On April 23, 2025 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported it will host a conference call and live webcast at 8:30 a.m. ET on Monday, April 28, 2025, to review updated safety and efficacy data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), including data from patients who have reached the 12-month evaluation timepoint (Press release, Protara Therapeutics, APR 23, 2025, https://ir.protaratx.com/news-releases/news-release-details/protara-therapeutics-host-conference-call-and-webcast-review [SID1234652042]). The data will be featured during an interactive poster session at the American Urological Association 2025 Annual Meeting on Saturday, April 26, 2025, at 7:00 a.m. PT.

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The live call can be accessed by registering as a participant here. Upon registration, participants will receive conference call dial-in information. A live webcast of the event can be accessed by visiting the Events and Presentations section of the Company’s website: View Source A replay of the webcast will be archived for a limited time following the event.

About ADVANCED-2

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive (n≈100) and BCG-Naïve (n=31). The BCG-Unresponsive cohort has been designed to be registrational in alignment with the U.S. Food and Drug Administration’s 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment, Draft Guidance for Industry.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

On April 23, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported review of their January 2016 Research Collaboration and License Agreement (the "2016 Agreement") with Sanofi (Press release, Innate Pharma, APR 23, 2025, View Source [SID1234652025]):

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As previously disclosed and in alignment with its current strategic priorities, Sanofi will opt to pursue the development of SAR’514/IPH6401 (BCMA ANKET) in autoimmune indications under the terms of the 2016 License Agreement;
In alignment with both company’s current strategic priorities, Sanofi and Innate agreed to terminate the 2016 Agreement as it relates to SAR’579/IPH6101 (CD123 ANKET); Innate will regain its rights on SAR’579/IPH6101 (CD123 ANKET).
As part of these discussions, Sanofi and Innate have agreed to a potential investment by Sanofi of up to €15M in new shares of Innate. The size and price of this equity investment will be determined on the basis of the ongoing market conditions, if they are satisfactory.

The 2022 research collaboration and license agreement remain unchanged.

"We are very pleased that Sanofi has chosen to further strengthen our relationship through a potential strategic equity investment in the company. This would further validate the innovation and scientific progress at Innate Pharma delivered by our research and development. We acknowledge Sanofi’s portfolio prioritization, and we are encouraged to see our ANKET platform being pursued in autoimmune indications. We will continue to evaluate, plan and execute next steps for our proprietary ANKET programs in oncology and beyond," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

SAR’579 (NCT05086315)/IPH6101

The originally Sanofi-led Phase 1/2 study with SAR’579 / IPH6101 (clinical study identifier: NCT05086315) is ongoing. Efficacy and safety results from the dose-escalation part, were shared in an oral presentation at the EHA (Free EHA Whitepaper) 2024 Congress. The data demonstrated that SAR’579 had clinical benefit and durable responses along with a favorable safety profile in patients with relapsed or refractory acute myeloid leukemia (AML), with 5 complete responses (4 CR / 1 CRi) achieved at 1 mg/kg, with durable CR (>10 months) observed in 3 patients.
In April 2024, Sanofi advanced SAR’579 / IPH6101 to the Phase 2 preliminary dose expansion of the trial.
The Parties will discuss a transition plan with regard to ongoing studies.
SAR’514/IPH6401:

The continued Sanofi-led Phase 1/2 study (clinical study identifier: NCT05839626) for the treatment of patients with relapsed or refractory multiple myeloma will be terminated early and SAR’514/IPH6401 will now be refocused to pursue development in autoimmune indications.
IPH62 and one additional target

IPH62 is a NK-cell engager program targeting B7-H3 under development from Innate’s ANKET platform. Following a research collaboration period and upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
Sanofi still retains the option of one additional ANKET target under the terms of the 2022 research collaboration and license agreement.

On April 22, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that its ongoing pivotal Phase 3 clinical study (listed on ClinicalTrials.gov as NCT06072612 ) has consented over 100 and has enrolled over 75 patients (Press release, BriaCell Therapeutics, APR 22, 2025, View Source [SID1234652429]). BriaCell anticipates completing patient enrollment in late 2025 or early 2026, and may report top line data as early as H1-2026.

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BriaCell’s pivotal Phase 3 clinical study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, plus immune check point inhibitor versus physician’s choice in a dvanced metastatic b reast c ancer (Bria-ABC).

"We are pleased at the expanding patient enrollment in our Phase 3 study, and expect this to continue to grow," stated Dr. William V. Williams, BriaCell’s President & CEO. "We believe our novel therapeutic approach has the potential to transform cancer care for metastatic breast cancer patients, and are determined to bring our novel immunotherapy to market to help these patients."

"Enrollment pace and clinical investigator interest in our Bria-ABC study is above any I have seen," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We would like to thank our dedicated clinical investigators and patients for participating in this important study. Through their efforts, we will advance our novel cancer immunotherapy to other MBC patients whose medical needs remain unmet."

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

Fifty-four clinical sites in the US are actively enrolling patients in BriaCell’s pivotal Phase 3 study in metastatic breast cancer. Additional sites are in various stages of start-up.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell recently announced positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612.

On April 22, 2025 Egle Therapeutics, a clinical-stage biotechnology company developing therapies targeting regulatory T cells (Tregs) for immuno-oncology and autoimmune diseases, reported that it will present two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper) 2025 being held in Chicago April 25-30, 2025 (Press release, Egle Therapeutics, APR 22, 2025, View Source [SID1234652036]).

