BioShares Biotechnology Clinical Trials (BBC): $21.73, -$0.28, -25.2% YTD
BioShares Biotechnology Products (BBP): $32.83, -$0.10, -6.5% YTD
U.S. stock index futures rose as investors saw less chance of Republican nominee Donald Trump winning next month’s presidential election. Employment-trends for September is on the economic calendar. Deutsche Bank’s shares weighed on European stock markets, while Asian shares eked out minor gains. The pound dropped against the dollar, boosted by expectations the Federal Reserve will raise interest rates in December. Gold rebounded from its weakest week since November as Chinese buyers returned after the Golden Week holiday. Oil prices pared losses.
Onconova Therapeutics announced that it will host a Key Opinion Leader lunch discussion on novel approaches to targeting the RAS Pathway in oncology, including the Company’s late-stage drug candidate, rigosertib, a small molecule that inhibits cellular signaling by interacting with the RAS-binding domain (RBD) of RAS effector proteins. The event and live webcast will take place on Monday, October 17 in New York City.
Mateon Therapeutics announced that the U.S. Patent and Trademark Office has issued U.S. Patent 9,458,103 to Mateon and Baylor University for “Compositions and methods for inhibition of cathepsins.” The patent covers compounds which modulate cathepsin activity, particularly cathepsin L or cathepsin K, and methods of using these compounds for the treatment of conditions in which their regulation may be therapeutically useful.
Rexahn Pharmaceuticals today announced preliminary efficacy data for RX-3117 in an ongoing Phase Ib/IIa clinical trial in patients with metastatic pancreatic cancer and provided an update on the Phase I clinical trial with Supinoxin™ (RX-5902) at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen, Denmark.
OncoSec Medical will present a corporate overview at the 15th Annual BIO Investor Forum on October 19, and the Annual Sofinnova Japan Biopharma Partnering Conference on October 25.
TRACON Pharmaceuticals announced final updated results from a Phase 1b clinical trial combining TRC105 with Inlyta® (axitinib) in patients with advanced or metastatic renal cell carcinoma (RCC). Data were presented today at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark. Preliminary data from this trial were previously presented at the Kidney Cancer Association meeting in November 2015 and the ASCO Genitourinary Cancers Symposium in February 2015.
Bristol-Myers Squibb Company and Innate Pharma SA announced safety data for two Phase I studies conducted by Bristol-Myers Squibb, testing lirilumab in combination with nivolumab or ipilimumab, respectively, in patients with advanced refractory solid tumors. Lirilumab is a first-in-class antibody directed against the inhibitory killer-cell immunoglobulin-like receptors (KIRs) expressed predominantly on natural killer (NK) cells and some T cells. It was licensed by Innate to Bristol-Myers Squibb and is being studied for its potential to complement nivolumab or ipilimumab, which act on different cell types and via different mechanisms of action. The safety profile of the combination of lirilumab and nivolumab therapy was similar to that of nivolumab monotherapy, with the exception of an increased frequency of low grade infusion-related reactions in patients treated with the lirilumab combinations. These reactions were clinically managed and similar to those seen with lirilumab alone. In the limited population (22 patients) studied for the combination of lirilumab and ipilimumab, there did not appear to be additional safety concerns compared to ipilimumab monotherapy. Based on these data, further evaluation of lirilumab in combination with nivolumab is warranted. Efficacy data from the lirilumab and nivolumab combination study will be reported separately.
Reuters reported that Tesaro’s experimental drug niraparib improved outcomes for all women with recurrent ovarian cancer in a clinical study, boosting prospects for the product, part of a closely watched class of new medicines called PARP inhibitors. The finding suggests that a Myriad Genetics companion diagnostic test, designed to select suitable patients, may not be necessary. Following the news, Leerink analyst Seamus Fernandez increased his price target to $115 from $108; RBC analyst Adnan Butt increased his price target to $128 from $122; Credit Suisse analyst Alethia Young increased her price target to $122 from $90; Guggenheim analyst Tony Butler increased his price target to $112 from $102; Baird analyst Michael Ulz increased his price target to $120 from $105; FBR analyst Ed White increased his price target to $115 from $102; Wells Fargo analyst Jim Birchenough increased his valuation range to $151-$165 from $122-$132; Wedbush analyst David Nierengarten increased his price target to $139 from $107; Citi analyst Robyn Karnauskas increased her price target to $125 from $120; Bank of America/Merrill Lynch analyst Tazeen Ahmad upgraded the stock to “buy” from “neutral” and increased her price target to $123 from $97.
