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BioShares Biotechnology Clinical Trials (BBC): $20.82, +$0.02, +13.1% YTD

BioShares Biotechnology Products (BBP): $37.11, -$0.25, +13.3% YTD

 

 

MARKET COMMENTARY

 

World equities rose on renewed hopes that President Donald Trump’s tax reform plans will help in boosting the economy and corporate earnings. Wall Street looked set to open higher on the first trading day of the week after closing at record highs in the previous session. The greenback hit a two-week high against the yen, while gold prices slipped further. Increase in U.S. production pushed the oil lower.

 

 

MARKET HIGHLIGHTS

 

Mateon Therapeutics announced encouraging preliminary data from four different syngeneic mouse models evaluating Mateon’s lead investigational drug CA4P in combination with checkpoint inhibitors.  The most compelling results were found combining Mateon’s CA4P with an anti-CTLA4 antibody in an EMT-6 mammary model. In this study, 7 of 8 mice receiving the combination were tumor free at the study’s completion, compared to 1 of 8 in the CA4P monotherapy arm and 2 of 8 in the anti-CTLA4 antibody monotherapy arm.  Three of four follow-up studies also demonstrated that CA4P combined with immune oncology agents delayed tumor growth. These studies were conducted in a larger tumor EMT-6 mammary model, a C3H mammary model and a CT26 colon model. The results provide additional supportive evidence that CA4P enhances anti-CTLA4 antibody activity, as well as initial evidence that CA4P enhances anti-PD-1 and PD-L1 activity.

 

Zogenix announced the initiation of the clinical efficacy portion of Study 1504 for ZX008 in patients with Dravet syndrome.  Study 1504 is a multi-center, two-cohort study to initially assess the pharmacokinetic and safety profile of single doses of ZX008 (fenfluramine hydrochloride), clobazam and valproate when added to stiripentol, followed by a randomized, double-blind, placebo-controlled parallel group evaluation of the efficacy, safety and tolerability of ZX008 as adjunctive antiepileptic therapy to a drug regimen that includes stiripentol, clobazam and valproate. Stiripentol in combination with clobazam and valproate is approved for the treatment of seizures in Dravet syndrome in Europe, Canada, Australia, and Japan.  Although stiripentol is not approved in the United States (U.S.), the U.S. Food and Drug Administration (FDA) permits the use of this drug through its Expanded Access regulations and it is a current treatment option for many patients with Dravet syndrome in the U.S.

 

DelMar Pharmaceuticals announced its financial results for the quarter ending December 31, 2016, the second quarter of the Company’s 2017 fiscal year.  For the six months ended December 31, 2016 the Company reported a net loss of $3,612,312 or $0.36 per share, compared to a net loss of $4,268,078, or $0.40 per share for the six months ended December 31, 2015.  We estimate that our current working capital, including non-dilutive funding support and cash from warrant exercises subsequent to December 31, 2016, is sufficient to fund our current operations through the end of calendar 2017.

 

DelMar Pharmaceuticals announced today that patient dosing has commenced in a Phase 2 clinical study of its investigational drug VAL-083 (dianhydrogalactitol) for MGMT-unmethylated Avastin® (bevacizumab)-naïve recurrent glioblastoma. The first patient was dosed by DelMar’s collaborators at the University of Texas MD Anderson Cancer Center in Houston Texas.

 

BioTime will be presenting at the BIO CEO & Investor Conference on Tuesday, February 14, at 2:30 p.m. Eastern Time, and at the Disruptive Growth Conference on Wednesday, February 15, at 1:15 p.m. Eastern Time.

 

Evogene will release its financial results for the fourth quarter and full year 2016 on Monday, February 27, 2017.

 

Aeterna Zentaris announced that, following a comprehensive review of data obtained from the confirmatory Phase III clinical trial of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults ("AGHD"), using the insulin tolerance test (the "ITT") as a comparator, it concluded that Macrilen demonstrated performance supportive of achieving registration with the FDA. The FDA has agreed to consider the Company’s conclusions during a Type A meeting, which is currently being scheduled.

 

Sage Therapeutics announced encouraging top-line results from its Phase II clinical trial of orally-administered SAGE-217 for the treatment of major depressive disorder (MDD). The primary endpoint of the 13 patient Part A open-label trial was to evaluate safety and tolerability. SAGE-217 was found to be generally well-tolerated with no serious adverse events or discontinuations reported. The trial also examined the effect of SAGE-217 on the Hamilton Rating Scale for Depression (HAM-D) total score, in addition to other secondary measures. Patients in the trial had a mean HAM-D total score of 27.2 at baseline. Data demonstrated a mean reduction from baseline in the HAM-D of 19.9 points at Day 15, with 85% (11 of 13) patients showing at least a 50% reduction of their HAM-D and 62% (8 of 13) of patients achieving remission, as determined by a HAM-D ≤7. Statistically significant mean change from baseline was observed by Day 2 of the study, following the first of once-daily, nighttime oral dosing of 30 mg of SAGE-217. A significant mean change from baseline was maintained throughout the treatment period (p<0.0001 at Day 15). The reduction from baseline in depression ratings seen in Part A of the trial met the company’s criteria for advancing SAGE-217 into a planned double-blind, placebo-controlled study (Part B).

