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Phase 2 Dosimetry Data for Progenics’ AZEDRA Presented at EANM Congress 2015

On October 12, 2015 Progenics Pharmaceuticals, Inc., (Nasdaq:PGNX) reported that data from its Phase 2 study of Azedra for the treatment of ultra-orphan indications pheochromocytoma and paraganglioma were highlighted during an oral presentation at the 28th Annual European Association of Nuclear Medicine (EANM) Congress being held in Hamburg, Germany (Press release, Progenics Pharmaceuticals, OCT 12, 2015, View Source [SID:1234507697]).

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Daniel Pryma, M.D., Associate Professor of Radiology and Radiation Oncology, Clinical Director of Nuclear Medicine and Molecular Imaging, University of Pennsylvania Perelman School of Medicine presented preliminary dosimetry data from the Phase 2 study in patients with iobenguane-avid metastatic and/or recurrent pheochromocytoma/paraganglioma. The study was designed to evaluate the efficacy and safety of two therapeutic doses of Azedra given 3 months apart, with dosimetric evaluation prior to the first therapeutic dose to ascertain avidity and tissue distribution. 44 patients had received a dosimetry dose before Molecular Insight suspended patient enrollment due to lack of funding.

"Prospective treatment planning via dosimetric evaluation for high-dose therapy is a critical component of radio-therapeutic development, serving as a safety check-point from which we can estimate the potential risk to critical organs," said Dr. Pryma. "This allows for dose adjustment for each individual if necessary, enhancing the safety profile of Azedra in this setting."

In this study, 44 patients underwent dosimetric evaluation, of which 41 (93.2%) demonstrated tumor avidity. 38 (86.4%) were eligible to receive up to 37 GBq based on dosimetry, while 6 (13.6%) required dose reduction based on pre-specified limits for the kidneys, liver, and lungs. Azedra was generally well tolerated with gastrointestinal and hematologic toxicity most frequently reported.

Dr. Pryma also presented updated preliminary long-term survival data from the first 41 patients dosed before enrollment in the trial was suspended in 2010. Seven of those patients had received one and 34 had received two therapeutic doses of Azedra. The study’s primary endpoint, a reduction of all anti-hypertensive medications for at least 50% and for at least six months, was achieved by 31.7% of patients. As of April 2015, the 34 patients receiving two therapeutic doses of Azedra had a median survival of 48.5 months.

About Azedra

Azedra is a radio-therapeutic with FDA Fast Track status currently being studied in a phase 2 registrational trial under a SPA with the FDA using a surrogate marker as registrational endpoint. In addition to potentially treating pheochromocytoma and paraganglioma, Azedra may also have utility in treating neuroblastoma and other neuroendocrine tumors. Clinical trials for Azedra have not been completed and regulatory approvals for Azedra remain subject to the successful completion of all required studies.

About Pheochromocytoma and Paraganglioma

Pheochromocytomas and paragangliomas are rare neuroendocrine tumors that arise from cells of the sympathetic nervous system. When pheochromocytomas are located outside the adrenal glands, they are called paragangliomas. Standard treatment options for these tumors include surgery, palliative therapy and symptom management. Malignant and recurrent pheochromocytomas and paragangliomas may result in unresectable disease with a poor prognosis, representing a significant management challenge with very limited treatment options and no approved anti-tumor therapies.

LabCorp to Offer New PD-L1 Test for Bristol-Myers Squibb’s OPDIVO® Following Collaboration in Clinical Trial

On October 12, 2015 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported the nationwide availability of a new FDA-approved diagnostic test for PD-L1 associated with the expanded approval of Bristol-Myers Squibb Company’s (BMS) OPDIVO (nivolumab) for the treatment of all appropriate patients with previously-treated non-small cell lung cancer (NSCLC) (Press release, LabCorp, OCT 12, 2015, View Source [SID:1234507696]). The PD-L1 IHC 28-8 pharmDx assay was developed by Dako, an Agilent Technologies company. The assay was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, in which OPDIVO demonstrated superior overall survival compared to chemotherapy in patients with previously treated metastatic non-squamous NSCLC. This approval expands the indication for OPDIVO to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication. The test, although not required for OPDIVO, is a new tool that provides physicians with information on the potential survival benefit of treatment with OPDIVO.

"The launch of this innovative assay reinforces the importance of the LabCorp-Covance combination," said David P. King, Chairman and Chief Executive Officer of LabCorp. "Our central laboratory was the sole provider of testing for PD-L1 expression in the CheckMate-057 trial, which trial was the basis for regulatory approval, and LabCorp is one of the first laboratory providers of the PD-L1 IHC 28-8 pharmDx assay. We remain committed to our three strategic priorities: bringing innovative medicines to patients, using information to change the way care is delivered, and providing world-class diagnostic information."

