Expecting Big Things From Peregrine Pharmaceuticals Inc (NASDAQ:PPHM)

A lot has already happened with Peregrine Pharmaceuticals Inc (NASDAQ:PPHM) since our January 4th article titled "Don't Bet Against Peregrine Pharmaceuticals In 2016." First, the company announced a new research collaboration with the National Comprehensive Cancer Network to expand the company’s ongoing clinical research and development of bavituximab for the treatment of a range of tumors. This affiliation is a pretty big deal for PPHM. NCCN, a not-for-profit alliance of 26 of the world's leading cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care so that patients can live better lives. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN’s Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.Peregrine expects results from this collaboration to further support the ongoing development of bavituximab as a key component of various combination cancer treatments. Bavituximab is currently being evaluated in combination with docetaxel (chemotherapy) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) in the ongoing Phase III SUNRISE trial. In addition, as part of its recently formed collaboration with AstraZeneca, Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in patients with previously treated squamous or non-squamous NSCLC. The company will also be evaluating bavituximab with chemotherapy combinations in HER2-negative breast cancer.Second, PPHM is expanding its bavituximab clinical program in lung, breast and other cancers. The planned trials include a Phase II NSCLC trial in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), and a Phase II trial in early stage triple negative breast cancer (TNBC). These are in addition to the recently initiated Phase II/III study in combination with chemotherapy in human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC). The company expects that initial data from these trials may be available in late 2016 or early 2017. Additionally, the company looks forward to the initiation of additional trials of bavituximab combinations through its ongoing collaborations with AstraZeneca and NCCN. CEO Stephen King pretty much summed it up:

“As we wrap up enrollment in the SUNRISE trial, we recognize that we are at an ideal juncture to continue expanding the potential of bavituximab with standard of care and immunotherapy combinations in multiple solid tumor types. Combined with the SUNRISE trial, the new studies we have planned can help solidify the potential of bavituximab in NSCLC while significantly expanding the market opportunity in breast cancer. Driving our strategy is the goal of further demonstrating that bavituximab can provide therapeutic benefit to available cancer treatments, regardless of whether those are traditional therapies such as chemotherapy and radiation, or the emerging novel class of immuno-oncology agents. In today’s update, it is evident that we are moving aggressively to compile a significant body of clinical evidence to support bavituximab’s utility in multiple cancers and across a range of treatment regimens. By doing so, we hope to optimally position bavituximab for success.”

The current status updates are as follows. For bavituximab in NSCLC, Peregrine’s Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) trial is evaluating the use of bavituximab and docetaxel in patients with previously treated locally advanced or metastatic non-squamous NSCLC. Peregrine expects that the first interim analysis (33% of targeted number of deaths) will be conducted in early 2016 and the second interim analysis (50% of targeted number of deaths) in mid-2016. The final analysis, which will trigger the unblinding of the study data, is currently projected to occur at the end of 2016.

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Peregrine expects to initiate a global Phase II study of bavituximab in combination with AstraZeneca’s durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC during the first quarter of 2016. The goal of this trial is to generate data on the combination of bavituximab and durvalumab to inform the potential advancement of this treatment regimen into later stage clinical trial. The study’s primary endpoints are overall response rate (ORR) and safety. The trial is also designed to retrospectively evaluate patients for the correlation between their PD-L1 levels and clinical outcomes, providing further critical data to guide future development. The randomized, open-label trial will evaluate approximately 200 patients at sites in the U.S. and Europe. The company has filed a study protocol to its existing investigational new drug (IND) application for bavituximab in the U.S. and is currently working to open clinical trial sites.

For bavituximab in the treatment of breast cancer, in December 2015, Peregrine initiated an open-label, randomized Phase II/III study comparing the efficacy and safety outcomes for taxane monotherapy (paclitaxel or docetaxel at investigator discretion) versus taxane therapy in combination with bavituximab in HER2-negative MBC patients. The goal of the Phase II portion of this study is to generate mature data on the combination of bavituximab and chemotherapy in MBC to guide the design and execution of the trial’s Phase III component. The primary efficacy endpoint of the Phase II study is ORR, with secondary endpoints including progression free survival (PFS), overall survival (OS), duration of response and safety. The Phase II portion of the study will enroll approximately 150 patients at sites in the U.S. and Europe.

