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Innate Pharma Announces Advancement of Sanofi-developed NK Cell Engager SAR443579 / IPH6101 Progressing to Phase 2 for Blood Cancer Patients

On April 15, 2024 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the first patient was dosed in the Phase 2 dose expansion part of the Sanofi-sponsored clinical trial of SAR443579 / IPH6101 (NCT05086315), evaluating SAR443579 as a monotherapy for the treatment of blood cancers with high unmet needs, including relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia and high-risk myelodysplasia (Press release, Innate Pharma, APR 15, 2024, View Source [SID1234642045]).

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SAR443579 is an investigational trifunctional anti-CD123 NKp46xCD16 NK cell engager from a joint research collaboration between Innate Pharma and Sanofi. SAR443579 received FDA Fast Track Designation for the treatment of acute myeloid leukemia. Efficacy and safety results from the dose-escalation part of the trial were shared in a poster presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Meeting in San Diego, California.

"The progression of SAR443579 to the Phase 2 expansion part of the clinical trial in blood cancers is another step in bringing this innovative NK cell engager to patients," said Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. "SAR443579 has shown promising clinical efficacy in the dose escalation of the Phase 1/2 in R/R AML patients, and we look forward to the dose expansion part of the study."

Under the terms of the 2016 research collaboration with Sanofi, the progression to the dose expansion part of the trial has triggered a milestone payment from Sanofi to Innate of €4m.

"Our goal is to continue to develop the best and most impactful treatments for patients with cancer," said Peter Adamson, Global Development Head, Oncology, Sanofi."We are encouraged by our progress in this study for patients with AML, and look forward to sharing results in the future as data continues to emerge."

More information about the Phase 1/2 trial can be found on clinicaltrials.gov.

About ANKET

ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer.

This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About the Innate-Sanofi research collaboration and licensing agreements

The Company has a research collaboration and license agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the 2016 research collaboration and license agreement, Sanofi is responsible for the development, manufacturing and commercialization of products resulting from the research collaboration, which includes SAR443579/IPH6101 (Trifunctional anti-CD123 NKp46xCD16 NK cell engager) and SAR445514/IPH6401 (Trifunctional anti-BCMA NKp46xCD16 NK cell engager). As part of the 2016 agreement, Innate Pharma is eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.

As part of the license agreement entered in December 2022, Sanofi licensed IPH62 and IPH67 and has the option for one additional target. Under the terms of the 2022 agreement, Innate Pharma is eligible to up to €1.35bn total in preclinical, clinical, regulatory and commercial milestones plus royalties on potential net sales.

Bile Tract Cancer expansion study opens following clearance of Imugene’s MAST trial high dose cohort

On April 15, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that enrolment has opened for its expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing virus CF33-hNIS (VAXINIA) (Press release, Imugene, APR 15, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/d90ab1d4-f16c-5d92-40f9-240afd491d30/Bile_Tract_Cancer_Study_Opens_after_MAST_High_Dose_Clearance.pdf [SID1234642044]).

Imugene Managing Director & CEO Leslie Chong said: "As a team we’re particularly eager to begin the cholangiocarcinoma expansion study, given the meaningful difference we’ve seen VAXINIA make for patients with gastrointestinal cancers, including one patient with cholangiocarcinoma who achieved a complete response and another who achieved stable disease. It’s timely for enrolment to open as we present our VAXINIA technology to the 2024 Cholangiocarcinoma Foundation Annual Conference later this week."

The expansion of the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial is planned for 10 patients with bile tract cancers, after early positive responses were observed in gastrointestinal cancers, particularly in cholangiocarcinoma.

Cholangiocarcinoma is a rare disease in which malignant cancer cells form in the bile ducts. It is difficult to treat and generally responds poorly to immunotherapy drugs.

One patient with cholangiocarcinoma who had failed three prior lines of therapy received a mid-dose of IT-administered monotherapy VAXINIA achieved a complete response, meaning the disappearance of all signs of cancer in response to treatment, with no known recurrence in more than 430 days. A second patient with cholangiocarcinoma, who has also progressed on prior drug therapies, achieved stable disease for more than four months upon receiving IV-administered VAXINIA.

In November 2023, the FDA granted the VAXINIA MAST clinical program Fast Track Designation for the treatment of bile duct cancer (cholangiocarcinoma), which allows Imugene closer cooperation with the FDA to expedite the program and potential approval process. This designation followed the promising data detailing Phase 1 efficacy and tolerability.

On Friday 12 April 2024, the Cohort Review Committee cleared the fifth cohort in the IT arm of the monotherapy dose escalation portion of the MAST trial, with no safety signals seen to date. In addition to the patients dosed in the monotherapy dose escalation portion of the trial, enrolment is ongoing for the VAXINIA and pembrolizumab combination portion of the trial, with 16 patients dosed to date.

The multicenter, Phase 1, MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. With no safety signals identified to date, the trial has since progressed through the monotherapy dose escalation cohorts as well as the combination study, whereby VAXINIA is administered with well-known checkpoint inhibitor pembrolizumab. CF33 oncolytic virus, developed by City of Hope, has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models.

SparX Group Announces First Patient Dosed with SPX-303 Injection, the First in Its Class of anti-LILRB2/PD-L1 Bispecific Antibody Drugs

On April 12, 2024 SparX reported that the first patient has been successfully dosed with SPX-303, a First-in-Class anti-LILRB2/PD-L1 bispecific antibody drug candidate, reaching a significant milestone in the fight against cancer. This innovative treatment, developed by SparX Group, is currently undergoing clinical trials at the HonorHealth Research Institute, with Dr. Justin Moser leading the study.

