Portfolio | Gritstone Oncology与bluebird bio合作开发肿瘤免疫细胞疗法，并筹划IPO

2018年8月23日，总部位于美国麻州剑桥的bluebird bio公司和总部位于美国北加州湾区的Gritstone Oncology公司联合宣布，双方进入战略合作，将共同研发针对癌症的细胞疗法。

Gritstone Oncology将利用其专有的EDGE™人工智能（AI）平台分析特定的肿瘤类型，以确认这些肿瘤的特异性靶标或新生抗原（neoantigen）, 并挑选能够识别这些靶标的天然T细胞受体（TCR）。在此基础上， bluebird bio将利用已建立的细胞治疗平台推出针对这些特定肿瘤的细胞疗法，并负责其所有的开发、制造和商业推广活动。另外， Gritstone Oncology还将利用其AI技术平台，帮助bluebird bio在未来的临床试验中选择合适的病人。

根据协议，Gritstone将提供给bluebird十个肿瘤靶标和若干针对这些靶标的TCR。Gritstone将获得2千万美元的首付和1千万美元的C轮股权投资，在未来还有可能得到里程碑付款和销售提成。

在同一天，Gritstone向美国证券交易委员会（SEC）递交了招股说明文件 （S-1）， 准备在纳斯达克IPO募资至多8千万美元。

Gritstone于2015年8月成立，专注开发针对多种癌症类型的肿瘤特异性免疫疗法。Gritstone的技术平台有两个关键支柱：第一是Gritstone EDGE™，一个基于机器学习的AI平台。该平台可以高效、准确地从常规肿瘤活检中预测每个癌症患者的肿瘤特异性新生抗原（TSNA）。第二，利用患者的TSNA，设计、开发和制造高效免疫疗法，从而驱使患者的免疫系统攻击和破坏肿瘤。

2018年7月19日，百时美施贵宝（BMS）和Gritstone宣布开展临床试验合作，探索Gritstone的管线领头项目、个性化癌症疫苗GRANITE-001, 与BMS的免疫检查点抑制剂Opdivo和Opdivo + Yervoy在治疗晚期实体瘤方面的联合用药前景。

2017年9月，Gritstone完成了由礼来亚洲基金领投的9.27千万美元的B轮融资。

更多详情，请访问：

gritstoneoncology.com

www.sec.gov

附英文新闻：

bluebird bio and Gritstone Oncology Announce Strategic Collaboration to Develop Novel Cancer Cell Therapies

CAMBRIDGE, MASS. and EMERYVILLE, CALIF. – Aug. 23, 2018 – bluebird bio, Inc. (Nasdaq: BLUE) and Gritstone Oncology, Inc. today announced a collaboration to research, develop and commercialize products for the treatment of cancer using cell therapy. Gritstone Oncology will leverage its proprietary EDGE™ artificial intelligence platform to analyze specific tumor types to identify tumor-specific targets and natural T-cell receptors (TCRs) directed to those targets for use in bluebird bio’s established cell therapy platforms. bluebird bio will conduct all development, manufacturing and commercial activities. Gritstone Oncology will utilize its proprietary technology platform to enable patient selection for clinical development of such therapies.

“By combining our expertise in gene and cell therapy with Gritstone Oncology’s unique target identification and TCR technology, we hope to bring the power of cell therapy to a broader set of newly-validated targets, enabling us to treat previously unaddressable patient populations,” said Philip Gregory, D.Phil., chief scientific officer of bluebird bio. “As we expand our immuno-oncology focus and portfolio, this collaboration with Gritstone Oncology is highly complementary to our goal of rapidly advancing novel cellular therapies with the potential to transform the lives of people with cancer, particularly in solid tumor indications.”

“As the field of immuno-oncology has evolved, it has become clear that targeting T-cell therapeutics to solid tumors in a highly specific manner is vital to enable potent tumor cell killing with sparing of normal tissues,” said Andrew Allen, M.D., Ph.D., president and chief executive officer of Gritstone Oncology. “We believe that our artificial intelligence-based approach to identifying tumor-specific targets and corresponding, naturally occurring TCRs, combined with bluebird bio’s expertise in gene and cell therapy, will allow us to develop cellular immunotherapies against differentiated oncology targets. We look forward to collaborating with the bluebird bio team in order to develop innovative treatments for patients in need.”

Under the terms of the agreement, Gritstone Oncology will provide 10 tumor-specific targets across several tumor types and, in certain cases, TCRs directed to those targets to bluebird bio. Gritstone Oncology will receive $20 million in an upfront payment and an additional $10 million in the form of a Series C preferred equity investment. In addition, Gritstone Oncology is eligible for significant development, regulatory and commercial milestones on any therapies, and tiered royalties on certain approved therapies.

About bluebird bio, Inc.

With its lentiviral-based gene therapies, T cell immunotherapy expertise and gene editing capabilities, bluebird bio has built a pipeline with broad potential application in severe genetic diseases and cancer.

bluebird bio’s gene therapy clinical programs include investigational treatments for cerebral adrenoleukodystrophy, transfusion-dependent β-thalassemia, also known as β-thalassemia major, and severe sickle cell disease.

bluebird bio’s oncology pipeline is built upon the company’s lentiviral gene delivery and T cell engineering, with a focus on developing novel T cell-based immunotherapies, including chimeric antigen receptor (CAR T) and T cell receptor (TCR) therapies. The company’s lead oncology programs are anti-BCMA CAR T programs partnered with Celgene.

bluebird bio’s discovery research programs include utilizing megaTAL/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline.

bluebird bio has operations in Cambridge, Massachusetts; Seattle, Washington; Durham, North Carolina and Zug, Switzerland.

About Gritstone Oncology, Inc.

Gritstone Oncology is developing tumor-specific cancer immunotherapies to fight multiple cancer types. The company has built its approach on two key pillars—first, a proprietary machine learning-based platform, Gritstone EDGE™, which provides the powerful ability to predict from a routine tumor biopsy the tumor-specific neoantigens, or TSNA, that are presented on a patient’s tumor cells; and second, the ability to develop and manufacture potent immunotherapies utilizing patients’ TSNA to drive the patient’s immune system to attack and destroy tumors. Gritstone brings together distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors and deep financial backing from Versant Ventures, The Column Group, Clarus Funds, Frazier Healthcare Partners, Redmile Group, Casdin Capital, Lilly Asia Ventures, Trinitas Capital, GV, Alexandria Venture Investments and Bay City Capital. More information can be found at www.gritstone.com or @gritstoneonc.

Gritstone Oncology Contacts

Dan Budwick

1AB

[phone]

[e-mail]

or

Alexandra Santos

Wheelhouse Life Science Advisors

[e-mail]

bluebird bio Contacts

Investor Relations

Elizabeth Pingpank, 617-914-8736

[e-mail]

or

Media Relations

Stephanie Fagan, 201-572-9581

[e-mail]

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