On August 15, 2016 Heat Biologics, Inc. ("Heat") (Nasdaq: HTBX), an immuno-oncology company developing novel therapies that activate a patient’s immune system against cancer, reported a general business update and reported its financial results for the second quarter and six months ended June 30, 2016 (Filing, Q2, Heat Biologics, 2016, AUG 15, 2016, View Source [SID:1234514608]).

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"We are pleased to report a number of important scientific, clinical and financial developments at the company," said Jeff Wolf, Heat’s Founder and CEO. "First, the preclinical findings demonstrating that our ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection were published in the journal, ‘Cancer Immunology Research.’ Additionally, we reported encouraging interim study findings from our Phase 1b trial evaluating HS-110 in combination with nivolumab (Opdivo), a Bristol-Myers Squibb anti-PD-1 checkpoint inhibitor, for the treatment of non-small cell lung cancer."

"We remain focused on driving shareholder value and minimizing dilution. We have implemented a number of cost-saving measures to help ensure we achieve important data readouts expected in the fourth quarter with current cash on-hand. Furthermore, I am pleased to report we have generated approximately $2.0 million in additional cash from the exercise of warrants. Significantly, we have also regained compliance with NASDAQ’s minimum closing bid price requirement, which alleviates the immediacy of effecting a reverse stock split."

"Overall, we remain encouraged by the outlook for the business and the growing interest from within the industry to utilize our platform technology with checkpoint inhibitors and other immunotherapies to activate a patient’s immune system against cancer. Importantly, our allogeneic cell-based immunotherapy has the potential to offer a broader, off-the-shelf solution that addresses many of the past challenges that have plagued the immuno-oncology market."

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Recent Developments & Second Quarter 2016 Corporate Highlights

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Heat remains on track to report topline data in the fourth quarter from its Phase 2 trial evaluating HS-410 for the treatment of non-muscle invasive bladder cancer (NMIBC) and its Phase 1b trial evaluating HS-110 in combination with an anti-PD-1 checkpoint inhibitor for the treatment of non-small cell lung cancer (NSCLC).

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In July, Heat announced that preclinical findings from its ComPACT platform technology were published online in the journal "Cancer Immunology Research." Heat demonstrated that its ComPACT technology secreting the co-stimulator OX40L significantly enhanced tumor rejection in two cancer tumor types compared to OX40 agonist antibody treatment. Heat also reported that ComPACT-enhanced antigen-specific T cell infiltration into tumors improved memory T cell responses and demonstrated greater specificity than OX40 agonist antibody treatments. Furthermore, the findings also showed that the ComPACT platform can be adapted to secrete other costimulatory molecules, including TL1A, 4-1BBL and ICOSL.

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In June, Heat reported interim study findings from its Phase 1b trial evaluating HS-110 in combination with nivolumab for the treatment of NSCLC. The findings suggested that the addition of HS-110 to nivolumab does not alter the nivolumab safety profile to-date. In addition, case studies of three trial patients (one non-responder and two responders) were characterized. While all three patients showed a decrease in immune cell PD-1 expression, which is consistent with nivolumab’s mechanism of action, both responders also showed a decrease in immunosuppressor cells, as well as increases in activated effector T cells in the peripheral blood. Furthermore, the two responders showed an increase in CD8+ T cells in biopsy samples after treatment with HS-110 + nivolumab. These early data appear to suggest that HS-110 in combination with nivolumab may improve response rates for patients with "cold tumors," who have historically not responded to checkpoint inhibitors alone.

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In June, Heat presented a poster at the ASCO (Free ASCO Whitepaper) Annual Meeting reviewing the design and endpoints for the ongoing Phase 1b trial of HS-110 in combination with nivolumab.

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In April, Heat presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting. In the poster entitled "Phase I/II Study of Patients with NMIBC Treated with Vesigenurtacel-L (HS-410) with or without BCG," Heat reported that no additional recurrences had been reported to-date, with all patients at least 18 months out from enrollment. In another poster, Heat reported initial preclinical results from its collaboration with OncoSec Medical Incorporated. In the third poster, Heat reported positive preclinical data on its next generation ComPACT platform technology.

