On May 11, 2017 Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, reported financial and operational results for the quarter ended March 31, 2017, as well as recent corporate progress (Press release, BioTime, MAY 11, 2017, View Source [SID1234519026]). Schedule your 30 min Free 1stOncology Demo! "We are making good progress so far in 2017," said Steve Cartt, President and Chief Executive Officer. "In January and March, we reported positive clinical results from the SCiStar study for the AIS-A patients who received 10 million AST-OPC1 cells (Cohort 2), highlighting the potential of AST-OPC1 to help patients with complete paralysis regain arm, hand and finger function, and thus greater independence. We also recently reported encouraging MRI results from the study that indicated no spinal cord lesion cavities were forming in any patient treated with AST-OPC1." Mr. Cartt continued, "Our clinical team continues to enroll patients in our SCiStar study, and we expect to complete enrollment in 2017 as well as initiate discussions with the FDA around mid-year to determine the next stage of this important clinical program. Finally, we look forward to reporting 12-month efficacy and safety data from Cohort 2, as well as additional data from other cohorts, later this year."
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First Quarter 2017 and Recent Key Achievements
Reported efficacy results in January for the first five AIS-A spinal cord injury patients in Cohort 2. The results showed that each of the patients in this cohort, who had previously shown improvement in upper extremity motor function at 3-months following administration of AST-OPC1, maintained or showed additional motor function improvement as of their most recent follow-up (6-months or 9-months following administration of AST-OPC1). Asterias subsequently reported that the sixth, and final, patient in Cohort 2 showed additional motor function improvement at 6-months following administration of AST-OPC1. The results suggest a meaningful and favorable improvement to date in recovery of arm, hand and finger function in patients treated with the 10 million cell dose of AST-OPC1 compared to the level of expected rates of spontaneous recovery based on the historical control data of a closely matched patient population.
Reported new MRI data from the SCiStar study that indicates AST-OPC1 cells have durably engrafted in patients post-implantation, and have the potential to prevent lesion cavity formation, possibly reducing spinal cord tissue deterioration after spinal cord injury.
Received recommendation from the Data Monitoring Committee for the SCiStar clinical trial to continue enrollment for the 10 million cell and 20 million cell dose cohorts in the SCiStar study, as planned.
Successfully completed the validation and start-up of its internal current Good Manufacturing Practices manufacturing facility in preparation for late-stage clinical trials of AST-OPC1.
Published positive AST-VAC1 Phase 2 clinical data in Acute Myeloid Leukemia in ‘Cancer,’ a leading peer-reviewed journal of the American Cancer Society.
Presented a clinical update on the SCiStar study during the American Spinal Cord Association 2017 Annual Scientific Meeting in Albuquerque, New Mexico.
Asterias’ President of Research and Development and Chief Scientific Officer will be presenting a clinical update on AST-OPC1 during the Presidential Symposium at the American Society of Gene and Cell Therapy 20th Annual Meeting on May 12, 2017.
Financial Results
Cash and cash equivalents as of March 31, 2017 were $18.1 million, while available-for-sale securities were $14.4 million. The combined total of cash, cash equivalents, and available-for-sale securities totaled $32.5 million.
Total revenues were $2.0 million for the first quarter. Revenues were comprised of grant income as well as royalty revenues on product sales by licensees. Research and development expenses were $6.6 million in the first quarter, with the primary driver being expenses associated with the Company’s AST-OPC1 program. General and administrative expenses were $4.5 million in the first quarter.
