|First Patient Dosed in Clinical Trial of Halozyme's PEGPH20; Rexahn Reports Interim Clinical Data for Archexin(R)|
|By Mary Davila|
|Thursday, 05 November 2015 20:55|
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 5, 2015.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) announced the first patient has received its investigational new drug, PEGPH20 in combination with Merck's KEYTRUDA (pembrolizumab) in a clinical trial to determine the maximum tolerated dose of PEGPH20 and antitumor activity of the combined therapies.
The Halozyme sponsored Phase 1b study is being conducted at a number of leading sites in the U.S., and is evaluating patients with advanced non-small cell lung and gastric cancers.
Following an initial dose escalation portion to determine the maximum tolerated dose of PEGPH20 in combination with KEYTRUDA, the study will be expanded to determine antitumor activity including overall response rate, duration of response and progression-free survival in patients with high levels of hyaluronan (HA). HA is a glycosaminoglycan, or chain of natural sugars in the body that can accumulate around cancer cells creating high pressure in a tumor, constricting blood flow and thereby reducing access of chemotherapy and immunotherapeutic agents, like KEYTRUDA. PEGPH20 degrades HA, reducing tumor pressure and increasing blood flow to treat the tumor.
During the expansion portion, the study seeks to enroll approximately 50 patients with high HA tumors who have relapsed or refractory stage IIIB/IV non-small cell lung cancer treated with at least one platinum-based regimen, or who have recurrent locally advanced/metastatic gastric adenocarcinoma who are also PDL-1 positive and have failed at least one chemotherapy regimen.
"Our goal is to make a difference in the lives of patients, and that starts by studying the safety, tolerability and efficacy of PEGPH20 in a broad range of tumor types and in combination with a broad range of therapeutic agents," said Dr. Helen Torley, president and CEO of Halozyme. "With this study, we see an opportunity to expand the potential benefits of immunotherapy through the novel combination of KEYTRUDA and PEGPH20, targeting two of the most difficult to treat cancers." For information on Keytruda, please go to keytruda.com.
Rexahn Pharmaceuticals, Inc. (NYSE:RNN), announced interim clinical data from an ongoing Phase IIa study of its novel anti-cancer drug candidate, Archexin(R) , will be presented on Friday, November 6, 2015 at the 14(th) International Kidney Cancer Symposium in Miami, Florida.
“We are excited to present interim data from the ongoing Phase IIa clinical trial showing that Archexin, in combination with everolimus (Afinitor(R) ), appears to be safe and well tolerated at the doses tested to date. We have also noted early evidence of clinical activity at low doses in patients with metastatic kidney cancer,” commented Peter D. Suzdak, Chief Executive Officer. “We look forward to completing the randomized, open-label, 2-arm dose expansion study of Archexin in combination with everolimus versus everolimus alone in order to further evaluate Archexin in metastatic renal cell carcinoma.”
Archexin Clinical Data --- Interim data from the Phase IIa Archexin clinical trial will be presented on Friday, November 6, 2015 by study investigators, Drs. S. Tagawa, G. Chatta and N. Agarwal in a poster presentation entitled “RX-0201, An Anti-Sense Targeting AKT-1 to Treat Metastatic Renal Cancer — Preliminary Phase IIa Data.”
The interim results show that at the dose levels tested to date, Archexin appeared to be safe and well tolerated. The most commonly reported adverse events in the patients taking both Archexin and everolimus included: thrombocytopenia, mouth ulcerations, decreased weight, facial edema, and hyponatremia. To date, none of these adverse events has been dose limiting.
Early evidence of the potential clinical activity of Archexin in combination with everolimus has been observed. Among the patients enrolled in the study, two patients experienced stable disease, which has persisted for 170 and 334 days (as of October 28, 2015). In addition, at the lowest dose tested one patient experienced a 15% reduction in tumor size, as compared to a baseline CT scan taken prior to treatment with Archexin and everolimus.
