Biotechnology Events


ImmunoGen, Inc.




Daniel M. Junius, President and CEO, gave guidance for data from the phase-I program for IMGN-853. He stated, "We are preparing to expand the development program for our lead wholly-owned compound, IMGN-853, based on the findings we’re seeing in the disease-specific cohorts of our phase-I trial, treatment of patients with platinum-resistant ovarian cancer and those with relapsed refractory endometrial cancer and we plan to move into advanced testing for one or both of these indications this year. We are targeting ASCO for presentation of our latest findings with 853, so you can see what we are seeing."
Source: Q2 FY2015 earnings conference call, 1/30/15.


Daniel M. Junius, President and CEO, gave guidance for data from the IMGN-853 program. He stated, "We have submitted an abstract and expect to present data at AACR of the PK modeling that gets us to the adjusted ideal body-weight. We are also submitting an abstract to ASCO that will provide additional data. So it will have more expanded clinical database that will reference the PK modeling work that we have done. So we think you will find that interesting. In terms of the first meaningful amount of disease and specific data, that won’t come until the back half of this year probably at ESMO or EORTC."
Source: Q2 FY2014 earnings conference call, 1/31/14.


Daniel M. Junius, President and CEO, gave guidance for data from the IMGN-853 program. He stated, "So, for IMGN-853 we expect the expansion cohort to start sometime during the first half of this year but we will have data on the relationship of dose efficacy and toxicity in the second quarter and as I noted during at the earlier portion we would expect to see the first disease specific data in the second half of this year."
Source: Q2 FY2014 earnings conference call, 1/31/14.


ImmunoGen expects to begin enrolling patients with platinum-resistant ovarian cancer and those with relapsed/refractory endometrial cancer in 1H 2014 in the first IMGN853 Phase I expansion cohorts and to report the first disease-specific data with the compound in 2H 2014. These patients will receive IMGN853 using the current dosing schedule.
Source: press release, 1/31/14.


Charles Morris, M.B., Ch.B., M.R.C.P., EVP and Chief Development Officer, gave guidance for the development and data read for IMGN-853. He stated, "We expect to be able to begin assessment of 853, specifically for ovarian and endometrial cancer, early in 2014 and the alternative dosing schedule at that time. We believe we will be able to report data, at least initial disease-specific data, at ASCO 2014."
Source: Q1 FY2014 earnings conference call, 10/25/13.


Compound/DeviceSpecialtyIndicationCompound ClassTarget
Mirvetuximab Soravtansine (IMGN-853) Ovarian cancerOncologyOvarian CancerAntibody drug conjugate (ADC)Tubulin and microtubule assembly/disassembly

Mechanism of action: Mirvetuximab Soravtansine (IMGN-853) is an immunoconjugate consisting of the humanized monoclonal antibody M9346A against folate receptor 1 (FOLR1) conjugated, via the disulfide-containing cleavable linker sulfo-SPDB, to the cytotoxic maytansinoid DM4, with potential antineoplastic activity. The anti-FOLR1 monoclonal antibody moiety of IMGN853 targets and binds to the cell surface antigen FOLR1. After antibody-antigen interaction and internalization, the immunoconjugate releases DM4, which binds to tubulin and disrupts microtubule assembly/disassembly dynamics, thereby inhibiting cell division and cell growth of FOLR1-expressing tumor cells. FOLR1, a member of the folate receptor family is overexpressed on a variety of epithelial-derived cancer cells. The sulfo-SPDB linker prevents cleavage in the bloodstream and may improve this agent’s efficacy in multidrug resistant tumor cells.

Phase of Development: I

Event Type: Data: Phase I trial results

Dates: 2015-05-29 - 2015-06-02



ImmunoGen Reports Efficacy and Safety Data from a 46-Patient Cohort of Mirvetuximab Soravtansine in FRα-Positive Ovarian Cancer
Confirmed objective response rate of 44% and median progression-free survival of 6.7 months seen in cohort subset mirroring patient population selected for planned Phase 3 study.
Company preparing to meet with FDA in early 3Q2016; targeting initiation of Phase 3 study in 4Q2016.
Data will be presented at ASCO Annual Meeting on June 6, 2016.
WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company developing novel antibody-drug conjugate (ADC) cancer therapeutics, today reported the clinical data from a 46-patient Phase 1 cohort evaluating the efficacy and safety of mirvetuximab soravtansine as single-agent therapy for platinum-resistant, folate receptor alpha (FRα)-positive ovarian cancer. These results have informed the Company's selection of the patient population and primary endpoint for a Phase 3 study scheduled to begin before year-end.

This Phase 1 cohort, which was expanded from 20 to 46 patients to provide additional information for the design of subsequent trials, enrolled patients with platinum-resistant ovarian cancer who had received up to five previous treatment regimens. Patients also needed to have FRα expressed at or above a predefined level on at least 25% of tumor cells. Patients were classified as having low, medium, or high FRα expression based on the percent of tumor cells meeting this criterion (25-49%, 50-74%, and 75-100%, respectively). Among the 46 patients, 23 had high, 14 had medium, and 9 had low expression of FRα. All had previously received platinum and a taxane.

Among all 46 patients, the confirmed objective response rate (ORR) was 26% and median progression-free survival (PFS) was 4.8 months (95% confidence interval, 3.9-5.7 months). Among the 16 patients who received up to three prior regimens and had high or medium FRα expression - the population selected for the planned Phase 3 trial - the ORR was 44% and median PFS was 6.7 months (95% CI, 3.9-11.0 months). For the 30 patients with low FRα and/or who had received four or five prior regimens, ORR was 17% and median PFS was 4.2 months (95% CI, 2.6-5.5 months).

