On August 6, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported updated results from its retrospective analysis of the Company’s 701-patient HEAT Study of ThermoDox, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation (RFA) in primary liver cancer, also known as hepatocellular carcinoma (HCC) (Press release, Celsion, AUG 6, 2015, View Source [SID:1234507062]). As of July 15, 2015, the latest overall survival (OS) analysis demonstrated that in a large, well bounded, subgroup of patients (n=285, 41% of the HEAT Study patients), treatment with a combination of ThermoDox and optimized RFA provided an average 58% improvement in OS compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.63 (95% CI 0.43 – 0.93) with a p-value of 0.0198. Median overall survival for the ThermoDox group has been reached which translates into a 25.4 month (2.1 year) survival benefit over the optimized RFA group (79 months for the ThermoDox plus optimized RFA group versus 53.6 months for the optimized RFA only group).

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In the most recent post-hoc analysis of the HEAT Study, data continued to support and further strengthen ThermoDox’s potential to significantly improve OS compared to an RFA control in patients with lesions that undergo optimized RFA treatment for 45 minutes or more. Findings from this analysis apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm), representing a subgroup of 285 patients. Additional findings from this most recent analysis specific to the Chinese cohort of patients with single lesions (74% of the HEAT Study Chinese patient population) showed a 75% improvement (HR = 0.57 with a p-value of 0.08) in OS for the ThermoDox plus optimized RFA group compared to optimized RFA only group. Patients in the Chinese cohort with single lesions between 3-5 cm showed a doubling of improvement (HR = 0.50 with a p-value of 0.06) in OS when treated with ThermoDox plus optimized RFA.

"These results from the HEAT study reinforce the potential for ThermoDox in combination with an optimized RFA regimen to serve as an effective treatment option that could significantly improve overall survival in primary liver cancer patients," stated Dr. Nicholas Borys, Celsion’s senior vice president and chief medical officer. "The data from our study suggests a greater than two year median survival advantage for the ThermoDox plus optimized RFA group, a meaningful finding given that few treatments are effective in prolonging survival in HCC. We look forward to continued analyses from the maturing HEAT Study data in China and learning more about how this regimen can prolong survival in this deadly cancer.

"The continuing strength of the HEAT Study data reinforces our confidence in ThermoDox as the first and only front line therapy for newly diagnosed HCC patients and further improves the risk profile of our Phase III OPTIMA Study, currently enrolling patients in 12 countries globally," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Equally important is the maturing data and the remarkable clinical benefit seen in the Chinese patient cohort. This large 221 patient subgroup represents a country with over 50% of the world’s incidence (over 400,000 new cases) of HCC every year. These specific findings, along with the 25.4 months improvement in time to death seen in the global population, strengthen our options for discussions with the CFDA to identify a faster path to commercialization."

The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 75 clinical sites in the United States, Europe, China and Asia Pacific, and will evaluate ThermoDox in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and clinical sites for treating lesions three to seven centimeters, versus standardized RFA alone. The primary endpoint for the trial is Overall Survival, which is supported by post-hoc analysis of data from the Company’s 701 patient HEAT Study, where optimized RFA has demonstrated the potential to significantly improve survival when combined with ThermoDox. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC).

On August 6, 2015 Oncothyreon Inc. (NASDAQ:ONTY) reported financial results for the second quarter ended June 30, 2015 (Press release, Oncothyreon, AUG 6, 2015, View Source [SID:1234507100]).

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Net loss for the three months ended June 30, 2015 was $10.9 million, or $0.11 per basic and diluted share, compared with a net loss of $6.0 million, or $0.09 per basic and diluted share, for the comparable period in 2014. The $4.9 million increase in net loss was primarily attributable to the difference in the change in the fair value of warrant liability of $4.3 million. The increase in net loss was also due to increases in research and development expenses of $0.3 million and increases in general and administrative expenses of $0.2 million.

