ImmunoGen, Inc . (NASDAQ: IMGN), a biotechnology company that develops targeted, antibody-based anticancer therapeutics, today announced the first clinical findings with SAR650984 reported in an oral presentation at the ASH annual meeting. The data are from an ongoing Phase I trial assessing this CD38-targeting therapeutic antibody in patients with CD38-positive MM or other hematologic malignancy. SAR650984 was initially developed by ImmunoGen with the Company’s target evaluation and antibody development expertise and was licensed to Sanofi as part of a broader collaboration between the companies. The findings reported today are from a Phase I trial designed to determine the maximum tolerated dose (MTD) and maximum administered dose of SAR650984, which is identified by administering increasing doses of the compound to new cohorts of patients until dose-limiting toxicity is reported. Secondary objectives of the trial include characterization of the compound’s safety profile, assessing its pharmacokinetics, and identifying preliminary evidence of disease response. SAR650984 was found to have a favorable safety profile. The most common treatment emergent adverse events (TEAEs), of any grade, were fatigue, nausea, pyrexia, cough, anemia, and headache. At the time of data cutoff for presentation, the highest dose evaluated was 20 mg/kg given over a two week period (10 mg/kg weekly or 20 mg/kg every two weeks) and the MTD had not been established. Infusion reactions were reported, and typically occurred during the first dose. These were managed with routine measures, with standard premedications required. Twenty-four of the patients with MM enrolled in the trial received SAR650984 at or above a dose of 1 mg/kg every two weeks. All of these patients had received prior Revlimid ® (lenalidomide) and Velcade ® (bortezomib), most had previously been treated with Kyprolis ® (carfilzomib) and/or Pomalyst ® (pomalidomide), and many had received other prior therapies as well. Response information was available for 22 of these 24 patients at the time of data cutoff for analysis, and was assessed by European Group for Blood and Marrow Transplantation (EBMT) criteria:
- Among these 22 patients, the best response to therapy reported was: 2 complete response (CR), 4 partial response (PR), 2 minimal response (MR), 9 stable disease (SD), and 5 progressive disease (PD).
- Among the 11 of these patients treated with a dose of 10 mg/kg or more, there were 2 CRs, 2 PRs, 1 MR, 4 SDs, and 2 PDs.
- Among the 8 patients with objective responses (CR, PR or MR), 6 were still on treatment at the time of data cutoff for presentation. Four of these patients had been on treatment for more than 26 weeks, and one had been on for over one year.
About SAR650984SAR650984 is a CD38-targeting antibody developed by ImmunoGen and licensed to Sanofi as part of a broader collaboration. A therapeutic or “naked” (non-antibody-drug conjugate) antibody, it was selected based on its pronounced direct induction of cancer cell apoptosis (cell suicide). It also demonstrated marked antibody-dependent cellular-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activity in preclinical testing, and has been found to interfere with allosteric inhibition of CD38 enzymatic activity. About CD38 CD38 was selected as a target based on its high expression on MM and other hematological malignancies and its role in these cancer processes. CD38 has been reported to be highly expressed on 80-100% of MM cases 1, 30-80% of non-Hodgkin lymphoma cases 2,3, and 58% of acute myeloid leukemia cases 4. About this trial To qualify for enrollment in this Phase I trial, adult patients must have certain types of hematologic malignancies, confirmed CD38 expression (FC or IHC), and disease that has relapsed after receipt of standard therapy. Its dose-escalation phase began with one patient cohorts for dose levels below 0.1 mg/kg, then had 3-6 patients per cohort for doses of 0.1 mg/kg and above. Once the recommended Phase II dose is established, SAR650984 will be evaluated at that dose specifically in patients with MM in the expansion cohort of this trial. About ImmunoGen, Inc. ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s antibody-drug conjugate (ADC) technology uses a tumor-targeting engineered antibody to deliver one of ImmunoGen's highly potent cancer-cell killing agents specifically to tumor cells; the Company has also developed antibodies with anticancer activity of their own. The most advanced compound with ImmunoGen’s ADC technology is Roche’s Kadcyla ®, which is marketed in the US by Genentech and is also gaining approvals internationally. Additional compounds are in clinical testing by ImmunoGen and through the Company’s partnerships with Amgen, Bayer HealthCare, Biotest and Sanofi. More information about ImmunoGen can be found at www.immunogen.com. References 1 Lin et al , Am J Clin Pathol 2004;121:482-488 2 Angelopoulou et al, Eur J Haematol 2002;68:12-21 3 Schwonzen et al, Brit J Haematol 1993;83:232-239 4 Keyhani et al , Leukemia Res 1999;24:153-159 Revlimid ®, Velcade ®, Kyprolis ®, Pomalyst ®, and Kadcyla ® are registered trademarks of their respective owners. This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including SAR650984. A review of these risks can be found in ImmunoGen's Annual Report on Form 10-K for the fiscal year ended June 30, 2013 and other reports filed with the Securities and Exchange Commission.