xr_biotech_consult
8年前
Immunovaccine's Lead Immuno-Oncology Candidate to Enter Investigator-Sponsored Phase 2 Clinical Trial in DLBCL in Combination with Approved Anti-PD-1 Drug
Company's Clinical Program Continues to Expand with Second Phase 2 Trial Announced This Year Evaluating the Combination of DPX-Survivac and Anti-PD-1 Therapies in Hard-to-Treat Cancers
HALIFAX, NOVA SCOTIA--(Marketwired - May 16, 2017) - Immunovaccine Inc. (TSX:IMV)(OTCQX:IMMVF), a clinical stage vaccine and immuno-oncology company, today announced that an investigator-sponsored Phase 2 clinical trial will evaluate the use of a triple-combination immunotherapy in patients with measurable or recurrent diffuse large B-Cell lymphoma (DLBCL). Investigators will assess the efficacy and safety of Immunovaccine's lead candidate, DPX-Survivac, along with a checkpoint inhibitor drug currently marketed by a large pharmaceutical company, and low-dose cyclophosphamide. Immunovaccine expects the trial to begin enrolling patients following receipt of regulatory clearance from Health Canada.
"While immunotherapies, such as checkpoint inhibitors, are rapidly changing the standard of care in many cancers, it has been reported that only about 20 percent of patients are able to respond to these therapies alone, leaving the vast majority of patients with a significant unmet medical need," said Frederic Ors, Chief Executive Officer at Immunovaccine.i "Our clinical strategy builds on our earlier research, which indicated that novel combination immunotherapies-particularly those with the ability to increase T-cell tumor infiltration-may work together synergistically to increase the number of patients responding to today's advanced treatments. We remain committed to working with world-class partners to bring these combinations through clinical development. Our goal is to generate more therapeutic options for patients currently underserved in today's treatment landscape."
Researchers conducting the investigator-sponsored study will test the novel immunotherapy combination in patients whose DLBCL expresses survivin, a tumor antigen highly expressed in 60 percent of DLBCL patients. DPX-Survivac stimulates the immune system to produce T cell responses targeting survivin. The non-randomized, open-label study is expected to enroll 25 evaluable participants at five centers in Canada.
This clinical trial is the third ongoing triple-combination study using DPX-Survivac with low-dose cyclophosphamide and other immuno-modulating agents. The Company announced earlier this year that an investigator-sponsored Phase 2 study will evaluate the anti-tumor activity of Merck's pembrolizumab with DPX-Survivac and cyclophosphamide in patients with recurrent, platinum-resistant ovarian cancer. In addition, Immunovaccine recently released positive early data from its Phase 1b triple-combination trial with Incyte Corporation, evaluating DPX-Survivac, low-dose cyclophosphamide and Incyte's IDO1 inhibitor epacadostat in patients with recurrent ovarian cancer.
Advanced analysis of one of the patients in Immunovaccine's initial Phase 2 study in DLBCL patients provided a strong rationale for this novel triple combination. Early data indicated that there was a correlation between immune response and tumor changes following administration of DPX-Survivac. Specifically:
The patient experienced changes in tumor-infiltrating T cells, which correlated with an immune response produced by DPX-Survivac and detected in the blood.
Tumor cells showed significant PD-L1 expression, which indicates the likely suppression of the anti-tumor activity of their T cells. This effect may be alleviated with anti PD-1 or anti PD-L1 agents.
Based on these findings, and to bring the clinical program in line with Immunovaccine strategy of focusing its immuno-oncology pipeline on combinations with checkpoint inhibitors, Immunovaccine has elected to conclude operations on its initial Phase 2 DLBCL study, opting to replace it with this triple-combination trial.
http://www.marketwired.com/press-release/immunovaccines-lead-immuno-oncology-candidate-enter-investigator-sponsored-phase-2-clinical-tsx-imv-2216565.htm
John-Knee
8年前
ImmunoVaccine Inc. (IMV) Insider Buys C$10,800.00 in Stock
Posted by Grant Hamersma on May 4th, 2017
ImmunoVaccine Inc. (TSE:IMV) insider Pierre Labbé acquired 10,000 shares of the business’s stock in a transaction that occurred on Monday, April 17th. The shares were purchased at an average cost of C$1.08 per share, for a total transaction of C$10,800.00.
