On April 28, 2025 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it has successfully closed a registered direct offering (the "offering") whereby an affiliate of Oramed Pharmaceuticals Inc. ("Oramed") (Nasdaq: ORMP) (TASE: ORMP) purchased 14,110,121 of Alpha Tau’s ordinary shares, no par value, at a purchase price of $2.612 per ordinary share (Press release, Alpha Tau Medical, APR 28, 2025, View Source [SID1234652216]). The offering closed on April 28, 2025.

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The total gross proceeds of the offering were approximately $36.9 million, before deducting estimated offering expenses payable by Alpha Tau. Alpha Tau intends to use the net proceeds from the offering for general corporate purposes, including research and development-related purposes in connection with its product candidates, for expansion of its manufacturing capabilities and for potential commercialization of its product candidates.

In addition, the parties have entered into an agreement whereby an affiliate of Oramed will provide Alpha Tau with certain strategic services (investor relations and public relations) over the next three years in exchange for payments from Alpha Tau as well warrants to purchase additional Alpha Tau shares.

Alpha Tau CEO Uzi Sofer commented, "We are delighted to welcome Oramed as a strategic partner and to leverage their extensive expertise in navigating diverse capital markets channels. This investment comes at the perfect time for Alpha Tau given the rapid expansion of our business activities, including four parallel trial approvals in the U.S., expansion into trials in multiple internal organs, and continued expansion of our manufacturing capacity and pre-commercial preparations. We look forward to a long and fruitful relationship with Oramed."

Oramed CEO Nadav Kidron added, "We are incredibly excited about this alliance with Alpha Tau. We have tremendous conviction in the strength of the Alpha DaRT technology and the Alpha Tau management team. We anticipate significant advancements and milestone achievements as they execute their clinical and commercial roadmap."

A registration statement on Form F-3 relating to the securities to be sold in the registered direct offering has been filed with the U.S. Securities and Exchange Commission (the "SEC") and was declared effective on April 13, 2023. This registered direct offering was made only by means of a prospectus. A copy of the prospectus supplement and the accompanying prospectus relating to this offering was filed with the SEC and may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, 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 April 28, 2025 SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and global leader in data-driven medicine, reported the expansion of its ongoing collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to accelerate the deployment of MSK-ACCESS powered with SOPHiA DDM globally (Press release, AstraZeneca, APR 28, 2025, View Source [SID1234652267]). Building on the initial collaboration announced in October 2024, this new phase will extend the test’s reach to a total of 30 clinical institutions worldwide in 2025.

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Developed in collaboration with Memorial Sloan Kettering Cancer Center, MSK-ACCESS powered with SOPHiA DDM is an innovative liquid biopsy testing application designed to detect actionable genomic alterations from a single blood draw using proprietary, state-of-the-art algorithms which analyze circulating tumor DNA (ctDNA). The application supports real-time cancer monitoring and treatment selection when traditional tissue biopsies are not feasible due to cost, turnaround time, insufficient tissue, or the invasiveness of the procedure.

The expanded rollout will continue to contribute to AstraZeneca’s global real-world evidence initiatives and help further validate the clinical impact of decentralized liquid biopsy testing across diverse healthcare systems. By increasing the availability of MSK-ACCESS powered with SOPHiA DDM, SOPHiA GENETICS and AstraZeneca aim to understand further how liquid biopsy testing can complement solid tissue testing and, in some cases, provide greater benefit for labs and patients.

The announcement coincides with SOPHiA GENETICS’s presentation at AACR (Free AACR Whitepaper), in which the company presented data demonstrating the robust transferability of the decentralized MSK-ACCESS powered with SOPHiA DDMTM solution. Historically, site-to-site discordance has been a major barrier to the widespread adoption of liquid biopsy testing. SOPHiA GENETICS presented real-world data highlighting the consistent accuracy and precision of MSK-ACCESS powered with SOPHiA DDMTM across various laboratory settings. Interim results from the multi-center study demonstrated the high analytical performance of the decentralized test in line with the original single-site test at Memorial Sloan Kettering Cancer Center in New York.

