On April 2, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune-modulating antibodies, cancer vaccines, adjuvants and adoptive cell therapies1, reported that the first patient was dosed in the clinical trial of its next-generation anti-CTLA-4 antibody (AGEN1181) (Press release, Agenus, APR 2, 2019, View Source [SID1234534906]). AGEN1181, a novel ‘Fc engineered’ antibody with potential for enhanced anti-tumor functions, is specifically designed to boost cancer killing immune cells and deplete cells that block the activity of these cancer killing cells.

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The first patient in the trial was dosed by Dr. Steven J. O’Day, M.D., Executive Director of the John Wayne Cancer Institute & Cancer Clinic, and a pioneer in delivering immune therapies to patients with cancer. Dr. O’Day’s pivotal work has led to the approvals of commercial antibodies targeting CTLA-4 and PD-1. "AGEN1181 represents an important next-generation breakthrough with its potential for enhanced immune activation and tumor fighting abilities," said Dr. O’Day. "The pre-clinical data so far suggest that AGEN1181 may bring superior benefit compared to first generation anti-CTLA-4 antibodies and may be an optimal partner for combinations. I am thrilled to be working with this compound."

"AGEN1181 is a product of Agenus’ innovation engine that has been key to rapidly delivering new discoveries to patients," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "AGEN1181 was developed based on a new mechanism of action discovered by our scientists. In addition to this monotherapy trial, we plan to pursue combination studies with AGEN1181 soon. Besides AGEN1181, additional important discoveries from our innovation engine are also advancing towards the clinic this year."

The Phase 1, open-label, multicenter study is designed to assess the maximum tolerated dose of AGEN1181 in subjects with advanced solid tumors. It will also evaluate the safety, tolerability, PK, and PD profiles and immunogenicity of this antibody. The outcome will determine the recommended phase II dose of AGEN1181.

AGEN1181 was developed based on a discovery made by Agenus scientists, that involves modification of a key region of an antibody, known as the "Fc region", to design next-generation, ‘Fc engineered’ antibodies that may significantly enhance functionality and antitumor immunity. To learn more about AGEN1181 and its potential advantages over first-generation anti-CTLA-4 antibodies, please see Agenus’ Newsletter here.

On April 2, 2019 Novocure (NASDAQ:NVCR) reported that it will report financial results for the first quarter 2019 on Thursday, May 2, 2019, before the U.S. financial markets open (Press release, NovoCure, APR 2, 2019, View Source [SID1234534922]). Novocure management will host a conference call and webcast to discuss its financial results for the three months ended March 31, 2019, at 8 a.m. EDT on Thursday, May 2, 2019.

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Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 8956998. The webcast and earnings slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the call.

On April 2, 2019 Geron Corporation (Nasdaq: GERN) reported that John A. Scarlett, M.D., Chairman and Chief Executive Officer, is scheduled to present a company overview at the 18th Annual Needham Healthcare Conference in New York at 3:30 p.m. ET on Tuesday, April 9, 2019 (Press release, Geron, APR 2, 2019, View Source [SID1234534940]).

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A live audio webcast of the presentation will be available on Geron’s website, www.geron.com/investors/events. If you are unable to listen to the live presentation, an archived webcast will be available on the Company’s website for 30 days.

On April 2, 2019 Massive Bio, Inc., a leader in providing simplified and affordable access to clinical trials and precision oncology to cancer patients treated at community-based oncology practices, reported that its Trials-in-Progress poster titled "SYNERGY-AI: Artificial intelligence based precision oncology clinical trial matching and registry" will be presented by Dr. Selin Kurnaz, a lead investigator, at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 in Atlanta, GA, USA, during the Phase I-III Trials in Progress session on April 2nd, 2019 (Press release, Massive Bio, APR 2, 2019, View Source [SID1234534977]).

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The poster (Abstract #CT218), View Source!/6812/presentation/10031 discusses the ongoing, pivotal global registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool powered by a virtual tumor board (VTB) program. The SYNERGY-AI registry is the first of its kind to combine artificial intelligence, genomic biomarkers and multi-variate analysis to accelerate clinical trial matching and promote access to promising cancer therapies.

"We continue active enrollment in this innovative precision oncology and artificial intelligence project, and we are honored and excited to be among the highly selected group of clinical trials to be presented at AACR (Free AACR Whitepaper). Moreover, we are the only company in the market that operationalizes technology – we not only pre-screen patients, we find sites to the patients, eliminate insurance barriers and truly close the last mile in oncology clinical trial enrollment. We clean massive operational inefficiencies and we are making a leap frog in clinical research," said Selin Kurnaz, PhD., CEO and Co-Founder of Massive Bio.

