Next-gen T cell player TCR2 Therapeutics sets stage for $100M-plus IPO as MPM's Baeuerle caps prolific year

肿瘤免疫疗法新锐TCR2 Therapeutics 为首次公开募股做好准备

2019-01-02 07:25:05 endpoint News


Patrick Baeuerle has been busy. Right after steering next-gen BiTE company Harpoon Therapeutics toward an IPO, the MPM partner and immunologist is shepherding another oncology company with preclinical assets — TCR2 Therapeutics — into a public listing. And this time the biotech is looking for $100 million-plus in a market that’s been on a wild roller coaster ride. The immunotherapy company is developing next-gen T-cell drugs for cancer in an effort to confront limitations posed by current T-cell and CAR-T therapies in solid tumors. One of the key components of the immune system are T cells, which obliterate cancer cells by using T cell receptor (TCR) recognition of cell surface markers known as antigens. When a T cell recognizes a tumor antigen via the TCR, it snuffs the malignant cell on which it resides. Existing T cell therapies for cancer, including CAR-T cells and engineered TCR-T cells, attempt to replicate this mechanism. The drug developer’s technology — called TRuC-T cells — is designed to recognize and kill cancer cells by harnessing the TCR signaling complex, unlike CAR-T for instance, which only taps into a part of the TCR structure. In contrast to existing T cell therapies, the TCR2 technology is fashioned such that it could be used across patients that express the cancer surface antigen irrespective of human leukocyte antigens (HLA) subtype, which could potentially address a larger group of patients. The company has 5 drugs in its arsenal. Its lead candidate — TC-210 — is being developed to target mesothelin-positive solid tumors. An application to test the drug in humans was submitted in December and the company expects to conduct a Phase I/II study early in 2019, and eventually apply for the FDA’s fast track status. Its second drug, TC-110, is being evaluated for CD19-positive B-cell hematological malignancies. An IND is expected to be filed in the second half of 2019 and the company will also seek a fast track designation for this asset.  The rest — TC-220, TC-310 and TC-410 — are in earlier stages of preclinical development. TCR2 will have two experienced scientific minds working on their pipeline in the clinic: Robert Hofmeister, who developed one of the first PD-L1 inhibitors — Bavencio — while at EMD Serono, will serve as CSO, while Alfonso Quintás Cardama, who was pivotal in the approval process for one of the two licensed T cell therapies for hematological malignancies — Novartis’ Kymriah — will serve as CMO. The company will be listed on the Nasdaq under the symbol $TCRR, according to the S-1 posted last week. TCR2 was founded by Baeuerle, a partner at MPM who previously served as CSO at Micromet before it was swallowed by Amgen. Baeuerle was ushered into Amgen — where R&D was then run by Roger Perlmutter — following the buyout, to help take Micromet’s Blincyto across the finish line. TCR2 also worked closely with Mitchell Finer, an MPM Capital executive partner who has decades of cell therapy manufacturing experience, including the design of GMP processes for bluebird bio and Cell Genesys. Overall, just under half of the 30 companies MPM has invested in are oncology-focused. So far, TCR2  has raised roughly $170 million from investors, including MPM Capital, F2 Ventures, Dimensions Capital, ArrowMark Partners, Cathay Fortune Capital, Curative Ventures, Hillhouse Capital Group, MiraeAsset Financial Group and Redmile Group. Prior to the IPO, MPM has the biggest holding with a 19.18% stake, and F2 is a runner up with a 15.97% stake.
Patrick Baeuerle 一直很忙。在指导下一代 BiTE 公司 Harpoon Therapeutics 进行 IPO 之后, MPM 合伙人和免疫学家正将另一家拥有临床前资产—— TCR2 Therapeutics ——的肿瘤治疗公司上市。这一次,生物技术公司正在寻找1亿美元以上的市场,这是一个疯狂的过山车。 免疫治疗公司正在开发用于癌症的下一代 T 细胞药物,以努力对抗目前 T 细胞和 CAR-T 疗法在实体肿瘤中带来的局限性。 免疫系统的关键组成部分之一是 T 细胞,它通过 T 细胞受体( TCR )识别被称为抗原的细胞表面标记来消灭癌细胞。当 T 细胞通过 TCR 识别肿瘤抗原时,它会抑制住它所在的恶性细胞。现有的 T 细胞治疗癌症,包括 CAR-T 细胞和工程 TCR-T 细胞,试图复制这一机制。 与 CAR-T 不同的是, TRuC-T 细胞是通过利用 TCR 信号复合体识别和杀死癌细胞而设计的,而 CAR-T 只是利用 TCR 结构的一部分。与现有的 T 细胞疗法不同的是, TCR2技术被设计成可以在表达肿瘤表面抗原的患者中使用,而不考虑人类白细胞抗原( HLA )亚型,后者有可能针对更多的患者。 该公司的武器库中有5种药物。它的主要候选物—— TC-210——正在被开发用于靶向间皮素阳性实体肿瘤。12月提交了人体内药物试验申请,公司预计2019年初进行 I / II 期研究,最终申请 FDA 快速通道状态。其第二种药物 TC-110正在接受 CD19阳性 B 细胞恶性血液病的评估。IND 预计将在2019年下半年提交备案,该公司还将寻求对该资产进行快速指定。其余—— TC-220、 TC-310和 TC-410——处于临床前开发的早期阶段。 TCR2将有两位经验丰富的科学家在临床上研究他们的管道: RobertHofmeister ,他开发了第一个 PD-L1抑制剂 Bavencio ,而在 EMD Serono ,将作为 CSO ,而 Alfonso Quint á s Cardama ,在批准用于血液肿瘤的两种许可 T 细胞疗法中,一种是诺华( Novartis )的 Kymriah ,他将担任 CMO 。 根据上周发布的 S-1,该公司将在纳斯达克上市,代码为 TCRR 。TCR2由 MPM 的合伙人 Baeuerle 创立,此前他曾在 Micromet 担任 CSO ,后来被 Amgen 吞并。在收购完成后, Baeuerle 被引入 Amgen 公司,由 Roger Perlmutter 负责研发,以帮助 Micromet 的 Blincyto 跨越终点线。 TCR2还与拥有数十年细胞治疗制造经验的 MPM 资本执行合伙人 Mitchell Finer 密切合作,包括为蓝鸟生物和 Cell Genesys 设计 GMP 流程。总体而言, MPM 投资的30家公司中,只有不到一半是以肿瘤学为重点的。 到目前为止, TCR2已经从投资者那里筹集了大约1.7亿美元,包括 MPM Capital 、 F2 Ventures 、 Dimensions Capital 、 ArrowMark Partners 、 Cathay Fortune Capital 、 Curtive Ventures 、 Hillhouse Capital Group 、 MiraeAsset Financial Group 和 Red英里集团。在 IPO 之前, MPM 拥有最大的股份,持有19.18%的股份, F2是15.97%的股份的亚军。