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BioShares Biotechnology Clinical Trials (BBC): $22.54, -$0.51, +22.4% YTD

BioShares Biotechnology Products (BBP): $37.12, -$0.05, +13.3% YTD

 

 

MARKET COMMENTARY

 

U.S. stock index futures were little changed and the dollar remained under pressure as investors remained on the sidelines ahead of a meeting between the U.S. President Donald Trump and his Chinese counterpart Xi Jinping later this week. ADP employment data and latest reading from ISM and Markit on non-manufacturing activity occupies the day’s economic calendar. European stocks gained as oil and basic resource stocks strengthened, while Asian markets ended broadly higher. Oil prices rose after data showed a decline in U.S. crude oil inventories. Gold prices steadied ahead of the minutes from the Federal Reserve’s March meeting due later in the day.

 

 

MARKET HIGHLIGHTS

 

Albireo Pharma announced that clinical data from the ongoing Phase 2 study of its lead product candidate A4250 in children with cholestatic liver disease has been selected by the European Association for the Study of the Liver (EASL) for an oral presentation during the late breaker session at The International Liver Congress™ (ILC) 2017 being held April 19-23, 2017, at the RAI Amsterdam in Amsterdam.

 

DelMar Pharmaceuticals has presented three abstracts at the American Association for Cancer Research (AACR) Annual Meeting. These abstracts are all focused on pre-clinical research to elucidate the mechanism of action (MOA) of DelMar Pharmaceuticals’ lead anti-cancer product candidate, VAL-083 (dianhydrogalactitol), a "first-in-class" small-molecule, DNA-targeting, chemotherapeutic agent.

 

VBI Vaccines is scheduled to present updates on two of its programs at the World Vaccine Congress on Tuesday, April 11, 2017 at 3:40 PM ET and 4:40 PM ET. The event is being held at the Grand Hyatt in Washington, D.C.

 

Alcobra provided an update on the request from Brosh Capital L.P., and certain of their affiliates (“Brosh"), to hold an Extraordinary General Meeting of Shareholders. After a thorough review process, Alcobra found the proposals to be contradictory to the incorporation documents of the Company, and, in accordance with applicable law, the request has subsequently been rejected, respectfully, by Alcobra’s Board of Directors.

 

Heat Biologics announced that it presented new preclinical data from its collaboration with OncoSec Medical Incorporated, focused on evaluating the combination of Heat’s immunotherapy platforms with intratumoral electroporation (EP), at the AACR Annual Meeting. In the poster entitled “Combined Intratumoral Electroporation and Allogenic Vaccination of Gp96-Ig/Fc-OX40L Stimulates CD8+ T cell Cross Priming to Tumor-Specific Neoantigens and Enhances Anti-Tumor Response,” (abstract #5617) researchers combined EP of ComPACT DNA (expressing Gp96-Ig and FC-OX40L) directly into a tumor, with cell-based ComPACT vaccination, to explore the effects of an intratumoral plus vaccination approach in a preclinical mouse model of melanoma. Results confirmed that this combination approach led to increased antigen-specific CD8+ T cells, enhanced anti-tumor response and improved overall survival compared to individual treatments.

 

Galmed Pharmaceuticals announced that it will present data at the 53rd Annual Meeting of the European Association for the Study of the Liver (EASL) during the International Liver Congress (ILC) 2017. The congress is being held in Amsterdam, Holland during April 19-23, 2017.

 

Arrowhead Pharmaceuticals announced that it will present clinical data on ARC-520, ARC-521, and ARC-AAT, the company’s prior generation investigational medicines that were being studied for the treatment of chronic hepatitis B infection and liver disease associated with alpha-1 antitrypsin deficiency, at The International Liver Congress™ 2017 (ILC), the annual meeting of the European Association for the Study of the Liver (EASL) being held in Amsterdam, the Netherlands from April 19-23, 2017.

 

OSE Immunotherapeutics SA announced today that the Company presented significant results at the AACR meeting.  OSE-172 (Effi-DEM) is a first-in-class checkpoint inhibitor that blocks these suppressive cells, allowing parallel mobilization of T cells and produces dramatic anti-tumorigenic results in monotherapy and in combination with other immunotherapies as T checkpoint inhibitors.  The preclinical safety of OSE-172 was first established without any binding to or potential interaction with human red blood cells and platelets while CD47 is expressed on these hematological cells. Furthermore, CD47 interacts with several other ligands and physiological functions, such as the CD47/SIRP-gamma axis, another member of the SIRP family, which has been observed to play a role in human T cell proliferation. OSE-172, as selective antagonist of SIRP-alpha, is not a binder of SIRP-gamma, thus avoiding a deleterious impact on T cell immune response and allowing for a strong human effector T cell proliferation, a key advantage of this mechanism of action.