Net loss was $6.3 million, or $0.13 per share, for the first quarter. For the quarter ended March 31, 2017, net cash used in operating activities was $7.2 million and net cash provided from financing activities was $5.4 million.a
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DelMar Formalizes Collaboration with PRA Health Sciences for Phase 3 Trial of VAL-083 in Recurrent Glioblastoma Multiforme (GBM)
On May 11, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing new cancer therapies, reported the formalization of an agreement with PRA Health Sciences (Nasdaq: PRAH), a leading contract research organization (CRO) to conduct the Company’s Phase 3 trial of VAL-083 in recurrent glioblastoma multiforme (GBM) (Press release, DelMar Pharmaceuticals, MAY 11, 2017, View Source [SID1234519023]). Schedule your 30 min Free 1stOncology Demo! "We have been working with PRA for quite some time in preparing for VAL-083’s Phase 3 study in GBM," said Jeffrey Bacha, chairman and chief executive officer of DelMar Pharmaceuticals. "Given our recent $9M financing, we have the resources to facilitate the initiation of our pivotal Phase 3 study of VAL-083 as a single agent treatment for GBM patients who have failed both temozolomide (Temodar) and bevacizumab (Avastin), for whom there is no currently approved therapy. We are delighted to formally engage with a CRO of the caliber and reputation of PRA to run this Phase 3 study of a treatment for a cancer indication in which there is an utmost medical need in the eyes of oncologists and the FDA."
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PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and approximately 13,000 employees worldwide. Since 2000, PRA has performed approximately 3,500 clinical trials worldwide and has worked on more than 100 marketed drugs across several therapeutic areas. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 70 drugs.
About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT and MMR in vitro. Further details can be found at View Source
VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer. Based on historic clinical trials run by the NCI, the modern Phase 1/2 dose finding trial run by DelMar in GBM (ASCO 2016), and recent guidance from the FDA, the Company has embarked on Phase 2 or 3 trials for VAL-083 across recurrent and newly diagnosed GBM. DelMar has announced plans to advance VAL-083 into a controlled Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate overall survival versus salvage chemotherapy for GBM patients who have previously failed both temozolomide and bevacizumab (Avastin) and for whom there exists no approved treatment option; a Phase 2 trial (with MD Anderson Cancer Center) in first recurrence GBM patients prior to bevacizumab therapy is currently enrolling; and a separate international Phase 2 trial for newly diagnosed MGMT-unmethylated GBM is planned. DelMar believes that data from its clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available therapies.
About Glioblastoma Multiforme (GBM)
GBM is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ), however nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for MGMT. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%. VAL-083 (dianhydrogalactitol) is a first-in-class bi-functional DNA-targeting agent that induces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cell death in GBM cell lines and GBM cancer stem cells, independent of MGMT or MMR status in vitro. VAL-083 readily crosses the blood-brain barrier and accumulates in brain tumor tissue. Our recent Phase 1/2 clinical trial in recurrent GBM patients failing both TMZ and bevacizumab, suggested that VAL-083 offers clinically meaningful survival benefits for patients with recurrent GBM and pinpointed a new dosing regimen (40 mg/m2/d on days 1,2,3 of a 21-day cycle) which was well-tolerated and was selected for study in subsequent GBM trials. These trials include, i) an ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab improves overall survival, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962) ii) A pivotal controlled Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") to evaluate the overall survival of VAL-083 versus salvage chemotherapy for GBM patients who have previously failed both temozolomide and bevacizumab (Avastin).The control arm will consist of a limited number of salvage chemotherapies currently used in bevacizumab-failed GBM. If successful, this study will serve as the basis for a New Drug Application (NDA) submission for VAL-083. iii) A single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels. The results of these studies may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM.
Heat Biologics Provides Business and Clinical Update for the First Quarter of 2017
On May 11, 2017 Heat Biologics, Inc. ("Heat") (Nasdaq: HTBX), a leader in the development of novel therapies designed to activate a patient’s immune system against cancer, reported a business and clinical update for the first quarter ended March 31, 2017 (Press release, Heat Biologics, MAY 11, 2017, View Source [SID1234519012]).
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During the first quarter, Heat announced a number of major developments. First, it met the safety and efficacy endpoints in its Phase 1b lung cancer trial evaluating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), enabling it to progress to Phase 2 clinical trials. Preliminary data suggests Heat’s therapeutic vaccine has the potential to significantly expand the percentage of patients responding to checkpoint inhibitors by increasing T cell activity within the tumor, thereby converting "cold’’ tumors into "hot" tumors.
