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Calidi Biotherapeutics Presents Systemic Oncolytic Platform with CD55-Enhanced Expression and IL-15 Superagonist Payload at ASCO Annual Meeting

On June 2, 2025 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the ability to deliver genetic payloads, reported the presentation of its lead RedTail platform candidate, CLD-401, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Calidi Biotherapeutics, JUN 2, 2025, View Source [SID1234653601]).

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Calidi has previously demonstrated its pioneering efforts in developing an enveloped form of its proprietary oncolytic virus that is significantly more resistant to immune clearance than non-enveloped forms, allowing for systemic delivery and efficacy in syngeneic tumor-bearing pre-clinical models. Calidi has further advanced this technology with CLD-401, its first therapeutic candidate from the RedTail platform. New data presented at the meeting demonstrate a novel genetic modification in which a chimeric CD55 receptor is incorporated into the envelope shielding the virus. Because CD55 receptor expression acts as a robust inhibitor of complement, this modification further enhances the virus’s resistance to rapid clearance by the humoral immune system following intravenous administration.

In addition, the RedTail viral platform also allows for the delivery of potent genetic payloads directly into the tumor microenvironment. CLD-401 expresses an IL-15 superagonist, a next-generation cytokine known to activate and expand natural killer (NK) cells and CD8+ T cells—key components of the immune system with demonstrated clinical efficacy.

"The integration of CD55 into our RedTail platform marks a major advancement in systemic virotherapy," said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "By improving the shielding of the virus from complement-mediated destruction, we enhance its stability in circulation and enable the in situ expression of immune-activating payloads—such as the IL-15 superagonist—directly within the tumor microenvironment, where they can stimulate a robust antitumor immune response."

"RedTail is the result of over a decade of focused innovation at Calidi," added Eric Poma, PhD, Chief Executive Officer. "Our systemic approach overcomes the limitations of traditional intratumoral oncolytic viruses and enables the treatment of metastatic cancers through intravenous administration. The use of a chimeric CD55 enhancement is a critical enabler of this vision."

Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application in the second half of 2026. The company is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform

A copy of the ASCO (Free ASCO Whitepaper) poster featuring the CD55 data is available.

BriaCell Reports Robust Overall Survival and Clinical Benefit Data at ASCO 2025

On June 2, 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 clinical data in three clinical poster presentations and one publish-only abstract at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, BriaCell Therapeutics, JUN 2, 2025, View Source [SID1234653600]). BriaCell has featured robust survival and clinical benefit data from its Bria-IMT Phase 2 clinical study, clinical progress data from its ongoing pivotal Bria-IMT Phase 3 study (ClinicalTrials.gov identifier: NCT06072612 ), and Phase 1/2 study of Bria-OTS (ClinicalTrials.gov identifier: NCT06471673 ) in metastatic breast cancer.

"Prolonging survival and providing meaningful clinical benefit for patients whose disease has demonstrated resistance to multiple treatment options remains a critical unmet need in breast cancer. These Bria-IMT regimen results are promising for individuals with metastatic breast cancer," said Sara A. Hurvitz, MD, FACP, Senior Vice President, Director of the Clinical Research Division, and Smith Family Endowed Chair in Women’s Health at Fred Hutch Cancer Center, as well as Professor and Head of the Division of Hematology and Oncology at the University of Washington, Seattle, WA, and co-author of one of the clinical posters. "The low incidence of all grade and grade 3/4 adverse events is particularly notable."

"We are thrilled with our Phase 2 overall survival and clinical benefit data which meets and exceeds those of FDA approved drugs — even in very heavily pre-treated patients in our study," noted Dr. William V. Williams, BriaCell’s President & CEO. "We look forward to further confirming these impressive results in our ongoing pivotal Phase 3 study with the ultimate goal of bringing novel treatments to cancer patients in need."

The details of the poster presentation sessions and publish-only abstract are listed below.