 

TiGenix NV will be presenting at the 24th annual BioCentury Future Leaders in the Biotech Industry on Friday, April 7th, and the Alliance for Regenerative Medicine (ARM) 5th Annual Cell and Gene Therapy Investor Day on Thursday, April 17th, and will also be attending the 10th Kempen & Co Life Sciences Conference on Wednesday, April 19th.

 

Addex Therapeutics reported full-year 2016 financial results.  Net loss for the year decreased significantly to CHF3.1 million for 2016, compared to CHF4.2 million for 2015, or a net loss per share of CHF0.28 for 2016, compared to CHF0.39 for 2015.  Cash and cash equivalents decreased by 46% to CHF1.4 million at December 31, 2016, compared to CHF2.6 million at December 31, 2015. During the period January 1 to February 28, 2017, the group sold 1,623,427 treasury shares for gross proceeds of CHF3,282,093, increasing cash and cash equivalents to CHF3.9 million at February 28, 2017.

 

Abivax launched a Phase IIa ABX464-005 trial to assess the effect of ABX464 on the duration of viral load and the level of inflammation in HIV reservoirs in HIV-infected patients. The company announced it enrolled the first of the 36 patients in the trial (including 24 infected with the virus and 12 healthy) launched to examine the pharmacokinetics of ABX464 in HIV reservoir cells. The preliminary results of the ABX464-005 trial are expected to be out in the third quarter of 2017.

 

Ignyta announced that preclinical data on RXDX-106 – which represents a novel class of immunomodulatory agents that appears to restore innate immunity in preclinical models via potent inhibition of the TYRO3, AXL and MER (or TAM) family of receptors – will be presented at the 2017 Annual Meeting of the American Association for Cancer Research (AACR) in Washington D.C. In addition, the company will also showcase its first ever data in hematological malignancies for entrectinib – an orally available, CNS-active tyrosine kinase inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions – in molecularly defined acute myeloid leukemia (AML). Entrectinib is currently being studied in a registration-enabling Phase 2 clinical trial known as STARTRK-2.

 

AIT Therapeutics announced that it raised an aggregate of approximately $10.9 million in gross proceeds through two separate private placements.  In addition, the Company completed its previously disclosed reverse merger on January 13, 2017 to become a publicly-traded company.

 

Ohr Pharmaceutical announced that it has priced a registered public offering at a price to the public of $0.70 per share of common stock and accompanying warrant to purchase 0.7 of a share of common stock at an exercise price of $1.00. The warrants are immediately exercisable and have a term of five years.  Pursuant to signed securities purchase agreements received by the Company, a closing with respect to an aggregate of 20,250,032 shares of common stock accompanied by warrants to purchase up to an aggregate of 14,175,059 shares of common stock is expected to be held on or about April 10, 2017, subject to receipt of investors’ funds in escrow and satisfaction of customary closing conditions.

 

Valneva was featured in a New York Post article entitled “We’re on the brink of an epic Lyme disease outbreak.

 

Takeda Pharmaceutical announced that it has completed enrollment of 20,100 children and adolescents ages 4 through 16 in its global, pivotal Phase III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial, a double-blind, randomized and placebo-controlled study designed to evaluate the efficacy, safety and immunogenicity of its live-attenuated tetravalent dengue vaccine candidate (TAK-003). Takeda initiated the TIDES trial, the largest vaccine clinical trial for Takeda to date, in September 2016 and completed enrollment in less than seven months.

 

Kura Oncology announced the presentation of preclinical data for KO-947, its development candidate targeting the ERK1/2 kinases, and KO-539, its development candidate targeting the menin-MLL interaction, at the American Association for Cancer Research (AACR) Annual Meeting 2017.

 

InVivo Therapeutics announced that a new patient has been enrolled into The INSPIRE Study (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury) at the Carolinas Medical Center in Charlotte, NC. Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates, Chief of Neurosurgery at the Carolinas Medical Center, and a member of the INSPIRE Study Steering Committee, performed the implantation with his partner, Byron Branch, M.D. Surgery was performed approximately 42 hours after the injury occurred. Dr. Coric and Dr. William Bockenek, Chief Medical Officer at Carolinas Rehabilitation, are Co-principal Investigators at this site.

 

Neothetics announced the issuance of U.S. Patent Number 9,597,531 by the USPTO.  This patent is directed to specific methods of using LIPO-202 and other agents for the reduction of fat accumulation. The ’531 patent is expected to expire no earlier than the fourth quarter of 2031, extending the coverage time of the company’s intellectual property portfolio. This is the eighth issued U.S. patent directed to Neothetics’ lead product candidate LIPO-202, which is being evaluated for the reduction of submental fat.

