Refreshed data from several trials of BriaCell Therapeutics Corp.'s (BCT:TSX.V) Bria-IMT in metastatic breast cancer "continue to demonstrate positive efficacy and survival," reported H.C. Wainwright & Co. analyst Emily Bodnar in an April 17 research note. Bria-IMT is a genetically engineered human breast cancer cell line with features of immune cells.
The Canadian immunotherapy firm remains Buy rated. H.C. Wainwright's target price on BriaCell is US$25 per share, and its stock is trading at about US$7.20 per share.
Data From Three Studies
The updated data BriaCell recently announced are from three trials, all in patients with metastatic breast cancer. One was the ongoing Phase 1/2 trial evaluating combination treatment with Bria-IMT plus retifanlimab. The others were previous trials, one assessing Bria-IMT plus pembrolizumab and the other testing Bria-IMT as a monotherapy.
In all three trials, the disease was severe, and patients had been heavily pretreated, with a median of five prior lines of therapy. In the monotherapy studies, 54% of patients were HR-positive and HER2-negative (HR+/HER2-); in the combination studies, 70% were.
Bodnar presented the key takeaways from the updated data.
Response Rates on Par
Updated trial data show the response rate in both Bria-IMT combination treatment trials to be comparable to that of fulvestrant even though patients in the Bria-IMT studies were more heavily pretreated than those in the CONFIRM Phase 3 trial of fulvestrant (Faslodex) in recurrent or metastatic breast cancer.
In the monotherapy study, the disease control rate (DCR) was 44%, and the overall response rate (ORR) was 0%. In the combination trials, the DCR was 40%, and the ORR was 10%.
"While 10% ORR does not appear to be high, patients with metastatic breast cancer do not typically have high responses," Bodnar explained.
The ORR was 9.1% with fulvestrant in second-line HR+/HER2- breast cancer patients in CONFIRM.
Survival Data Impressive
In the updated data, the progression-free survival (PFS) and overall survival (OS) rates "continue to impress and look favorable to standard of care," Bodnar pointed out.
The expected progression-free survival for these patients is generally less than two months, noted Bodnar. PFS in the mono and combination Bria-IMT studies exceeded that.
Specifically, with monotherapy, the median PFS was 2.6 months, and modified PFS, in patients with assessable disease outcomes, was 2.8 months days.
With combination therapy, the median PFS was 2.7 months, and the modified PFS was three months.
In comparison, the PFS was 2.79 months for second-line HR+/HER2- breast cancer patients on recently approved Orserdu (elacestrant). It was 1.91 months for ER+/HER2- advanced breast cancer patients on the physician's choice of treatment in the EMERALD trial of elacestrant versus standard of care.
Bodnar summed up the PFS comparisons: "Bria-IMT's PFS is potentially consistent or superior to Orserdu, despite more severe patients enrolled, and PFS is potentially improved from expected PFS with standard of care therapies such as chemotherapy or hormone therapy."
Also, study data showed a correlation between PFS and delayed-type hypersensitivity (DTH). Median PFS for patients positive for DTH was 96 days, and for DTH-negative patients, was less, 71 days.
As for OS, out of the 18 patients enrolled post-2022, four survived past 12 months, and 15, or 83%, are still alive. These patients were treated in the ongoing Phase 1/2 study of Bria-IMT plus retifanlimab.
Of the 25 patients treated before and after 2022, seven survived past 12 months, and 15, or 60%, are still alive. Pre-2022 patients were treated in a previous combination study of Bria-IMT with either pembrolizumab or retifanlimab.
In comparison, the expected OS for chemotherapy in second-line patients with metastatic breast cancer is 6.7 to 9.8 months but less than six months in patients who failed a median of five prior lines of treatment.
What's Happening Now?
BriaCell is still enrolling patients in the Phase 1/2 combination study of Bria-IMT plus retifanlimab.
Also, the company is seeking a partner, specifically a large pharma, and is in discussions with several, with which to evaluate Bria-IMT in combination with a PD-1/PD-L1 inhibitor, in a pivotal trial, Bodnar reported. H.C. Wainwright expects the study will evaluate Bria-IMT plus the selected inhibitor against physicians' choice of chemotherapy in about 200 late-line metastatic breast cancer patients.
"We expect the company to finalize an agreement and initiate study launch prep around mid-2023," added Bodnar.
Q2 FY23 Financial Results
Bodnar reported BriaCell's results of Q2 in the fiscal year 2023 (FY23). The company posted a net loss of US$4.5 million ($4.5M) and earnings per share of (US$0.77). It ended the quarter with US$33.5M in cash and cash equivalents, enough, Bodnar indicated, to fund operations into 2024.
After the release of the Q2 financials, H.C. Wainwright updated its model on BriaCell. Given it has one trial in progress and may initiate another one, boosting expenses, H.C. Wainwright forecasts the immunotherapy company's operating loss for the entire FY23 to be US$22.3M and its EPS to be (US$1.62).
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Disclosures For H.C. Wainwright & Co., BriaCell Therapeutics Corp., April 17, 2023
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