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First patient dosed in IPH5201 Phase I clinical trial in advanced solid tumors

On March 9, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that the first patient was dosed in a Phase I clinical trial evaluating IPH5201, an anti-CD39 blocking monoclonal antibody, in adult patients with advanced solid tumors (Press release, Innate Pharma, MAR 9, 2020, View Source [SID1234555329]). The purpose of the study, which is sponsored by AstraZeneca (LSE/STO/NYSE: AZN), is to evaluate IPH5201 as monotherapy and in combination with durvalumab (anti-PD-L1) with or without oleclumab (anti-CD73 monoclonal antibody).

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The IPH5201 Phase I program is supported by positive pre-clinical results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2019 Congress, which demonstrated that blocking CD39 in combination with PD-L1 checkpoint inhibitors provides increased antitumor efficacy over PD-L1 alone and supports the rationale for assessing this combination in clinical trials. Pre-clinical data recently published by Innate Pharma1 also demonstrates the rationale to further evaluate the combination of CD39 and CD73 blockade in cancer indications, given their potential synergistic effect on an anti-tumor response. The blockade of CD39 not only prevents production of immunosuppressive adenosine, but also promotes accumulation of immunostimulatory adenosine triphosphate (ATP). It is increasingly recognized that the adenosine pathway is critical in tumor immunosuppression.

"We’re pleased that the IPH5201 clinical studies have started, as blockade of CD39 represents an innovative and differentiated approach to potentially reverse immunosuppression mediated by adenosine in the cancer microenvironment. In particular, IPH5201’s potential to unleash immune responses makes it an interesting molecule to investigate for the treatment of solid tumors, particularly in combination therapies," said Pierre Dodion, Chief Medical Officer of Innate Pharma. "AstraZeneca is a very valuable partner given their expertise in the adenosine pathway and leadership in this field. We’re excited to see our first molecule progressing to the clinic from our multi-faceted partnership, helping to accelerate our Company strategy and advance our immuno-oncology portfolio."

The multicenter, open-label, dose-escalation Phase I study will evaluate the safety, tolerability, antitumor activity, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of IPH5201 alone, or in combination with AstraZeneca’s anti-programmed cell death ligand 1 (PD-L1) therapy, durvalumab, with or without its anti-CD73 monoclonal antibody, oleclumab. More information on the Phase I clinical trial can be found at View Source

About IPH5201:
In October 2018, Innate Pharma and AstraZeneca entered into a development collaboration and option agreement for further co-development and co-commercialization for IPH5201.

IPH5201 is a blocking antibody targeting the CD39 immunosuppressive pathway.

CD39 is an extracellular enzyme that is expressed in the tumor microenvironment, on both tumor infiltrating cells and stromal cells in several cancer types. CD39 inhibits the immune system by degrading adenosine tripohsphate (ATP) into adenosine monophosphate (AMP), that is then further degraded into adenosine by CD73. By promoting the accumulation of immune-stimulating ATP, and preventing the production of immune-suppressive adenosine, the blockade of CD39 may stimulate anti-tumor activity.

GenFleet Closes $57 Million B Round for Oncology/Immunology Portfolio

On March 9, 2020 GenFleet Therapeutics (Shanghai) reported that it has closed a $57 million Series B financing, co-led by CDH Investments and Shenzhen Capital Group (Press release, GenFleet Therapeutics, MAR 9, 2020, View Source [SID1234555328]). Founded in 2017, GenFleet is developing novel large and small therapeutic molecules for oncology and immunology targets. The company says its projects are potential first-in-class therapeutics with technical advantages and large markets. It will use the capital for ex-China development and clinical trials of its existing pipelines, plus expanding its immunology platform, working on new projects and building an industrial base.

Curadigm announces the selection of its Nanoprimer technology by the National Cancer Institute for a characterization & development collaboration

On March 9, 2020 Curadigm, an early-stage nanotechnology company committed to improving treatment outcomes by redefining the therapeutic balance between bioavailability, toxicity, and efficacy, reported the selection of its Nanoprimer technology by the National Cancer Institute’s (NCI) Nanotechnology Characterization Laboratory (NCL) for characterization, based on its potential to significantly impact treatments in multiple disease indications, including cancer (Press release, Curadigm, MAR 9, 2020, View Source [SID1234555326]).

The broad utility of the Nanoprimer technology is due to its unique nanomedicine approach to improve therapeutic action without modifying the therapeutic in any way. Rather, the Nanoprimer is administered intravenously just prior to a therapeutic, specifically and transiently occupying the liver pathways responsible for clearance. This temporarily increases the therapeutic’s bioavailability and subsequent accumulation in target tissue. This mechanism, targeting the universal upstream pathways involved in intravenous drug clearance, means the Nanoprimer can be used in combination with multiple classes of nanomedicines including nucleic acid and small molecule therapeutics or gene editing technologies.

Through this collaboration, the NCL, a leader in the characterization and development of Nanomedicines, will perform in-depth pre-clinical characterizations. These studies will support the Nanoprimer’s development, driving advancement toward filing an Investigational New Drug (IND) with the Food and Drug Administration (FDA) and future clinical development. This work will also support ongoing and future collaborations combining the Nanoprimer with therapeutics across diverse clinical indications.

Curadigm is a 2019 Nanobiotix spin-off, that aims to reshape and elevate the efficacy of intravenously administered therapeutics. The Nanoprimer technology is based on engineered, biocompatible nanoparticles that are administered just prior to the therapeutic and acts rapidly to temporarily occupy the Kupffer and liver sinusoidal endothelial (LSEC) cells. This precision-based approach leads to enhanced systemic bioavailability for increased therapeutic action.