 

Fortress Biotech announced that the U.S. Department of Health & Human Services has confirmed the transfer of two FDA Orphan Drug Designations for CAEL-101 (also known as 11-1F4) from Columbia University to Fortress’ subsidiary, Caelum Biosciences. The two Orphan Drug Designations include the use of CAEL-101 as a therapeutic agent for patients with AL amyloidosis, and the use of CAEL-101 as a radio-imaging agent in amyloidosis. Caelum in-licensed CAEL-101 from Columbia in January 2017.

 

OncoMed Pharmaceuticals highlighted data presented during the American Association for Cancer Research (AACR) Annual Meeting related to its clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) and preclinical studies of rosmantuzumab (anti-RSPO3, OMP-131R10) and GITRL-Fc trimer (OMP-OMP-336B11).

 

Bio-Path Holdings announced results of preclinical in vitro and in vivo studies supporting the potential of BP1002 in the treatment of aggressive non-Hodgkin’s lymphoma (NHL). These results are being presented at the annual meeting of the American Association for Cancer Research (AACR) taking place in Washington, DC.

 

Agenus announced that the first patient has been dosed in a Phase I clinical trial of AutoSynVax (ASV), Agenus’ neoantigen vaccine. Preclinical data presented at the American Association for Cancer Research (AACR) 2017 Annual Meeting show ASV to be active and synergistic with checkpoint blockade.

 

Ligand Pharmaceuticals announced that it has entered into commercial License and Supply Agreements (License Agreement) with Marinus Pharmaceuticals, granting rights to use Ligand’s Captisol in the formulation of its intravenous (IV) ganaxolone. Captisol is a patent protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Marinus is preparing to initiate clinical trials with Captisol-enabled ganaxolone IV in patients with postpartum depression (PPD) and status epilepticus (SE).

 

Nimbus Therapeutics and Charles River Laboratories International launched a multi-year strategic partnership to advance new programs spanning the disease areas of immunology, metabolic disorders and oncology from the discovery phase through to IND submission.

 

Innovus Pharmaceuticals announced that it received the CPNP notification number required to commercialize Zestra Glide in all 28 member countries of the European Union. This represents the third Innovus Pharma product to receive CPNP notification in the European Union in the last two months, the others being for Zestra and Sensum+.

 

Acorda Therapeutics announced a corporate restructuring to reduce its cost structure and focus its resources on its two late-stage programs, CVT-301 and tozadenant, as well as on maximizing patient access to AMPYRA (dalfampridine) Extended Release Tablets, 10 mg at least through July 2018.

 

Aralez Pharmaceuticals announced that it has begun implementing a program of cost savings initiatives with the immediate aim of providing additional financial flexibility while maximizing the value of its assets. The plan includes a 32% reduction in the U.S. sales force and realignment of certain financial resources to support a successful phased launch of Zontivity that is expected to begin in mid-April, together with a significant decrease in marketing spend on Yosprala. The Company has also commenced other initiatives that are expected to reduce spending across the business, some of which were already assumed in the Company’s previously issued financial guidance, and is in the process of finalizing its overall cost savings plan. The Company intends to communicate details of this plan in its first quarter 2017 earnings release to be issued in early May 2017.

 

Idera Pharmaceuticals reported additional clinical translational and pre-clinical data from its ongoing intratumoral IMO-2125 development program at the AACR 2017 Annual Meeting being held in Washington, DC. In the poster presentation entitled, “Translational evidence of reactivated innate and adaptive immunity with intratumoral IMO-2125 in combination with systemic checkpoint inhibitors from a Phase I/II study in patients with anti-PD-1 refractory metastatic melanoma,” Cara Haymaker, Ph.D. from the University of Texas, MD Anderson Cancer Center, presented an update on the translational findings from the ongoing Phase I/II trial of intratumoral IMO-2125 in combination with ipilimumab in patients with anti-PD-1 refractory metastatic melanoma.

 

Immunomedics reported that sacituzumab govitecan (IMMU-132), the Company’s lead antibody-drug conjugate (ADC), has activity and manageable toxicity in patients with advanced and heavily-pretreated metastatic small-cell lung cancer (SCLC).

 

RedHill Biopharma announced the signing of an exclusive license agreement withEntera Health, granting RedHill the exclusive U.S. rights to EnteraGam(2).

 

Oncolytics Biotech announced data demonstrating a statistically significant (p=0.03) overall survival (OS) benefit for patients with mutated p53 metastatic breast cancer, when treated with REOLYSIN, an immuno-oncology viral agent in combination with paclitaxel. Results from IND 213, an open-label, randomized, phase II study were presented at the Annual Meeting of the American Association of Cancer Research (AACR), April 1-5, 2017 in Washington, D.C.

 

Finch Therapeutics and Takeda Pharmaceuticals announced a global collaboration agreement to jointly develop FIN-524. FIN-524 is a live biotherapeutic product in pre-clinical research. It is composed of cultured bacterial strains that have been linked to favorable clinical outcomes in studies of microbiota transplantations in IBD. The collaboration combines Finch’s unique discovery platform with Takeda’s strength in drug development for gastrointestinal (GI) diseases to advance a new class of microbial therapy.

