On May 17, 2017 Bayer reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies (Press release, Bayer, MAY 17, 2017, View Source [SID1234519171]). Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms. FL is the most common subtype of indolent non-Hodgkin’s lymphoma (iNHL). Schedule your 30 min Free 1stOncology Demo! "Patients with relapsed or refractory follicular lymphoma have a poor prognosis, and new treatment options which are well tolerated and effective are needed to prolong progression-free survival and improve quality of life for these patients," said Martin Dreyling, Professor of Medicine at the University of Munich Hospital in Grosshadern and lead investigator of the CHRONOS-1 study. "Based on the CHRONOS-1 results, where copanlisib showed durable efficacy with a manageable and distinct safety profile, the compound may have the potential to address this unmet medical need."
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"Bayer is advancing one of the most diverse oncology portfolios and pipelines and our first priority is to deliver new treatments to cancer patients as quickly and prudently as possible," said Robert LaCaze, Executive Vice President and Head of the Oncology Strategic Business Unit at Bayer. "With this milestone, we are one step closer to making copanlisib available in the U.S. to the community of doctors and patients facing a very difficult-to-treat disease in follicular lymphoma. We look forward to continuing to work with the FDA throughout the review process."
The FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions, when compared to standard applications. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within six months (compared to 10 months under standard review).
The regulatory submission for copanlisib is based on data from the Phase II open-label, single-arm study CHRONOS-1 evaluating patients with relapsed or refractory indolent Non-Hodgkin’s Lymphoma (iNHL). The full analysis set comprised 142 patients, of which 141 patients had iNHL. At the time of analysis, median duration of treatment was 22 weeks and 46 patients remained on treatment. The results across all patient groups show an objective response rate (ORR) of 59.2%, with a 12% complete response (CR) rate, and a median duration of response (DOR) of more than 98 weeks (687 days). In the FL subset (n=104), copanlisib achieved an ORR of 58.7%, with 14.4% of these patients achieving a CR, and a median DOR of more than 52 weeks (370 days). The safety and tolerability were consistent with previously published data on copanlisib. The most common treatment-related adverse events were transient hyperglycemia (all grades: 49%/Grade ≥3: 40%), which did not show severity above Grade 4 and hypertension (all grades: 29%/Grade ≥3: 23%), which did not show severity above Grade 3. These data were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017. Data from the FL subset of the CHRONOS-1 trial will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2017 in June.
Bayer is seeking accelerated approval of copanlisib for FL under FDA regulations 21 CFR Part 314 Subpart H. The compound was also granted Fast Track and Orphan Drug Designation by the FDA in this indication.
About CHRONOS-1
CHRONOS-1 is an open-label, single-arm Phase II study (ClinicalTrials.gov Identifier: NCT01660451) evaluating copanlisib as a monotherapy in patients with relapsed or refractory indolent NHL, including follicular lymphoma (FL), who received at least two prior therapies. The primary endpoint of CHRONOS-1 is the objective tumor response rate, with duration of response, overall survival, progression-free survival, quality of life, and safety serving as secondary endpoints.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma (NHL) is the most common hematologic malignancy and the tenth most common cancer worldwide, with nearly 386,000 new cases diagnosed in 2012. It accounts for nearly 200,000 deaths per year worldwide. NHL comprises a highly heterogeneous group of diseases that can be indolent or aggressive with a poor prognosis. Follicular lymphoma is the most common histological subtype of indolent NHL, for which there is a need to improve treatment options.
About Copanlisib
Copanlisib is a novel pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor with predominant inhibitory activity against PI3K-α and PI3K-δ isoforms, being developed by Bayer. The PI3K pathway is involved in cell growth, survival and metabolism, and its dysregulation plays an important role in non-Hodgkin’s lymphoma (NHL). Copanlisib is administered as a 1-hour infusion on an intermittent weekly basis (3 weeks on/1 week off).
The compound has shown promising clinical activity in Phase I and Phase II studies in heavily pretreated patients with recurrent indolent and aggressive NHL. The broad clinical development program also includes Phase III studies in indolent NHL patients who have relapsed or are refractory to prior therapies. Information about these trials can be found at www.clinicaltrials.gov and www.chronostrials.com.
