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 Oncoceutics, Inc. reported the receipt of a Small Business Innovation Research (SBIR) Phase IIB Bridge Award from the National Cancer Institute (NCI) (Press release, Oncoceutics, SEP 10, 2018, View Source [SID1234558366]). The NCI SBIR Bridge Award will allow Oncoceutics to expand and accelerate its clinical trials evaluating ONC201 in patients with a specific type of lethal brain cancer called H3 K27M-mutant glioma.

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The awarded project, "Adaptive Clinical Efficacy Evaluation of ONC201 in Recurrent High-Grade Glioma" (grant number 2R44CA192427-04), builds upon the work supported by previous NCI SBIR Fast-Track grant that supported Oncoceutics’ effort demonstrating the activity of ONC201 in high-grade gliomas, including those with the H3 K27M mutation that is commonly present in the midline region of the brain. Each year, the NCI’s SBIR Development Center presents the Phase IIB Bridge Award to a select number of companies based on NCI and external expert review of the scientific merits and commercial potential of the technology. Awardees are required to allocate third-party investment to match the Bridge funding prior to submitting the funding application which occurred in mid-2017. The NCI Bridge Award will provide $3 million to Oncoceutics to advance the clinical development of ONC201 over the next 3 years.

Patients with H3 K27M-mutant glioma often have significant neurological symptoms from their disease and lack proven therapeutic options other than palliative radiotherapy. However, emerging clinical results have shown that some patients treated with single agent ONC201 have stable disease, have had their tumor shrink, and/or have had improvements in neurological symptoms, such as paralyses of peripheral and cranial nerves. This has been observed in adults and children treated with ONC201, including children with diffuse intrinsic pontine glioma (DIPG), a type of high-grade glioma that almost uniformly (80-90%) harbors the H3 K27M mutation.

"We are extremely pleased to see continued support from the NCI for the ONC201 clinical program in H3 K27M-mutant gliomas based on the clinical activity observed in our Phase II study supported by the Fast-Track SBIR grant," said Patrick Wen, MD, Director, Center For Neuro-Oncology, Dana-Farber Cancer Institute.

"The emerging clinical experience with ONC201 to treat gliomas at our institution and other leading cancer centers around the country is exciting," added said Yazmin Odia, MD MS, Lead Physician of Medical Neuro-Oncology, Miami Cancer Institute. "The dismal prognosis of midline gliomas and the dearth of therapeutic options means that this therapy could be practice-changing for neuro-oncology. We are eager to follow up on the radiographic and clinical improvements in biomarker-defined patients that we have seen with ONC201 as a single agent in our ongoing clinical trials. Future co-operative group efforts between NRG Oncology and the Children’s Oncology Group to test this drug in children and adults with newly diagnosed H3 K27M-mutant midline gliomas are in the planning process."

In addition to the support from the NCI, Oncoceutics has also received support from The Musella Foundation, a non-profit organization that helps brain tumor patients through education, advocacy, and financial support. The Musella Foundation has supported Oncoceutics’ development of ONC201 in high-grade gliomas for several years from bench to Phase II clinical trials. The Musella Foundation, in collaboration with Cancer Commons, Michael Mosier Defeat DIPG Foundation, The Cure Starts Now Foundation and xCures, has committed to contribute at least $1 million in hopes of accelerating the development of ONC201.

"Having represented and supported brain tumor patients’ interests for several decades, it has been frustrating to experience the failures of new treatments that have been developed to impact the outcome of this disease," said Al Musella, Founder and President of the Musella Foundation. "As highlighted in a recent ODAC meeting, the FDA, in collaboration with the NCI, is tasked with determining whether a molecular target is or is not considered substantially relevant to the growth or progression of pediatric cancer. We are excited to work with Oncoceutics that is developing a molecularly targeted agent, ONC201, that demonstrates the potential to advance the concept of Precision Medicine in patients that harbor the H3K27M mutation, a genetic aberration that is considered substantially relevant for the outcome of this disease. We are looking forward to contribute to making this drug available for as many patients as possible."

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