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BriaCell Receives FDA Clearance to Initiate Bria-BRES+™ Clinical Study in Breast Cancer

On May 6, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported it has received FDA clearance to initiate clinical evaluation of Bria-BRES+, its next generation, personalized, off-the-shelf, cell-based immunotherapy for metastatic breast cancer.

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"We are honored to announce FDA clearance of the first IND for our next generation personalized immunotherapy, Bria-BRES+," stated Dr. William V. Williams, BriaCell’s President & CEO. "The unique design of Bria-BRES+ offers the potential for a favorable safety profile and meaningful therapeutic benefit in metastatic breast cancer. We look forward to advancing Bria-BRES+ into the clinic as we seek to bring new hope to these patients who have few to no effective treatment options."

As reported in BriaCell’s recent AACR (Free AACR Whitepaper) preclinical poster presentation, Bria-BRES+ demonstrated activation of both adaptive and innate immunity including activation of naïve (resting) T-cells, dendritic cells and natural killer (NK) cells. BriaCell believes this multipronged immune activation may enhance clinical efficacy and help prevent immune escape in patients with metastatic breast cancer.

BriaCell’s Bria-BRES+ builds on its Bria-OTS breast cancer clinical program, where the first patient dosed experienced the sustained complete resolution of a lung metastasis. This 78-year-old woman with advanced metastatic breast cancer and multiple prior treatment failures achieved complete (100%) resolution of a lung metastasis following four doses of Bria-OTS single agent therapy. The complete response of the lesion, initially observed at 2 months, was subsequently confirmed at 4 months, 6 months, and at 11 months. The patient received 17 cycles of Bria-OTS, completed 12 months of the study, and remains in survival follow-up.

(Press release, BriaCell Therapeutics, MAY 6, 2026, View Source [SID1234665232])

Erasca to Present at the Bank of America Securities Health Care Conference

On May 6, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported its participation in the Bank of America Securities 2026 Health Care Conference being held at the Encore Hotel in Las Vegas, Nevada. Management will participate in a fireside chat on Wednesday, May 13, 2026, at 3:00 pm Pacific Time and will also participate in one-on-one investor meetings.

A live audio webcast of the event will be available online at Erasca.com/events. An archived replay of the event will be available for 30 days following the webcast at Erasca.com/events.

(Press release, Erasca, MAY 6, 2026, View Source [SID1234665231])

Ernexa Therapeutics Unveils Breakthrough Preclinical Results: ERNA-101 Achieves 100% Survival and Complete Tumor Elimination in Ovarian Cancer Models

On May 6, 2026 Ernexa Therapeutics (Nasdaq: ERNA), an industry innovator developing novel cell therapies for the treatment of advanced cancer and autoimmune disease, reported new preclinical data demonstrating that its lead cell therapy candidate, ERNA-101, in combination with PD-1 blockade, drives complete tumor clearance and 100% long-term survival in syngeneic ovarian cancer models.

"This data represents a significant step forward," said Robert H. Pierce, M.D., Chief Scientific Officer of Ernexa Therapeutics. "We are not just seeing strong response, we are seeing complete tumor eradication and durable survival, driven by a powerful immune activation mechanism within the tumor itself. These findings underscore the potential of ERNA-101 to overcome one of the biggest challenges in ovarian cancer – an immunologically ‘cold’ TME – and to unlock the full potential of checkpoint inhibition. Subsequent to a positive clinical proof-of-concept trial in collaboration with the MD Anderson Cancer Center in platinum-resistant ovarian cancer, we anticipate broadening the scope of indications to include other solid tumors, where strong immunosuppression in the tumor microenvironment limits the clinical benefit of anti-PD-1 therapy."

In the study, treatment with ERNA-101 in combination with anti-PD-1 therapy resulted in complete tumor clearance (i.e., loss of detectable tumor signal by bioluminescence imaging) and 100% survival through long-term follow-up. These outcomes significantly exceeded those observed with either therapy alone and suggest potential curative activity.

The data further demonstrate that ERNA-101 remodels the TME from immunosuppressive to immune-activated, enabling robust and sustained anti-tumor immune responses.

"What we are seeing goes beyond expectations. Achieving complete tumor elimination and 100% survival in a model where current approaches typically fall short reinforces both the strength of the data and the underlying mechanism driving this response. These results give us increased confidence in ERNA-101’s ability to meaningfully enhance the activity of checkpoint inhibitors and potentially shift treatment outcomes in ovarian cancer. This approach may also extend beyond ovarian cancer, with the potential to drive meaningful responses across other immunologically ‘cold’ solid tumors characterized by highly suppressive tumor microenvironments. We believe ERNA-101 has the potential to become a foundational therapy in combination regimens, significantly expanding treatment effectiveness," said Sanjeev Luther, President and Chief Executive Officer of Ernexa Therapeutics.

ERNA-101 is an allogeneic induced mesenchymal stem cell (iMSC) therapy derived from induced pluripotent stem cells (iPSCs) and engineered to home to tumors and secrete a potent IL-7/IL-15 fusion cytokine directly within the TME. This localized cytokine delivery approach is designed to maximize immune activation while minimizing systemic toxicity.

