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Lilly and Boehringer Ingelheim Announce Clinical Trial Collaboration in Metastatic Breast Cancer

On July 13, 2016 Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim reported a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in combination with BI 836845, Boehringer Ingelheim’s insulin-like growth factor (IGF)-1/IGF-2 ligand neutralizing antibody, in patients diagnosed with HR+, HER2- mBC (Press release, Eli Lilly, JUL 13, 2016, View Source [SID:1234513853]). Based on the Phase 1b trial results, the collaboration has the potential to expand to Phase 2 trials in patients with HR+, HER2- mBC and other solid tumors. Enrollment is scheduled to begin in late 2016, and Boehringer Ingelheim will be the sponsor of the study program.

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"We are pleased to join with Boehringer Ingelheim to study the potential of their molecule in combination with Lilly’s abemaciclib, for which we have an active Phase 3 development program underway," said Richard Gaynor, M.D., senior vice president, product development and medical affairs for Lilly Oncology. "For patients living with metastatic breast cancer, the limited treatment options available make this an important area of focus for our efforts to advance the most innovative treatments."

Dr. Mehdi Shahidi, medical head, solid tumor oncology, Boehringer Ingelheim commented, "Boehringer Ingelheim is excited about initiating this collaboration with Lilly to investigate a novel combination of two compounds that have individually shown promising results in metastatic breast cancer and have a complementary mode of action. We hope that this study will lay foundations for making much needed new therapies available to patients with metastatic breast cancer."

Lilly’s abemaciclib is designed to block the growth of cancer cells by specifically inhibiting CDK 4 and CDK 6. In many cancers, uncontrolled cell growth arises from a loss of control in regulating the cell cycle due to increased signaling from CDK 4 and CDK 6. Boehringer Ingelheim’s BI 836845 is an IGF ligand-neutralizing antibody that binds to both IGF-1 and IGF-2 preventing activation of the respective receptor resulting in decreased growth-promoting signaling, which may decrease tumor growth. In a Phase 1b/2 trial BI 836845 has shown promising preliminary efficacy and good clinical safety in combination with everolimus and exemestane in patients with HR+ mBC.1

The rationale for the collaboration is based upon the hypothesis that these two agents, in combination, could offer a more complete pathway interference and could potentially prolong cell cycle arrest. For HR+, HER2- mBC patients, this could translate to a reversal of resistance to hormone therapy.

About Metastatic Breast Cancer
Breast cancer is the most common cancer in women worldwide with nearly 1.7 million new cases diagnosed in 2012.2 In the U.S. this year, approximately 246,600 new cases of invasive breast cancer will be diagnosed and about 40,450 women will die from breast cancer.3 Of all early stage breast cancer cases diagnosed in the U.S., approximately 30 percent will become metastatic, spreading to other parts of the body, with an estimated six to 10 percent of all new breast cancer cases initially being stage IV, or metastatic.4 Approximately 75 percent of breast cancers are hormone receptor-positive and are typically managed with endocrine therapies, including aromatase inhibitors and selective estrogen receptor modulators.5 Metastatic breast cancer is considered incurable, but is generally treatable.

About Abemaciclib
Abemaciclib (LY2835219) is an investigational, oral cell cycle inhibitor, designed to block the growth of cancer cells by specifically inhibiting cyclin-dependent kinases, CDK 4 and CDK 6. In many cancers, uncontrolled cell growth arises from a loss of cell cycle regulation due to increased signaling from CDK 4 and CDK 6. Abemaciclib inhibits both CDK 4 and CDK 6, and was shown in cell-free enzymatic assays to be most active against Cyclin D 1 and CDK 4.

In 2015, the FDA granted abemaciclib Breakthrough Therapy Designation based on data from the breast cancer cohort expansion of the company’s Phase 1 trial, JPBA, which studied the efficacy and safety of abemaciclib in women with advanced or metastatic breast cancer. In addition to its current MONARCH clinical trials evaluating abemaciclib in breast cancer, a Phase 3 trial of abemaciclib in lung cancer is also underway.

