coltuximab ravtansine (SAR3419) / AbbVie - LARVOL DELTA

Targeting CD19-positive lymphomas with the antibody-drug conjugate loncastuximab tesirine: preclinical evidence as single agent and in combination therapy. (PubMed, Haematologica) - "Loncastuximab tesirine was more potent than other anti-CD19 ADCs (coltuximab ravtansine, huB4-DGN462), albeit the pattern of activity across cell lines was correlated. Loncastuximab tesirine activity was also largely correlated with cell line sensitivity to R-CHOP...Our data support the further development of loncastuximab tesirine as a single agent and in combination for patients affected by mature B-cell neoplasms. The results also highlight the importance of CD19 expression and the existence of lymphoma populations characterized by resistance to multiple therapies."

Combination therapy • IO biomarker • Journal • Preclinical • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • CD19

Micromet unveils another fast route to market, marks Pfizer as lead competitor (SeekingAlpha) - Blinatumomab is about to be in two small pivotal P2 trials in ALL, both could generate data in the 1st half of 2013 & potentially support filing; BLAST study could support registration in Europe but probably not in the USA; Both studies should complete enrollment towards the end of 2012; Top line results could be available in the 1st half of 2013; Sanofi just started a P2 in ALL with SAR3419, which should trigger a $4M milestone to Immunogen

Anticipated enrollment completion • Anticipated filing • Anticipated P2 data • Sales projection • Hematological Malignancies

The novel CD19-targeting antibody-drug conjugate huB4-DGN462 shows improved anti-tumor activity than SAR3419 in CD19-positive lymphoma and leukemia models. (PubMed, Haematologica) - "The response of B-cell lymphoma lines to huB4-DGN462 was not correlated with CD19 expression, the presence of BCL2 or MYC, TP53 inactivation or lymphoma histology. In conclusion, huB4-DGN462 is an attractive candidate for clinical investigation in patients with B-cell malignancies."

IO Biomarker • Journal • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

ImmunoGen reports second quarter fiscal year 2016 financial results and provides corporate update (Immunogen Press Release) - "[Immunogen]...intends to present initial biomarker data from [the 20-patient Phase 1 expansion cohort for mirvetuximab soravtansine] at a medical meeting in 2Q2016 in addition to reporting mature data from the 40-patient Phase 1 cohort in this disease at the meeting....Patient enrollment in a Phase 2 trial assessing IMGN529 in combination with rituximab is expected to begin early this year. Enrollment in a Phase 2 trial assessing coltuximab ravtansine in a different combination regimen is expected to begin in 2H2016....ImmunoGen is preparing to initiate Phase 1 testing of IMGN779 for the treatment of acute myeloid leukemia in 1H2016."

Anticipated conference • Anticipated enrollment status • Anticipated new P1 trial • Anticipated P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

ImmunoGen, Inc. reports second quarter fiscal year 2012 financial results and provides quarterly update (Immunogen) - Phase II trials are now in process that evaluate SAR3419 as a single agent for DLBCL; in combination with Rituxan for DLBCL & as a single agent for B-ALL; Clinical data are expected to be reported at a mid-year medical conference from the Phase I trial establishing the optimized dosing schedule being used in Phase II

Anticipated P1 data • P2 trial update • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

ImmunoGen, Inc. earns milestone with start of SAR3419 phase II testing (Market Watch) - Immunogen has started P2 testing for SAR3419; Sanofi's Phase 2 testing will focus on treatment for diffuse large B-cell lymphoma and for B-cell acute lymphoblastic lymphoma

P2 trial update • Hematological Malignancies

SAR3419 as single agent in relapsed-refractory diffuse large B-cell lymphoma (DLBCL) patients (clinicaltrials.gov) - P2, N=55; Not yet recruiting -> Recruiting; Completion date: Mar ’14 -> Jun ‘14

Completion date • Enrollment open • Hematological Malignancies

SAR3419 in Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=100; Active, not recruiting; Sponsor: Sanofi; Recruiting -> Active, not recruiting

Enrollment closed • Acute Lymphocytic Leukemia • Biosimilar • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology

ImmunoGen, Inc. reports third quarter fiscal year 2010 financial results (Immunogen) - SAR3419 / ImmunoGen; P2 for NHL TX begins in H2’ 10

ImmunoGen, Inc. announces clinical data presentations at upcoming 55th ASH annual meeting and exposition (Immunogen Press Release) - "...There will be an oral presentation on SAR650984, the CD38-targeting therapeutic antibody developed by ImmunoGen and licensed to Sanofi as part of a broader collaboration between the companies....There also will be an oral presentation on BT062, the CD138-targeting antibody-drug conjugate (ADC) in development through the Company's collaboration with Biotest....In addition to these two oral presentations, there also will be a poster presentation on SAR3419, the CD19-targeting ADC also in development through the Company's collaboration with Sanofi."

