On May 2, 2016 BIND Therapeutics, Inc. (NASDAQ:BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS, reported that it has elected to file a voluntary petition under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware (Press release, BIND Therapeutics, MAY 2, 2016, View Source [SID:1234511739]). Schedule your 30 min Free 1stOncology Demo! "We believe this decision is in the best interests of the company and its stockholders," said Andrew Hirsch, president and chief executive officer, BIND Therapeutics. "The protections afforded by Chapter 11 provide for an orderly process and additional time that enables us to pursue the strategic and financial alternatives that are in process. The filing minimizes the impact from the recent demand by our lender, Hercules Technology III, L.P, for accelerated repayment of our outstanding loan. Our current cash and assets exceed the loan amount, and we are current on our regularly scheduled repayment obligations. Through this process, we expect to be able to maintain ongoing financing activities and collaborator obligations while moving our R&D initiatives and pipeline forward."
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BIND intends to continue to manage and operate its business under the jurisdiction of the Bankruptcy Court and in accordance with the applicable provisions of the Bankruptcy Code and the orders of the Bankruptcy Court. The Company is working with an investment bank to review financial and strategic alternatives with the goal of maximizing stockholder value. Potential alternatives to be explored further and evaluated during the review process may include raising additional capital, a strategic collaboration with one or more parties, or the licensing, sale or divestiture of some, or all, of the Company’s proprietary technologies.
BIND plans to continue its development and collaboration activities in accordance with its current innovative medicines strategy throughout this process.
Month: May 2016
Celsion Corporation Announces Positive Data from the First Cohort of Patients in the OVATION Study
On May 2, 2016 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported data from the first cohort of patients in its Phase Ib dose escalating clinical trial (the OVATION Study) combining GEN-1, the Company’s DNA-based immunotherapy, with the standard of care for the treatment of newly-diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery (Press release, Celsion, MAY 2, 2016, View Source [SID:1234511730]). Schedule your 30 min Free 1stOncology Demo! In the first three patients dosed, GEN-1 plus standard chemotherapy produced excellent results, with no dose limiting toxicities and highly promising efficacy signals leading to successful surgical outcomes. The three patients were treated at the University of Alabama at Birmingham.
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"These results, while early, are very impressive and speak to the potential of GEN-1 to improve patient outcomes in ovarian cancer," said Ronald D. Alvarez, M.D., Professor, Division of Gynecologic Oncology at the University of Alabama at Birmingham. "In particular, we see improvements across a number of important and meaningful measures used to assess ovarian cancer, which reinforce our confidence in this IL-12 immunotherapy approach and provide a strong rationale for continued development of GEN-1 for the treatment of ovarian cancer."
OVATION Study – First Cohort Results
Of the three patients treated in the first cohort, two patients demonstrated stable disease (SD) and one patient demonstrated a complete response (CR), as measured by RECIST criteria.
All patients had successful resections of their tumors, with two patients having an R0 resection, which indicates a microscopically margin-negative resection in which no gross or microscopic tumor remains in the tumor bed, and one patient with an optimal R1 resection.
One patient demonstrated a pathological complete response (pCR). pCRs are typically seen in less than 7% of patients receiving neoadjuvant chemotherapy followed by surgical resection, and have been associated with a median overall survival (OS) of 72 months, which is more than three years longer than those who do not experience a pCR&supl;.
All patients experienced a dramatic > 96% drop in their CA-125 protein levels as of their most recent study visit. CA-125 is used to monitor certain cancers during and after treatment. CA-125 is present in greater concentrations in ovarian cancer cells than in other cells. A 50% reduction in CA-125 levels is considered meaningful. All patients’ CA-125 levels were below the standard cutoff level of 35 U/mL.
"These results build on the impressive clinical findings we observed in the GOG Study as well as the translational data from this same study reported earlier this year. As we move closer towards initiating a Phase I/II trial to evaluate the synergistic anti-cancer effects of GEN-1 together with Avastin and Doxil, these results also provide strong validation for the potential of GEN-1 in ovarian cancer," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We will continue to evaluate the maturing dataset from the OVATION study, and may evaluate ways to leverage insights from this trial to help accelerate the clinical development of this highly promising therapy and inform the design of future studies."
The OVATION Study will continue into 2016 at higher doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an immune response. Celsion has initiated four clinical sites at the University of Alabama at Birmingham; Oklahoma University Medical Center; Washington University in St. Louis and the Medical College of Wisconsin. The trial is designed to enroll three to six patients per dose cohort and will evaluate safety and efficacy and attempt to define an optimal dose. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin and Doxil. With the second cohort fully enrolled, Celsion expects to complete the OVATION Study this year.
GOG Study – GEN-1 Data
Celsion also recently announced clinical data from a dose-escalation study evaluating GEN-1 plus Doxil in platinum resistant ovarian cancer (the GOG Study). In the GOG Study, at the highest dose level, GEN-1 plus Doxil produced an objective response rate (ORR) of 29%. This compares favorably to the data from the Phase 3 AURELIA trial in platinum-resistant ovarian cancer, which demonstrated that Avastin plus chemotherapy produced an ORR of 27%. Historical data for trials evaluating Doxil monotherapy in platinum resistant ovarian cancer suggest an ORR of only 8% to 12%.