Poster Title: Update on phase III pivotal trial of Bria-IMT + CPI vs physician’s choice in advanced metastatic breast cancer (BRIA-ABC)
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1138
Poster Board Number: 108a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

"Trial in Progress" poster presents early enrollment data and the overall design of the Phase 3 pivotal trial along with updated clinical outcomes from the Phase 2 Bria-IMT study.

Poster Title: Bria-IMT + checkpoint inhibitor: Phase I/II survival results compared to benchmark trials in metastatic breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: 1096
Poster Board Number: 75
Session Type and Title: Poster Session – Breast Cancer—Metastatic

In the Phase 2 study of Bria-IMT combined with an immune checkpoint inhibitor (CPI) in 54 heavily pre-treated metastatic breast cancer (MBC) patients (median of six prior systemic therapies; range 2–13), Bria-IMT demonstrated promising efficacy and safety. Notably, 44% of patients had failed a prior antibody-drug conjugate, and 20% had failed a prior CPI. Among these patients, the overall clinical benefit rate (CBR; defined as CR, PR, or SD) was 55%, with CBRs of 100% in HER2+, 55% in HR+/HER2-, and 45% in triple-negative breast cancer (TNBC) subgroups, indicating antitumor activity across MBC subtypes. Additionally, patients treated with the selected Phase 3 formulation (without IFNγ; N=37) experienced significantly improved overall survival (13.9 vs. 6.93 months; P=0.01) compared to those receiving the alternate formulation, highlighting the potential of Bria-IMT for advancing in clinical development.

Table 1. Median overall survival (OS) in BriaCell Phase 2 Study patients who were treated with Phase 3 formulation (without IFNγ) compared with comparable patients in the literature

N = 54 Breast Cancer
Types Median Prior
Lines of Therapy Median (months)
Phase 3 formulation
(without IFNγ) 61% HR+
33% TNBC
6% HER2+ 6 17.3*
13.9
Cortes et al. 1 57% HR+
18-19% TNBC
18-20% HER2+ 4 9.1-9.3
Kazmi et al. 2 51-52% HR+
25-29% TNBC
9-24% HER2+ 2 7.2-9.8
* Patients treated since 2022
1. Cortes J, et al. Annals of Oncology 2018
2. Kazmi S, et al. Breast Cancer Res Treat. 2020
Table 2. Median overall survival (OS), and clinical benefit rate (CBR) in TNBC patients treated with Bria-IMT Phase 3 formulation compared with pivotal Phase 3 ASCENT 1 study results (Trodelvy (SG) vs. Treatment of Physicians Choice (TPC) in triple-negative breast cancer (TNBC))
Trial (Cohort) Age (Median,
Range) Prior
Therapies
(Median) Prior ADC/CPI
(%) CNS
Mets OS
(Median,
Months) CBR
(%)
TNBC Bria-
IMT (Phase 3
Formulation) 62 (44-80) 6 (2-13) 20/19 4 11.4 45 %
ASCENT (SG) 54 (27-82) 4 (2-17) 27/None Listed None
Listed 11.8 40%
ASCENT (TPC) 53 (27-81) 4 (2-14) 27/None Listed None
Listed 6.9 8%

1 Bardia, A., et al Journal of Clinical Oncology, 42(15), 1738–1744.
As shown in table 2, both OS and CBR values were in line or higher than those reported in the treatment arm of the ASCENT study for TNBC patients treated with Phase 3 formulation of Bria-IMT regimen but were almost 2 times higher than those shown in the TPC comparator arm.
Table 3: Median overall survival (OS), and clinical benefit rate (CBR) in HR+/HER2- patients treated with the Bria-IMT (Phase 3 formulation) compared with pivotal Phase 3 TROPiCS-02 2 study results (SG or Chemo in Hormone Receptor +/HER2- MBC)
Trial (Cohort) Age
(Median,
Range) Prior
Therapies
(Median) Prior
ADC/CPI
(%) CNS
Mets OS
(Median,
Months) CBR (%)
HR+/HER2-
Bria-IMT (Phase 3
Formulation) 62 (44-80) 6 (2-13) 17/2 1 17.3 60 %
TROPiCS (SG) 57 (49-65) 3 None
Listed None
Listed 14.4 34%
TROPiCS (Chemo) 55 (48-63) 3 None
Listed None
Listed 11.2 22%