 

Inovio Pharmaceuticals announced that it has entered into a collaboration and license agreement providing ApolloBio with the exclusive right to develop and commercialize VGX-3100, Inovio’s DNA immunotherapy product designed to treat pre-cancers caused by human papillomavirus (HPV), within Greater China (China, Hong Kong, Macao, Taiwan). The agreement provides for potential inclusion of the Republic of Korea three years following the effective date.

 

Dow Jones reported that Teva Pharmaceuticals Industries swung to a loss in its latest quarter on an acquisition write-down as its interim chief executive contends with a deal-driven debt load. However, the company beat revenue and profit expectations. For the quarter, Teva reported a loss of $973 million, or $1.10 a share, compared with a profit of $500 million, or 55 cents a share, the same quarter the year before. Excluding certain items, per-share earnings were $1.38, up from $1.28 a share in the prior-year quarter. Revenue grew 33% to $6.49 billion. Analysts polled by Thomson Reuters had expected earnings of $1.35 a share on $6.28 billion in revenue. Teva reaffirmed its annual guidance.

 

Axovant Sciences announced preliminary results from the planned interim analysis of the first 11 patients to complete its Phase II study of nelotanserin in Lewy body dementia patients. Based on these interim results, Axovant plans to expand patient recruitment in this study and will begin preparations for a Phase III registration program expected to start in the second half of 2017.

 

Zosano Pharma announces that its lead product candidate, M207, achieved both co-primary endpoints of pain freedom and most bothersome symptom freedom at 2 hours in the recently completed ZOTRIP trial. The ZOTRIP pivotal efficacy study was a multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial comparing three doses (1.0mg, 1.9mg and 3.8mg) of M207, a novel transdermal therapeutic, to placebo for a single migraine attack. A total of 589 subjects were enrolled at 36 sites across the US. The 3.8mg dose achieved significance in the secondary endpoints of pain freedom at 45 minutes and 1 hour and showed durability of effect on pain freedom at 24 and 48 hours. Additionally, M207 was not associated with any Serious Adverse Events (SAEs).

 

Akebia Therapeutics announced that it has entered into an exclusive agreement with Janssen Pharmaceutica, NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to license HIF-targeting product candidates. The portfolio includes AKB-5169 (formerly JNJ5169), a differentiated preclinical compound in development as an oral treatment for inflammatory bowel disease (IBD). The agreement, facilitated by Johnson & Johnson Innovation, also provides Akebia with access to an extensive proprietary library of well-characterized HIF pathway compounds with potential applications across multiple therapeutic areas.

 

Allergan and ZELTIQ Aesthetics announced that they have entered into a definitive agreement under which Allergan has agreed to acquire ZELTIQ for $56.50 per share, or $2.475 billion, subject to customary adjustments.

 

RedHill Biopharma announced enrollment of the last patient in the Phase III study with BEKINDA 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study).

 

Acacia Pharma announced positive results from its fourth and final pivotal Phase III study investigating BAREMSIS (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea & vomiting (PONV), despite having received prior antiemetic prophylaxis.

 

Ferring Pharmaceuticals and Foresee Pharmaceuticals announced that the companies have entered into an exclusive worldwide development and option agreement to leverage Foresee’s proprietary and unique Stabilized Injectable Formulation platform (SIF) for the development of long duration, controlled release formulations of a peptide therapeutic.

 

Dr Matthias Baumann MD will join the Executive Board of MOLOGEN AG as Chief Medical Officer on 1 May 2017. Dr Baumann’s areas of responsibility within the Company on taking office will comprise research, preclinical and clinical development, approval and MOLOGEN’s clinical strategy. The focus of the Company’s development activities is on the TLR9 agonists lefitolimod and EnanDIM as powerful immunotherapeutics in phase III and in preclinical development respectively.

 

Merck, operating as EMD Serono in Canada, announced the publication of the results of a post hoc analysis of the Phase III CLARITY study in Multiple Sclerosis Journal. The post hoc analysis showed that Cladribine Tablets reduced the annualized rate of brain volume loss – also known as brain atrophy – compared with placebo in patients with relapsing remitting multiple sclerosis (RRMS).

 

Emergent BioSolutions announced that it has received a task order from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $30.5 million to develop monoclonal antibody therapeutics for viral hemorrhagic fever. This task order will utilize the company’s Center for Innovation in Advanced Development and Manufacturing (CIADM) facility located in Baltimore, Maryland. Using monoclonal antibodies from Mapp Biopharmaceutical Inc., the company will conduct technology transfer of process materials and information, perform process and analytical method development, execute small-scale production runs, and perform cGMP cell banking leading to cGMP manufacture of bulk drug substance. The task order consists of a 36-month period of performance with a base task order valued at $7.4 million and options that, if executed, will bring the total task order value over three years to up to $30.5 million.

