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BriaCell’s Bria-IMT(TM) Demonstrates Survival Advantage over Trodelvy® and Control Group in Metastatic Breast Cancer

On July 11, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported updated Phase 2 survival data for its lead immunotherapy candidate, Bria-IMT, in combination with an immune check point inhibitor (CPI) (Press release, BriaCell Therapeutics, JUL 11, 2025, View Source [SID1234654348]).

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The data show a meaningful survival advantage in heavily pretreated metastatic breast cancer (MBC) patient subtypes:

Triple negative breast cancer (TNBC): median overall survival (OS) of 13.9 months vs. 11.8 months for antibody drug conjugate Trodelvy (sacituzumab govitecan-hziy) and 6.9 months single agent chemotherapy data. BriaCell’s median OS has improved from 11.4 months last reported at ASCO (Free ASCO Whitepaper) in June 2025 . 1
Hormone receptor positive (HR+): median overall survival (OS) of 17.3 months vs. 14.4 months for Trodelvy and 11.2 months in single agent chemotherapy data.
"We are thrilled to see our Bria-IMT regimen outperform established benchmarks like Trodelvy in TNBC and HR+ MBC patients," stated Dr. William V. Williams, BriaCell’s President and CEO. "BriaCell’s patients had failed a median of six prior therapies, underscoring the potential clinical impact of our novel immunotherapy. We look forward to validating these findings in our ongoing pivotal Phase 3 study with overall survival as its primary endpoint."

Table 1: Analysis of survival data for BriaCell’s Phase 2 study versus Trodelvy in MBC patient subsets

Breast Cancer
Type Treatment Median
# of prior
lines of
therapy Median
Overall
Survival
(months) Survival
rate at 6
months (%) Survival
rate at 12
months (%)

TNBC Bria-IMT plus CPI* 6 13.9 78 56
TNBC Trodelvy 1
(sacituzumab govitecan-hziy) 3** 11.8 80*** 49***
Single agent chemotherapy 3** 6.9 56*** 22***

HR+

Bria-IMT plus CPI* 6 17.3 90 61
HR+ Trodelvy 1
(sacituzumab govitecan-hziy) 4 14.4 83*** 61
Single agent chemotherapy 4 11.2 76*** 47
* Patients treated with the Phase 3 formulation
** Prior chemotherapy-containing regimens
*** Derived from published Kaplan-Meier curves see 1

Abbreviations:
TNBC: Triple-negative breast cancer (lacks the estrogen receptor, progesterone receptor, and lacks or has low levels of human epidermal growth factor receptor 2 (HER2))

As shown in table 1, median OS number with Bria-IMT is higher than that reported in the treatment arm of the ASCENT study (SG) for TNBC patients, and twice that reported in treatment of physician’s choice arm.
HR+ : hormone receptor-positive

The Phase 2 Bria-IMT study enrolled 54 heavily pre-treated metastatic breast cancer patients (median number of prior treatments = 6) who received the Bria-IMT regimen plus checkpoint inhibitor. Of these 54 patients, 37 received the same formulation currently being used in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612 ). No Bria-IMT related discontinuations have been reported to date.

Epitopea Expands its Clinical Development and Research Capabilities as it Accelerates to the Clinic

On July 10, 2025 Epitopea, a transatlantic cancer immunotherapeutics company developing accessible, off-the-shelf RNA-based immunotherapies, reported the formation of its dedicated clinical team and the expansion of its research team. These developments represent a significant milestone in the company’s ongoing progress in advancing its RNA-based immunotherapies, known as CryptiVaxTM, into clinical trials.

Siri Brinchmann-Hansen Torhaug, Head of Oncology Development, and Gertrud Koefoed Rasmussen, Head of Development Operations, will both join Epitopea’s Executive leadership team. They report into Dr. Klaus Edvardsen, who has served as Epitopea’s Chief Medical Officer (CMO) since February 2025, and oversees the strategic direction of clinical trials and regulatory affairs.

Epitopea’s research team in Cambridge has been extended to include translational immunology capabilities with the appointment of Dr. Theres Oakes as Director of Translational Sciences and Dr. Lisa Smith as Director of Research (UK). Both report into Dr. Jon Moore, Co-founder and Chief Scientific Officer (CSO) of Epitopea, and will work in close collaboration with the clinical team to ensure the seamless integration of research and clinical strategies.

