On December 6, 2021 Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported 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 (Press release, Bellicum Pharmaceuticals, DEC 6, 2021, View Source [SID1234596502]). 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.
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"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 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 5×106 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 5×106 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 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 0.1×106 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 1×106 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."
Private Placement Completed
Bellicum will issue, in the private placement, pre-funded warrants to purchase up to 20,559,210 shares of common stock and accompanying warrants to purchase up to 2,055,920 shares of common stock. Each pre-funded warrant to purchase common stock is being sold together with one warrant to purchase one-tenth of one share of common stock at a combined unit price of $1.7024. The common stock warrants will be immediately exercisable at an exercise price of $1.69 per share of common stock and will expire seven years from the date of issuance. Each pre-funded warrant will have an exercise price of $0.0001 per share and will be exercisable immediately.
The aggregate offering size, before deducting placement agent commissions and other offering expenses, is expected to be approximately $35.0 million, excluding any proceeds that may be received upon exercise of the common warrants. Bellicum anticipates using the net proceeds from the offering, together with its existing capital resources, to fund ongoing and planned BPX-601 and BPX-603 clinical trials, and for general corporate purposes, including research and development and to fund working capital.
In conjunction with the equity financing announced today, the holders of the option to purchase securities associated with Bellicum’s August 2019 Private Placement have waived their rights, in full, to exercise their right to purchase Series 2 preferred stock and associated warrants, and Series 3 preferred stock and associated warrants, respectively.
Mr. Fair added, "We are pleased to have the support provided in the financing announced today. The waiver of the rights to exercise the Series 2 and Series 3 options is also a positive step in the simplification of our capital structure."
The private placement is expected to close on December 7, 2021. A Current Report on Form 8-K containing more detailed information regarding the financing will be filed with the Securities and Exchange Commission.
MTS Securities, LLC, an affiliate of MTS Health Partners, L.P., is acting as exclusive placement agent in the financing.
The Securities issued or to be issued to the purchasers in the Offering announced today, subject to the closing, were, or will be issued, as applicable, pursuant to an exemption from registration under the Securities Act of 1933 (the "Securities Act"). The securities have not been and will not be registered under the Securities Act or any state or other jurisdiction’s securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdiction’s securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the Securities or any other securities, nor shall there be any offer, solicitation or sale of the Securities or any other securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful.