On December 10, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported the start of the Phase 1 study of ADU-214 (also known as JNJ-64041757), a LADD immuno-oncology therapy for the treatment of lung cancer, with the dosing of the first patient in the trial. Janssen Biotech, Inc., Aduro’s license partner for ADU-214, is conducting the multi-center study (Press release, Aduro BioTech, DEC 10, 2015, View Source;p=RssLanding&cat=news&id=2121848 [SID:1234508532]).

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"We are extremely pleased to see the first immuno-oncology therapy resulting from our license agreement with Janssen enter the clinic," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "With more than 200,000 new diagnoses this year and over 400,000 people living with lung cancer in the United States alone, new therapeutics are desperately needed. We believe ADU-214 may offer new hope to patients suffering from this aggressive disease."

The Phase 1 study will evaluate intravenous administration of ADU-214 in patients with advanced or metastatic non-small cell lung cancer. The trial is expected to enroll up to 40 patients, approximately 12 of whom will participate in the dose escalation portion of the trial where two dose levels of ADU-214 will be evaluated for safety and immunogenicity. The trial will then expand to further characterize safety and preliminary immunological and clinical activity in an additional 30 patients. Additional information may be found at clinicaltrials.gov, using identifier NCT02592967.

About LADD

LADD is Aduro’s proprietary platform of live-attenuated double-deleted Listeria monocytogenes strains that have been engineered to induce a potent innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. The LADD technology has been applied to several novel compounds in clinical and preclinical testing including CRS-207 (pancreatic cancer, mesothelioma and ovarian/fallopian/peritoneal cancer (collaboration with Incyte Corporation to be tested in combination with epacadostat)), ADU-623 (brain cancer) ADU-214 (lung cancer, licensed to Janssen Biotech, Inc.) and ADU-741 (prostate cancer, licensed to Janssen Biotech, Inc.).

On December 10, 2015 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body’s immune system to fight cancer, reported financial results for the second quarter of fiscal year (FY) 2016 ended October 31, 2015, and provided an update on its advancing clinical pipeline and other corporate developments (Press release, Peregrine Pharmaceuticals, DEC 10, 2015, View Source [SID:1234508530]).

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Highlights Since July 31, 2015

"I am pleased to report that we are nearing completion of enrollment for our Phase III SUNRISE trial with over 90% of the intended number of patients enrolled. We have also made substantial progress toward initiating several new trials including a Phase II/III breast cancer study and a Phase II NSCLC trial in combination with AstraZeneca’s anti-PD-L1 antibody, durvalumab," said Steven W. King, president and chief executive officer of Peregrine. "Our goal is to transition our leading SUNRISE clinical sites into our new Phase II NSCLC trial which should significantly expedite study start-up activities. We are encouraged by the fact that a number of investigators from hospitals that participated in the SUNRISE trial have already enthusiastically agreed to participate in our upcoming NSCLC trial."

"As treatment paradigms shift to incorporate new drugs, it is clear that both chemotherapy and immuno-oncology agents will continue to be critical to patient care. Taken together, we believe our SUNRISE trial, as well as the newly planned breast and lung cancer trials will allow us to maximize the potential of bavituximab in both settings," said Joseph Shan, vice president of clinical and regulatory affairs of Peregrine. "We are committed to continuing to identify new potential indications, patient populations and therapies that can benefit from combination treatment with bavituximab. From what we have seen to date in our preclinical and translational studies, the opportunity appears vast, and we are hard at work converting the most promising prospects into true value."

Clinical Development Highlights

As of today, more than 90% of the planned number of patients have been enrolled in the Phase III SUNRISE trial, representing a sufficient number of patients required to trigger the two pre-planned interim analyses as well as the final analysis for trial unblinding. The company expects to reach the trial’s estimated enrollment of 582 patients in the coming weeks.

Peregrine and AstraZeneca expanded their cancer immunotherapy clinical trial collaboration to evaluate bavituximab in combination with AstraZeneca’s investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The companies are currently planning a global Phase II study in patients with previously treated squamous or non-squamous NSCLC, as well as a Phase I/Ib trial that will evaluate the safety and efficacy of bavituximab in combination with durvalumab and chemotherapy in multiple solid tumors. The company expects the Phase II study to be initiated in early 2016 with the Phase I/Ib study beginning later in 2016.

Peregrine continues to finalize plans for its Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is on track to be initiated by the end of calendar year 2015.

Supportive Research Highlights

Positive results were presented at the 2015 annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from multiple new preclinical studies demonstrating enhanced anti-tumor activity and immune activation for combinations of a preclinical bavituximab equivalent and checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 in preclinical models of breast cancer and melanoma. Additionally, the company announced preliminary results for a new clinical test specifically designed to illustrate how bavituximab modulates immune responses in the tumor microenvironment.