Key findings from the preclinical studies include:

Complete tumor clearance and survival: Combination therapy eliminated detectable tumors and achieved 100% survival in treated mice through long-term follow-up
Tumor microenvironment remodeling: ERNA-101 converted the tumor environment from immunosuppressive to immune-activated, enabling stronger immune attack on the tumor
Enhanced immune cell activity: Treatment increased the activity, survival, and persistence of key cancer-fighting T cells
Immune infiltration: Significantly more CD4⁺ and CD8⁺ T cells were able to enter tumors and engage cancer cells directly
Macrophage reprogramming: Immune cells within the tumor shifted toward a cancer-fighting state rather than a tumor-supporting state
Reduced disease burden: Treatment reduced tumor burden and decreased ascites fluid accumulation associated with advanced disease
Ovarian cancer, particularly high-grade serous ovarian carcinoma (HGSOC), remains a significant unmet medical need, with most patients diagnosed at advanced stages and high relapse rates following standard therapies. Existing treatments, including checkpoint inhibitors, have shown limited efficacy due to the highly immunosuppressive TME.

Ernexa plans to incorporate these findings into its development strategy as it advances ERNA-101 toward a first-in-human clinical trial in patients with advanced ovarian cancer. Ongoing studies are evaluating ERNA-101 in combination with checkpoint inhibitors and other immuno-oncology agents.

(Press release, Ernexa Therapeutics, MAY 6, 2026, View Source [SID1234665230])

Totus Medicines Presents Early Phase 1b Clinical Data Demonstrating 100% Disease Control Rate and Class-Leading Safety for TOS-358 + Fulvestrant Doublet Therapy in HR+/HER2- Breast Cancer at ESMO Breast Cancer Annual Congress 2026

On May 6, 2026 Totus Medicines, a clinical-stage, precision medicines company leveraging AI-powered small molecule drug discovery to advance a differentiated pipeline of therapeutics against high-value, historically difficult-to-drug targets, reported the presentation of interim Phase 1b clinical data from its ongoing study of TOS-358, a next-generation pan-mutant, covalent, alpha-selective PI3Ka inhibitor, in combination with Fulvestrant, in heavily pre-treated metastatic HR+/HER2− breast cancer patients. The data were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Annual Congress, taking place in Berlin, Germany, May 5–8, 2026.

Presentation Details:

Conference: ESMO (Free ESMO Whitepaper) Breast Cancer 2026

Session: Poster Presentation

Abstract Number: 492P

Date / Time: 13:15, Thursday, May 7, 2026

"These initial combination data with TOS-358 and Fulvestrant are highly encouraging and reinforce our confidence in TOS-358’s differentiated profile as a covalent, pan-mutant PI3Ka inhibitor," said Zelanna Goldberg, M.D., Chief Medical Officer of Totus Medicines. "Achieving 100% disease control and an 89% clinical benefit rate in women, including patients with prior PI3K/AKT/mTOR pathway therapy, alongside a class-leading tolerability profile, underscores the potential of TOS-358 to address a critical unmet need in HR+/HER2− metastatic breast cancer. The durability of responses, with more than 60% of patients remaining on therapy beyond 24 weeks, further validates our approach of near-total, sustained PI3Ka pathway suppression."

First Combination Data: TOS-358 + Fulvestrant Efficacy and Durability

The poster (Abstract 492P) presents the early clinical data from the doublet cohort of TOS-358-001, the ongoing open-label, global, multi-center Phase 1 study. Ten evaluable HR+/HER2− breast cancer patients were treated with TOS-358 in combination with Fulvestrant (median 3.5 prior lines of therapy; range 1–5), with a data cutoff of March 31, 2026. Key efficacy and durability findings include:

100% Disease Control Rate (DCR) in women treated with TOS-358 + Fulvestrant
89% Clinical Benefit Rate (CBR) in women, including patients who had received prior PI3K/AKT/mTOR (PAM)-directed therapy and patients in the 4th line and beyond
Responses continued to deepen over time, including conversions from stable disease (SD) to partial responses (PR), consistent with TOS-358’s near-total inhibition of PI3Ka signaling
60% of patients on TOS-358 + Fulvestrant remained on therapy beyond 24 weeks, with an additional 20% of patients ongoing at less than 24 weeks on trial; median time on therapy exceeds 24 weeks for the overall Phase 1 population
A 72-year-old heavily pre-treated patient with an H1047K/G106V dual PI3Ka mutation achieved a confirmed RECIST partial response of ~68%, with near complete PET-CT resolution of bone metastases
Class-Leading Safety and Tolerability

Across the overall TOS-358 safety population to date (N=56, including monotherapy and doublet patients), TOS-358 demonstrated a class-leading tolerability profile with an absence of toxicities that have limited other PI3Ka inhibitors:

0% bone marrow toxicity
0% hepatic toxicity
0% renal toxicity
0% ocular symptoms
0% rash
0% stomatitis/mucositis
0% grade 3 diarrhea
Hyperglycemia was manageable: only 3.6% of patients (2/56) required ongoing insulin, and all patients who received insulin were obese (BMI >30)
No treatment discontinuations due to intolerance to TOS-358
Maturing Overall Phase 1 Experience

The overall Phase 1 cohort currently demonstrates a 78% DCR and 57% CBR, with data continuing to mature. Among the overall population treated with TOS-358, median time on therapy now exceeds 24 weeks, with 50% of patients maintaining disease control beyond this landmark. The ongoing Phase 1b expansion cohort is currently enrolling across doublet (TOS-358 + Fulvestrant) and triplet (TOS-358 + Fulvestrant + CDK4/6 inhibitor) arms.