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In April, Heat implemented cost-saving measures and a focused corporate strategy to achieve important data readouts in the fourth quarter with its current cash on-hand.

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In April, Heat appointed John Prendergast, Ph.D., to its Board of Directors.

Second Quarter 2016 Financial Highlights

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Research and development (R&D) expenses decreased to approximately $0.5 million in the second quarter of 2016 compared to approximately $0.6 million in the second quarter of 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in non-cash stock compensation expense related to equity grants awarded to one of our Scientific Advisory Board members in 2015.

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Clinical and regulatory expenses decreased to approximately $1.3 million in the second quarter of 2016 compared to approximately $3.4 million in the second quarter of 2015, a decrease of approximately $2.1 million. The decrease is primarily attributable to reductions in clinical trial execution costs.

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General and administrative (G&A) expenses increased to approximately $1.1 million in the second quarter of 2016 compared to approximately $0.9 million in the second quarter of 2015, an increase of approximately $0.2 million. The increase is primarily attributable to separation expenses related to the departure of two of our former executive officers, as well as other incremental operating expenses.

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Net loss for the second quarter of 2016 was $3.0 million compared to a net loss of $4.9 million for the second quarter of 2015.

Six Months Ended June 30, 2016 Financial Highlights

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R&D expenses decreased to approximately $1.0 million for the six months ended June 30, 2016 compared to approximately $1.1 million for the six months ended June 30, 2015, a decrease of approximately $0.1 million. The decrease is attributable to reductions in patent, license and other professional fees, as well as reductions in compensation costs attributable to deferral in salary as part of our cost-savings initiatives.

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Clinical and regulatory expenses decreased to approximately $4.5 million for the six months ended June 30, 2016 compared to approximately $5.5 million for the six months ended June 30, 2015, a decrease of approximately $1.0 million. The decrease is primarily attributable to reductions in clinical trial execution costs.

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G&A expenses decreased to approximately $2.1 million for the six months ended June 30, 2016 compared to approximately $2.2 million for the six months ended June 30, 2015, a decrease of approximately $0.1 million. The decrease is primarily attributable to reductions in professional services as we bring more services in-house.

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Net loss for the six months ended June 30, 2016 was $7.8 million compared to a net loss of $8.9 million for the six months ended June 30, 2015.

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Cash and cash equivalents totaled approximately $7.1 million at June 30, 2016 compared to cash, cash equivalents and short-term investments totaled approximately $11.6 million at December 31, 2015. This does not include approximately $2.0 million raised from the exercise of warrants subsequent to June 30, 2016.

On August 15, 2016 Hemispherx Biopharma (NYSE MKT: HEB) reported its financial results for the six months ended June 30, 2016. The net loss was approximately $3,467,000 or $(0.01) per share as compared to a net loss of $8,290,000 or ($0.04) per share for the same six month period in 2015 (Filing, Q2, Hemispherx Biopharma, 2016, AUG 15, 2016, View Source [SID:1234514609]). Cash, cash equivalents and marketable securities were approximately $6,512,000 at June 30, 2016 as compared to $8,910,000 as of December 31, 2015. The Company also has $1,750,000 of restricted cash which is designated for litigation settlement.

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Hemispherx Biopharma has made changes to its senior management team and has implemented austerity measures which included the reduction of executive compensation and elimination of non-essential contractors and personnel. These measures have resulted in a significant reduction in costs and expenses. The company is now focusing on commercial success by seeking co-development partners and working closely with the research and regulatory communities to bring disease fighting technologies to the world.

On August 15, 2018 Bavarian Nordic reported the signature of a drug supply agreement with Bristol-Myers Squibb (Press release, Bavarian Nordic, AUG 15, 2016, View Source [SID1234527669]). Based on the agreement, BMS will supply OPDIVO (nivolumab) to Bavarian Nordic for use in a clinical study. The trial, which will be sponsored by Bavarian Nordic, will enroll approximately 160 patients and will look to explore the benefit of combining CV301 with OPDIVO in patients with previously treated non-small cell lung cancer (NSCLC). OPDIVO is approved for treatment of patients with NSCLC in the second line setting, among other indications.

