On April 1, 2020 Oncoceutics, Inc., reported that it was informed by its Japanese licensee, Ohara Pharmaceutical Co., Ltd., of the initiation of a Phase I/II clinical study of OP-10 (the Japanese name for ONC201) in Japan and the administration of the drug to the first patient (Press release, Oncoceutics, APR 1, 2020, View Source [SID1234558313]).

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ONC201 is a novel small molecule with a unique mechanism of action that has demonstrated anti-cancer activity and safety in preclinical models and in several ongoing clinical trials, including clinical trials in adult and pediatric patients with high-grade glioma. In February 2019, Oncoceutics outlicensed rights to ONC201 for Japan to Ohara. Under this strategic partnership, Ohara is responsible for conducting clinical trials required to obtain Marketing Authorization in Japan and the commercialization of ONC201 in the Japanese market.

"We are excited to continue to work with the dedicated team of experts at Ohara as we expand the development of ONC201 to important markets outside the U.S.," said Lee Schalop, MD, Chief Operating Officer of Oncoceutics. "This clinical trial provides Japanese patients with high-grade glioma immediate access to ONC201, and data from this study will be an important part of working toward a Japanese market approval for ONC201."

On April 13, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that H. Lee Moffitt Cancer Center ("Moffitt") plans to present clinical results from a Phase 1 trial using Moffitt’s tumor infiltrating lymphocytes (TIL) in patients with non-small cell lung cancer (NSCLC) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, to be held April 27-28, 2020 (Press release, Iovance Biotherapeutics, APR 13, 2020, View Source [SID1234556314]). The Phase 1 study is being conducted at Moffitt with support from Iovance Biotherapeutics, a Stand Up To Cancer Catalyst grant, and other partners.

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Maria Fardis, Ph.D., MBA, President and Chief Executive Officer of Iovance, stated, "We are very pleased that Moffitt will present clinical data demonstrating the potential for tumor infiltrating lymphocytes, or TIL, in such an unmet medical need indication, non-small cell lung cancer. This data is the basis of our strategy to investigate Iovance TIL in two cohorts of non-small cell lung cancer patients in our IOV-COM-202 ‘basket’ study. We continue to be excited about the broader potential of Iovance TIL in additional tumor types."

Abstract Title: Durable complete responses to adoptive cell transfer using tumor infiltrating lymphocytes (TIL) in non-small cell lung cancer (NSCLC): a phase I trial.
Authors: Ben Creelan, et al.
Session: VCTPL05 – Adoptive Cell Transfer Therapy
Date and Time: April 28, 2020, 12:45 PM – 12:55 PM
Abstract Number: 20-LB-10617-AACR
Location: AACR (Free AACR Whitepaper) Virtual Annual Meeting I at www.aacr.org
The AACR (Free AACR Whitepaper) Virtual Annual Meeting I will include more than 30 oral presentations in several clinical trial plenary sessions along with commentaries from expert discussants, as well as clinical trial poster sessions consisting of short videos providing the authors’ perspectives. This Virtual Meeting will be available free to everyone, although attendees will be asked to register to participate. For more information please visit the AACR (Free AACR Whitepaper) Virtual Annual Meeting I page at www.aacr.org.

On April 1, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AFM13, its lead CD30- and CD16A-binding innate cell engager, for the treatment of patients with T-cell lymphoma (Press release, Affimed, APR 1, 2020, View Source [SID1234556107]). The granted designation includes peripheral T cell lymphoma (pTCL), a subtype of T-cell lymphoma. AFM13 is being investigated as a monotherapy for the treatment of relapsed or refractory CD30-positive pTCL in a Phase 2 registration-directed study.

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The FDA may grant orphan designation to drugs and biologics intended to treat a rare disease or condition affecting fewer than 200,000 persons in the U.S. The designation qualifies a company for certain benefits, including financial incentives to support clinical development and the potential for seven years of market exclusivity in the U.S. upon regulatory approval.

