Lancet publishes data on MacroGenics' Margetuximab in gastric cancer » 18:4707/0907/09/20
MacroGenics announced that Lancet Oncology has published results from a Phase 2 study of margetuximab plus pembrolizumab as a chemotherapy-free regimen for patients with advanced HER2-positive gastroesophageal adenocarcinoma who have previously been treated with chemotherapy and trastuzumab. The Phase 2 study enrolled patients with gastric cancer or gastroesophageal junction cancer whose tumors were IHC3-positive or IHC2-positive/FISH-positive at diagnosis. Enrollment was regardless of PD-L1 expression status, which was subsequently determined from available archived tumor tissue. Tolerability of margetuximab and pembrolizumab was acceptable in patients treated in this study. Grade 3 or higher treatment-related adverse events were reported in 20% of patients, with anemia and infusion-related reactions being the most common. No treatment-related deaths were reported. Patients who had received margetuximab at the recommended Phase 2 dose of 15 mg/kg every three weeks were evaluable for response. In this overall population, the objective response rate was 18%, including complete responses. Median progression-free survival was 2.7 months and median overall survival was 12.5 months.
|Over a week ago|
MacroGenics announces presentation of preclinical data at AACR meeting » 09:2306/2206/22/20
MacroGenics announced presentations at the American Association for Cancer Research Virtual Annual Meeting II, taking place June 22-24, 2020. MGC018, a duocarmycin-based antibody-drug conjugate targeting B7-H3, exhibits immunomodulatory activity and enhanced antitumor activity in combination with checkpoint inhibitors: MGC018 is an investigational antibody-drug conjugate targeting B7-H3 that has shown preliminary anti-tumor activity in an ongoing Phase 1 dose escalation study in patients with advanced solid tumors. The poster presented at AACR describes preclinical data suggesting that MGC018 can promote immune surveillance or stimulate immune responses to dying cancer cells that led to immunological memory, and when combined with checkpoint blockade may enhance anti-tumor activity. These studies used a mouse model system designed to evaluate anti-tumor activity in an intact and functioning immune system. In this in vivo model, MGC018 demonstrated targeted activity against tumors expressing human B7-H3. Mechanistically, in vitro data suggested that MGC018 induced immunogenic cell death of target cells with the translocation of calreticulin to the cell surface during apoptosis. In addition, treatment with MGC018 in this model system led to an increased infiltration of T cells into the tumor microenvironment. Depleting these T cells attenuated the anti-tumor activity by MGC018, demonstrating their role in mediating response. Furthermore, MGC018 combined with an anti-PD-1 antibody enhanced anti-tumor activity observed in this study. Finally, mice that had achieved a complete response to initial treatment with MGC018 with or without checkpoint blockade survived longer when re-challenged with tumor without subsequent treatment compared to mice that had not received treatment with MGC018, suggesting immunological memory. Investigational CD25 x CTLA-4 bispecific DART molecule for depletion of tumor infiltrating Tregs via an enhanced Fc-dependent effector mechanism: The poster presented at AACR described a preclinical bispecific CD25 x CTLA-4 DART molecule containing an Fc region engineered to enhance clearance of target cells by antibody-dependent cellular cytotoxicity. This molecule was designed to deplete tumor-associated regulatory T cells co-expressing CD25 and CTLA-4 to reduce immune suppression mediated by these cells but preserve effector T cell function. CD25 is the alpha subunit of IL-2 receptor and CTLA-4 is a molecule involved in regulatory T cell function. In vitro studies showed that the Fc-engineered bispecific CD25 x CTLA-4 DART molecule depleted regulatory T cells, with minimal effect on effector T cells. This depletion of regulatory T cells was shown to occur through an Fc-dependent mechanism, as a control CD25 x CTLA-4 DART molecule with an inactivated Fc domain had no effect in this assay. In addition, the bispecific CD25 x CTLA-4 DART molecule preserved cytotoxic T cell effector function in vitro compared to a combination of Fc-engineered monoclonal antibodies independently targeting CD25 and CTLA-4.
