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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.

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"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."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

(Filing, 10-K, Generex, OCT 9, 2015, View Source [SID:1234507694])

8-K – Current report

On October 9, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) ("Bio-Path"), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, treported the successful completion of Cohort 7 of its Phase Ib clinical trial evaluating the toxicity of its lead compound, Liposomal Grb-2, combined with low-dose cytarabine (LDAC) chemotherapy in patients with advanced Acute Myeloid Leukemia (AML) (Filing, 8-K, Bio-Path Holdings, OCT 9, 2015, View Source [SID:1234507687]). Bio-Path has opened enrollment into Cohort 8, which will complete the Company’s Phase Ib study of Liposomal Grb-2.

Three patients were evaluated in Cohort 7, which was the first cohort of the Company’s Phase Ib trial to evaluate the toxicity of Liposomal Grb-2 as a combination therapy. Patients were treated twice a week for four weeks with 60 mg/m2 of Liposomal Grb-2, for a total of eight doses in combination with the standard regimen of LDAC. Results were consistent with previous cohorts, showing Liposomal Grb-2 to be safe and well tolerated.

Furthermore, one patient achieved complete remission during treatment. A second patient demonstrated improvement in bone marrow blasts at the end of the first treatment cycle and is continuing Liposomal Grb-2 treatment as part of an additional treatment cycle. The third evaluable patient completed the treatment cycle, but did not show improvement. One patient ended the study early due to disease progression, and therefore was not evaluated in this cohort.

"I am highly encouraged to see that a patient suffering from advanced AML who was treated with Liposomal Grb-2 has achieved complete remission, and that another patient is continuing to improve," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "Complete remission in a patient with refractory and treatment-resistant AML is an exciting milestone for Bio-Path and blood cancer patients, suggesting that Liposomal Grb-2 might have the potential to improve survival rates in combination with frontline chemotherapy. We anticipate that these positive results will support rapid enrollment into Cohort 8, and look forward to continuing the development of Liposomal Grb-2."

Bio-Path has opened Cohort 8 for patients to be treated with 90 mg/m2 of Liposomal Grb-2, in combination with frontline LDAC. Upon successfully completing the evaluation of three patients in Cohort 8, the Company will finalize the Phase Ib clinical study.