izeltabart tapatansine (IMGC936) / MacroGenics, AbbVie - LARVOL DELTA

IMGC936: Protection of composition-of-matter patent until 2039 (Immunogen) - Corporate Presentation

Patent • Oncology

Results from a phase 1/2, first-in-human, dose escalation and dose expansion study of an investigational anti-ADAM9 antibody-drug conjugate IMGC936 in patients with advanced solid tumors (EORTC-NCI-AACR 2024) - P1/2 | "This novel ADAM9-ADC showed expected maytansine-related G1-3 ocular AEs (blurred vision, keratopathy) which limited dose escalation. Most ocular AEs resolved with dose delays and reductions, and the use of brimonidine eye drops delayed onset of ocular AEs. Limited anti-tumor activity was observed; IMGC936 development has been discontinued.RP2D ptsN=29Age, yrMedian age (range)60 (35-78)Tumor type %Non-squamous NSCLC 45TNBC 21CRC 28Pancreatic 7TEAEs in > 20% of pts All Grades % ≥G3 %Blurred vision event 69 3Keratopathy 45 7Dry eye 31 0Nausea 24 0Anemia 21 7Abdominal pain 21 0Cough 21 0Vomiting 21 0"

Clinical • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ADAM9

First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=56 | Completed | Sponsor: ImmunoGen, Inc. | Recruiting ➔ Completed | N=245 ➔ 56 | Trial completion date: Apr 2024 ➔ Dec 2023

Enrollment change • Metastases • Trial completion • Trial completion date • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

AbbVie Completes Acquisition of ImmunoGen (PRNewswire) - "AbbVie...announced today that it has completed its acquisition of ImmunoGen...With the completion of the acquisition, ImmunoGen is now part of AbbVie...ELAHERE (mirvetuximab soravtansine-gynx) is the first and only antibody-drug conjugate (ADC) approved by the U.S. Food and Drug Administration (FDA) in ovarian cancer...ImmunoGen's investigational Phase 1 asset, IMGN-151, is a next-generation FRα ADC for ovarian cancer with the potential for expansion into other solid tumor indications...Pivekimab sunirine, currently in Phase 2, is an investigational anti-CD123 ADC targeting blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer, which was granted FDA breakthrough therapy designation for the treatment of relapsed/refractory BPDCN....AbbVie has acquired all outstanding ImmunoGen common stock for $31.26 per share."

M&A • Gynecologic Cancers • Hematological Malignancies • Oncology • Ovarian Cancer • Solid Tumor

ImmunoGen Reports Recent Progress and Third Quarter 2023 Financial Results (Businesswire) - "ANTICIPATED UPCOMING EVENTS: Report data from the 802 trial, evaluating the pivekimab sunirine (pivekimab) triplet with Venclexta (venetoclax) and Vidaza (azacitidine) in frontline acute myeloid leukemia (AML) at the American Society of Hematology (ASH) Annual Meeting in December 2023; Report top-line data from the pivotal frontline de novo cohort in the Phase 2 CADENZA trial of pivekimab in blastic plasmacytoid dendritic cell neoplasm (BPDCN) in 2024; Provide an update on the IMGC936 non-small cell lung cancer (NSCLC) cohort following a prespecified interim analysis."

P1/2 data • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ImmunoGen Reports Recent Progress and First Quarter 2023 Financial Results (Businesswire) - "ANTICIPATED UPCOMING EVENTS...Report data from two cohorts evaluating the pivekimab triplet with Venclexta® (venetoclax) and Vidaza^® (azacitidine) in frontline AML at the American Society of Hematology (ASH) Annual Meeting in December. Report data from the IMGC936 NSCLC cohort following an interim analysis."

P1/2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

[VIRTUAL] IMGC936, an investigational ADAM9-targeting antibody drug conjugate, is active against patient-derived ADAM9-expressing xenograft models (AACR 2021) - P1 | "ADAM9 was highly expressed in multiple tumor types. A majority of the tumor samples had medium to high levels of ADAM9 with 62% of non-small cell lung carcinoma (NSCLC), 65% of triple negative breast cancer (TNBC), 73% of gastric cancer, and 85% of pancreatic cancer samples having H- scores of 101 to 300. The remaining tumor samples had lower levels of ADAM9 expression (H-score 1 to 100) with only 1.2% of NSCLC samples being ADAM9-negative."

Preclinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • ADAM9

ImmunoGen Reports Recent Progress and 2022 Financial Results (Businesswire) - "ANTICIPATED UPCOMING EVENTS...Initiate the combination cohort of pivekimab with magrolimab in R/R AML in collaboration with Gilead in the second half of 2023. Report dose escalation data in Phase 1 trial of IMGC936 and initial experience in expansion cohorts in the second quarter of 2023."

