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CytomX (CTMX) Gets FDA Nod to Begin Study in Solid Tumors

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CytomX Therapeutics, Inc. (CTMX - Free Report) announced that the FDA has approved its investigational new drug application for commencing a clinical study that will evaluate CX-904 for the treatment of advanced solid tumors.

CytomX is co-developing CX-904, a conditionally activated T-cell-engaging bispecific antibody, against the epidermal growth factor receptor (“EGFR”) on tumor cells and CD3 receptor on T cell, in partnership with biotech giant Amgen Inc. (AMGN - Free Report) .

In 2017, CytomX entered into a collaboration and license agreement with Amgen. Back then, the company received an upfront payment of $40 million from Amgen.

In October 2021, CytomX and Amgen amended their existing agreement. Following the amendment, CytomX and Amgen decided to co-develop a conditionally activated T-cell-engaging bispecific therapeutic in EGFR.

Per the latest press release, CX-904 is the first T-cell-engaging bispecific antibody and the sixth Probody therapeutic candidate developed by CytomX to have entered clinic development.

CytomX is planning to initiate a phase I dose-escalation study on CX-904 for treating patients with advanced solid tumors in the days ahead.

Shares of CytomX have plunged 38.1% in the past year compared with the industry’s decrease of 36.8%.

Zacks Investment ResearchImage Source: Zacks Investment Research

CytomX’s pipeline includes various candidates that are being developed for treating different types of cancer indications. The company is evaluating its wholly owned conditional antibody-drug conjugate, praluzatamab ravtansine, as a monotherapy in a phase II study for treating patients with human EGFR 2-non-amplified breast cancer, and in combination with CytomX’s conditionally activated anti-PD-L1 antibody, pacmilimab (CX-072), for treating patients with triple-negative breast cancer. Initial data from the study is expected later in 2022.

CytomX is developing CX-2029, an investigational conditionally activated ADC, in mid-stage studies for treating squamous non-small-cell lung cancer, and head and neck squamous cell carcinoma. CX-2029 is being developed in partnership AbbVie.

CytomX’s other pipeline candidates include BMS-986249 and BMS-986288, which are developed in partnership with Bristol Myers for treating several types of cancer indications.

Zacks Rank & Stocks to Consider

CytomX currently carries a Zacks Rank #3 (Hold). Top-ranked stocks in the biotech sector include Cara Therapeutics, Inc. (CARA - Free Report) and AnaptysBio, Inc. (ANAB - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Cara Therapeutics’ loss per share estimates have narrowed 1.3% for 2022, over the past 60 days.

Cara Therapeutics’ earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

AnaptysBio’s loss per share estimates have narrowed 0.3% for 2022, over the past 60 days. The stock has rallied 28.4% in the past year.

AnaptysBio’s earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.