2 Rugo, H. S., et al. The Lancet, 402(10411), 1423–1433.
As shown in table 3, both OS and CBR values for patients treated with Phase 3 formulation of the Bria-IMT regimen were higher than those reported in both arms of the TROPICS study.
Favorable tolerability profile: Bria-IMT was well-tolerated with no treatment-related discontinuations. 22% of patients are still in active survival follow up with one patient remaining on study now for over 18 months.
The efficacy data and favorable safety profile of the Phase 3 formulation support the continued evaluation of Bria-IMT in BriaCell’s ongoing pivotal Phase 3 trial ( NCT06072612 ), which compares Bria-IMT to the treatment of physician’s choice. The ongoing patient subset analysis in this trial aims to identify the patients who may derive the greatest benefit from Bria-IMT treatment.

Poster Title: Trial in progress: A study of Bria-OTS cellular immunotherapy in metastatic recurrent breast cancer
Session Date and Time: June 2, 2025 9:00 AM-12:00 PM CDT
Abstract Number for Publication: TPS1136
Poster Board Number: 107a
Session Type and Title: Poster Session – Breast Cancer—Metastatic

In a dose-escalation Phase 1/2 study, heavily pre-treated MBC patients received Bria-OTS monotherapy (single agent Bria-OTS cells only). The Phase 1 segment enrolled and treated 3 patients with the first patient achieving a confirmed resolution of a breast cancer lung metastasis and remaining on study with single agent Bria-OTS. Following successful completion of safety evaluations, BriaCell has initiated the combination cohort dosing the first patient with Bria-OTS plus checkpoint inhibitor (CPI).

Publish-Only Abstract Title : Impact of HLA Matching on Clinical Outcomes in a Phase 2 Trial of Bria-IMT Plus Anti PD1 in Advanced Breast Cancer

Following the presentations, copies of the presentations will be posted on View Source

bluebird bio Announces Completion of Acquisition by Carlyle and SK Capital

On June 2, 2025 bluebird bio (NASDAQ: BLUE) ("bluebird"), a pioneer in gene therapies for severe genetic diseases, reported the completion of its sale to funds managed by global investment firms Carlyle (NASDAQ: CG) and SK Capital Partners, LP ("SK Capital") (Press release, bluebird bio, JUN 2, 2025, View Source [SID1234653597]). With the closing of the transaction, bluebird’s common stock has ceased trading and will no longer be publicly listed. Carlyle and SK Capital have provided significant primary capital to support and scale bluebird’s commercial delivery of gene therapies for patients with sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy.

David Meek, who became Chief Executive Officer of bluebird at close, said, "Today marks the beginning of a new era for bluebird as its go-forward financial backing and leadership team will better enable all stakeholders to realize the full potential of our revolutionary therapies. Historically, bluebird has excelled as a scientific innovator and should be very proud of the many achievements it has delivered to patients. Our vision is to further that legacy of scientific excellence while improving the commercial execution of our approved products to rapidly expand access to lifechanging gene therapies."

"We are excited to back bluebird in partnership with SK Capital. We believe providing bluebird the necessary funding along with the new leadership team will help bluebird realize its full potential," said Joe Bress, Carlyle Partner and Global Co-Head of Healthcare. Bali Muralidhar, Co-Managing Partner and Chief Investment Officer & COO of Abingworth, Carlyle’s life sciences investment franchise, added, "There is an incredible opportunity to bring bluebird’s groundbreaking therapies to more patients in need, and we look forward to advancing bluebird in its mission."

"SK Capital looks forward to partnering with David and his team as well as Carlyle to scale bluebird’s pioneering gene therapies that can make a lifechanging difference for patients around the world," said Aaron Davenport, Managing Director at SK Capital, adding, "We believe our deep collective experience in manufacturing and commercializing therapies can help drive the next chapter of bluebird’s growth."

