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Initiation Of A Phase I Clinical Trial Of Lirilumab In Combination With Elotuzumab

By: Press Release Reporter; Published: October 1, 2014 @ 10:00 am | Comments Disabled

  • This Phase I trial will test the safety and tolerability of lirilumab (BMS-986015) in combination with elotuzumab (BMS-901608) in patients with multiple myeloma
  • This new Phase I initiated by Bristol-Myers Squibb is the first combination trial of lirilumab in a hematological tumor type

Marseille, France (Press Release) - Innate Pharma SA (the "company" -  euronext paris:FR0010331421 - IPH), the innate immunity com­pany devel­op­ing first-in-class thera­peutic anti­bodies for cancer and in­flam­ma­tory dis­eases, to­day an­nounced that a new Phase I com­bi­na­tion trial with lirilumab, a first-in-class NK cell checkpoint in­hib­i­tor, was pub­lished on ClinicalTrials.gov: "A Phase I Open Label Dose Escalation and Randomized Cohort Expansion Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Admin­is­tered in Com­bi­na­tion With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma" (study identifier: NCT02252263).

Lirilumab is licensed to Bristol-Myers Squibb Com­pany, and this Phase I trial is being con­ducted by Bristol-Myers Squibb.

Nicolai Wagtmann, Chief Scientific Officer of Innate Pharma, said: "Therapeutic anti­bodies that act by in­duc­ing anti­body-mediated cel­lu­lar cyto­tox­icity (ADCC), such as elotuzumab, are being in­ves­ti­gated as po­ten­tial ther­a­pies for cancer treat­ment. We are ex­cited to learn more about how elotuzumab and lirilumab work to­geth­er in patients with mul­ti­ple myeloma, an area where there is a high unmet need for new treat­ment op­tions."

About the Phase I trial with lirilumab in com­bi­na­tion with elotuzumab in mul­ti­ple myeloma

The pur­pose of this Phase I open label study is to in­ves­ti­gate elotuzumab in com­bi­na­tion with lirilumab in order to de­ter­mine whether this com­bined treat­ment ap­proach is safe and to provide pre­lim­i­nary in­­for­ma­tion on the clin­i­cal ac­­tiv­ity of the com­bi­na­tion. A sec­ond arm will test the com­bi­na­tion of elotuzumab and the anti-CD137 anti­body urelumab.

The pri­mary out­come will be safety. Secondary out­comes will in­clude a pre­lim­i­nary assess­ment of ef­fi­cacy. The study will be con­ducted in two parts - dose escalation and ran­dom­ized cohort ex­pan­sion - and is ex­pected to en­roll up to approx­i­mately 68 patients per arm. Patients should have mul­ti­ple myeloma with mea­sur­able dis­ease (according to the IMWG criteria).

The poten­tial of ADCC-enhancement with an anti-KIR anti­body has been dem­onstrated in pre­clin­i­cal models (Kohrt, Blood, 2013).

About lirilumab (IPH2102/BMS-986015)

Lirilumab is a fully human mono­clonal anti­body (mAb) that blocks the inter­action be­tween Killer-cell im­mu­no­globulin-like re­cep­tors (KIR) on NK cells and their ligands. Blocking these re­cep­tors facilitates activation of NK cells and, poten­tially, destruction of tumor cells.

Lirilumab is licensed to Bristol-Myers Squibb Com­pany. As part of the agree­ment be­tween Innate Pharma and Bristol-Myers Squibb, Bristol-Myers Squibb holds ex­clu­sive world­wide rights to de­vel­op, manu­fac­ture and com­mer­cial­ize lirilumab and re­lated com­­pounds blocking KIR re­cep­tors, for all indi­ca­tions. Under the agree­ment, Innate Pharma con­ducts the devel­op­ment of lirilumab through Phase II in AML.

In addi­tion to the EffiKIR trial, where lirilumab is cur­rently being tested in a ran­dom­ized, double-blind, placebo-controlled Phase II trial in elderly patients as a single-agent in AML, lirilumab is also being eval­u­ated by Bristol-Myers Squibb in clin­i­cal trials in com­bi­na­tion with other immuno-oncology agents in a variety of tumor types.

About Innate Pharma

Innate Pharma S.A. is a bio­pharma­ceu­tical com­pany discovering and devel­op­ing first-in-class thera­peutic anti­bodies for the treat­ment of cancer and in­flam­ma­tory dis­eases.

Its inno­va­tive ap­proach has translated into major alliances with leaders in the bio­pharma­ceu­tical industry such as Bristol-Myers Squibb and Novo Nordisk A/S.

The Com­pany has two clin­i­cal-stage pro­grams in immuno-oncology, a new thera­peutic field that is changing cancer treat­ment by enhancing the ca­pa­bil­i­ty of the body's own im­mune cells to recog­nize and kill cancer cells. Innate Pharma science also has poten­tial in chronic in­flam­ma­tory dis­eases.

Listed on Euro­next-Paris, Innate Pharma is based in Marseille, France, and had 90 employees as at June 30, 2014.

Learn more about Innate Pharma at www.innate-pharma.com

Practical In­for­ma­tion about Innate Pharma shares

ISIN code:  FR0010331421
Ticker code:  IPH

Disclaimer

This press re­lease con­tains cer­tain for­ward-looking state­ments. Although the com­pany be­lieves its ex­pec­ta­tions are based on reason­able assump­tions, these for­ward-looking state­ments are subject to nu­mer­ous risks and un­cer­tain­ties, which could cause actual re­­sults to differ ma­teri­ally from those an­tic­i­pated. For a dis­cus­sion of risks and un­cer­tain­ties which could cause the com­pany's actual re­­sults, finan­cial con­di­tion, per­for­mance or achieve­ments to differ from those con­tained in the for­ward-looking state­ments, please refer to the Risk Factors ("Facteurs de Risque") section of the Document de Reference pros­pectus filed with the AMF, which is avail­able on the AMF website (http://www.amf-france.org) or on Innate Pharma's website.

This press re­lease and the in­­for­ma­tion con­tained herein do not con­sti­tute an offer to sell or a so­lic­i­ta­tion of an offer to buy or subscribe to shares in Innate Pharma in any country.

Source: Innate Pharma.


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