Dec. 10, 2014, 9:14 AM
- In a presentation at the San Antonio Breast Cancer Symposium, Merck's (NYSE:MRK) PD-1 inhibitor Keytruda (pembrolizumab) shows an overall response rate of 18.5% in patients with PD-L1 positive, advanced triple-negative breast cancer, one of the most aggressive forms of breast cancer, in a Phase 1b trial. Most of the patients in the study had received two or more prior chemotherapies for metastatic disease and 87.5% had received prior neo-adjuvant or adjuvant therapy.
- Five patients (18.5%) responded to pembrolizumab out of the 27 who were evaluable. One (3.7%) had a complete response and four (14.8%) showed a partial response. Seven patients (25.9%) showed stable disease. 33% of patients achieved tumor shrinkage. At six months, progression-free survival (PFS) was 23.3%.
- At the time of analysis, the median duration of response had not been reached in three of five responders on therapy for 11 months or longer. The mean time to response was 18 weeks.
- Merck intends to start a Phase 2 trial in 1H 2015.
- PD-1 inhibitors are considered by many observers to be the most promising immunotherapeutic weapons in the fight against cancer.
- Previously: Merck PD-1 inhibitor extends PFS in melanoma (Nov. 17, 2014)
Dec. 9, 2014, 7:14 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Moventig (naloxegol) for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxatives. It is the first once-daily oral peripherally -acting mu-opioid receptor agonist (PAMORA) approved in the EU.
- Moventig is part of an exclusive worldwide license agreement initiated in 2009 with Nektar Therapeutics (NASDAQ:NKTR). The product utilizes Nektar's oral small molecule polymer conjugate technology.
- Previously: Ad Comm supports approval of Moventig for OIC (Sept. 26, 2014)
- Previously: FDA clears OIC drug (Sept. 16, 2014)
- OIC-related tickers: (NASDAQ:PGNX) (NASDAQ:CBST) (NASDAQ:SLXP) (NASDAQ:SGYP)
Dec. 8, 2014, 6:11 PM
- The judge handling Cubist's (NASDAQ:CBST) infringement suit against Hospira (NYSE:HSP) over a generic version of Cubist's Cubicin has ruled several of Cubist's patent claims are invalid.
- Commenting on the ruling, Evercore ISI thinks Hospira will be able to launch a generic version of the drug by June 2016 in a "worst-case scenario." Cubist received a favorable ruling regarding its patent claims last year.
- Merck (NYSE:MRK), which announced this morning it's buying Cubist for $9.5B, is down 1.4% AH. Cubist is down 2.1%, and Hospira is up 2.3%.
Dec. 8, 2014, 5:04 PM
- Amgen (NASDAQ:AMGN) and Merck (NYSE:MRK) initiate a collaborative study to evaluate the safety and efficacy of the former's talimogene laherparepvec and the latter's Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma.
- The study will have two phases: Phase 1 will determine the safety and tolerability of talimogene laherparepvec in combination with Keytruda in patients with previously untreated, unresected stage IIIB to IVM1c melanoma. The second phase will be randomized to evaluate the safety and efficacy of the two drugs. Approximately 110 patients will be enrolled across 35 sites in the U.S., Europe and Australia.
- Pembrolizumab is a PD-1 inhibitor. Talimogene laherparepvec is designed to promote tumor antigen release to initiate an anti-tumor immune response which may be complimentary to pembrolizumab's role in releasing PD-1 pathway-mediated inhibition of anti-tumor immune responses.
- The FDA recently accepted for review Amgen's BLA for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma. The PDUFA date is July 28, 2015. An MAA has also been submitted in Europe.
- Previously: Amgen submits MAA for cancer immunotherapeutic (Sept. 2, 2014)
Dec. 8, 2014, 1:23 PM
- Micro cap Cellceutix (OTCPK:CTIX +22.1%) jumps on a 5x surge in volume after the FDA grants Qualified Infectious Disease Product (QIDP) status to Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The company is scheduled to meet with the FDA later this month on a planned Phase 3 trial evaluating the safety and efficacy of Brilacidin for ABSSSI.