"LabCorp’s support for CheckMate-057, a pivotal phase 3 registration trial evaluating survival benefit compared to chemotherapy, was an important contribution to OPDIVO’s clinical development program," said Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb. "We are very pleased with LabCorp’s seamless role supporting clinical development and regulatory approval of this new assay which can provide additional information to physicians."

"LabCorp’s support of a variety of BMS clinical trials involving OPDIVO gives us experience that no other lab has in performing and interpreting the results of this important complementary diagnostic assay," stated Steve Anderson, Chief Scientific Officer of Covance. "The availability of this test in support of an important new therapy reflects how our combined capabilities in drug development and diagnostics will support improved patient outcomes and reduced healthcare costs by delivering world class diagnostics and bringing innovative new medicines to patients."

According to the American Cancer Society, lung cancer is the leading cause of cancer death in the U.S. and is the second most commonly diagnosed cancer, with an estimated 221,200 new cases diagnosed in 2015. Approximately 85-90% of patients with lung cancer are diagnosed with either squamous or non-squamous NSCLC, and a majority of these patients present with advanced stage disease at their initial diagnosis. For more information on the PD-L1 IHC 28-8 pharmDx, contact LabCorp’s Center for Molecular Biology and Pathology customer service line at (800) 345-4363.

Celsion Announces Impressive Preclinical Data for its GEN-1 IL-12 Immunotherapy in Combination with Avastin® and Doxil® for Ovarian Cancer

On October 12, 2015 Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, reported data from a large preclinical study of the Company’s GEN-1 IL-12 immunotherapy in combination with Avastin and Doxil for the treatment of ovarian cancer (Press release, Celsion, OCT 12, 2015, View Source [SID:1234507690]). Results from the comprehensive studies confirmed remarkable initial GEN-1 + Avastin findings and show convincingly that GEN-1 when combined with Avastin and Doxil, standard of care for platinum resistant patients, demonstrated a greater than 98% reduction in tumor burden when compared to the untreated control group. The findings represent a statistically significant reduction in tumor burden and disease progression when compared to the combination of Avastin and Doxil in a SKOV3 human cell line implanted into immunocompromised (nude) mice.

"The immune stimulating nature of GEN-1 in combination with Avastin and Doxil makes for an ideal therapy, bolstering the anti-cancer effect beyond what has been observed when used alone," said Nicholas Borys, M.D., senior vice president and chief medical officer of Celsion. "Results from this study are highly encouraging and suggest that when these therapies are combined, they offer the potential to significantly reduce tumor burden and disease progression in this highly aggressive cancer in patients who have failed first line platinum-based therapies."

The study was designed to evaluate in a mouse model of disseminated ovarian cancer, the efficacy of a combined treatment regimen that consisted of weekly administrations of GEN-1 with therapeutically relevant doses of Doxil and Avastin. In the study, the combination of GEN-1 with Avastin and Doxil demonstrated a robust anti-tumor advantage compared to untreated animals as well as a statistically significant improvement over the combination of Avastin and Doxil.

Analysis of serum chemistry and hematology suggested no overt toxicities associated with the combined treatments. The preclinical data are consistent with the mechanism of action for GEN-1, which exhibits certain anti-angiogenic properties in addition to its well-characterized immunomodulatory activities.

GEN-1 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. GEN-1 has already demonstrated encouraging safety and efficacy clinical data in combination with PEGylated doxorubicin (Doxil) in patients with platinum-resistant ovarian cancer, with a clinical response rate (CR+PD+SD) of 86% at the highest GEN-1 dose cohort. GEN-1 has also produced encouraging data in combination with Avastin alone in earlier preclinical studies in a model of ovarian cancer, leading to a significant reduction in tumor burden and disease progression. Additionally, the data show that GEN-1 treatment alone resulted in anti-tumor activity that was as good as or better than Avastin treatment alone.

"The biology of GEN-1 continues to demonstrate a strong anti-tumor effect when combined with Avastin and Doxil, two of the most widely used cancer therapies," said Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "In addition to evaluating GEN-1 in first-line ovarian cancers, with Avastin’s recent approval for platinum resistant ovarian cancer patients, we now have an opportunity to study how our IL-12 immunotherapy may work in a clinical setting with Avastin, one of the most widely used cancer treatments with 2014 revenues of over $7 billion, to improve efficacy while enhancing tolerability. Confirmation of our initial findings now provides substantial evidence for a clinical program that includes Doxil and Avastin. We look forward to completing enrollment of the OVATION Study, next year, followed by the launch of this combination trial later in 2016."

