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.

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"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])

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.

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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])

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.

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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])

On May 6, 2026 Signadori Bio SAS ("Signadori" or the "Company"), a preclinical-stage biopharmaceutical company developing a next generation, off-the-shelf, in vivo engineered, monocyte immunotherapy platform to treat solid tumours, reported the successful completion of its seed extension financing round, bringing the total raised to €11.1 million. This latest investment was through participation from Taiho Ventures, and existing investors Sofinnova Partners and Invivo Partners.

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The proceeds from the financing will support the advancement of Signadori Bio’s lead programme SiB-2101 towards lead candidate nomination, further development of its proprietary in vivo monocyte engineering platform, and expansion of its scientific and operational teams.

Signadori Bio is developing a novel immunotherapy approach based on engineering monocytes in vivo to regulate and enhance myeloid anti-tumour activity. By harnessing the innate immune system, the company aims to overcome the immunosuppressive tumour microenvironment and address key limitations of existing immunotherapies and autologous cell therapies, particularly in solid tumours.

"This financing represents an important milestone for Signadori Bio as we continue to build on our promising preclinical data and advance our platform toward the clinic," said Dr. Selwyn Ho, Chief Executive Officer of Signadori Bio. "Our approach to in vivo engineering of monocytes has the potential to unlock a new class of immunotherapies that are more accessible, scalable, and effective for patients with solid tumours. We are delighted to welcome Taiho Ventures alongside our existing investors, Sofinnova Partners and Invivo Partners."

"Signadori Bio is advancing a highly differentiated strategy in immuno-oncology by targeting monocytes and leveraging in vivo engineering," said Seiji Miyahara, Partner & Senior Investment Director at Taiho Ventures, LLC. "The company’s compelling preclinical data and strong scientific foundation position it well to address significant unmet needs in solid tumours. We are excited to support the team in this next phase of development."

"Since inception, Signadori Bio has made strong progress in validating its platform and demonstrating the therapeutic potential of p21-driven monocyte reprogramming," said Matthieu Coutet, Chair of the Board at Signadori Bio and Partner at Sofinnova Partners. "This financing will enable the company to accelerate its development strategy and move closer to clinical translation."

Founded by Dr Jean-Luc Perfettini and Professor Nathalie Chaput, and based on research conducted at Gustave Roussy, Signadori Bio is focused on developing off-the-shelf immunotherapies that reprogram innate immune cells directly in the patient.

(Press release, Signadori Bio, MAY 6, 2026, View Source [SID1234665227])

On May 6, 2026 Kanvas Biosciences, a full-stack spatial biology company, reported it has raised a $48 million Series A funding round co-led by existing investors DCVC and Lions Capital LLC. Additional participating investors include Gates Foundation, ATHOS KG, Germin8, Ki Tua Fund, Pangaea Ventures and more. The fresh capital follows a July 2024 round and brings Kanvas’ total funding to $78 million. The funding will be used to conduct clinical trials for the lead drug candidate in the company’s immuno-oncology program, KAN-001, and advance commercial partnerships that leverage Kanvas’ spatial imaging and manufacturing platform for next generation live biotherapeutic product (LBP) development.

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A microbiome is a collection of microorganisms and their genes that live in the gut, lungs, on skin and in other tissue. Malfunctioning microbiomes can lead to inflammatory bowel disease, celiac disease, cardiovascular problems and even impact how cancer patients respond to immunotherapy. Kanvas has developed the unique ability to spatially map microbial cells and host cells, which allows the company to manufacture LBPs made of complex consortia containing hundreds of members that can restore microbiome health, and clearly visualize LBP engraftment and activity – two longstanding roadblocks in the quest to develop effective therapeutics for restoring the microbiome.

Clinical Applications and Development Pathway
KAN-001 is a LBP designed for cancer patients who don’t respond to immune checkpoint inhibitors (ICIs). While over 50% of solid organ cancer patients receive ICIs, only 10% achieve complete responses. Fecal microbiota transplants (FMT) from ICI responders can convert non-responders into responders, but they pose manufacturing challenges, pathogen risks and scalability issues. KAN-001 addresses these limitations, and has demonstrated safety and efficacy across multiple mouse models and tumor types. Importantly, the clinical pathway has been substantially de-risked: In a recent FMT trial for anti-PD-1 refractory microsatellite instability high cancers, fecal material from the same donor from which the specific KAN-001 strains were isolated was delivered to study participants via FMT. Results showed high engraftment rates, restored anti-PD-1 response and no ICI-induced colitis. Kanvas will now launch its own clinical trials and operationalize its newly opened GMP manufacturing suite.

"I began my career as a physician and always dreamed of being able to develop new drugs that could help the patients I hadn’t been able to treat with existing therapies," said Matthew Cheng, co-founder and CEO of Kanvas Biosciences. "Most physicians never get the opportunity to realize this dream, so it’s an incredible privilege to bring Kanvas’ technology to the broader LBP market and begin conducting clinical trials of our lead drug candidate, which offers a new way to improve the therapeutic efficacy and safety of immunotherapy for cancer patients."

Recent Company Momentum
Since announcing its Seed round in 2024, Kanvas has made significant progress. Recent milestones include:

Investment from Gates Foundation: With new funding from Gates Foundation and other investors, Kanvas is developing the world’s first fully synthetic microbiome replacement product designed to treat and prevent maternal environmental enteric dysfunction, a major contributor to maternal undernutrition, low infant birthweight and heightened neonatal health risk.
Clinical Trial: Preparations for patient recruitment are underway for a Phase 1 clinical trial of KAN-004, Kanvas’ immuno-oncology drug candidate that targets ICI-induced colitis and may allow cancer patients to stay on ICI therapy longer with improved response rates.
Board Additions: Stephen Quake, the Lee Otterson Professor of Bioengineering and Professor of Applied Physics at Stanford University and former Chief Science Advisor for the Chan Zuckerberg Initiative, joined Kanvas’ Board.
New Research: Kanvas recently unveiled new research that demonstrates how the company’s spatial imaging platform outperforms gold standard methods such as metagenomics sequencing, especially in low biomass settings.
Novel Lightsheet Microscope: The company has developed the Kanvas Spectral Lightsheet, a high-resolution, multispectral lightsheet microscope that generates vastly more spatial biology data to train Kanvas’ AI platform and build the world’s first microbiome atlas.
"Creating a brand new microscope capable of collecting spatial biology data at unprecedented scale and quality is a testament to Kanvas’ deep engineering prowess and relentless commitment to unlocking the gut microbiome as a distinct organ that can be safely modified using microbial-based drugs," said Jason Pontin, General Partner at DCVC and chair of Kanvas’ board. "Kanvas’ ability to generate novel data about host-microbiome interactions is fueling powerful AI models that are helping the company design new cancer treatments, nutritional supplements and even gastrointestinal restoration products for animals."

Additional investors in Kanvas’ Series A include Alumni Ventures, Boutique Venture Partners, Cornell University, FemHealth Ventures, Gaingels, Mana Ventures, Red Bear Ventures, RIT Venture Fund, Triple Impact Capital, Kicker Ventures and Uncommon Denominator. For more information on Kanvas or to inquire about clinical trial site opportunities and/or LBP development partnerships, visit View Source

(Press release, Kanvas Bioscience, MAY 6, 2026, View Source [SID1234665226])