Copanlisib has also been granted Orphan Drug Designation for the treatment of splenic, nodal, and extranodal subtypes of marginal zone lymphoma. The compound is not approved by the U.S. Food and Drug Administration, the European Medicines Agency or any other health authority.
Author: [email protected]
Moleculin Biotech, Inc. Reports Financial Results for the First Quarter Ended March 31, 2017
On May 15, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), reported its financial and operating results for the first quarter ended March 31, 2017 and other recent developments Moleculin Biotech, Inc. Reports Financial Results for the First Quarter Ended March 31, 2017.
First Quarter & Recent Highlights
Annamycin
· Appointed Theradex Systems, Inc. as its contract research organization ("CRO") for its planned Phase I/II clinical trial for Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML").
· Received Orphan Drug Designation by the U.S. Food and Drug Administration ("FDA") for the treatment of AML. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trial costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
· Recently filed the IND application for Annamycin, with a Phase I/II approach with the intent of increasing the Maximum Tolerable Dose ("MTD"). In subsequent discussions, the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls ("CMC"). The Company has the additional information, has made the requested revisions to the protocol, and is working on developing the CMC data. In the interim, Moleculin has withdrawn the IND application in order to resubmit it when the requested data are available. The Company believes that the resubmission of the IND application will occur in time for the IND to go into effect prior to the end of July 2017 and allow for clinical trials. However, if the Company is unable to obtain the required CMC data on a timely basis, it will be delayed in resubmitting its IND application, which will delay the commencement of the clinical trials for Annamycin beyond July 2017.
· Updated the Annamycin clinical strategy to add a Phase I arm to its next Phase II trial that leverages a potential increase in the MTD, which could increase the chance for positive outcomes. The Company believes that it will be able to publicly announce results from its Phase I/II clinical trial sometime in 2018.
WP1066
· An MD Anderson physician is sponsoring a study of WP1066 for the treatment of brain tumors. While the Company is not participating in and has no influence on the conduct of this study, we understand that the sponsoring physician has submitted an IND to the FDA and the IND is on hold until documentation of Good Manufacturing Process or GMP production of WP1066 can be presented to the FDA, which Moleculin has agreed to provide. The Company expects that the sponsor’s IND will move forward in 2017 and may produce publishable clinical results in 2018.
· Physician-scientists at another major US cancer center have requested and Moleculin has agreed to supply them with WP1066 for testing in a potential grant-funded clinical trial for children with Diffuse Intrinsic Pontine Gliomas (DIPG), a rare and very aggressive form of brain tumor. Studies conducted at this center have suggested that DIPG may be particularly sensitive to the inhibition of the activated form of a cell-signaling protein called STAT3, a primary target of WP1066, and their studies have demonstrated significant anti-tumor activity of WP1066 in DIPG in vitro and in vivo tumor models.
Corporate
· Announced the closing of an underwritten public offering of securities for net proceeds of approximately $4.5 million. Roth Capital Partners and National Securities Corporation acted as joint book-running managers. Subsequently, approximately $0.8 million of additional funds have been received through the exercise of associated warrants issued in the offering bringing the total net raised in excess of $5 million.
· Announced that Drs. Sandra Silberman and Paul Waymack have joined the Company’s Scientific Advisory Board ("SAB"). The Company’s current SAB also includes Dr. Waldemar Priebe (Chair) and Dr. Madeleine Duvic.
Planned Activities and Upcoming Potential Milestones
Anticipated Milestone Potential Timeframe
Announcement that our IND for Annamycin has become effective and that we may begin clinical trials End of July 2017
IRB (Institutional Review Board) approvals and site initiations of various clinical sites participating in our Phase I/II clinical trial of Annamycin Second Half of 2017
Establishment of a new MTD for Annamycin Second Half of 2017
A clinician sponsored IND for WP1066 for treatment of adult brain tumors moving forward Second Half of 2017
Announcement of Phase II data for Annamycin 2018
Announcement of further benefits of our sponsored research agreement with MD Anderson 2018
Walter Klemp, Chairman and CEO of Moleculin stated: "We remain focused on developing the CMC data needed to submit our IND to move forward with the FDA by the end of July and to allow for clinical trials to begin. Additionally, we are pleased to have Theradex Systems as our CRO for our planned Phase I/II clinical trial for Annamycin. As we transition from a preclinical to a clinical stage company, we will continue to provide updates on our upcoming key milestones. We believe we have sufficient funds to pursue our planned operations into the first quarter of 2018."