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In the poster, entitled "Preferential tumor uptake and retention of EGL-001, an anti-CTLA4-IL2 mutein fusion antibody achieving selective tumor Treg depletion".

Egle Therapeutics unveils preclinical biodistribution data on EGL-001, a novel anti-CTLA4-IL2 mutein fusion antibody designed to selectively deplete tumor-infiltrating regulatory T cells (Tregs). EGL-001 mode of action combines competitive inhibition of IL-2 signaling and potent downregulation of surface CD25, leading to induction of Treg apoptosis.

In vivo EGL-001 preferentially bound to the surface of Tregs due to their high CTLA-4 and CD25 expression and depleted them from the tumor microenvironment without affecting other immune cells. In a biodistribution study, EGL-001 accumulated and persisted in tumors while rapidly clearing from healthy tissues. This targeted approach resulted in deep tumor Treg depletion and was associated with compelling anti-tumor efficacy in multiple mouse tumor models.

EGL-001 is currently under evaluation in a First-In-Human clinical trial (NCT06622486), offering a new therapeutic strategy for alleviating immune suppression mediated by Treg to overcome resistance to immune checkpoint inhibitors.

Session Title: Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators; Session Date and Time: Tuesday, Apr. 29, 2025 02:00 PM – 05:00 PM; Location: Poster Section 37; Poster Board Number: 21 Presentation Number: 6080

In the poster, entitled "Enhanced anti-tumor efficacy through prolonged plasma membrane retention of a novel anti-CCR8/IL2 mutein fusion antibody".

Egle scientists present evidence on EGL-002, a novel anti-CCR8/IL2 mutein fusion antibody engineered to enhance Treg depletion in solid tumors. Via the dual binding of CCR8 and CD25 EGL-002 showed prolonged retention on the surface of tumor-infiltrating Tregs, avoiding the rapid internalization that limited the efficacy of conventional CCR8 antibodies. This led to superior ADCC and ADCP potency, resulting in near complete tumor Treg depletion and potent anti-tumor activity in mouse models and ex vivo human tumors. These findings position EGL-002 as a best-in-class anti-CCR8 and a promising monotherapy or combination partner for immune checkpoint blockade.

Session Title: Enhanced Antibodies, TCR Constructs, Cytokines and Chimeric Proteins; Session Date and Time: Monday, Apr. 28, 2025 02:00 PM – 05:00 PM; Location: Poster Section 35; Poster Board Number: 26 Presentation Number: 3767

On April 22, 2025 NeoGenomics, Inc. ("NeoGenomics" or the "Company") (NASDAQ:NEO), a leading provider of oncology testing services, reported the analytical validation of its PanTracer LBx assay, a next-generation sequencing (NGS) liquid biopsy panel designed for comprehensive pan-solid tumor profiling (Press release, NeoGenomics Laboratories, APR 22, 2025, View Source [SID1234652035]). The validation study, along with five additional abstracts, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025 in Chicago, April 25–30.

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PanTracer LBx is a blood-based test that analyzes circulating tumor DNA to identify key genomic alterations in patients with advanced-stage solid tumors. It is designed to support treatment decisions when tumor tissue is unavailable or insufficient—a common challenge in oncology care. In the validation study, PanTracer LBx demonstrated high performance in identifying key biomarkers—including MSI (microsatellite instability) and TMB (tumor mutational burden)—across multiple cancer types, reinforcing its potential to guide therapy selection and expand access to precision oncology. The poster, "Analytical validation of PanTracer LBx performance, a comprehensive pan-solid tumor liquid biopsy assay," will be presented on Tuesday, April 29, from 9 AM – 12 PM CT, Section 10, Poster 27.

NeoGenomics has also launched an Evaluation Assessment Program for PanTracer LBx, allowing select physicians to use the assay ahead of full commercial availability. The program is intended to identify opportunities to streamline logistics, reporting, and customer support.

"The clinical validation of PanTracer LBx is the result of extensive analytical testing and represents a meaningful addition to our specialized testing menu designed to serve our community oncologists," said Andrew A. Lukowiak, Ph.D., Chief Innovation Officer at NeoGenomics. "Our presence at AACR (Free AACR Whitepaper) reflects a deep commitment to advancing the accessibility of cutting-edge oncology diagnostics and developing practical, real-world solutions that support patients and providers alike."

The company will present five additional posters that span topics such as spatial profiling, tumor biology, and genomic co-occurrence, including:

Characterization of GM-CSF and G-CSF expressing cell subtypes in the tumor microenvironment using the Integrated MultiOmyx-RNAscope assay
April 28, 2:00 PM – 5:00 PM, Section 7, Poster 30
Accurate, high-throughput spatial profiling of whole slide samples with the NeoLYTX pipeline
April 28, 9:00 AM – 12:00 PM, Section 46, Poster 29
High throughput quantitative molecular characterization of cytotoxic antibody-drug conjugates in spheroid models for improved functional characterization, screening and candidate selection
April 28, 9:00 AM – 12:00 PM, Section 1, Poster 14
Co-occurrence of gene fusions with SNV/Indels and with CNVs on solid tumors in a cohort of 795 patients from the community setting
April 28, 2:00 PM – 5:00 PM, Section 31, Poster 27
Comprehensive characterization of renal cell carcinomas identifies metabolic reprogramming of the tumor microenvironment associated with disease progression
April 29, 2:00 PM – 5:00 PM, Section 12, Poster 10
NeoGenomics will also showcase its oncology diagnostics solutions at booth #2449.