 

Endo International announced that it is seeking to refinance its existing credit facilities with new senior secured credit facilities consisting of a revolving credit facility and a term loan facility (the "New Credit Facilities"). Endo intends to use the net proceeds of the New Credit Facilities, together with the net proceeds of other debt (which may be secured), to repay all outstanding loans and other obligations under its existing credit facilities and for general corporate purposes (collectively, the "Transactions").  The New Credit Facilities are expected to be guaranteed by Endo and certain of its subsidiaries. These Transactions, if completed, would not be expected to materially change Endo’s total debt.

 

Geron announced a poster presentation by Janssen Research & Development describing non-clinical data on the telomerase inhibitor imetelstat at the 2017 American Association for Cancer Research (AACR) Annual Meeting held in Washington, D.C. from April 1-5, 2017.

 

Bristol-Myers Squibb announced that the FDA accepted a sBLA that seeks to extend the use of Opdivo (nivolumab) to patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. The FDA granted the application priority review, and the FDA action date is August 2, 2017.

 

Blueprint Medicines announced the closing of its previously announced underwritten public offering of 5,750,000 shares of its common stock at a public offering price of $40.00 per share, including the exercise in full by the underwriters of their option to purchase additional shares of common stock. Blueprint Medicines estimates net proceeds from the offering will be approximately $215.6 million, after deducting underwriting discounts and commissions and estimated offering expenses. Goldman SachsMorgan Stanley and Cowen acted as joint book-running managers for the offering. Raymond James is acting as co-manager for the offering.

 

Evotec AG announced that its strategic alliance (TargetBCD) with Sanofi in the field of diabetes has reached an important milestone, triggering a payment of EUR 3.0M to Evotec, for achieving pre-clinical proof-of-concept. This milestone was achieved under the agreement between Evotec and Sanofi signed in August 2015. The goal of this collaboration is to develop a beta cell replacement therapy based on functional beta cells derived from human stem cells. In addition, Sanofi and Evotec also aim to use human beta cells for high-throughput drug screening to identify small molecules or biologics beneficial for beta cell activity.

 

Adaptimmune Therapeutics announced that it has entered into a definitive agreement with Matrix Capital Management to purchase an aggregate of approximately $42,000,000 of its American Depositary Shares (“ADSs”) in a registered direct offering. The transaction was completed from the company’s shelf registration at $6.00 per ADS, a premium of approximately 3% to the closing ADS trade price on April 3(rd). The closing of this offering is expected to take place on or about April 10, 2017, subject to the satisfaction of customary closing conditions.

 

 

ANALYST RECOMMENDATIONS

 

Bernstein analyst Ronny Gal made price target changes to the following companies:Bayer to EUR125 from EUR122; Amgen to $178 from $170. 

 

Cowen analyst Tyler Van Buren initiated coverage of Neos Therapeutics with an “outperform” rating and $20 price target, citing Neos has two approved drug products, generic Tussionex and Adzenys XR-ODT, and two more candidates that will likely receive approval later this year.

 

Wedbush analyst David Nierengarten increased his price target of Blueprint Medicines to $50 from $43, citing BLU-667’s high selectivity and potent activity will allow rapid proof of concept in a targeted population and with a better safety profile than multi-kinase inhibitor therapies targeting RET.

 

Jefferies analyst Eun Yang downgraded Amgen to “hold” from “buy” and decreased her price target to $180 from $194, citing continuing Repatha reimbursement challenges from payor poll, scarcity of blockbuster potential pipeline products, unabating drug price pressure & unlikely transformative M&A.

 

Cowen analyst Steve Scala upgraded Roche to “outperform” from “market perform” and increased his price target to $38 from $35, citing exciting new products, positive recent news flow, and a potentially better position in IO than generally perceived provide opportunity for upside in EPS estimates, and could fuel PE multiple expansion.

 

SunTrust analyst Ed Nash upgraded Sarepta to “buy” from “hold,” citing the encouraging long-term cardiac and pulmonary function data that SRPT presented at the MDA Scientific Conference could provide additional support for the clinical benefit from Exondys 51 treatment.

 

Goldman analyst Terence Flynn increased his price of Vertex to $121 from $78, citing the Teza Phase III data should expand VRTX’s CF market opportunity by offering an improved profile in F508del homozygous patients (~45% of population) relative to Orkambi and providing a treatment option for patients with residual function mutations.

 

Cowen analyst Steve Scala downgraded Novartis to “market perform” from “outperform” and decreased his price target to $77 from $87, citing current weakness in Alcon with no quick fix, Entresto’s slow rollout, Kisqali’s uncompetitive label, few major new pipeline opportunities, and below industry average growth prospects.