Healthcare Industry News: avelumab
News Release - July 24, 2017
eFFECTOR Therapeutics Completes $38.6 Million Series C FinancingSAN DIEGO, July 24, 2017 -- (Healthcare Sales & Marketing Network) -- eFFECTOR Therapeutics, Inc., a leader in the development of selective translation regulators for the treatment of cancer, today announced that the company has raised $38.6M in Series C financing. Pfizer Venture Investments (PVI) led the round and was joined by additional new investors including Alexandria Venture Investments. All existing investors participated in the round including U.S. Venture Partners, Abingworth, Novartis Venture Fund, SR One, The Column Group, Altitude Life Science Ventures, Sectoral Asset Management, Abbvie Biotech Ventures, BioMed Ventures, and Astellas Ventures. In conjunction with the financing, eFFECTOR has appointed Elaine V. Jones, Ph.D., vice president, PVI, to its board of directors.
The funds will be deployed to advance a broad Phase 2 development program for eFT508, eFFECTOR's investigational small molecule MNK1/2 inhibitor, including a combination study in colorectal cancer with avelumab* (BAVENCIO), conducted under a clinical collaboration agreement between eFFECTOR, Pfizer and Merck KGaA. Additional studies to be conducted with the current financing include monotherapy studies designed to demonstrate immunological proof of mechanism in certain solid tumors and objective response in diffuse large B cell lymphoma, and a second checkpoint inhibitor combination study in solid tumors. The Series C proceeds will also enable the company to advance eFT226, an inhibitor of the eukaryotic initiation factor 4A (eIF4A), into the clinic in 2018. eFT226 blocks translation of key oncogenes including MYC, BCL2, cyclin D1 and CDKs 4/6. eFFECTOR also intends to continue advancing its discovery pipeline, including a program targeting eukaryotic initiation factor 4E (eIF4E), which is expected to enter preclinical development in 2018. eFFECTOR retains global rights to its entire pipeline, including eFT508, as well as its selective translation regulator platform technology.
"The addition of Pfizer to our already strong roster of corporate investors, as well as Dr. Jones to our board, with her track record of providing guidance to emerging biotechnology companies, provides us with invaluable financial and strategic support as we advance our clinical pipeline," said Steve Worland, Ph.D., president and chief executive officer of eFFECTOR. "Our successful fundraising validates the potential we see for selective translation regulators as a new class of cancer treatment and eFFECTOR is well-positioned to capitalize on the opportunity created by this exciting technology."
"PVI is delighted to further support eFFECTOR's efforts to develop a promising novel class of investigational compounds for the treatment of cancer by leading this Series C financing," said Dr. Jones, Vice President, Pfizer Venture Investments. "This investment is a testament to eFFECTOR's unique approach in targeting selective translation regulators and the potential of eFT508 as a new immuno-oncology drug candidate."
eFT508 is a selective translation regulator and is part of a new class of cancer treatments known as immunotherapies that are designed to harness the body's own immune system in fighting cancer. eFT508 is a highly potent and selective, oral inhibitor of MNK1 and MNK2. MNK1/2 are terminal kinases in key oncogenic signaling pathways, including KRAS-BRAF-MEK-ERK, and are activated by the mitogen-activated protein kinases (MAPK) in multiple immune cell types. MNK1 and MNK2 integrate MAPK pathway signaling at the level of mRNA translation, resulting in decreased anti-tumor immune activity due to selective upregulation of several immune checkpoint receptors and specific immunosuppressive cytokines. By selectively blocking MNK1/2-driven mRNA translation, eFT508 promotes anti-tumor immune response. eFT508 is currently being evaluated in a Phase 1/2 clinical trial in patients with solid tumors (NCT02605083) and in a Phase 1/2 clinical trial in patients with lymphoma (NCT02937675).
*avelumab is under clinical investigation for treatment of microsatellite stable colorectal cancer and has not been demonstrated to be safe and effective for this indication. There is no guarantee that avelumab will be approved for microsatellite stable colorectal cancer by any health authority worldwide. avelumab is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. avelumab is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T-cells, exposing them to anti-tumor responses. avelumab has been shown to induce 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.
The U.S. Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIOŽ) for the treatment of (i) metastatic Merkel cell carcinoma (mMCC) in adults and pediatric patients 12 years and older and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who 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. avelumab is not approved for any indication in any market outside the U.S.
Important Safety Information
The warnings and precautions for avelumab (BAVENCIOŽ) 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 avelumab 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 eFFECTOR Therapeutics
eFFECTOR Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of selective translation regulators as a new class of small molecule therapeutics for cancer. The company's investigational compounds are designed to restore translational control to halt underlying disease mechanisms while preserving healthy physiological processes. eFFECTOR's most advanced program focuses on the development of eFT508. The company has additional selective translation regulator programs currently in discovery and development and maintains global rights to all of its development programs. For more information visit www.effector.com.
Source: eFFECTOR Therapeutics
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