Mylan N.V. announced that its subsidiary, Mylan Inc., has agreed to the terms of a $465 million settlement with the DOJ and other government agencies that will resolve questions that have been raised about the classification of EpiPen Auto-Injector and EpiPen Jr Auto-Injector for purposes of the Medicaid Drug Rebate Program. The terms of the settlement do not provide for any finding of wrongdoing on the part of Mylan Inc. or any of its affiliated entities or personnel.
Bristol-Myers Squibb announced superior efficacy with Yervoy 10 mg/kg versus placebo on all survival endpoints in the Phase III trial CA184-029 (EORTC 18071) evaluating stage III melanoma patients who are at high risk of recurrence following complete surgical resection. In the study, Yervoy compared with placebo significantly improved overall survival (OS) (HR=0.72 [95.1% CI: 0.58-0.88; p=0.001]), a secondary endpoint, with five-year OS rates at 65.4% in the Yervoy group and 54.4% in the placebo group. Distant metastasis-free survival (DMFS), a secondary endpoint, was also significantly improved versus placebo (HR=0.76 [95.8% CI: 0.64-0.92; p=0.002]) and had five-year DMFS rates of 48.3% and 38.9% in the Yervoy and placebo groups, respectively.
Merck announced positive findings from the Phase II KEYNOTE-052 study investigating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in previously untreated patients with unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. Data presented at the ESMO 2016 Congress, the annual meeting of the ESMO, showed an overall response rate (ORR) of 24 percent (n=24/100) (95% CI, 16-34) in the total study population, which included patients with and without PD-L1 expression.
Peregrine Pharmaceuticals reported that top-line data from the Phase III SUNRISE trial of bavituximab in patients with previously treated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) were presented in an oral presentation at the European Society for Medical Oncology (ESMO) 2016 Congress. The presentation included interim efficacy and safety outcomes, as well as initial findings from the company’s ongoing biomarker analysis of samples collected during the study. The SUNRISE Phase III trial was discontinued earlier this year based on a pre-specified interim analysis although patient treatment and follow-up in the study were allowed to continue. The pre-planned biomarker analysis has been taking place as patient follow-up has continued and available results were evaluated as part of the recent top-line data analysis.
Cascadian Therapeutics announced the presentation of clinical activity of tucatinib, its investigational, highly selective small molecule HER2 inhibitor, in combination therapy at the European Society for Medical Oncology (ESMO) 2016 Congress being held October 7-11, 2016 in Copenhagen, Denmark.
Exelixis announced detailed results from the CABOSUN randomized Phase II trial of cabozantinib in patients with previously untreated advanced renal cell carcinoma (RCC) with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC).
ZIOPHARM Oncology announced the presentation of preliminary data from the Company’s Phase Ib/II study of Ad-RTS-hIL-12 + veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer. The poster presentation, titled "Phase Ib/II study of intratumoral Ad-RTS-hIL-12+veledimex in patients with chemotherapy-responsive locally advanced or metastatic breast cancer," was presented at the European Society for Medical Oncology (ESMO) 2016 Congress today in Copenhagen, Denmark.
Cellceutix announced interim results observed for the first four patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), a type of Inflammatory Bowel Disease (IBD). Clinically meaningful improvements were demonstrated, as measured by physician assessments, patient reported outcomes and endoscopic evaluation of disease activity.
Alnylam Pharmaceuticals announced that the Data Monitoring Committee (DMC) for the Phase III APOLLO study of patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy (hATTR-PN) met on October 7, 2016 and recommended continuation of the trial without modification. The APOLLO DMC met at the request of the Company following the decision — announced on October 5, 2016 — to discontinue development of revusiran for the treatment of hereditary ATTR amyloidosis with cardiomyopathy (hATTR-CM). The DMC will continue to meet periodically per their remit to monitor the overall safety of patisiran in the APOLLO study through its completion.
