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Overview
MacroGenics has a diverse portfolio of oncology product candidates with several clinical trials currently underway or planned for the near future. Set forth below is the company’s development pipeline of product candidates for which we have retained commercialization or other important rights in the U.S. or more broadly (as of April 2024).
| Program (Target) | Potential Indication(s) | Modality | Preclinical | Phase 1 | Phase 2 | Phase 3 | Partner / Sponsor | ||
|---|---|---|---|---|---|---|---|---|---|
| Vobramitamab Duocarmazine (B7-H3) | mCRPC TAMARACK study | ADC |
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| Lorigerlimab (PD-1 × CTLA-4) | mCRPC (+docetaxel) LORIKEET Study | DART® |
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| Enoblituzumab (B7-H3) | Neo-adjuvant Prostate Cancer HEAT Study(a) | Fc-optimized mAb |
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| Tebotelimab(b) (PD-1 × LAG-3) | Solid Tumors & Heme Malignancies | DART |
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| MGC026 (B7-H3) | Multiple Solid Tumors | ADC |
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| MGC028 (ADAM9) | Multiple Solid Tumors | ADC |
IND submitted
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Oncology
Vobramitamab Duocarmazine (B7-H3)
mCRPC TAMARACK study
Modality: ADC
| Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|
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Lorigerlimab (PD-1 × CTLA-4)
mCRPC (+docetaxel) LORIKEET Study
Modality: DART®
| Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|
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Enoblituzumab (B7-H3)
Neo-adjuvant Prostate Cancer HEAT Study(a)
Modality: Fc-optimized mAb
| Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|
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Partner / Sponsor
Tebotelimab(b) (PD-1 × LAG-3)
Solid Tumors & Heme Malignancies
Modality: DART
| Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|
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MGC026 (B7-H3)
Multiple Solid Tumors
Modality: ADC
| Preclinical | Phase 1 | Phase 2 | Phase 3 |
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MGC028 (ADAM9)
Multiple Solid Tumors
Modality: ADC
| Preclinical | Phase 1 | Phase 2 | Phase 3 |
|---|---|---|---|
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IND submitted
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Partnered Programs
In addition to the molecules identified above, MacroGenics has out-licensed various product candidates for which it retains certain economic rights. These molecules provide potential sources of future cash flow and platform validation and are identified below.
| Program (Target) | Potential Indication(s) | Modality | Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed | Partner | ||
|---|---|---|---|---|---|---|---|---|---|---|
| MARGENZA® (HER2) | HER2+ Metastatic Breast Cancer | Fc-optimized mAb |
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 (c) |
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| ZYNYZ® (PD-1) | Merkel Cell Carcinoma | mAb |
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| Squamous Cell Anal Carcinoma | mAb |
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| NSCLC | mAb |
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| TZIELD® (CD3) | Stage 2 “At Risk” T1D | mAb |
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| Stage 3 “Early Onset” T1D | mAb |
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| MGD024 (CD123 × CD3) | CD123+ Heme Malignancies | DART |
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Exclusive Option |
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| Bispecific (Undisclosed) | Multiple Solid Tumors | DART/TRIDENT® |
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MARGENZA® (HER2)
HER2+ Metastatic Breast Cancer
Modality: Fc-optimized mAb
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
|---|---|---|---|---|
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Partner / Sponsor
(c)
(c)ZYNYZ™ (PD-1)
Merkel Cell Carcinoma
Modality: mAb
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
|---|---|---|---|---|
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Partner / Sponsor
Squamous Cell Anal Carcinoma
Modality: mAb
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
|---|---|---|---|---|
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Partner / Sponsor
NSCLC
Modality: mAb
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
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Partner / Sponsor
TZIELD® (CD3)
Stage 2 “At Risk” T1D
Modality: mAb
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
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Stage 3 “Early Onset” T1D
Modality: mAb
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
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Partner / Sponsor
MGD024 (CD123 × CD3)
CD123+ Heme Malignancies
Modality: DART
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
|---|---|---|---|---|
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Partner / Sponsor
Exclusive Option
Bispecific (Undisclosed)
Multiple Solid Tumors
Modality: DART/TRIDENT®
| Preclinical | Phase 1 | Phase 2 | Phase 3 | Marketed |
|---|---|---|---|---|
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Partner / Sponsor
MGD = DART MGC = ADC
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established. Pipeline reflects current status of each program or most recently completed phase of development.
- The “Help Elucidate & Attack Longitudinally” (HEAT) study is an investigator-sponsored trial.
- MacroGenics currently has no active/ongoing tebotelimab studies.
- MARGENZA global rights were sold to TerSera Therapeutics LLC, pursuant to which TerSera paid MacroGenics $40M at closing; MacroGenics may receive additional sales milestone payments of up to aggregate of $35M. MacroGenics paid $8M amendment fee to its current commercialization partner in 4Q2024. MacroGenics will manufacture MARGENZA drug substance on behalf of TerSera going forward.