The Company is currently enrolling patients in the OVATION Study, a Phase 1b dose escalating trial combining GEN-1 with neo-adjuvant therapies in newly diagnosed ovarian cancer patients which will provide a starting dose for the follow-on Phase 1/2 study combining GEN-1 with Avastin and Doxil. The Phase 1/2 combination trial is expected to begin in mid-2016.

About GEN-1 Immunotherapy

GEN-1, designed using Celsion’s proprietary TheraPlas platform technology, is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anti-cancer immunity acting through the induction of T-lymphocyte and natural killer (NK) cell proliferation. The Company has previously reported positive safety and encouraging Phase I results with GEN-1 given as monotherapy in patients with peritoneally metastasized ovarian cancer, and recently completed a Phase Ib trial of GEN-1 in combination with PEGylated doxorubicin in patients with platinum-resistant ovarian cancer. GEN-1 has also demonstrated preclinical activity in glioblastoma multiforme (brain cancer) and the Company plans to initiate a Phase I study in this indication in the second half of 2015.

Boehringer Ingelheim and Philogen collaborate to investigate novel treatment approaches for Acute Myeloid Leukemia

October 12, 2015 Boehringer Ingelheim and Philogen reported, that they will collaborate on investigating novel treatment approaches for Acute Myeloid Leukemia (AML) (Press release, Boehringer Ingelheim, OCT 12, 2015, View Source [SID:1234507689]). As part of the collaborative effort, the partners have agreed on an exploratory trial investigating novel immunotherapy concepts for relapsed AML patients.

Despite being a rare disease, AML is one of the most common types of leukemia in adults, accounting for approximately one third of all adult leukemias in the Western world. There is a particularly high medical need in AML, as it has one of the lowest survival rates of all leukemias. It predominantly occurs in older adults; the average age of newly diagnosed patients is 65 years and the prognosis worsens with increasing age, with a median survival of six months or less following diagnosis in older patients.

"We look forward to working with Philogen – a highly innovative biotechnology company -, and to progressing our clinical understanding of treatment strategies for AML" said Martin Stefanic, Head Clinical Development Hemato-Oncology, at Boehringer Ingelheim. "This new collaboration adds a highly innovative new approach to our existing broad hematological cancer pipeline."

Dr. Duccio Neri, CEO of Philogen commented "With its impressive success in bringing innovative new therapies to market and its broad experience in oncology research and development Boehringer Ingelheim is the right partner, to accelerate the transition of our novel targeted therapies into clinical development.".

Further details about the planned clinical trial will be communicated at a forthcoming scientific meeting. Financial details will not be communicated.

Lilly and Innovent Biologics Expand Their Strategic Alliance to Include Immuno-Oncology Bispecific Antibodies in China and Globally

On October 11, 2015 Eli Lilly and Company (NYSE:LLY) and Innovent Biologics, Inc. (Innovent) reported an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company (Press release, Eli Lilly, OCT 11, 2015, View Source [SID:1234507692]).

Below are details of the expanded agreement:

The companies will collaborate to support the development and potential commercialization of up to three anti-PD-1 based bispecific antibodies for cancer treatments over the next decade, both inside and outside of China.
Under the previous agreement, Lilly will exercise its rights to develop, manufacture and commercialize these potential cancer treatments outside of China.
Innovent will now have the rights to develop, manufacture and commercialize these potential cancer treatments for China, subject to a Lilly opt-in right for co-development and commercialization.
Under the terms of the expanded agreement, Innovent could receive additional milestones totaling more than $1 billion if the products reach certain development, regulatory and sales milestones, both inside and outside of China. Sales royalties and other payments would occur on certain products if commercialized outside China. Further financial terms were not disclosed.

Lilly will create the three preclinical anti-PD-1 based bispecific antibodies using an antibody sequence contributed by Innovent.

"We believe that combination therapy in immuno-oncology has the potential to transform the way cancer is treated," said Greg Plowman, M.D., Ph.D., vice president of oncology research at Lilly. "We are pleased to be expanding our collaboration with Innovent to further the development of potential therapies for those fighting cancer in China and around the world."

Michael Yu, Ph.D., co-founder, president and CEO of Innovent, stated, "We are honored that Lilly is so quickly expanding our relationship and that Lilly is trusting Innovent to develop and manufacture their newly created bispecific antibodies for China. We are excited to be at the forefront of immuno-oncology drug development and to benefit from Lilly’s deep experience in bispecific antibodies."