Siri Brinchmann-Hansen Torhaug is a highly accomplished, board-certified, oncology specialist with extensive experience in clinical strategy and development. Siri has worked in various senior leadership roles, including as Chief Medical Officer at Nykode Therapeutics, where she was instrumental in developing clinical strategies for oncology and autoimmune disease therapies. She brings a wealth of experience from working across both early-phase translational research and late-stage clinical trials. At Epitopea, Siri will focus on clinical strategy and development, ensuring that the company’s pipeline moves forward with precision and efficacy.

"It’s a pleasure to join Epitopea’s Executive and clinical leadership team," said Siri Brinchmann-Hansen Torhaug, Head of Oncology Development. "With my background in oncology clinical trials, I am excited to contribute to the company’s innovative work in cancer immunotherapy. I look forward to working alongside Klaus and Gertrud to advance Epitopea’s promising pipeline, with the aim of improving patient outcomes in oncology."

Gertrud Koefoed Rasmussen brings over 20 years of experience in clinical operations across multiple therapeutic areas, including oncology and rare diseases. Most recently, Gertrud held the position of VP and Head of Development Operations at Nykode Therapeutics, where she built and expanded the clinical operations department and led clinical trials across all phases of development. She has extensive experience in vendor management, regulatory compliance, and process optimization. At Epitopea, Gertrud will lead clinical trial management and regulatory compliance, ensuring that trials are conducted efficiently and in accordance with regulatory guidelines.

"Joining Epitopea is an exciting opportunity to leverage my expertise in clinical operations and contribute to the development of innovative therapies," said Gertrud Koefoed Rasmussen, Head of Development Operations. "I look forward to collaborating with the team to manage and execute clinical trials that will bring groundbreaking cancer immunotherapies to patients with significant unmet medical needs."

Dr. Klaus Edvardsen, CMO of Epitopea, commented, "It is an honor to lead the formation of this clinical team, and I am thrilled to work with Gertrud and Siri, who both bring invaluable experience and expertise to Epitopea. Their leadership will be crucial as we move forward with our clinical trials and work to bring our transformative cancer immunotherapies to the clinic."

As part of the research team appointments, Dr. Theres Oakes brings extensive expertise in antigen-directed immuno-oncology through her academic training and prior role at Achilles Therapeutics. Dr. Lisa Smith brings considerable experience in drug discovery and oncology from her previous roles at Kudos Therapeutics, Mission Therapeutics and Benevolent AI.

Dr. Jon Moore, CSO and Co-Founder of Epitopea commented, "We are harnessing the talents of our existing research team and recent joiners to build world-class cancer immunotherapeutics. To this end, we welcome Lisa to accelerate these efforts. Furthermore, with the translational sciences team we are building around Theres, we will have the capability to assess the performance of our immunotherapeutics in patients with unrivalled precision. It has been a real privilege to be able to build such a strong biology group, and I am very excited to see what impact we can make on the treatment of these devastating diseases."

(Press release, Epitopea, JUL 10, 2025, View Source [SID1234661167])

BriaCell Reports Complete and Sustained Resolution of Brain Metastasis and Sustained Regression of Orbital Metastasis in “Eye-Bulging” Breast Cancer Patient

On July 10, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care reported updated results from its ongoing Phase 2 study of Bria-IMT in combination with check point inhibitor in patients with advanced metastatic breast cancer (MBC) (Press release, BriaCell Therapeutics, JUL 10, 2025, View Source [SID1234654347]).

BriaCell is pleased to report the sustained complete resolution of temporal lobe brain metastasis and continued orbital (behind the eye) tumor reduction after > 18 months of treatment in the Phase 2 study. The metastatic tumor initially caused proptosis –a visibly bulging of the eye. As previously reported, the heavily pre-treated MBC patient had demonstrated a complete resolution of a temporal lobe brain metastasis and a significant response in a right orbital metastasis at 8 months, then at 11 months. The patient has now maintained both responses for more than 18 months, with no evidence of brain tumor recurrence and ongoing tumor shrinkage in the orbital lesion.

This patient had failed eight prior treatment regimens, including an antibody-drug conjugate (ADC), before initiating therapy with Bria-IMT plus checkpoint inhibition. She has now completed 29 treatment cycles and has been on BriaCell’s Phase 2 study for over 21 months. Serial imaging at 8, 11, and now 20 months have confirmed no detectable disease in the right temporal lobe, along with continued response in the orbital lesion. Additionally, the patient’s tumor markers have remained markedly reduced from baseline, further supporting the sustained radiologic response.

