KP1237, a CD38-Targeting Anti­body Recruiting Molecule (ARM™), to Be Tested in Com­bi­na­tion with NK Cells to Treat Post-Transplant Multiple Myeloma Patients

{{image}}New Haven, CT (Press Release) – Kleo Pharma­ceu­ticals, Inc., an immuno-oncology com­pany devel­op­ing next-generation, fully syn­thet­ic bispecific com­pounds designed to emulate or en­hance the activity of biologics, announced today that it has re­ceived Inves­ti­ga­tional New Drug (IND) authori­za­tion to proceed from the U.S. Food and Drug Admin­istra­tion (FDA) to ini­ti­ate a safety and tolerability clin­i­cal study combining KP1237, a CD38-targeting anti­body recruiting molecule (ARM™), with patients' own Natural Killer (NK) cells to treat multiple myeloma (MM) in post-transplant patients.

The single-arm study will be conducted in 25-30 patients with exploratory end­points that assess the MRD (minimal residual dis­ease) conversion rate at 90-100 days after trans­plan­ta­tion. Recent clin­i­cal trials have identified MRD negativity post-transplant as a poten­tial surrogate of long-term remission in MM. The trial is ex­pec­ted to begin enrollment in the first half of 2020, and topline data are ex­pec­ted in the second half of 2021.

"We are ex­cited to have clear­ance to ini­ti­ate a clin­i­cal trial in the US that addresses a sig­nif­i­cant unmet medical need in newly diag­nosed, post-transplant multiple myeloma patients," said Kleo CEO Doug Manion, MD. "Approximately 30,000 in­di­vid­uals are diag­nosed with multiple myeloma in the United States each year, with at least 1/3 of those patients undergoing au­tol­o­gous stem cell trans­plants."

In this trial, KP1237 is being in­ves­ti­gated as a "cell homing" molecule to target the patient's activated NK cells to the CD38-expressing tumor. Current anti-CD38 thera­peutic anti­bodies kill NK cells and are not approved for use in this clin­i­cal settingⁱ.

Nonclinical efficacy data pre­sented at the 2019 American Society of Hematology (ASH) Annual Meeting dem­onstrated that CD38-ARMs are able to kill multiple myeloma cells by anti­body-dependent cellular cyto­tox­icity without depleting CD38-expressing immune cells. Nonclinical data also dem­onstrated that the CD38-ARM molecule did not induce com­ple­ment-dependent cyto­tox­icity (CDC) sug­gesting it is not likely to cause CDC in humans. Kleo's 2019 ASH posters can be viewed here and here.

About Kleo Pharma­ceu­ticals, Inc.

Kleo Pharma­ceu­ticals is a unique immuno-oncology com­pany devel­op­ing next-generation bispecific com­pounds designed to emulate or en­hance the activity of biologics based on the groundbreaking re­search of its scientific founder Dr. David Spiegel at Yale University. Similar to complex biologic drugs, Kleo's com­pounds recruit the immune sys­tem to destroy cancer cells, with the ad­van­tage of being smaller and more versatile, leading to poten­tially im­proved safety and efficacy over biologics. They are also much faster and less costly to design and produce, particularly against novel targets. Kleo is ad­vanc­ing several drug can­di­dates based on its pro­pri­e­tary tech­nology plat­forms, all of which are modular in design and enable rapid generation of novel immuno­therapies that can be optimized against cer­tain cancers, or en­hance the properties of existing immuno­therapies. These in­clude Anti­body Recruiting Molecules (ARMs), Synthetic Anti­body Mimics (SyAMs) and Monoclonal Anti­body Therapy Enhancers (MATEs). Biohaven Pharma­ceu­tical Holding Com­pany (NYSE:BHVN) and PeptiDream Inc. (Nikkei:PPTDF) are in­vestors in Kleo Pharma­ceu­ticals. For more in­for­ma­tion visit http://kleopharmaceuticals.com.

Forward-Looking Statements

This news release in­cludes for­ward-looking state­ments within the meaning of the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995. These for­ward-looking state­ments in­volve­ sub­stan­tial risks and un­cer­tainties, in­clud­ing state­ments that are based on the current ex­pec­ta­tions and assump­tions of the Com­pany's man­agement. All state­ments, other than state­ments of historical facts, in­cluded in this press release re­gard­ing the Com­pany's plans and objectives, ex­pec­ta­tions and assump­tions of man­agement are for­ward-looking state­ments. The use of cer­tain words, in­clud­ing the words "esti­mate," "project," "intend," "expect," "believe," "antic­i­pate," "will," "plan," "could," "may" and similar ex­pres­sions are in­tended to identify for­ward-looking state­ments. The for­ward-looking state­ments are made as of this date and the Com­pany does not under­take any obli­ga­tion to update any for­ward-looking state­ments, whether as a result of new in­for­ma­tion, future events or other­wise.

Footnote

[i] DARZALEX® (dara­tu­mu­mab) injection [package insert on the internet]. Horsham, PA: Janssen Biotech, Inc., http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf (2019, accessed 05 Feb­ru­ary 2020).

Source: Kleo Pharma­ceu­ticals.