Anticipated clinical data • Anticipated conference • Hematological Malignancies • Oncology

Q1 ’11 results (Sanofi) - Company’s maytansin-loaded anti-CD19 mAb SAR3419 is currently in early stage pipeline of P1 study

Phase I study cohort evaluating an optimized administration schedule of SAR3419, an anti-CD19 DM4-loaded antibody drug conjugate (ADC), in patients (pts) with CD19 positive relapsed/refractory B-cell non-Hodgkin’s lymphoma (NCT00796731) (ASCO 2012) - Presentation time: Monday June 4, 1:15 PM to 5:15 PM; P1, N=21; TED6829; The optimized administration schedule shows an improved safety profile compared to prior tested schedules; The clinical efficacy is preserved essentially in aggressive lymphoma

P1 data • Hematological Malignancies

ImmunoGen: Corporate Presentation (Immunogen) - “STARLYTE Ph 2 trial, Single agent for previously treated DLBCL”; “Proof-of-concept achieved per study investigators, 43.9% ORR vs. 20% pre-set threshold (per protocol population); “Efficacy demonstrated in hard-to-treat DLBCL patient populations, Relapsed (n=26): 53.8% ORR, with 5 CRs, 9 PRs, Refractory to last treatment (n=15): 26.7% ORR, with 1 CR, 3 PRs, Primary refractory (n=14): 21.4% ORR, with 1 CR, 2 PRs”; “Favorable tolerability profile, few grade 3/4 adverse events, Any ocular events were grade 1/2, reversible and manageable”

P2 data • Non-Hodgkin’s Lymphoma • Oncology

ImmunoGen announces recent product program advancements and anticipated 2016 events in advance of J.P. Morgan Healthcare Conference (Immunogen Press Release) - "Events anticipated in 2016: [1] Advancing Phase 2 combination trial and potentially other program updates for IMGN529; [2] Disclosure of combination regimen to be assessed in 1H2016 and initiation of Phase 2 combination study midyear for coltuximab ravtansine; [3] Initiation of Phase 1 testing [of IMGN779] for the treatment of AML in 1H2016."

Anticipated new P1 trial • Anticipated new P2 trial • Acute Myelogenous Leukemia • Oncology

ImmunoGen, Inc. announces activity reported with SAR3419 plus Rituxan in difficult-to-treat patient population (Immunogen Press Release) - P2, N=52; NCT01470456; Sponsor: Sanofi; "Among the twelve study patients with relapsed but not refractory disease, the objective response rate (ORR) was 58%, with 2 complete responses (CRs) and 5 partial responses (PRs). Among the seven patients with disease refractory to the last treatment, the ORR was 43%, with 0 CRs and 3 PRs reported. Among the 26 patients with primary refractory disease - cancer that had never responded to any treatment - the ORR was 15%, with 2 CRs and 2 PRs reported."

P2 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

ImmunoGen, Inc. announces favorable STARLYTE phase II clinical data with Sanofi's SAR3419 in diffuse large B-cell lymphoma (Immunogen Press Release) - P2, N=41; STARLYTE (NCT01472887); Sponsor: Sanofi; "The ORR was 53.8% among the patients with relapsed disease, with 69.2% having stable disease or better. The 14 patients with objective responses included 5 patients with complete responses (CRs) and 9 patients with partial responses (PRs). Among the 15 patients with disease refractory to the last treatment, the ORR was 26.7%, with 46.7% having stable disease or better. These included 1 CR and 3 PRs."