Incoming Team Bolsters Commercial Gene Therapy Experience

The company’s momentum is reinforced by a deeply experienced management team, led by CEO David Meek. David brings more than 30 years of leadership in life sciences, including as CEO of Mirati Therapeutics and Ipsen. David is joined by Tom Klima as Chief Commercial & Operating Officer, Debasish Roychowdhury, M.D., as Chief Medical Officer, Wendy DiCicco as Chief Financial Officer, and Ellen Forest as Chief People Officer. Additional details are available at View Source

From Scientific Breakthroughs to Delivery at Scale

With the transaction now closed, bluebird is prioritizing expanding its manufacturing infrastructure, streamlining the patient journey, supporting treatment centers, and strengthening its payer partnerships. The acquisition provides the strategic and financial backing needed to meet rising demand and drive commercial and operational excellence across the organization.

"bluebird has demonstrated what’s possible through effective gene therapy," David added. "Now we will build the ecosystem to ensure every patient who needs these therapies can access them."

BioNTech and Bristol Myers Squibb Announce Global Strategic Partnership to Co-Develop and Co-Commercialize Next-generation Bispecific Antibody Candidate BNT327 Broadly for Multiple Solid Tumor Types

On June 2, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech") and Bristol Myers Squibb (NYSE: BMY, "BMS") reported that the companies have entered into an agreement for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types (Press release, BioNTech, JUN 2, 2025, View Source [SID1234653596]). Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate.

BioNTech’s BNT327, a next-generation bispecific antibody candidate targeting PD-L1 and VEGF-A, is currently being evaluated in multiple ongoing trials with more than 1,000 patients treated to date, including global Phase 3 trials with registrational potential evaluating BNT327 as first-line treatment in extensive stage small cell lung cancer ("ES-SCLC") and non-small cell lung cancer ("NSCLC"). A global Phase 3 trial evaluating the candidate in triple negative breast cancer ("TNBC") is planned to start by the end of 2025. Preliminary data from ongoing trials underscore the potential for combining anti-PD-L1 and anti-VEGF-A – two well-established therapeutic targets – into a single molecule to deliver synergistic clinical benefits for patients across multiple tumor types.

Under the terms of the agreement, the companies will jointly develop and commercialize BNT327, including the development of BNT327 as monotherapy and in combination with other products. Both companies have the right to independently develop BNT327 in further indications and combinations, including combinations of BNT327 with proprietary pipeline assets.

"We believe BNT327 has the potential to become a foundational immuno-oncology backbone, moving beyond single-mechanism checkpoint inhibitors and expanding into multiple solid-tumor indications. Our collaboration with BMS, a pioneering leader in immuno-oncology, aims to accelerate and broadly expand BNT327’s development to fully realize its potential," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "Our focus remains on advancing high-impact, pan-tumor programs and combination strategies in oncology, with BNT327 complementing our antibody-drug conjugate programs and mRNA-based immunotherapies. We are dedicated to delivering truly transformative options for patients in need."

"Our deep experience and expertise in advancing and delivering groundbreaking immuno-oncology medicines positions BMS well to collaboratively realize the potential of BNT327, an asset with significant potential for transforming the standard of care for patients with solid tumors," said Christopher Boerner, Ph.D., Board Chair and CEO of Bristol Myers Squibb. "The science behind BNT327 and its leading clinical position in multiple hard-to-treat tumor types, further bolsters our pursuit of novel mechanisms and multiple modalities in oncology, and enhances our growth trajectory. We are impressed by the innovation that BioNTech has achieved to date, and we look forward to partnering to accelerate existing clinical trials and time to market, while expanding the number of potential indications."

BMS will pay BioNTech $1.5 billion in an upfront payment and $2 billion total in non-contingent anniversary payments through 2028. These tax-deductible charges will be recorded as Acquired IPR&D Expense when incurred, with the $1.5 billion being incurred in Q2. In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones. BioNTech and BMS will share joint development and manufacturing costs on a 50:50 basis, subject to certain exceptions. Global profits/losses will be equally shared between BioNTech and BMS.

