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Automation of MicroC as a CDx for myeloma therapies

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA217480-01
Agency Tracking Number: R43CA217480
Amount: $299,712.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: 102
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-04-04
Award End Date (Contract End Date): 2019-03-31
Small Business Information
1001 S BROOKS ST APT 3
Madison, WI 53715-1980
United States
DUNS: 079164044
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 CHOROM PAK
 (213) 422-1352
 cpak@lynxbiosciences.com
Business Contact
 CHOROM PAK
Phone: (213) 422-1352
Email: cpak@lynxbiosciences.com
Research Institution
N/A
Abstract

Multiple myeloma MM is a debilitating and currently incurable hematological malignancy While the median
survival has increased to years MM patients ultimately relapse and become resistant to therapy Once
they reach this stage it is often a trial and error process until an effective therapy can be found Furthermore
the MM bone marrow tumor microenvironment plays a significant role in disease progression and resistance to
therapy There is a critical need for a clinical tool able to predict therapeutic response to drugs for specific
patients We have developed an ex vivo microfluidic platform MicroC that can rapidly analyze the therapeutic
response of a patient s MM cells to various drugs in coculture with their own microenvironmental cell
components When MicroC was initially tested by measuring the ex vivo toxicity responses of patient MM cells
to bortezomib a drug commonly used in MM therapy MicroC responses could be segregated into two groups
which retrospectively correctly identified all patients as either clinically responsive or non responsive to
bortezomib containing therapies We propose to develop and automate MicroC as a companion diagnostic for
bortezomib and other MM therapies To achieve this project Lynx Biosciences is uniquely positioned through
four key collaborations Dr Natalie Callander as a collaborator and Director of the University of Wisconsin
Myeloma Clinical Program Professor David Beebe as an expert consultant and pioneer of simple microfluidic
devices Salus Discovery as a collaborator to develop an automated sample processing workflow and
Microfluidic ChipShop a manufacturing partner with years of experience in development and fabrication of
microscale medical device platforms The proposal consists of two aims To develop a GMP process for
fabrication of injection molded MicroC devices To automate cell isolation seeding and treatment within
MicroC At the conclusion of Phase I we will have developed a large portion of the framework for the clinical
rollout of the technology We will have a reliable and robust process for both the fabrication and operation of the
MicroC ready to handle the larger scale required for Phase II Phase II will include a prospective clinical trial to
test the predictive capabilities of MicroC by using the automated assay platform to segregate patients for therapy
containing bortezomib and potentially other therapies Ultimately MicroC may be applied for use in reviving
drugs which were not successful in late stage clinical trials identifying potentially successful preclinical drugs
prior to initiation of clinical trials and hematological malignancies other than MM Project Narrative
Currently many cancer patients including multiple myeloma MM patients are treated empirically or with drug
combinations based on their physician s experience and clinical trial data it is impossible to predict which cancer
therapies will be successful for individual patients Cancer therapies including MM therapies are also very
costly andgt $ per month with potentially significant side effects In this proposal we aim to develop and
automate an assay technology which enables clinicians to make more informed decisions regarding therapy
course utilize precious time more effectively and reduce the cost associated with ineffective therapies

* Information listed above is at the time of submission. *

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