"We are encouraged by these results, showing signs of synergistic efficacy with nivolumab," said Jeff Wolf, Heat’s founder and CEO. "Patients with increased levels of tumor infiltrating lymphocytes (TIL) at 10 weeks saw a durable benefit, with 75% (6 out of 8 of these patients) alive at the one-year follow-up point. Additionally, 60% of the patients (3 of the 5 patients) exhibiting low TIL experienced significant tumor reduction, which compares favorably to the 10% response rate of low TIL patients reported for existing data on nivolumab alone."
Researchers reported a strong correlation between T cell activation, tumor reductions and increased overall survival in the 12 of the 15 patients that were evaluable for ELISPOT analysis. Importantly, the timing of immune responses to HS-110 corresponded to the timing of observed clinical responses, and those responses appear to be sustained.
Mr. Wolf continued, "While checkpoint inhibitors have transformed the landscape in the fight against cancer, they are only effective as a monotherapy in a small minority of patients. Our approach has the potential to dramatically increase the response rate in the majority of patients who don’t respond to checkpoint therapy alone. As a result of the encouraging data in our checkpoint combination trials and the positive response from within the industry, we are now prioritizing combination therapies, with a particular emphasis on checkpoint inhibitors and T cell co-stimulators. As a result, we are discontinuing programs where we do not see an opportunity to immediately combine with checkpoints, such as our non-muscle invasive bladder cancer program, and will instead reallocate those resources to fund current and future checkpoint and T cell co-stimulator combination programs."
Heat recently completed the acquisition of Pelican Therapeutics, whose product candidates strengthen its portfolio in the emerging T cell activation space. Pelican’s approach has the potential to improve the durability of responses in combination with Heat’s vaccine platform, as well as others, by stimulating the production of "memory" CD8+ T cells, as supported by pre-clinical data. This acquisition also brings with it a $15.2 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT) to advance multiple products through preclinical development and at least one program through a 70-patient Phase 1 clinical trial.
"We believe our growing franchise in immuno-oncology and activating cytotoxic T cells places us in a unique position at the core of future combination therapies," Wolf said. "We plan to continue to remain at the forefront in the development of exciting new therapies to activate T cells as part of a broad-based combination approach against cancer."
Heat ended the quarter with over $11 million in cash, and $15 million in non-dilutive grant funding through Pelican.
Recent Developments & First Quarter 2017 Corporate Highlights
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In April 2017, Heat acquired an 80% controlling interest in Pelican Therapeutics, Inc. As of the acquisition date, Pelican is structured as a subsidiary to Heat focused on developing agonists to TNFRSF25, a highly differentiated and potentially "best-in-class" T cell costimulatory receptor. Pelican was the recipient of a highly-competitive $15.2 million New Company Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT), which will enable the Company to advance multiple products through preclinical development and at least one program through a 70-patient Phase 1 clinical trial.
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In April 2017, Heat presented new preclinical data from its collaboration with OncoSec Medical Incorporated at the AACR (Free AACR Whitepaper) Annual Meeting. Results suggested that combining ComPACT DNA electroporation and cellular vaccination led to increased tumor antigen-specific CD8+ T cells, delayed tumor progression and improved overall survival in preclinical models. The data demonstrated possible synergistic benefits of vaccination plus intratumoral injection.
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In March 2017, Heat reported positive interim results from its Phase 2 clinical trial evaluating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo) for the treatment of non-small cell lung cancer (NSCLC). Fifteen patients had completed the HS-110/nivolumab combination to-date and 12 of these 15 patients were evaluable for ELISPOT analysis. ELISPOT results suggest that HS-110 plays an integral role in tumor reduction and may enhance efficacy of checkpoint inhibitors in lung cancer patients.
