NICE fails to endorse Roche's Tecentriq for breast cancer; Elicio closes financing round with $33M
→ UK’s cost-effectiveness watchdog NICE is not backing Roche‘s PD-L1 checkpoint inhibitor Tecentriq (known chemically as atezolizumab), in another blow to the Swiss drugmaker who revealed the drug wasn’t strong enough to score approval in bladder cancer at the ESMO conference last weekend. NICE’s draft guidance, however, pertains to the immunotherapy’s use in advanced breast cancer in combination with the chemotherapy nab-paclitaxel.
“However, there was no trial data directly comparing atezolizumab plus nab-paclitaxel with other treatments currently used at this stage – weekly paclitaxel and docetaxel -and the committee felt that the company’s analysis indirectly comparing these treatments was unreliable and lacked validity,” NICE reviewers said.
→ Penn-allied Tmunity — which is run by Novartis $NVS vet Usman “Oz” Azam and bagged a $100 million mega-round last year — has partnered with Children’s Hospital of Philadelphia to advance a glypican 2 (GPC2) CAR-T therapy for the treatment of neuroblastoma (a rare cancer that affects the developing nervous system). “The therapy also has expansion potential in medulloblastoma and small cell lung cancer, among several other pediatric and adult cancers that express an abundance of the GPC2 protein on their cell surface.” Financial details have not yet been disclosed.
→ Darrell Irvine co-founded Elicio Therapeutics — focused on amphiphile immunotherapies — has closed its Series B with $33 million. The company says that the financing will advance Elicio’s pipeline, including its amphiphile mKRAS vaccine, ELI-002 — which targets seven KRAS mutations that drive 99% of all KRAS-driven cancers. Investors for the round included Clal Biotechnology Industries, Livzon Pharmaceutical Group and Efung Capital.
→ Back in August at the American Veterans National Convention, Donald Trump touted the benefits of Spravato for depression, and ordered the VA to get as much of the product as it could — and suggested its maker J&J $JNJ should offer it to veterans for free. Today, J&J’s Janssen announced the submission of an sNDA to the FDA for a new indication for Spravato for the rapid reduction of depressive symptoms in adult patients with major depressive disorder (MDD) who have active suicidal ideation with intent.
→ In June, Enanta Pharmaceuticals $ENTA put together plans for a new RSV study in adult patients after posting positive data in a Phase IIa study testing its drug, EDP-938. Enanta plans to initiate a Phase IIb clinical study of EDP-938 in adult out-patients with RSV by the end of 2019.
→ Goldfinch Bio — focused on developing treatments and medicines for kidney diseases — has inked a license agreement with Takeda for worldwide rights to a preclinical, peripherally-restricted cannabinoid receptor 1 (CB1) monoclonal antibody. Financial terms have not yet been disclosed. Goldfinch Bio plans to file an IND for the CB1 inhibitor, renamed GFB-024, in the second half of 2020.