Corvus Pharmaceuticals announced biomarker findings from its ongoing Phase I/Ib study of CPI-444 as a single agent and in combination with Genentech‘s TECENTRIQ (atezolizumab), a fully humanized monoclonal antibody targeting protein programmed cell death ligand 1 (PD-L1). CPI-444 is a selective and potent inhibitor of the adenosine A2A receptor. The data were presented in a poster session by Ian McCaffery, Ph.D., vice president, Translational Sciences at Corvus, at the European Society for Medical Oncology (ESMO) 2016 Congress at the Bella Center in Copenhagen, Denmark.
Galena Biopharma presented interim safety data from the Company’s NeuVax (nelipepimut-S) Phase IIb combination study with trastuzumab at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark. The clinical trial is a randomized, multicenter, investigator-sponsored, 300 patient Phase IIb study. It is currently enrolling HER2 1+ and 2+ node positive, and high-risk node negative patients to study NeuVax in combination with trastuzumab to prevent breast cancer recurrence.
Medivir AB announces a reorganization of the company and a significant cost reduction in both early research and administrative functions. The board has decided that the company onwards will have an exclusive focus on oncology, utilizing both of Medivir’s technology platforms and competences in protease inhibition and nucleotide-/nucleoside science. Partnering discussions for all remaining infectious disease assets in the R&D pipeline will be initiated by year-end, as well as for MIV-711 once the Phase IIa program has been completed.
Janssen-Cilag International NV presented the first reported primary treatment outcome data from The Prostate Cancer Registry, Europe’s first and largest prospective study of men with metastatic castration-resistant prostate cancer (mCRPC), at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen, Denmark. The preliminary data suggest that chemotherapy-naïve patients benefit more from treatment than post-chemotherapy patients, and that after first line docetaxel treatment, patients have a higher prostate-specific antigen (PSA) response when treated with androgen receptor-targeted agents than with taxanes.
Novo Nordisk announced that it has received a CRL from the FDA regarding the NDA for faster-acting insulin aspart. In the letter, the FDA requests additional information related to the assay for the immunogenicity and clinical pharmacology data before the review of the nda can be completed. Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to resolve the outstanding issues.
Genmab A/S announced that the FDA has granted Priority Review to the sBLA for the use of daratumumab (DARZALEX(r)) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. The sBLA was submitted by Genmab’s licensing partner, Janssen Biotech in August 2016.
Ligand Pharmaceuticals partner Lundbeck announced that the FDA has approved Carnexiv (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv received orphan drug designation for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Lundbeck plans to make Carnexiv commercially available in the United States in early 2017. With the approval, Ligand has earned a $1.25 million milestone payment. Ligand is also entitled to receive a royalty of 2.75% on net sales of Carnexiv.
Novartis announced data from the Phase III COMBI-v study demonstrating an overall survival (OS) and a progression-free survival benefit for patients with BRAF V600 mutation-positive advanced melanoma when treated first-line with the combination of Tafinlar (dabrafenib) + Mekinis (trametinib) compared to vemurafenib monotherapy. The results of this study, which was conducted in 704 patients, are being presented at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen.
Boehringer Ingelheim announced results from the LUX-Lung 7 trial that directly compared the efficacy and safety of second-generation EGFR-directed therapy afatinib* (Giotrif) and first-generation gefitinib (Iressa), in the first-line treatment of patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). The trial investigated overall survival (OS) as a primary endpoint and a reduction in the risk of death (14%) was observed for patients treated with afatinib versus gefitinib. The median survival of patients treated with afatinib was 27.9 months compared to 24.5 months for those receiving gefitinib, without reaching significance. The OS outcomes observed with afatinib were consistent across common EGFR mutation types.
Genentech, a member of the Roche Group, announced data from the positive, pivotal Phase III OAK study of TECENTRIQ (atezolizumab) at the ESMO 2016 Annual Meeting in Copenhagen, Denmark. The study showed TECENTRIQ helped people live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62 – 0.87). The OAK study evaluated people with non-small cell lung cancer (NSCLC) whose disease had progressed on or after treatment with one or more platinum-based chemotherapy (second-line and third-line). The study enrolled people regardless of their programmed death-ligand 1 (PD-L1) status and included both squamous and non-squamous disease types. Adverse events (AEs) were consistent with those observed in previous TECENTRIQ studies.
