On July 15, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that patient enrollment has begun in the National Cancer Institute (NCI)’s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology (Press release, Guardant Health, JUL 15, 2025, View Source [SID1234654394]). Guardant’s Shield MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests—blood tests that can screen for several types of cancer simultaneously—in future randomized controlled trials.

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Guardant’s Shield MCD test was chosen for the study based on the overall performance of its Shield platform in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver and gastric. The data were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago. The Vanguard study was initiated following review and approval by the U.S. Food and Drug Administration (FDA) as part of the NCI’s submission for an investigational device exemption (IDE).

"New screening technology like the Shield MCD test has the potential to detect multiple cancers earlier through a simple blood draw," said Craig Eagle, MD, Guardant Health Global Chief Medical Officer. "The earlier we can screen and diagnose cancers, the more options we can bring to patients and ultimately the more lives we can save. The Vanguard Study is a critical step in research to evaluate the role of this breakthrough technology in helping reduce cancer deaths."

The Vanguard Study, conducted by the Cancer Screening Research, a new NCI-sponsored clinical trials network, is enrolling individuals ages 45-75 who do not currently have cancer and who have not received a cancer diagnosis in the past five years. All participants will be offered standard cancer screenings as part of their care. Results from the study will inform the design of a much larger randomized controlled trial to evaluate the use of MCD tests for cancer screening.

"Initiation of the Vanguard Study is an exciting milestone, as we look to evaluate a new way to screen for cancer," said Scott Ramsey, M.D., Ph.D., director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Center and principal investigator for the Vanguard Study. "The study will help us learn more about multi-cancer detection tests and assess whether they can help people from all backgrounds find cancer early, when it may be easier to treat."

The Shield MCD test recently received Breakthrough Device Designation from the FDA for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA’s Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review.

On July 15, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported it has entered into an exclusive worldwide licensing agreement with Debiopharm International S.A. ("Debiopharm"), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standards of care to cure cancer and infectious diseases, for lunresertib, a first-in-class precision oncology PKMYT1 inhibitor (Press release, Repare Therapeutics, JUL 15, 2025, View Source [SID1234654393]).

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"The exclusive worldwide licensing agreement with Debiopharm allows for the continued development of lunresertib, a novel PKMYT1 inhibitor, that has demonstrated encouraging results across multiple clinical trials in difficult-to-treat solid tumors. This agreement builds upon the success of Repare and Debiopharm’s existing collaboration studying the combination of lunresertib and Debio 0123," said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. "Our recent business development efforts have continued to enable Repare to focus on the advancement of our clinical priorities and sustained value creation. We remain focused on two ongoing Phase 1 clinical trials with readouts expected in the second half of 2025: the LIONS trial evaluating our RP-1664 PLK4 inhibitor and the POLAR trial evaluating our RP-3467 Polθ ATPase inhibitor."

Under the terms of the agreement, Repare will receive a $10 million upfront payment, and is eligible to receive up to $257 million in potential clinical, regulatory, commercial and sales milestones, including up to $5 million in potential near-term payments, and single-digit royalties on global net sales. Repare and Debiopharm entered into a clinical study and collaboration agreement in January 2024 to explore the synergy between lunresertib and Debio 0123, a potential best-in-class, brain penetrant and highly selective WEE1 inhibitor. Debiopharm will assume sponsorship of the MYTHIC study and take over existing and future development activities related to lunresertib.

"We are excited to enter into this worldwide license agreement with Repare for lunresertib. Based on very promising Phase 1/1b clinical data, we believe the combination of lunresertib and Debio 0123 is highly synergistic and could potentially drive rapid and deep tumor regressions," said Bertrand Ducrey, CEO of Debiopharm. "We believe the synthetic lethality approach of lunresertib in combination with Debio 0123 will allow us to bring this innovative precision therapy to patients with difficult to treat cancers."

Continued Prioritization of RP-3467 and RP-1664

Moving forward, Repare will remain focused on the advancement of its two ongoing Phase 1 clinical trials, POLAR and LIONS. The POLAR clinical trial is a multicenter, open-label, dose-escalation Phase 1 clinical trial designed to investigate the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of RP-3467, a small molecule inhibitor of polymerase theta (Polθ) that is a synthetic lethality target associated with BRCA mutations and other genomic alterations, alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer, or pancreatic adenocarcinoma. Topline safety, tolerability and early efficacy data from the Phase 1 POLAR clinical trial of RP-3467 alone and in combination with olaparib is expected in the third quarter of 2025. The LIONS clinical trial is a first-in-human, multicenter, open-label Phase 1 clinical trial designed to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664, a first-in-class, highly selective, oral inhibitor of Polo-like kinase 4 (PLK4) that is a synthetic lethality target associated with TRIM37 overexpression. Initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS clinical trial of RP-1664 is expected in the fourth quarter of 2025.