Peregrine is planning to initiate a Phase II trial of bavituximab in combination with neoadjuvant chemotherapy in early stage TNBC. The primary endpoint of this study is to determine the pathologic complete response rate (pCR), an accepted surrogate endpoint in early stage TNBC. The concept for this neoadjuvant setting trial, which will be conducted at a few select U.S. sites, originated from Peregrine’s ongoing collaboration with Memorial Sloan Kettering Cancer Center (MSKCC). The company has filed a study protocol to its existing bavituximab IND application in the U.S. and is currently working to open clinical trial sites, including one that will be led by David B. Page, M.D., at the Providence Cancer Center in Oregon.

In the treatment of other tumors, Peregrine plans to initiate a Phase I/Ib study of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors in 2016 in collaboration with AstraZeneca. The Phase I part of the trial is designed to confirm the tolerability of the combination of bavituximab and durvalumab and establish a recommended dose regimen for the Phase Ib part of the trial, which will assess the safety and activity of the combination of bavituximab, durvalumab and chemotherapy.

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What can move the needle this week for PPHM is the company is presenting at two Cancer Immunotherapy Conferences. Jeff T. Hutchins, Ph.D., Peregrine’s vice president, preclinical research, will speak at Immunotherapy World 2016, being held January 25-27, 2016 in Washington, D.C. Additionally, Bruce Freimark, Ph.D., research director, preclinical oncology at Peregrine, will present at GTCBio’s 8th Immunotherapeutics & Immunomonitoring Conference, being held January 25-26, 2016 in San Diego, CA.

Dr. Hutchins will discuss strategies for expanding the therapeutic benefit seen with immuno-oncology monotherapies to a broader range of patients using combination treatment approaches. Specifically, he will highlight the strategy of leveraging treatments capable of increasing the number and activity of T-cells in the tumor microenvironment to optimize the therapeutic benefit of immune checkpoint inhibitors such as anti-PD-1/anti-PDL-1 agents.

Dr. Freimark will highlight data showing that blocking PS signaling in combination with immune checkpoint inhibitors promotes a localized, anti-tumor response. He will share research findings demonstrating that PS-targeting antibodies enhance the anti-tumor activity of anti-CTLA-4 and anti-PD-1 antibodies in models of melanoma and breast cancer and correlate with an increase in the infiltration of activated T-cells and the induction of adaptive immunity.

Both presentations will also highlight key recent research findings showing that PS-signaling pathway inhibitors demonstrate multiple signs of immune activation in low or negative PD-L1 tumors. This suggests that PS-targeting antibodies have the potential to show a clinical benefit in patients with low PD-L1 levels and who do not generally benefit from checkpoint treatment alone. The potential for bavituximab to improve the clinical outcome of checkpoint inhibitors will be evaluated as part of Peregrine’s ongoing clinical research collaboration with AstraZeneca. To this end, a global Phase II study of bavituximab in combination with AstraZeneca’s durvalumab, an anti-PD-L1 immune checkpoint inhibitor, in patients with previously treated squamous or non-squamous NSCLC is expected to begin during the first quarter of 2016.

Currently trading at a $234 million market cap, we see tremendous upside in shares of PPHM. Unlike other early stage biotechs, PPHM is well-funded and generates revenue. The company just raised $20 million to fund its operations well into next year and beyond. Lastly and something we always like to look for in a stock is whether smart money is getting involved. With PPHM, we’re in luck as billionaire Kenneth Dart’s Eastern Capital now owns 30 million shares, or 13.1% of the company. We expect 2016 to be a great year for PPHM and its shareholders. Get the latest updates on PPHM by signing up to Insider Financial today!

Disclosure: We have no position in PPHM either long or short. We have not been compensated for this article.