Dynavax Technologies announced the first presentation of findings from an ongoing Phase I/II study evaluating SD-101, Dynavax’s intratumoral TLR9 agonist, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 treatment. Early results evaluating five patients with metastatic melanoma for efficacy and 16 patients for safety were reported. In patients naïve to anti-PD-1 treatment objective responses were observed in three out of four (75%) including one complete response (CR) and two partial responses (PR’s). One patient with progressive disease while receiving anti-PD-1 therapy was observed to have stable disease (SD). These data were presented in a poster session on Sunday at the ESMO Annual Congress 2016 in Copenhagen, Denmark.
Adaptimmune Therapeutics announced a poster presentation of updated data on its lead clinical program, an NY-ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell receptor therapy, in patients with synovial sarcoma at the ESMO 2016 Congress.
Pfizer announced data from an ongoing, investigational Phase Ib study of INLYTA (axitinib) combined with the checkpoint inhibitor pembrolizumab (A4061079, NCT02133742), a PD-1 inhibitor known as KEYTRUDA and marketed by Merck, in treatment-naïve patients with advanced renal cell carcinoma (RCC). The study was designed to establish dosing and evaluate the safety and anti-tumor activity of INLYTA when combined with pembrolizumab in first-line treatment of advanced RCC. Preliminary results from a similar, separate study combining INLYTA with avelumab (JAVELIN Renal 100, NCT02493751), an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody that is being co-developed by Merck KGaA and Pfizer were also presented. The data suggest evidence of anti-tumor activity for INLYTA in combination with avelumab and were presented during a poster discussion session at the ESMO 2016 Congress.
Ablynx announced that the first patient with acquired thrombotic thrombocytopenic purpura (aTTP), who completed the Phase III HERCULES study of caplacizumab, has rolled-over into a three-year follow-up study.
Nicox S.A. announced that it has received a CRL from the FDA regarding the NDA for AC-170, its novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis. The FDA’s stated reason for the CRL pertains solely to a Good Manufacturing Practice (GMP) inspection at a third party facility producing the active pharmaceutical ingredient (API) cetirizine and supplying it to the manufacturer of the finished product. The safety and efficacy data submitted by Nicox in the AC-170 NDA have not resulted in the FDA requesting any further clinical or non-clinical testing for the approval of the AC-170 NDA. Furthermore, the CRL did not include any concerns related to the finished product manufacturing facility.
Pfizer announced results from the Phase III S-TRAC clinical trial (Sunitinib Trial as Adjuvant Treatment of Renal Cancer) investigating SUTENT (sunitinib) as adjuvant therapy. The trial showed SUTENT extended disease-free survival (DFS) by more than one year versus placebo in patients who were at high risk for recurrence after surgical resection of renal cell carcinoma (RCC) (HR 0.761; P=0.030 [95% CI: 0.594-0.975]). These results will be presented during a Presidential Symposium (Abstract #LBA11_PR) at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology being held in Copenhagen, Denmark. The results have also been published online by The New England Journal of Medicine.
ARIAD Pharmaceuticals announced updated clinical data on its investigational tyrosine kinase inhibitor (TKI), brigatinib, in patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) from an ongoing Phase I/II trial.
Xenetic Biosciences announced positive topline data from the third cohort of its Phase II dose-escalation study with its lead drug candidate ErepoXen for the treatment of anemia in pre-dialysis chronic kidney disease patients. This trial is being conducted for Xenetic by Novotech (Australia) Pty Ltd.
Endocyte presented poster updates on its two lead clinical programs at the European Society for Medical Oncology (ESMO) 2016 Congress, being held in Copenhagen, Denmark October 7-11, 2016.
Crescendo Biologics Limited and Takeda Pharmaceutical Company Limited announced a global, strategic, multi-target collaboration and license agreement for the discovery, development and commercialization of Humabody -based therapeutics for cancer indications with a high unmet medical need.
