On March 14, 2023 Onchilles Pharma, a private biotech company developing new cancer therapeutics that leverage myeloid biology, reported the presentation of preclinical data for N17350 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, to be held April 14 to 19 at the Orange County Convention Center in Orlando, Florida (Press release, Onchilles Pharma, MAR 14, 2023, View Source [SID1234628681]). Onchilles’ lead drug development candidate, N17350, is a first-in-class biologic therapeutic that is inspired by the immunobiology of neutrophils, a key part of the innate immune system, with the potential to be effective against a wide range of cancer types. The company is targeting to start first-in-human clinical trials in 2024.

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Presentation Details

Poster Title: N17350 Selectively Kills Cancer Cells with Far Reaching Anti-Cancer Effects
Date and Time: Wednesday, April 19, 9:00 AM to 12:30 PM ET
Session Category: Immunology
Session Title: Immune Mechanisms Mediated by Other Therapies
Session Location: Section 24
Poster Board Number: 3
Abstract number: 6390
About N17350 and the ELANE Pathway

First described in research published in Cell from the lab of Onchilles’ Co-Founder Lev Becker, human neutrophils release catalytically active neutrophil elastase, called ELANE, to selectively kill many cancer cell types while sparing non-cancer cells. As part of innate immunity, neutrophils have broad efficacy and specificity to eliminate genetically diverse cellular threats. Research shows that ELANE initiates a complex killing mechanism that culminates in cancer cell apoptosis at the initial tumor site as well as increases adaptive immunity that attacks distant metastases. ELANE consistently activated this cancer-killing program in more than 45 different cancer cell lines but not in any non-cancer cells tested. To advance this research into a therapeutic, Onchilles generated N17350, a first-in-class biologic, to mobilize the ELANE-mediated cancer-killing pathway.

On March 14, 2023 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that it will provide an operational update and report its financial results for full-year ending December 31, 2022, on Tuesday, March 28, 2023, after the close of the US market (Press release, Nanobiotix, MAR 14, 2023, View Source [SID1234628680]).

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This release will be followed by a conference call and live audio webcast on Wednesday, March 29, 2023, at 2:00 PM CET/8:00 AM EDT, prior to the open of the US market. During the call, Laurent Levy, chief executive officer, and Bart Van Rhijn, chief financial officer, will briefly review the Company’s year-end results and provide an update on business activities before taking questions from analysts and investors. Investors are invited to email their questions in advance to [email protected].

Details for the call are as follows:

Dial-In Information:

Live (US): 1-877-423-9813

Live France: 0 800 912 848

Live (international): 1-201-689-8573

A live webcast of the call may be accessed by visiting the investors section of the Company’s website at www.nanobiotix.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored Phase 1 dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a Phase 3 global registrational study was launched in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.

Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company-sponsored Phase 1 clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC, or lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a strategic collaboration strategy with world class partners to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

On March 14, 2023 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM, HKEX:​13) reported that, further to its announcement on January 23, 2023 and following the completion of customary closing conditions including antitrust regulatory reviews, the exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (TSE:​4502, NYSE:​TAK) to further the global development, commercialization and manufacture of fruquintinib outside China has closed (Press release, Hutchison China MediTech, MAR 14, 2023, View Source [SID1234628679]).

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With a strong preclinical and clinical profile, fruquintinib offers a potential new treatment option for patients with refractory metastatic colorectal cancer ("CRC"), supporting the shared goal of Takeda and HUTCHMED to improve the lives of those living with cancer worldwide. Takeda is now responsible for the development, commercialization and manufacture of fruquintinib in all included territories worldwide excluding mainland China, Hong Kong and Macau, where it is marketed by HUTCHMED.

Following the closing of the exclusive license agreement, HUTCHMED Limited will receive US$400 million shortly, and is eligible to receive up to US$730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales. Marketing authorization submissions in the U.S., Europe and Japan are planned to complete in 2023, with the rolling submission to the U.S. Food and Drug Administration ("FDA") initiated in December 2022.

About Fruquintinib
Fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity with the intention of minimizing off-target toxicities, improving tolerability and providing more consistent target coverage. Fruquintinib has been generally well tolerated in patients to date, and is being investigated in combinations with other anti-cancer therapies.

On March 14, 2023 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported an oral presentation of preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Annual Meeting, taking place April 14 – 19, 2023, in Orlando, FL (Press release, CRISPR Therapeutics, MAR 14, 2023, View Source [SID1234628678]).

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Title: CTX112 and CTX131: Next-generation CRISPR/Cas9-engineered allogeneic (allo) CAR T cells incorporating novel edits that increase potency and efficacy in the treatment of lymphoid and solid tumors
Session Type: Drug Development Special Track Session
Session Title: New Drugs on the Horizon: Part 1
Location: Tangerine Ballroom 2, Convention Center
Date and Time: April 16, 2023, 1:25 – 1:40 p.m. ET

The data are embargoed until the beginning of the Drug Development Special Track Session: New Drugs on the Horizon: Part 1 at 1:00 p.m. ET on April 16, 2023. A copy of the presentation will be available at www.crisprtx.com once the presentation concludes.

On March 14, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that preclinical data exploring purposeful armoring of CAR T-cells to enhance efficacy of MUC1 CAR T-cells in targeting triple-negative breast cancer, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in Orlando, Florida on April 14-19, 2023 (Press release, Cellectis, MAR 14, 2023, View Source [SID1234628677]).

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"We are proud to present updated preclinical data on our product candidate UCARTMUC1 for solid tumors at AACR (Free AACR Whitepaper) 2023" said Laurent Poirot, Ph.D., Senior Vice President Immunology at Cellectis. "As immune-therapies continue to develop for solid tumors, the tumor microenvironment (TME) poses many challenges that CAR T-cells need to overcome for efficient tumor cell clearance. Our preclinical data make us confident that UCART MUC1 could be a valuable product candidate for patients with highly unmet medical needs."

Presentation includes:

Poster presentation:

Therapeutic options for triple negative breast cancer (TNBC) remain limited to date despite it being the most aggressive subtype of breast cancers and carrying the poorest prognosis. Tumor-associated MUC1 antigen is overexpressed in a large number of TNBC patients offering an effective discriminatory target for CAR T-cell therapy.

Cellectis will present innovative strategies exploring purposeful armoring of CAR T-cells to boost efficiency while preserving safety. To maintain anti-tumor CAR T-cell activity and proliferation in the hostile TME of solid tumors, Cellectis developed state-of-the-art multiplexed gene editing using high precision TALEN technology. With that aim, we armored allogeneic CAR T-cells with specific attributes to locally release immune inflammatory cytokines and protect from inhibitory effects of the TGFB1 and PD1 pathways. A combination of strategies using allogeneic CAR T-cells with diverse attributes were evaluated against TNBC tumors in various in vivo pre-clinical models. The recirculation pattern of MUC1 CAR T-cells was also explored in relationship with their delivery routes.

Title: Deciphering the benefits of variable delivery routes and molecular armoring to enhance efficacy of MUC1-CAR T-cells in targeting triple-negative breast cancer

Session Title: Adoptive Cell Therapy 1

Presenter: Piril, Erler, Ph.D., Scientist II, Immuno-Oncology, Cellectis

Session Date and time: Sunday April 16, 2023, 1:30-5:00 PM ET
Location: Section 37
Poster Board Number: 14
Abstract Presentation Number: 899