Translational data from the GOG Study reported in January 2016 is highlighted below:
Intraperitoneal administration of GEN-1 in platinum-resistant ovarian cancer patients resulted in a significant increase in IL-12 levels in peritoneal fluid samples. IL-12 levels were quantifiable in 91% of evaluable fluid samples collected post GEN-1 treatment. None of the evaluable pre-treatment peritoneal fluid samples had any detectable IL-12 levels.
The IL-12 levels were detectable for at least seven days after GEN-1 treatment.
In comparison to peritoneal fluid, the IL-12 levels in plasma samples (systemic exposure) following GEN-1 treatment were not detectable or were very low in quantity.
Significant increases in levels of IFN-γ, a key downstream mediator of IL-12 action, were observed in peritoneal fluid but not in plasma samples. At least a 5-fold increase above pre-treatment level in IFN- γ was observed in most samples, with the highest increase observed at 120-fold. Similar results were observed with TNF-α levels, with the highest increase observed at 77-fold over pre-treatment control.
About GEN-1 Immunotherapy
GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer.
Cempra Reports First Quarter 2016 Financial Results and Provides Corporate Update
On May 01, 2016 Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, reported financial results for the quarter ended March 31, 2016 and provided an update on recent corporate developments (Press release, Cempra, MAY 1, 2016, View Source [SID:1234511732]). The company will host a webcast and conference call tomorrow at 8:00 a.m. ET.
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First Quarter 2016 and Recent Corporate Highlights
In April, Cempra completed its rolling submission of two New Drug Applications (NDA) to the U.S. Food and Drug Administration (FDA) for solithromycin (intravenous and capsules) in community-acquired bacterial pneumonia (CABP). Having been granted qualified infectious diseases product (QIDP) designation in 2013, solithromycin’s NDAs qualify for an eight month priority review. Subject to approval by the FDA, Cempra plans to launch solithromycin in the U.S. in the first quarter of 2017.
In March, Cempra received authorization under its existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to receive funding of $25.5 million through mid-2018 for a Phase 2/3 pivotal clinical study of solithromycin in pediatric patients. Cempra is responsible for an additional designated portion of the cost of the planned Phase 2/3 study. Three dosage formulations of solithromycin, intravenous, capsule and oral suspension, will be tested in the trial and may provide pediatricians with greater dosing flexibility.
In January, Cempra completed a public offering of 4,166,667 shares at a price of $24.00 per share. Net proceeds after underwriting discounts and commissions and expenses of the offering were approximately $93.8 million. Cempra intends to use the funds for the commercial launch of solithromycin in CABP in the U.S., subject to the drug receiving FDA approval, and on research and development activities, working capital and general corporate and administrative expenses.
The Taksta (fusidic acid) acute bacterial skin and skin structure infection (ABSSSI) Phase 3 trial is enrolling patients, which is expected to be completed during the first half of 2017.
"I am truly delighted that Cempra is able to mark the tenth anniversary of its founding with our submission to the FDA of two NDAs for solithromycin in community-acquired bacterial pneumonia," said Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra. "As a new chemical entity, we expect that solithromycin will be subject to an advisory committee review, however given the compelling data package that we have assembled, we look forward to working with the agency during the review process to bring this important new macrolide antibiotic to patients with CABP and the physicians who treat them. Our development programs for solithromycin for pediatric patients and urogenital gonorrhea, as well our development program for Taksta, are continuing to move forward."
Upcoming Clinical Development Milestones
Solithromycin
Solithromycin pediatric: patient enrollment for Phase 1b trial continues.
Enrollment in a Phase 2/3 pivotal trial with solithromycin for bacterial infections in pediatric patients is expected to initiate in Q2 2016.
Phase 3 trial for solithromycin in urogenital gonorrhea is ongoing.
Phase 2 trial in chronic obstructive pulmonary disease (COPD) is ongoing.
Phase 2 trial in nonalcoholic steatohepatitis (NASH) is ongoing.
Completion of the EMA submission for solithromycin in the treatment of CABP is expected by the end of the first half of 2016.
Taksta
Phase 3 trial in ABSSSI is ongoing.
An exploratory trial for Taksta in patients with refractory bone or joint infections is ongoing.
Financial Results for the Three Months Ended March 31, 2016
For the quarter ended March 31, 2016, Cempra reported a net loss of $29.4 million, or $0.61 per share, compared to a net loss of $17.4 million, or $0.41 per share for the first quarter in 2015. Research and development expense in the first quarter of 2016 was $23.5 million, a decrease of 10% compared to the same quarter in 2015. The lower R&D expense was primarily due to the timing of payments for the order of active pharmaceutical ingredient (API) necessary to support the launch of solithromycin as the company begins its commercial readiness activities and a decrease in clinical expenses as the Phase 3 Oral and Phase 3 IV-to-Oral studies are complete. General and administrative expense was $8.3 million, a 79% increase compared to the quarter ended March 31, 2015, driven primarily by commercial readiness activities and increased headcount as the company begins to plan for commercialization.
As of March 31, 2016, Cempra had cash and equivalents of $223.6 million and 48.2 million shares outstanding.
Financial Guidance
The company’s current cash and equivalents are expected to be sufficient to fund ongoing operations into the second quarter of 2017, assuming continued timely receipts under the BARDA contract and receipt of expected milestone payments from Toyama. This projection does not include any funds from new financings or partnerships.