On March 8, 2017 (GLOBE NEWSWIRE) — Heat Biologics, Inc. ("Heat") (Nasdaq:HTBX), a leader in the development of immunotherapies designed to activate a patient’s immune system against cancer, reported that the company has entered into a definitive agreement with the holders of 75.5% of the outstanding capital stock of Pelican Therapeutics, Inc (Press release, Heat Biologics, MAR 8, 2017, View Source [SID1234518030]). ("Pelican") to acquire an 80% controlling interest in Pelican. Headquartered in Austin, Texas, Pelican is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a highly differentiated and potentially "best-in-class" T cell costimulatory receptor.

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Key highlights include:

Pelican was the recipient of a highly competitive $15.2 million New Company Product Development Award from the Cancer Prevention and Research Institute of Texas (CPRIT), which should enable the company to advance multiple products through preclinical development and at least one program through a 70-patient Phase 1 clinical trial. The CPRIT grant is subject to customary CPRIT funding conditions and was awarded in 2016 following a rigorous scientific and clinical evaluation process.
Pelican’s T cell costimulator, PTX-25, in combination with other immunotherapies, including Heat’s ImPACT and ComPACT technologies, has the potential to enhance durability of responses due to its preferential specificity to ‘memory’ CD8+ T cells.
Preclinical studies demonstrate PTX-25 has superior "best-in-class" costimulatory activity for CD8+ cytotoxic T cells as compared to other costimulators.

"The acquisition of Pelican aligns with our strategic focus targeting exciting immuno-oncology combinations, strengthening Heat’s portfolio in the emerging T cell activation space," said Jeff Wolf, Heat’s Founder and Chief Executive Officer. "Pelican’s two product candidates are transformative assets for us as there are compelling data indicating that targeting TNFRSF25 may have significant advantages over competing costimulatory receptors currently under development. This is important because many of the leading global pharmaceutical companies are focused on T cell costimulators to enhance the effectiveness of their existing immuno-oncology therapies."

"Pelican’s PTX-25 has the potential to dramatically improve the durability of antigen-specific immune responses due to its preferential specificity for stimulating the production of ‘memory’ CD8+ T cells," added Jeff Hutchins, Ph.D., Heat’s Chief Scientific Officer and Senior Vice President of Preclinical Development. "We look forward to advancing these new product candidates with synergistic combinations including Heat’s existing T cell-activating platform technologies, ImPACT and ComPACT, vastly expanding our reach within oncology and possibly beyond."

The acquisition is contingent upon certain closing conditions, including agreements of the holders of 80% of the outstanding capital stock of Pelican, on a fully diluted basis, to participate in the acquisition and enter into a stockholders agreement with respect to their remaining Pelican shares. As consideration for the sale of 80% of the Pelican Stock, Heat will pay the Pelican stockholders that participate in the acquisition an upfront cash payment not to exceed $500,000 and will issue an aggregate of 1,323,021 shares of Heat common stock, representing 4.99% of the outstanding shares of Heat common stock. In addition, Heat will cause Pelican to pay certain clinical and commercialization milestone payments, royalty and sublicensing income payments, and Heat will loan Pelican amounts sufficient to pay Pelican’s transaction expenses. Cassel Salpeter & Co. served as financial advisor to the Heat special committee and Geller Biopharm served as financial advisor to the Pelican special committee and Pelican stockholders.

The acquisition is expected to close no later than April 30, 2017, subject to applicable regulatory approvals and other customary terms and conditions.

About Pelican Therapeutics, Inc.
Pelican Therapeutics, Inc. is a privately held immuno-oncology company focused on developing agonists to TNFRSF25, a differentiated and potentially "best-in-class" T cell costimulatory receptor. TNFRSF25 has shown great promise due to its preferential specificity for stimulating the production of "memory" CD8+ T cells, the strongest predictive biomarker of clinical benefit from cancer immunotherapy. T cell costimulatory therapy, when combined with checkpoint inhibitors and other treatments, could significantly improve clinical responses for a broader range of patients. Pelican has conducted extensive preclinical studies and completed humanization of its lead monoclonal antibody, PTX-25.