- Brilacidin is a member of a new class of antibiotics called defensin-mimetics, which are modeled after host defense proteins. These are the "front line" of defense in the human immune system.
- In a Phase 2b clinical trial, a single dose of Brilacidin demonstrated equivalent effectiveness as a seven-day regimen of daptomycin (CBST +35.4%) for the treatment of ABSSSI.
- Among the benefits of QIDP is Fast Track and Priority Review status and a five-year period of market exclusivity if approved.
Dec. 8, 2014, 12:45 PM
Dec. 8, 2014, 12:37 PM
- Biotech investors are giving Seattle Genetics (SGEN -8.4%) the cold shoulder today on increased volume. It appears that all the love is being directed to the potential of competitors' PD-1 inhibitors in fighting cancer despite the company's presentations at the American Society of Hematology meeting of positive results for Adcetris (brentuximab vedotin), an antibody-drug conjugate directed to CD30 in Hodgkin lymphoma (HL).
- Long-term data from a Phase 1 trial of Adcetris combined with AVD (adriamycin, vinblastine, dacarbazine) demonstrated a 100% overall survival rate at year three and 92% failure-free survival rate at year 3 in frontline HL.
- Adcetris in combination with bendamustine as a second-line therapy demonstrated an objective response rate of 96% and a complete remission rate of 83% in patients with relapsed or refractory HL.
- In a Phase 2 trial in previously untreated HL patients aged 60 and older, Adcetris showed a 93% objective response rate.
- The company is collaborating with Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY) on the development of the product.
- Previously: Positive results in Adcetris Phase 3 label expansion trial (Sept. 29, 2014)
- PD-1 inhibitor-related tickers: (BMY +0.2%)(FPRX +4.8%)(MRK -0.2%)(CELG +4.2%)(OTCQX:RHHBY -0.5%)(AZN -0.6%)
Dec. 8, 2014, 7:20 AM
- Merck (NYSE:MRK) acquires Cubist Pharmaceuticals (NASDAQ:CBST) for $102 per share in cash or ~$9.5B. The equity value is $8.4B plus $1.1B in debt.
- CBST +34.5% to $99.98, MRK +0.15% premarket
- Previously: Merck close to $7B deal to acquire Cubist Pharmaceuticals (Dec. 7, 2014)
Dec. 7, 2014, 5:27 AM
- Merck (NYSE:MRK) is in talks to buy Cubist Pharmaceuticals (NASDAQ:CBST), in a deal valued at more than $7B, Bloomberg reports.
- Merck would pay about $100 per share. An offer in that range would represent a 34% premium over Cubist’s closing price on Dec. 5.
- An agreement could be announced as early as this week.
Dec. 5, 2014, 1:57 PM
- As expected, the Biotechnology Industry Organization (BIO) gives a resounding thumbs up in support of adding Ebola to the FDA Priority Review Voucher Program Act. Under the act, developers of a vaccine or treatment for a qualified tropical disease receive a voucher for FDA priority review for another product of its choice.
- Late Wednesday, the U.S. House of Representatives voted unanimously to add Ebola to the Act. Additional refinements to the legislation include making it easier for the Secretary of Health and Human Services to add to the list of qualified diseases, allowing the vouchers to be sold and transferred multiple times and shortening the timeline for notifying the FDA of the intention to use a priority review voucher.
- The changes bring the tropical diseases priority review voucher program more in line with the rare pediatric disease priority review voucher program.