TOS-358: A Differentiated Approach to PI3Ka Inhibition

TOS-358 is the first and only clinical-stage covalent PI3Ka inhibitor. As a pan-mutant, a-selective oral small molecule, TOS-358 achieves >95% continuous target engagement at clinically relevant doses through covalent binding to a cysteine residue equally accessible in helical, kinase-domain, and other mutants of PI3Ka while avoiding high plasma concentrations that can potentially lead to off-target effects. This broad mutant coverage – extending to acquired resistance mutations – differentiates TOS-358 from non-covalent and mutation-selective PI3Ka inhibitors currently approved or in development. The near-total, sustained suppression of oncogenic signaling enabled by this mechanism is reflected in the depth and durability of responses observed clinically, as well as the absence of many of the class-effect toxicities that have limited other agents.

PI3Ka driver mutations are present in approximately 40% of ER-positive/HER2-negative breast cancer, 50% of endometrial adenocarcinoma, and a meaningful subset of head and neck squamous cell carcinoma (HNSCC) patients. Totus Medicines is advancing TOS-358 as a potential best-in-class PI3Ka inhibitor across selected solid tumor indications. TOS-358-001 (EU CT 2023-505346-26-01; NCT#05683418) is an ongoing open-label, global, multi-center Phase 1 study evaluating the safety and efficacy of TOS-358 alone and in combination.

(Press release, Totus Medicines, MAY 6, 2026, View Source [SID1234665229])

CellCentric Announces Oversubscribed $220 Million Series D Financing to Advance Pivotal Trials of Inobrodib in Multiple Myeloma

On May 6, 2026 CellCentric, a clinical-stage biotechnology company developing inobrodib as a first-in-class, oral p300/CBP inhibitor for the treatment of multiple myeloma, reported the completion of an oversubscribed $220 million Series D financing. The financing was led by specialist investor Venrock Healthcare Capital Partners, with participation from a strong syndicate of new and existing investors.

Proceeds will support the advancement of inobrodib through pivotal clinical development studies, including continued enrollment of the company’s recently initiated Phase 2 DOMMINO-1 study in the UK and US and initiation of the global Phase 3 DOMMINO-2 trial in the second half of 2026. Capital raised will also fund expansion of inobrodib into additional combination and maintenance treatment settings.

"We are thrilled to have the support of top-tier investors who believe in inobrodib’s potential to address a critical need in multiple myeloma, notably after bispecific T cell engager or anti-BCMA therapies. This is a significant and growing unmet need," said Will West, Ph.D., CEO of CellCentric. "Inobrodib is a new modality and a potential fresh option for patients that is orally administered. In combination with pomalidomide and dexamethasone as InoPd, we have demonstrated deep responses in heavily pretreated relapsed or refractory multiple myeloma patients. Fueled by this funding, we are well positioned to complete registration enabling studies for the all-oral triplet and advance our progress toward delivering a transformative treatment."

Phase 2 dose-optimization data shared in December 2025 at ASH (Free ASH Whitepaper), demonstrated that 20 mg inobrodib in combination with standard doses of pomalidomide and dexamethasone (InoPd) represents at least a two-fold increase in response rates compared to historic alternative therapies in patients with relapsed or refractory multiple myeloma (RRMM) who were heavily pretreated (median five lines of prior therapy).

"What stands out with inobrodib is the consistency of clinical activity alongside a manageable safety profile in a heavily pretreated population," said Ken Greenberg, M.D., Partner at Venrock. "An oral drug with a novel, additive approach could play an important role in later-line therapy, as well as across the treatment landscape in multiple myeloma. We are excited to support its advancement into pivotal studies."

About Inobrodib

Inobrodib is a potential new treatment for people with multiple myeloma (MM) and other cancers. It has been evaluated in over 500 patients to date, and clinical activity has been seen in both hematologic malignancies and solid tumors. Delivered as an oral capsule, inobrodib is designed to be used at home without the need for intensive monitoring.

Alongside InoPd, inobrodib is also being explored in combination with bispecific therapies elranatamab and teclistamab. Proof of concept in a maintenance setting is also being explored. CellCentric maintains all development and commercial rights to inobrodib and is free to expand the program in combination with other agents. The FDA previously granted Fast Track and orphan drug designations to inobrodib for RRMM.

(Press release, CellCentric, MAY 6, 2026, View Source [SID1234665228])