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BioCentury Extra
As published Thursday, December 01, 2016 5:08 PM PST


  • Impel raising $36M series C round

    Drug delivery company Impel NeuroPharma Inc. (Seattle, Wash.) raised $21 million in the first tranche of a planned $36 million series C round from new investors venBio, 5AM Ventures and Vivo Capital. The company is eligible to receive another $15 million contingent upon achieving certain device development and clinical milestones.

    Impel uses inhaler technology to deliver liquid or powder drug formulations to the deep nasal cavity and CNS. Interim CEO John Hoekman told BioCentury the company plans to seek approval of its lead candidate, INP-104, to treat migraine through FDA's 505(b)(2) pathway. He said the intranasal formulation of dihydroergotamine (DHE) mesylate is at an "early clinical stage."

    Originally a device company, Impel is increasingly focusing on innovative and combination products, Hoekman said. Along with academic partners, the company is conducting multiple trials of INP-102, an intranasal insulin in development to treat Alzheimer's disease. Impel expects results by 2018. Impel also has innovative compounds in preclinical development for depression and pain management, Hoekman said.

  • Parker Institute, CRI form neoantigen initiative

    The Parker Institute for Cancer Immunotherapy and the Cancer Research Institute (New York, N.Y.) announced a partnership to improve algorithms used to identify cancer neoantigens. Nonprofit organization Sage Bionetworks (Seattle Wash.) will manage bioinformatics and data analysis for the project.

    The Tumor neoantigEn SeLection Alliance (TESLA) will include 30 academic and industry research groups. Each will use its own algorithms to predict a set of neoantigens recognizable by the immune system based on genetic sequences from normal and cancerous tissues. Participants will seek to improve the algorithms based on data from tests of their predictions. The program will focus initially on advanced melanoma, colorectal cancer and non-small cell lung cancer (NSCLC).

    Industry partners will include Advaxis Inc. (NASDAQ:ADXS), Agenus Inc. (NASDAQ:AGEN), Amgen Inc. (NASDAQ:AMGN), BioNTech AG (Mainz, Germany), Bristol-Myers Squibb Co. (NYSE:BMY), the Genentech Inc. unit of Roche (SIX:ROG; OTCQX: RHHBY), ISA Pharmaceuticals B.V. (Leiden, the Netherlands), the MedImmune LLC unit of AstraZeneca plc (LSE:AZN; NYSE:AZN), Neon Therapeutics Inc. (Cambridge, Mass.) and Personalis Inc. (Menlo Park, Calif.).

    The Parker Foundation (San Francisco, Calif.), founded by entrepreneur Sean Parker, established the Parker Institute in April. Its six core research organizations are to participate in TESLA, as are ten additional U.S. institutions and four in other countries (see BioCentury Extra, April 13).

  • Keytruda gets FDA review in cHL, NICE nod in NSCLC

    Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab to treat refractory classical Hodgkin's lymphoma, or cHL in patients who relapsed after three or more prior lines of therapy. The PDUFA date is March 15, 2017. The mAb against PD-1 has breakthrough therapy designation in the indication, and Merck is seeking the drug's accelerated approval for cHL.

    In May, FDA approved rival PD-1 inhibitor Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat cHL that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and treatment with Adcetris brentuximab vedotin from Seattle Genetics Inc. (NASDAQ:SGEN) (see BioCentury Extra, May 17).

    Separately, the U.K.'s NICE issued draft guidance recommending Keytruda to treat locally advanced or metastatic PD-L1-positive non-small cell lung cancer (NSCLC) in adults who have had at least one chemotherapy. Patients with EGFR-positive or anaplastic lymphoma kinase (ALK)-positive disease must also have received targeted treatment. The European Commission approved Keytruda in the indication in August.

    NICE recommended Keytruda only if it is stopped at two years of uninterrupted treatment with no documented disease progression, and if Merck provides the drug with an undisclosed discount.

    In October, NICE recommended against use of Keytruda in the indication, citing doubts about its long-term benefits and cost-effectiveness (see BioCentury Extra, Oct. 4).

    NICE said it reversed its recommendation after Merck provided a more recent analysis of clinical data and agreed to an enlarged discount.

  • Bicycle, AZ in bicyclic peptide deal

    Bicycle Therapeutics Ltd. (Cambridge, U.K.) and AstraZeneca plc (LSE:AZN; NYSE:AZN) partnered to identify and develop bicyclic peptides to treat respiratory, cardiovascular and metabolic diseases. Bicyclic peptides are small molecules designed to show affinity and target specificity similar to antibodies.

    The deal covers an undisclosed number of targets specified by AstraZeneca. If all the programs reach the market, Bicycle would receive more than $1 billion, including an undisclosed upfront payment, R&D funding and milestones, plus royalties.

    Bicycle will use its platform to identify the bicyclic peptides, while the pharma will be responsible for development and commercialization.