P2 data • Clinical oncology content • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Phase I/II study of the anti-CD19 maytansinoid immunoconjugate SAR3419 administered weekly to patients (pts) with relapsed / refractory B-cell non-Hodgkin’s lymphoma (NHL) (ICML 2011) - P1/2, N=44; Of 38 pts at doses of 20 mg/m2 or higher, 12 (32%) pts achieved an objective response including 6 CR/CRu, with no obvious dose effect; Of 22 pts at the MTD (55 mg/m2), 8 (36%) had a response, including 3 CR/CRu; Of 9 pts evaluable for response duration (RD), 4 pts had a RD ranging from 6 to at least 12 months

P1/2 data

STARLYTE: SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients (clinicaltrials.gov) - P2; N=55; Active, not recruiting; Sponsor: Sanofi; Trial primary completion date: Jun 2016 ➔ Sep 2016

Trial primary completion date • Biosimilar • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Phase II study of anti-CD19 antibody drug conjugate (SAR3419) in combination with rituximab: clinical activity and safety in patients with relapsed/refractory diffuse large B-cell lymphoma (NCT01470456) (ASH 2013) - Presentation time: Monday, December 9, 2013: 6:00 PM-8:00 PM; Abstract #4395; P2, N=53; NCT01470456; "The combination of SAR3419 plus R showed moderate ORR in R/R DLBCL; however the study population was of poor prognosis (60% refractory to first line therapy). In the relapsed DLBCL patients a higher ORR was observed."

P2 data • Hematological Malignancies • Oncology

ImmunoGen: Corporate Presentation (Immunogen) - Anticipated initiation of P2 trial in combination regimen for DLBCL in H2 2016

Anticipated new P2 trial • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

ImmunoGen: Q2 FY 2016 Results (Immunogen) - Anticipated initiation of enrollment in P2 trial in combination regimen for B-cell malignancies in H2 2016

Anticipated enrollment status • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Phase I/II study of the anti-CD19 maytansinoid immunoconjugate SAR3419 administered weekly to patients (pts) with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) (ASCO 2011) - Presentation time: Sat, Jun 4, 8:00 AM to 12:00 PM; P1/2, N=44; Six of 28 pts who enrolled in the dose escalation part at 70mg/m², one pt had a protocol defined dose limiting toxicity of neutropenia & two pts had grade 2 significant toxicities with late onset; Of 38 pts at doses of 20mg/m² or higher, 12 (32%) pts achieved an OR including 6 CR/CRu, with no obvious dose effect; Of 22 pts at the MTD (55mg/m²), 8 (36%) had a response, including 3 CR/CRu; Of 9 pts evaluable for response duration (RD), 4 pts had a RD ranging from 6 to at least 12 months

P1/2 data

Starlyte phase II study of coltuximab ravtansine (CoR, SAR3419) single agent: Clinical activity and safety in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL; NCT01472887) (ASCO 2014) - Presentation time: Sunday, Jun 1; 10:00 AM - 10:12 AM; Abstract #8506; P2, N=41; NCT01472887; "DOR, OS and PFS data are not mature (11 pts ongoing). The most common (>10%) all grades (gr) non-hematologic treatment-emergent adverse events (TEAEs) were nausea (23.0%), diarrhea (19.7%), fatigue and cough (18.0%), vomiting and decrease appetite (13.1%), asthenia, abdominal and back pain (11.5%). TEAEs led to treatment discontinuation in 4 pts."

P2 data • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

ImmunoGen: Corporate Presentation (Immunogen) - "Coltuximab Ravtansine – Notable Single-Agent Activity in Heavily Pre-treated Patients"; "Proof-of-concept achieved: 44% ORR (n=41) exceeded pre-set threshold for success; 4 CRs, 14 PRs, 54% ORR – relapsed disease; (n=26), 27% ORR – refractory to last treatment (n=15), Median duration of response: 5.5 months; "Activity seen in hard-to-treat DLBCL patient populations: 21% ORR – primary refractory disease (n=14);1 CR, 2 PRs, Benefit in hard-to-treat recurrent GCB DLBCL comparable to recurrent ABC DLBCL"; "Favorable tolerability profile, few grade 3/4 adverse events"

P2 data • Non-Hodgkin’s Lymphoma • Oncology

ImmunoGen, Inc. announces presentations at 2012 ASCO Annual Meeting on product candidates with the company's TAP technology (Immunogen) - ImmunoGen announced that there will be four presentations at the upcoming 2012 ASCO Annual Meeting; The findings in the trastuzumab emtansine EMILIA Phase III trial will be featured in an ASCO plenary session on June 3, and findings with SAR3419 administered with its Phase II dosing schedule and Phase I data will be reported on June 4

Anticipated data presentation • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology