In Other (Biopharma) News: This Week's Non-Coronavirus Stories
COVID-19, the disease caused by the novel coronavirus, has dominated headlines over the past few weeks as the virus has spread across the globe and the pharmaceutical industry has marshaled its forces to develop therapies and diagnostics against the disease.
While all of that is being well documented, other accomplishments across the industry are being overlooked. BioSpace takes a quick look at some recent, key industry news that is not related to the coronavirus.
Genentech and AbbVie – Bay Area-based Genentech, a Roche company, announced its late-stage VIALE-A study met its primary endpoint and showed Venclexta (venetoclax) plus azacitidine helped people with the most common type of aggressive leukemia in adults live longer compared to azacitidine alone. Venclexta is being developed by AbbVie and Genentech.
Safety for the two medications appeared consistent with the known profiles of these medications, Genentech said. Acute myeloid leukemia is the most common type of aggressive leukemia in adults, which has the lowest survival rate for all types of leukemia. Data from the VIALE-A study will be shared with global health authorities and presented at an upcoming medical meeting. Venclexta has previously been granted accelerated approval by the U.S. Food and Drug Administration in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of people with newly-diagnosed AML who are aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions.
In the United States, Venclexta has been granted five Breakthrough Therapy Designations by the U.S. Food and Drug Administration: one for previously untreated chronic lymphocytic leukemia (CLL), two for relapsed or refractory CLL and two for previously untreated acute myeloid leukemia.
Aravive – Houston-based Aravive announced the first patients had been dosed in a Phase I/II study of the company’s GAS6/AXL inhibitor AVB-500 in combination with PD-L1 inhibitor avelumab in patients with advanced urothelial carcinoma. AVB-500 is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity. The primary endpoint of the study is objective response rate. Secondary outcome measures include progression-free survival, clinical benefit rate, duration of response and overall survival.
IASO Bio – China’s IASO Biotherapeutics secured $60 million in a series B financing round that will be used to expand the company’s product pipeline, promoting the progress of current projects (including regulatory applications and clinical trials in China and the United States), improving the technology of fully-human antibody development platform, expanding cooperation with leading international research and development institutions, and accelerating the construction of commercial facilities. The company is developing autologous and universal CAR-T products for hematological tumors. All products are based on fully human sequence. Additional development efforts include unique TCR-like CAR-T cell therapy products for solid tumor indications such as viral infection related gastric cancer and nasopharyngeal carcinoma. The funding round was led by GL Ventures, which is a venture capital fund of Hillhouse Capital.
DBV Technologies – At a recent meeting of the American Academy of Allergy, Asthma & Immunology, DBV Technologies presented detailed safety and efficacy results from the Phase III PEOPLE study of its Viaskin Peanut, an investigational patch utilizing epicutaneous immunotherapy (EPIT) technology. The company said about 75% of those who are allergic to peanuts and received the treatment benefitted. Trial results suggest that Viaskin Peanut may have the potential to durably modify immune response in children with peanut allergy and offer long-term protection against reactions from accidental peanut exposure, the company said.
Avectas – Ireland’s Avectas and Vycellix, Inc. entered into a collaborative agreement to develop proprietary approaches for cell-based immunotherapeutic products. The companies will collaborate on the delivery of Vycellix's novel RNA immunomodulator VY-M using Avectas' cell engineering platform, Solupore. The collaboration will address current limitations for cell-based therapies, in particular with respect to the need to accelerate the manufacturing process, reduce the cost of manufacture, and ultimately improve patient outcomes.
MaxCyte – Maryland’s MaxCyte, a cell-based therapies company, signed a commercial licensing agreement with Allogene Therapeutics to allow the Bay Area company the rights to its Flow Electroporation technology and ExPERT platform to develop and advance allogeneic CAR T (AlloCAR T) therapies for cancer. Allogene intends to deploy the MaxCyte technology to effect the gene editing steps during the production process. The first two Allogene investigational therapies intended to utilize this validated gene-editing and advanced proprietary cell manufacturing technology are directed at CD19 and BCMA targets. Under terms of the agreement, MaxCyte will receive undisclosed development, approval and commercial milestones in addition to other licensing fees.