About AFM13
AFM13 is a first-in-class tetravalent, bispecific innate cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells. AFM13 is being developed in peripheral T cell lymphoma (pTCL) and in other CD30-positive lymphomas. AFM13 has shown a favorable safety profile and signs of therapeutic efficacy as a monotherapy in CD30-positive non-Hodgkin lymphoma with cutaneous manifestation. In addition, data from a combination study of AFM13 with Merck’s anti-PD-1 antibody Keytruda (pembrolizumab) in Hodgkin lymphoma (HL) supports proof of principle for the combination of NK cell engagement with checkpoint inhibition. AFM13 has been granted orphan drug designation by the U.S. Food and Drug Administration for HL.

On April 1, 2020 Legend Biotech Corporation (Legend), a global, clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it has raised $150.5 million in Series A financing (Press release, Legend Biotech, APR 1, 2020, View Source [SID1234556095]). Proceeds from the financing will be used to advance the research and development and commercialization of Legend’s pipeline programs and expansion of manufacturing facilities, enhancement of its research and development platform, as well as general corporate expenses.

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New investors included Hudson Bay Capital Management LP, Johnson & Johnson Innovation-JJDC, Inc., Lilly Asia Ventures, Vivo Capital, RA Capital Management and other large, reputable institutional investor.

Morgan Stanley Asia Limited and Jefferies Hong Kong Limited advised Legend in this transaction.

On April 1, 2020 OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE) reported that the primary endpoint was met in the predefined Step-1 analysis of its Phase 3 clinical trial of investigational product Tedopi, called Atalante 1, in HLAA2 positive non-small cell lung cancer (NSCLC) patients after failure from immune checkpoint inhibitors (PD-1/PD-L1) (Press release, OSE Immunotherapeutics, APR 1, 2020, View Source [SID1234556093]).

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Considering the population of the treated patients in both trial arms randomized at least 12 months before the time of the Step-1 analysis (N=99), the primary objective of Step-1 of the Atalante 1 trial planned in the protocol was met:

In the Phase 3 Step-1 analysis, the statistically positive preliminary results show at least 12-month survival for 29 patients out of 63 patients in the Tedopi arm, corresponding to a 12-month survival rate of 46% with the lower limit (33%) of the 95% confidence interval* [33%-59%], above the pre-specified futility boundary of 25%.

The observed rate of 46% is also above the assumption of a survival rate of 40% specified for the alternative efficacy hypothesis in the protocol.

In the chemotherapy control arm the results show at least 12-month survival for 13 patients out of 36 patients, corresponding to a 12-month survival rate of 36%.

Alexis Peyroles, CEO of OSE Immunotherapeutics, said: "We are very pleased with these positive results for Tedopi in Step-1 and with a 10% absolute difference in 12-month survival rate versus chemotherapy in NSCLC patients after failure of checkpoint inhibitor treated in Atalante 1 Step-1 trial. This outcome confirms the therapeutic value of our neoepitope product in a patient population for whom there are no registered product today and who needs new therapeutic options. Based on these positive results, we are now eager to engage in discussions with regulatory authorities to evaluate Tedopi’s current clinical results and agree upon the best options for further development to maximize on the product’s positive data in terms of benefit/risk ratio. In parallel, given the significant value added by positive Step-1 results, we continue exploring potential partnership opportunities for Tedopi."

As explained in the recent press release from March 26, 2020, the Company together with the Independent Data Monitoring Committee (IDMC) and the Steering Committee of the trial have reviewed the potential impact of the COVID-19 outbreak on the Atalante 1 trial. As of today, there is ongoing concern that trial data may be markedly impacted given the current worldwide COVID19 pandemic and the increased risk for patients with NSCLC as COVID-19 can cause serious pulmonary complications in this immunocompromised patient population. In addition, recommendations from several medical societies include voluntary holds on recruitment of new patients in oncology trials for the time being, due to patient safety concerns.

Consequently, following the recommendation from both IDMC and Steering Committee of Atalante 1, OSE Immunotherapeutics voluntarily decided to terminate patient screening and accrual in the initially planned and now cancelled Step-2. Further analysis of the positive Step-1 data will commence while engaging with regulatory agencies on the best development path forward for the product given the significant unmet medical need in the NSCLC patient population post-checkpoint inhibitor therapy failure.

*The 95% confidence interval (CI) is a range of values which has a 95% chance of containing the true value of the estimated parameter. With less rigor, it can be said that the CI represents the range of values within which it is 95% certain to find the true value sought. It provides a visualization of the uncertainty of the estimate.