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BioCentury Extra
As published Friday, September 30, 2016 5:49 PM PST


  • Boehringer returns olmutinib rights to Hanmi

    Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940) fell W112,000 (18%) to W508,000 after Boehringer Ingelheim GmbH (Ingelheim, Germany) said it returned rights for olmutinib (HM61713; BI 1482694) to the Korean company. According to Boehringer, the Korean Ministry of Food and Drug Safety reported three serious skin reactions, including one fatal case, in a drug safety letter for the candidate.

    Boehringer told BioCentury the ministry's letter described two cases of toxic epidermal necrolysis and one non-fatal case of Stevens-Johnson syndrome. The company said the toxic epidermal necrolysis was reported in the Phase I/II HM-EMSI-101 study and the Phase II HM-ESMI-102 trial. Both studies are evaluating olmutinib to treat non-small cell lung cancer (NSCLC).

    Boehringer said its decision to return the rights was based on "a re-evaluation of all available clinical data and recent advances made in the treatment of EGFR mutation-positive lung cancer." In July 2015, Boehringer paid Hanmi $50 million up front to gain the therapy's rights outside South Korea, China and Hong Kong (see BioCentury Extra, July 28, 2015).

    Zai Lab Ltd. (Shanghai, China) has rights in China to olmutinib, a third-generation EGFR mutation-specific tyrosine kinase inhibitor (TKI) (see BioCentury Extra, Nov. 23, 2015).

    Olmutinib is approved in South Korea to treat T790M EGFR mutation-positive lung cancer. Data presented in June at the American Society for Clinical Oncology meeting showed the treatment led to an overall response rate of 61% in the HM-EMSE-101 trial to treat NSCLC patients with T790M mutations who developed resistance to previous EGFR TKIs.

  • Celgene acquiring EngMab

    Celgene Corp. (NASDAQ:CELG) will acquire EngMab AG (Pfaeffikon, Switzerland) for $600 million. In a statement, Celgene said the acquisition will help it pursue tumor necrosis factor receptor superfamily member 17 (BCMA; TNFRSF17; CD269) as a target to treat multiple myeloma.

    EngMab develops T cell bispecific antibodies that bind simultaneously to a tumor antigen and the T cell receptor (TCR) complex to destroy malignant cells. Last year, it presented data showing that EM801, a T cell bispecific antibody targeting BCMA, induced death of malignant cells in vitro and in a mouse xenograft model.

    Last year, Celgene and bluebird bio Inc. (NASDAQ:BLUE) narrowed an existing partnership to focus on development of chimeric antigen receptor (CAR) T cell therapies targeting BCMA. In February, Celgene exercised its option to gain rights to bb2121, which comprises autologous T cells transduced ex vivo with an anti-BCMA02 CAR lentiviral vector delivering the CAR targeted to BCMA (see BioCentury Extra, February 17).

  • Prothena's Schenk passes away

    Antibody company Prothena Corp. plc (NASDAQ:PRTA) said President and CEO Dale Schenk passed away after a battle with pancreatic cancer.

    The company's board intends to discuss a succession plan. When Prothena announced Monday that Schenk would take medical leave, it had said COO Gene Kinney would lead the company during his absence.

    In a BioCentury commentary published in May, Schenk discussed his experiences as a patient and emphasized the need for "compassionate communications" with patients during drug development.

    "Among us industry folks, patient perspectives may not be regarded as scientifically rigorous, and can be perceived as anecdotal or subjective when compared with the hard data we're used to dealing with," Schenk wrote. "However, in the end, the patient voice and experience is every bit as important as the p-value" (see BioCentury, May 16).

  • PTC rises after Roche starts SMA trial

    Roche (SIX:ROG; OTCQX:RHHBY) is recruiting patients for a Phase II trial of RG7916 to treat spinal muscular atrophy, according to an update posted Thursday to a ClinicalTrials.gov entry. Roche has rights to the candidate from PTC Therapeutics Inc. (NASDAQ:PTCT) under a 2011 agreement.

    RG7916 is a survival of motor neuron 2 centromeric (SMN2) splicing modifier.

    PTC gained $2.45 (21%) to $14.01 on Friday.