Scott Tagawa, MD, MS, Medical Director, Genitourinary Oncology Research Program, Associate Professor of Clinical Medicine and Urology, Division of Hematology & Medical Oncology, Weill Cornell Medical College, commented, “The treatment of patients with metastatic RCC remains a significant unmet medical need and the early evidence supporting the potential clinical benefit of Archexin is therefore very promising. With a unique mechanism of action targeting a well validated cancer pathway (Akt-1 suppression), it is possible that Archexin in combination with everolimus could have a two-fold effect in the treatment of RCC, both by inhibiting the growth and proliferation of RCC, but also potentially by overcoming resistance to mTOR inhibitors. I look forward to further evaluation of this promising approach.”
The ongoing Phase IIa clinical study is designed to evaluate the efficacy of Archexin in combination with everolimus (Afinitor(R) ) to treat metastatic RCC patients and is being conducted in two stages. Stage 1 is an open-label, dose-escalation study designed to identify a safe and tolerable dose of Archexin when given in combination with everolimus. Stage 2 is a randomized, open-label, 2-arm dose expansion study of Archexin in combination with everolimus versus everolimus alone to determine safety and efficacy of the combination.
In Stage 1, escalating doses of Archexin of 125, 200 and 250 mg/m(2) /day are administered by continuous IV infusion for 14 days followed by 1 week of rest. Based on previous clinical data, the target dose of Archexin is anticipated to be no more than 250 mg/m(2) per day. Patient assessments include safety, pharmacokinetics, laboratory and physical exams. Once the maximum tolerated dose of Archexin in combination with everolimus has been determined, thirty RCC patients will be randomized to receive either Archexin in combination with everolimus, or everolimus alone, in a ratio of 2:1.
The primary endpoint of Stage 2 is the percentage of progression free patients following eight cycles of therapy. Patients are scanned (CT or MRI) for the assessment of tumor progression after every 2 cycles of therapy. Secondary endpoints include pharmacokinetic profile, incidence of adverse events, changes in clinical laboratory tests and vital signs over time, tumor response, duration of response, time to response, and response rate. Exploratory endpoints include blood levels of AKT pathway biomarkers, tumor apoptosis biomarkers, or other relevant biomarkers.
In preclinical studies, Archexin has been shown to inhibit the growth of human renal cell carcinoma (RCC) cells in tissue culture. Archexin has also been shown to exhibit an additive anti-tumor effect when combined with other cancer drugs in inhibiting the growth of human RCC cells in tissue culture.
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today reported financial results for the three and nine months ended September 30, 2015. For the third quarter of 2015, Achillion reported a net income of $26.3 million or $0.19 per share, compared with a net loss of $15.7 million or $0.16 per share for the third quarter of 2014. Cash, cash equivalents, marketable securities, and interest receivable as of September 30, 2015 were $476 million.
“In just the few months following our announced worldwide collaboration with Janssen, I am pleased with the significant progress achieved in advancing short duration therapy for HCV, highlighted by the recently initiated Phase 2a trial evaluating a regimen consisting of odalasvir, simeprevir and ALS-335. We look forward to next quarter when we anticipate top-line SVR results from this study", commented Milind S. Deshpande, Ph.D., President and Chief Executive Officer of Achillion."
Dr. Deshpande continued, “Significant progress has been made with our internally discovered complement inhibitor platform. We anticipate making a regulatory filing by year-end that will allow for initiation of human clinical trials with our first small-molecule factor D inhibitor in the first quarter. The advances in our program are highlighted by the research generated by Dr. Robert Brodsky and his colleagues from Johns Hopkins University which has been selected for both an oral presentation at the ASH Annual Meeting this December and inclusion in the 2016 Highlights of ASH.”
Allscripts Healthcare Solutions, Inc. (NASDAQ:MDRX) announced its financial results for the three and nine months ended September 30, 2015.
Third-Quarter and Nine-Month Bookings Highlights --- Bookings were $272 million, a third-quarter record, compared with $223 million in the third quarter of 2014, a 22 percent increase. Sales were strong across core clinical and financial solutions, population health management and managed services. Growth was robust across both the ambulatory and acute markets, including two new client footprints for the Sunrise™ electronic health record (EHR) solution.