Unaudited Financial Results for the Quarter Ended March 31, 2017
Research and development (R&D) expense was $0.68 million and $0.02 million for the three months ended March 31, 2017 and 2016, respectively. The increase of approximately $0.66 million is mainly due to the Company becoming fully operational post its June 1, 2016 Initial Public Offering ("IPO"). The difference mainly consists of increases of $0.15 million in sponsored research and research consultants, $0.13 million in employee related costs, $0.14 million in manufacturing and stability costs associated with the Company’s IND application, $0.1 million in regulatory counsel, $0.07 million in costs associated with the Company’s licenses, and $0.07 million of other costs. This increased activity represents the Company’s efforts in obtaining Orphan Drug designation for Annamycin and its associated IND application with the FDA.
General and administrative ("G&A") expense was $0.85 million and $0.31 million for the three months ended March 31, 2017 and 2016, respectively. The expense increase of approximately $0.54 million is mainly due to the Company becoming fully operational post its June 1, 2016 IPO. Specifically, these increases were attributable to $0.25 million associated with added headcount and associated payroll costs, $0.23 million in legal, auditing, and accounting costs, and $0.06 million in other G&A costs.
The Company recorded a gain of $1.06 million in the first quarter of 2017 for the change in fair value on revaluation of its warrant liability associated with the warrants issued in conjunction with its stock offering on February 14, 2017. The Company is required to revalue certain of its 2017 warrants at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of the warrant in the period in which the change occurred. A gain results principally from a decline in the Company’s share price during the period and a loss results principally from an increase in the Company’s share price.
During the period, the Company settled a previously incurred expense utilizing shares of its common stock with an attributed value of $3.00 per share. The gain of $0.15 million reflects the difference in the Company’s share price in the open market as of the settlement date and $3.00 per share.
Interest expense includes expense accrued on convertible promissory notes issued in 2015 and 2016 bearing interest at the rate of 8% per annum.
The net loss for the three months ended March 31, 2017 was $0.33 million, which included the non-cash gains mentioned above aggregating to $1.21 million. Excluding this amount, the net loss for the period was $1.54 million, which is an increase of $1.21 million over the previous years’ $0.33 million net loss. Included in both net loss numbers for the three months presented was $0.11 million and $0.00 million for the 2017 and 2016, respectively, in stock based compensation.
As of March 31, 2017, the Company had $8.88 million of cash and cash equivalents compared to $5.00 million at December 31, 2016. In February 2017, Moleculin completed a public offering of its common stock and warrants, pursuant to which it received approximately $4.5 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses. Additionally, during the three months ended March 31, 2017, $0.80 million in cash was received due to warrants being exercised. Cash used in operations was $1.39 million for the first quarter of 2017. The Company believes that its existing cash and cash equivalents as of March 31, 2017 continues to be sufficient to fund planned operations into the first quarter of 2018.
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Xenetic Biosciences Reports 2017 First Quarter Financial Results and Provides Business Update
On May 16, 2017 Xenetic Biosciences, Inc. (NASDAQ: XBIO) ("Xenetic" or the "Company"), a clinical-stage biopharmaceutical company focused on the discovery, research and development of next-generation biologic drugs and novel orphan oncology therapeutics, reported its financial results for the quarter ended March 31, 2017. As previously announced, the Company’s management team will host a quarterly update conference call with a live webcast today, May 16, 2017 at 8:30 AM ET for investors, analysts and other interested parties (details below). Schedule your 30 min Free 1stOncology Demo! Xenetic also provided an update on its license deal with Shire plc (LSE: SHP, NASDAQ: SHPG), a significant stockholder of the Company, along with the clinical status of the product candidate SHP656, or PSA-Recombinant Factor VIII ("rFVIII") being developed as a long-acting therapeutic for the treatment of hemophilia utilizing Xenetic’s proprietary PolyXen platform technology. The stated goal of Shire is to introduce an innovative, modified rFVIII protein with a significantly prolonged circulating half-life, with the objective of providing a once weekly treatment or reaching higher trough activity levels for greater efficacy. SHP656 is currently in a Phase 1/2 clinical study. Shire expects to report topline data from this Phase 1/2 study in the second quarter of 2017 and, if the outcome of the trial is successful, Xenetic expects Shire to launch a Phase 3 trial before the end of 2017. Xenetic has the potential to receive from Shire up to $100 million in cash milestones plus royalties linked to sales.