"Our collaboration with AstraZeneca represents a significant step toward scaling next-generation oncology diagnostics globally," said Ross Muken, President, SOPHiA GENETICS. "This expanded deployment reflects the growing momentum behind liquid biopsy and our shared ambition to make these technologies more accessible and impactful worldwide."

Visit SOPHiA GENETICS at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s Annual Meeting in Chicago, Illinois from April 25th–30th to learn more about how SOPHiA GENETICS is collaborating with AstraZeneca to transform patient care with data-driven medicine.

On April 28, 2025 Schrödinger, Inc. (Nasdaq: SDGR) reported preclinical data on SGR-3515, its investigational Wee1/Myt1 co-inhibitor today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 (Press release, Schrodinger, APR 28, 2025, View Source [SID1234652283]). The data demonstrated that SGR-3515 has improved anti-tumor activity in preclinical models compared to known Wee1 and Myt1 monotherapy inhibitors. The poster also described how the dosing schedule of SGR-3515 can be optimized to preserve efficacy and minimize target-related side effects. New data was also presented on the development of a computational method that predicts the response to Wee1-based drug combinations, including in novel cancer settings such as head and neck cancers. Schrödinger expects to report initial data from the ongoing Phase 1 clinical trial of SGR-3515 in patients with advanced solid tumors in the second half of 2025.

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Additionally, Schrödinger presented its first preclinical data for SGR-4174, its SOS1 inhibitor that disrupts the interaction between SOS1 and KRAS, the most frequently mutated oncogene in human cancers. SGR-4171 demonstrated high selectivity for SOS1 over SOS2 as well as over other kinases. The data also demonstrated that SGR-4174 has strong tumor growth inhibition as a monotherapy as well as in combination with MEK or KRAS inhibitors, while maintaining a favorable safety profile. SOS1 development opportunities include cancers such as lung adenocarcinoma or RASopathies such as Neurofibromatosis Type 1.

"The preclinical data for SGR-3515 and SGR-4174 further demonstrate that molecules discovered and developed by Schrödinger have favorably differentiated molecular profiles compared to existing development-stage molecules," said Karen Akinsanya, Ph.D, president of R&D therapeutics at Schrödinger. "The preclinical profiles of these development candidates reinforce the power of our computationally-driven approach to designing molecules that meet challenging target product profiles and have the potential for meaningful benefit to patients."

SGR-3515 Data at AACR (Free AACR Whitepaper)

The poster (Abstract #3025), "Optimization of therapeutic index of SGR-3515, a first-in-class Wee1/Myt1 inhibitor through intermittent dosing for monotherapy and combination with chemotherapy in xenograft tumor models," includes preclinical data demonstrating that SGR-3515 monotherapy has superior anti-tumor activity compared to the Wee1 inhibitor ZN-c3 and the Myt1 inhibitor RP-6306 in multiple tumor models as well as synergistic efficacy when used in combination with chemotherapy. The poster also shares for the first time preclinical data demonstrating that the potential efficacy and tolerability of SGR-3515 can be optimized with three to five days of dosing, depending on the tumor type, in a two-week dosing cycle across multiple tumor settings. The optimized dosing schedule preserves efficacy while allowing for complete recovery from reversible on-target myelosuppression in preclinical tumor models.

A second poster (Abstract #3660), "Machine learning-based combination prediction for Wee1 inhibitor," presents data showing that a machine learning model, built on the integration of two large cell line combination screening studies of the Wee1 inhibitor AZD1775, successfully identified known and novel synergistic Wee1 drug combinations such as with tyrosine kinase inhibitors in ovarian and breast cancers, and with chemotherapy in head and neck or cancers. The data suggests potential for machine learning based approaches to make predictions with a high degree of confidence and gain novel insights beyond the data they are trained on.