New data presented at the International Association for the Study of Lung Cancer’s (IASLC’s) World Conference on Lung Cancer (WCLC) from a translational study of bavituximab demonstrated the ability of bavituximab, alone or in combination with docetaxel, to induce signs of immune activation in non-small cell lung cancer (NSCLC) patient-derived tumor samples, particularly when there was negative PD-L1 expression in the tumor sample. These data further support the potential mechanistic synergies for bavituximab with chemotherapy and checkpoint inhibitors targeting the PD-1/PD-L1 pathway.

Summary data presented at the Combination Immunotherapy Strategies session at the 10th Annual Immunotherapy and Vaccine Summit (ImVacS), highlighted key findings from several recent bavituximab-focused studies including: the potential of bavituximab to shift the tumor microenvironment from immuno-suppressive in which tumors evade immune detection to a state of immune activation in which the immune system recognizes and fights the tumor; bavituximab’s potential to increase the number of activated CD8+ cells in the tumor, which stimulates PD-1 expression, potentially increasing the number of patients able to respond to PD-1 and PD-L1 targeting immunotherapies; and, results from several clinical and preclinical studies in a range of tumor types showing that bavituximab and bavituximab-like antibodies, in combination with conventional therapy, have consistently demonstrated Kaplan-Meier graphs that follow the classic immunotherapy survival plateau.

Corporate Highlights

Peregrine closed a registered direct offering to a single institutional investor raising $20 million dollars. The funds raised from this financing will support the ongoing Phase III SUNRISE trial, and newly planned later-stage company-sponsored trials in breast cancer and NSCLC.

Avid Bioservices Highlights

"Our contract manufacturing business continues to strengthen with a 52% current quarter increase in revenue compared to the prior year period and year-to-date growth of 61%," stated Paul Lytle, chief financial officer of Peregrine. "Our new state-of-the-art manufacturing facility is now ready for the initial phase of GMP manufacturing and demand for Avid’s capacity continues to grow with our current backlog now at $49 million. Given the revenue growth and committed backlog, we are increasing our contract manufacturing revenue guidance to a range of $35 to $40 million for the full-year 2016."

During the second quarter of FY 2016, Avid Bioservices achieved record-breaking revenues generating approximately $9.5 million dollars, a 52% increase in revenue compared to the same quarter in the prior year.

Avid’s new manufacturing facility is now ready for the initial phase of GMP manufacturing. The state-of-the-art facility will accommodate single use bioreactors (SUBs) at up to 2,000 liter scale. Upcoming production runs will support late stage clinical development as well as process validation activities in anticipation of bavituximab and other client commercial product needs. The facility has the capacity to potentially generate approximately $40 million in new revenue annually.

Contract manufacturing committed backlog reached $49 million from existing customers covering services to be completed in FY 2016 and into FY 2017.

Financial Results

Total revenues for the second quarter of FY 2016 were $9,523,000, compared to $6,300,000 for the same quarter of the prior fiscal year. The increase was attributed to an increase in contract manufacturing revenue generated from Avid Bioservices.
Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services provided to its third-party clients for the second quarter FY 2016 were $9,523,000, compared to $6,263,000 for the same quarter of the prior fiscal year. Peregrine expects third-party contract manufacturing revenue for the entire fiscal year to be between $35 million and $40 million, compared to previous guidance of $30 million to $35 million during last quarter’s earnings call. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical development and potential commercialization of bavituximab.

Total costs and expenses in the second quarter of FY 2016 were $23,347,000, compared to $18,437,000 in the second quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the SUNRISE Phase III trial, newly planned later-stage company-sponsored trials in breast cancer and NSCLC, and an increase in the cost of contract manufacturing associated with higher reported revenue. For the second quarter of FY 2016, research and development expenses were $14,190,000, compared to $10,003,000 for the second quarter of FY 2015. For the second quarter of FY 2016, cost of contract manufacturing was $4,741,000, compared to $4,139,000 for the second quarter of FY 2015.
Peregrine’s consolidated net loss attributable to common stockholders was $14,578,000, or $0.07 per share, for the second quarter of FY 2016, compared to a net loss attributable to common stockholders of $13,131,000, or $0.07 per share, for the same prior year quarter.

Peregrine reported $72,005,000 in cash and cash equivalents as of October 31, 2015 compared to $68,001,000 at fiscal year ended April 30, 2015.