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Additionally, Xenetic provided an update to its corporate progress as well as clinical and regulatory status and anticipated milestones for the Company’s lead product candidate, XBIO-101 (sodium cridanimod), a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor ("PrR") expression in endometrial tumor tissue. The Company is currently on track to commence patient recruitment in the second quarter of 2017 for a Phase 2 clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of progestin resistant endometrial cancer, and has filed a protocol under its existing Investigational New Drug application ("IND") to expand the development of XBIO-101 into a biomarker study in triple negative breast cancer ("TNBC") patients.
Recent Corporate Highlights
Presented case study of PolyXen platform technology at the 13th Annual Protein Engineering Summit ("PEGS") Boston;
Rang Nasdaq Stock Market Opening Bell;
Appointed James F. Parslow, MBA, CPA as Chief Financial Officer;
Filed a protocol under existing IND for a biomarker study of XBIO-101 in TNBC patients;
Expanded its patent portfolio geographically into key markets including areas of Europe, Asia and North America and strengthened the patent portfolio in the US providing robust protection of its platform technology;
Received a $3 million milestone payment from Shire plc related to Shire’s advancing the Phase 1/2 clinical study for SHP656 being developed as a long-acting therapeutic for the treatment of hemophilia; and
Appointed Curtis A. Lockshin, Ph.D. as Chief Scientific Officer.
"We have continued to lay a strong foundation for the Company in the first quarter of 2017, showcasing our commitment to operational excellence and importantly, further positioning ourselves for what we believe will be a truly transformational year. We’ve continued to make corporate advancements with key appointments to our management team, as well as clinical advancements with the preparatory work for our XBIO-101 Phase 2 trial and the filing of a protocol under our existing IND for TNBC. We look forward to the topline data from the Shire Phase 1/2 study of SHP656 in the second quarter, and our team remains focused on advancing our flagship product candidate, XBIO-101, with the launch of patient recruitment in our Phase 2 trial for the treatment of endometrial cancer, both of which are value-driving events for Xenetic," stated M. Scott Maguire, Xenetic’s CEO.
Expected Near-Term Milestones
Commence patient recruitment in Q2 2017 for a Phase 2 clinical study of XBIO-101 in conjunction with progestin therapy for the treatment of endometrial cancer in women with recurrent or persistent disease who have failed progestin monotherapy;
Announce topline data from the Shire Phase 1/2 study of SHP656 in Q2 2017;
Receive milestone payment from Shire if endpoints are achieved in Phase 1/2 study of SHP656; and
Leverage Shire SHP656 program to enter into more industry collaborations involving the PolyXen technology.
Summary of Financial Results for First Quarter 2017
Net loss for the three months ended March 31, 2017, was $2.9 million compared to a net loss of approximately $3.6 million for the same period in 2016. The net loss in the first quarter of 2016 included a net charge of approximately $1.7 million associated with hybrid debt instruments including changes in derivative fair value, issuance losses as well as interest expense associated with the instruments. All hybrid debt instruments were settled in 2016 and none were issued or outstanding during the three months ended March 31, 2017.
The Company ended the quarter with approximately $4.3 million of cash.
