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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.

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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.

ARIA® Oncology Information System Certified for Use to Demonstrate "Meaningful Use" of an Electronic Health Record

On October 9, 2015 Varian Medical Systems (NYSE:VAR) reported that its ARIA oncology information system has been certified as a Complete Electronic Health Record (EHR). As a result, hospitals and clinics can use ARIA to qualify for financial incentives from the Medicare and Medicaid programs when they demonstrate meaningful use of the technology (Press release, Varian Medical Systems, OCT 9, 2015, View Source [SID:1234507685]).

"Varian is committed to the creation of digital tools that connect the entire oncology community, and enable coordinated care," said Sukhveer Singh, vice president of Varian’s Oncology Continuum Solutions group. "The ARIA system provides a seamless flow of information for managing the patient’s entire journey—from diagnosis through follow-up. This certification means that our customers in the U.S. can continue to use ARIA to attest for the Meaningful Use 2014 measures, and thereby qualify for incentive payments from the federal government."

ARIA is a comprehensive electronic medical record and image management system that aggregates patient data into an organized, oncology-specific medical chart with functional components for managing clinical, administrative and financial operations for medical, radiation and surgical oncology.

The ARIA oncology information system (version 13.6 MR1), coupled with the Equicare Health Patient Portal for providing patients with secure web-based access to important portions of their medical records, were certified together to meet the federal requirements for Complete Ambulatory EHR.

Additional Information

The ARIA system for both medical and radiation oncology (version 13.6 MR1) was tested and certified in accordance with applicable certification criteria adopted by the U.S. Department of Health and Human Services. The software is compliant with the Office of National Coordinator (ONC) 2014 Edition criteria. ARIA received certification for Complete EHR from the Drummond Group, an ONC Authorized Certification Body. The ONC 2014 Edition criteria support both Stage 1 and Stage 2 meaningful use measures required to qualify eligible professionals for Medicare and Medicaid HIT incentive payments. This certification does not represent an endorsement by the U.S. Department of Health and Human Services or guarantee the receipt of incentive payments.

ARIA version 13.6 MR1 was certified on September 17, 2015. Certified ID numbers are 0917201526316 (for radiation oncology) and 0917201526306 (for medical oncology). The modules tested were: 170.314 (a)(115); (b)(15, 7); (c)(13); (d)(18); (e)(13); (f)(13); (g)(24). Clinical Quality Measures tested were: 2v3; 50v2; 68v3; 69v2; 124v2; 125v2; 129v3; 130v2; 138v2; 139v2; 140v2; 141v3; 154v2; 156v2; 157v2; 165v2.

Price Transparency

These certified products generally involve one-time license fees plus some ongoing costs:

ARIA Disease Management, a one-time initial license fee and ongoing Software Support Agreement (SSA) fees.
Equicare Health Solutions Active Patient Portal, a one-time initial license fee and ongoing SSA fees.
ePrescribing, a one-time initial license fee and ongoing SSA fees.
Interfaces: In and Outbound Laboratory, Immunization, Syndromic Health, a one-time initial license fee/interface and ongoing SSA fees.
DIRECT, a one-time initial license fee and ongoing service fees.