Benzinga | Dec 6, 2021 07:32AM EST

Bellicum Announces Positive Interim Data From Phase 1/2 GoCAR-T Studies, Secures $35 Million Private Placement Equity Financing Priced At Market

- Confirmed partial response observed in one patient in first cohort of metastatic castration-resistant prostate cancer (mCRPC) patients treated with BPX-601 -

- Favorable safety profile observed in initial dose cohort of BPX-603 in HER2+ solid tumors -

- Financing expected to extend cash runway through mid-2023 and will be used to fund ongoing GoCAR-T clinical development programs -

HOUSTON, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, today announced positive interim data from its ongoing Phase 1/2 GoCAR-T clinical trials, including a confirmed partial response (PR) in the first cohort of mCRPC patients treated in the clinical trial for BPX-601. Bellicum has also entered into an agreement for a $35 million private placement of equity securities with two biotechnology specialist investment funds. Proceeds from the financing will be used to support ongoing clinical development of BPX-601 and BPX-603.

"We are highly encouraged by the observation of anti-tumor activity of BPX-601 in the first mCRPC cohort, particularly in this heavily pre-treated patient population with limited therapeutic options," said Rick Fair, President and Chief Executive Officer of Bellicum. "The additional capital we raised through this private placement will support our ongoing clinical development of BPX-601 and BPX-603 to further pursue this early efficacy signal."

Clinical Trial Updates

BPX-601 GoCAR-T(r) in Metastatic Castration-Resistant Prostate Cancer

Cell dose escalation and optimization of the lymphodepletion regimen was completed in the Phase 1/2 clinical trial of BPX-601 in metastatic pancreatic cancer patients. Earlier this year, enrollment was initiated in previously-treated mCRPC patients at the previously-cleared dose level.

In the first three-patient cohort of mCRPC treated at 5x106 cells/kg BPX-601 followed by single-dose rimiducid:

* No dose-limiting toxicities were observed. Adverse events were comparable to those previously seen with BPX-601 and rimiducid in metastatic pancreatic cancer and typical of other cell therapy regimens.

* A confirmed partial response was observed in one patient by RECIST v1.1 criteria on CT scan, accompanied by substantial reduction in PSA in response to treatment with BPX-601 and rimiducid.

Enrollment is ongoing in the second dose cohort in mCRPC of 5x106 cells/kg followed by weekly rimiducid, and results from these patients will be submitted for presentation at a medical meeting in 2022.

BPX-603 Dual-Switch GoCAR-T in HER2+ Solid Tumors

Enrollment is ongoing in the Phase 1/2 clinical trial for BPX-603 in patients with solid tumors that express human epidermal growth factor 2 (HER2), including breast, endometrial, ovarian, gastric, and colorectal cancers. BPX-603 is Bellicum's first dual-switch GoCAR-T product candidate incorporating Bellicum's iMC activation and CaspaCIDe(r) safety switch technologies, which in tandem may serve to enhance cell proliferation, persistence, and anti-tumor effect while also enabling effective management of adverse events.

In the first patients treated in this trial at dose level 1 of 0.1x106 cells/kg BPX-603 alone or followed by weekly rimiducid:

* No dose-limiting toxicities were observed.

* Serious adverse events reported were pleural effusion and pneumonia. Neither was determined to be related to study drug.

* Other Grade 3+ treatment-emergent adverse events reported were neutropenia, leukopenia, and anemia.

* No CRS or ICANS events were reported.

* Limited cell engraftment and expansion were observed.

Enrollment is ongoing at dose level 2 of 1x106 cells/kg alone or followed by weekly rimiducid, and results from these patients will be submitted for presentation at a medical meeting in 2022.

Stated Charity Scripture, PharmD, Chief Development Officer of Bellicum, "The early clinical activity we have observed with BPX-601 in mCRPC and the manageable safety profiles observed across both studies are highly encouraging. Given the very low starting cell dose in the BPX-603 trial, the lack of clinical efficacy at dose level 1 was in line with our expectations. I am thrilled to be re-joining Bellicum in a full-time capacity at such an exciting time in our programs' development. We look forward to continued dose escalation to more fully evaluate the safety and potential efficacy of these product candidates."