SGR-4174 Data at AACR (Free AACR Whitepaper)

The poster (Abstract #4376), "Preclinical characterization of SGR-4174, a potent and selective SOS1 inhibitor for the treatment of pan KRAS mutant cancers in combination with KRAS pathway inhibitors," includes preclinical data demonstrating the superior binding, selectivity, and drug-like properties of SGR-4147 compared to MRTX0902 as assessed via comprehensive in vitro potency, ADME, and safety assays. The preclinical data for SGR-4174 also show robust suppression of the RAS signaling pathway and potent cell killing activity across multiple cancer types harboring diverse KRAS mutations as well as EGFR and SOS1 mutations. SGR-4174 monotherapy achieved dose-dependent target engagement and tumor growth inhibition and induced tumor shrinkage when used in combination with MEK or KRAS inhibitors in preclinical models of pancreatic and non-small cell lung cancer.

On April 28, 2025 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company working to develop a new class of drugs based on targeted protein degradation, reported data from preclinical combination studies of ARV-393, the company’s investigational PROteolysis TArgeting Chimera (PROTAC) B-cell lymphoma 6 protein (BCL6) degrader (Press release, Arvinas, APR 28, 2025, View Source [SID1234652219]). BCL6 is a transcriptional repressor protein and a known driver of B-cell lymphomas. Data demonstrated synergistic antitumor activity, including complete regressions, in combination with standard of care (SOC) chemotherapy, SOC biologics, and investigational oral small molecule inhibitors (SMIs) in high grade B-cell lymphoma (HGBCL) and aggressive diffuse large B-cell lymphoma (DLBCL) models. The results from these preclinical studies were shared in a poster presentation at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in Chicago, Illinois.

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Key findings from the studies included:

ARV-393 in combination with SOC chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]), induced significantly greater tumor growth inhibition compared with rituximab, CHOP, R-CHOP, or ARV-393 alone, with complete tumor regressions in all mice treated with the ARV-393 and R-CHOP combination.
ARV-393 in combination with SOC biologics targeting CD20 (rituximab), CD19 (tafasitamab), or CD79b (polatuzumab vedotin) resulted in tumor regressions and demonstrated significantly stronger tumor growth inhibition compared with each agent alone.
In preclinical models, ARV-393 increased CD20 expression, providing additional support for the exploration of combinations with CD20-targeted agents and in the context of low or loss of CD20 expression.
ARV-393 in combination with investigational small molecule inhibitors targeting clinically validated oncogenic drivers of lymphoma, such as BTK (acalabrutinib), BCL2 (venetoclax), or EZH2 (tazemetostat), resulted in superior tumor growth inhibition compared with each agent alone, with tumor regressions in all mice treated with the combinations.
"Given that combination regimens are the foundation of lymphoma treatment, we are encouraged by the strength of these preclinical combination data, which demonstrate complete tumor regressions in aggressive lymphoma models," said Noah Berkowitz, M.D., Ph.D., Chief Medical Officer at Arvinas. "We believe these preclinical data demonstrate potential for broad combinability of ARV-393 and provide a compelling rationale for considering combination strategies as we work to bring forward new therapeutic options for lymphoma patients."

A Phase 1 study of ARV-393 is enrolling patients with relapsed/refractory non-Hodgkin lymphoma, including DLBCL (NCT06393738).

Additional detail on the ARV-393 data presentation at AACR (Free AACR Whitepaper) 2025:

Poster Title: ARV-393, a PROteolysis TArgeting Chimera (PROTAC) BCL6 Degrader, Combined With Biologics or Small-Molecule Inhibitors Induces Tumor Regressions in Diffuse Large B-Cell Lymphoma Models
Abstract: 1655
Session Title: Degraders and Glues 2
Session Type: Experimental and Molecular Therapeutic
Location: Poster Section 18
Poster Board Number: 15
Date: Monday, April 28, 2025
Lecture Time: 9:00 a.m. – 12:00 p.m. CT

About ARV-393
ARV-393 is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) designed to degrade B-cell lymphoma 6 protein (BCL6), a transcriptional repressor and major driver of B-cell lymphomas. During B-cell development, tightly controlled BCL6 protein expression regulates >600 genes to facilitate rapid B-cell proliferation and tolerance of somatic hypermutation and gene recombination for antibody generation. Deregulated BCL6 expression is common in B-cell lymphoma and promotes cancer cell survival, proliferation, and genomic instability. PROTAC-mediated degradation has the potential to address the historically undruggable nature of BCL6. ARV-393 is currently in a Phase 1 clinical trial in patients with relapsed/refractory non-Hodgkin lymphoma.