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CV301 targets two tumor-associated antigens, CEA and MUC-1, which are over-expressed in major cancer types, including lung, bladder and colorectal cancer. Similar to PROSTVAC, CV301 uses an off-the-shelf, prime/boost dosing schedule. CV301 incorporates a modified version of vaccinia (MVA-BN) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.

Preclinical data shows the ability of CV301 to upregulate PD-L1 by mounting an immune response against a tumor target. The upregulation of PD-L1 is a marker indicating the tumor is under attack from T-cells, presenting an opportunity for a greater response in patients who might otherwise not benefit from treatment with a checkpoint inhibitor alone.

"We are extremely excited to announce this agreement between Bavarian Nordic and BMS. While we have discussed the potential benefit of combining our cancer vaccines with checkpoint inhibitors for some time, this is now within reach as we have once again been able to strike an agreement with the leading immune-oncology company in the world, this time to explore the potential synergy between our programs to benefit patients with lung cancer. We look forward to the initiation of this study later this year," stated Paul Chaplin, President and CEO of Bavarian Nordic.

Bavarian Nordic continues to retain all commercial rights for CV301. There is no obligation on behalf of BMS, beyond the contribution of drug material.

Oncbiomune has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, OncBioMune Pharmaceuticals, 2017, AUG 15, 2016, View Source [SID1234522114]).

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On August 15, 2016 Celsion Corporation (NASDAQ:CLSN) reported updated results from its final 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 15, 2016, View Source [SID:1234514543]). The 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 54% risk improvement in OS compared to optimized RFA alone. The Hazard Ratio (HR) at this analysis is 0.65 (95% CI 0.45 – 0.94) with a p-value of 0.02. Median overall survival for the ThermoDox group has been reached which translates into a two year survival benefit over the optimized RFA only group (projected to be greater than 80 months for the ThermoDox plus optimized RFA group compared to less than 60 months projection for the optimized RFA only group).

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Additional findings from this most recent analysis specific to the Chinese patient cohort of 223 patients are summarized below:

In the population of 154 patients with single lesions (70% of the HEAT Study Chinese patient cohort) who received optimized RFA treatment for 45 minutes or more showed a 53% risk improvement in OS (HR = 0.66) when treated with ThermoDox plus optimized RFA.
These data continue 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. The clinical benefit seen in the ITT Chinese patient cohort further confirms the importance of RFA heating time as 72% of patients in this large patient cohort in China received an optimized RFA treatment.
"Data from the HEAT Study have consistently been a foundation and provides additional evidence for our thesis that ThermoDox, when combined with RFA standardized to a minimum of 45 minutes for intermediate size lesions has the potential to significantly improve survival in primary liver cancer, where the current overall survival rate is far too short," stated Nicholas Borys, M.D., Celsion’s senior vice president and chief medical officer. "These findings, if borne out in our ongoing OPTIMA trial, will position ThermoDox as a potentially curative treatment in primary liver cancer."

"We are delighted to present our investors and the medical community with the findings from the final data sweep from the HEAT Study which reinforces the substantial and mounting support for our ongoing global Phase III OPTIMA Study," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "Particularly, with the growing incidence of primary liver cancer in China representing approximately 50% of the 850,000 cases diagnosed annually, the data generated from the Chinese subgroup underscore the importance of ThermoDox and the role that it will play as a first line therapy for this, the largest unmet medical need in oncology. Along with our China focused manufacturing strategy, the results from the HEAT Study will support our regulatory and long-term commercialization strategy for ThermoDox in this important region."

The OPTIMA Study is a pivotal, double-blind, placebo-controlled Phase III clinical trial, and is expected to enroll up to 550 patients at up to 75 sites in the North America, Europe, China and Asia Pacific. As of July 31, 2016, the study has been successfully enrolling patients at more than 57 clinical sites in 13 different countries. In December 2015, Celsion announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the OPTIMA Study at up to 15 additional clinical sites in China, the country where approximately 50% of the 850,000 new cases of primary liver cancer are diagnosed each year and where the Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.