Forty-four percent of third-quarter bookings related to software delivery, while the remaining 56 percent was derived from client services. This compares with 52 and 48 percent of bookings attributable to these revenue categories, respectively, in the third quarter of 2014. Software delivery bookings increased 4 percent year over year in the third quarter of 2015. Client services bookings increased 42 percent year over year in the third quarter of 2015.
For the nine months ended September 30, 2015, bookings totaled $768 million compared with $679 million in the first nine months of 2014, a 13 percent increase.
Contract revenue backlog as of September 30, 2015, totaled $3.6 billion, a 4 percent increase over the prior-year amount.
Paul M. Black, Chief Executive Officer of Allscripts, stated, "Allscripts third-quarter and nine-month results illustrate our momentum in the global health care IT market. Bookings grew 22 percent in the third quarter of 2015 and increased 13 percent year-to-date. Total bookings were at record levels for a third quarter, driven by a healthy mix of sales across major software solution categories and value-added services. We added major new EHR clients in the US and United Kingdom and expanded strategic partnerships with key ambulatory clients such as Catholic Health Initiatives."
In a release issued previously by Akebia Therapeutics, Inc. (NASDAQ:AKBA), the company is updating the presentation time to 3:00 p.m. Mountain Time instead of 3:30 p.m. Mountain Time. The updated release follows:
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor (HIF), today announced that Jason A. Amello, Senior Vice President, Chief Financial Officer and Treasurer, will present at the Credit Suisse 24th Annual Healthcare Conference on Tuesday, November 10, 2015 at 3:00 p.m. Mountain Time. The conference will take place at The Phoenician resort, in Scottsdale, Arizona.
Interested institutional investors that wish to schedule a meeting with management should contact Credit Suisse directly.
Applied Genetic Technologies Corporation (NASDAQ:AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV) based gene therapies for the treatment of eye diseases where there is high unmet need, today announced financial results for the quarter ended September 30, 2015.
"The past few months have been a period of rapid growth and progress for AGTC," said Sue Washer, President and CEO of AGTC. "Continuing to employ a careful, rational approach to the selection of our product candidates, we expanded our pipeline of products developed both internally and with our partner, Biogen. We continue to execute against our ultimate goal of becoming a leading gene therapy company developing life-changing products for patients with severe eye diseases."
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company focused on developing meaningful therapies for patients with unmet medical needs in diseases that have seen limited therapeutic innovation, today reported operational highlights and financial results for the third quarter ended September 30, 2015.
Third Quarter 2015 Operational Highlights
“We made substantial progress in our lead programs during the third quarter,” said Isaac Ciechanover, Chief Executive Officer and President of Atara Bio. “This includes completion of patient enrollment in our PINTA 745 Phase 2 clinical trial in ESRD patients with PEW, for which we plan to report top-line data in December of this year. In addition, we closed a follow-on public offering with the proceeds being used to further advance our pipeline programs, including the initiation of our two upcoming pivotal trials in our EBV-CTL program.”
Avinger, Inc., (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today reported results for the third quarter ended September 30, 2015.
"Our momentum continued to build through the third quarter, with the achievement of several strategic milestones, including exceptional six-month data from our VISION trial and 510(k) clearance from the FDA to begin commercializing Pantheris in the U.S.," said Jeff Soinski, Avinger's President and Chief Executive Officer. "We also successfully piloted a number of new programs designed to accelerate adoption of our lumivascular platform, including a Lightbox placement-to-purchase option. As a result, we were able to more than double the growth in new accounts compared to Q2. We believe a larger account base targeted towards higher-volume institutions will be key to our success as we commence U.S. sales of Pantheris early in 2016."
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the third quarter ended September 30, 2015.