Net loss for the six months ended June 30, 2015 was $18.8 million, or $0.19 per basic and diluted share, compared with a net loss of $15.6 million, or $0.22 per basic and diluted share, for the comparable period in 2014. The $3.2 million increase in net loss was attributable to the difference in the change in the fair value of warrant liability of $1.7 million, increases in research and development expenses of $1.3 million and increases in general and administrative expenses of $0.2 million.

As of June 30, 2015, Oncothyreon’s cash, cash equivalents and investments were $70.0 million, compared to $63.7 million at December 31, 2014, an increase of $6.3 million, or 9.9 percent. The increase was primarily attributable to net proceeds of $22.4 million from the closing of concurrent but separate underwritten offerings of common stock and Series B convertible preferred stock in February 2015, partially offset by $15.6 million of cash used in operations during the six months ended June 30, 2015.

Financial Guidance

Oncothyreon believes the following financial guidance to be correct as of the date provided. Oncothyreon is providing this guidance as a convenience to investors and assumes no obligation to update it.

Oncothyreon currently expects operating expenses in 2015 to be lower than in 2014, which included the upfront payment to Array BioPharma Inc. for the exclusive license to ONT-380. Oncothyreon currently expects cash used in operations in 2015 to be approximately $32.0 – $34.0 million.

(Filing, 10-Q, Merck & Co, AUG 6, 2015, View Source [SID:1234507096])

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On August 6, 2015 Dr. Reddy ’ s Laboratories Ltd. (NYSE: RDY) reported that it has entered into a strategic collaboration with Amgen – one of the world ’ s leading independent biotechnology companies – to market and distribute three Amgen medicines in India in the area s of oncology and cardiology (Press release, Dr Reddy’s, AUG 6, 2015, View Source [SID:SID1234515194]). Under the terms of the collaboration , Dr. Reddy ’ s shall perform a full range of regulatory and commercial services to seek approval and launch Kyprolis (carfilzomib), BLINCYTO (blinatumomab) and Repatha (evolocumab) in India. The collaboration leverages the capabilities of both companies , combining three of Amgen ’ s innovative therapies with Dr. Reddy ’ s deep understanding of patient and physician needs in India.

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Dr. Reddy ’ s Executive Vice President and Head of India Business & Global Business Development Alok Sonig stated, " We are excited about our strategic collaboration with an innovation powerhouse like Amgen and look forward to making their innovative medicines accessible to Indian patients. Addressing significant unmet needs of patients in oncology and cardiovascular are key area s in India and , therefore, a priority for us at Dr. Reddy ’ s. We believe that good health can’t wait and that this is an important milestone for us in our journey as we improve patient care. "

" We are pleased to be joining forces with Dr. Reddy ’ s Laboratories in order to make Amgen ’ s innovative medicines available to patients in India, " said Penny Wan, Amgen vice president and general manager, Japan Asia Pacific Region. " Dr. Reddy ’ s has significant experience serving oncology and cardiovascular patients in India and shares Amgen ’ s interest in delivering new treatment options to seriously ill patients."

Kyprolis was approved by the U.S. Food and Drug Administration in July 2015, in combination with lenalidomide and dexamethasone, for the treatment of patients with relapsed multiple myeloma who have received o ne to three prior lines of therapy. Kyprolis is also indicated under FDA accelerated approval as a single agent for the treatment of patients with multiple myeloma who have received at least two prior therapies including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of completion of the last therapy. Approval is based on response rate. Clinical benefit, such as improvement in survival or symptoms, has not been verified. A form of blood cancer that a rises from plasma cells, multiple myeloma usually grows in bone marrow, the soft, tissue found inside most bones where normal blood cells are produced.

