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Adagene (ADAG) Gets FDA Nod to Begin Solid Tumor Antibody Study

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Adagene (ADAG - Free Report) announced that the FDA cleared the investigational new drug (IND) application, which sought approval for initiating a clinical study of its anti-CTLA-4 monoclonal antibody (mAb) ADG116 in combination with Keytruda (pembrolizumab) in patients with advanced/metastatic solid tumors.

Adagene plans to begin dosing the first patient in a phase I/II study ADG116-P001 in early 2022. The study will evaluate the safety and tolerability of the combination of ADG116 with Keytruda, determine the maximum tolerated dose and assess the combo’s preliminary efficacy.

Shares of Adagene were up 22.2% in after-hours trading following the news above. However, the stock has plunged 71.7% so far this year compared with the industry’s 15.2% decline.

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Developed by Adagene using its proprietary NEObody platform technology, ADG116 is designed with a soft ligand blocking to address the safety concerns associated with the existing CTLA-4 therapeutics.

ADG116 targets a unique conserved epitope of CTLA-4 with enhanced efficacy by potent Treg depletion in the tumor microenvironment (TME).

Pembrolizumab is an anti-PD-1 therapy developed by Merck (MRK - Free Report) . The same is marketed by Merck under the brand name Keytruda. Adagene entered into a clinical collaboration and supply agreement with Merck to develop ADG116 in combination with pembrolizumab for advanced/metastatic solid tumors.

Keytruda is currently the top-line driver for Merck. Its revenues are gaining from a continued uptake for lung cancer and an increasing usage for other cancer indications.  Keytruda is already approved for treating many cancers globally and is continuously growing and expanding into new indications and markets globally. During third-quarter 2021, Merck recorded $4.5 billion sales from Keytruda.

Apart from ADG116, Adagene has two product candidates in its pipeline: an anti-CD137 agonist called ADG106 and an anti-CTLA-4 mAb product candidate, ADG126. The company also has clinical collaborations and supply agreements with Merck for each of these clinical candidates.

While ADG126 is being evaluated in combination with pembrolizumab in patients with advanced/metastatic solid tumors, ADG106 is being evaluated in combination with pembrolizumabfor advanced or metastatic solid and/or hematological malignancies.

Zacks Rank & Stocks to Consider

Adagene currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the same sector are Precision BioSciences (DTIL - Free Report) and IVERIC bio (ISEE - Free Report) . While Precision BioSciences sports a Zacks Rank #1 (Strong Buy), IVERIC bio carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Precision BioSciences’ loss per share estimates for 2021 have narrowed from $1.17 to 65 cents in the past 30 days. The same for 2022 has narrowed from $2.39 to $1.91 in the past 30 days. Shares of Precision BioSciences have risen 4.4% in the year so far.

Earnings of Precision BioSciences beat estimates in all the last four quarters, delivering a surprise of 76.9%, on average.

IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.12 in the past 30 days. The same for 2022 has narrowed from $1.17 to $1.10 in the past 30 days. Shares of IVERIC bio have gained 117.7% in the year so far.

The bottom line of IVERIC bio missed estimates in three of the last four quarters and surpassed expectations once, the negative surprise being 5.6%, on average.