Genomic Health announced results from eight Oncotype DX Breast Recurrence Score (RS) presentations at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, highlighting superior clinical evidence in identifying which patients with node-negative and node-positive invasive breast cancer should be treated with chemotherapy. Specifically, prospective clinical outcomes in more than 7,400 patients with node-positive invasive breast cancer from two independent studies show excellent survival in women with RS results less than 18.
Dr. Reddy’s Laboratories announced that it has launched Lamotrigine Orally Disintegrating Tablets in 25 mg, 50 mg, 100 mg, and 200 mg, a therapeutic equivalent generic version of Lamictal ODT (lamotrigine) Orally Disintegrating Tablets in the United States market approved by the FDA.
OncoMed Pharmaceuticals announced the presentation of interim clinical data from its ongoing Phase Ib trials of ipafricept (FZD8-Fc, OMP-54F28) and vantictumab (anti-Fzd, OMP-18R5) at the European Society of Medical Oncology (ESMO) 2016 Congress.
Cerus announced that Hemolife Fundación Banco Nacional de Sangre (Hemolife) is now offering INTERCEPT-treated pathogen reduced platelet units to its hospitals.
PharmaMar announced the positive results of its Phase II study of lurbinectedin (PM1183) in patients with BRCA 1 / 2 -associated metastatic breast cancer, who had previously received a maximum of 3 prior chemotherapy regimens.
Aprea Therapeutics AB announced that it enrolled the first patients in the Phase II part of the ongoing clinical study of APR-246 for the treatment of high-grade serous ovarian cancer.
Aprea Therapeutics AB presented clinical data from the Phase Ib part of the ongoing PiSARRO Phase Ib/II clinical study in collaboration with the European Network for Translational Research in Ovarian Cancer (EUTROC). The Phase Ib portion of the PiSARRO clinical study investigated the safety and efficacy of APR-246 in combination with carboplatin and pegylated liposomal doxorubicin (PLD) in patients with relapsed, p53-mutated high-grade serous ovarian cancer.
RedHill Biopharma announced that a Phase II clinical study evaluating YELIVA (ABC294640) in patients with advanced hepatocellular carcinoma (HCC) has been initiated, with enrollment expected to commence shortly, pending final regulatory clearance.
The following analysts revised their price target of Myriad Genetics, citing a disappointing setback and the company’s myChoice HRF; Ladenburg Thalmann analyst Kevin DeGeeter downgraded the stock to “sell” from “neutral” and established a $16 price target; Barclays analyst Jack Meehan decreased his price target to $22 from $24.
Chardan analyst Gbola Amusa decreased his price target of Novartis to $92 from $95, citing adjusted LEE011 revenues following safety concerns.
Mizuho analyst Irina Koffler decreased her price target of Ironwood Pharmaceuticals to $19 from $24, citing a slower Zurampic launch, and greater R&D spend on sGC along with the positive impact of a debt refinancing announcement.
Raymond James analyst Elliot Wilbur upgraded Mylan to “strong buy” from “market perform” and established a $57 price target, citing negative headlines around EpiPen pricing practices and concerns over deteriorating generic pricing have driven multiple levels to 20-year lows
RBC analyst Adnan Butt increased his price target of Seattle Genetics to $62 from $55 to reflect SGEN’s potential as a multi-product, multi-modality, cancer therapeutics company, with multiple potential blockbuster products with pivotal data pending.
JMP analyst Liisa Bayko increased her price target of Incyte to $110 from $100 based on increased POS for epacadostat in melanoma from 60% to 70%; and based on emerging PFS data, increased the treatment months to 12, vs. nine months of treatment previously.
Leerink analyst Geoffrey Porges assumed coverage of Epizyme with a “buy” rating and $39 price target, citing the proprietary platform for developing inhibitors of histone methyltransferases, an important class of enzymes that control gene expression.
Leerink analyst Michael Schmidt assumed coverage of OncoMed with a “market perform” rating and $13 price target, citing OMED presented encouraging Phase Ib updates on ipafricept and vantictumab in combination with Gem/Abraxane in pancreatic cancer at ESMO this weekend.