On June 18, 2026 FivepHusion, an advanced clinical-stage biotechnology company, reported that an independent Human Research Ethics Committee (HREC) has approved progression to phase II of the Deflexifol at Relapse Trial (DART). The phase II trial is investigating Deflexifol monotherapy as a treatment for refractory or recurrent paediatric ependymoma. This HREC approval follows the successful completion of the phase I DART study in 2025 and incorporation of a recommended phase II dose and other updates into the phase II trial protocol.
Key design elements of the phase II DART study include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A multi-centre single-arm clinical trial involving all major paediatric oncology centres in Australia, with patients enrolled to determine the objective response rate to Deflexifol.
Recruitment of ten evaluable participants (aged 1-21 years) with refractory or recurrent paediatric ependymoma, including three participants currently evaluable from the phase I study.
Primary Objective: To evaluate the anti-tumour activity of Deflexifol as a single agent in patients with refractory or recurrent ependymoma.
Secondary Objectives: To assess overall survival and progression-free survival, and to further characterise the pharmacokinetics of Deflexifol monotherapy.
The phase II DART study is an Australian trial led by Principal Investigators Professor David Ziegler and Dr Marion Mateos and sponsored by the Australian and New Zealand Children’s Haematology / Oncology Group (ANZCHOG) in collaboration with FivepHusion. The phase II study follows the successful completion of the phase I DART study, the results of which were presented as a poster in November 2025 at the Society of Neuro-Oncology (SNO) Annual Meeting in Honolulu, Hawaii, USA. The phase II trial is designed to investigate Deflexifol monotherapy as a treatment for refractory or recurrent paediatric ependymoma. The trial is coordinated by the KOALA National Coordinating Centre at the Sydney Children’s Hospitals Network and all major Australian paediatric oncology centres are participating in the study. Significant trial funding has been provided by the Kids with Cancer Foundation and the Robert Connor Dawes Foundation.

Dr Christian Toouli, CEO and Managing Director of FivepHusion commented, "Paediatric ependymoma is the third most common brain cancer in children, and with no approved drugs to treat this condition, presents a significant unmet medical need for a safe and efficacious therapy. The ethics approval of the Phase II DART protocol is an exciting milestone towards our goal of evaluating Deflexifol as a promising therapy for these patients."

Deflexifol is an innovative next-generation novel co-formulation of 5-fluorouracil (5-FU) and leucovorin (LV), a drug that significantly enhances 5-FU anti-tumour activity. Deflexifol has previously been evaluated in the phase I DART study in paediatric brain cancer patients and two successfully completed clinical trials in adults with a variety of solid tumours. FivepHusion is harnessing the proven cytotoxic activity of 5-FU together with the unique, optimised attributes of the Deflexifol co-formulation to pursue Deflexifol development in a range of strategic solid tumour indications presenting with significant unmet medical needs, including paediatric ependymoma.

Ependymomas are rare central nervous system tumours (annual incidence of ~4 patients per million) that are more common in young children 0-4 years of age. The current standard treatment for ependymoma is surgery and radiotherapy, though relapse occurs in one third of all paediatric patients and is associated with a poor prognosis. Currently, there are no therapeutic drugs approved for the treatment of ependymoma, presenting a significant unmet medical need for the development of safe and efficacious new treatments for this disease.

Previously, 5-FU has been reported as a promising drug candidate for the treatment of paediatric ependymoma by independent research groups1,2, and in a clinical trial conducted at the St Jude Children’s Research Hospital (Memphis, Tennessee, USA)3. Recently, independent studies have gained further insights into understanding the susceptibility of paediatric ependymoma to 5-FU4. Research by FivepHusion collaborators indicates that Deflexifol, as a novel optimised co-formulation of 5-FU and LV, may be efficacious against paediatric ependymoma and other brain cancers. Due to its superior safety, tolerability and anti-tumour efficacy, Deflexifol offers the exciting opportunity to address the limitations of current 5-FU formulations to enable development as potentially the first approved drug for ependymoma and possibly other brain tumours.

(Press release, FivepHusion, JUN 18, 2026, View Source [SID1234668795])

On June 18, 2026 Gandeeva Therapeutics, Inc., a biotech at the forefront of cryo-electron microscopy (cryo-EM)–driven drug design, and Zymeworks Inc. (Nasdaq: ZYME), a global biotechnology company, reported to have partnered to visualize structures of antibody-antigen interfaces at high resolution.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

While cryo-EM is now used routinely to determine structures of antibody complexes formed with compact and well-folded antigens, mapping antibody epitope footprints on small and flexible antigens remains highly challenging. In a new advance, Gandeeva scientists have determined the structure of a small and flexible antigen (< 20 kDa) bound to the Fab fragment of an antibody developed at Zymeworks. Of note, the team was able to visualize the nine amino acids that form the antibody-binding epitope at 2.6 Å resolution. The rest of the antigen is highly flexible and was not resolved in the reconstruction.

