On December 5, 2017 Neon Therapeutics, a clinical-stage immuno-oncology company developing neoantigen therapies, reported the successful completion of an additional $36 million extension to its Series B financing which, combined with $70 million announced in January 2017, brings the total raised during this Series B crossover round to $106 million (Press release, Neon Therapeutics, DEC 5, 2017, View Source [SID1234522416]).

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Proceeds from the financing will support ongoing clinical development of Neon Therapeutics’ lead product candidate, NEO-PV-01, a personal neoantigen vaccine, currently in Phase 1b development. Additionally, the funding will support the ongoing preclinical development of NEO-PTC-01, a personal neoantigen T cell program; and the company’s NEON / SELECT approach focusing on shared neoantigen targets.

The Series B extension included participation from existing investors, as well as new investors. Participants included Fidelity Management & Research Company, Partner Fund Management, Access Industries, Wellington Management, Pharmstandard International, Arrowmark Partners, Nextech Invest, Hillhouse Capital Group and Casdin Capital.

"Our team has made strong progress across the full breadth of our neoantigen portfolio," said Hugh O’Dowd, chief executive officer of Neon Therapeutics. "We remain focused on leading this neoantigen field in the development of new therapeutic options for patients."

On December 4, 2017 Radius Health, Inc. (Nasdaq:RDUS), reported that it will present data from multiple clinical and pre-clinical studies of elacestrant, an oral selective estrogen degrader, in ER-positive breast cancer at the San Antonio Breast Cancer Symposium Meeting December 5-9, 2017 at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, Radius, DEC 4, 2017, View Source [SID1234522365]).

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Details for the abstracts related to elacestrant are below:

Abstract Title: Elacestrant, a novel oral selective estrogen receptor degrader (SERD), decreases tumoral 18F-FES uptake in a phase 1 study of ER+, HER2 -, advanced breast cancer patients
Poster Session 1 (P1-10-04)
Session Title: Treatment: New Drugs and Treatment Strategies
Session Date: Wednesday, 12/6/2017
Session Time: 5:00 PM — 7:00 PM
Location: Hall 1

Abstract Title: Elacestrant, oral selective estrogen receptor degrader (SERD) in patients with ER positive (ER+)/HER2- advanced breast cancer: Updated phase 1 efficacy, safety and pharmacodynamic results
Spotlight Session 5 (PD5-08)
Session Title: Endocrine Therapy: SERDS for metastatic ER+ breast cancer
Session Date: Thursday, 12/7/2017
Session Time: 5:00 PM — 7:00 PM
Location: Ballroom 1&2 – 3rd Level

Abstract Title: New oral SERD elacestrant (RAD1901) shows efficacy in breast cancer models harbouring ESR1 mutations and enhances the antiproliferative activity of mTORC1 and CDK4/6 inhibitors
Poster Session 4 (P4-04-09)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: Friday, 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstract Title: Anti-tumor activity of elacestrant (RAD1901) in combination with alpelisib (BYL-719) in patient-derived xenograft models of ER+ breast cancer
Poster Session 4 (P4-04-14)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstract Title: Elacestrant (RAD1901) demonstrates anti-tumor activity in a fulvestrant-resistant PDX model
Poster Session 4 (P4-04-17)
Session Title: Tumor Cell and Molecular Biology: Endocrine Therapy and Resistance
Session Date: 12/8/2017
Session Time: 7:00 AM — 9:00 AM
Location: Hall 1

Abstracts for the posters can be found on the SABCS website at View Source

Webcast Information

Radius will host an investor meeting and webcast on Thursday, December 7th to highlight the elacestrant data presented at SABCS and provide a company update at 8:00 p.m. CT / 9:00 p.m. ET.

The live webcast titled "Oncology Program Update from San Antonio Breast Cancer Symposium — 2017" will be available at View Source or by visiting the Investors section of Radius’ website at View Source

A replay of the webcast will be archived on Radius’ website for 30 days following the presentation.

About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Elacestrant is currently being investigated for potential use in women with advanced estrogen receptor positive, HER2 negative, breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

Additional information on the clinical trial program of elacestrant (RAD1901) is available on www.clinicaltrials.gov.

On December 4, 2017 Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported the appointment of Prof. Stéphane Depil, MD, PhD, to the role of Senior Vice President Research & Development and Chief Medical Officer (Press release, Cellectis, DEC 4, 2017, View Source [SID1234522366]). Prof. Depil’s responsibilities include bringing Cellectis’ product candidates to clinical-stage development, strategic and operational management of all therapeutic activities, and supervising research and development projects for the Company. Stéphane Depil will keep academic and research activities as adjunct Professor at Léon Bérard Cancer Center & University Claude Bernard Lyon 1, France.

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"Stéphane Depil’s deep medical, academic, and clinical regulatory oncology experience – specifically in R&D for all phases within the pharmaceutical, biotechnology, and clinical research spaces – will be invaluable as he leads Cellectis’ strategy and promotes awareness of the breakthrough work that we are doing as a leader and innovator in the gene-editing field," said Dr. André Choulika, Cellectis CEO. "His strategic alliance-building, collaboration skills, understanding of the global environment with oncological clinical research, and firsthand experience running a pharma company all add a great degree of ability and depth to our leadership team. This will be tremendously advantageous as Cellectis continues its efforts to cure cancer with our off-the-shelf gene-edited CAR T-cell product candidates."