On July 15, 2025 GT Medical Technologies, Inc., a medical device company dedicated to improving the lives of patients with brain tumors, reported the company has completed the close of its oversubscribed $53 million Series D equity financing (Press release, GT Medical Technologies, JUL 15, 2025, View Source [SID1234654392]).

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The final close of the Series D comprised an additional $16 million from new investors including FemHealth Ventures, Warren Point Capital, an undisclosed strategic investor, and increased commitments from all existing institutional investors. Earlier this year, GT Medical Technologies announced the completion of a $37 million first close of the Series D equity financing led by Evidity Health Capital, alongside new investor Accelmed Partners and existing investors MVM Partners, Gilde Healthcare, and Medtech Venture Partners.

"Increasing the size of the Series D allows us to stay focused on driving results for patients into the foreseeable future," said Per Langoe, Chief Executive Officer at GT Medical Technologies. "We are thankful for our investors’ continued support as we expand our commercial footprint and clinical initiatives for GammaTile."

The company will use the funds to drive the expansion of its U.S. commercial activities for GammaTile. In addition, the financial resources will enable GT Medical Technologies to complete enrollment of its ROADS randomized controlled trial for newly diagnosed brain metastases and will fund an additional randomized control trial of GammaTile in newly diagnosed glioblastoma cases.

"FemHealth Ventures is excited to join GT Medical Technologies as an investor and support the commercial acceleration of GammaTile Therapy," stated Maneesha Ghiya, Managing Partner at FemHealth Ventures. "We are proud to back a company that is transforming the standard of care in oncology and shares our commitment to improving health outcomes, including meaningful applications in women’s health."

GammaTile is an innovative form of radiation therapy placed at the time of brain tumor removal surgery, delivering immediate, targeted radiation to the tumor site when cancer cells are at their lowest levels. Unlike conventional approaches, which often require a delay between surgery and radiation therapy to allow for wound healing, GammaTile eliminates this treatment gap. By delivering immediate, localized radiation directly at the tumor site, it is designed to maximize the treatment’s effectiveness against remaining cancer cells to reduce the risk of regrowth.1

"The completion of an oversubscribed Series D equity financing from premier medical device investors is a testament to the important work of our team and mission," added James Leech, Chief Financial & Strategy Officer of GT Medical Technologies.

Recent GT Medical Technologies Milestones

GT Medical Technologies recently celebrated important milestones, reflecting the growing adoption of GammaTile. To date, more than 1,900 patients have been treated with GammaTile Therapy, and over 800 patients have been enrolled in GammaTile clinical studies.

Looking Ahead

GT Medical Technologies anticipates completing enrollment in both the ROADS and GESTALT studies in Q3 2025.

On July 15, 2025 Pierre Fabre Pharmaceuticals, Inc. reported the transfer of the Investigational New Drug Application for tabelecleucel from its partner, Atara Biotherapeutics, Inc. (Nasdaq: ATRA) (Press release, Pierre Fabre, JUL 15, 2025, View Source [SID1234654391]). "This announcement marks an important milestone as Pierre Fabre Laboratories assumes global responsibility for clinical development of tabelecleucel following transfer of manufacturing responsibilities earlier in the year," said Adriana Herrera, Chief Executive Officer of Pierre Fabre Pharmaceuticals., the Pierre Fabre Laboratories pharmaceutical subsidiary in the United States. "Ongoing recruitment into the ALLELE study demonstrates our commitment to clinical research and development as we await regulatory action on the BLA resubmitted by our partner Atara."

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Atara Biotherapeutics resubmitted the tabelecleucel BLA on July 11, having rapidly addressed the third-party manufacturing facility observations outlined in the January 2025 Complete Response Letter in collaboration with Pierre Fabre Pharmaceuticals (PFP). On March 31, PFP assumed global responsibility for tabelecleucel manufacturing, including commercial product supply for European markets where the innovative cell therapy is already approved, as well as for global clinical trial supply. On July 14, 2025, Atara Biotherapeutics transferred the tabelecleucel IND to Pierre Fabre Medicament, a subsidiary of Pierre Fabre Laboratories.

The two studies currently open for tabelecleucel access in the US are:

NCT03394365: Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (ALLELE)

The ALLELE study is investigating the effects of tabelecleucel, an off-the-shelf allogeneic Epstein-Barr virus (EBV)-specific cytotoxic T cell therapy, to treat relapsed/refractory EBV-associated post-transplant lymphoproliferative disease arising after SOT or HCT.

NCT04554914: A Study to Evaluate Tabelecleucel in Participants with Epstein-Barr Virus-associated Diseases

This study is a multicenter, multicohort, open-label, single-arm, Phase 2 study investigating the efficacy and safety of tabelecleucel for the treatment of EBV-associated diseases.

