On June 23, 2025 Enterome SA, a clinical-stage company developing first-in-class OncoMimics immunotherapies to treat cancer, reported positive interim results for its OncoMimics immunotherapy EO2463 from Cohorts 1 and 4 of the ongoing open label Phase 1/2 SIDNEY trial in patients with indolent non-Hodgkin lymphoma (iNHL), at the International Conference on Malignant Lymphoma (ICML) in Lugano (Press release, Enterome, JUN 23, 2025, View Source [SID1234654050]). Interim data including 24 patients with follicular and marginal zone lymphoma (relapsed/refractory iNHL) showed that treatment with EO2463 in combination with lenalidomide and rituximab (R2) was well tolerated and demonstrated encouraging signs of efficacy that appear better than historical data in similar patients treated with R2.

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Importantly, EO2463 showed direct anti-lymphoma activity, including partial responses to the OncoMimics monotherapy, during the first six weeks of the study, a short time period during which just the first three doses of EO2463 were administered, before the protocol called for initiation of treatment with lenalidomide (followed subsequently by adding rituximab). Moreover, once lenalidomide and rituximab were added, the effect of EO2463 appeared to support a deepening of responses, resulting in a complete response rate of 60%, higher than would have been expected with R2 alone, based on historical data[1].

Pierre Belichard, CEO of Enterome said, "The EO2463 interim results are very encouraging, demonstrating exceptional tolerability for an active immunotherapy, and showing a clear signal that the combination with R2 can provide more robust responses in this patient population over R2 alone. This is consistent with the strong response rate we observed with EO2463 monotherapy in patients with low tumor burden disease, the so-called ‘watch-and-wait’ population, included in Cohort 2 of SIDNEY. While we plan to focus our near-term efforts on initiating a registrational Phase 3 trial of EO2463 for the watch-and-wait population, this evidence of a complementary effect in combination with R2 in relapsed/refractory iNHL is very exciting and offers new hope for this patient group, most of whom still see insufficient efficacy with available therapeutics."

EO2463 is designed to expand pre-existing memory CD8+ T cells recognizing non-self-protein sequences from gut bacteria, which mimic several purposefully selected B cell antigens. The interim SIDNEY data from Cohorts 1 and 4 presented at ICML show fast, robust, and durable expansion of the specific CD8+ T cells that were active against EO2463 mimic peptides and the targeted B cell epitopes. Most important, the magnitude of the EO2463-driven expansion of specific CD8+ T cells correlated with the probability of complete remission upon treatment with EO2463 combined with R2 in the SIDNEY study. EO2463 in combination with lenalidomide and rituximab (R2 ) is well tolerated in patients with follicular and marginal zone lymphoma.

Jan Fagerberg, Chief Medical Officer of Enterome, said, "These early efficacy results suggest EO2463 offers additional benefit when used together with the R2 regimen in patients with relapsed/refractory iNHL. We previously reported data from Cohort 2 of SIDNEY, at ASH (Free ASH Whitepaper) in December 2024, showing that EO2463 OncoMimics monotherapy generated a 46% objective response rate in patients who are usually proposed ‘watchful waiting’ and no active anti-lymphoma therapy – and also had an excellent tolerability profile. In short, taken together, these SIDNEY data indicate that this well tolerated novel active immunotherapy may well have broad potential across hematological malignancies."

EO2463 is an innovative, off-the-shelf OncoMimics active immunotherapy that combines four synthetic peptides. These non-self, microbial-derived peptides correspond to CD8 HLA-A2 epitopes that exhibit molecular mimicry with the B lymphocyte-specific lineage markers CD20, CD22, CD37, and CD268 (BAFF receptor). It also includes the helper peptide (CD4+ epitope) universal cancer peptide 2 (UCP2).

The unique ability of EO2463 active immunotherapy to selectively target multiple B cell markers enables the destruction of malignant B lymphocytes. By ensuring broad target coverage across malignant B cells, this novel approach aims to simultaneously improve safety and maximize efficacy, reducing the tumor cells’ capacity to develop immune-resistance mechanisms such as antigen escape.