Oncodesign announces the launch of its first clinical study on a
radiotracer in patients with non-small cell lung cancer

On July 12, 2016 ONCODESIGN (ALONC – FR0011766229), a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, reported the official launch of a clinical study focusing on the evaluation of its first radiotracer in humans, as part of the IMAkinib project conducted jointly with Cyclopharma and the study sponsor, the Cancer Centre Georges-François Leclerc (CGFL) in Dijon (Press release, Oncodesign, JUL 12, 2016, View Source [SID:1234513845]).

The objective of this radiotracer (ODS2004436) is to measure increased EGFR1 kinase activity during the development of a tumour, to select the treatment best suited to individual patients and to detect the emergence of any resistance early on. The radiotracer will be visualised by PET (Positron Emission Tomography), a standard nuclear imaging technique used for clinical diagnosis.

Mutations activating EGFR kinase are responsible for non-small cell lung adenocarcinoma, which accounts for 10 to 15% of lung cancers and affects 6,000 patients each year in France alone.

The clinical study, authorised by the French National Agency for Medicines and Health Products ANSM, is now ready to begin at the CGFL Cancer Centre, which has been granted the CLIP designation2 to conduct early-stage clinical trials. The first patient with lung cancer will be recruited within the next few weeks in the medical oncology department of the CGFL Cancer Centre in Dijon (Dr. Isambert, Head of the early-stage unit).

The objective of this phase 0/1 is to demonstrate the sensitivity and specificity of the radiotracer in human lung tumours. The clinical study will include 3 successive stages, designed to verify the specific labelling of tumours expressing the mutated EGFR receptor, verify the absence of significant marking on non-mutated tumours, and finally confirm the findings in a larger number of patients.

"With the advent of targeted therapies and precision medicine, the development of new molecular imaging biomarkers has become essential to provide the best treatment for patients," comments Prof. Fumoleau, Director of the CGFL Centre. "As a founding member of the Pharmimage platform with Oncodesign, it was only natural that we should conduct this phase 0/1 clinical study on the first radiotracer generated by the IMAkinib programme."

"This radiotracer was generated using our Nanocyclix technology, a chemical platform of next generation kinase inhibitors. The specificity of our molecules is a key advantage for the development of therapeutic molecules as well as for associated biomarkers, in a context of precision medicine and personalised treatments," adds Jan Hoflack, PhD, CSO of Oncodesign. "Our approach, which combines research on new therapies and identification of high-precision imaging tracers as of the first stage of our discovery programmes, is unique."

"Reaching the clinical stage in the development of an internal program for the first time is crucial for Oncodesign and its teams. It marks the culmination of 20 years of work and commitment to Oncodesign’s mission, i.e. provide patients with new cancer treatments," concludes Philippe Genne, PhD, founder and CEO of Oncodesign. "The IMAkinib project launched in 2009 includes several radiotracer programmes, the most advanced being the development of the radiotracer targeting the activated EGFR receptor. Our role in this programme is that of a pioneer in pharmaco-imaging focusing on new molecular markers. As this approach may lead to more effective treatments of tumours expressing EGFR-activating mutations using specific kinase inhibitors, it is important to identify such mutations."

About IMAkinib

IMAkinib is an Oncodesign research programme, conducted jointly with Cyclopharma and Ariana Pharmaceuticals. This programme received a grant from Bpifrance of €10.3m as part of the Industrial Strategic Innovation Programme, with an overall funding of €25m. The objective of IMAkinib is to develop biomarkers used in nuclear medicine to provide diagnostic solutions in oncology and help select the treatment best suited to individual patients, then monitor its efficacy and any potential resistance. The radiotracers developed are small molecules generated by Oncodesign’s Nanocyclix technology, labelled with radioactive 18F-fluorine [18F]. The IMAkinib programme includes several independent projects, the most advanced entering its phase 0/1 clinical study in lung cancer. Oncodesign has also worked jointly with Guerbet, and the teams of Prof. Denis Guilloteau of University François Rabelais in Tours and Dr Louisa Barré of CEA-Cycéron in Caen, on the development of radiochemical synthesis and on the preclinical studies on the radiotracer targeting the EGFR receptor.

Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab

On July 12, 2016 Amgen (NASDAQ:AMGN) reported that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee (Press release, Amgen, JUL 12, 2016, View Source;p=RssLanding&cat=news&id=2184704 [SID:1234513830]). ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.

During the meeting, Amgen will present a comprehensive data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical comparability to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.

"As a developer of innovative medicines and biosimilars, Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Today, we’re looking forward to discussing the efficacy, safety and immunogenicity profile of ABP 501, Amgen’s first prospective biosimilar, with the FDA advisory committee. If approved, ABP 501 has the potential to provide an additional treatment option for patients with chronic inflammatory diseases, as well as play a key role in long-term disease management."

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.

About ABP 501

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

Provectus Biopharmaceuticals Announces Acceptance of Abstract for Poster Presentation at European Society for Medical Oncology 2016 Congress

On July 12, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that the European Society for Medical Oncology’s Scientific Committee has accepted an abstract for a poster presentation detailing the use of PV-10 as a treatment for stage III and IV melanoma as part of ESMO (Free ESMO Whitepaper)’s 2016 Congress (Press release, Provectus Pharmaceuticals, JUL 12, 2016, View Source [SID:1234513829]).

The exact date and time of the presentation, titled "Intralesional Rose Bengal for Stage III and IV Melanoma," has yet to be decided. When the schedule is set, the details for this abstract, #3438, will be available at View Source

In addition, the abstract will also be published in the ESMO (Free ESMO Whitepaper) 2016 Congress Abstract Book, a supplement to the official ESMO (Free ESMO Whitepaper) journal, Annals of Oncology. ESMO (Free ESMO Whitepaper) has not yet announced the final publication number. The ESMO (Free ESMO Whitepaper) 2016 Congress will be held in Copenhagen, Denmark, from October 7-11, 2016.

PRIMA BIOMED COLLABORATES IN INVESTIGATOR SPONSORED NEW CLINICAL TRIAL FOR IMP321 IN SOLID TUMORS

On July 12, 2016 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported a new collaborative study investigating the intra-tumoural injection of IMP321 (Filing, 6-K, Prima Biomed, JUL 12, 2016, View Source [SID:1234513866]). The investigator sponsored study will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt Germany ("IKF"; Institute for clinical oncology research at the Northwest University Hospital in Frankfurt). The new study will explore the potential for IMP321 as an activator of dendritic cells found within solid cancer tumours.
The new clinical trial is called "INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities".

The Lead Investigator of this up to 40 patients trial is Professor Doctor Salah-Eddin Al-Batran, the Medical Director of the IKF. The study will commence subject to receiving the necessary approvals from the competent regulatory authority and ethics committee.
Dr Al-Batran commented: "The promising results from previous studies and favourable safety profile of IMP321 have led us to conduct a phase I trial investigating a potential enhancement of the immune-activating effects of IMP321 by new routes of administration. Furthermore, we will explore the possibility to extend the positive results obtained by subcutaneous injections of IMP321 in metastatic renal cell and breast carcinomas to further solid tumour entities."

Marc Voigt, Chief Executive of Prima, said: "This is potentially an exciting new therapeutic application for IMP321 and is the result of the extensive research carried out by Dr Frédéric Triebel and the Prima team in our Paris laboratory. It is the first ever investigation into whether direct injection of IMP321 into a solid tumour can activate the antigen presenting cells located inside the tumour to boost the body’s immune response. As this trial is investigator initiated, it will also not require any significant near-term resource commitment from Prima."

Clinical Trial Synopsis

Title of Study INSIGHT: An explorative, single centre, open-label, phase I study to evaluate the feasibility and safety of intra-tumoural, intra-peritoneal, and subcutaneous injections with IMP321 (LAG-3Ig fusion protein) for advanced stage solid tumour entities
Objectives
Feasibility, safety and toxicity
Immune response in whole blood and tumour tissue
Identification of biomarkers that correlate with clinical response / clinical outcome
Study design Monocentre, open-label, phase I study
Planned Sample size up to 40 patients
Clinical trial identifier: To be determined