BLINCYTO is an example of immunotherapy, a treatment that uses certain parts of a person ’ s immune syst em to fight diseases such as cancer. BLINCYTO is the first approved bispecific CD19 – directed CD3 T – c ell engager . It engages the body ’ s T – cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. It was approved by the U.S. FDA in 2014, t o treat patients with Philadelphia chromosome – negative relapsed or refractory B – cell precursor acute lymphoblastic leukemia (B – cell ALL), an uncommon form of ALL. This indication is approved under accelerated approval. Continued approval for this indicatio n may be contingent upon verification of clinical benefit in subsequent trials.

In July, this year, the European Commission (EC) granted marketing authorisation for Repatha , the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol despite taking maximum doses of statins or who cannot take statins, who require additional intensive low – density lipoprotein cholesterol (LDL – C) reduction. Elevated LDL – C or " bad " cholesterol is an abnormality of cholesterol and/or fats in the blood and is recognized as a major risk factor for cardiovascular disease.

On August 6, 2015 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel nucleic acid-based therapeutics for oncology and rare diseases, reported its financial and operational results for the second quarter ended June 30, 2015 (Press release, Idera Pharmaceuticals, AUG 6, 2015, View Source;p=RssLanding&cat=news&id=2076539 [SID:1234507065]).

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"From a program execution perspective, we’ve continued to make steady progress across the board during the second quarter of 2015," stated Vincent Milano, Idera’s Chief Executive Officer. "We recently announced our strategic clinical research alliance with MD Anderson, with the first planned study of this alliance evaluating the combination of IMO-2125 (TLR9 agonist) and ipilimumab (an anti-CTLA4 antibody) in melanoma patients. We are targeting commencing this study in the fourth quarter of this year. Our B-cell lymphoma programs with IMO-8400 (TLR7, 8 and 9 antagonist) are advancing, as we are rapidly approaching the release of data from the Waldenström’s macroglobulinemia (WM) trial in the fourth quarter. Also in the second quarter, we began enrolling patients into the first dose cohort in the diffuse large B-cell lymphoma (DLBCL) clinical trial. Our rare disease programs are moving forward nicely, most notably with the initiation of our dermatomyositis Phase 2 study planned for the fourth quarter. Finally, we continue to expect to announce the first two diseases we plan to target with our exciting third generation antisense platform technology, which was previously referred to as our GSO program, by the end of this year."

Continued Milano, "Our team at Idera has made good progress executing against the goals that we established for ourselves at the beginning of the year. Importantly, I am pleased with the progress we’ve made developing and implementing a corporate culture and value system that aligns all facets of our company towards both near and long term success. While these are not necessary externally-viewed measures, they are paramount elements to any organization that places high expectations upon itself. During the most recent quarter, we’ve added several extremely skilled individuals to our team who’ve made immediate impacts on our organization and programs to enhance our ability to achieve our goals. By no means have we completed building out our team at Idera, however, I am pleased with the progress that has been made to date; and with this group’s ability to adapt and grow, while continuing to remain focused and execute our programs with the rigor that is necessary."

Research and Development Program Updates

Toll-like Receptor (TLR) Agonism Program

Immuno-Oncology Program

In June 2015, the company announced that it had entered into a strategic clinical research alliance with MD Anderson Cancer Center to advance the clinical development of intratumoral TLR9 agonists in combination with checkpoint inhibitors. The company also announced that it expects to initiate the first trial from the alliance, a Phase 1/2 study to assess the safety and efficacy of intratumoral IMO-2125 in combination with ipilimumab in approximately 45 patients with metastatic melanoma. The company intends to initiate this study in the fourth quarter of 2015 with data expected in 2016. Planning of additional studies as part of the clinical research alliance with MD Anderson Cancer Center is in progress. Additionally, the company recently has had two abstracts accepted with new pre-clinical data on intratumoral IMO-2125 activity, and its impact on the tumor microenvironment and checkpoints at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) taking place in September in New York.