More detailed financial information and analysis may be found in Peregrine’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

On December 10, 2015 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) treported that results from an investigator-initiated retrospective analysis demonstrated Lymphoseek (technetium Tc 99m tilmanocept) injection was successful in lymph node identification rate, node-positivity rate, and number of total nodes evaluated in sentinel lymph node biopsy (SLNB) procedures in clinically node-negative breast cancer patients undergoing neoadjuvant chemotherapy (NAT) compared to patients undergoing initial surgical treatment (Press release, Navidea Biopharmaceuticals, DEC 10, 2015, View Source;p=RssLanding&cat=news&id=2121860 [SID:1234508529]). These findings suggest that Lymphoseek offers breast surgeons the confidence to specifically identify and remove sentinel lymph nodes in this patient population. Results of the study conducted at the University of California, San Diego, School of Medicine, led by Anne Wallace M.D., professor of surgery, and Jonathan Unkart, M.D., Department of Surgery, UC San Diego Health, were presented today at the San Antonio Breast Cancer Conference in San Antonio, Texas.

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"Prior thinking suggests that neoadjuvant chemotherapy may induce fibrosis and inflammation that alters lymphatic drainage of axillary lymph nodes in breast cancer and may obscure lymphatic mapping procedures," said Dr. Wallace, who is also director of the Comprehensive Breast Health Center at UC San Diego Moores Cancer Center. "This analysis provides compelling evidence that Lymphoseek was successfully used for SLNB in the breast cancer neoadjuvant chemotherapy population and could potentially reduce the necessity for unnecessary and morbid axillary dissections, and improve the quality of life for patients.

"One of the most frequently asked questions we encounter from physicians is on the effectiveness of Lymphoseek in NAT patients," commented Michael Tomblyn, M.D., Navidea’s Chief Medical Officer. "These findings show Lymphoseek’s usefulness in the complicated NAT population and that the outcomes are not different from the standard breast cancer population."

The aim of the study was to compare identification rate, node-positivity rate and total number of nodes evaluated during SLNB with Lymphoseek and vital blue dye (VBD) in clinically node-negative patients receiving neoadjuvant endocrine or chemotherapy versus initial surgical treatment. A retrospective review of patients undergoing SLNB with Lymphoseek plus VBD from May 2013-2015 at UCSD was conducted. Of the 417 total sentinel lymph node (SLN) cases identified, 72 (17.2%) cases were in patients who had received NAT (61- chemo, 11- endocrine). The SLN identification rate was 100% in both groups (p=1.0). Overall, there were 68 (16.3%) cases of SLN-positivity, 14 (19.4%) in the NAT group versus 54 (15.7%) in the non-NAT group (p= 0.54). The median number of identified nodes was 3 in both groups. In the a zero-truncated negative binomial count model, age, surgeon and evaluating pathologist were significant predictors of the total number of SLNs evaluated. The use of NAT did not significantly affect the number SLNs evaluated.

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA), with or without scintigraphic imaging, for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

On December 10, 2015 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, reported the presentation of the study design and a trial update for a Phase 1b/2 study of Ad-RTS-hIL-12 + veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer (Press release, Ziopharm, DEC 10, 2015, View Source [SID:1234508528]). The poster presentation, titled "Phase 1b/2 study of intratumoral Ad-RTS-hIL-12 + veledimex in patients with chemotherapy-responsive locally advanced or metastatic breast cancer," was presented as part of the "Ongoing Trials – Immunotherapy" session of the 2015 San Antonio Breast Cancer Symposium, and is available online at www.ziopharm.com.

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The study, which is being conducted at the Memorial Sloan Kettering Cancer Center in New York and began enrollment in June 2015, is designed to examine the safety, tolerability and efficacy of Ad-RTS-hIL-12 immunotherapy in up to 40 women with locally advanced or metastatic breast cancer of all subtypes. Ad-RTS-hIL-12 + veledimex is a novel gene therapy which controls local expression of IL-12 and may induce tumor stroma collapse and stimulation of an anti-cancer T cell immune response. The ability to regulate the production of IL-12 by modulating veledimex dosing is designed to improve its therapeutic index with standard of care.

Following entry into the trial, patients go on a chemotherapy holiday and enter an immunotherapy phase of treatment. A single cycle of Ad-RTS-hIL-12, along with the oral activator ligand veledimex, is given during the immunotherapy phase, with the goal of maintaining or improving pre-study response. Continuation of HER2-targeted antibody therapy is permitted during this immunotherapy phase for women with HER2+ disease. The study design allows for a review of the trial after every five subjects with HER2‑ and with HER2+ disease are treated. To date, five patients have been enrolled, including four with HER2- disease and one with HER2+ disease.

"Following standard of care treatment with an immunotherapy has the potential to deliver a one-two punch in breast cancer, particularly in a setting where IL-12, a potent immune cytokine, has demonstrated profound effects on the tumor environment," said Francois Lebel, M.D., Executive Vice President, Research and Development, Chief Medical Officer at ZIOPHARM. "We are pleased to see patient enrollment in this study accelerating and, beginning in 2016, look forward to understanding how the promise of this approach translates into outcomes."