Pierre Labbé also recently made the following trade(s):
On Tuesday, April 18th, Pierre Labbé acquired 10,000 shares of ImmunoVaccine stock. The shares were purchased at an average cost of C$1.13 per share, for a total transaction of C$11,300.00.
On Tuesday, February 28th, Pierre Labbé acquired 15,000 shares of ImmunoVaccine stock. The shares were purchased at an average cost of C$1.17 per share, for a total transaction of C$17,550.00.
On Monday, February 27th, Pierre Labbé purchased 10,000 shares of ImmunoVaccine stock. The shares were bought at an average cost of C$1.17 per share, for a total transaction of C$11,700.00.
On Monday, February 13th, Pierre Labbé purchased 2,400 shares of ImmunoVaccine stock. The shares were bought at an average cost of C$1.12 per share, for a total transaction of C$2,688.00.
On Tuesday, February 14th, Pierre Labbé purchased 5,000 shares of ImmunoVaccine stock. The shares were bought at an average cost of C$1.18 per share, for a total transaction of C$5,900.00.
Shares of ImmunoVaccine Inc. (TSE:IMV) opened at 1.61 on Thursday. ImmunoVaccine Inc. has a one year low of $0.51 and a one year high of $1.62. The stock’s market cap is $191.52 million. The stock’s 50 day moving average is $1.22 and its 200-day moving average is $0.94.
John-Knee
8年前
Immunovaccine to Present at 19th Annual TIDES: Oligonucleotide and Peptide Therapeutics Conference
2017-05-02 07:05:00 AM ET (Marketwired)
Researchers Will Highlight DepoVax(TM) Vaccine Delivery Platform's Novel Applications in Ovarian Cancer and Respiratory Syncytial Virus (RSV)
HALIFAX, NOVA SCOTIA--(Marketwired - May 2, 2017) - Immunovaccine Inc. (TSX:IMV)(OTCQX:IMMVF), a clinical stage immuno-oncology company, today announced that the company's Vice President of Product Development and Manufacturing Leeladhar Sammatur will present research at the 19th Annual TIDES: Oligonucleotide and Peptide Therapeutics Conference in San Diego, Calif. His presentation will focus on the commercial potential enabled by the Company's proprietary DepoVax™ platform formulations. Specifically, he will discuss how the Company translated the unique pharmacokinetics that were facilitated by antigens encapsulated in nanoparticles and suspended in oil - a signature of the DepoVax™ platform - into novel clinical candidates in immuno-oncology (DPX-Survivac) and infectious diseases (DPX-RSV).
Details for the presentation are as follows:
Date: Wednesday, May 3, 2017
Time: 2:45 p.m. - 3:15 p.m. PDT
Location: Manchester Grand Hyatt San Diego
Abstract Title: CMC strategy for a clinically approved "Nanoparticle-in-oil based vaccine delivery system (water free) with an effective, long lasting and durable immune responses against 'Multi peptide Vaccine' encoding T-Cell for treatment of Ovarian Cancer immunotherapy (IO) and B-cell Epitope for RSV (Infectious disease (ID)"
"Our DepoVax™ platform's unique oil-based delivery formulation provides a powerful way to present stimulants to the human immune system and sustain them over time," said Frederic Ors, Immunovaccine's Chief Executive Officer. "Leeladhar's presentation strengthens the underlying credibility of a DepoVax™-enabled approach to pipeline development. It demonstrates how this incredibly stable, no-release depot delivery system is able to mitigate the propensity for synthetic peptides or antigens to break down. Utilizing this platform, our vaccine candidates are positioned to powerfully and precisely activate the immune system against ovarian cancer and RSV, two serious diseases that represent areas of high unmet medical need."
This TIDES forum provides access to an extensive network of industry leaders focused on oligonucleotide and peptide research. The conference focuses on building partnerships and accelerating product development.
About DepoVax™
DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the potential for single-dose effectiveness. The DepoVax™ platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability. Fully synthetic, off-the-shelf DepoVax™-based vaccines are also relatively easy to manufacture, store, and administer. These characteristics enable Immunovaccine to pursue vaccine candidates in cancer, infectious diseases and other vaccine applications.
