On May 15, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, and Alpine Immune Sciences, Inc., Seattle, WA, (NASDAQ:ALPN), a leading immunotherapy company focused on developing treatments for autoimmune diseases and cancer, reported a collaboration and license agreement to develop next-generation SPEAR T-cell products which incorporate Alpine’s secreted and transmembrane immunomodulatory protein (termed SIP and TIP) technology (Press release, Adaptimmune, MAY 15, 2019, View Source;p=RssLanding&cat=news&id=2398682 [SID1234536302]). This collaboration will further enhance Adaptimmune’s efforts to design and develop next-generation SPEAR T-cell therapies.

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"Our directed evolution platform has successfully generated many unique, multi-functional protein domains designed to favorably modulate the tumor microenvironment via validated immune targets," said Stanford Peng, MD PhD, Alpine’s President and Head of Research & Development. "We look forward to working with Adaptimmune to develop next-generation SPEAR T-cell therapies to achieve improved clinical outcomes."

Alpine and Adaptimmune will collaborate on a specified number of programs to develop SIP and TIP candidates with tailored affinities and modulatory activities that may enhance the anti-tumor responses seen with Adaptimmune’s SPEAR T-cells.

Alpine and Adaptimmune will collaborate on a specified number of programs to develop SIP and TIP candidates with tailored affinities and modulatory activities that may enhance the anti-tumor responses seen with Adaptimmune’s SPEAR T-cells.

Under the terms of the collaboration agreement, Adaptimmune will provide an upfront payment and research funding for ongoing programs. In addition, Alpine may be eligible for downstream development and commercialization milestones up to $288M, if all pre-specified milestones for each program are achieved.

Alpine will receive low-single digit royalties on worldwide net sales of the applicable products.

On May 15, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the United States Food and Drug Administration (FDA) has recommended that the Company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer as part of a Type C meeting held this week (Press release, ImmunoGen, MAY 15, 2019, View Source [SID1234536332]).

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ImmunoGen requested the meeting to discuss the results of the Phase 3 FORWARD I trial and a potential path to registration for mirvetuximab monotherapy. The agency advised that, because FORWARD I did not meet its primary endpoint under the pre-specified statistical analysis plan, the data generated assessing the secondary endpoints from the study could not be used to support an application for accelerated approval. FDA acknowledged that platinum-resistant ovarian cancer is a disease with unmet need, provided guidance regarding the design and endpoints of a potential registration study, and encouraged the Company to return to discuss a proposed study design.

"We are encouraged by the consistent signal of anti-tumor activity and the favorable benefit-risk profile in patients with high FRα expression in our Phase 3 FORWARD I trial," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We appreciate the constructive engagement with FDA and look forward to aligning with the agency on the design of a new registration trial in this population."

"Our meeting with FDA enabled us to clarify a regulatory path forward for mirvetuximab and we are evaluating all avenues to bring this promising therapy to ovarian cancer patients," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "The mirvetuximab combination cohorts continue to advance and, with approximately $270 million on the balance sheet as of the end of Q1, we remain focused on developing innovative ADC therapeutics and delivering more good days to people with cancer."

As previously announced, ImmunoGen is conducting an operational review of the business with the objective of extending the Company’s cash runway.

CONFERENCE CALL INFORMATION
ImmunoGen will host a conference call on May 15, 2019 at 8 a.m. ET to discuss the recent regulatory meeting with FDA. To access the live call by phone, dial 334-323-0505; the conference ID is 5203727. The call may also be accessed through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through May 29, 2019.

ABOUT FORWARD I
FORWARD I is a Phase 3 trial in which 366 patients were randomized 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligible patients were diagnosed with platinum-resistant ovarian cancer that expresses medium or high levels of FRα and were treated with up to three prior regimens. The primary endpoint of this study was progression free survival (PFS), which was assessed in the entire study population and in the subset of patients with high FRα expression. ImmunoGen estimates that 12,000-14,000 patients per year in the U.S. meet these criteria, with a comparable number in the major markets in Europe.

ImmunoGen partnered with the GOG Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which was conducted in North America and Europe.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On May 15, 2019 The SanBio Group (SanBio Co., Ltd. and SanBio, Inc.)(TOKYO:4592), a scientific leader in regenerative medicine for neurological disorders, reported the appointment of Bijan Nejadnik, M.D., as its new Chief Medical Officer in charge of development and regulatory affairs (Press release, Sanbio, MAY 15, 2019, View Source [SID1234536348]).