Dr. Gui-Dong Zhu, Chief Executive Officer of SparX Group, expressed his enthusiasm: "The dosing of the first patient with SPX-303 at HonorHealth Research Institute is a crucial step forward in its clinical development process. We are honored to collaborate with Dr. Moser’s team at the Research Institute to bring this innovative therapy into clinical trials. By fusing a best-in-class (BIC) nano-anti-PD-L1 with mAb-anti-LILRB2 epitopes, SPX-303 aims to unlock the full potentials in the immune system’s ability to fight cancer. The trailblazing preclinical data of SPX-303 instilled confidence in us to harness its therapeutic prowess in clinical settings, particularly for patients who previously had limited treatment options."

Dr. Justin Moser, associate clinical investigator at the Institute and clinical assistant professor at the University of Arizona College of Medicine-Phoenix, shared his optimism about the potential impact of SPX-303. "SPX-303 is designed to combat the myeloid cell-induced immunosuppression that often hinders the effectiveness of current cancer therapies. SPX-303’s unique dual mechanism, targeting both myeloid cell and T-cell immune checkpoints, may offer a new avenue for enhancing the immune system’s weaponry against cancer," said Dr. Moser.

With the successful dosing of SPX-303, SparX Group is initiating three additional study sites for the ongoing Phase 1 clinical study. This study aims to evaluate SPX-303’s safety, tolerability, and preliminary efficacy in patients with resistant or refractory solid tumors, potentially ushering in a new era of superior therapeutic solutions.

SPX-303 stands as a first-in-its-class bispecific antibody therapy, ingeniously designed to simultaneously target two crucial immune checkpoint proteins, LILRB2 and PD-L1. These proteins play essential roles in maintaining immune balance and preventing autoimmune diseases. However, cancer cells often exploit these checkpoints as a defense against immune attacks. SPX-303 seeks to overcome this by enabling the immune system to recognize and destroy cancer cells effectively, representing a significant leap forward in cancer therapy.

(Press release, Sparx Therapeutics, APR 12, 2024, View Source [SID1234661038])

Illumina’s planned divestment of GRAIL approved by the European Commission

On April 12, 2024 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported it has received approval of its divestment plan for GRAIL from the European Commission (EC) (Press release, Illumina, APR 12, 2024, View Source [SID1234642040]).

While this does not mean the method of divestment has been finalized, the company is pleased to reach an agreement with the EC on specific divestment options as it represents an important milestone in the process. Illumina continues to explore divesting GRAIL through either a trade sale or a capital markets transaction, each of which are contemplated by the plan approved today. In the event of a capital markets transaction, Illumina must capitalize GRAIL with two-and-a-half years of funding, which is estimated at approximately $1 billion based on GRAIL’s long-range plan.

Illumina looks forward to working with the EC on approval of final terms consistent with the divestment plan. As previously stated, Illumina has a goal of finalizing those terms by the end of the second quarter of 2024.

TransThera announces clinical data of tinengotinib to treat patients with advanced solid tumors harboring actionable FGFR1-3 alterations

On April 12, 2024 TransThera Sciences, a clinical-stage biopharmaceutical company focused on inventing differentiated drugs for global patients, reported the poster presentation at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) to discuss the latest breaking research of tinengotinib for patients with advanced solid tumors harboring actionable FGFR1-3 alterations (Press release, TransThera Biosciences, APR 12, 2024, View Source [SID1234642039]).

Monotherapy for patients with advanced solid tumors harboring actionable FGFR1-3 mutations:

Fibroblast growth factor receptor (FGFR) alterations occur across various malignancies and are potent oncogenic drivers in multiple tumor types. FGFR inhibitors have demonstrated efficacy in several cancers with FGFR alterations. However, no effective therapies are available worldwide for patients with advanced solid tumors harboring actionable FGFR1-3 mutations currently.

Tinengotinib is a unique multi-kinase inhibitor that has very distinct binding mode to FGFR 1-3 proteins, rendering it highly potent to a series of FGFR mutations, including gatekeeper mutations, molecular brake mutations, cystine binding site mutations, and others. This feature has made it highly differentiated from existing FGFR inhibitors, indicating its potential to target cancer patients bearing a broad range of FGFR mutations.

The retrospective analysis of the pooled results from four clinical studies of tinengotinib in advanced solid tumors harboring actionable FGFR1-3 mutations showed efficacy in multiple tumor types, including cholangiocarcinoma, breast, prostate, urothelium, colon and head and neck cancer. Our data demonstrate 33.3% BOR and 88.2% DCR, 6.90 months mPFS. The promising results validated the novel mechanism of tinengotinib and clinical applications for potentially FGFR 1-3 altered patients with solid tumors.

About tinengotinib

Tinengotinib is an innovative, global phase III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells proliferation, angiogenesis and immune-oncology pathways by inhibiting the cytokine signaling and angiogenesis (FGFRs and VEGFRs), mitotic kinases Aurora A/B and Janus kinases (JAK). Ongoing clinical trials in the US and China have revealed the potential of tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of CCA, the Breakthrough Therapy Designation (BTD) by NMPA in China, the Orphan Drug Designation(ODD) for the treatment of biliary tract cancer by EMA.