Forty Seven Inc. to Collaborate with Merck KGaA, Darmstadt, Germany, on a Novel Immuno-Oncology Combination for Ovarian Cancer
Forty Seven Inc.'s CD47 antibody to be evaluated in combination with avelumab
MENLO PARK, January 11, 2017 - Forty Seven Inc. a clinical-stage company focused on developing the next generation of transformational immuno-oncology treatments to enable a patient's immune system to defeat their cancer, today announced an agreement with Merck KGaA, Darmstadt, Germany to conduct a Phase 1b clinical trial combining Hu5F9-G4 with avelumab* in patients with ovarian cancer.
PD-L1 and CD47 are immunosuppressant molecules overexpressed on cancer cells that send inhibitory signals to T cells and macrophages, respectively. Binding of avelumab to PD-L1 takes the brakes off T cells and, in a similar way, binding of Hu5F9-G4 to CD47 takes the brakes off macrophages.
"PD-L1 inhibitors, like avelumab, belong to a class of new immunological therapies for cancer known as checkpoint inhibitors that offer the opportunity for long-term remissions in some cancer patients," said Forty Seven Inc. CMO Chris Takimoto. "Not all patients however, respond to checkpoint inhibitors, so additional scientifically driven combination approaches are required."
"Ovarian cancer patients have limited treatment options, especially as they are often diagnosed at a late stage in their disease," says Dr. Alise Reicin, Head of Global Clinical Development at the Biopharma business of Merck KGaA, Darmstadt, Germany, which in the US and Canada operates as EMD Serono. "We have two ongoing registrational studies exploring the role that avelumab could play both as a monotherapy and in combinations in ovarian cancer. This collaboration enhances our strategic approach to novel I-O combinations in this disease setting. We are hopeful that through these efforts we will discover viable options to help patients with this hard-to-treat cancer."
*Avelumab is jointly developed by Merck KGaA, Darmstadt, Germany, and Pfizer. Avelumab is under clinical investigation for the treatment of ovarian cancer and has not been demonstrated to be safe and effective for this indication. There is no guarantee that avelumab will be approved for ovarian cancer by any health authority worldwide.
CD47 blockade as another immune checkpoint therapy for cancer. Robert H. Vonderheide, Nature Medicine 21, 1122, 2015.
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.
Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including nine Phase III trials, and more than 7,000 patients across more than 15 different tumor types, including gastric/gastroesophageal junction, non-small cell lung cancer, renal cell carcinoma and ovarian cancer. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.
Indications in the US
The FDA granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
Important Safety Information from the US FDA Approved Label
The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.
For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.
About Hu5F9-G4 and Forty Seven Inc.
Forty Seven Inc. is a clinical-stage immuno-oncology company that is developing therapies licensed from Stanford University targeting cancer immune evasion pathways. The lead program Hu5F9-G4 is a monoclonal antibody against the CD47 receptor, a "don't eat me" signal that cancer cells commandeer to avoid being ingested by macrophages. This antibody is currently being evaluated in five clinical studies in patients with solid tumors, acute myeloid leukemia, non-Hodgkin's lymphoma and colorectal carcinoma. For a comprehensive list of all Hu5F9-G4 trials, please visit clinicaltrials.gov. Forty Seven is located at 1490 O'Brien Drive, Suite A, Menlo Park, CA 94025, U.S.A.
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