On May 30, 2025 Enterome SA, a clinical-stage company developing first-in-class OncoMimics immunotherapies to treat cancer, reported it will present new positive data from its ongoing Phase 1/2 "AUDREY" trial of its OncoMimics immunotherapy, EO4010, to treat microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC), at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, IL, May 30-June 3 (Press release, Enterome, MAY 30, 2025, View Source [SID1234653517]). The poster presentation (Abstract #3536) will be given in the poster session Gastrointestinal Cancer—Colorectal and Anal (poster board 205) on May 31 from 9:00 AM – 12:00 PM CDT, and will be available for download.

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Pierre Bélichard, Chief Executive Officer of Enterome, said: "These exciting interim clinical data exemplify the strong therapeutic potential of our OncoMimics immunotherapy for cancer. Current treatment options are limited for cancers like MSS/pMMR mCRC, and, so far, EO4010 has already delivered promising survival outcomes and objective responses including in liver metastases without complex side effects. We believe EO4010 will become a welcome addition to the therapeutic armamentarium for CRC and look forward to gaining more knowledge based on the current data."

EO4010 combines five microbial-derived peptides that mimic HLA-A2 restricted CD8+ T cell epitopes from five human tumor associated antigens (TAAs) commonly observed in patients with CRC (BIRC5, FOXM1, UBE2C, CDC20 and KIF2C). Data from 20 patients with MSS/pMMR mCRC enrolled in the open label AUDREY trial showed that EO4010 plus nivolumab, with or without bevacizumab, was well tolerated.

EO4010 also generated fast, robust, and durable expansions of CD8+ T cells against the targeted TAAs causing clinically meaningful responses in this challenging patient population. Specifically, EO4010 plus nivolumab showed direct anti-tumor activity in MSS/pMMR mCRC. Survival in patients treated with EO4010 plus nivolumab at a median follow-up of 15.4 months, was 40% at 12-months and there is currently a plateau at 34% survival, with 7 of 20 patients still alive; the median survival is currently 11.3 months.

Jan Fagerberg, MD, PhD, Chief Medical Officer of Enterome, said: "Objective response is a very rare event in immunotherapy in patients with MSS/pMMR mCRC; yet we observed direct tumor impact by EO4010 as measured by CT scan tumor shrinkages and CEA/CA19-9 tumor marker declines, including RECIST partial response in liver and lung metastases. This and the survival are exciting results and we look forward learning more about how to most effectively use EO4010 in CRC."

Dr. Arvind Dasari, Professor at the Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at MD Anderson Cancer Center, University of Texas, who is a principal investigator and will present the AUDREY data at ASCO (Free ASCO Whitepaper), said: "The preliminary AUDREY findings support continued development of EO4010 for colorectal cancer. Treatment options for metastatic colorectal cancer remain limited, and the interim data generated on EO4010 so far indicate that it might add to the treatment possibilities for CRC. EO4010 has shown it can induce targeted immune responses and shrinkage of metastases."

AUDREY (EOCRC2-22/NCT05589597) is a multicenter, open-label Phase 1/2 trial investigating EO4010 as monotherapy and in combination with nivolumab +/- bevacizumab for treatment of patients with unresectable, previously treated, MSS/pMMR mCRC. The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in patients enrolled at sites in Europe and the USA.

Poster presentation (Abstract #3536)

Title: Survival of patients (pts) with microsatellite stable/mismatch repair proficient (MSS / pMMR) metastatic colorectal carcinoma (mCRC) treated with EO4010 + nivolumab (EO/N)

Poster Session: May 31, 9:00 AM – 12:00 PM CDT

Session title: Gastrointestinal Cancer – Colorectal and Anal

Poster Board: 205

OncoMimics immunotherapies are designed to activate pre-existing effector memory T cells against bacterial (non-self) peptides that strongly cross-react with corresponding Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer cells. TAAs escape detection through a process known as Thymic deletion, whereby the immune system learns not to attack "self" proteins. OncoMimics work by tricking the immune system because they are different enough from TAAs to raise an immune response that is specific to the OncoMimics and also against the TAAs, thereby mounting a natural and potent immune response against cancer.

EO4010, Enterome’s third clinical-stage OncoMimics candidate, combines five microbial-derived peptides that mimic HLA-A2 restricted CD8+ T cell epitopes from five TAAs: BIRC5/survivin, FOXM1, UBE2C (UBCH10), CDC20, and KIF2C (MCAK). It also includes a CD4 helper peptide, Universal Cancer Peptide 2 (UCP2), to bolster immune activation.