SIDNEY is an ongoing open label Phase 1/2 study that aims to assess safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 monotherapy and combination therapy with lenalidomide/rituximab in up to 55 patients with follicular lymphoma and marginal zone lymphoma including four cohorts of three patient populations:

Cohort 2: patients with newly diagnosed, previously untreated low tumor burden disease, not in need of standard of care therapy, i.e., the "watch-and-wait" setting; treatment = EO2463 monotherapy
Cohort 3: patients with newly diagnosed, previously untreated low tumor burden disease, in need of therapy; treatment = EO2463 in combination with rituximab
Cohorts 1 and 4: patients with relapsed/refractory disease and at least one prior treatment; treatment = EO2463 in combination with lenalidomide and rituximab (R2)
OncoMimics are synthetically produced peptides designed in silico using AI and machine learning to mine Enterome’s extensive proprietary database of microbial bacteria. Unlike cancer antigens, OncoMimics bypass a gating process, known as thymic deletion, that prevents the immune system from mounting an attack against the "self" proteins (e.g. antigen) on tumor and blood cancer cells. Furthermore, that they trigger a more targeted, rapid and robust immune response than would otherwise be possible, because very early in human development the immune system learns to protect the body from microbiome bacteria. This means that OncoMimics call up memory CD8+ T cells that selectively target the cancer cells that carry the mimicked antigen(s). This therapeutic strategy takes inspiration from and is de-risked by emulating the gut microbiome’s causal role in certain autoimmune diseases.

OncoMimics are easy to manufacture, store, distribute and administer as an "off-the-shelf" subcutaneous injection. In clinical testing to date they have been shown to be extremely well tolerated, especially compared to other potent immunotherapies.

On June 23, 2025 Cidara Therapeutics, Inc. ("Cidara") (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, reported its plans to commence an underwritten public offering, subject to market and other conditions, to issue and sell $250.0 million of shares of its common stock (Press release, Cidara Therapeutics, JUN 23, 2025, View Source [SID1234654049]). All of the shares are being offered by Cidara. In connection with the proposed offering, Cidara expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock sold in the public offering. There can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

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J.P. Morgan, Morgan Stanley, Guggenheim Securities and Cantor are acting as joint book-running managers for the proposed offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3 that was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 8, 2025, and declared effective by the SEC on May 15, 2025. A preliminary prospectus supplement and accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering may be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at [email protected]; Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]; or Cantor Fitzgerald & Co. by mail at Attention: Capital Markets, 110 East 59th Street, New York 10022 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 23, 2025 Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells in regions of inflammation, reported promising results from two novel nanomedicine radiotracers at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, taking place June 21 – 24, 2025 in New Orleans (Press release, Ashvattha Therapeutics, JUN 23, 2025, View Source [SID1234654048]).

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The two agents are designed to address key gaps in neuroinflammation and cancer imaging by targeting activated microglia and macrophage, respectively.

Neuroinflammation Imaging Validation
Data presented in the poster titled "[18F]F-Flurimedrimer, a Novel Nanomedicine Radiotracer, Selectively Targeting Activated Microglia in Human Brain" showed that flurimedrimer (FMD), an investigational radiotracer engineered to selectively target activated microglia within the human brain, provided important validation of selective brain targeting. FMD is constructed from a hydroxyl dendrimer Generation 4 (HD4) with superior blood brain barrier penetration in regions of neuroinflammation compared to larger HDs (HD5 or HD6). The [18F]F-FMD was safe and well tolerated with rapid renal clearance, no tissue retention, and no brain uptake in healthy volunteers. [18F]F-FMD demonstrated selective uptake in areas of neuroinflammation in a primary progressive multiple sclerosis patient while showing no uptake in age-matched healthy volunteers, highlighting its specificity for activated microglia. These results support the agent’s potential for precise imaging of neuroinflammatory conditions.