In addition, today, Massive Bio and Admera Health announced a non-exclusive collaborative agreement as active participants in SYNERGY-AI registry. Under the terms of the agreement, Massive Bio and Admera Health will focus on real world evidence, biomarker data and clinical trial matching in precision oncology studies. In addition, Admera Health also provides genomics and bioinformatics services to customers wishing to conduct research in a CLIA environment.

"By combining the expansive technology and precision oncology capabilities of Massive Bio with Admera Health’s specialization in genomics and bioinformatics, we hope to develop and provide the next wave of molecular-based portfolio of technology innovations and services," stated Jeffrey R. Mitchell, Associate Director of Strategy and Marketing of Admera Health. Mitchell continued, "In addition, given the geographic strengths of our respective companies, there will also be opportunities to expand clinical trials using each other’s proprietary technology around the globe."

Commenting on the announcement, Chief Medical Advisor and Co-Founder of Massive Bio Inc., Dr. Arturo Loaiza-Bonilla, MD, MSEd, stated, "Massive Bio’s Artificial Intelligence technology platform is extremely well positioned to enable just-in-time clinical trial matching and enrollment, with a targeted therapy and immunotherapy focus, and is proven to accelerate access to innovative therapies, sponsor and CRO efficiency, as well as time to market. We certainly welcome collaborations with all stakeholders in the diagnostics and research space, aiming to close existing gaps in cancer research." Chief Business Officer of Massive Bio Inc, Harry Buchman also stated, "With a growing number of successful development applications, it is our goal to continue to promote precision oncology approaches at the point-of-care, and to ease access to clinical trials, while reducing patient and provider burden and overall cancer care costs."

About the Study

The SYNERGY-AI Registry is an international prospective, observational cohort study of adult and pediatric patients with advanced solid and hematological malignancies. Using a proprietary application programming interface (API) linked to existing electronic health records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a parametric database of existing institutional and non-institutional CT. Machine learning algorithms allow for optimized matching based on CT allocation and availability. Enrollment is ongoing, with a target of ≥1,500 patients. Please refer to View Source for details.

On April 2, 2019 Nordic Nanovector ASA (OSE: NANO) reported that promising results from its preclinical research collaboration to develop a novel CD37-targeting alpha therapy for B-cell tumours have been reported today in an oral presentation at TAT11, the 11th International Symposium on Targeted-Alpha-Therapy (1-4 April, Ottawa, Canada) (Press release, Nordic Nanovector, APR 2, 2019, View Source [SID1234553453]).

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The research collaboration with Orano Med (formerly known as AREVA Med) was established in June 2016 to develop and investigate a next-generation targeted alpha therapy comprising Nordic Nanovector’s chimeric anti-CD37 antibody (NNV003) and the alpha-particle-generator lead-212 (212Pb) for the treatment of B-cell malignancies.

The results reported in an oral presentation given today describe promising findings from preclinical studies investigating the tolerability and dose-dependent efficacy of 212Pb-NNV003 in mouse models of chronic lymphocytic leukaemia (CLL) and Burkitt’s lymphoma (a type of non-Hodgkin’s lymphoma, NHL).

In the studies, 212Pb-NNV003 displayed a favourable toxicity profile after a single intravenous injection. In one study, 100% of mice with tumour xenografts were alive five months after the injection of 212Pb-NNV003, while only 50% of control mice receiving cold antibody where alive after 1.5 months.

Jostein Dahle, Chief Scientific Officer of Nordic Nanovector, said: "Our research collaboration with Orano Med continues to produce promising preclinical results and provides an early demonstration of the potential of 212Pb-conjugated CD37-targeted alpha therapy to treat leukaemias and lymphomas where there is no substantial tumour mass and tumour cells are near healthy tissues. This approach also may prove useful for CLL and NHL patients who have relapsed or become refractory to standard CD20-targeting agents that are used in front-line therapy. We look forward to further results from this research programme."

The oral presentation entitled 212Pb-NNV003 as a Novel Targeted Alpha Therapy for CD37 Positive B-cell Chronic Lymphocytic Leukaemia (CLL) and Non-Hodgkin’s Lymphoma (NHL) was given by Dr A. Saidi of Orano Med.