Colorectal cancer (CRC) is the third most common cancer in men and the second in women, contributing to 10% of all cancers worldwide. It is the fourth most common cause of cancer-related death, with more than 600,000 deaths annually. Despite all efforts with surgery and adjuvant therapy, 25% of patients with localized CRC later develop metastases, and around 20% of cases are metastatic at diagnosis. Thus, CRC continues to be a major therapeutic challenge with a considerable number of patients experiencing premature death, fewer than 20% of those diagnosed with recurring/metastatic disease surviving beyond 5 years from diagnosis.

On May 30, 2025 Plus Therapeutics, Inc. (Nasdaq: PSTV) ("Plus" or the "Company"), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform technologies for central nervous system (CNS) cancers, reported financial results for the first quarter ended March 31, 2025, and provides an overview of recent and upcoming business highlights (Press release, Cytori Therapeutics, MAY 30, 2025, View Source [SID1234653516]).

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"We improved our cash position in the first quarter as a result of both a financing and grant support," said Marc H. Hedrick, M.D., Plus Therapeutics President and Chief Executive Officer. "With the additional cash and further anticipated grant support in 2025, we are well positioned to make solid progress in our 2 key business goals: enrollment in our REYOBIQ CNS cancer radiotherapeutic clinical trials and the planned launch of the CNSide cerebral spinal fluid (CSF) assay platform."

Q1 2025 & RECENT HIGHLIGHTS AND MILESTONES

Corporate

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Raised gross proceeds of $15 million in a private placement financing – along with a $2.0 million grant award advance from the Company’s existing grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to accelerate development of REYOBIQ for our leptomeningeal metastases (LM) program.
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Added industry veteran Kyle Guse to the Board of Directors – Mr. Guse brings 30 years of professional experience in multiple executive roles, including as a Chief Financial Officer and a General Counsel of innovative companies.
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Strengthened management team with addition of Dr. Michael Rosol as Chief Development Officer – Dr. Rosol will lead the Company’s clinical, pre-clinical, and biomarker development activities.

REYOBIQ Clinical Trials

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Presented updated interim data on its lead compound REYOBIQ at the Nuclear Medicine and Neuro-oncology conference held May 9-10, 2025 in Vienna, Austria that highlighted the safety and clinical benefit of REYOBIQ in patients with LM.
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Published Phase 1 clinical trial results for REYOBIQ in peer-reviewed publication Nature Communications, demonstrating safety and potential efficacy in treating recurrent glioblastoma (GBM), with patients receiving a radiation dose >100 Gy achieving a median overall survival of 17 months, more than double the standard of care. Additional details can be found here.
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Completed ReSPECT-LM Phase 1 single dose administration trial and determined the maximum tolerated and recommended Phase 2 dose. Additional details can be found here.
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Granted U.S. FDA Orphan Drug Designation for REYOBIQ for the treatment of LM in patients with lung cancer.
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Received U.S. FDA conditional agreement for the proprietary name REYOBIQ for the Company’s lead radiotherapeutic, rhenium Re186 obisbemeda.

CNSide CSF Assay Platform

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Strengthened management team with key leadership appointments:
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Russell Bradley as President and General Manager of Plus Therapeutics’ wholly owned subsidiary, CNSide Diagnostics, LLC ("CNSide Diagnostics") – Mr. Bradley provides leadership to CNSide Diagnostics with an immediate focus on commercialization of the CSF assay platform.
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Dr. Jonathan Stein as Medical Director, CNSide Diagnostics – Dr. Stein provides technical leadership to support the CNSide CSF assay platform.

Q1 2025 FINANCIAL RESULTS

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The Company’s cash balance was $9.9 million at March 31, 2025 compared to $0.1 million at December 31, 2024.
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The Company recognized $1.1 million in grant revenue in the first quarter of 2025 compared to $1.7 million in in the first quarter of 2024, which represents CPRIT’s share of the costs incurred for our REYOBIQ platform advancement for the treatment of patients with LM.
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Total operating loss for the first quarter of 2025 was $3.5 million compared to $3.3 million in the same period of 2024. The increase is primarily due to increased legal fees.
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Net loss for first quarter of 2025 was $17.4 million, or $(1.19) per share, compared to a net loss of $3.3 million, or $(0.75) per share, for the same period the prior year.