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Dr. Nejadnik has held many important positions, including key roles at Johnson & Johnson Services, Inc., a major pharmaceutical company, as well as pioneering clinical programs in the pharmaceutical and biotech industry, such as Jazz Pharmaceuticals, Inc., Galena Biopharma, Inc., and Eureka Therapeutics, Inc. At Johnson & Johnson, he was involved in the development of immunological and oncology therapeutics, including the development of infliximab (trade name: Remicade) used for the treatment of rheumatic and other autoimmune disorders. At Jazz Pharmaceuticals, he submitted Biologics License Applications (BLA) for multiple oncology therapeutics and obtained approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As Chief Medical Officer at Galena Biopharma, he led the research of immunotherapy for multiple cancers and research in adoptive T-cell therapy in combination with checkpoint inhibitor drugs. As Chief Medical Officer at Eureka Therapeutics, he was involved in the development of genetically modified T-cells and obtained FDA approval for several IND and launched the clinical trials. Dr. Nejadnik thus is a leading figure in clinical development, with diverse experience.

In Japan, using the conditional and term-limited authorization system for regenerative medicine products under the Revised Pharmaceutical Affairs Act, the SanBio Group is currently working toward applying for manufacturing and marketing approval of SB623 for the treatment of chronic motor deficit resulting from traumatic brain injury (TBI) during the fiscal year ending January 31, 2020 (February 1, 2019–January 31, 2020). Further, it plans to initiate a Phase 3 clinical trial of SB623 for the same indication by the end of the fiscal year ending January 31, 2020. Dr. Nejadnik will work on leading these clinical developments for obtaining approval, and in the long term, will work to promote global expansion of the Group.

Damien Bates, M.D., PhD, FRACS, MBA, who until today has served as the Group’s Chief Medical Officer and Head of Research, will continue to contribute to the global development of the regenerative cell medicine SB623 as the Group’s senior advisor.

Accepting the position of Chief Medical Officer, Dr. Nejadnik commented, "I have been involved in the development of many new pharmaceutical drugs with a view to meeting unmet medical needs that lack effective treatment. SanBio is a pioneer in drug development for patients suffering central nervous system disorders. I understand that the development of SB623 has already come close to the stage of product launch in Japan; taking advantage of my past experiences, I will do my best to bring SB623 to patients worldwide as soon as possible."

"I am very pleased to welcome Dr. Bijan Nejadnik as SanBio’s new Chief Medical Officer," said Keita Mori, CEO of SanBio, Co., Ltd. "In Japan, the development program for SB623 as a treatment for chronic motor deficit resulting from TBI has already advanced to a stage that we are preparing for obtaining the approval for launch under the conditional and term-limited authorization system for regenerative medicine products. Going forward, we aim to bring the product to the global market. We expect that Dr. Nejadnik will receive the baton from Dr. Damien Bates and, by drawing on his extensive experience, will make further contributions to the clinical development and submission process towards the approval of SB623."

On May 15, 2019 Epic Sciences, Inc. reported its poster presentations for the upcoming 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 31 through June 4 in Chicago, Illinois (Press release, Epic Sciences, MAY 15, 2019, View Source [SID1234536365]). The data to be presented by Epic researchers and its partners feature multiple novel circulating tumor cell (CTC) biomarkers associated with therapeutic response to different drug classes including PARP inhibitors, androgen-targeted therapies and checkpoint inhibitors for prostate and bladder cancer.

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"This new data further strengthens the clinical evidence of CTCs to predict disease progression and response to different cancer therapies," said Rick Wenstrup, M.D., chief medical officer at Epic Sciences. "There are a number of very exciting, novel therapies for cancer in development, and we are working with several biopharma and academic clinical researchers to utilize Epic’s functional cell profiling technology platform as part of their biomarker strategies. Our CTC approach creates opportunities for drug developers to optimize and enrich their clinical trials, and ultimately for oncologists and patients to benefit from predictive information that could extend lives."

