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News Breaks
August 25, 2014
05:17 EDTMRK, ADXSAdvaxis, Merck enter clinical trial collaboration agreement
Advaxis (ADXS) has entered into a clinical trial collaboration agreement with Merck (MRK), through its subsidiaries, to evaluate the combination of Advaxis's Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck's investigational anti PD-1 antibody, pembrolizumab. The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer. Both ADXS-PSA and pembrolizumab are investigational members of a new class of cancer treatments known as immunotherapies that are designed to enhance the body's own defenses in fighting cancer. Preclinical evidence suggests that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response.
News For ADXS;MRK From The Last 14 Days
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June 29, 2015
08:39 EDTMRKMerck says Phase 3 Emend data shows it provides 'greater protection' from nausea
Merck announced results from a Phase 3 study investigating the safety and efficacy of single-dose Emend for Injection, Merck’s substance P/neurokinin receptor antagonist, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting, or CINV, in adult cancer patients receiving moderately emetogenic chemotherapy, or MEC. In the study, the first to evaluate an intravenous NK-1 receptor antagonist for the prevention of CINV associated with MEC, the single-dose Emend for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines. These data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology Annual Meeting on “Supportive Care in Cancer” in Copenhagen.
June 25, 2015
07:34 EDTADXSAdvaxis provides milestones outlook for 2015 and 2016
The company anticipates the following milestones through the remainder of 2015 and into 2016 for ADXS-HPV: Commence enrollment in the Phase 3, registration quality trial, AIM2CERV; Complete enrollment in Stage 2 of the ongoing GOG-0265 Phase 2 trial of ADXS-HPV in persistent or recurrent cervical cancer being conducted by the Gynecologic Oncology Group, anticipating up to 38 patients enrolled by June 30, 2016 with Final Stage 1 safety and efficacy data to be presented at an upcoming major medical meeting in 2015. Final study data to be available in the first half of 2017; Enroll the first patient this summer in a collaborative Phase 1/2 study of ADXS-HPV in combination with AstraZeneca/MedImmune's MEDI4736 in cervical cancer and HPV-associated head and neck cancer in second half of 2015 with data available in the first half of 2016; Complete enrollment in Part A of our Phase 1 study evaluating higher doses of ADXS-HPV immunotherapy and repeat cycles of treatment with data available from Part A in 2016. Complete enrollment of the Mount Sinai investigator-sponsored Phase 1/2 study of ADXS-HPV in patients with HPV-associated head and neck cancer. Data to be available in the first half of 2016; Commence enrollment in a Phase 2 study in patients with HPV-associated metastatic anal cancer by year's end with data available in the second half of 2016; Commence enrollment in the second half of 2015 on the Phase 1/2 combination study with Incyte Corporation's IDO-1 inhibitor. Expects to complete enrollment in Part A in the first half of 2016 in the Phase 1/2 study of ADXS-PSA as a monotherapy or in combination with Merck's anti-PD-1 therapy, Keytruda, in metastatic, castration-resistant prostate cancer. Data to be available in second half of 2016. Expects to enroll the first patient in a Phase 1 first-in-human trial of ADXS-HER2 in metastatic HER2 expressing solid tumors in the second half of 2015 with data to be available in the second half of 2016; Initiate a clinical study of ADXS-HER2 in pediatric osteosarcoma in partnership with the Children's Oncology Group in 2016; Secure conditional license for ADXS-HER2 for the treatment of canine osteosarcoma from the U.S. Department of Agriculture in 2016.
June 24, 2015
11:19 EDTADXSAdvaxis management to meet with Jefferies
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09:07 EDTMRKCAR-T cancer drug researchers seen as M&A targets, Bloomberg says
Juno Therapeutics (JUNO), Kite Pharma (KITE) and Bluebird Bio (BLUE) are trading well above their IPO levels as takeovers predictions have spurred interest and share increases for the developers of CAR-T gene therapies, said Bloomberg's "Real M&A" column, quoting Dimo Dimov, a professor at the University of Bath’s School of Management, as having said that companies such as Pfizer (PFE), Merck (MRK), Roche (RHHBY) and AstraZeneca (AZN) are "closely watching" the firms. Cellectis (CLLS), which is working with Pfizer on its own approach to CAR-T therapy, has said it wants to bring its therapy to market and doesn’t anticipate a sale, the report noted. Reference Link
June 21, 2015
13:14 EDTMRKMerck shares could return 25%, Barron's says
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June 19, 2015
10:42 EDTADXSAdvaxis to host business news update conference call
Conference call to be held on June 25 at 8:30 am. Webcast Link
June 17, 2015
17:00 EDTMRKOncoSec CEO expects 'to be in a better position to attract a strategic partner'
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10:00 EDTMRKOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: AbbVie (ABBV) initiated with an Overweight at Piper Jaffray... Arista Networks (ANET) initiated with a Buy at Sterne Agee CRT... Astec (ASTE) initiated with a Buy at Maxim... Bristol-Myers (BMY) initiated with an Underweight at Piper Jaffray... Community Healthcare (CHCT) initiated with an Outperform at Oppenheimer... Eli Lilly (LLY) initiated with an Overweight at Piper Jaffray... Fitbit (FIT) initiated with a Buy ahead of IPO at Dougherty... Hortonworks (HDP) initiated with a Buy at Mizuho... II-VI (IIVI) initiated with a Buy at Benchmark Co.... J Sainsbury (JSAIY) initiated with an Underperform at Credit Suisse... McDermott (MDR) initiated with an Outperform at Cowen... Merck (MRK) initiated with a Neutral at Piper Jaffray... Molina Healthcare (MOH) initiated with a Buy at UBS... Pacific DataVision (PDVW) initiated with a Buy at Canaccord... Pfizer (PFE) initiated with an Overweight at Piper Jaffray... Quest Resource (QRHC) initiated with a Buy at Roth Capital... Regional Management (RM) initiated with a Buy at Janney Capital... Rofin-Sinar (RSTI) initiated with a Buy at Benchmark Co.... Salesforce (CRM) initiated with a Neutral at Exane BNP Paribas... Sprouts Farmers Markets (SFM) initiated with a Neutral at Cleveland Research... Tesco (TSCDY) initiated with an Underperform at Credit Suisse... WM Morrison (MRWSY) initiated with a Neutral at Credit Suisse... WWE (WWE) initiated with a Buy at BTIG... World Acceptance (WRLD) initiated with a Buy at Janney Capital... Zafgen (ZFGN) initiated with a Buy at SunTrust.
08:03 EDTMRKMerck Keytruda granted FDA orphan designation as gastric cancer treatment
The FDA granted Merck, Sharp & Dohme, a subsidiary of Merck, orphan status for Keytruda as a treatment of gastric cancer, including gastroesophageal junction adenocarcinoma. Reference Link
05:31 EDTMRKMerck initiated with a Neutral at Piper Jaffray
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June 16, 2015
10:07 EDTMRKAlkermes spike attributed to takeover speculation
The spike higher in shares of Alkermes (ALKS) is being attributed by traders to speculation of a takeover. Shares jumped 6% to $61.89 in morning trading. The Ireland based drugmaker focuses on treatments of central nervous system disorders, such as addiction, schizophrenia and depression. The speculative chatter has Merck (MRK) as a potential acquirer of Alkermes. The company’s June 60 and 65 calls are actively trading, according to The Fly's options specialist.

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