Blood Cancer Research Partnership (BCRP) site St. Francis Hospital in Hartford, CT is open for enrollment for the study entitled "A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL." Information about the clinical trial can be found at ClinicalTrials.gov (NCT02268851).
Celator Pharmaceuticals received FDA Fast Track designation for CPX-351 for the treatment of elderly patients with secondary AML. FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
TAP funding assists both clinical investigators and companies in gaining critical proof of concept data that better enables them to obtain the resources they need or a partner to complete the testing, registration and marketing of new treatments for leukemia, lymphoma and myeloma.
How TAP Works
The program comprises three divisions, each with designated strategies, to speed the development of blood cancer treatments and supportive diagnostics:
The Academic Concierge Division capitalizes on LLS's academic grant-supported portfolio of development-stage projects comparable to the pipeline of a medium-sized pharmaceutical company. This division supports the further development of selected projects that have near-term clinical promise by partnering with companies that can manufacture clinical-grade materials and service providers such as CROs or platform technology companies that can conduct medicinal chemistry and preclinical studies related to toxicology, pharmacodynamics and pharmacokinetics to support IND-enabling studies. This division can also provide support needed to assemble the large amounts of formal documentation required by the FDA before clinical trials can start. In addition, this division can provide support for clinical trials that have FDA approval. Successful projects will potentially be advanced for further clinical development by creating additional partnerships (biotech/pharma).
The Academic Concierge Division provides the funding and support needed to advance leukemia, lymphoma and myeloma studies into and through the next development stage.
For more information about our TAP Academic Concierge partners visit our TAP Pipeline page.
The Biotechnology Accelerator Division identifies companies developing novel anti-cancer therapies and invests in specific projects to assist in gaining proof-of-concept findings that can demonstrate safety and therapeutic efficacy for blood cancer patients. Your company must have potential or active projects related to preventing, diagnosing or treating blood cancers.
When a company seeks funding, it needs to demonstrate:
- Therapeutic potential of its drug candidate
- Capabilities of its management and scientific staff
- Financial strength
- Freedom to operate, including intellectual property protection
- Well-designed regulatory and commercialization strategies
The Biotechnology Accelerator Division is more likely to fund projects that will potentially net key results that will enable a company to partner or raise additional funding to complete the testing, registration and marketing of new therapies or diagnostics for a blood cancer indication.
For more information about our TAP Biotechnology Accelerator partners visit our TAP Pipeline page.Clinical Trials Division
The Clinical Trials Division helps patients gain easier access to clinical trial studies in the community and familiar settings. In June 2013, LLS joined with the Dana-Farber Cancer Institute in Boston to establish a network of eleven sites around the country for clinical testing of innovative blood cancer therapies in community oncology settings across the country.
This Blood Cancer Research Partnership (BCRP) aims to accelerate the advancement of and expansion of access to well-designed and innovative clinical trials for blood cancer patients being treated at community sites.
For a listing of BCRP enrolling trials please visit this link.
Please contact Jun Xu, Director Therapy Acceleration Program for interest in the Clinical Trials Division.
Criteria/How to Apply
If you'd like your company or organization to be considered for TAP funding, you must meet the following criteria:
- Your company or organization must have potential or active projects related to preventing, diagnosing or treating blood cancers.
- Your project must be at a late preclinical or an early clinical development stage.
- The compounds, biologics or diagnostic devices in development must have a high, near-term probability of providing benefits to patients.
TAP funding is designed to build a therapeutic asset in a company, not for building a company's infrastructure. Therefore, companies must have additional funding sources to complement the LLS funding.
LLS's TAP team reviews all companies or organizations that make an inquiry but will only invite those deemed to meet initial diligence criteria to complete a proposal template and be considered for TAP funding.
TAP builds business alliances and collaborations with companies. The funding TAP provides is not a grant. Each company approved for funding works with LLS to negotiate specific deliverables, milestones and Go/No-Go decision points that must be met before funds are allocated.
To submit an inquiry for initial non-confidential review, contact Jun Xu, Director, Therapy Acceleration Program, The Leukemia & Lymphoma Society, 1311 Mamaroneck Ave, Suite 310, White Plains, NY 10605; firstname.lastname@example.org.