On April 28, 2025 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, reported new preclinical data for MaaT034, the Company’s next generation product, showing compelling anti-tumor efficacy results in germ-free mice at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, Illinois, taking place from April 25 to 30, 2025 (Press release, MaaT Pharma, APR 28, 2025, View Source [SID1234652236]).

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MaaT Pharma has built a versatile platform combining two complementary approaches. The first one leverages a GMP-compliant approach to produce standardized donor-derived therapies (MaaT013, MaaT033) using pooled donations, proven to restore a rich and diverse gut microbiome for patients with severe dysbiosis and currently in late-stage of clinical evaluation (Phases 2 and 3). In parallel, the Company is advancing a next-generation, AI-driven co-culture technology to develop a donor-independent synthetic microbiome ecosystem at large industrial scale targeting indication-specific diseases. MaaT034, the first-in-class co-cultured product, aims to optimize intestinal microbiome functions and to improve patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors.

Below are the key results presented at AACR (Free AACR Whitepaper) for MaaT034:

Metagenomic analysis shows that MaaT034 reproduces the microbial functions of MaaT013 – the Company’s lead asset, currently evaluated in the randomized Phase 2 PICASSO trial in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy) and nivolumab (Opdivo) for unresectable or metastatic melanoma.
MaaT034 improves DC-mediated T cell activation and potentiates anti-tumor effects mediated by anti-PD-1 checkpoint blockade in vitro.
70% of MaaT034 microbial species engraft in mice, ensuring an enduring presence of beneficial bacteria in the gut environment.
MaaT034 increases the production of key microbial-derived metabolites such as short-chain fatty acids in germ-free mice. This translates into an improved gastrointestinal physiology as evidenced by gut mucosal restoration.
MaaT034 optimizes anti-PD1 mediated activity in tumor-bearing, germ-free mice. While anti-PD1 alone reduced tumor growth by 10%, the combination of anti-PD1 and MaaT034 resulted in a 83.7% tumor growth reduction (compared to a 24.2% reduction when using a single strain of Akkermansia muciniphila bacteria). These results demonstrate that improved tumor control is achieved with anti-PD1 in combination with MaaT034, as compared to PD-1 alone or in combination with a reference single bacterial strain.
"These positive data in tumor-bearing mice demonstrate the significant potential of MaaT034 as a microbiome ecosystem therapy candidate and provide a robust basis for the progression of this therapy into clinical development for solid tumors. We look forward to further evaluating the potential benefits of MaaT034 in the next phases of our research," said Gianfranco Pittari, MD PhD, Chief Medical Officer, MaaT Pharma.

Upcoming conferences participation

May 5-6, 2025 – Swiss Biotech Day, Basel
May 13, 2025 – Forum Midcaps Gilbert Dupont, Paris
June 12-15 – European Hematology Association (EHA) (Free EHA Whitepaper) Congress, Milan, IT
June 16-19, 2025 – Bio International Convention, Boston, MA – Company Presentation
June 18-19, 2025 – Portzamparc Conference Mid & Small Caps 2025, Paris
September 25, 2025 – KBC Healthcare Conference, Brussels
About MaaT034

MaaT034, currently in preclinical development, is a next-generation donor-independent full ecosystem synthetic microbiome therapy, dedicated to improving patient responses to immunotherapy in combination with Immune Checkpoint Inhibitors. Developed using the Company’s co-culturing proprietary MET-C platform, MaaT034 is optimized for large-scale production in oncology. Previous presented preclinical data showed that MaaT034 produced key metabolites, recognized as promoting gut barrier restoration and modulating immune responses, such as Short-Chain Fatty Acids (SCFA), secondary bile acids, and tryptophan derivatives. These data support the role of MaaT034 in gut barrier repair and in T cell reactivation either in combination with anti-PD1 or with anti-PD-L1. By enhancing gut barrier repair and modulating immune responses, MaaT034 is expected to complement the action of these immunotherapeutic agents, potentially improving their efficacy in treating solid tumors cancer.