  • AbbVie HCV regimen gets breakthrough designation

    AbbVie Inc. (NYSE:ABBV) said FDA granted breakthrough therapy designation to its glecaprevir/pibrentasvir regimen to treat chronic HCV genotype 1 infection in patients who have failed therapy with direct-acting antivirals (DAAs). AbbVie is developing the regimen as a pan-genotypic HCV therapy.

    Glecaprevir (ABT-493) is a next-generation HCV NS3/4A protease inhibitor. Pibrentasvir (ABT-530) is a next-generation HCV NS5A protein inhibitor.

    Enanta Pharmaceuticals Inc. (NASDAQ:ENTA) and AbbVie discovered glecaprevir under a 2006 deal. Enanta gained $0.91 to $26.61 on Friday.

  • Regeneron combo fails to top Eylea alone in AMD study

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said intravitreal injections of REGN2176-3 missed the primary endpoint in the ongoing Phase II CAPELLA study to treat wet age-related macular degeneration. The therapy, which combines the company's ophthalmic drug Eylea aflibercept with rinucumab, an antibody against platelet derived growth factor receptor B (PDGFRB; PDGFR1; CD140B), failed to significantly improve visual acuity compared with Eylea alone.

    After 12 weeks, both of the study's doses of REGN2176-3 led to a 5.8-letter improvement from baseline in best corrected visual acuity (BVCA), compared with 7.5 letters for Eylea alone. Ocular adverse events were more common in the REGN2176-3 groups, which Regeneron said was driven by an increase in conjunctival hemorrhage, eye irritation and eye pain.

    In CAPELLA, about 500 patients received an intravitreal injection every four weeks of Eylea monotherapy or one of two doses of REGN2176-3: either 1 mg or 3 mg rinucumab plus 2 mg Eylea. Regeneron intends to evaluate data after 28 and 52 weeks, and to present detailed data at a medical meeting. Regeneron and Bayer AG (Xetra:BAYN) are developing REGN2176-3 under a 2014 deal.

    Regeneron slipped $4.34 to $402.02 on Friday.

    Ophthotech Corp. (NASDAQ:OPHT) slid $7.99 (15%) to $46.13 on the news. The company's Fovista pegpleranib, a pegylated aptamer against PDGFB (PGDF2), is in Phase III testing to treat wet AMD in combination with Eylea or anti-VEGF-A therapy Lucentis ranibizumab. An August regulatory filing said Ophthotech expects data from the studies in 4Q16. The company did not respond to an inquiry.

    The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) and Novartis AG (NYSE:NVS; SIX:NOVN) share ex-U.S. rights to Fovista. The companies also market Lucentis.

  • Gruenenthal's cebranopadol meets Phase III pain endpoint

    Gruenenthal Group (Aachen, Germany) said once-daily cebranopadol (GRT6005) met the primary endpoint of a Phase III study to treat cancer-related pain. The company said cebranopadol was non-inferior, as well as superior, to twice-daily prolonged-release morphine sulfate based on statistically significant improvements on the primary endpoint, which assessed average amount of daily rescue medication over the last two weeks of the trial's maintenance phase (p<0.05).

    The company said cebranopadol was well-tolerated, with side effects comparable to morphine sulfate. Results from the study were presented at the World Congress on Pain in Yokohama, Japan.

    Gruenenthal said it is seeking partners for cebranopadol in Asia. Depomed Inc. (NASDAQ:DEPO) has rights in the U.S. and Canada to the small molecule opioid analgesic.

    Neither Depomed nor Gruenenthal responded to inquires regarding regulatory plans for cebranopadol.

    Depomed gained $1.10 to $24.99 on Friday.

  • SQZ raises $16M in series B

    SQZ Biotechnologies Co. (Boston, Mass.) raised $16 million in a series B round led by NanoDimension and Polaris Partners. Undisclosed new and existing investors also participated.

    SQZ's CellSqueeze microfluidic-based system constrains cells to force open transient pores in the cell membrane and allows delivery of bioactive materials into the cells. CEO Armon Sharei told BioCentury the company hopes to use its protein delivery system to engineer antigen presentation mechanisms for immuno-oncology applications (see BioCentury Innovations, Nov. 3, 2014).

    The company also named Kris Elverum CBO. He was U.S. marketing director for chimeric antigen receptor (CAR) T cell therapies at Novartis AG (NYSE:NVS; SIX:NOVN).