MacroGenics appoints Stephen Eck as CMO » 07:3406/1606/16/20
MacroGenics (MGNX) announced the appointment of Stephen Eck, M.D., Ph.D. as SVP, Clinical Development & chief medical officer, effective beginning July 1, 2020. Eck most recently served as chief medical officer of Immatics US, a company focused on TCR-based immunotherapies, and as president and chief executive officer of Aravive Biologics (ARAV). Ezio Bonvini, M.D., SVP, Research and chief scientific officer, who was overseeing MacroGenics' clinical development and related functions on an interim basis will return to serving as the Company's CSO.
|Over a month ago|
MacroGenics participates in a conference call with Credit Suisse » 08:4806/1006/10/20
Conference call with…
Conference call with President & CEO Koenig on June 10 at 10 am hosted by Credit Suisse.
MacroGenics granted Orphan Drug designation in the U.S. for margetuximab » 07:3206/0506/05/20
MacroGenics announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to margetuximab, an investigational, Fc-engineered monoclonal antibody targeting HER2 for the treatment of gastric and gastroesophageal junction cancer. Margetuximab is currently being evaluated in the Phase 2/3 MAHOGANY clinical trial in combination with checkpoint inhibition, with or without chemotherapy, as a potential first-line treatment for patients with HER2-positive gastric cancer or gastroesophageal junction cancer. The MAHOGANY study is based on results from an ongoing Phase 2 study of margetuximab plus pembrolizumab, an anti-PD-1 monoclonal antibody, for patients with advanced HER2-positive GC or GEJ cancer who have previously been treated with chemotherapy and trastuzumab in the metastatic setting. Data were presented at the European Society for Medical Oncology Annual Congress in September 2019.
MacroGenics announces flotetuzumab research published » 16:0906/0306/03/20
MacroGenics announced research published in the journal Science Translational Medicine that describes a gene expression signature of the tumor microenvironment in patients with acute myeloid leukemia, or AML, that is associated with resistance to chemotherapy and response to flotetuzumab, an investigational, bispecific CD123 x CD3 DART molecule currently in clinical development for the treatment of primary induction failure and early relapsed AML. The study analyzed several hundred primary bone marrow samples from independent cohorts of pediatric and adult AML patients to identify differences in immune gene expression in the bone marrow tumor microenvironment across age groups and molecular subtypes. The data indicated that an inflammatory signature related to INF gene expression was predictive of resistance to chemotherapy and potential response to flotetuzumab immunotherapy in patients with primary refractory or early relapsed AML.
MacroGenics price target raised to $25 from $15 at Citi » 06:3906/0206/02/20
Citi analyst Yigal…
Citi analyst Yigal Nochomovitz raised the firm's price target on MacroGenics to $25 from $15 and keeps a Buy rating on the shares. The company reported "compelling" early data for MGC018 with five of seven metastatic castration-resistant prostate cancer patients achieving deep PSA50 responses, Nochomovitz tells investors in a research note. The analyst added MGC018 to his model with a 50% probability of success and model peak risk-adjusted U.S. revenues of $260M.
Guggenheim upgrades MacroGenics to Buy on pipeline prospects » 07:1206/0106/01/20
Guggenheim analyst Etzer…
Guggenheim analyst Etzer Darout upgraded MacroGenics to Buy from Neutral with a $30 price target. Following the company's presentations at the American Society of Clinical Oncology meeting, the analyst believes that MacroGenics' pipeline "can overcome" conservative margetuximab assumptions. MGC018 is an opportunity for the company to play a dominant role in late-line prostate cancer, while MGD013's early activity provides longer-term optionality to its bispecific platform, Darout tells investors in a research note.
MacroGenics upgraded to Buy from Neutral at Guggenheim » 06:0906/0106/01/20
Guggenheim analyst Etzer…
Guggenheim analyst Etzer Darout upgraded MacroGenics to Buy from Neutral.
MacroGenics to hold a pharmaceutical update conference call » 15:5505/2905/29/20
Management reviews MGD013…
Management reviews MGD013 and MGC018 preliminary clinical results as presented at the 2020 Virtual Annual Meeting of ASCO on a conference call to be held on May 29 at 4:30 pm. Webcast Link