"Knowledge of the precise interactions at the binding interface of these types of challenging targets is incredibly useful for us in selecting antibody leads and provides us with crucial insights for the optimization of biologics", said Dr. Paul Moore, Chief Scientific Officer of Zymeworks.

"Our ability to obtain near-atomic resolution cryo-EM structures of the antibody binding epitope within flexible and structurally intractable proteins is a game-changer, especially in the context of accelerating design of AI-driven antibodies", said Dr. Sriram Subramaniam, Founder and CEO of Gandeeva Therapeutics. "Experimental validation by high-resolution and high-throughput cryo-EM using Gandeeva’s platform provides exactly the kind of rapid feedback that is essential for testing and validating antibodies derived by immunization and by computational design."

(Press release, Gandeeva Therapeutics, JUN 18, 2026, View Source [SID1234668794])

On June 18, 2026 Oncoinvent, a clinical-stage radiopharmaceutical company developing Radspherin, a receptor-independent alpha-emitting therapy to eradicate cancer cells in the abdominal cavity after surgery with a single, targeted dose, reported that its ongoing Phase 2 trial of Radspherin in patients with peritoneal metastases from ovarian cancer has reached the 50% patient recruitment milestone.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A total of 54 patients have now been enrolled in the study, representing half of the planned trial population. Recruitment momentum has accelerated significantly in 2026, with 11 patients enrolled in the first quarter and 17 patients recruited in the second quarter to date, marking the highest recruitment levels achieved in the study so far. Year-to-date recruitment of 28 patients has already surpassed total enrollment for 2025.

Four new sites have opened for recruitment in 2026 and in total ten hospitals across the United States, Spain, Norway, Belgium, the United Kingdom and Italy are currently active in the trial, and further site activations are ongoing to support continued recruitment.

"Reaching the halfway point for recruitment in our Phase 2 trial is an important milestone for Oncoinvent and reflects the strong commitment of investigators and study sites," said Oystein Soug, CEO of Oncoinvent. "We are pleased to see the steps taken to accelerate recruitment translating into the strong enrollment momentum seen in 2026. Building on the encouraging safety profile and preliminary efficacy signals observed in earlier studies, we look forward to further evaluating Radspherin’s potential to improve outcomes for patients with peritoneal metastases from ovarian cancer, who have limited treatment options following surgery."

The Phase 2 trial (ClinicalTrials.gov: NCT06504147) is a randomized controlled study evaluating the efficacy and safety of Radspherin in patients with peritoneal metastases from ovarian cancer. The primary objective is to compare progression-free survival between patients receiving Radspherin following complete surgical resection and pre-operative chemotherapy, and those receiving standard of care treatment consisting of chemotherapy and surgery alone.

Previous Phase 1 and Phase 1/2a data have demonstrated that Radspherin is well tolerated, with no dose-limiting toxicity observed at the recommended dose of 7MBq, and encouraging signals of efficacy. Results from the Phase 1 study in ovarian cancer have been published in the peer-reviewed journal Gynecologic Oncology, and results from the Phase 1/2a study in colorectal cancer have been published in the peer-reviewed journals Journal of Surgical Oncology and Frontiers in Medicine.

(Press release, Oncoinvent, JUN 18, 2026, https://www.oncoinvent.com/press-release/oncoinvent-achieves-50-recruitment-milestone-in-phase-2-ovarian-cancer-study-of-radspherin/ [SID1234668780])

On June 17, 2026 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech" or the "Company"), a global leader in cell therapy, reported that it has commenced an underwritten public offering of $225 million of American Depositary Shares ("ADSs"), each representing two ordinary shares of the Company. All of the ADSs will be offered by Legend Biotech. Legend Biotech also intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the ADSs sold in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Morgan Stanley, Jefferies, Citigroup, and Deutsche Bank Securities are serving as joint book-running managers for the offering.

The ADSs are being offered by Legend Biotech pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the preliminary prospectus supplement and the accompanying prospectus can be obtained, when available, from Morgan Stanley Asia Limited, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, email: [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone: (877) 821-7388, or by email: [email protected]; Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone: (800) 831-9146; or Deutsche Bank Securities Inc., Attention: Prospectus Group, 1 Columbus Circle, New York, NY 10019, by telephone: (800) 503-4611, or by email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, 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 registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Legend Biotech, JUN 17, 2026, View Source [SID1234668792])