"These encouraging results continue to suggest that our novel Bria-IMT regimen may provide durable immunotherapeutic benefit in late-stage breast cancer patients with brain metastases who have exhausted other options," stated Dr. William V. Williams, BriaCell’s President & CEO. "The long-term response observed in this patient reinforces the potential of Bria-IMT to improve outcomes while maintaining a favorable tolerability profile."

Arcus Biosciences’ Quemliclustat Receives Orphan Drug Designation for Pancreatic Cancer

On July 10, 2025 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported that quemliclustat, an investigational small molecule CD73 inhibitor, was granted orphan drug designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer (Press release, Arcus Biosciences, JUL 10, 2025, View Source [SID1234654336]).

"The orphan drug designation indicates the importance of developing new treatment options for rare diseases like pancreatic cancer, which has the highest mortality rate of all major cancers, and which has seen few treatment advancements over the past 30 years," said Richard Markus, M.D., Ph.D., chief medical officer at Arcus Biosciences. "We expect the Phase 3 PRISM-1 study to be fully enrolled this year and, if positive, intend to quickly bring this new first-line treatment option to patients, with the goal of prolonging survival for those with metastatic pancreatic cancer."

Orphan drug designation is intended to support the development and evaluation of new treatments for rare diseases affecting fewer than 200,000 people in the United States. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees including New Drug Application (NDA), and a potential seven years of market exclusivity after approval.

In January 2024, Arcus presented results from the Phase 1 ARC-8 study, which showed no new safety signals and median overall survival (OS) of 15.7 months in a pooled analysis of all patients treated with the 100mg quemliclustat-based regimens. The median OS exceeded the historical benchmark data for chemotherapy alone, including for patients with liver metastasis, which account for more than half of all pancreatic cancers. Based on the ARC-8 results, the company initiated PRISM-1, a registrational Phase 3 study to evaluate quemliclustat plus gemcitabine/nab-paclitaxel chemotherapy versus gemcitabine/nab-paclitaxel chemotherapy alone in approximately 610 patients with pancreatic ductal adenocarcinoma (PDAC) that have not been previously treated in the metastatic setting. The study is expected to be fully enrolled this year.

Quemliclustat is an investigational molecule. Approval from any regulatory authority for its use has not been received, and its safety and efficacy have not been established.

About the Phase 3 PRISM-1 Trial

PRISM-1 is a global, randomized, double-blind, placebo-controlled, multi-center Phase 3 study that will enroll approximately 610 patients with treatment-naïve metastatic PDAC. Participants will be randomized 2:1 between quemliclustat plus gemcitabine/nab-paclitaxel chemotherapy and gemcitabine/nab-paclitaxel chemotherapy plus placebo arms. The primary endpoint is overall survival (OS), and secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.

About Quemliclustat

Quemliclustat is an investigational, potent and selective small molecule CD73 inhibitor that is being co-developed in collaboration with Gilead Sciences. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types. Quemliclustat has been shown to block the production of adenosine. Once the immunosuppressive effects of adenosine are removed, activation of antitumor immune cells may be restored, resulting in cancer cell death.

About Pancreatic Cancer

According to the American Cancer Society, approximately 67,440 Americans will be diagnosed with pancreatic cancer in the U.S. in 2025, and pancreatic cancer has the highest mortality rate of all major cancers. Approximately 50% of people with PDAC are diagnosed in the metastatic setting, which is associated with a five-year survival rate of only 3%. Pancreatic cancer occurs in the pancreas, an organ located behind the stomach that helps with digestion and controlling blood sugar. The majority (over 90%) of pancreatic cancers are adenocarcinomas, a type of cancer that forms in tissues that line certain internal organs and release fluids like those that help with digestion. There have been limited advancements for treating pancreatic cancer, and chemotherapy has been the standard of care for more than 30 years.

IceCure Announces Commencement of Rights Offering

On July 10, 2025 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported that it has commenced its previously disclosed rights offering (the "Rights Offering") (Press release, IceCure Medical, JUL 10, 2025, View Source [SID1234654335]).

Pursuant to the Rights Offering, the Company is distributing to all holders of record of the Company’s ordinary shares, no par value per share ("Ordinary Shares") as of 5:00 p.m., Eastern Time, on July 9, 2025 (the "Record Date"), at no charge, non-transferable subscription rights (the "Subscription Rights") to purchase up to an aggregate of 10,000,000 units ("Units") at a subscription price of $1.00 per whole Unit.