Toll-like Receptor (TLR) Antagonism Programs

Genetically Defined Forms of B-cell Lymphoma

Idera’s program in genetically defined forms of B-cell lymphoma is based on independent research conducted at Idera. Pre-clinical studies have demonstrated that, in certain B-cell lymphomas, the presence of the MYD88 L265P oncogenic mutation led to over-activation of TLR7 and TLR9 signaling and that blocking these TLRs with our antagonists promoted tumor cell death.

In the company’s Phase 1/2 study in Waldenstrom’s macroglobulinemia, the targeted number of patients at each of the three dose levels have completed assessment through the end of their first cycle of treatment and the dose escalation portion of the study has been completed. The trial is designed to evaluate IMO-8400’s safety, tolerability and potential clinical activity in patients who have a history of relapse after or failure to respond to prior therapies. Idera anticipates data from this trial will be available in the fourth quarter of 2015.

During the second quarter the company also continued to activate clinical sites and enroll patients into the first of three dose cohorts of our Phase 1/2 clinical trial of IMO-8400 in patients with relapsed or refractory DLBCL, who are harboring the MYD88 L265P oncogenic mutation. The company anticipates that data from this trial will be available in 2016. Idera also announced during the second quarter that the U.S. Food and Drug Administration (FDA) had granted us orphan drug designation for IMO-8400 for the treatment of DLBCL.

Rare Disease Programs

The company is planning to initiate clinical development of IMO-8400 for the treatment of rare diseases. The company has selected dermatomyositis and Duchenne muscular dystrophy (DMD) as the first rare diseases for which we plan to develop IMO-8400. The company selected these indications for development based on the reported increase in TLR expression in these disease states, expression of cytokines indicative of key TLR-mediated pathways, the identification of prospective biomarkers for evaluation in early clinical trials and significant unmet needs. The company anticipates commencing clinical development in these two indications by initiating a Phase 2 clinical trial in dermatomyositis by the end of 2015 and a Phase 2 clinical trial in DMD in 2016.

Third Generation Antisense Platform

The company is currently undertaking an analysis and prioritization of oncology and rare disease indications for potential development of drug candidates from our third generation antisense technology platform. Idera’s key considerations in identifying disease indications in our third generation antisense program include: strong evidence that the disease is caused by a specific protein; clear criteria to identify a target patient population; biomarkers for early assessment of clinical proof-of-concept; a targeted therapeutic mechanism for action; and unmet medical need to allow for a well-defined development path to approval and commercial opportunity. The company is currently conducting disease model studies and plans to begin IND-enabling development programs in the first two disease indications selected for further development in our third generation antisense program in the second half of 2015.

Recent Corporate Highlights

In June 2015, Idera announced the appointment of Mark J. Casey as General Counsel and Secretary of the Board of Directors.

Financial Results

Second Quarter 2015 Results

Net loss applicable to common stockholders for the three months ended June 30, 2015 was $12.7 million, or $0.11 per diluted share, compared to a net loss applicable to common stockholders of $8.4 million, or $0.10 per diluted share, for the same period in 2014. For the six month period ended June 30, 2015, the Company’s net loss applicable to common stockholders was $25.2 million, or $0.23 per diluted share, compared to a net loss applicable to common stockholders of $17.6 million, or $0.22 per diluted share, for the same period in 2014. The company recognized nominal revenue in the second quarter and six month periods of 2015 and 2014.

Research and development expenses for the three months ended June 30, 2015 totaled $9.0 million compared to $5.6 million for the same period in 2014. For the six month period ended June 30, 2015, research and development expenses totaled $17.7 million compared to $12.6 million for the same period in 2014.

General and administrative expenses for the three months ended June 30, 2015 totaled $3.8 million compared to $2.7 million for the same period in 2014. For the six month period ended June 30, 2015, general and administrative expenses totaled $7.7 million compared to $4.8 million for the same period in 2014.

As of June 30, 2015, Idera’s cash, cash equivalents and investments totaled $106.3 million compared to $48.6 million as of December 31, 2014.