About Immunovaccine
Immunovaccine Inc. is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. Immunovaccine develops T cell activating cancer immunotherapies and infectious disease vaccines based on DepoVax™, the Company's patented platform that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer. The Company is also exploring additional applications of DepoVax™, including DPX-RSV, an innovative vaccine candidate for respiratory syncytial virus (RSV), which has recently completed a Phase 1 clinical trial. Immunovaccine also has ongoing clinical projects to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.com.
John-Knee
8年前
Biotech Stock Immunovaccine At All-Time High, Breaking Out
https://www.investing.com/analysis/biotech-stock-immunovaccine-at-all-time-high,-breaking-out-200186099
It was only 2 months ago when we wrote that biotech stock Immunovaccine had strong bullish momentum. That was the momentum we spotted quite some upside potential in that stock.
At the time of writing Immunovaccine Inc (TO:IMV) had a market cap of $104M. Meantime, it has reached $176M.
Immunovaccine has a candidate for one of the hard-to-treat forms of cancer (ovarian cancer). The company keeps on announcing encouraging test results, which feeds the assumption that is well on its way to have potentially a breakthrough treatment of ovarian cancer.
We wrote in February that stocks in momentum typically run out of steam after some weeks or even days. Immunovaccine went 20 percent higher after that call, retraced till $1.00, and rallied sharply higher to touch all-time highs at $1.50 per share today. That happened on very high volume which suggests a lot of buying interest as prices are skyrocketing. That is definitely a very solid sign of investment interest, one that should not be ignored.
InvestingHaven considers this setup to be a breakout: all-time highs on increasing volume, after 4 attempts, is very promising. This stock will probably trade at $2.00 in no time.
It still has ten-bagger potential.
John-Knee
8年前
Insiders are buying consistently these past few weeks.
----
Frederic Ors Acquires 20,000 Shares of ImmunoVaccine Inc. (IMV) Stock
Posted by Casey Walker on Apr 25th, 2017 //
ImmunoVaccine Inc. (TSE:IMV) Director Frederic Ors bought 20,000 shares of the business’s stock in a transaction dated Thursday, April 20th. The stock was purchased at an average price of C$1.20 per share, for a total transaction of C$24,000.00.
Frederic Ors also recently made the following trade(s):
On Thursday, February 9th, Frederic Ors bought 22,300 shares of ImmunoVaccine stock. The stock was purchased at an average price of C$0.99 per share, for a total transaction of C$22,077.00.
On Tuesday, February 7th, Frederic Ors bought 5,000 shares of ImmunoVaccine stock. The stock was purchased at an average price of C$1.07 per share, for a total transaction of C$5,350.00.
Shares of ImmunoVaccine Inc. (TSE:IMV) traded up 10.00% on Tuesday, hitting $1.32. 364,270 shares of the stock traded hands. The firm has a 50 day moving average price of $1.17 and a 200 day moving average price of $0.91. The firm’s market cap is $157.02 million. ImmunoVaccine Inc. has a 52-week low of $0.51 and a 52-week high of $1.40.
xr_biotech_consult
8年前
Positive Year-Long Immunogenicity Data from Phase 1 Clinical Trial for Respiratory Syncytial Virus Vaccine Candidate
100 Percent of Healthy Older Adult Volunteers Who Responded to Vaccine Achieved a Sustained Antigen-Specific Immune Response that Remains at Peak One Year Post-Vaccination with DPX-RSV; This Level of Response with a Low-dose Volume of a Small Peptide is Groundbreaking and Highlights Potential of DepoVax™ Platform
HALIFAX, NOVA SCOTIA--(Marketwired - April 12, 2017) - Immunovaccine Inc. (TSX:IMV)(OTCQX:IMMVF), a clinical stage immuno-oncology company, today announced updated data on its investigator-sponsored Phase 1 clinical trial testing the safety and immunogenicity of its DepoVax™-based, small B-cell epitope peptide vaccine candidate for respiratory syncytial virus (RSV). In the 25 µg dose cohort, which was the only dose tested out to one year, 100 percent of older adults (7/7 immune responders) vaccinated with DPX-RSV maintained the antigen-specific immune responses one year after receiving the booster dose. At one year, the antibody levels measured were still at peak with no sign of decrease. The 25 µg dose was delivered in a volume of 50 microliters. A standard flu vaccine is typically 60 µg delivered in 10 times this volume.