"Celldex continues to advance one of the most robust, well-staged pipelines in immuno-oncology," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "As we move closer to final data from the ACT IV study in newly diagnosed glioblastoma, we continue to build on the potential promise of RINTEGA in the recurrent setting and look forward to presenting long-term survival data from the ReACT study at the SNO meeting later this month.
In the third quarter we continued to execute on all fronts, including enrolling patients to seven ongoing Celldex-sponsored clinical trials. In addition, there are now numerous investigator initiated studies ongoing with additional concepts under discussion. We look forward to data in 2016 from several of these studies that we believe will further support the critical role of immunotherapy in oncology."
Ekso Bionics Holdings, Inc. (OTCQB:EKSO), a robotic exoskeleton company, today reported financial results for the quarter ended September 30, 2015 as well as recent highlights.
"I am pleased to share the progress Ekso Bionics continued to make this past quarter, our highest revenue quarter ever. On the medical front, we continue to grow the number of our multi-unit centers and we see utilization by customers accelerating in the form of steps taken in our Ekso medical rehabilitation devices," shared Nathan Harding, chief executive officer and co-founder of Ekso Bionics. "On the able-bodied front, we continue to win cutting-edge projects with our government partners and we are seeing prospective customers experiencing quantifiable outcomes from using our industrial exoskeleton prototypes in the field."
"Our vision, however, is to do more. We are striving to make exoskeleton use in the hospital and in the home ubiquitous. We are expecting the industrial workplace to be transformed. This will take time, and this past quarter we kicked off a number of initiatives and made some important changes to strengthen our path towards commercial, financial and technological success," added Harding.
Emisphere Technologies, Inc. (OTCBB:EMIS) today announced that President and Chief Executive Officer, Alan L. Rubino, will present at the SeeThruEquity MicroCap Investor Forum at 9:30 AM ET on Thursday, November 12, 2015. The SeeThruEquity conference is being held at the Convene Grand Central in New York City.
Emisphere’s presentation will be webcast live the day of the SeeThruEquity conference, and will be available on the company’s website at ir.emisphere.com/events.cfm. An archive of the webcast will be available for 90 days following the day of the conference and can be accessed by following the same link.
Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on delivering superior patient and physician experiences through products designed for the minimally invasive treatment of chronic and recurrent sinusitis patients, today reported its financial results for the quarter ended September 30, 2015.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, announced that three posters featuring the company's research activities are being presented during the Annual Meeting of the Society for Immunotherapy of Cancer (SITC), taking place November 4-8, 2015, in National Harbor, Maryland. The posters will be made available at http://www.fiveprime.com/news-media/publications-presentations following the presentations.
cmFPA008, an Anti-Mouse CSF-1R Antibody, Combines with Multiple Immunotherapies to Reduce Tumor Growth in Nonclinical Models
Bellovin D, Wondyfraw N, Levin A, et al
Thursday, November 5, 2015
Geron Corporation (Nasdaq: GERN) today reported financial results for the third quarter ended September 30, 2015.
For the third quarter of 2015, the company reported net income of $27.2 million, or $0.17 per share, compared to a net loss of $9.5 million, or $(0.06) per share, for the comparable 2014 period. Net income for the first nine months of 2015 was $8.5 million, or $0.05 per share, compared to a net loss of $26.7 million, or $(0.18) per share, for the comparable 2014 period. The company ended the third quarter of 2015 with $151.8 million in cash and investments.
Revenues for the third quarter of 2015 were $35.4 million compared to $160,000 for the comparable 2014 period. Revenues for the first nine months of 2015 were $36.2 million compared to $975,000 for the comparable 2014 period. Revenues for the three and nine month periods ending September 30, 2015 included the full recognition of the $35.0 million upfront payment from Janssen Biotech, Inc. (Janssen) as collaboration revenue upon the company’s transfer of the imetelstat license rights and completion of technology transfer-related activities outlined under the imetelstat collaboration agreement with Janssen. The upfront cash payment was received in December 2014 and recorded as deferred revenue at that time.
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, today announced that its management will be presenting at the Canaccord Genuity Medical Technologies and Diagnostics Forum on Thursday, November 19, 2015 in New York.