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In March 2017, Heat announced that Natasa Strbo, M.D., D.Sc., Research Assistant Professor of Microbiology and Immunology at the University of Miami Miller School of Medicine, received a three-year $981,901 grant from the Florida Department of Health 2016-17 Zika Research Grant Initiative to further develop and test gp96-based Zika vaccine. This vaccine is being developed under a collaboration between the University of Miami and Heat’s wholly-owned subsidiary, Zolovax, Inc., which has licensed the intellectual property from the University of Miami.
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In March 2017, Heat announced that it had achieved the safety and efficacy endpoints for its Phase 1b trial evaluating HS-110 in combination with nivolumab for the treatment of NSCLC and that the trial met the expansion criteria to advance into a Phase 2. Five out of 15 patients treated with the HS-110/nivolumab combination had 20% or greater tumor reduction. Patients with increased levels of tumor infiltrating lymphocytes (TIL) at 10 weeks appeared to have a durable benefit, with six out of eight of these patients (75%) alive at the one-year follow-up point.
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In January 2017, Heat announced the appointment of Jeff Hutchins, Ph.D., as its Chief Scientific Officer and Senior Vice President of Preclinical Development. Dr. Hutchins brings over 24 years of research and clinical development experience from both large pharmaceutical and biotechnology companies.
First Quarter 2017 Financial Highlights
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Research and development expenses decreased to approximately $1.9 million in the first quarter of 2017 from $3.7 million in the first quarter of 2016, a decrease of $1.8 million. The decrease is attributable to reductions in clinical trial costs, professional and consulting fees, personnel-related expenses, travel and other costs.
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General and administrative expenses increased to $1.5 million in the first quarter of 2017 from $1.0 million in the first quarter of 2016, an increase of $0.5 million. The increase is attributable to professional services and third-party expenses related to the acquisition of Pelican.
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Net loss for the first quarter of 2017 was $3.2 million compared to a net loss of $4.7 million for the first quarter of 2016.
· Cash and cash equivalents totaled approximately $11.1 million at March 31, 2017 compared to $7.8 million at December 31, 2016. Through the acquisition of Pelican, the Company also has access to a $15.2 million grand from CPRIT, which will enable it to advance multiple products through preclinical development and at least one program through a 70-patient Phase 1 clinical trial.
BIO-PATH HOLDINGS REPORTS FIRST QUARTER 2017 FINANCIAL RESULTS
On May 11, 2017 Bio-Path Holdings, Inc. (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the first quarter ended March 31, 2017 and provided an update on recent corporate developments (Filing, Q1, Bio-Path Holdings, 2017, MAY 11, 2017, View Source [SID1234519008]). Schedule your 30 min Free 1stOncology Demo!
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"Our ongoing Phase 2 trial of prexigebersen for the treatment of acute myeloid leukemia (AML) is advancing according to plan and we remain on track to complete our 19 patient interim analysis by the end of this year," said Peter Nielsen, President and CEO of Bio-Path Holdings. "Additionally, we were honored to welcome Dr. William Hahne to our team as Vice President of Clinical Research. His extensive experience directing clinical research programs, curating product pipelines, and liaising with regulatory agencies will be critical as we see our next candidate, BP1002, into the clinic for the treatment of lymphoma."
Recent Corporate Highlights
· Presented Pre-Clinical Results Showing Potential of BP1002 as Treatment for Aggressive Non-Hodgkin’s Lymphoma at AACR (Free AACR Whitepaper) Annual Meeting. In an in vitro study, lymphoma cell lines were incubated with BP1002. It was determined that BP1002 induced greater than 50% inhibition in 11 of the 15 cell lines tested. In two in vivo mice studies, BP1002 enhanced survival of mice over untreated and control arms. Bio-Path is preparing to submit an investigational new drug (IND) application for evaluating BP1002 in lymphoma.
