Innate Pharma Regains Its Rights on CD123 Targeting ANKET® and Announces Sanofi’s Intention to Make a Strategic Investment in the Company

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.

Alligator Bioscience announces initiation of HLX22 Phase 2 trial in breast cancer by Shanghai Henlius Biotech, Inc.

On April 23, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that Shanghai Henlius Biotech, Inc. ("Henlius") has initiated a Phase 2 clinical trial with HLX22, an anti-HER2 monoclonal antibody originally developed by Alligator’s subsidiary, Atlas Therapeutics (Press release, Alligator Bioscience, APR 23, 2025, View Source [SID1234652046]). HLX22 is being developed by Henlius under a sublicense from AbClon, Inc., which had previously licensed the antibody from Alligator.

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The Phase 2 study is being conducted in mainland China and is designed to evaluate HLX22 in combination with trastuzumab deruxtecan for the treatment of patients with locally advanced or metastatic breast cancer. The study aims to assess the efficacy and safety of the combination therapy.

Søren Bregenholt, CEO of Alligator, commented:
"Henlius’ progress with HLX22 underscores the continued clinical momentum behind this antibody. While Alligator is not directly involved in its development, we continue to monitor its progress with interest, as HLX22 may represent a potential future revenue stream for Alligator."
Under the terms of the license agreement, Alligator is entitled to 35% of AbClon’s revenue from its sublicense agreement with Henlius.

ImCheck Announces Oral Presentation of Updated ICT01 Efficacy Data in First-line AML at the ASCO Annual Meeting 2025

On April 23, 2025 ImCheck Therapeutics reported an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2025, taking place from May 30 to June 3, in Chicago, Illinois, USA (Press release, ImCheck Therapeutics, APR 23, 2025, View Source [SID1234652062]). The presentation will focus on results from its ongoing open-label, randomized Phase I/II study EVICTION, including updated efficacy, safety and dose-selection data on the company’s lead γ9δ2 T-cell activator, ICT01, in combination with azacitidine and venetoclax for the treatment of older or unfit patients with newly diagnosed acute myeloid leukemia (AML).

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Details of the oral presentation at ASCO (Free ASCO Whitepaper) 2025 are:

Abstract Title: "γ9δ2 T-cell activation with ICT01 combined with azacitidine-venetoclax for older/unfit adults with newly diagnosed AML: Preliminary efficacy and dose selection in phase 1/2 study EVICTION"

Session: Oral Abstract Session S100a – Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Date: Monday, June 2, 2025

Time: 5:12 p.m.- 5:24 p.m. Central Time

The ASCO (Free ASCO Whitepaper) presentation will be available on ImCheck’s corporate website after the presentation has been held.

Novocure to Present Results from the Phase 3 PANOVA-3 Clinical Trial of its Tumor Treating Fields (TTFields) Therapy for Pancreatic Cancer as a Late-Breaking Oral Presentation at the 2025 ASCO Annual Meeting

On April 23, 2025 Novocure (NASDAQ: NVCR) reported that it will present additional results from the Phase 3 PANOVA-3 trial of its Tumor Treating Fields (TTFields) therapy for pancreatic cancer at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 to June 3 in Chicago (Press release, NovoCure, APR 23, 2025, View Source [SID1234652078]).

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The PANOVA-3 trial evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel as a first-line treatment for unresectable, locally advanced pancreatic adenocarcinoma. The company previously announced positive topline results from PANOVA-3 that demonstrated the trial met its primary endpoint, achieving a statistically significant improvement in median overall survival in patients treated with TTFields therapy concomitantly with gemcitabine and nab-paclitaxel compared to those treated with gemcitabine and nab-paclitaxel alone.

Data Presentation Details

Oral Presentation: Late Breaking Abstract 4005: PANOVA-3: Phase 3 study of tumor treating fields (TTFields) with gemcitabine and nab-paclitaxel for locally advanced pancreatic ductal adenocarcinoma (LA-PAC)

Presenting Author: Vincent Picozzi, MD

Date/Time: May 31, 2025, 3:00 – 6:00 PM CDT

Novocure Investor Event

Novocure will host an investor event featuring the principal investigator of the PANOVA-3 trial and Novocure leadership after the oral presentation. Event details and a link to a live webcast of the event will be available on the investor relations page of www.novocure.com. For more information or to request in-person attendance, please contact Novocure investor relations at [email protected].

