On September 10, 2018 Editas Medicine, Inc. (NASDAQ: EDIT), a leading genome editing company, reported that the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed the U.S. Patent and Trademark Office (USPTO) decision that ended the U.S. patent interference between the University of California, the University of Vienna, and Emmanuelle Charpentier (collectively, UC) and the Broad Institute, Inc. (Broad) concerning certain CRISPR/Cas9 patents Editas Medicine exclusively licenses from Broad (Press release, Editas Medicine, SEP 10, 2018, View Source;p=RssLanding&cat=news&id=2366755 [SID1234529383]). This favorable action by the CAFC upholds the USPTO decision issued in February 2017, granting Broad’s motion for no interference-in-fact.

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"We are pleased with the Federal Circuit’s decision affirming the Patent Trial and Appeal Board decision on the patents that were granted to the Broad Institute for its innovative and fundamental work on CRISPR/Cas9 genome editing," said Katrine Bosley, President and Chief Executive Officer, Editas Medicine. "This decision is highly favorable for Editas and for the Broad as it reaffirms the strength of our intellectual property foundation and has profound implications for making CRISPR medicines."

Editas Medicine’s foundational intellectual property includes issued patents covering fundamental aspects of both CRISPR/Cas9 and CRISPR/Cpf1 (also known as CRISPR/Cas12a) gene editing. The patents broadly cover CRISPR/Cas9 and CRISPR/Cpf1 gene editing in eukaryotic cells, which includes all human cells. Successfully editing this cell type is essential to making CRISPR-based medicines. Overall, the Company holds a wide range of fundamental intellectual property directed to all of the components of its genome editing platform as well as product-enabling and product-specific intellectual property.

In 2014, the USPTO granted the first of several foundational patents to Broad with broad claims covering CRISPR/Cas9 in eukaryotic cells. In 2016, the USPTO declared an interference proceeding between Broad and UC that involved several of Broad’s issued CRISPR patents. While scientists in both groups had made important scientific contributions to the field, this proceeding was initiated by the USPTO to determine which of the two groups first invented the use of CRISPR/Cas9 for editing DNA in eukaryotic cells.

In February 2017, the Patent Trial and Appeal Board of the USPTO determined that the patent claims that had been granted to Broad were separately patentable from, and thus, do not interfere with, the claims of the UC application. This ruling ended the interference proceeding and upheld Broad’s fundamental CRISPR/Cas9 patents as originally granted. Today’s decision affirms that USPTO decision from February 2017. The Broad patents continue to be valid and in force. Foundational claims covering the use of CRISPR/Cas9 for gene editing in eukaryotic cells have also issued to Broad as patents in each of the United States, Europe, and Australia.

On September 10, 2018 The Centre for the Commercialization of Antibodies and Biologics (CCAB) and Triumvira Immunologics, Inc. (Triumvira), reported a new licensing agreement between the University of Toronto (U of T) and Triumvira (Press release, Triumvira Immunologics, SEP 10, 2018, View Source [SID1234529369]). The agreement provides Triumvira with an exclusive license for antibodies discovered at the U of T on specified therapeutic targets. Triumvira is a privately held biopharmaceutical company with R&D facilities in Hamilton, ON, that is developing a novel platform for engineering T cells to attack multiple cancer types.

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CCAB is the assigned agent for the U of T for the commercialization of a large portfolio of human antibodies. Under the terms of the agreement, U of T will receive up-front fees, milestone payments and royalty payments on net sales of products on three therapeutic targets: BCMA, ROR1 and one undisclosed target.

"We are very pleased to be working with The Centre for the Commercialization of Antibodies and Biologics and the University of Toronto under this new licencing agreement," said Paul Lammers, MD, MSc, President and Chief Executive Officer of Triumvira. "This partnership is critical as we work to bring new treatments to patients in need through our proprietary T Cell-Antigen Coupler (TAC) technology."

Triumvira’s lead therapeutic candidate, TAC01-CD19, is a CD19-directed T cell product for the treatment of B cell malignancies and is anticipated to enter Phase I clinical trials in H1 2019 in patients with diffuse large B cell lymphoma (DLBCL). The company is also developing a series of products for solid tumors.

"Collaboration is a vital part in the development of new therapeutics. These types of agreements continue to strengthen the connection between academia and industry and help to translate the wealth of scientific knowledge from the laboratories at our world-class universities to the clinic," CCAB Chief Executive Officer Robert Verhagen said.

On September 10, 2018 Alkermes plc (Nasdaq : ALKS ) reported that it has expanded its ongoing phase 1 study for ALKS 4230, the company’s immuno-oncology drug candidate, to evaluate its safety and anti-tumor activity when administered in combination with the FDA-approved PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with advanced solid tumors (Press release, Alkermes, SEPT 10, 2018, View Source [SID1234529370]). ALKS 4230 is an engineered fusion protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response. Pembrolizumab is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

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"The emergence of therapeutics targeting the PD-1 pathway has revolutionized the field of oncology, yet there remains significant opportunity to improve the clinical benefit of checkpoint inhibitors for the treatment of solid tumors. There is strong scientific rationale supporting the combination of PD-1 pathway inhibition with cytokine therapy such as ALKS 4230 to activate the body’s own immune system to fight cancer, and the potential synergies of ALKS 4230 and pembrolizumab on anti-tumor activity may expand treatment options for patients in a variety of tumor settings," said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. "We’ve accelerated clinical evaluation of ALKS 4230 in combination with pembrolizumab based on data from our ongoing monotherapy dose-escalation stage of the phase 1 study, where ALKS 4230 demonstrated dose-dependent pharmacodynamic effects on circulating natural killer cells and CD8+ T cells, and minimal and non-dose dependent effects on immunosuppressive regulatory T cells. These data validate our design rationale for ALKS 4230, and we look forward to sharing initial data from our dose-escalation cohorts at a medical meeting later this year."

