MAb Theragnostics
The term theragnostic test is herein defined as a molecular test that
is integrated into the drug development process so as to guide patient
selection and drug treatment protocols. Subtle genotypic or phenotypic
variations, including nucleotide or amino acid substitutions at the
level of DNA, RNA or protein, are measured by this molecular test.
Application of such theragnostic tests in the development of MAb
therapies and patient treatment protocols is termed MAb Theragnostics™.
PIKAMAB is initially developing two proprietary MAb theragnostic tests: ADCC Therasight; and Lupus Therasight‡:
- ADCC Therasight measures the ADCC profile of a patient before, during, and/or after treatment. The test quantifies the patients’ ability to respond to MAb therapies which use ADCC as the major mechanism of action.
- Lupus Therasight determines the progression and severity of the disease in SLE (systemic lupus erythematosus) and lupus nephritis patients before, during, and/or after treatment.
Use of these theragnostic products offers the much needed critical guidance in drug development and treatment protocols by providing a powerful framework to customize therapies to all patient groups because these tests are clearly correlated either to the mechanism of action (MOA) by which therapies work or to the underlying mechanism of disease progression. Thus, excellent therapeutic outcomes can be achieved in all patient groups.
Strategy
The theragnostic test can act as a gatekeeper in a crowded market
landscape, ensuring that the right patients receive the most
appropriate treatment. Moreover, the development of a combination
product (Drug + Theragnostic Test) provides market exclusivity and
added patent protection to the drug, and thus can command higher
pricing premium.
PIKAMAB will initially commercialize these theragnostic products with
partners whose MAb candidates are in clinical development and whose MAb
therapies are currently available on the market.
By partnering with biopharma companies, PIKAMAB’s theragnostic (Tx)
tests will be co-developed with MAb candidates, possibly as combination
products (MAb+Tx). In addition, based on systematic retrospective or
prospective analysis of clinical trials, these tests will also be
developed as stand-alone products to be incorporated into drug
treatment protocols for already approved MAb therapies such as Rituxan,
Erbitux, Herceptin, Campath, and Remicade. As necessary, these tests
will be customized to individual MAb therapies.
R&D costs for new biopharmaceuticals (including the costs of
failures and time costs) have been estimated to average in excess of
$1.2B. Theragnostics-guided MAb development can potentially reduce
drug development cost and time. For several strategic reasons,
biopharma companies may need to embrace the stratified medicine
paradigm because the payers in the U.S., as well as Europe and Canada
are gearing up for pay-for-performance model. A case in point is the label restriction by EMEA and Health Canada for the administration of Erbitux® and Vectibix® therapies only to the K-RAS-wild type colorectal cancer patients as determined by the K-RAS genetic test.
PIKAMAB is well positioned to advance the field of MAb theragnostics because of its proprietary IP position.
‡: Both theragnostic tests will be developed as
CLIA-certified tests which will be made available worldwide with
testing locations in the U.S., and Europe. These products provide
therapeutic guidance to several marketed MAbs by stratifying patients
to predict response rates; thus, improved treatment outcomes can be
achieved. This leads to higher pricing premium, market refinement, and
market exclusivity for biopharma companies.
Highlights
PIKAMAB’s theragnostic tests guide:
- The administration of MAb therapies in patients
- The clinical development of MAb candidates
PIKAMAB’s MAb theragnostic tests can be used to determine:
- Excellent responders from moderate responders and poor responders for a MAb therapy
- The timing of the administration of a MAb therapy after chemotherapy
PIKAMAB’s theragnostic tests offer significant advantages and incentives to:
- Biopharma companies
- Regulatory agencies
- Governments
- Payers
- Physicians, and
- Patients