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Advaxis Presents Oral Late-breaking Data on Phase 2 GOG-0265 Study of Axalimogene Filolisbac at SGO’s Annual Meeting on Women’s Cancer

On March 15, 2017 (GLOBE NEWSWIRE) — Advaxis, Inc. (NASDAQ:ADXS), a biotechnology company developing cancer immunotherapies, presented data from the GOG-0265 study at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer in National Harbor, MD (Press release, Advaxis, MAR 15, 2017, View Source [SID1234518121]).

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GOG-0265 is a single arm, Phase 2 trial evaluating axalimogene filolisbac for the treatment of persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC). The primary endpoints of the study were to assess the safety and efficacy of axalimogene filolisbac in women with PRmCC. The primary efficacy endpoint was overall survival at 12 months from initial treatment with axalimogene filolisbac. The primary safety endpoints were to evaluate the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The final efficacy results of GOG-0265 demonstrated that 38% of patients (n = 19/50) with heavily pretreated PRmCC were alive 12 months following treatment with axalimogene filolisbac. The GOG-0265 study protocol used a logistic model-based calculation to establish the expected 12-month survival rate. The model identified the key prognostic factors of age, race and performance status significantly related to survival from a database of approximately 500 patients with PRmCC who participated in 17 previous phase 2 studies conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology. Using this model, the expected 12-month survival rate of patients enrolled in the study was calculated to be 24.5%. As a result, the 38% 12-month survival rate of patients treated with axalimogene filolisbac represents a 52% improvement over the expected survival rate and is the highest 12-month survival rate achieved to date in this setting. The probability of this survival improvement being detected by chance versus a true treatment effect was calculated to be 0.02. A compelling and ongoing complete response of 18.5 months was observed and the longest ongoing survival is 40.6 months.

"The 12-month survival rate of axalimogene filolisbac reached unprecedented levels in this study, which is both impressive and important given the lack of innovation in metastatic cervical cancer," said Warner K. Huh, MD, Division Director of Gynecologic Oncology at the University of Alabama at Birmingham, and Lead Investigator of the study.

The safety profile was consistent with previous clinical experience. The most common Grade 1 or Grade 2 treatment-related adverse events (TRAEs) were hypotension and symptoms related to cytokine release (e.g., nausea, chills, fever). Eighteen out of 50 patients experienced a Grade 3 TRAE and two out of 50 patients experienced a Grade 4 TRAE, which were hypotension and symptoms related to cytokine release.

The abstract was selected by SGO for prominence as an oral late-breaking presentation by Charles A. Leath III, M.D., MSPH, Associate Professor of Obstetrics and Gynecology at the University of Alabama at Birmingham School of Medicine, entitled, "A prospective phase 2 trial of the listeria-based HPV immunotherapy axalimogene filolisbac in second and third-line metastatic cervical cancer: A NRG Oncology Group trial," on March 14 at 2:30 p.m. ET. Slides from the presentation are available at www.advaxis.com/sgo2017.

Highlights from Dr. Leath’s presentation include:

A 38% (n = 19/50) 12-month survival rate in second- and third-line PRmCC treated with axalimogene filolisbac, representing a 52% improvement over the expected 12-month milestone survival rate of 24.5%
Eight patients remain alive as of January 31, 2017 (Range 12.02 – 40.6 months)
Disease control (complete response, partial response, or stable disease) was achieved in 32% of patients based on investigator assessment of best response
A durable complete response in a patient with PRmCC previously treated with chemotherapy and bevacizumab remains ongoing at 18.5 months
Results compare favorably to GOG Study 227C of bevacizumab, which demonstrated a 12-month milestone overall survival (OS) rate of 30% in a similar patient population which subsequently supported regulatory approval in first-line treatment in combination with chemotherapy in 2014
Consistent with its immunotherapy mechanism of action, axalimogene filolisbac demonstrated a promising plateau in the survival curve, indicating potential long-term clinical benefit for a subset of patients with PRmCC
Axalimogene filolisbac was generally well-tolerated, with primarily infusion-associated, low grade, transient TRAEs (≥30%), such as fatigue, chills, anemia, nausea and fever
Only 2 patients experienced grade 4 TRAEs

Advaxis plans to initiate a global, phase 3 randomized registration study in patients with metastatic cervical cancer later this year.

About the Phase 2 GOG-0265 Study

GOG-0265 is an open-label, single arm 2-stage study designed to evaluate the safety, tolerability and efficacy of axalimogene filolisbac to treat PRmCC as conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology. Patients who progressed on or after at least 1 prior line of systemic-dose chemotherapy receive one cycle (three doses) of axalimogene filolisbac at 1 x 109 CFU every 28 days. The primary efficacy endpoint was the 12-month survival rate, with secondary efficacy objective to evaluate progression-free survival, overall survival and objective tumor response. The primary safety endpoints were to evaluate the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The expected 12-month overall survival rate (null hypothesis) was established using a prospectively-defined logistic model-based calculation derived from 17 serially conducted GOG/NRG 2-stage studies in PRmCC involving approximately 500 patients, adjusting for prognostic factors (age, performance status, race) significantly related to survival. In accordance with the prior trials, GOG/NRG used a consistent protocol design/data collection methodology for the current 2-stage GOG-0265 study in PRmCC, which contributed to a robust and homogeneous patient dataset for the primary endpoint analysis.