Evaluation of the safety and anti-tumor activity of ALKS 4230 in combination with pembrolizumab will be assessed in certain PD-1 approved tumor types in both refractory and treatment naïve patients, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma, gastric cancer, urothelial carcinoma and microsatellite instability-high cancers. Melanoma and renal cell carcinoma will also be evaluated in the cohort of treatment naïve patients. The combination of ALKS 4230 and pembrolizumab will also be assessed in certain PD-1 unapproved tumor types, including colorectal cancer, triple-negative breast cancer, ovarian carcinoma, soft tissue sarcomas, and patients with metastatic NSCLC whose tumors express low or undetectable PD-L1 (tumor proportion score <1%).

About the Phase 1 Study

The Alkermes-sponsored phase 1 study for ALKS 4230 includes three distinct stages: the ongoing monotherapy dose-escalation stage, the planned monotherapy dose-expansion stage and the newly initiated combination therapy stage with pembrolizumab. The dose-escalation stage is designed to determine a maximum tolerated dose of ALKS 4230 in a monotherapy setting and to identify the optimal dose range of ALKS 4230 based on measures of immunological-pharmacodynamic effects. Upon completion of the dose-escalation stage, the company expects to initiate the monotherapy dose-expansion stage in up to 42 patients with renal cell carcinoma or melanoma. The newly initiated combination therapy stage of the phase 1 study will assess the safety profile and anti-tumor activity of ALKS 4230 with pembrolizumab in up to 148 patients with select advanced solid tumors. This combination therapy stage will be run independent of, and concurrently with, the monotherapy dose-escalation and dose-expansion stages of the trial.

Anti-tumor response and duration of response assessments in the dose-expansion and combination stages of the phase 1 study will be based on investigator-assessed, immune-related response (irRC) criteria and independent, central, blinded radiographic review per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.

About ALKS 4230

ALKS 4230 is an engineered fusion protein designed to preferentially bind and signal through the intermediate affinity interleukin-2 (IL-2) receptor complex, thereby selectively activating and increasing the number of immunostimulatory tumor-killing immune cells while avoiding the expansion of immunosuppressive cells that interfere with anti-tumor response. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects while overcoming limitations of existing IL-2 therapy, which activates both immunosuppressive and tumor-killing immune cells.

On September 10, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that CFO and Head of Corporate Strategy John Leaman, M.D., will present at the Janney Healthcare Conference in New York City at 9:05 a.m. ET on Monday, September 17, 2018 (Press release, Selecta Biosciences, SEPT 10, 2018, View Source [SID1234529371]). A live webcast of the presentation can be accessed via the Investors & Media section of the company’s website, View Source

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On September 10, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that updated data from ongoing clinical trials evaluating first-in-class antibody, IPH4102, and lead asset, monalizumab, partnered with AstraZeneca/MedImmune, will be presented at the EORTC CLTF* 2018 Meeting in St Gallen, Switzerland, September 27-29, 2018 and at the ESMO (Free ESMO Whitepaper)** 2018 Congress in Munich, Germany, October 19-23, 2018, respectively (Press release, Innate Pharma, SEP 10, 2018, View Source [SID1234529424]). Moreover, Eric Vivier, Chief Scientific Officer, is invited to the ESMO (Free ESMO Whitepaper) Congress as speaker in the Early detection of cancer using minimally invasive biomarkers Special Symposium.

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EORTC CLTF 2018 for IPH4102:

Title: IPH4102 in relapsed/refractory cutaneous T cell lymphoma (CTCL): Results of the first-in-human multicenter phase 1 study
Date and time: September 29, 2018, 8:30 – 9:45
Presentation number: 078
Session: Oral presentation, Session 8 / Treatment and clinical cases
Presenter: Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris, France
Location: Olma Messen Hall 9.2, St-Gallen, Switzerland

ESMO 2018 Congress for monalizumab:

Results of a Phase II study evaluating monalizumab in combination with cetuximab in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
Date and time: October 20, 2018, 15:00
Presentation number: 1049PD
Session: Poster Discussion session – Head and neck
Presenter: Jérôme Fayette, Medical Oncologist at the Centre Léon Bérard Lyon, France
Location: Hall B3 – Room 23, ICM München, Munich, Germany
Title: Translational endpoints in patients with metastatic microsatellite-stable colorectal cancer (MSS-CRC) treated with Durvalumab plus Monalizumab (anti-NKG2A)
Date & time: October 20, 2018, 12:30
Presentation number: 1194P
Session: Poster Display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research (ID 259)
Presenter: Jennifer R. Diamond, Associate Professor, Division of Medical Oncology at the Colorado University, Denver, US
Location: Hall A3, Poster Area Networking Hub, ICM München, Munich, Germany

Title: Changes in the innate immune system as early events in cancer
Date & time: October 22, 2018, 15:05 – 15:25
Session: Special Symposium Early detection of cancer using minimally invasive biomarkers
Presenter: Eric Vivier, Chief Scientific Officer of Innate Pharma, Marseille, France
Location: Hall A1 – Room 17, ICM München, Munich, Germany