 

XOMA announced that it has agreed to sell 1,200,000 shares of its common stock and 5,003 shares of convertible preferred stock directly to Biotechnology Value Fund, L.P. and certain of its affiliates (“BVF”) in a registered direct offering.  XOMA anticipates its aggregate gross proceeds from the offering will be approximately $25.0 million.

 

Voyager Therapeutics announced the selection of VY-SOD101, a clinical candidate for the treatment of ALS due to mutations in the superoxide dismutase 1 gene (SOD1). Multiple studies have demonstrated that mutant SOD1 is toxic to motor neurons, and leads to their progressive loss. VY-SOD101 is composed of a proprietary adeno-associated virus (AAV) capsid and transgene with a micro RNA (miRNA) expression cassette that harnesses the RNAi pathway to selectively silence, or knock-down, the production of SOD1 messenger RNA. With a single intrathecal (IT) injection, VY-SOD101 has the potential to durably reduce the levels of toxic mutant SOD1 protein in the CNS to slow the progression of disease. Preclinical pharmacology and toxicology studies are now underway to support filing of an IND application for VY-SOD101 during the fourth quarter of 2017.

 

NanoViricides reported that a substantial portion of its Series B Convertible Debentures, with a maturity date of January 31, 2017, have been converted into restricted common stock, effectively retaining $5 million in cash for the Company.

 

OncoMed Pharmaceuticals announced it has enrolled and dosed the first patient in a Phase Ib clinical trial of its anti-DLL4/VEGF bispecific antibody (OMP-305B83) in combination with paclitaxel in patients with platinum-resistant ovarian cancer. OncoMed’s anti-DLL4/VEGF bispecific antibody is designed to have anti-angiogenic, anti-cancer stem cell and immuno-modulatory activity.

 

MabVax Therapeutics Holdings announced results from a pre-clinical study evaluating the potential benefits of using MabVax’s HuMab-5B1antibody, MVT-5873, currently in Phase I clinical trials for the treatment of metastatic pancreatic cancer with Halozyme Therapeutic‘s investigational drug PEGPH20, which targets the tumor microenvironment potentially allowing increased access of co-administered cancer drug therapies to solid tumors. PEGPH20 is currently in phase III clinical development for metastatic pancreatic cancer and in Phase I clinical trials for non-small cell lung cancer, gastric cancer, and metastatic breast cancer. Results from the preclinical study were positive demonstrating improvement in accumulation of MVT-5873 on tumors in an animal model of pancreatic cancer when administered in sequence with PEGPH20.

 

Infinity Pharmaceuticals announced that Jeffery Kutok, M.D., Ph.D. has been promoted to the role of chief scientific officer, effective immediately.

 

Reuters reported that German generic drugmaker Stada has received a 3.6 billion euro takeover offer from private equity group Cinven, the Financial Times reported. Cinven’s offer follows a year-long activist campaign to improve Stada’s profitability by Active Ownership Capital, one of its largest shareholders, and is believed to be pitched at close to 58 euros a share, the Financial Times reported, citing sources. Cinven declined to comment. Stada was not immediately available to comment. Advent, Bain Capital, CVC and Permira are all assessing the bidding war closely and could make a bid, the FT sources said.

 

Ipsen announced that it has entered into a definitive agreement to acquire from Sanofi five consumer healthcare products in certain European territories. The most significant product is Prontalgine, an analgesic for the treatment of moderate to severe pain, which has grown at double digit rates over the last four years and is available only in France. The portfolio also includes Buscopan, an antispasmodic; Suppositoria Glycerini, a laxative; and Mucothiol and Mucodyne, expectorants for cough and flu. Combined, these regional brands span a geographic scope of eight European countries. Manufacturing will be provided by third parties. Under the terms of the agreement, Ipsen will pay €83 million cash upon closing for the products. The transaction, which is subject to customary closing conditions, including the EC’s approval, is expected to close in the second quarter of 2017. The transaction will be fully financed by Ipsen’s existing cash and lines of credit.

 

Ritter Pharmaceuticals announced that it is collaborating with Dr. B Brett Finlay from the Michael Smith Laboratories at the University of British Columbia ("UBC") to study the role of the microbiome and RP-G28 in environmental enteropathy ("EE").

 

 

Analyst Recommendations

 

Piper Jaffray analyst Edward Tenthoff upgraded Regeneron to “overweight” from “neutral,” citing expectations of the FDA to approve Dupixent and Kevzara, which should turn the company’s antibody alliance with Sanofi profitable.

 

Credit Suisse analyst Kennen MacKay increased his price target of Seattle Genetics to $66 from $62, citing the IMMU-132 deal adds potential for near-term accelerated submission and potential approval in 2018 with potential for blockbuster sales.

 

BMO analyst Ian Somaiya increased his price target of Amgen to $212 from $202, citing an analysis of published literature correlating LDL-C with outcomes benefit without a floor effect.

 

Rodman & Renshaw analyst Joseph Pantginis initiated coverage of BioLineRX with a “buy” rating and $3 price target, citing the company’s lead asset is BL-8040, and its program is running on multiple pistons with focus on oncology and stem cell mobilization (transplant).

 

Goldman analyst Jami Rubin increased her price target of Portola to $31 from $27, citing the impact of the financing.