About the Cancer Prevention and Research Institute of Texas (CPRIT)
Beginning operations in 2009, CPRIT has to-date awarded $1.78 billion in grants to Texas researchers, institutions and organizations. CPRIT provides funding through its academic research, prevention, and product development research programs. Programs made possible with CPRIT funding have reached all 254 counties of the state, brought more than 123 distinguished researchers to Texas, advanced scientific and clinical knowledge, and provided more than three million life-saving education, training, prevention and early detection services to Texans. Learn more at www.cprit.texas.gov.

On March 7, 2017 (GLOBE NEWSWIRE) — Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the fourth quarter and full year ended December 31, 2016 (Press release, Immune Design, MAR 7, 2017, View Source [SID1234518036]).

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"Throughout 2016, we continued enrollment of our key clinical programs, recruited senior leadership with late-stage oncology drug development expertise, and further evolved our ZVex platform to potentially enable a wider range of differentiated products. In addition, we successfully closed a follow-on offering that brought in new investors, as well as additional support from some key existing investors," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "We look forward to a year in which clinical data begin to validate Immune Design’s approaches to treating patients."

2016 Highlights and Corporate Update

Product Development: Progress on all programs and targeting data releases throughout 2017

Antigen Specific: CMB305 Program and ZVexMulti Next-Generation Product Candidates

CMB305 is the prime-boost approach targeting NY-ESO-1-expressing tumors to generate anti-NY-ESO-1 T cells in vivo via a mechanism of action Immune Design believes differs from traditional cancer vaccines. CMB305 is being evaluated in soft tissue sarcoma (STS) patients in ongoing Phase 1 and 2 monotherapy and combination studies with the anti-PD-L1 antibody, atezolizumab.
CMB305 monotherapy
Follow-up of 48 STS patients from two fully enrolled monotherapy Phase 1 trials continues (CMB305; n=25 patients, and its vector-only component, LV305; n=23 patients). As of December 31, 2016:
The safety profile remains favorable, with a consistent rate of NY-ESO-1-triggered T cell responses that appear stronger with CMB305.
The median overall survival (OS) has still not been reached in either the CMB305 or LV305 study.
Given that chemotherapeutic agents approved to treat second line metastatic STS have shown a median OS of 12.4-13.5 months, Immune Design believes this survival trend and favorable safety profile seen to date warrants evaluating further development of CMB305 as a monotherapy in recurrent STS patients.
CMB305 in combination with TECENTRIQ (atezolizumab)
Enrollment continues in this randomized 80 patient, Phase 2 study in which patients receive CMB305 plus atezolizumab vs. atezolizumab alone, pursuant to a collaboration with Genentech.
In addition to the potential of CMB305 as a monotherapy, the combination of CMB305 with a checkpoint inhibitor offers an additional potential approval path.
2017 Presentation Planning
Immune Design submitted data for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2017 (ASCO 2017) from the CMB305 monotherapy trial in STS patients.
Immune Design intends to submit data from the first 36 patients in the study combining CMB305 with atezolizumab for presentation at the European Society for Medical Oncology 2017 Congress in September 2017.
ZVexMulti, the evolution of the ZVex platform designed to deliver multiple, full length antigens and immunomodulatory molecules, continues to progress in preclinical development.
ZVexMulti is engineered to avoid potential antigenic competition and enable the delivery of multiple RNA genes selectively to dendritic cells to induce a simultaneous and balanced T cell response against all antigens.
Immune Design believes this is a potentially significant advancement in its product development capabilities, enabling the development of therapies with the potential to target a wide range of conserved antigens and large number of neo-epitopes. ZVexMulti should allow for the expression of a much larger number of epitopes than achievable with other platforms, obviating the need for a proprietary predictive algorithm to derive a limited set of epitopes.

Antigen Agnostic: G100 Program

G100, consisting of a synthetic, formulated TLR4 agonist injected intratumorally, continues to be evaluated in an ongoing randomized Phase 1/2 trial in patients with follicular non-Hodgkin lymphoma (fNHL) as both a monotherapy and combination therapy.
In the monotherapy portion, patients receive either G100 and low-dose radiation (RadRx) or G100 and low-dose RadRx with the systemic administration of the anti-PD-1 antibody, Keytruda (pembrolizumab), pursuant to a collaboration with Merck.
In contrast with CMB305’s focus on OS, the initial endpoint focus for this study is on response rates in both treated and distal, non-treated lesions (abscopal effect).
Immune Design submitted data from the G100 monotherapy portion of the study for presentation at ASCO (Free ASCO Whitepaper) 2017 and intends to submit data from the first 24 patients in the randomized part of the study of G100 with or without pembrolizumab for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 Annual Meeting to be held in December.