P1/2 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

ImmunoGen Reports Recent Progress and Third Quarter 2022 Financial Results (Businesswire) - "ANTICIPATED UPCOMING EVENTS: Obtain accelerated approval of mirvetuximab for FRα-positive platinum-resistant ovarian cancer; Present initial data from relapsed and frontline unfit AML expansion cohorts combining pivekimab, azacitidine, and venetoclax in an oral presentation at the 2022 American Society of Hematology (ASH) Annual Meeting in December; Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated before year-end."

BLA • Clinical data • P1 data • Trial status • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Peritoneal Cancer • Solid Tumor

ImmunoGen Reports Recent Progress and First Quarter 2022 Financial Results (Businesswire) - "ANTICIPATED UPCOMING EVENTS: Present additional efficacy and safety analyses from the mirvetuximab program at the American Society of Clinical Oncology (ASCO) Annual Meeting in June; Generate top-line data for MIRASOL in early 2023; Report preliminary efficacy data from the pivotal CADENZA study of pivekimab in BPDCN before year-end; Present initial data from frontline and relapsed AML expansion cohorts combining pivekimab, azacitidine, and venetoclax at the 2022 American Society of Hematology (ASH) Annual Meeting in December; Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated before year-end; Begin enrollment in the Phase 1 study of IMGN151 following the submission of supplemental CMC information to the FDA."

Clinical data • Enrollment status • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Preclinical Evaluation of IMGC936, a Next Generation Maytansinoid-based Antibody-drug Conjugate Targeting ADAM9-expressing Tumors. (PubMed, Mol Cancer Ther) - P1/2 | "Our preclinical data provide a strong scientific rationale for the further development of IMGC936 as a therapeutic candidate for the treatment of ADAM9-positive cancers. A first-in-human study of IMGC936 in patients with advanced solid tumors has been initiated (NCT04622774)."

Journal • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • ADAM9

ImmunoGen Reports Recent Progress and 2021 Financial Results (Businesswire) - "ANTICIPATED UPCOMING EVENTS: (i) Present full SORAYA data during the plenary session at the Society of Gynecologic Oncology (SGO) Annual Meeting in March; (ii) Initiate expansion cohort combining pivekimab, azacitidine, and venetoclax in frontline AML; (iii) Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in 2022."

P1 data • P3 data • Trial status • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • Solid Tumor

MacroGenics Provides Update on Corporate Progress and Third Quarter 2021 Financial Results (GlobeNewswire) - "Flotetuzumab: The Company anticipates providing further updates on the clinical development of flotetuzumab in 2022...MGD019: The Company anticipates sharing data from its ongoing Phase 1 dose expansion study next year....ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in multiple solid tumors and has indicated they anticipate disclosing initial data in 2022."

Clinical • P1 data • Hematological Malignancies • Oncology • Solid Tumor

ImmunoGen Reports Recent Progress and Third Quarter 2021 Financial Results (Businesswire) - "ANTICIPATED UPCOMING EVENTS: Release top-line data from the pivotal SORAYA study this quarter, with the goal of submitting the biologics license application (BLA) in the first quarter of 2022 to support potential accelerated approval in 2022. Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) Annual Meeting in December. Submit the IND application for IMGN151 by the end of 2021. Complete dose-escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in 2022. Generate top-line data for the confirmatory MIRASOL study in the third quarter of 2022."

BLA • Clinical data • IND • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Oncology • Ovarian Cancer

[VIRTUAL] Next-generation ADCs (IMGN151 & IMGC936) (ADC-USA 2021) - "Innovated next-generation ADCs IMGN151 is a next generation FRα-targeting ADC engineered to include multiple technological innovations to maximize the potential clinical benefit for patients with a broad range of target expression IMGC936 is an investigational ADAM9-targeting ADC, comprised of a high-affinity humanized monoclonal antibody site-specifically coupled to DM21"

ADAM9 • FOLR1

First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2; N=245; Recruiting; Sponsor: ImmunoGen, Inc.; Phase classification: P1 ➔ P1/2; N=42 ➔ 245; Trial completion date: Oct 2021 ➔ Apr 2024; Trial primary completion date: Jul 2021 ➔ Oct 2023

Clinical • Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

ImmunoGen Reports Recent Progress and First Quarter 2021 Financial Results (Businesswire) - “ANTICIPATED UPCOMING EVENTS: Initiate a single-arm study of mirvetuximab monotherapy in recurrent platinum-sensitive ovarian cancer in the second half of 2021 to support potential label expansion. Support the start of a randomized Phase 2 investigator-sponsored study of mirvetuximab plus carboplatin in recurrent platinum-sensitive ovarian cancer in the second half of 2021. Present initial AML combination data for IMGN632 at the 2021 American Society of Hematology (ASH) Annual Meeting in December. Complete dose escalation in the Phase 1 study evaluating IMGC936, with initial data anticipated in early 2022.”