About Cervical Cancer

Cervical cancer is the fourth most common cancer in women worldwide. An estimated 13,000 new cases will be diagnosed in the United States in 2016, and 4,100 people will die of the disease, according to the National Cancer Institute. Persistent HPV infection is the most important factor in the development of cervical cancer, research shows. According to the ICO Information Centre on HPV and Cervical Cancer, about 4.4% of women in the United States are estimated to harbor high-risk cervical HPV infection at a given time, and about 72% of cervical cancers are attributed to high-risk HPV strains. PRmCC is a fatal disease, and the prognosis for women with advanced and recurrent cervical cancer remains poor, with survival of only 4 to 7 months following failure of first-line treatment, research has shown. There is no therapy following failure of first-line treatment. According to the American Cancer Society, the five-year mortality rate for metastatic disease is at just 17%, with the area continuing to be a high unmet medical need.

About the GOG Foundation, Inc.

The GOG Foundation, Inc. (GOG) is a non-profit international organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of its processes is utilized in order to constantly improve the quality of patient care. The GOG conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina and vulva. General information on many of these trials for medical professionals and the lay public can be obtained from ClinicalTrials.gov.

NRG Oncology is one of four adult US Network groups funded under the newly structured NCI National Clinical Trials Network. NRG Oncology is comprised of three legacy cooperative groups, the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG).

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

ChemoCentryx has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-K, Kura Oncology, MAR 14, 2017, View Source [SID1234518147])

Mirna Therapeutics Reports Financial Results for the Fourth Quarter and Full Year Ended December 31, 2016

On March 14, 2017 Mirna Therapeutics, Inc. (Nasdaq: MIRN), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2016 and provided a corporate update (Press release, Mirna Therapeutics, MAR 14, 2017, View Source [SID1234518172]).

Following its November 2016 decision to discontinue all research and development activities including the development of MRX34, Mirna began implementing operating cost reductions and organizational restructuring to reduce overall cash burn, including a reduction in its workforce. The Company engaged a financial advisor and has been pursuing activities to identify and evaluate strategic alternatives, including a possible merger or sale of the Company.

"Our strategic process is active and ongoing and we are pursuing discussions with third parties on a range of potential transactions," said President and CEO Paul Lammers, M.D., M.Sc. "We are committed to serving our shareholders’ best interests through our efforts to identify, evaluate and potentially consummate a transaction that may result from these activities."

2016 FINANCIAL RESULTS

Cash Position and Guidance: Cash, cash equivalents, and marketable securities totaled $60.5 million as of December 31, 2016, compared to $89.7 million as of December 31, 2015. The Company has no debt.

The Company expects its quarterly cash burn rate to remain within the range of $2.1 million and $2.3 million. This quarterly guidance includes contractual commitments and obligations for future minimum lease payments, but excludes any one-time charges related to any strategic transaction should such be consummated and contractual payments for executive severance or change-in-control provisions.
Research and development expenses: Research and development expenses were approximately $2.3 million and $13.9 million for the quarter and year ended December 31, 2016 compared to research and development expenses of $6.4 million and $18.9 million during the comparable periods in 2015. The decrease was primarily due to the closing of the Company’s Phase 1 clinical trial of MRX34 in September 2016 and discontinuing all research and development activities.
General and administrative expenses: General and administrative expenses were approximately $2.0 million and $8.1 million for the quarter and year ended December 31, 2016, compared to general and administrative expenses of $2.5 million and $6.1 million during the comparable periods in 2015. The increase for the year ended December 31, 2016 was primarily attributable to increased employee compensation expense due to a higher headcount and higher outside professional and consulting costs, the majority of which were incurred to comply with public company operating and reporting requirements in the Company’s first full year operating as a public company.
Restructuring charges: Restructuring charges were approximately $4.4 million for the quarter and year ended December 31, 2016 and $0 for the year ended December 31, 2015. In September 2016, Mirna announced its decision to close the ongoing Phase 1 study of MRX34 and voluntarily halted the enrollment and dosing of patients in the study prior to receiving notice from the U.S. Food and Drug Administration ("FDA") that its Investigational New Drug Application for MRX34 had been placed on full clinical hold. Following the Company’s announcement and notification from the FDA, Mirna’s Board of Directors approved a reduction of the total number of full-time employees from 36 to 12. The restructuring charges recognized during the year ended December 31, 2016 included approximately $1.5 million for employee severance and benefits, an accounting charge under U.S. Generally Accepted Accounting Principles ("U.S. GAAP") of $1.5 million for lease facility termination costs, and $1.4 million for non-cash impairment charges of property and equipment. The majority of these employee severance and related benefits are expected to be settled in the first quarter of 2017. The Company expects to incur additional restructuring charges under U.S. GAAP of approximately $0.3 million through the six months ended June 30, 2017.
Net Loss: Net loss was approximately $8.7 million and $26.3 million for the quarter and year ended December 31, 2016, compared to a net loss of $8.8 million and $25.0 million for the comparable periods in 2015. The results included non-cash, stock-based related compensation charges of $1.6 million and $1.0 million for the years ended December 31, 2016 and December 31, 2015, respectively.