  • Cytokinetics bags milestone as Amgen starts CVOT

    Cytokinetics Inc. (NASDAQ:CYTK) said partner Amgen Inc. (NASDAQ:AMGN) started the Phase III GALACTIC-HF study of omecamtiv mecarbil (AMG 423) to treat chronic heart failure (CHF). The cardiovascular outcomes trial's launch triggers a $26.7 million milestone payment to Cytokinetics from Amgen (see BioCentury Extra, Sept. 1).

    The trial will evaluate if the cardiac myosin activator is superior to placebo, if given with standard of care, in reducing the risk of cardiovascular death or heart failure events in high risk CHF patients with reduced ejection fraction.

    Data presented in November 2015 from the Phase II COSMIC-HF trial of omecamtiv mecarbil suggested that in addition to increasing contractility in the short term, the compound could improve heart function and health over time in patients with CHF and left ventricular systolic dysfunction (see BioCentury, Nov. 16, 2015).

    Cytokinetics lost $0.80 to $11.20 on Thursday. Amgen shed $1.68 to $142.39.

  • Blueprint, Deciphera present Phase I GIST data

    Blueprint Medicines Corp. (NASDAQ:BPMC) and Deciphera Pharmaceuticals LLC (Waltham, Mass.) each presented Phase I data Thursday for candidates targeting stem cell factor (SCF) receptor tyrosine kinase (c-KIT; KIT; CD117) and platelet derived growth factor receptor A (PDGFRA; PDGFR2; CD140A) to treat gastrointestinal stromal tumors.

    In a Phase I study, Blueprint said BLU-285 produced partial responses (PRs) in seven of 28 patients evaluable at a Nov. 1 data cutoff. Six of 15 patients with PDGFRA-driven GIST had a PR as defined by RECIST criteria, as did one of 13 with a KIT mutation.

    The company said it observed radiographic tumor reduction in 14 of 15 patients with PDGFRA mutations, and five of 13 KIT-mutant patients. Nine patients discontinued treatment due to progressive disease among a total of 36 who were dosed.

    BLU-285 is an inhibitor of KIT exon 17 mutations and PDGFRA with the D842V amino acid substitution. Blueprint said the candidate was well tolerated, with Grade 3 adverse events occurring in three patients.

    Blueprint slipped $1.37 to $28 on Thursday.

    In a separate study in patients with solid tumors, Deciphera said KIT and PDGFRA inhibitor DCC-2618 led to partial metabolic responses in 14 of 15 patients with KIT-mutant GIST, according to EORTC criteria. The company also said two patients had PRs according to RECIST criteria: one with KIT, PDGFRA and VEGF receptor 2 (VEGFR-2; KDF/Flk-1) co-amplified glioblastoma multiforme (GBM), and one with GIST and a KIT Exon 11/17 mutation. The company said it also observed "preliminary evidence of significant decreases in circulating tumor DNA." Data from 24 patients were evaluated as of a Nov. 11 cutoff.

    Maximum tolerated dose has not been reached in the study. Deciphera reported one case of dose limiting toxicity in a patient receiving 100 mg of DCC-2618. Twice-daily doses have ranged from 20 mg-150 mg.

    Both companies presented the results at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Munich.

  • FDA approves IND for injectable anti-PD-L1

    3DMed (Shanghai, China) and Suzhou Alphamab Co. Ltd. (Suzhou, China) said FDA approved an IND for KN035, a subcutaneous anti-PD-L1 single domain antibody fused to an Fc.

    The companies partnered earlier this year to develop KN035 to treat cancer. The partners said they plan to begin a clinical trial of the candidate "shortly."

  • V-Bio closes EUR 76M fund

    V-Bio Ventures closed its first life sciences fund at EUR 76 million ($81 million). LPs include the European Investment Fund (EIF), PMV-ARKimedes, Korys, KU Leuven, Gimv, SFPI-FPIM, BNP Paribas Fortis Private Equity and Ghent University.

    V-Bio Ventures Fund 1 is designed to fund 15-18 early stage companies developing therapeutics, diagnostics and agricultural products.

    Managing partner Christina Takke said V-Bio will invest in companies throughout Europe, with substantial deal flow coming from the Flanders Institute for Biotechnology (VIB), a translational life sciences research institute based in Belgium.

    The fund has already invested in drug delivery company Oxular Ltd. (Oxford, U.K.) and two VIB spinouts: drug discovery company Confo Therapeutics N.V. (Brussels, Belgium) and Orionis Biosciences LLC (Boston, Mass.). Takke declined to disclose details regarding Orionis' pipeline.

  • ASCO releases oncology pathways criteria

    In newly released criteria describing high-quality clinical pathways in oncology, the American Society for Clinical Oncology emphasized the importance of transparent, clinically-driven pathways that reflect input from patients, stakeholders, and oncology providers.

    ASCO said it produced the criteria in response to wide variations among oncology-specific pathways, particularly from individual health insurance plans. The guidelines encourage patient participation in clinical trials and public disclosure of provider performance over time, along with evaluations of the impact of pathways on patient and provider experience, clinical outcomes, and value.

    An ASCO policy statement issued in January expressed concerns that existing pathways were developed and applied inconsistently, and without proper transparency (see BioCentury Extra, Jan. 12).


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