Current single-agent therapies for platinum-resistant ovarian cancer typically have an ORR of 15-20% and median PFS of 3-4 months, including in patients receiving no more than two prior regimens.1

Based upon the findings in this Phase 1 cohort, the planned Phase 3 trial assessing mirvetuximab soravtansine as single-agent therapy for platinum-resistant ovarian cancer will enroll patients who previously received up to three treatment regimens and whose cancer has high or medium FRα expression, with PFS as the primary endpoint.

"There is a significant need for new therapies for ovarian cancer," commented Dr. Kathleen Moore, Christy Everest Endowed Chair in Cancer Research and Director of the Oklahoma TSET Phase I Unit, Stephenson Cancer Center, University of Oklahoma HSC. "We're excited about the findings with mirvetuximab soravtansine from this study and to be advancing this first-in-class agent into a Phase 3 trial for platinum-resistant ovarian cancer."

"We plan to have Phase 3 testing of mirvetuximab soravtansine up and running by year end," commented Dr. Charles Morris, ImmunoGen's EVP and Chief Development Officer. "Now that we have the full results from the 46-patient ovarian cancer cohort, we've submitted a meeting request to the FDA to discuss our proposed path to approval. This meeting should take place early in 3Q2016, and we are targeting initiation of FORWARD I Phase 3 testing in 4Q2016."

Mirvetuximab soravtansine was generally well tolerated, with most side effects Grade 1 or 2 (least severe grades). Of particular note, incidence of blurred vision was reduced from 55%, mostly Grade 2, in the first 20 patients enrolled to 39%, mostly Grade 1, among the 26 patients added with the expansion of the cohort. Other side effects reported in more than 20% of patients were diarrhea, fatigue, nausea, vomiting, peripheral neuropathy, increased AST, keratopathy, and abdominal pain.

Data Presentation at ASCO 2016

"IMGN853 (mirvetuximab soravtansine), a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC): single-agent activity in platinum-resistant epithelial ovarian cancer patients" will be presented in the Gynecologic Cancer Poster Session (Poster Board #390) taking place on Monday, June 6, from 1:00-4:30 pm CT. (Abstract #5567).
Source: press release, 5/08/16.


Nov 8, 2015

Treatment Response to ImmunoGen's Mirvetuximab Soravtansine Found to be Substantially Greater in Ovarian Cancer with High Expression of Folate Receptor Alpha
Objective response on mirvetuximab soravtansine in nine of ten (90%) patients with high amounts of target on cancer cells; majority of these responders remained on treatment for at least 24 weeks
Most patients with ovarian cancer found to have high or medium expression of target
FORWARD I ovarian cancer trial on track to begin in late 2015 - intended to support potential Accelerated Approval pathway
WALTHAM, Mass.--(BUSINESS WIRE)-- ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its antibody-drug conjugate (ADC) technology, today reported findings with mirvetuximab soravtansine, its novel folate receptor alpha (FRα)-targeting ADC product candidate, being presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (abstract #C47). Analysis of the association between the amount of FRα present on patient cancer cells and response to treatment with mirvetuximab soravtansine found nine of ten (90%) patients with high levels of FRα had an objective response on treatment.

"These early findings are highly encouraging as they underscore the potential of mirvetuximab soravtansine to make an important difference for patients with ovarian cancer," said Dr. Charles Morris, chief development officer. "The data are from patients with heavily pretreated platinum-resistant ovarian cancer, which is a difficult disease to treat. We will be assessing mirvetuximab soravtansine as single-agent therapy for patients with pretreated FRα-positive ovarian cancer in our FORWARD I trial, a study we intend to use for registration purposes."

The findings presented today are from an analysis of 20 efficacy-evaluable patients with platinum-resistant ovarian cancer who received mirvetuximab soravtansine in Phase 1 testing at its selected dose. Patients were categorized as having high, medium or low amounts of FRα on their cancer cells.1 Enrollment criteria for the clinical study required all patients to have at least low expression.

Nine of the ten patients with high FRα expression had an objective response (2 complete responses/CRs, 7 partial responses/PRs by RECIST 1.1 criteria). Six of these responders remained on treatment for at least 24 weeks.
The six patients with medium expression all had tumor regression. One patient had an objective response (unconfirmed PR) and one had tumor shrinkage with new lesion formation (mixed response/MR). An additional patient remained on treatment for more than six months but did not have an objective response.
Four patients had low expression and none had an objective response. One patient was still on treatment at the time of data cut off for presentation.
The ORR was 50% for all 20 efficacy-evaluable patients. Among all 22 patients evaluable for tolerability, the majority of adverse events reported were low grade (grade 1 or 2), with diarrhea, blurred vision, vomiting, fatigue, and nausea the most common treatment-emergent events reported ( > 30% of patients).

ImmunoGen anticipates reporting mature data from the full 46-patient cohort in this study at a medical meeting in 2016.


ImmunoGen's FORWARD I trial will assess mirvetuximab soravtansine as single-agent therapy for the treatment of ovarian cancer previously treated with three to four prior regimens. Patients will have medium or high expression of FRα to qualify for enrollment in this Phase 2 study. Patient enrollment is expected to start in late 2015.
Source: press release, 11/08/15.