On June 17, 2026 Elicio Therapeutics, Inc. (Nasdaq: ELTX) ("Elicio" or the "Company"), a clinical-stage biotechnology company developing next-generation immunotherapies for KRAS-driven cancers, reported preliminary clinical observations which the Company believes support the evaluation of ELI-002 7P in combination with checkpoint inhibition. The Company also announced plans to conduct a Phase 1 study in first-line metastatic mKRAS PDAC, subject to funding. If validated by a Phase 1 study, activity in metastatic PDAC may allow a rapid development pathway for ELI-002 7P and inform the design of the future Phase 3 trial in adjuvant PDAC.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Three patients who received ELI-002 7P during Elicio’s recently completed Phase 2 AMPLIFY-7P study experienced disease progression after treatment and subsequently achieved confirmed complete radiographic and complete metabolic responses after receiving nivolumab-based therapy with concurrent normalization of tumor biomarker CA19-9 levels. Two of the three patients maintained complete responses for at least eight months, with one ongoing complete response at >13 months. In addition, all three patients demonstrated persistent mKRAS-specific T cell responses. The Company believes these observations provide preliminary clinical support for the hypothesis that ELI-002 7P-induced immune responses may enhance sensitivity to checkpoint inhibition and support prospective evaluation of ELI-002 7P and anti–PD-1 combination strategies.

These observations represent the first three patients identified following recurrence after treatment with ELI-002 7P during the Phase 2 AMPLIFY-7P study and subsequent gemcitabine/nab-paclitaxel chemotherapy and nivolumab. Elicio intends to continue monitoring additional patients who participated in the AMPLIFY-7P study and are currently following a similar course of treatment.

Importantly, all three patients were microsatellite stable (MSS) / mismatch repair proficient (MMR-p), a population that has historically demonstrated limited responsiveness to immune checkpoint inhibitors. Published studies evaluating chemotherapy-, checkpoint inhibitor-, or RAS inhibitor-based regimens in metastatic pancreatic cancer have reported complete response rates of approximately 0% to 8%, with durable complete responses rarely observed.

Christopher Haqq, M.D., Ph.D., Executive Vice President, Head of Research and Development and Chief Medical Officer of Elicio, added, "The observations reported today provide a compelling rationale for a Phase 1 study evaluating ELI-002 7P in combination with checkpoint inhibition and standard therapy in metastatic pancreatic cancer. Because radiographic responses can be assessed within months, the metastatic setting offers an efficient opportunity to evaluate the combination strategy. Given the historically low complete response rates reported in this disease, a relatively small number of complete responses could provide important evidence of clinical activity and support a rapid pathway to a potential pivotal study in metastatic PDAC and inform our Phase 3 design in adjuvant PDAC."

"Three complete responses observed following subsequent nivolumab-based therapy are particularly intriguing because complete, durable tumor responses in this setting are historically rare," said Robert Connelly, President and Chief Executive Officer of Elicio Therapeutics. "These observations suggest that ELI-002-induced immune priming may synergize with other therapies to enable tumor eradication, supporting prospective evaluation of ELI-002 7P in combination with checkpoint inhibition. We look forward to evaluating outcomes in additional patients as longer-term follow-up becomes available."

Subject to funding, Elicio plans to initiate a Phase 1 study evaluating ELI-002 7P in combination with standard gemcitabine/nab-paclitaxel chemotherapy and an anti-PD-1 inhibitor in treatment-naïve metastatic mKRAS pancreatic cancer.

The planned study is designed to prospectively evaluate the hypothesis generated by these observations and assess whether ELI-002 7P may enhance anti-tumor immunity and improve responsiveness to checkpoint inhibition.

Virtual KOL Event

Elicio is hosting a virtual KOL Event on Wednesday, June 24, 2026, at 1:00 PM ET, to further discuss these observations. To register, click here. Company management will be joined by Peter Hosein, M.D., Professor of Clinical Medicine, Sylvester Comprehensive Cancer Center, University of Miami, and Zev Wainberg, M.D., Professor of Medicine at UCLA and co-director of the UCLA GI Oncology Program.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational AMP cancer immunotherapy that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s proprietary AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.

ELI-002 7P (7-peptide formulation) was evaluated in the randomized Phase 2 AMPLIFY-7P trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The Phase 2 AMPLIFY-7P trial included patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. Based on topline results and post-hoc analyses, Elicio has refined its Phase 3 development strategy to focus on patients with lower residual disease burden and extended treatment duration. Elicio intends to initiate a Phase 1 study in metastatic PDAC designed to provide a rapid assessment of clinical activity through a focused, confirmatory study, subject to funding. Elicio plans to use the study findings to further evaluate checkpoint inhibitor combinations and help inform future development strategies in metastatic PDAC and the adjuvant PDAC Phase 3 trial. At the time of the Phase 2 AMPLIFY-7P analysis, data for overall survival remained immature. The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.

About the AMP Platform

Elicio’s proprietary AMP platform delivers investigational immunotherapy directly to the "brain center" of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In pre-clinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies.

Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The AMP platform has been shown to deliver immunotherapy directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.

(Press release, Elicio Therapeutics, JUN 17, 2026, View Source [SID1234668791])