Clinical data • Trial status • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Oncology • Ovarian Cancer

MacroGenics Provides Update on Corporate Progress and First Quarter 2021 Financial Results (GlobeNewswire) - "MGC018: MacroGenics will provide a clinical data update via poster presentation at the upcoming American Society of Clinical Oncology (ASCO) 2021 Annual Meeting, June 4-8, 2021...ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in patients with select cancers and have indicated they anticipate disclosing initial data by early 2022."

Clinical data • P1 data • Oncology • Solid Tumor

ImmunoGen Presents Preclinical Data on IMGC936 at the AACR Virtual Annual Meeting (Businesswire) - "'IMGC936 showed compelling anti-tumor activity against multiple patient-derived xenograft models with clinically relevant levels of ADAM9 and was well-tolerated across all models tested. We continue to enroll patients in our Phase 1 dose-escalation study of IMGC936 in multiple tumor types and look forward to sharing initial data by the end of 2021 or early 2022.'"

Enrollment status • P1 data • Preclinical • Oncology • Solid Tumor

MacroGenics Announces Presentations at the 2021 AACR Annual Meeting (GlobeNewswire) - “We are presenting pre-clinical data on MGC018...At clinically relevant dose levels, MGC018 demonstrated potent antitumor activity in vivo in mouse patient-derived xenograft (PDX) models of squamous cell carcinoma of the head and neck (SCCHN)....A second poster demonstrates that margetuximab...can upregulate checkpoint molecules on Natural Killer (NK) cells, CD8 T cells and tumor cells, potentially sensitizing them to immune checkpoint blockade...Finally, our third poster highlights pre-clinical data on IMGC936..."

Preclinical • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

ImmunoGen Reports Recent Progress and 2020 Financial Results (Businesswire) - “Support initiation of two investigator-sponsored trials of mirvetuximab plus carboplatin, including a randomized Phase 2 study in recurrent platinum-sensitive ovarian cancer and a neo-adjuvant study. Enroll patients in the pivotal cohort of the 801 Phase 1/2 study of IMGN632 in frontline BPDCN patients and generate top-line data in 12 to 18 months. Advance the 802 Phase 1b/2 study of IMGN632 in combination with azacitidine and venetoclax in R/R and frontline AML patients and as a monotherapy in minimal residual disease positive (MRD+) AML following frontline induction therapy. Present updated R/R BPDCN and initial AML combination data for IMGN632 at ASH 2021. Complete dose escalation and move to expansion cohorts in the Phase 1 study evaluating IMGC936, with initial data anticipated by the end of 2021 or early 2022. Submit the investigational new drug (IND) application for IMGN151 by the end of 2021.”

Enrollment status • IND • P1 data • Trial status • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Oncology • Ovarian Cancer

First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: ImmunoGen, Inc.

Clinical • New P1 trial • Breast Cancer • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

MacroGenics Provides Update on Corporate Progress and Second Quarter 2020 Financial Results (GlobeNewswire) - "MGD019 (bispecific PD-1 × CTLA-4 DART molecule): Data from the Phase 1 dose escalation study of MGD019 are scheduled to be presented during an oral session at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 to be held September 19-21; IMGC936 (ADAM9 antibody-drug conjugate): ImmunoGen expects to initiate a Phase 1 dose escalation study in patients with select advanced solid tumors in the fourth quarter of 2020."

New P1 trial • P1 data • Oncology • Solid Tumor

ImmunoGen reports recent progress and first quarter 2020 financial results (Businesswire) - “ANTICIPATED UPCOMING EVENTS: Present updated data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab in the fall; Continue enrollment in IMGN632 monotherapy and combination cohorts; File IND for IMGC936 at the end of Q2; Transition IMGN151 into pre-clinical development.”

Enrollment status • IND • P2 data • Preclinical • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

ImmunoGen reports recent progress and 2019 financial results (Businesswire) - "ANTICIPATED 2020 EVENTS....Continue enrollment with IMGN632 monotherapy in relapsed AML, ALL, BPDCN, and MRD+ AML expansion cohorts and in combinations in AML; Present IMGN632 BPDCN and AML combination and MRD+ monotherapy data at ASH in December; File IND for IMGC936 in the first half of 2020; Transition next generation anti-folate receptor alpha (FRα) ADC, IMGN151, to pre-clinical development in mid-2020."

Clinical • Clinical data • Enrollment status • IND