The NCL was established to study the use of nanoparticles and nanomedicines to advance cancer research and to accelerate the development of promising and safe nanotechnology-based cancer therapeutics. The program provides pre-clinical testing and services on a competitive acceptance basis to companies, such as Curadigm, and is working in concert with other US agencies such as the FDA to accelerate the use of nanomedicines from early-stage development to clinical applications.

"The selection of our nanoprimer by the NCL is a major step for Curadigm," said Matthieu Germain, CEO of Curadigm. "The standardized cascade assay developed by the NCL is a great opportunity to accelerate the development of the Nanoprimer by providing additional data about its physico-chemical properties, safety and mechanism of action that will facilitate regulatory review. The results generated through this collaboration will also be instrumental in supporting our discussions with partners to develop their therapeutics with the Nanoprimer."

Invicro Collaborates with Yale’s Dr. David Rimm to Expand the Utility of Quanticell™ for Clinical Pathology Applications

On March 9, 2020 Invicro LLC, a Konica Minolta Company reported it has entered into a strategic research partnership with industry leading pathologist, Dr. David Rimm, MD, PhD, at The Yale University School of Medicine to advance the development of Quanticell, Konica Minolta’s proprietary tissue biomarker detection technology (Press release, invicro, MAR 9, 2020, View Source [SID1234555325]).

Invicro is a global provider of imaging biomarkers, core lab services, CAP-CLIA pathology services, advanced analytics and software solutions for drug discovery and development. Dr. Rimm is the Professor of Pathology and Medicine; Director of Pathology Tissue Services; and Director of Translational Pathology at Yale University.

Quanticell is an ultra-sensitive, quantitative, amplification-free technology that detects proteins at the cellular and subcellular level using photostable, highly bright phosphor-integrated dots (PIDs). This nanoparticle-based detection technology circumvents the limitations observed with traditional multiplex chromogenic and fluorescent-based assays, such as signal saturation, non-linearity and high background.

"With his unmatched knowledge and experience in anatomical pathology, product commercialization, and late-stage clinical trials, Dr. Rimm is a leading pioneer in the quantitative pathology space," said Dr. Ken Bloom, Chief Medical Officer for Advance Pathology Solutions for Invicro. "We could not be happier to have him as a scientific research partner. I am highly confident that his efforts will support the advancement of Quanticell for specific drug development initiatives."

Chromogenic-based Immunohistochemistry (IHC) is ubiquitously used in research and clinical practice, including companion diagnostics (CDx). Despite IHC’s wide use, underperforming assays often require additional molecular testing due to narrow detection range. With expertise in quantitative and digital pathology and having invented the AQUA technology for predicting response to therapies or recurrence in a myriad of disease indications, Dr. Rimm and his research team will evaluate a multitude of assay conditions to assess Quanticell’s technology performance for quantifying HER-2 expression across a much wider dynamic range.

"I am thrilled to be working on this cutting-edge technology that has the potential to revolutionize molecular drug target testing that will in turn maximize therapeutic efficacy and reduce undesired toxicity," said Dr. Rimm. "In previous studies performed in my laboratory, we have found that HER-2 protein expression spanned three logs of dynamic range and discovered DAB-based methods typically only show a linear range of one log, which we hypothesize can be addressed with Konica Minolta’s novel detection technology."

Refuge Biotechnologies Promotes Francesco M. Marincola, M.D., to President

On March 9, 2020 Refuge Biotechnologies, Inc. ("Refuge"), a synthetic biology company developing intelligent cell therapeutics for cancer immunotherapy, reported the promotion of Francesco M. Marincola, M.D., to president (Press release, Refuge Biotechnologies, MAR 9, 2020, View Source [SID1234555324]). He will retain his role as chief scientific officer.

"Since Franco joined Refuge as our chief scientific officer in 2018, he has transformed our immune cell therapy research program into one that can compete with the best in the world. His knowledge, insight and relationships in both academia and industry have paved a clear path for us as we continue to advance our pipeline of intelligent cell therapies to fight cancer," said Bing C. Wang, Ph.D., co-founder and chief executive officer of Refuge. "In parallel, he has demonstrated a strength in mentorship by training internal scientists to grow into their potential and has set the standard for our company’s culture and expectation of leadership in scientific pursuits. We are proud to recognize his leadership across the organization with the promotion to president."

"One key motivation behind pioneering the CRISPR interference and activation technology was to find new ways to innovate treatments of cancers in a precise way without making permanent cuts to the DNA. With this approach, the technology can deliver multiplex treatments to T cells all at once – making the process inexpensive and efficient," said Stanley Qi, Ph.D., scientific founder. "It’s been remarkable to witness the progress that Refuge has made with translating this technology into next-generation cell immunotherapies that could have meaningful impacts. Much of that success is in part to Franco’s profound scientific vision, leadership, and clinical mindset as Refuge matures into a clinical-stage program. This promotion is well-deserved."

Dr. Marincola joined Refuge as chief scientific officer in May 2018, focused on the development of the intelligent cell therapy platform and lead therapeutic programs. In his career, he served as a distinguished research fellow and strategist for immune oncology discovery at AbbVie, developed and led a genetic research institute at Sidra Medical and Research Center in Qatar, and served as president of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Dr. Marincola has spent his career studying tumor immunology and was a pioneer in the development of technologies for studying the dynamics of the tumor microenvironment adaptations during immune therapy in real-time.