On January 3, 2018 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing tumor-targeted and immuno-oncology therapies based on its pioneering research in cancer epigenetics, reported that President and Chief Executive Officer Jigar Raythatha will present a company overview at the 36th Annual JP Morgan Healthcare Conference on January 11 at 11:00 a.m. PST (2:00 p.m. EST), in room Elizabethan D (Press release, Constellation Pharmaceuticals, JAN 3, 2018, View Source [SID1234522848]). The conference is being held January 8-11 at the Westin St. Francis in San Francisco, California.

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On January 3, 2018 GeneCentric Therapeutics, Inc. reported a research collaboration to evaluate the potential of GeneCentric’s Cancer Subtype Platform (CSP) to identify responders to G1 Therapeutics’ oral CDK4/6 inhibitor G1T38 for the treatment of non-small cell lung cancer (NSCLC) (Press release, GeneCentric Therapeutics, JAN 3, 2018, View Source [SID1234522885]). As part of the research collaboration, GeneCentric will apply its lung cancer subtyping profilers (LSP) in preclinical, patient-derived xenograft models to determine NSCLC subtype associations with G1T38 response, as well as examine potential drug response associations with specific genes. Financial terms were not disclosed.

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GeneCentric’s proprietary core technology, CSP, identifies biologic subtypes of cancer through an integrated analysis of tumor genomics. The subtypes, which combine gene expression data with disease-related molecular pathways and immune cell expression have potential to function as universal biomarkers of drug response and enable more precision drug development. GeneCentric’s Lung Cancer Profilers (LSP 210 and LSP 220) define molecular subtypes of the two most common forms of NSCLC, adenocarcinoma and squamous cell carcinoma. Published studies have demonstrated that the subtypes, while indistinguishable by standard morphology, have different genetic, molecular and clinical attributes, and immune profiles that may drive drug response.

"G1T38 is a novel and promising targeted therapeutic with potential in many cancers," said Myla Lai-Goldman, M.D., CEO of GeneCentric. "This collaboration could identify subtypes of lung cancer where the compound is most likely to be efficacious."

On January 3, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported the December 2017 submission of an Investigational New Drug (IND) application for FPA150, a first-in-class immuno-oncology antibody that targets B7-H4 (Press release, Five Prime Therapeutics, JAN 3, 2018, View Source [SID1234522850]). Five Prime discovered FPA150 using the company’s protein therapeutics platform and anticipates initiating a Phase 1 trial of FPA150 during the first half of 2018.

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FPA150 is a high affinity, afucosylated monoclonal antibody designed with a dual mechanism of action: blocking a T cell checkpoint pathway and delivering enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) against tumor cells expressing B7-H4. B7-H4 expression is seen in tumor types such as breast, ovarian and endometrial cancer, and has been correlated with poor prognosis in some studies. Non-clinical data of FPA150 featured in an oral poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress described potent ADCC and T cell checkpoint blockade activity in vitro and significant dose-dependent anti-tumor efficacy in vivo.

"We are excited to expand our clinical pipeline with the addition of FPA150, which offers a differentiated approach to existing immunotherapies," said Bryan Irving, Ph.D., Senior Vice President of Research at Five Prime. "B7-H4 represents a T cell checkpoint ligand that is not currently targeted by other immuno-oncology agents and is also expressed in several solid tumor types not typically associated with elevated PD-L1 expression."

Five Prime designed the planned Phase 1 trial with a standard 3+3 dose escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and urothelial carcinomas. Phase 1a dose escalation endpoints include identification of a maximum tolerated dose (MTD), safety, and pharmacokinetics (PK) of FPA150. Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.

About FPA150
FPA150 is a novel, high affinity, afucosylated monoclonal antibody discovered by Five Prime with its protein therapeutics platform. FPA150 is designed with a dual mechanism of action: blocking a T cell checkpoint pathway and delivering enhanced antibody-dependent cell-mediated cytotoxicity against tumor cells expressing B7-H4. B7-H4 expression is seen in tumor types such as breast, ovarian and endometrial cancer, and has been correlated with poor prognosis in some studies. Five Prime anticipates initiating Phase 1 development of FPA150 during the first half of 2018.

On January 3, 2018 Angiochem Inc. and Xinogen (Hong Kong) Pharma Co. Ltd. ("Xinogen"), a wholly-owned subsidiary of Beijing Shenogen Pharma Group Ltd. entered a license and collaboration agreement to develop and commercialize ANG1005 in China for treatment of patients with leptomeningeal carcinomatosis from breast cancer. (Press release, AngioChem, JAN 3, 2018, View Source [SID1234573598]). Xinogen was granted exclusive rights to develop and commercialize ANG1005 in the Greater China region. In return, Angiochem will receive upfront and milestone payments as well as a royalty based on future product sales.

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Angiochem is currently developing ANG1005 for treatment of leptomeningeal carcinomatosis from breast cancer. The company’s next clinical trial is due to start in 2018.

"Angiochem is looking forward to collaborating with Xinogen," said John Huss, Executive Chairman of Angiochem. Dr. Kun Meng, CEO of Beijing Shenogen Pharma Group Ltd, also expressed his enthusiasm and confidence about collaborating with Angiochem.

On January 3, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that a development milestone payment of USD 6 million has been triggered under the partnership agreement for ADC-1013 (JNJ-64457107) with Janssen Biotech, Inc (Press release, Alligator Bioscience, JAN 3, 2018, View Source [SID1234538672]).

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The milestone payment is for the partnership agreement to initiate a clinical combination study of ADC-1013 with one of Janssen’s proprietary PD-1 inhibitors. This is the first out of a number of pre-defined milestones, related to the start of combination or phase II studies as part of the ADC-1013 clinical program, which all together have an aggregated potential value of 35 MUSD.

The licensing agreement with Janssen Biotech Inc. encompasses milestone payments up to a potential total value of USD 695 million. Alligator is also eligible to receive tiered royalties on worldwide net sales upon successful launch and commercialization of ADC-1013.

"We are pleased that our collaboration with Janssen is continuing to progress according to plan", said Per Norlén, CEO at Alligator Bioscience. "The upcoming combination is a very important step in the continued clinical development. Synergy between ADC-1013 and PD-1 blocking antibodies is supported by pre-clinical data. If this translates to the clinic, it could create new treatment opportunities for many cancer patients".

Alligator’s partner Janssen Biotech, Inc. is performing a phase I dose-escalation clinical study (ClinicalTrials: NCT02829099) with intravenous administration of JNJ-64457107 (ADC-1013). This study is ongoing with approximately 50 patients recruited to date.

For further information, please contact:
Per Norlén; CEO
Phone: +46 46 286 42 80
E-mail: [email protected]

Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

This press release contains such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 1.30 p.m. CEST on 3 January 2018.

About ADC-1013
ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Recent results from a clinical phase I first-in-human study show that ADC-1013 is generally well tolerated supporting the further clinical development of ADC-1013 as a mono- or combination therapy. Pre-clinical data have previously shown that the ADC-1013 antibody effectively activates T-cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T cell activation enables the immune system to attack the cancer.