CANbridge and AmoyDx enter into strategic partnership for CAN008 companion diagnostic development
On May 16, 2017 CANbridge Life Sciences and Amoy Diagnostics reported that they have entered into a strategic partnership to develop a companion diagnostic assay for CANbridge’s lead candidate, CAN008, a fully human Fc fusion protein (Press release, CANbridge Life Sciences, MAY 16, 2017, View Source [SID1234519169]). Previous clinical work, in a Phase II trial conducted in Europe, demonstrated a significant overall survival benefit for recurrent glioblastoma multiforme (GBM) patients with high expression of the CD95 ligand, or low methylation of CD95L promotor, CpG2. CAN008 is currently in a Phase I/II clinical study in GBM patients in Taiwan. CANbridge plans to initiate a CAN008 Phase II trial in GBM in China in 2018. The patients will be screened for the CAN008 biomarkers to determine trial enrollment eligibility. Schedule your 30 min Free 1stOncology Demo! "We are pleased to partner with AmoyDx , a leader in providing highly-reliable and effective diagnostic solutions to clinical practices in China," said James Xue, CANbridge Chairman and CEO. "AmoyDX’s diagnostic CD95 IHC andCpG2 qPCR kits will provide CANbridge with personalized medicine tools in the Phase II trial to deliver optimized treatment to GBM patients as early as possible."
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"We are excited that our diagnostic technology will play a key role in the CAN008 clinical development," said Dr. Li-Mou Zheng, Chairman and CEO of AmoyDx. "We believe that the joint effort by CANbridge and AmoyDx could help to realize the therapeutic potential of CAN008 in critically-ill GBM patients in China sooner. AmoyDx has multiple existing strategic partnerships with multi-national corporations providing diagnostic products and services in China and other countries. The CANbridge – AmoyDx collaboration is the first in which both parties are innovative Chinese companies with leadership positions in their respective fields."
About CAN008
CAN-008 is a fully human fusion protein which consists of the extracellular domain of CD95, fused to the Fc region of human IgG that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s previous developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan.
Syndax Pharmaceuticals Announces Advancement of ENCORE 601 in Non-Small Cell Lung Cancer Patients with Disease Progression on or After PD-1 Therapies
On May 16, 2017 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, reported that the ENCORE 601 non-small cell lung cancer (NSCLC) cohort enrolling patients with disease progression on or after PD-1 therapy (programmed death receptor-1 (PD-1) and/or programmed death ligand 1, (PD-L1)) has met the pre-specified objective response threshold to advance into the second stage of the Phase 2 trial, and will re-open enrollment immediately (Press release, Syndax, MAY 16, 2017, View Source [SID1234519168]). Schedule your 30 min Free 1stOncology Demo! ENCORE 601, a Phase 1b/2 clinical trial evaluating the combination of entinostat plus Merck’s anti-PD-1 blocking therapy, KEYTRUDA (pembrolizumab), is enrolling two distinct cohorts of NSCLC patients: 1) patients who had previously progressed on PD-1 or PD-L1 therapy; and 2) patients naïve to PD-1 or PD-L1 therapy. To advance into the definitive stage of the Phase 2 study, at least 2 out of 20 NSCLC patients who had previously progressed on PD-1 or PD-L1 therapy or 3 out of 13 NSCLC patients previously naïve to PD-1 or PD-L1 therapy need to demonstrate an objective response, defined as either a partial response (PR) or complete response (CR), to entinostat – KEYTRUDA treatment.
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The cohort of NSCLC patients who had previously progressed on PD-1 or PD-L1 will now re-open and enroll a total of 56 patients. Completion of enrollment is anticipated in the first half of 2018. Later this quarter, the Company anticipates being able to determine whether to expand the cohort of NSCLC patients naïve to PD-1 or PD-L1 therapy.
"PD-1 therapies have offered important clinical benefit to patients with NSCLC, but unfortunately only a subset of patients respond. There is tremendous need for new combinations to further improve responses to PD-1 therapies. The early data here with several objective responses to the entinostat – pembrolizumab combination in patients with NSCLC who previously progressed on PD-1 therapy is promising and certainly worth additional investigation," said Matthew D. Hellmann, M.D., medical oncologist and immunotherapy expert at Memorial Sloan Kettering Cancer Center.
"We are pleased to report that the entinostat – KEYTRUDA treatment combination has generated objective responses in patients whose disease has progressed on or after PD-1 antagonist therapies," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "This data, along with the responses we observed in the melanoma cohort earlier in the year, give us additional confidence in the ability of entinostat to enhance the patient’s response to immunotherapy. We look forward to providing additional details on these patient responses at an appropriate scientific forum."