UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
September 5, 2015
Date of Report (Date of earliest event reported)
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Bellicum Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
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Delaware | 001-36783 | 20-1450200 | ||
(State or other jurisdiction | (Commission File Number) | (IRS Employer Identification No.) | ||
of incorporation) | ||||
2130 W. Holcombe Blvd., Ste. 800 Houston, TX | 77030 | |||
(Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code: 832-384-1100
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Item 8.01 | Other Events. |
On September 5, 2015, a principal investigator for an ongoing phase I/II study of BPX-501 by Bellicum Pharmaceuticals, Inc. (the “Company”) presented information on the trial (the “Information”) at an international medical symposium held in Parma, Italy. A copy of the Information is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The information contained in this Current Report on Form 8-K and in the accompanying Exhibit 99.1 are being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section and will not be incorporated by reference into any registration statement filed by the Company, under the Securities Act of 1933, as amended, unless specifically identified as being incorporated therein by reference. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is being disclosed pursuant to Regulation FD.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number | Description | |
99.1 | Information Materials for Bellicum Pharmaceuticals, Inc. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Bellicum Pharmaceuticals, Inc. | ||||||
Dated: September 8, 2015 | By: | /s/ Ken Moseley | ||||
Ken Moseley | ||||||
Senior Vice President and General Counsel | ||||||
INDEX TO EXHIBITS
Exhibit No. | Description | |
99.1 | Information Materials for Bellicum Pharmaceuticals, Inc. | |
What’s next….. How can we quickly restore T-cell mediated immunity and, thus, further protect patients from life- threatening pathogens in the first 3 months after HSCT, while preventing GvHD occurrence?
Study sponsor: Bellicum Pharmaceuticals Participating Centers: Rome, Freiburg, London, Newcastle PI: F. Locatelli Co-PIs: A. Bertaina, P. Merli, B. Lucarelli, B. Strahm, W. Qasim, M. Slatter Phase I/II study of CaspaCide T cells from an HLA- partially matched family donor after negative selection of TCR αβ+ T cells in pediatric patients affected by hematological disorders ClinicalTrials.gov identifier: NCT02065869
CaspaCide T cell Clinical Schema 4
Trial design • This is a phase I-II open label study. The trial design consists of 3 cohorts, receiving escalation doses of BPX-501 of 2.5 x 105, 5 x105, and 1x106 cells/kg, respectively. Dose escalation will occur according to a 3+3 design. • If none of the initial 3 patients in a cohort experiences a dose- limiting toxicity, another 3 patients will be treated at the next higher dose level. If one of the first three patients experiences a DLT, three more patients will be treated at the same dose level. Dose escalation will continue until at least 2 patients in a cohort of 3 to 6 patients experience dose limiting toxicities. • A Phase 2 extension will occur after dose escalation, enrolling at the highest tolerated dose for a maximum of 60 paediatric patients total, enrolled over a period of 12 months and the minimum active study follow-up for each patient will be 2 years. The maximum duration of the study will be 3 years.
Ospedale Pediatrico Bambino Gesù – Protocol Tαβ depletion non malignant- update September 2, 2015 First 30 patients included 15 with malignant disease and 15 with non malignant disorders Non malignant disorders included in the study 15 Severe combined immunodeficiencey (SCID) 4 Wiskott-Aldrich syndrome (WAS) 3 Fanconi Anemia 4 Beta Thalassemia 3 Hemophagocytic lymphohistiocytosis 1
Clinical outcome of initial 15 children with non- malignant disorders in the study so far • BPX-501 T cells engraft and expand in all patients • In no patients given BPX-501 cells did secondary graft failure occur • Grade II skin-only GvHD was observed in 1 patient, but it promptly responded to topical steroids; • None of the patients so far have developed chronic GvHD; • No patient died from transplantation-related complications and all children are alive and disease-free
0 2 0 4 0 6 0 8 0 0 2 0 4 0 6 0 8 0 1 0 0 0 5 0 0 0 0 1 0 0 0 0 0 1 5 0 0 0 0 C D 3 + /C D 1 9 + a n d C M V re a c t iv a t io n D a y s p o s t H S C T C D 3 + /C D 1 9 + ( / µ l) c o p ie s /m l C D 3 + /C D 1 9 + ( /µ l) C M V D N A (c o p ie s /m l) 30 50 7010 Expansion of iC9-transduced T cells in patient #002 0 100 200 300 Media PHA EBV pp65 IE1 IE2 CMV proteins IF N γ S FC /1 05 PB M C