Each holder of the Company’s Ordinary Shares will receive one Subscription Right for every Ordinary Share owned on the Record Date. Each Subscription Right will entitle its holder to purchase 0.1703 of a Unit, each comprised of one Ordinary Share and a warrant to purchase one Ordinary Share (the "Warrant") at a subscription price of $1.00 per Unit or, in lieu of such Unit, one Unit, each comprised of one pre-funded warrant to purchase one Ordinary Share and one Warrant, at a subscription price of $0.9999 per Unit . No fractional Subscription Rights are being distributed and no fractional Units will be issued upon the exercise of any Subscription Rights in the Rights Offering. Shareholders must exercise Subscription Rights for at least one whole Unit to participate in the Rights Offering. The Subscription Rights will expire if they are not exercised by 5:00 p.m., Eastern Time, on July 28, 2025, the expected expiration date of the Rights Offering. The Company may extend the period for exercising the Subscription Rights. Subscription Rights which are not exercised by the expiration date of the Rights Offering will expire and will have no value.

Assuming the Rights Offering is fully subscribed, the Company expects to receive aggregate gross proceeds of $10 million. Holders who fully exercise their basic Subscription Rights will be entitled to subscribe for additional Units that remain unsubscribed as a result of any unexercised basic Subscription Rights. If over-subscription privilege requests exceed the remaining Units available, the remaining Units will be allocated pro-rata among holders who over-subscribe based on the number of Ordinary Shares held by all holders exercising the privilege. Epoch Partner Investments Limited ("Epoch"), the Company’s largest shareholder, has committed to participate in the Rights Offering and exercise its Subscription Right in full and any over-subscription privilege to purchase Units not subscribed for by other shareholders with an aggregate subscription price of up to $5 million. Li Haixiang, the sole director of Epoch, is a member of the board of directors of the Company. As previously announced by the Company on May 21, 2025, Epoch granted IceCure a $2 million unsecured loan on May 17, 2025 bearing interest of 4.05% (the "Bridge Loan"). The Bridge Loan will be repaid after 12 months or upon the completion of the Rights Offering, whichever is earlier. The Company intends to use the proceeds of the Rights Offering, including proceeds directly raised from Epoch’s participation in the Rights Offering, to repay the principal and any accrued interest from the Bridge Loan and for general corporate and working capital purposes.

The subscription period for the Rights Offering commenced on July 10, 2025 and will end at 5:00 p.m., Eastern Time, on July 28, 2025, unless extended by the Company (the "Subscription Period"). The Subscription Rights are non-transferable and will only be exercisable during the Subscription Period. Once holders have exercised their Rights, such exercise may not be revoked, canceled, or changed, even if holders subsequently learn information about the Company or its business, financial position, results of operations or cash flows that is material or adverse or that the holders otherwise consider to be unfavorable. The Company may cancel, modify or amend the Rights Offering at any time and for any reason prior to the expiration of the Subscription Period.

The Company has engaged Maxim Group LLC as dealer-manager for the Rights Offering. Questions about the Rights Offering or requests for copies of the final prospectus may be directed to Maxim Group LLC at 300 Park Avenue, New York, NY 10022, Attention Syndicate Department, or via e-mail at [email protected] or telephone at +1 (212) 895-3745.

The Rights Offering is being made pursuant to the Company’s registration statement on Form F-1 (File No. 333-288062) (as amended, the "Registration Statement"), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on July 9, 2025. The Rights Offering is being made only by means of a prospectus, copies of which will be delivered to holders of the Company’s Ordinary Shares as of 5:00 p.m., Eastern Time, on the Record Date and can be accessed through the SEC’s website at www.sec.gov. Questions about the Rights Offering or requests for a copy of the prospectus related to the Rights Offering may be directed to the Information Agent, Broadridge Corporate Issuer Solutions, LLC, at (855) 793-5068 or via e-mail at [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy any Subscription Rights, Ordinary Shares, Warrants, Units or any other securities, nor will there be any offer, solicitation or sale of any Subscription Rights, Ordinary Shares, Warrants, Units or any other securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful under the securities laws of such state or jurisdiction. This press release is not an offering and an offering can only be made by the prospectus and any prospectus supplements for the Rights Offering, which should be read carefully before making an investment decision.

The Company has not made and will not make any recommendation to shareholders regarding the exercise of Subscription Rights. The Company’s shareholders as of 5:00 p.m., Eastern Time, on the Record Date should make an independent investment decision about whether to exercise their Subscription Rights based on their own assessment of the Company’s business, financial condition, prospects for the future and the terms of the Rights Offering.