On February 17, 2022 Philogen S.p.A. ("Philogen" or "the Company"), a clinical-stage biotechnology company focused on antibody and small molecule-based targeted therapeutics, reported that France’s National Agency for the Safety of Medicines and Health Products (ANSM) has authorized the Company to run a Phase II study of Nidlegy in patients affected by different nonmelanoma skin cancer indications (Press release, Philogen, FEB 17, 2022, View Source [SID1234608209]). A favourable opinion about the study had already been obtained by one of the country’s ethic committees (Comité de Protection des Personnes Sud-Est III) in January 2022.

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Patients affected by Basal Cell Carcinoma (BCC), cutaneous Squamous Cell Carcinoma (cSCC), Merkel Cell Carcinoma, Keratoacanthoma, tumoral cutaneous T-Cell Lymphoma, Kaposi’s Sarcoma or Adnexal Tumors of the Skin, for whom available alternatives have already been exhausted or who are no candidates to such alternative approaches will be eligible for the clinical study.

Nidlegy, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional treatment of patients with advanced melanoma and in BCC and cSCC in an ongoing Phase II study. The durable responses, excellent safety profile and favourable cosmetic outcome of injected lesions have encouraged the investigation of efficacy and safety of Nidlegy in injectable lesions of numerous non-melanoma skin cancer indications, which are underserved by alternatives presently available.

Prof. Dario Neri, co-founder and President of the Scientific Advisory Board of Philogen said: "We are delighted to start this clinical Phase II study in non-melanoma skin cancers in France under the leadership of Prof. Jean-Jacques Grob, a world-class expert in this group of tumors and to explore the potential of Nidlegy in patients for whom existing therapeutic alternatives are not or no longer practicable."

On February 17, 2022 Remix Therapeutics (Remix), a biotechnology company developing small molecule therapies designed to reprogram RNA processing and address the underlying drivers of disease, reported a strategic collaboration with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the discovery and development of small molecule therapeutics that modulate RNA processing using Remix’s REMaster drug discovery platform (Press release, Janssen Pharmaceutica, FEB 17, 2022, View Source [SID1234608228]). The agreement was facilitated by Johnson & Johnson Innovation.

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Under the terms of the agreement, Remix will receive an initial payment of $45 million in cash for upfront and research funding, and may also receive preclinical, clinical, commercial, and sales milestone payments and tiered royalties for any resulting products. In exchange, Janssen will have exclusive rights to three specific targets with applications in immunology and oncology. Remix will have the ability to opt into a portion of the costs of clinical development on one program in exchange for higher royalties. Under the agreement, Remix is eligible to receive total payments potentially exceeding $1 billion, subject to regulatory approvals and other conditions.

"We look forward to collaborating with this innovative team," said Peter Smith, Ph.D., Co- Founder and Chief Executive Officer of Remix Therapeutics. "Janssen is an ideal strategic partner for our REMaster platform. This collaboration further validates the therapeutic potential of our proprietary REMaster drug discovery platform and provides additional resources to translate our cutting-edge science into new medicines."

On February 17, 2022 Immune-Onc Therapeutics, Inc. ("Immune-Onc"), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IO-202, a first-in-class myeloid checkpoint inhibitor targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) (Press release, Immune-Onc Therapeutics, FEB 17, 2022, View Source [SID1234608244]). The Company received Orphan Drug Designation for IO-202 for the treatment of AML in 2020.

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"We are pleased that the FDA has granted IO-202 Fast Track designation in recognition of its potential to improve outcomes for people with relapsed or refractory AML," said Paul Woodard, Ph.D., chief medical officer of Immune-Onc. "We look forward to working closely with the FDA to accelerate the clinical development of IO-202, which is currently being evaluated as a monotherapy and in combination with other agents in a Phase 1 dose escalation and expansion trial in patients with AML with monocytic differentiation and in chronic myelomonocytic leukemia (CMML)."

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need to get important new medicines to patients earlier. Drugs that receive Fast Track designation may be eligible for more frequent interactions and written communications with the FDA to discuss the development plan and data collection to support an approval pathway. The designation also supports the eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

ABOUT LILRB4 (also known as ILT3)

LILRB4, also known as ILT3, is an immune inhibitory transmembrane protein found on monocytic myeloid cells, including dendritic cells. LILRB4 inhibits antigen-presenting cell activation, resulting in immune tolerance. LILRB4 is also expressed on certain hematologic cancer cells and monocytic myeloid cells in the solid tumor microenvironment. Immune-Onc and The University of Texas published pioneering research in Nature illuminating the role of LILRB4 in immune suppression and tumor infiltration in AML and presented the rationale for targeting LILRB4 in solid tumors at the AACR (Free AACR Whitepaper) Annual Meeting 2021.

ABOUT IO-202

IO-202 is a first-in-class LILRB4 antagonist antibody with broad potential as an immunotherapy in both blood cancers and solid tumors. In hematologic malignancies, preclinical studies showed that IO-202 converts a "don’t kill me" to a "kill me" signal by activating T cell killing and converts a "don’t find me" to a "find me" signal by inhibiting infiltration of blood cancer cells. In solid tumors, preclinical data showed that IO-202 enhances dendritic cell function and T cell activation in vitro and inhibits tumor growth in a solid tumor model in vivo.

IO-202 is currently in Phase 1 clinical development for the treatment of AML and CMML. The U.S. Food and Drug Administration granted IO-202 Orphan Drug Designations for treatment of AML in 2020. The company has received IND clearance to evaluate IO-202 in solid tumors in January 2022.

On February 17, 2022 Emmanuelle BETTENDORF reported that it will participate in BioEurope Spring from March 28 to 31, 2022 and will be available to meet with you on partnership opportunities (Press release, Vect-Horus, FEB 17, 2022, View Source [SID1234608261]).

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On February 17, 2022 ISA Pharmaceuticals reported that it will be attending the following in person scientific and business conferences from February through to April 2022 (subject to travel restrictions), in addition to virtual conferences (Press release, ISA Pharmaceuticals, FEB 17, 2022, View Source [SID1234608210]).

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BioCapital Europe

Date: 10 March 2022, Amsterdam

American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting

Date: 8-13 April 2022, New Orleans

2nd Chronic HBV drug development

Date: 25-27 April 2022, Boston

If you would like to meet with the ISA Pharmaceutical team at any of the above events, please contact us!