Kura Oncology Reports Fourth Quarter and Full Year 2016 Operational and Financial Results

On March 14, 2017 Kura Oncology, Inc., (NASDAQ:KURA) a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported fourth quarter and full year 2016 financial results and provided a corporate update (Press release, Kura Oncology, MAR 14, 2017, View Source;p=RssLanding&cat=news&id=2253894 [SID1234518171]).

"Our precision medicine approach continues to deliver results, and we are pleased to have achieved important milestones in each of our programs," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "We are encouraged by the durability of responses observed in patients with HRAS mutant squamous cell carcinomas of the head and neck treated with tipifarnib, and believe our data validate HRAS as a driver oncogene in that disease. In our Phase 2 trial in PTCL, we have observed initial signals of clinical activity and identified potential biomarkers, including genes that are expressed and/or altered, which appear to be associated with the activity of tipifarnib. In our Phase 2 trial of tipifarnib in lower-risk MDS, based on anecdotal evidence of hematological improvement observed in several patients, we have amended the study to evaluate further dose regimens in an effort to optimize those initial findings. With KO-947, our ERK inhibitor, we anticipate initiating the Phase 1 study, and through preclinical studies have identified potential development opportunities, including KRAS and BRAF mutant cancers and squamous cell carcinomas. We also selected a development candidate in our menin-MLL inhibitor program, KO-539, which demonstrates potent anti-tumor activity in certain preclinical models of acute leukemia."

Recent Operational Highlights

Selection of KO-539, an orally-available small molecule inhibitor of the menin-MLL interaction, as a development candidate for the treatment of mixed lineage leukemias, a genetically-defined subset of the two most common forms of acute leukemia, acute myeloid leukemia and acute lymphoblastic leukemia
FDA acceptance of an Investigational New Drug (IND) application to begin Phase 1 clinical testing of KO-947, a small molecule inhibitor of extracellular-signal-regulated kinases 1 and 2 (ERK1/2) as a treatment for cancers in which the mitogen activated protein kinase (MAPK) pathway is dysregulated
Appointment of Steven H. Stein, M.D., to Kura’s board of directors. Dr. Stein currently serves as Executive Vice President and Chief Medical Officer of Incyte Corporation and has extensive experience in the discovery, development and commercialization of oncology therapeutics.
First patient dosed in Phase 2 clinical trial of tipifarnib in patients with chronic myelomonocytic leukemia (CMML)
Presentation of preclinical data highlighting the characterization of KO-947, and preclinical data relating to the identification and optimization of potent and selective inhibitors of the menin-MLL interaction. Both presentations took place at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Munich, Germany.
Upcoming Potential Milestones and Expectations for Clinical and Preclinical Programs

Initiation of the Phase 1 clinical trial for KO-947 during the first half of 2017
Data from the first and second stages of the Phase 2 trial of tipifarnib in peripheral T-cell lymphomas (PTCL) and associated biomarkers in the first half of 2017
Preclinical data for KO-947 and KO-539 in the first half of 2017
Additional data from the Phase 2 trial of tipifarnib in HRAS mutant squamous cell carcinomas of the head and neck (SCCHN) during the second half of 2017
Additional preclinical and clinical data for tipifarnib in PTCL in the second half of 2017
Data from the Phase 2 tipifarnib trials in lower risk myelodysplastic syndromes (MDS) and in CMML during the first half of 2018
Financial Results for the Fourth Quarter and the Full Year 2016

Cash, cash equivalents and short-term investments totaled $67.8 million as of December 31, 2016, compared with $74.6 million as of September 30, 2016 and $85.7 million as of December 31, 2015. Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into the second half of 2018.
Research and development expenses for the fourth quarter of 2016 were $5.5 million, compared to $5.1 million for the fourth quarter of 2015. Research and development expenses for the full year 2016 were $20.4 million, compared to $17.8 million for the prior year.
General and administrative expenses for the fourth quarter of 2016 were $2.0 million, compared to $1.7 million for the fourth quarter of 2015. General and administrative expenses for the full year 2016 were $8.0 million, compared to $6.1 million for the prior year.
Net loss for the fourth quarter of 2016 was $7.3 million, compared to a net loss of $6.5 million for the fourth quarter of 2015. Net loss for the full year 2016 was $27.6 million, compared to a net loss of $22.6 million for the prior year.