On May 30, 2025 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that it will be participating in the Jefferies Global Healthcare Conference, taking place in New York on June 3 – 5, 2025 (Press release, CorMedix, MAY 30, 2025, View Source [SID1234653515]).

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Jefferies Global Healthcare Conference
Date: Thursday, June 5, 2025
Time: 3:45p.m. EDT
Format: Presentation
Webcast: Link

On May 30, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported that management will participate in the Jefferies 2025 Global Healthcare Conference (Press release, ALX Oncology, MAY 30, 2025, View Source [SID1234653514]). Details are as follows:

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Format: Fireside Chat
Date: Thursday, June 5, 2025
Time: 1:25 PM ET
Location: New York, NY
Webcast link: Available here

The live webcast of the Jefferies fireside chat can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com under the Events section of the Events and Presentations tab. A replay of the webcast will be archived for up to 90 days following the fireside chat date.

On May 30, 2025 Coherus Oncology, Inc. (Coherus Oncology, Nasdaq: CHRS), a commercial-stage innovative oncology company, formerly named Coherus BioSciences Inc., reported its name change, to better align with its exclusive focus on proprietary innovative immuno-oncology medicines (Press release, Coherus Biosciences, MAY 30, 2025, View Source [SID1234653513]).

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"The field of cancer immunotherapy has been reinvigorated by the promise and power of combination therapies. Coherus Oncology has the expertise and pipeline to become a significant player in this dynamic space and unlock the potential of these next-generation therapeutic approaches," said Jill O’Donnell-Tormey, Ph.D., Coherus Oncology board member. Dr. O’Donnell-Tormey is a Senior Advisor to the Cancer Research Institute and its former CEO.

"The next wave of breakthroughs in cancer immunotherapy will come from new mechanistic orthogonal approaches that synergize for optimal clinical efficacy. CCR8+ Tregs represent one of the most promising targets in cancers, enabling selective depletion of tumor immune suppression while mitigating the risk of breaking tolerance and leading to severe autoimmunity," said Alexander Rudensky, Ph.D., Coherus Scientific Advisory Board Co-Chair, Chairman and Member, Immunology Program, Sloan Kettering Institute, Lloyd Old Chair in Clinical Investigation Investigator, Howard Hughes Medical Institute Director, Ludwig Center for Cancer Immunotherapy Tri-Institutional Professor at MSKCC, The Rockefeller University and Cornell University.

"Coherus Oncology is firmly committed to the oncology community and developing the next generation of therapies focused on extending survival of cancer patients and improving their quality of life," said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer of Coherus Oncology. "Our objective is to set new standards of cancer care with novel combinations that broadly target the immune system and resistance."

Our Novel Oncology Pipeline

Coherus Oncology is developing a portfolio of novel combination therapies with the aim of unlocking immune resistance to current therapies.

LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor, is the foundation of our immuno-oncology franchise. LOQTORZI is the only available FDA-approved treatment indicated in combination with chemotherapy for recurrent or metastatic nasopharyngeal carcinoma (NPC), and it is in development for the treatment of additional tumor types with the goal of being the PD-1/ICI backbone of future treatment combinations that may extend survival for patients.

CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. CHS-114 is currently being evaluated in combination with toripalimab in Phase 1b studies in patients with advanced solid tumors, including second-line head and neck squamous cell carcinoma and second-line gastric cancer.

Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory NSCLC and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC). A randomized Phase 2 study is underway evaluating casdozokitug in combination with toripalimab and bevacizumab, versus toripalimab and bevacizumab, in patients with first-line advanced metastatic HCC. Squamous NSCLC continues as an area of clinical focus and future development.

Our Oncology Team & Board

Coherus Oncology is led and advised by a world-class team with deep expertise in oncology drug development and commercialization. The Scientific Advisory Board includes pioneers in the fields of Treg immunology, T cell exhaustion, and cytokine biology. The Board of Directors is comprised of industry leaders from the Cancer Research Institute, Merck, United Healthcare, Bristol Myers Squibb, as well as others. The breadth and depth of these perspectives provide Coherus Oncology with valuable insights to navigate the rapidly evolving oncology landscape and drive innovation to advance patient benefit and shareholder value.

Learn more about our executive team, Board of Directors, Scientific Advisory Board, and Strategic Advisors: View Source