    Last year, SQZ partnered with Roche (SIX:ROG; OTCQX:RHHBY) to develop engineered B cells for oncology indications (see BioCentury Extra, Dec. 7, 2015).

  • Emergent lands BARDA contract for new anthrax vaccine

    Emergent BioSolutions Inc. (NYSE:EBS) gained $3.77 (14%) to $31.53 on Friday after it said it signed a contract with HHS's Biomedical Advanced Research and Development Authority worth up to $1.6 billion to develop NuThrax (AV7909). The company also said the CDC exercised an option to purchase all the remaining doses of its BioThrax vaccine under a 2011 contract.

    Emergent said the new contract includes about $200 million over five years to develop the vaccine and to supply an initial two million doses for the U.S. Strategic National Stockpile. NuThrax is in Phase III testing, and Emergent said it believes FDA could approve the vaccine for emergency use as soon as 2018.

    The new contract also includes up to $1.4 billion for the future supply of up to 50 million doses of NuThrax to the national stockpile.

    Emergent also said the CDC bought 44.8 million remaining doses of BioThrax under its 2011 contract, which was due to expire Friday. CDC has granted a two-month extension for their delivery. Emergent said the parties are negotiating a new five-year contract for 29.4 million doses of BioThrax.

    NuThrax is a third-generation vaccine that consists of BioThrax, which is an adsorbed anthrax vaccine, plus an immunostimulatory compound called CPG 7909 for post-exposure prophylaxis of anthrax disease. BioThrax is the only FDA-approved vaccine to prevent anthrax.

  • DNA Electronics awarded $51.9M BARDA contract

    DNA Electronics Ltd. (London, U.K.) said HHS's Biomedical Advanced Research and Development Authority awarded it a contract valued at up to $51.9 million to develop its Genalysis sequencing platform and seek marketing authorizations for its diagnostics from FDA. Genalysis is intended for rapid diagnosis of antimicrobial resistant infections and influenza.

    Genalysis is designed to allow sequencing of infectious organisms directly from clinical specimens and identify pathogens within a few hours. Its first application is a rapid blood-based diagnostic for sepsis, which DNA Electronics hopes to launch in 2018.

  • Rare disease voucher program extended

    President Obama signed into law an amended version of the Advancing Hope Act of 2016 (S.1878), extending the Rare Disease Priority Review Voucher program until YE16. The program was scheduled to sunset Oct. 1.

    The U.S. House of Representatives passed the bill on Thursday, following a unanimous vote from the U.S. Senate last week (see BioCentury Extra, Sept. 23).

  • House Republicans allege CMS overreach in 'experiments'

    In a letter to CMS Acting Administrator Andy Slavitt and Deputy Administrator and CMO Patrick Conway, a group of 179 members of the U.S. House of Representatives said CMS's Center for Medicare & Medicaid Innovation (CMMI) has "exceeded its authority, failed to engage stakeholders, and has upset the balance of power between the legislative and executive branches."

    The letter cites three large-scale experiments proposed in the past two years by CMMI: the planned value-based Part B drug purchasing project, and the proposed bundled payment models for joint replacement and severe cardiac conditions.

    The legislators said CMMI failed to meet statutory requirements for implementing models, and said CMS is experimenting with "thousands of patient lives" by evaluating the proposals in large-scale demonstrations that are mandatory for providers in designated geographical areas, instead of first testing the proposals on a smaller scale.

    "As a result, Medicare providers and their patients are blindly being forced into high-risk government-dictated reforms with unknown impacts," the legislators wrote. "We insist CMMI stop experimenting with Americans' health, and cease all current and future planned mandatory initiatives within the CMMI."

    The letter was signed by 178 Republicans and one Democrat, Brad Ashford (Neb.).

    In June, Conway deflected bipartisan criticism from U.S. Senate Finance Committee members of the Part B drug purchasing project. He said CMS would evaluate public comments before finalizing the rule for the Part B demo (see BioCentury Extra, June 28).

    The Part B proposal's first phase, set to start 60 days after a final rule is released, would test the effects of changing the reimbursement formula for Part B drugs to the average sales price (ASP) plus add-on payments of 2.5% of ASP and a $16.80 flat fee. Physician practices and outpatient facilities in about 75% of the U.S. would receive the new formula, while those elsewhere would continue to receive ASP plus 6%.


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