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 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that the company will host a webcast and conference call on Tuesday, June 24, 2025 at 8:00 a.m. ET, to discuss pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI pre-treated patients with advanced ROS1-positive non-small cell lung cancer from the global ARROS-1 Phase 1/2 clinical trial (Press release, Nuvalent, JUN 23, 2025, View Source [SID1234654074]).

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Webcast and Conference Call Information

To access the call, please dial +1 (800) 836-8184 (domestic) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined to the Nuvalent call.

Accompanying slides and a live video webcast will be available in the Investors section of the Nuvalent website at https://investors.nuvalent.com/events. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.

About Zidesamtinib and the ARROS-1 Phase 1/2 Clinical Trial

Zidesamtinib is a novel brain-penetrant ROS1-selective inhibitor created with the aim to overcome limitations observed with currently available ROS1 inhibitors. Zidesamtinib is designed to remain active in tumors that have developed resistance to currently available ROS1 inhibitors, including tumors with treatment-emergent ROS1 mutations such as G2032R. In addition, zidesamtinib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ROS1 inhibitors and to drive deep, durable responses for patients across all lines of therapy. Zidesamtinib has received breakthrough therapy designation for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ROS1 tyrosine kinase inhibitors and orphan drug designation for ROS1-positive NSCLC.

Zidesamtinib is currently being investigated in the ARROS-1 trial (NCT05118789), a first-in-human Phase 1/2 clinical trial for patients with advanced ROS1-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ROS1-positive NSCLC patients who previously received at least one ROS1 TKI, or patients with other ROS1-positive solid tumors who had been previously treated. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of zidesamtinib, with additional objectives including determination of the recommended Phase 2 dose, characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The ongoing global, single arm, open label Phase 2 portion is designed with registrational intent for TKI-naïve and TKI pre-treated patients with ROS1-positive NSCLC.

On June 23, 2025 Galapagos NV (Euronext & NASDAQ: GLPG) reported the appointment of Mr. Aaron Cox as Chief Financial Officer, effective July 7, 2025 (Press release, Galapagos, JUN 23, 2025, View Source [SID1234654108]). Mr. Cox succeeds Mr. Thad Huston, who will remain with the company through July 31, 2025, to ensure a smooth transition of responsibilities.

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Aaron brings more than two decades of leadership experience across biotechnology, capital markets, and M&A/corporate development. Most recently, he served as Executive Vice President and Chief Financial Officer at Horizon Therapeutics plc, where he played a pivotal role in the company’s $28 billion acquisition by Amgen. Prior to that, Aaron served as Horizon’s Head of Corporate Development and Chief of Staff to the CEO, supporting capital markets strategy, M&A execution, and the company’s transformation into a fully integrated biotech. His earlier career spans senior roles in investment banking.

"We are delighted to welcome Aaron to Galapagos," said Henry Gosebruch, CEO of Galapagos. "Aaron will be a key partner in accelerating pipeline growth through business development and focusing our resources through disciplined financial management. His dealmaking background and experience managing a global financial organization will be invaluable as we continue transforming Galapagos with the goal of making a meaningful impact on the lives of patients worldwide."

Aaron will lead the Finance, Accounting, Tax, Procurement, Communications and Investor Relations functions and will join the Executive Committee of Galapagos. As CFO, he will also work closely with leadership and the Board of Directors to execute transactions to build a new pipeline of innovative medicines and find a value-maximizing alternative for the cell therapy business.

"I am excited to join Galapagos at this pivotal moment," said Aaron Cox, incoming CFO of Galapagos. "I look forward to working with Henry and the talented team to help shape the company’s next chapter, create value for our shareholders, and advance meaningful innovations for patients."

Aaron holds a Bachelor’s degree in Finance from the University of Notre Dame and earned his MBA from the University of Chicago Booth School of Business.

In connection with this appointment, the Company will issue new restricted stock units (RSUs) and subscription rights.

On June 23, 2025 OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported a warrant exercise inducement and exchange offer to holders of its five-year warrants with a current exercise price of $1.12 per share that were issued in connection with a PIPE financing transaction that had an initial closing date of December 31, 2024 (the "Old Warrants") (Press release, OS Therapies, JUN 23, 2025, View Source [SID1234654076]). The Company is offering holders of Old Warrants the opportunity to exercise the Old Warrants now in consideration of the receipt of new five-year warrants to purchase a number of shares of common stock equal to the number of Old Warrants exercised with an exercise price of $3.00 per share, on substantially the same terms as the Old Warrants with the exception of exercise price (the "New Warrants"). The exercise of all Old Warrants would provide approximately $8 million in gross cash proceeds to the Company before offering related expenses. $1.76 million in Old Warrants exercise proceeds has already been received by the Company, extending its cash runway into the second half of 2026.

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The New Warrants also have an added forced exercise provision that allows the Company to require the holder to exercise the New Warrants in the event the closing price of the Company’s common stock equals or exceeds $9.00 (300% of the exercise price) for 20 consecutive days.

