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Will Black Diamond Regain Its Lost Sheen?

biotechipo march29 30jan21 lt

Shares of Black Diamond Therapeutics Inc. (BDTX) are down 46 percent from their all-time high of $46.25, recorded on June 3, 2020, and trade around $24.

Black Diamond, based in Cambridge, Massachusetts, is a precision oncology medicine company developing therapies that are directed against a novel class of allosteric mutant oncogenes. The company went public on the Nasdaq Global Select Market on January 30, 2020, by setting a public offering at $19.00 per share.

Before we get into the details of the company's pipeline, here's what oncogene and allosteric mutations mean in a nutshell.

An oncogene is a mutated gene that contributes to the development of a cancer. (Source: NIH). Oncogenes are activated by kinase domain mutations or by allosteric mutations. While kinase domain mutations have been successfully drugged with selective inhibitors and are standard of care in many malignancies, allosteric mutations represent an undrugged and unexplored space.

The company's lead drug candidate is BDTX-189 that is designed to be an orally available, irreversible small molecule inhibitor that targets undrugged oncogenic driver mutations of the ErbB kinases EGFR and HER2. These mutations are prevalent across a range of tumor types and cancers including in bladder, breast, colon, endometrial, gastric, and non-small cell lung cancer. Currently, there are no approved medications to target all of these oncogenic mutations with a single medication.

BDTX-189 advanced into a phase I/II trial in 2019. The phase I portion of the trial is evaluating escalating doses of BDTX-189 and is designed to determine the recommended phase II dose and to assess preliminary indications of anti-tumor activity.

The phase II portion of the trial will determine the objective response rate (ORR) and duration of response in patients with solid tumors that have an allosteric HER2 mutation or EGFR or HER2 exon 20 insertion mutation using next-generation sequencing (NGS).

The company expects the phase I portion of the BDTX-189 trial to be completed by first half of this year.

Also in the pipeline is BDTX-1535, which is designed to be potent, allosteric EGFR selective and to be brain penetrant. This compound is being developed for the treatment of glioblastoma multiforme (GBM).

IND-enabling studies with BDTX-1535 are underway. The IND-enabling studies are necessary to obtain the permission of regulatory authorities to advance a compound into human clinical trials.

Cash position:

Black Diamond ended September 30, 2020, with $333.1 million in cash, cash equivalents, and investments.

BDTX has thus far hit a low of $17.63 and high of $46.25. The stock closed Friday's (Jan.29, 2021) trading at $24.77, up 2.36%.

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