Prof. Depil is a board-certified physician in hematology, with over 15 years of experience in oncology clinical development, both in hospital / university and pharmaceutical companies. Prior to joining the Léon Bérard Cancer Center & Cancer Research Center of Lyon, France as Medical Director of the Cancer Immunotherapy Program, he served as Chief Executive Officer at Netris Pharma, where he was responsible for the management of an oncology startup and preclinical development of a first-in-class monoclonal antibody in Phase I. Prior to Netris, Stéphane Depil worked at Servier for 8 years in a variety of roles, including Director of Oncology Research and Development, where he managed 20 programs: 5 in the clinic, 7 at late preclinical stages, and 8 at early preclinical stages. He also directly supervised over 100 licensing opportunities.

"As we are at a transformative moment in history with CAR T-cell therapy, Cellectis is harnessing the power of gene editing to improve patients’ lives through the allogeneic approach," added Prof. Depil. "As such, Cellectis is well-positioned to make its mark with the Company’s unique pioneering approach, and I look forward to joining the team at this pivotal time. This is an unprecedented era of biopharmaceutical innovation to develop next-generation therapeutics that will transform patient care as we know it today."

On December 4, 2017 OncoTracker, Inc., a private medical diagnostics company, reported a license agreement with Juno Therapeutics (NASDAQ: JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, to advance its program in multiple myeloma using gamma secretase inhibitors (GSIs) in combination with BCMA-directed CAR T cells (Press release, OncoTracker, DEC 4, 2017, View Source [SID1234553990]).

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Through its agreement with OncoTracker, Juno will gain exclusive rights to intellectual property within the field of combinations of GSIs and BCMA-directed engineered T cells.

James R. Berenson, M.D., President and CSO of OncoTracker stated, "In the past 12 months, we have made significant advances in personalizing treatment for multiple myeloma patients utilizing our proprietary sBCMA diagnostic test. Our test has broad ranging applications, including clinical trial monitoring, companion diagnostic testing, and most importantly, clinical practice testing and monitoring. We believe that our simple, proprietary blood test can accurately and rapidly assess benefit of ongoing treatments, can accurately predict both PFS and OS, and can identify patients that require immediate treatment vs. wait and watch categories."

"BCMA appears to be an important target for treating patients with multiple myeloma, and Juno is dedicated to investigating novel approaches to maximize efficacy for these patients. These licenses open up an important approach to improve the activity and outcomes for CAR T cells targeted at BCMA," said Sunil Agarwal, M.D., Juno’s President of Research and Development. "We plan to combine gamma secretase inhibitors with our BCMA CAR T product candidates, initially testing combinations in 2018."

1Pont M. "Gamma secretase inhibition increases recognition of multiple myeloma by BCMA-specific chimeric antigen receptor modified T cells." Presented at Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). November 8-12, 2017. National Harbor, MD.

On December 4, 2017 Kymab’s reported that data at the British Society for Immunology Congress demonstrates efficient identification and validation of human antibodies (Press release, Kymab, DEC 4, 2017, View Source [SID1234537007])

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Three poster presentations at the 2017 British Society for Immunology Congress describe how Kymab’s efficient human antibody platforms were able to identify an anti-PD-L1 antibody, KY1003, and show it was an effective anti-tumour antibody in in vitro and in vivo models.

In Rachael Kimber’s poster, Cell based screening cascade to select anti-human PD-L1 antibodies, the team describe a cell-based, in vitro screening cascade that enabled functional characterisation of anti-human PD-L 1 antibodies.

They identified a panel of potent fully human, antagonistic antibodies that bind human and cynomolgus PD-L1 and enhance T-cell activity, identifying a lead clone, KY1003, that has the characteristics of a clinically relevant PD-L1 antibody.

Lucy Hepburn presents Development and characterization of a human T cell:tumour cell co-culture assay for assessment of immunomodulatory antibodies, which suggests that prolonged co-culture of human T-cells with the A375 tumour cell line, designed to mimic chronic antigen stimulation, generates T-cells that appear ‘exhausted’.

By using these T-cells, the team confirm that Kymab’s anti-PD-L1 antibody, KY1003, can enhance in vitro T-cell killing of A375 cells and inhibit immunosuppressive PD-1/PD-L1 signalling to increase tumour elimination by T cells in vivo.

Morgane Lecointre’s poster, Development of a "tumour-educated" T cell killing assay for predictive in vitro assessment of anti-PD-L1 antibodies, demonstrates how KY1003 can revert T-cell exhaustion in in vitro models using A375 tumour cells.

Importantly, KY1003 shows a strong anti-tumour efficacy in an in vivo human melanoma xenograft model. The approach is biologically relevant in validation of antibodies that target T-cell immune-modulatory molecules.

Notes to Editors
PDF versions of the posters
Cell based screening cascade to select anti-human PD-L1 antibodies (0.5 MB: Kimber et al., Poster P074)
Development and characterization of a human T cell:tumour cell co-culture assay for assessment of immunomodulatory antibodies (0.7 MB: Hepburn et al., Poster P077)
Development of a "tumour-educated" T cell killing assay for predictive in vitro assessment of anti-PD-L1 antibodies (4.3 MB: Lecointre et al., Poster P075)