- Ebola-related tickers: (GSK +0.2%)(JNJ +0.5%)(MRK +1%)(NLNK +2.2%)(TKMR -1.4%)(HEB +0.6%)(SRPT -0.8%)(BCRX +0.8%)(CMRX +3.2%)
Dec. 5, 2014, 12:48 PM
- At the Melanoma Bridge conference in Italy, OncoSec Medical (OTCQB:ONCS -1.8%) Chief Scientific Officer Dr. Robert Pierce presented six-month data from the first Phase 2 clinical trial of the company's investigational intratumoral plasmid IL-12 IL-12 electroporation (pIL-12 EP) monotherapy (ImmunoPulse IL-12) in patients with Stage III and IV metastatic melanoma.
- Tumor response were evaluated using modified RECIST criteria for cutaneous lesions. The primary endpoint was best overall response rate (bORR) by modified RECIST. In the 29 response-evaluable patients, bORR was 31% (9/29) while 14% (4/29) achieved a complete response.
- Based on these data, the company plans to initiate a Phase 2b trial to evaluate ImmunoPulse IL-12 with Merck's (MRK +1.4%) Keytruda (pembrolizumab).
Dec. 5, 2014, 7:19 AM
- Doctors say that simple intravenous fluid drips could save the lives of many Ebola patients, but they are not being deployed due to a perception that no treatment will work. Many patients are succumbing to extreme dehydration and electrolyte depletion caused by vomiting and diarrhea, according to Ian Roberts of the London School of Hygiene and Tropical Medicine and Anders Perner of Copenhagen University. "Ebola treatment must be more that just a setting for quarantine. Patients will be reluctant to attend treatment centers unless the care they receive...is superior to the care provided by family members."
- The epidemic in West Africa has claimed more than 6,000 lives out of ~17,000 that have been infected. All but 15 of the deaths have occurred in Sierra Leone, Guinea and Liberia.
- ETFs: IRY, IXJ
- Ebola-related tickers: (NYSE:GSK) (NYSE:JNJ) (NYSE:MRK) (NASDAQ:NLNK) (OTCQB:AEMD) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:SRPT) (NASDAQ:BCRX)
Dec. 4, 2014, 8:23 AM
- In a Phase 1 trial sponsored by the University of Oxford, 30 healthy volunteers will receive Bavarian Nordic's MVA-BN Filo booster vaccine in combination with the monovalent cAd3-EBO Z Ebola vaccine co-developed by GlaxoSmithKline (NYSE:GSK) and the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). Recent preclinical research suggests that employing an MVA-based booster dose may deliver a more robust and durable immune response to the primary vaccine.
- The study involves 60 healthy adults divided into three cohorts each receiving different doses of the cAd3-EBO Z vaccine. Half of each cohort will also receive the booster dose of MVA-BN Filo.
- The primary endpoint is safety and tolerability. The secondary endpoint is the cellular and humoral immune response. Preliminary results should be available in 1H 2015.
- Both cAd3-EBO Z and MVA-BN Filo have been developed in collaboration with NIAID, which also investigated the prime boost regimen of MVA-BN Filo and Crucell Holland B.V.'s AdVac technology. Crucell is part of J & J (NYSE:JNJ) unit Janssen Pharmaceuticals. Bavarian Nordic and Janssen are collaborating on the development and manufacture of large quantities of their vaccine regimen and intend to start clinical trials shortly.
- Related tickers: (NYSE:MRK) (NASDAQ:NLNK)
Nov. 28, 2014, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Nov. 25, 2014, 1:42 PM
- OncoSec Medical (OTCQB:ONCS +13.5%) and the University of California, San Francisco enter into a clinical collaboration to evaluate the safety, tolerability and efficacy of the combination of Merck's (MRK +0.6%) Keytruda (pembrolizumab) and OncoSec's ImmunoPulse (intratumoral IL-12) in metastatic melanoma.
- Immunopulse is an investigational intratumoral therapy that uses plasmid DNA that encodes for Interleukin-12 and delivers it directly into the tumor via a proprietary electroporation device.
- The collaboration will be a Phase 2 trial that will commence in Q1 2015. Merck will supply pembrolizumab and OncoSec will supply the electroporation devices and plasmid IL-12.
Nov. 25, 2014, 1:07 PM
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