· Appointed Dr. William Hahne as Vice President of Clinical Research. In April, the Company announced the appointment of Dr. William Hahne as Vice President of Clinical Research. Before joining Bio-Path, Dr. Hahne was a medical consultant for a number of organizations including Medimmune, Lion Biotechnologies, Seattle Genetics, Aminex Therapeutics, Therakos, and Celgene Cellular Therapeutics. He held executive positions in clinical research and medical affairs at Celator Pharmaceuticals (now a subsidiary of Jazz Pharmaceuticals), Celsion Corp, and CurGen Corp, during which he was integrally involved in the design and management of oncology clinical trials, development of key opinion leaders, and growth of clinical departments to meet needs of advancing pipelines. Earlier, he worked in various clinical and medical positions at Glaxo Inc., Marion Merrell Dow, Hoechst Marion Rousel, and Eisai, Inc. Dr. Hahne earned his BA in chemistry from Grinnell College and his MD from Cornell University. He conducted his residency in general surgery at Emory University Affiliated Hospitals in Atlanta, Georgia.
Financial Results for the First Quarter Ended March 31, 2017
The Company reported a net loss of $0.4 million, or $0.01 per share, for the three months ended March 31, 2017, compared to a net loss of $1.9 million, or $0.02 per share, for the same period in 2016. The decrease was primarily due to a non-cash change in the fair value of the Company’s warranty liability during the period of $1.6 million.
Research and development expenses for both the three months ended March 31, 2017 and March 31, 2016, were $1.0 million.
General and administrative expenses for the three months ended March 31, 2017 increased to $1.0 million, compared to $0.8 million for the three months ended March 31, 2016 primarily due to increased stock-based compensation expense during the period.
Change in fair value of the Company’s warrant liability for the three months ended March 31, 2017 resulted in non-cash income of $1.6 million. The company did not have the warrant liability in the comparable period for 2016.
As of March 31, 2017, the Company had cash of $7.1 million, compared to $9.4 million at December 31, 2016. Net cash used in operating activities for the three months ended March 31, 2017 was $1.8 million compared to $2.4 million for the comparable period in 2016. Net cash used in investing activities for the three months ended March 31, 2017 was $0.4 million.
Results of the J-ALEX Study for Chugai’s Alecensa® are Published in “The Lancet” Online
On May 11, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that the results of the Japanese phase III study (J-ALEX) of Alecensa, in patients with ALK fusion gene positive non-small cell lung cancer (NSCLC), were published in the electronic version of "The Lancet" on May 11, 2017 (Press release, Chugai, MAY 10, 2017, View Source [SID1234519004]). Schedule your 30 min Free 1stOncology Demo! (http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30565-2/fulltext)
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The initial results of the J-ALEX study were presented at a session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting held in Chicago, on June 6, 2016.
"The publication of the J-ALEX study results in ‘The Lancet’ assures the firm position of Alecensa in the first line therapy of patient with ALK fusion gene positive NSCLC," said Dr. Yasushi Ito, Senior Vice President, Head of Project & Lifecycle Management Unit. "We believe that Alecensa will also contribute to improving the outcomes for patients in first line therapy, as well as second line therapy in the future."
The J-ALEX study was an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by an independent review board. The secondary endpoints included overall survival, objective response rate, safety, and other endpoints.
The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34 (99.7% CI: 0.17-0.71, stratified log-rank p<0.0001) and Alecensa demonstrated significantly prolonged PFS. Median PFS was not reached (95% CI: 20.3-Not Estimated) in the Alecensa arm while it was 10.2 months (95%CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation (35%) was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea (74%), diarrhea (73%), vomiting (58%), visual disturbance (55%), dysgeusia (52%), constipation (44%), ALT elevation (32%), and AST elevation (31%) were each seen in >30% patients. Grade 3-4 AEs occurred in 26% of the Alecensa arm and in 52% of the crizotinib arm, there were no treatment-related deaths in either arm.
In February 2016, Chugai carried out a prospectively-defined interim analysis and had an independent data monitoring committee examine the results. Since the results showed that the Alecensa arm significantly prolonged the PFS, the committee decided to recommend an early discontinuation of the J-ALEX study.
Based on the results of the J-ALEX study, Alecensa was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in September 2016 for first line therapy of patients with ALK-positive non-small cell lung cancer.