San Diego Business Journal: Life Science Vets Leading BlossomHill’s Lung Cancer Treatment Pipeline

SAN DIEGO – Non-small cell lung cancer is the most common form of lung cancer in humans, accounting for nearly 90% of all lung cancer diagnoses.

Roughly one-fifth of patients with adenocarcinoma – the most common form of non-small cell lung cancer – are diagnosed with what’s known as epidermal growth factor receptor (EGFR)-mutated lung cancer, in which enzymes called tyrosine kinases that basically function as “on-off” switches within cells cause cancer cell overproduction.

BlossomHill Therapeutics believes it may have developed a first-in-class drug to inhibit and treat non-small cell lung cancer patients with a broad spectrum of EGFR mutations. The drug candidate, BH-30643, is currently in Phase 1/2 clinical trials as an orally administered pill.

“A lot of molecules struggle to get high (pharmacokinetic exposures) in EGFR because they hit off-target safety issues along the way,” said Dr. Geoff Oxnard, BlossomHill’s executive vice president and chief medical officer. “We’ve not seen that, so this drug really has outstanding exposures compared to contemporary molecules.”

There are an estimated early 290,000 EGFR-mutant non-small cell lung cancer patients around the world, according to the company, which has enrolled patients in its Phase 1/2 trial in eight countries.

BlossomHill aims to give its initial clinical safety and efficacy report on the trial for BH-30643 in 2026, with the goal of shifting into pivotal trials in 2027.

“Every lung cancer doctor has EGFR patients, and their fundamental experience is, after you start upfront targeted therapy, you quickly run out of options and patients are looking at chemotherapy,” Oxnard said. “So the appeal of a pill therapy that can address resistance is intuitive, and that becomes an opportunity to demonstrate the addressing of immediate need.”

BlossomHill’s drug candidate, BH-30643, is currently in Phase 1/2 clinical trials as an orally administered pill. Photo courtesy BlossomHill

Funding Raised for Clinical Trial
To move BH-30643 toward late-stage trials, BlossomHill announced in December that it raised $84 million in an extension of its February 2024 $100 million Series B funding round, which supported the company’s initial studies to file an Investigational New Drug application with the U.S. Food and Drug Administration.

According to Chief Financial Officer Jason Keyes, BlossomHill’s preclinical science led to a significant amount of interest from investors even in a relatively constrained funding environment for life sciences companies.

“I think companies with high-quality programs, sound assets, seasoned management teams with strong track records, with differentiated pipeline assets and clear development plans can get investors’ attention,” Keyes said. “That kind of played in our favor.”

Company President and CEO J. Jean Cui and Executive Chairman Y. Peter Li co-founded the company in 2020 while still leading their previous company, Turning Point Therapeutics, the maker of the non-small cell lunch cancer medication reptrectinib.

Cui and Li sold Turning Point Therapeutics in 2022 to Bristol Myers Squibb in a transaction valued at $4.1 billion.

In addition to BH-30643, BlossomHill has launched enrollment in its Phase 1/1b study for BH-30236, an orally administered inhibitor of CDC-like kinase (CLK) enzymes, which play a role in disease progression for patients with relapsed or refractory acute myeloid leukemia.

Healthy human bodies continuously convert juvenile stem cells into white or red blood cells, but this process is disrupted in patients with acute myeloid leukemia, which causes juvenile stem cells to proliferate instead of evolving into health cells, eventually overwhelming the body’s existing healthy cells.

The Phase 1/1b study is currently evaluating the safety and efficacy of BH30236, according to BlossomHill.

“We feel it is our obligation to develop and invent better molecules (for) patients and not see treatments, after 20 years, with the same molecules,” Cui said. “We need to go to the next level.”

BlossomHill Therapeutics
FOUNDED: 2020
CEO: J. Jean Cui
HEADQUARTERS: San Diego
BUSINESS: Precision medicine for oncology and autoimmune diseases
EMPLOYEES: Nearly 60
FUNDING: $257 million
WEBSITE: bhtherapeutics.com
CONTACT: ashlea@1abmedia.com
NOTABLE: J. Jean Cui has designed and developed three medications for the treatment of non-small cell lung cancer – repotrectinib, crizotinib and lorlatinib – that have received commercial approval from federal regulators.