Expansion of Board of Directors and Senior Leadership Team

Dr. Susan L. Kelley joined the Immune Design Board in June 2016, and brings more than 25 years’ experience in oncology and immunology drug development to the company.
Dr. Sergey Yurasov joined the Immune Design team as Senior Vice President of Clinical Development and Chief Medical Officer in October 2016. Dr. Yurasov brings more than 20 years’ experience in immunology and late-stage oncology drug development to the company.

Acquisition of Intellectual Property Rights and Settlement of Litigation and Patent Challenge

In October 2016, Immune Design announced the acquisition of intellectual property rights from, and settlement of outstanding legal proceedings with, Theravectys SA (TVS). Immune Design obtained a license to certain present and future intellectual property of TVS related to the company’s ZVex platform and resolved all outstanding proceedings in Delaware and Belgium and a patent opposition proceeding brought by TVS against one of the company’s patents related to ZVex. Please refer to Immune Design’s Current Report on Form 8-K filed on October 21, 2016 for a more complete description of the terms.

Completion of Follow-On Financing

In September 2016, Immune Design completed an underwritten follow-on public offering, which resulted in the sale of 5,226,369 shares of common stock, at a price of $6.25 per share. Net proceeds from the offering were $30.3 million after deducting underwriting discounts, commissions and estimated expenses. Both new and existing investors participated in the offering.

Financial Results

Full Year 2016

Immune Design ended the fourth quarter of 2016 with $110.4 million in cash and cash equivalents, short-term investments, and other receivables compared to $112.9 million as of December 31, 2015. Net cash used in operations for the year ended December 31, 2016 was $35.7 million.
Net loss and net loss per share for the year ended December 31, 2016 were $53.5 million and $2.47, respectively, compared to $39.4 million and $2.06, respectively, for the same period in 2015.
Revenue for the year ended December 31, 2016 was $13.3 million and was primarily attributable to $7.0 million in license revenue associated with Immune Design’s collaboration with Sanofi, $1.7 million in product sales to collaboration partner Sanofi and other third parties, and $4.6 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration. Revenue for the same period in 2015 was $9.5 million and was primarily attributable to $4.2 million in collaboration revenue associated with the Sanofi G103 collaboration, $3.5 million in license revenue associated with the company’s collaborations with Medimmune and Sanofi, and $1.9 million in product sales to collaboration partners Sanofi and Medimmune and other third parties.
Research and development expenses for the year ended December 31, 2016 were $45.1 million, compared to $33.1 million for the same period in 2015. The $12.0 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials.
General and administrative expenses for the year ended December 31, 2016 were $21.9 million, compared to $15.1 million for the same period in 2015. The $6.8 million increase was primarily attributable to the settlement and license agreements with TVS involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the Company, as well as related claims and counterclaims.

Fourth Quarter

Net loss and net loss per share for the fourth quarter of 2016 were $14.4 million and $0.57, respectively, compared to $12.1 million and $0.60, respectively, for the fourth quarter of 2015.
Revenue for the fourth quarter of 2016 was $2.1 million and was primarily attributable to $0.5 million in product sales to collaboration partner Sanofi and other third parties, and $1.6 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration. Revenue for the fourth quarter of 2015 was $1.1 million and was primarily attributable to $0.9 million in product sales to collaboration partners Sanofi and Medimmune and other third parties, and $0.2 million in collaboration revenue associated with the Sanofi G103 collaboration.
Research and development expenses for the fourth quarter of 2016 were $12.0 million compared to $8.9 million for the same period in 2015. The $3.1 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials and an increase in personnel-related expenses to support the company’s advancing research and clinical pipeline.
General and administrative expenses for the fourth quarter of 2016 were $4.4 million, relatively consistent with general and administrative expenses of $4.0 million recorded in the fourth quarter of 2015.

Cash Guidance

Based on current expectations, Immune Design expects to have cash to fund operations into the second half of 2018.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss the fourth quarter and full year 2016 financial results and provide a corporate update.

The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the Immune Design website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code 70907410.

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.