OS Therapies intends to use net proceeds from the offering to support US and International regulatory and pre-commercialization efforts aimed at securing marketing authorization for OST-HER2 in the prevention or delay of recurrent, fully resected, lung metastatic osteosarcoma, and for general corporate purposes.

The warrant exercise inducement and exchange offer is being made to the holders of Old Warrants during the period beginning on June 20, 2025 and ending at 5:00pm EDT on July 10, 2025 – subject to extension, termination or suspension by the Company in its sole discretion. The offering may be concluded in one or more closings with respect to exercises of the Old Warrants.

The Company reiterates that it will release additional data related to its Phase 2b clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, lung metastatic osteosarcoma at the MIB Factor meeting in Salt Lake City on June 28, 2025. The Company also reiterates its intention to submit a Biologics Licensing Application (BLA) for OST-HER2 osteosarcoma to the FDA in the third quarter of 2025.

OST-HER2 has received Rare Pediatric Disease Designation (RPDD) for osteosarcoma from the US FDA, and if it receives a conditional BLA via Accelerated Review prior to September 30, 2026, it will be eligible to receive a Priority Review Voucher (PRV) that it intends to sell. The most recent PRV sale occurred in June 2025, valued at $160 million.

The New Warrants to be issued in the private placement, as well as the common stock issuable upon exercise of the New Warrants, have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws and may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. The Company has agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") registering the resale of the shares of common stock underlying the New Warrants issued in this private placement (the "Resale Shares").

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offering of the Resale Shares under the resale registration statement will only be made by means of a prospectus.

On June 23, 2025 Illumina, Inc. (NASDAQ: ILMN) reported it has entered into a definitive agreement with Standard BioTools (NASDAQ: LAB) under which Illumina will acquire SomaLogic, a leader in data-driven proteomics technology, and other specified assets for $350 million in cash payable at closing, subject to customary adjustments, plus up to $75 million in near-term performance-based milestones and performance-based royalties (Press release, Illumina, JUN 23, 2025, View Source [SID1234654052]).

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"The acquisition of SomaLogic will enhance Illumina’s presence in the expanding proteomics market and advance the multiomics strategy we announced in 2024. This will strengthen the value of the NovaSeq X product today and unlock greater capabilities in the future," said Jacob Thaysen, chief executive officer of Illumina. "Illumina and SomaLogic have partnered closely for more than three years, and this combination increases our ability to serve our customers and accelerate our technology roadmap towards advanced biomarker discovery and disease profiling."

This transaction builds on a co-development agreement Illumina established with SomaLogic in December 2021 to bring the SomaScan Proteomics Assay onto Illumina’s high-throughput next-generation-sequencing (NGS) platforms. Illumina Protein Prep is currently in use with nearly 40 early-access customers globally and will become available to all customers starting in the third quarter of 2025. Combining SomaLogic’s proteomics technology with Illumina’s scalable NGS ecosystem, DRAGEN software, and Illumina Connected Multiomics will accelerate the technology development roadmap for proteomics and reduce time and cost of proteomic research.

"We are taking the scalability of NGS into proteomics," continued Thaysen. "Illumina will remain an open, accessible, and enabling NGS platform. The Company is committed to maintaining and supporting its existing proteomics partnerships as well as continuing to develop the sequencing ecosystem and supporting a wide variety of multiomics solutions."

Scientific evidence* presented over the past year demonstrates the strength of SomaLogic’s proteomics offerings in the areas of plexity, scalability, and technical reproducibility. In addition, researchers can generate significant and pivotal insights with high sensitivity, high throughput, and thousands of protein markers in a single experiment.

SomaLogic has approximately 250 employees worldwide working in commercial, R&D, lab operations, manufacturing, and other roles. The company’s Boulder, Colorado, facilities—including a CLIA- and CAP-certified lab, office, and manufacturing space—will be part of the purchase. SomaLogic has a global footprint serving customers.

This transaction brings SomaLogic’s aptamer-based affinity proteomics platform into Illumina’s portfolio, enhancing Illumina’s presence in a high-growth area within the proteomics market. The kitted NGS-based panels business will add a high-margin consumables revenue stream. Based on the projected closing date, Illumina expects this business to become profitable in 2027 on a non-GAAP operating income basis, and for non-GAAP operating margins to be in line with Illumina in 2028.

Completion of the transaction is subject to customary closing conditions, including the receipt of required regulatory clearance. The parties intend to make the necessary filing under the Hart-Scott-Rodino Act in the United States in due course. Illumina expects to close the transaction in the first half of 2026. Until then, the companies will continue to operate as separate and independent entities.

Goldman Sachs and Co. LLC is serving as financial advisor and Cravath, Swaine & Moore LLP is serving as legal advisor to Illumina. Centerview Partners LLC is serving as financial advisor to Standard BioTools, and Freshfields LLP and Richards, Layton & Finger P.C. are serving as its legal counsel. UBS Investment Bank is serving as financial advisor to the Special Committee of the Standard BioTools Board of Directors.