more durable control of the Primary tumor. Contrast-enhanced Magnetic Resonance Imaging (CE-MRI) is the preferred method for imaging IMD, but has limitations, particularly in follow-up surveillance scans to optimise patient care.1

About RAD101

RAD101 is the Company’s novel imaging small molecule that selectively binds to fatty acid synthase (FASN), a multi-enzyme protein that catalyses de-novo fatty acid synthesis and is overexpressed in cerebral metastasis from solid tumors. Targeting FASN activity may allow for the more accurate detection of cancer cells in the CNS, representing a clinically relevant method for the imaging of brain metastases. Positive data from the Imperial College of London’s Phase 2a imaging trial of 18F-RAD101 in patients with brain metastases (both SRS pre-treated and treatment naïve patients) showed significant tumor uptake that was independent from the tumor of origin. The study further indicated that PET-MRI may potentially represent a non-invasive prediction of overall-survival, warranting larger studies.

(Press release, Radiopharm Theranostics, AUG 17, 2026, View Source [SID1234670195])

Zentalis Pharmaceuticals Announces Closing of Underwritten Public Offering, Including Full Exercise of Underwriters’ Option to Purchase Additional Shares

On August 17, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL) ("Zentalis" or the "Company"), a clinical oncology innovator advancing late-stage development of an investigational, potentially first-in-class WEE1 inhibitor, azenosertib, as a biomarker-driven treatment approach for ovarian cancer, reported that it has closed its previously announced underwritten public offering of 26,450,000 shares of its common stock, including 3,450,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares. The shares of common stock were sold to the public at a price of $3.50 per share. The total gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $92.6 million. All of the shares of common stock sold in the public offering were sold by the Company.

The Company intends to use the net proceeds from the offering, together with the Company’s existing cash, cash equivalents and marketable securities, to fund clinical trials, preclinical studies, regulatory filings, manufacturing and the Company’s companion diagnostic in support of its programs, as well as for pre-commercial activities, capital expenditures, working capital and other general corporate purposes.

TD Cowen, Guggenheim Securities and Oppenheimer & Co. acted as joint bookrunners for the offering. H.C. Wainwright & Co. acted as a passive bookrunner for the offering. Rodman & Renshaw LLC acted as a manager for the offering.

The securities described above were offered pursuant to an effective shelf registration statement that was filed with the U.S. Securities and Exchange Commission (SEC) on March 26, 2025, and became effective on April 4, 2025. This offering was made only by means of a prospectus supplement and the accompanying prospectus which forms a part of the effective shelf registration statement.

A final prospectus supplement related to the offering (including the accompanying prospectus) has been filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement related to the offering and the accompanying prospectus may be obtained by visiting the SEC’s website or by contacting: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

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

(Press release, Zentalis Pharmaceuticals, AUG 17, 2026, View Source [SID1234670194])

InnoCare Announces Approval of Head-to-Head Registrational Phase III Trial of Mesutoclax with Azacitidine versus Venetoclax with Azacitidine in Treatment-Naive AML in China

On August 17, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the registrational Phase III study of the Company’s novel BCL2 inhibitor mesutoclax (ICP-248) in combination with azacitidine versus venetoclax with azacitidine in elderly or unfit patients with treatment naive (TN) acute myeloid leukemia (AML).

The head-to-head randomized, open-label, multicenter registrational Phase III clinical trial is designed to demonstrate the superiority of mesutoclax in combination with azacitidine over venetoclax with azacitidine in elderly or unfit patients with treatment naive AML. The primary endpoint is overall survival (OS).

Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Mesutoclax has been granted two Breakthrough Therapy Designations (BTD) by the CDE.

Data presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated that mesutoclax in combination with azacitidine in patients with AML achieved outstanding efficacy and safety. As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi). Among patients who achieved overall response, 86.5% were MRD (Minimal Residual Disease) negative. Among cCR responders, 83% achieved cCR in the first treatment cycle, demonstrating that the mesutoclax regimen enables rapid and deep remission. In terms of safety, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Notably, both 30-day mortality and 60-day mortality were 0% among TN AML patients. At the recommended dose, the 6-month overall survival (OS) rate was 90.5%.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, "The efficacy and safety mesutoclax has demonstrated to date give us the confidence to test it head-to-head against the global standard of care. Mesutoclax is one of our key global assets. We have been accelerating the global trial of mesutoclax in combination with azacitidine for AML, with patients enrolled in the U.S. and Australia. We will further advance its clinical development to bring this innovative therapy to more patients worldwide as early as possible."

AML is a malignant hematological disease originating from hematopoietic stem/progenitor cells. The risk of developing AML increases with age and is more common among older adults.

(Press release, InnoCare Pharma, AUG 17, 2026, View Source [SID1234670193])