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

Allogene Therapeutics to Present Updated ALLO-316 Clinical Results in Kidney Cancer in Oral Presentation and ALPHA3 Trial-in-Progress Poster for Cema-Cel at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 23, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it will present updated data from the completed Phase 1 TRAVERSE trial of ALLO-316 in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 29-June 2 in Chicago, Illinois (Press release, Allogene, APR 23, 2025, View Source [SID1234652047]). The trial evaluated ALLO-316 in patients with advanced or metastatic renal cell carcinoma (RCC) who had progressed following immune checkpoint inhibitor and VEGF-targeted therapies. In addition, a trial-in-progress poster is also being presented to highlight the ongoing pivotal Phase 2 ALPHA3 trial, which is evaluating cemacabtagene ansegedleucel (cema-cel) as part of first-line (1L) treatment for patients with large B-cell lymphoma (LBCL).

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ALLO-316 is an allogeneic, "off-the-shelf" CAR T product targeting CD70 and is the only allogeneic CAR T product to demonstrate potential in solid tumors. Data from the Phase 1 TRAVERSE trial previously showed a manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients with advanced or metastatic CD70+ RCC. Enrollment is now complete in the Phase 1b expansion cohort, which evaluated the safety and efficacy of ALLO-316 at dose level 2 (80M CAR T cells) following a standard lymphodepletion regimen of cyclophosphamide and fludarabine.

The ALPHA3 trial is the first pivotal study to evaluate an allogeneic CAR T product as a consolidation strategy aimed at eradicating minimal residual disease (MRD) following 1L treatment in LBCL. It is assessing cema-cel in patients with MRD after standard 1L chemoimmunotherapy, such as R-CHOP, with the goal of improving 1L cure rates. The trial identifies patients at high risk for relapse after 1L treatment by utilizing Foresight CLARITY, powered by PhasED-Seq, a novel Investigational Use Only (IUO) test for MRD. This randomized trial will enroll approximately 240 patients and is designed to demonstrate a meaningful improvement in event free survival (EFS) in patients treated with cema-cel relative to patients who receive the current standard of care (observation).

Allogene Presentations at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting:

ALLO-316 in advanced clear cell renal cell carcinoma (ccRCC): Updated results from the phase 1 TRAVERSE study.
Presenter: Samer A. Srour, M.D., The University of Texas MD Anderson Cancer Center
Session Title: Oral Abstract Session – Genitourinary Cancer – Kidney and Bladder
Abstract: #4508
Location: Hall D2
Presentation Date and Time: Sunday, June 1, 9:45AM – 12:45PM CT

ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy.

Presenter: Jason Westin, MD, MS, FACP, The University of Texas MD Anderson Cancer Center
Session Title: Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Abstract: TPS7085
Poster Board: #267a
Location: Hall A
Poster Session Display Date and Time: Sunday, June 1, 9:00AM – 12:00PM CT

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). In June 2022, the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to cema-cel in r/r LBCL. The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About ALLO-316 (TRAVERSE)
ALLO-316 is an AlloCAR T investigational product targeting CD70, which is highly expressed in renal cell carcinoma (RCC). CD70 is also selectively expressed in several cancers, creating the potential for ALLO-316 to be developed across a variety of both hematologic malignancies and solid tumors. The ongoing Phase 1 TRAVERSE trial is designed to evaluate the safety, tolerability, and activity of ALLO-316 in patients with advanced or metastatic clear cell RCC. In October 2024 the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation based on the potential of ALLO-316 to address the unmet need for patients with advanced or metastatic CD70+ RCC. The FDA previously granted Fast Track Designation (FTD) to ALLO-316 in March 2023. In April 2024, the Company announced a $15 million award from the California Institute for Regenerative Medicine (CIRM) to support the ongoing TRAVERSE trial with ALLO-316 in RCC.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care (SOC) after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.