Tabelecleucel is an allogeneic, off-the-shelf, EBV-specific T-cell immunotherapy designed to selectively target and eliminate EBV-infected cells. Unlike autologous CAR-T therapies, allogeneic T-cells are derived from third party donors and are not genetically modified. Immune cells are collected from the blood of healthy donors and exposed to Epstein-Barr virus antigens to help enrich for T cells that recognize EBV. These EBV T cells are expanded, characterized, kept alive and stored for future use to treat patients.

Tabelecleucel was granted marketing authorization under the brand name EBVALLO in December 2022 by the European Commission (EC) as a monotherapy for the treatment of adult and pediatric patients two years of age and older with r/r EBV+ PTLD who have received at least one prior therapy.

In December 2023, Atara announced an expanded global partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tabelecleucel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets.

About EBV+PTLD

EBV+ PTLD is an ultra-rare, acute, and potentially deadly hematologic malignancy that occurs after transplantation when patent T-cell immune responses are compromised by immunosuppression. It can impact patients who have undergone solid organ transplant (SOT) or allogeneic HCT. Poor median survival of 3 weeks and 4.1 months for HCT and SOT, respectively, is reported in EBV+ PTLD patents for whom standard of care failed, underscoring the significant need for new therapeutic options.

On July 15, 2025 Aethlon Medical, Inc. (Nasdaq: AEMD), a clinical-stage biotechnology company developing the investigational Aethlon Hemopurifier, an extracorporeal device for Oncology and other indications, reported that the independent Data Safety Monitoring Board (DSMB) overseeing its ongoing clinical trial AEMD-2022-06 has completed its scheduled safety review and recommended advancing to the next patient cohort without modification (Press release, Aethlon Medical, JUL 15, 2025, View Source [SID1234654390]).

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The trial, titled "Safety, Feasibility, and Dose-Finding Study of Aethlon Hemopurifier in Patients with Solid Tumors Who Have Stable or Progressive Disease While on a Treatment That Includes Pembrolizumab or Nivolumab", is being conducted to assess the Hemopurifier’s safety, feasibility, and optimal dosing.

The DSMB- comprising independent medical experts in nephrology and oncology- reviewed data from the initial cohort of three participants, each of whom received a single 4-hour Hemopurifier treatment. Based on their evaluation, the board found no safety concerns and confirmed that the Hemopurifier continues to demonstrate a favorable safety and tolerability profile. To date, no serious adverse events (SAEs) or Dose-Limiting Toxicities (DLTs) related to the Hemopurifier have been reported.

"The DSMB’s positive recommendation is encouraging and underscores the favorable safety profile observed to date in patients with cancer," according to Steven LaRosa, M.D, Chief Medical Officer of Aethlon Medical. "This marks a significant step forward in the clinical development program for the Hemopurifier in Oncology and brings the company closer to potentially addressing the significant unmet medical need for the approximately 60-70% of patients with cancer who do not experience a lasting clinical response to anti-PD-1 immunotherapy."

Enrollment for Cohort 2 is now open. In this phase, participants will receive two Hemopurifier treatments over a one-week period at the study’s three active clinical sites in Australia. This trial, which aims to enroll approximately 9 to 18-patients, is designed to evaluate the safety, feasibility of administering the Hemopurifier at varying dosing intervals in patients with solid tumors who have stable or progressive disease, while receiving treatment that includes Pembrolizumab (Keytruda) or Nivolumab (Opdivo).

The primary endpoint of this trial is the incidence of adverse events and clinically significant changes in safety laboratory tests of Hemopurifier- treated patients. In addition to safety monitoring, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs and if these changes in EV concentrations improve the body’s own natural ability to attack tumor cells. These findings are expected to inform the design of a future efficacy and safety, Premarket Approval (PMA), study required by regulatory authorities.

Aethlon Medical, Inc. remains committed to advancing the Hemopurifier for use in oncology and will continue to provide updates as the clinical trial progresses.

About the Hemopurifier

The Aethlon Hemopurifier is an investigational medical device designed to remove enveloped viruses and tumor-derived extracellular vesicles (EVs) from circulation. It is used extracorporeally with a blood pump and combines plasma separation, size exclusion, and affinity binding using a plant lectin resin that targets mannose-rich surfaces found on EVs and viruses. EVs released by solid tumors are believed to play a role in metastasis and the resistance to immunotherapies and chemotherapy. Removal of enveloped viruses and extracellular vesicles has been demonstrated in both vitro studies and human subjects.

The Hemopurifier holds a U.S. Food and Drug Breakthrough Device for:

The treatment of individuals with advanced or metastatic cancer unresponsive to or intolerant of standard-of-care therapy; and
The treatment of life-threatening viruses not addressed with approved therapies.
The Hemopurifier is being developed under an open Investigational Device Exemption (IDE) for both indications.