HTG management is scheduled to present at 2:00 p.m. ET. A live audio webcast of the presentation can be accessed by visiting the "Investors" section of HTG's website at: http://www.htgmolecular.com. The webcast will be available on HTG's website for 90 days following the completion of the presentation.
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced initial data from a Phase 1b/2 study of the company's lead investigational drug, CA4P, in combination with the anti-angiogenic agent Votrient™ (pazopanib) in patients with advanced recurrent ovarian cancer. The data are from the ongoing "PAZOFOS" study and were presented at the 19th International Meeting of the European Society of Gynaecological Oncology (ESGO) in Nice, France.
"The initial results we've seen to date from the Phase 1b portion of PAZOFOS are encouraging and we expect to move into the phase 2 portion of the study in early 2016," said Professor Gordon Rustin, Director of Medical Oncology, Mount Vernon Cancer Centre and a chief investigator for the trial. "We are excited about continuing our clinical evaluation of this complementary combination—a combination that utilizes the potential synergistic effects of CA4P and pazopanib and could offer a new treatment approach for patients with relapsed ovarian cancer."
Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of liver failure, today announced results for the third quarter ended September 30, 2015 and provided a corporate update.
"Since we announced in late August that our VTI-208 phase 3 clinical trial had failed to meet its primary and secondary endpoints, we have conducted extensive analyses of the VTI-208 data and now believe we have a better understanding of the appropriate patient population to target with the ELAD System," said Terry Winters, Ph.D., Chief Executive Officer and Co-Chairman of Vital Therapies. "We have used this to design a new phase 3 trial, VTL-308, and have started the process of seeking FDA approval of the trial design and statistical plan and commenced opening clinical sites that we anticipate will be mostly the high enrolling sites from VTI-208. We are excited about the path forward for ELAD."
Xenon Pharmaceuticals Inc. (NASDAQ:XENE), a clinical-stage biopharmaceutical company, today announced that it will report its 2015 third quarter financial and operating results after the close of U.S. financial markets on Tuesday, November 10, 2015. Xenon management will host a conference call and live audio webcast at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) the same day to discuss the results and to provide a corporate update.
The live call may be accessed by dialing (855) 779-9075 for domestic callers or (631) 485-4866 for international callers, and providing conference ID number 74074102. The webcast will be broadcast live on the investors section of Xenon's website at www.xenon-pharma.com and will be available for replay following the call for 30 days.
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced today it has agreed to sell its biologics manufacturing facilities, equipment, and associated real estate to Agenus Inc. (Nasdaq:AGEN). The transaction is expected to close in December 2015. In conjunction with the transaction, Agenus will offer employment to a select team of XOMA employees currently operating the facilities and may provide small-scale manufacturing services for XOMA in the future.
"We welcome Agenus as our neighbor and our manufacturing collaborator. We are very pleased our colleagues will have the opportunity to join Agenus where they can continue their leadership role in creating and advancing manufacturing technologies that allow for cost-effective antibody drug development," stated John Varian, Chief Executive Officer of XOMA. "With this transaction and the divesture of our biodefense program to Nano therapeutics, we will have trimmed our headcount by over 50 percent, and it will complete our transformation to an endocrine company. We are now laser focused on advancing our deep pipeline of endocrine assets, particularly XOMA 358, to offer new hope to underserved patient populations."
Under the terms of the agreement, Agenus will pay approximately $5.0 million in cash up-front and $1.0 million in common stock. In addition to the biologics manufacturing facility and a team of employees associated with the program, Agenus will also gain access to selected antibody technologies.
Concurrently, XOMA also announced it has divested its biodefense program to Nanotherapeutics, Inc., a biopharmaceutical company located in Alachua, FL. Nanotherapeutics will extend employment offers to all employees associated with the program and will prosecute related contract awards going forward. Future opportunities for advancement of XOMA's anti-botulinum assets will be solicited and conducted by Nanotherapeutics.