About BNT327
BNT327 is a novel investigational bispecific antibody combining two complementary, validated mechanisms in oncology into one single molecule. BNT327 combines PD-L1 checkpoint inhibition aimed at restoring T cells’ ability to recognize and destroy tumor cells with the neutralization of VEGF-A. The blocking of VEGF-A is aimed at reversing the tumor’s immuno-suppressive effect in its microenvironment and cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), with the intention of preventing the tumor from growing and proliferating. BNT327 may be differentiated via its mechanism of action of targeting PD-L1 on tumor cells to localize anti-VEGF activity within the tumor microenvironment, aiming to enhance therapeutic precision and minimize systemic exposure. A treatment with BNT327 is intended to help normalize blood vessels at the tumor site, improving delivery and potential effectiveness of combination therapies. This targeted vascular remodeling positions BNT327 as a potential backbone therapy across a wide range of solid tumors.1,2

More than 1,000 patients have been treated with BNT327 in clinical trials to date. More than 20 clinical trials are currently ongoing or planned to evaluate BNT327 either as a monotherapy or in combination with other treatment modalities targeting different oncogenic pathways in more than 10 solid tumor indications. Multiple global trials are ongoing or planned to start in 2025, including three global clinical trials with registrational potential in first-line small cell lung cancer ("SCLC"), first-line non-small cell lung cancer ("NSCLC") and first-line triple-negative breast cancer ("TNBC"). Additional trials will explore combining BNT327 and BioNTech’s proprietary antibody-drug conjugate candidates ("ADCs"). If successfully developed and approved, BioNTech aims to use this bispecific antibody candidate as a next-generation immuno-oncology ("IO") backbone in combination with other treatment modalities targeting a broad range of cancer indications.

Anixa Biosciences Announces Completion of Enrollment in Phase 1 Trial of Breast Cancer Vaccine

On June 2, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported the completion of enrollment in the Phase 1 clinical trial of its breast cancer vaccine (Press release, Anixa Biosciences, JUN 2, 2025, View Source [SID1234653595]). This novel vaccine, invented at Cleveland Clinic, is also being developed in partnership with Cleveland Clinic and the Phase 1 trial is fully funded by a grant from the U.S. Department of Defense (DoD).

The vaccine is designed to stimulate the immune system to target breast cancer before it can recur or develop. A total of 35 women have received the vaccine in the trial, including 26 in the triple-negative breast cancer ("TNBC") group, four in the prevention group, and five in the pembrolizumab group. These participants represent three distinct patient cohorts:

TNBC Group: Women who have completed treatment for triple-negative breast cancer, are currently cancer-free, and are at risk of recurrence.
Prevention Group: Women who are cancer-free but carry genetic mutations that place them at high risk of developing breast cancer and have elected to undergo preventative mastectomy to lower their risk.
Pembrolizumab (Keytruda) Group: Women who are receiving pembrolizumab in a post-operative setting. These women are receiving the vaccine concurrently with pembrolizumab.
The final patient visits are scheduled for August 2025. Once completed, the final study report will be submitted to the Department of Defense. A Clinical Study Report (CSR) will then be prepared for submission to the U.S. Food and Drug Administration. As part of the continued development process, the Investigational New Drug (IND) application will be transferred from Cleveland Clinic to Anixa.

Anixa and Cleveland Clinic plan to submit for presentation all trial data at a major upcoming scientific meeting.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "We are very encouraged by the data we are seeing from this trial. Preliminary results show that our breast cancer vaccine is well tolerated, with more than 70% of patients demonstrating protocol-defined immune responses. These encouraging findings are guiding our planning for Phase 2 trials, which will include discussions with the FDA, protocol development, manufacturing, and clinical site selection. While cancer vaccines have traditionally faced significant hurdles, our approach is aimed at a novel target that has not been previously explored in this context. We believe this could represent a new paradigm in immuno-oncology. The breast cancer market, particularly for triple-negative breast cancer and genetically high-risk populations, continues to face a major unmet need. Our vaccine may offer a unique, immunologic pathway for both prevention and treatment."