Novel Cancer Imaging Approach
Data presented in the poster titled "A Novel Nanomedicine Radiotracer, Selectively Targeting Tumor Associated Macrophages" showed that hydroxyl dendrimers Generation 6 (HD6)-NOTA, a radiotracer with superior tumor-associated macrophage (TAM) uptake compared to other hydroxyl dendrimers of smaller size (HD4 or HD5), achieving 41.6% ID/g peak tumor uptake at 48 hours post-dose in tumor-bearing mice. TAMs are immune cells known to promote tumor growth and treatment resistance and can constitute a significant portion of tumor mass. The radiotracer successfully targeted macrophages throughout tumor structures, supporting its potential for diagnostic oncology imaging. A follow-on study using a therapeutic isotope with HD6 will be presented at a future conference.

"These results highlight the ability to tune our hydroxyl dendrimer platform to selectively target key cell populations in neurology and oncology," said Jeff Cleland, PhD, CEO of Ashvattha Therapeutics. "FMD’s (HD4) selective brain uptake in regions of neuroinflammation demonstrates the potential to image and treat neurological diseases with neuroinflammation. For cancer, our tuned nanomedicine, HD6-NOTA, has selective TAM uptake enabling cancer imaging, and the potential to selectively kill TAMs with a therapeutic isotope. Together, they underscore our platform’s unique ability to leverage our nanomedicine for precision targeting of activated cells – without relying on traditional targeting ligands."

On June 23, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that it has dosed its first patient in the fourth dosage cohort in the ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer (Press release, Anixa Biosciences, JUN 23, 2025, View Source [SID1234654047]). The study is being conducted through a research partnership with Moffitt Cancer Center ("Moffitt") under the direction of Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt, the principal investigator.

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The fourth cohort in the trial will receive a dose of three million CAR-positive cells per kilogram of body weight, representing a thirtyfold increase from the first cohort. No dose-limiting toxicities were observed in the third cohort, enabling advancing to the fourth dosage cohort. This planned escalation marks a key step in assessing the safety and therapeutic effect of CAR-T cell therapy in patients with ovarian cancer.

Anixa’s FSHR-mediated CAR-T technology targets the follicle-stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells, tumor vasculature, and certain cancer cells. The first-in-human trial (NCT05316129) is enrolling adult women with recurrent ovarian cancer who have progressed after at least two prior therapies. The study is designed to evaluate safety, identify the maximum tolerated dose, and monitor efficacy.

Dr. Amit Kumar, Chairman and CEO of Anixa, stated, "With no dose-limiting safety issues observed in the third cohort, we have advanced to a higher dose level that is thirty times greater than the starting dose. Although the study is primarily focused on safety at these early, low-dose levels, we have seen promising signs of potential efficacy. "

On June 22, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, reported a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. ("Otsuka") to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases (Press release, Harbour BioMed, JUN 22, 2025, View Source [SID1234654042]).

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Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020, a BCMAxCD3 bispecific T-cell engager globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). In return, Harbour BioMed will receive a total of $47 million in upfront and near-term payments. The company is also eligible for additional payments of up to $623 million upon the achievement of specified development and commercial milestones, as well as tiered royalties on future net sales. This strategic collaboration establishes a foundation for potential future partnerships between the two companies in the T-cell engager area.

"We are delighted to collaborate with Otsuka, a global healthcare leader renowned for its innovative approach to addressing unmet medical needs," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "This collaboration underscores the strength of Harbour BioMed’s proprietary Harbour Mice and HBICE technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles. By leveraging our unique capabilities, we are well-positioned to advance next-generation biotherapeutics that can make a meaningful difference in patients’ lives worldwide."

Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical, noted, "Otsuka is expanding our development pipeline in the autoimmune disease field by leveraging the antibody drug platform of our subsidiary Visterra, and the small molecule drug discovery platform of our subsidiary Jnana. HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients."

About HBM7020

HBM7020 is a BCMAxCD3 bispecific antibody generated using Harbour BioMed’s fully human HBICE bispecific technology and Harbour Mice platform. It is designed to crosslink target cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and targeted cell elimination. By incorporating dual anti-BCMA binding sites for enhanced cell targeting and monovalent-optimized CD3 activity to minimize cytokine release syndrome (CRS), HBM7020 has demonstrated potent cytotoxicity with broad therapeutic potential in both immunological and oncological diseases. In August 2023, HBM7020 obtained IND clearance from the National Medical Products Administration (NMPA) to commence a Phase I trial for cancer in China.