Five presentations are listed below:

Title: CTC vs. biopsy tissue sequencing: A concordance analysis of genomic copy number profile from mCRPC patients (pts)
First Author: Howard I. Scher, M.D., FASCO, Memorial Sloan Kettering Cancer Center
Date and Time: Saturday, June 1, 2019, 8:00 am – 11:00 am CT
Poster Session: Developmental Therapeutics and Tumor Biology (Nonimmuno)
Abstract: 3050
Poster Board: 42

Title: Examination of the additive value of CTC biomarkers of heterogeneity (Het) and chromosomal instability to nuclear-localized (nl) AR-V7+ CTCs in prediction of poor outcomes to androgen receptor signaling inhibitor (ARSi) in metastatic castration resistant prostate cancer (mCRPC)
First Author: Howard I. Scher, M.D., FASCO, Memorial Sloan Kettering Cancer Center
Date and Time: Saturday, June 1, 2019, 1:15 pm – 4:15 pm CT
Poster Session: Genitourinary (Prostate) Cancer
Abstract: 5075
Poster Board: 187

Title: SLFN11 expression in advanced prostate cancer (APC) predicts response to platinum-based chemotherapy (PLT)
First Author: Vincenza Conteduca, M.D., Ph.D., Dana Farber Cancer Institute
Date and Time: Saturday, June 1, 2019, 1:15 pm – 4:15 pm CT
Poster Session: Genitourinary (Prostate) Cancer
Abstract: 5065
Poster Board: 177

Title: Pamiparib, an investigational PARP inhibitor in patients with metastatic castration-resistant prostate cancer (mCRPC) and a circulating tumor cell (CTC) homologous recombination deficiency (HRD) phenotype or BRCA defects: A trial in progress
First Author: Simon Chowdhury, M.D., Guy’s, King’s and St. Thomas’ Hospitals, and Sarah Cannon Research Institute
Date and Time: Saturday, June 1, 1:15 pm – 4:15 pm CT
Poster Session: Genitourinary (Prostate) Cancer
Abstract: TPS5086
Poster Board: 198a

Title: Circulating tumor cell (CTC) enumeration in patients (pts) with metastatic genitourinary (mGU) tumors treated in a phase I study of cabozantinib and nivolumab (CaboNivo) +/- ipilimumab (CaboNivoIpi)
First Author: Andrea B. Apolo, M.D., Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, NIH
Date and Time: Monday, June 3, 2019, 1:15 pm – 4:15 pm CT
Poster Session: Genitourinary (Nonprostate) Cancer
Abstract: 4555
Poster Board: 381

On May 15, 2019 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that the U.S. Food and Drug Administration (FDA or Agency) has lifted the partial clinical hold on AIM2CERV, the company’s Phase 3 clinical trial of axalimogene filolisbac (AXAL) for the treatment of patients with high-risk locally advanced cervical cancer (Press release, Advaxis, MAY 15, 2019, View Source [SID1234536303]). In its letter, the FDA acknowledged that the company satisfactorily addressed all hold questions.

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As announced on January 23, 2019, the FDA placed a partial clinical hold on this study relating to the Agency’s requests for additional information pertaining to certain AXAL chemistry, manufacturing and controls (CMC) matters. The Agency did not cite any safety issues related to the trial and all enrolled patients continued to receive treatment, per the trial protocol. However, no new patients were permitted to enroll in AIM2CERV during this partial hold.

"The Advaxis team worked diligently to provide a comprehensive response back to the FDA’s requests for additional CMC information, and through constructive dialogue, we successfully resolved the partial clinical hold," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "Our AXAL product has demonstrated a manageable safety profile in the over 400 patients we have dosed to date, and we look forward to working with our clinical research organization to reopen enrollment at AIM2CERV sites. We remain focused on our mission of developing innovative therapies to address unmet needs and improving the lives of people with cancer."

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack. In a Phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), the drug candidate showed a 12-month overall survival rate of 38% in 50 patients. This is a 52% improvement over the 12-month overall survival rate that was expected in the trial’s patient population based on prognostic factors.

Axalimogene filolisbac has received Fast Track designation for adjuvant therapy for high-risk locally advanced cervical cancer (HRLACC) and a Special Protocol Assessment for the Phase 3 AIM2CERV trial in HRLACC patients. The immunotherapy has also received orphan drug designation in three clinical indications.