Please do not leave this page until complete. This can take a few moments.
A drug being developed by New Haven’s Kleo Pharmaceuticals to treat the blood cancer multiple myeloma has been granted “orphan” status by the FDA.
The U.S. Food & Drug Administration awards “orphan” status to treatments for diseases affecting fewer than 200,000 people in the U.S., or for drugs that are not expected to recoup the costs of development and marketing, according to the agency.
The designation qualifies Kleo for incentives that include certain tax credits and a new drug application fee waiver. It also entitles Kleo to a period of market exclusivity after approval.
Kleo has described its lead drug, KP1237, as an antibody redirecting molecule, or ARM, that induces the body’s natural killer cells (a type of white blood cell) to recognize and destroy cancer cells. The platform is based on the research of Dr. David Spiegel, a chemistry professor at Yale.
The drug, which targets an antibody known as C38, has been shown in animal studies to have fewer toxic side effects than existing treatments, according to Kleo.
The company is planning to begin human testing in two separate clinical trials later this year.
One trial will test the drug as a systemic therapy in multiple myeloma patients ineligible for stem cell transplant who failed to respond or who relapsed on previous treatments.
The other trial will premix KP1237 with a patient’s own natural killer cells before administration and will focus on patients who show residual traces of the disease immediately following a stem cell transplant.
The company is also planning a third trial, combining the drug with “off-the-shelf” natural killer cells, for early 2021.
The American Cancer Society estimates there will be roughly 32,270 new cases of multiple myeloma diagnosed in the U.S. this year, and 12,830 deaths.
Another Kleo drug, targeting COVID-19, scored a $5 million grant from the Bill & Melinda Gates Foundation in July.
Contact Natalie Missakian at news@newhavenbiz.com
The Hartford Business Journal 2025 Charity Event Guide is the annual resource publication highlighting the top charity events in 2025.
Learn moreHartford Business Journal provides the top coverage of news, trends, data, politics and personalities of the area’s business community. Get the news and information you need from the award-winning writers at HBJ. Don’t miss out - subscribe today.
SubscribeDelivering vital marketplace content and context to senior decision-makers throughout Connecticut ...
All Year Long!
The Hartford Business Journal 2025 Charity Event Guide is the annual resource publication highlighting the top charity events in 2025.
Hartford Business Journal provides the top coverage of news, trends, data, politics and personalities of the area’s business community. Get the news and information you need from the award-winning writers at HBJ. Don’t miss out - subscribe today.
Delivering vital marketplace content and context to senior decision-makers throughout Connecticut ...
All Year Long!
In order to use this feature, we need some information from you. You can also login or register for a free account.
By clicking submit you are agreeing to our cookie usage and Privacy Policy
Already have an account? Login
Already have an account? Login
Want to create an account? Register
In order to use this feature, we need some information from you. You can also login or register for a free account.
By clicking submit you are agreeing to our cookie usage and Privacy Policy
Already have an account? Login
Already have an account? Login
Want to create an account? Register
This website uses cookies to ensure you get the best experience on our website. Our privacy policy
To ensure the best experience on our website, articles cannot be read without allowing cookies. Please allow cookies to continue reading. Our privacy policy
0 Comments