"The persistence of antigen-specific, circulating immune response at such a high level at six months was intriguing enough to warrant an assessment at the one year time point," said Joanne Langley, BA, MD, MSc, FRCPC, of the Canadian Center for Vaccinology (CCfV) based at Dalhousie University, and the trial's principal investigator. "The persistence of immunogenicity at one year to this peptide vaccine presented in a novel adjuvanting platform suggests that it is possible to create an immune response that lasts for at least an entire RSV season."
"We believe that the strength and duration of this immune response, particularly from a peptide epitope vaccine, is truly groundbreaking," said Frederic Ors, Immunovaccine's Chief Executive Officer. "We have long since maintained that, to effectively deal with complex diseases such as RSV, we need to pursue a novel target and a delivery formulation that is reliable and impactful. We believe that this DPX-RSV data validates this approach, and are hopeful that our vaccine candidate may offer those who suffer from RSV an option that goes beyond what can be accomplished with other vaccines in development."
"It is encouraging to observe such a prolonged serum antibody response against this membrane protein of RSV after DPX-RSV vaccination," said Xavier Saelens, group leader of the VIB-UGent Centre for Medical Biotechnology (VIB and Ghent University, Belgium).
"We have analyzed the year-one samples blinded and in a different way compared to the measurements performed by Immunovaccine. The results obtained in the two labs align clearly and show the longevity of the antibody response," said Bert Schepens, staff scientist in the Saelens group, which has been performing confirmatory testing of the clinical trial samples.
Last year, Immunovaccine reported positive top-line results from the Phase 1 dose-escalation trial evaluating the safety and immunogenicity of DPX-RSV in 40 healthy older adults six months after vaccination. In a further follow-up, antigen-specific immune responses were detected at least six months after the last vaccination in 93 percent (15/16) of patients receiving DPX-RSV, in both low-dose (8/8 participants) and high-dose (7/8 participants) cohorts. The new data reported today are based on the high-dose cohort, which was the only dose tested out to one year. The trial was conducted at the Canadian Center for Vaccinology (CCfV), based at Dalhousie University; the IWK Health Centre; and the Nova Scotia Health Authority; and funded in an industry-academic collaboration by the Canadian Institutes of Health Research and Immunovaccine.
About RSV
Respiratory syncytial virus (RSV) is a common virus that infects the lungs and breathing passages. While it usually leads to mild, cold-like symptoms, it can be severe in the elderly, infants and patients with compromised immune systems. It is second only to influenza as the most commonly identified cause of viral pneumonia in older persons. Globally, it is estimated that 64 million cases of RSV infection occur annually in all age groups, with 160,000 deaths. There is no vaccine currently available to prevent RSV.
About DPX-RSV
DPX-RSV is Immunovaccine's prophylactic, small B-cell epitope peptide vaccine candidate designed specifically to address the unmet medical needs in respiratory syncytial virus (RSV). DPX-RSV targets the SH antigen of RSV, which may provide additional immunogenic benefit over traditional approaches for high risk populations, including infants and the elderly. Scientists from VIB and Ghent University (Belgium) demonstrated the protective potential of the ectodomain of the small hydrophobic (SH) protein of RSV as a vaccine antigen.i In addition, the concentrated dosage enabled by the DepoVax™ delivery system may help mitigate injection site point-of-pain, which has been a limitation for other potential treatments. The Company reported Phase 1 data for DPX-RSV at the six-month time point, which indicated that the vaccine demonstrated a tolerable safety profile and induced a measurable immunogenic response in 93 percent of healthy adult volunteers across both dose cohorts. Immunovaccine holds exclusive worldwide license on applications that target the SH ectodomain antigen in RSV from VIB and Ghent University.
Gratefullife
11年前
IMMVF, prefer not to post my article...in the event they were to uplist, it might become viable, and SA prefers exclusivity.
CTIX...you know i loved the little strumpet, and certainly wish i had picked some up when i watched it trade around 1.40....feel like CTIX tied me to the bed and left me a few times, ended up cheating on me with Share Structure. Now i want to see the goods, not hear from shills, see institutions, not excuses.
This little Grey sheet here has a Dana Farber connection, less hype in Canada...
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