On December 10, 2015 Seattle Genetics, Inc. (Nasdaq: SGEN) reported data from an ongoing phase 1 clinical trial evaluating SGN-LIV1A, an antibody-drug conjugate (ADC) in development for patients with LIV-1-expressing metastatic breast cancer (MBC), at the 38th San Antonio Breast Cancer Symposium (SABCS) taking place in San Antonio, Texas, December 8-12, 2015 (Press release, Seattle Genetics, DEC 10, 2015, View Source;p=RssLanding&cat=news&id=2121626 [SID:1234508527]). SGN-LIV1A consists of a humanized anti-LIV-1 monoclonal antibody (mAb) and the microtubule-disrupting agent monomethyl auristatin E (MMAE), utilizing a protease-cleavable linker. ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.

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"While there have been important advances in the treatment of breast cancer, there remains a significant unmet medical need for improved therapies, particularly in the metastatic setting where there are no curative therapies and fewer than 25 percent of patients survive five years," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "The data presented at SABCS on SGN-LIV1A demonstrate early antitumor activity in heavily pretreated patients, notably among patients with triple negative disease, at generally well-tolerated doses. We are currently enrolling patients with triple negative breast cancer, a subtype for which there are no approved targeted treatments available, to further assess the activity of SGN-LIV1A in a disease-specific cohort."

Interim Analysis of a Phase 1 Study of the Antibody-Drug Conjugate SGN-LIV1A in Patients with Metastatic Breast Cancer (Abstract #638, Poster Session 3 at 5:00 – 7:00 p.m. CT on Thursday, December 10, 2015)

LIV-1 is highly expressed in breast cancer, and is present in 96 percent of 237 MBC samples screened to date. Moderate-to-high expression was observed in 88 percent of hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancers and in 79 percent of triple negative breast cancers (TNBC). The ongoing phase 1, open-label, dose-escalation trial is evaluating the safety, tolerability, antitumor activity, pharmacokinetics and maximum tolerated dose (MTD) of SGN-LIV1A monotherapy administered every three weeks in patients with LIV1-expressing MBC.

Data were reported from 27 patients with LIV-1-expressing MBC, of whom 18 were HR+/HER2- and nine were TNBC. The median age of patients was 57 years and the median number of prior systemic metastatic cytotoxic therapies was four. Key findings presented by Dr. Andres Forero, from the University of Alabama at Birmingham, included:

Of the 25 efficacy-evaluable patients, the objective response rate (ORR) was 12 percent, the disease control rate was 64 percent and the clinical benefit rate (CBR) was 24 percent. Disease control rate is defined as patients achieving a complete response (CR), partial response (PR) or stable disease (SD). CBR is defined as patients achieving CR, PR or SD lasting at least six months.
Among the eight patients with TNBC, the ORR was 38 percent and CBR was 63 percent.

At the time of data analysis, early estimates of median progression-free survival (PFS) for all patients was 11 weeks, with an estimated median PFS in TNBC patients of 18.4 weeks and an estimated median PFS in HR+/HER2- patients of 11.3 weeks.
The most common of the adverse events (AEs) of any grade occurring in 15 percent or more of patients included nausea (52 percent), fatigue (48 percent), alopecia and peripheral neuropathy (44 percent each) and decreased appetite and vomiting (33 percent each). There was a low incidence of myelosuppression, with grade 3 or 4 adverse events of neutropenia in 19 percent of patients and anemia in 11 percent of patients. Grade 3 peripheral neuropathy occurred in 11 percent of patients.

The MTD was not reached among doses ranging from 0.5 to 2.8 milligrams per kilogram (mg/kg). Dose escalation is complete.
Enrollment in a TNBC expansion cohort is ongoing.

More information about the SGN-LIV1A phase 1 clinical trial, including enrolling centers, is available by visiting www.clinicaltrials.gov.

About SGN-LIV1A

SGN-LIV1A is an ADC that combines a humanized anti-LIV-1 monoclonal antibody linked to a synthetic cytotoxic cell-disrupting agent, monomethyl auristatin E (MMAE). The ADC is designed to bind to LIV-1 proteins, which are expressed in most subtypes of metastatic breast cancer, and to release the potent cytotoxic agent MMAE into the target cell upon internalization into LIV-1-expressing tumor cells. This approach is intended to spare non-targeted cells and may reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity.

About Breast Cancer

While there are several therapies available or in development for breast cancer, there remains a significant need to identify improved treatment options. Breast cancer is a disease where malignant (cancer) cells form in the tissue of the breast. Metastatic breast cancer occurs when the cancer has spread to other parts of the body. Breast cancer is the most common cancer, excluding non-melanoma skin cancer, and the second leading cause of cancer death in women. The American Cancer Society estimates that more than 234,000 new cases of breast cancer will be diagnosed in the United States in 2015, and more than 40,000 people will die from the disease. While most new diagnoses of breast cancer are made at an early stage, approximately one-third of these patients will eventually develop recurrent or metastatic disease.