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Bellicum Pharmaceuticals Announces Submission of BPX-701 and BPX-601 Clinical Trial Protocols for Review by the NIH RAC
Bellicum is preparing for the initiation of clinical studies in 2016 of
its three most advanced CAR T and TCR adoptive cell therapy product
candidates, BPX-701, BPX-601, and BPX-401. Today the Company submitted
required documentation, including clinical trial protocols, for BPX-701
and BPX-601 for review by the
The Company further announced that it expects to begin enrolling patients in Phase 1 trials of BPX-701 and BPX-601 in mid-2016, and BPX-401 in the second half of 2016, with IND filings to follow RAC review in each case.
BPX-701 is a CaspaCIDe®-enabled natural high affinity T cell receptor (TCR) product candidate designed to target malignant cells expressing the preferentially-expressed antigen in melanoma (PRAME). Initial planned indications for BPX-701 development are Refractory or Relapsed Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) with an additional study planned for metastatic uveal melanoma. Each of these are orphan indications where PRAME is highly expressed and for which current treatment options are limited. The Company expects to submit European regulatory filings to allow initiation of clinical development at a European site after the U.S. IND has been allowed.
BPX-601 is a GoCAR-T™ product candidate containing Bellicum’s proprietary iMC (inducible MyD88/CD40) activation switch, designed to treat solid tumors expressing prostate stem cell antigen (PSCA). As reported at ASH, preclinical data shows enhanced T-cell proliferation, persistence and in vivo anti-tumor activity compared to traditional CAR T therapies. The initial planned indication for BPX-601 development is non-resectable pancreatic cancer.
BPX-401 is a CIDeCAR™ product candidate incorporating Bellicum’s proprietary MC co-stimulatory domain and the CaspaCIDe safety switch, designed to target blood cancers expressing CD19.
“Throughout 2015, we made significant progress across all of our
adoptive cell therapy programs,” said
Background on the NIH RAC Process
Clinical trial protocols and other required information for product
candidates that involve gene transfer are reviewed by both the
Bellicum is a clinical stage biopharmaceutical company focused on discovering and developing cellular immunotherapies for cancers and orphan inherited blood disorders. Bellicum is using its proprietary Chemical Induction of Dimerization (CID) technology platform to engineer and control components of the immune system. Bellicum is developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation (HSCT), and CAR T and TCR cell therapies. More information can be found at www.bellicum.com.
*CaspaCIDe® is a trademark registered with the U.S. Patent and Trademark Office. CIDeCAR™, GoCAR-T™ and GoTCR™ are trademarks of Bellicum Pharmaceuticals.
This press release contains forward-looking statements for purposes of
the safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. We may, in some cases, use terms such as "predicts,"
"believes," "potential," "proposed," "continue," "estimates,"
"anticipates," "expects," "plans," "intends," "may," "could," "might,"
"will," "should" or other words that convey uncertainty of future events
or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: the timing of our IND filings and our
clinical trials and of our research and development activities relating
to BPX-401, BPX-501, BPX-601 and BPX-701; the effectiveness and success
of our research and development activities relating to our CaspaCIDe,
CIDeCAR, GoCAR-T and GoTCR platforms; and the effectiveness of BPX-401,
BPX-501, BPX-601 and BPX-701 and their possible range of applications
and potential curative effects and safety profiles. Various factors may
cause differences between Bellicum’s expectations and actual results as
discussed in greater detail in Bellicum’s filings with the