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

On July 13, 2016 Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) reported a new collaboration on a Phase 1b study that will evaluate the safety and tolerability of BI 836845, Boehringer Ingelheim’s insulin-like growth factor (IGF)-1/IGF-2 ligand neutralising antibody, in combination with abemaciclib (LY2835219), Lilly’s cyclin-dependent kinase (CDK) 4 and 6 inhibitor, in patients diagnosed with HR+/HER2- mBC (Press release, Boehringer Ingelheim, JUL 13, 2016, View Source [SID:1234513868]). 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 tumours. Enrolment is scheduled to begin in late 2016 and Boehringer Ingelheim will be the sponsor of the study programme.

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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 programme 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
Dr. Mehdi Shahidi, Medical Head, Solid Tumour 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."

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

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% of breast cancers are hormone receptor-positive and are typically managed with endocrine therapies, including aromatase inhibitors and selective oestrogen receptor modulators.5 Metastatic breast cancer is considered incurable, but is generally treatable.

About BI 836845
BI 836845 is an investigational compound in Phase II clinical development. It is a humanised antibody that binds to insulin-like growth factor (IGF) signalling pathways, which may play a role in the development or spread of cancer by providing a growth mechanism for tumours. BI 836845 specifically binds to IGF-1 and IGF-2. It is being studied in combination with other agents for use in patients with advanced solid tumours.

Provectus Biopharmaceuticals Announces PV-10 Data Discussed at 6th European Post-Chicago Melanoma/Skin Cancer Meeting

On July 13, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.provectusbio.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "The Company"), reported that data on PV-10 as a treatment for melanoma was presented June 30, 2016 at the 6th European Post-Chicago Melanoma/Skin Cancer Meeting in Munich, Germany (Press release, Provectus Pharmaceuticals, JUL 13, 2016, View Source [SID:1234513864]).

Sanjiv Agarwala, MD, Professor of Medicine at Temple University, Chief, Oncology & Hematology at St. Luke’s Cancer Center in Bethlehem, Pennsylvania and Global Lead Investigator for the phase 3 study of PV-10 in locally advanced cutaneous melanoma (protocol PV-10-MM-31), participated in a symposium, "Current Clinical Trials I." His presentation covered the status of clinical trials of leading oncolytic agents for the treatment of soft tissue and skin metastases, including the ongoing phase 3 study of PV-10 and the phase 1b study of PV-10 in combination with pembrolizumab (Keytruda).

During his presentation, Dr. Agarwala noted that "systemic therapy is not always possible or appropriate" for patients with locally advanced disease, and that "local-regional control of soft tissue/skin metastases is clinically important." Touching on six different types of oncolytic therapy, he highlighted key efficacy and safety data for PV-10 when used for direct ablation of dermal and soft tissue metastases, and noted that PV-10 is the only one currently being studied as both monotherapy and in the combination setting (with pembrolizumab). With regard to combination therapy, he noted that newer intralesional therapies like PV-10 are the "backbone for future combinations" since they are capable of producing a systemic anti-tumor immune response complementary to that of immune checkpoint inhibitors.

To view his presentation, please visit
http://www.pvct.com/presentation/EuropeanPostChicago-2016.

For more information about the meeting visit: View Source

Amgen And Daiichi Sankyo Announce Agreement To Commercialize Biosimilars In Japan

On July 13, 2016 Amgen (NASDAQ:AMGN) and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo; TSE: 4568) reported the execution of an exclusive agreement to commercialize nine biosimilars in Japan (Press release, Amgen, JUL 13, 2016, View Source [SID:1234513874]). The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab.

Under the terms of the agreement, Amgen will remain responsible for the development and manufacturing of the biosimilars. Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan, while Amgen will have a limited right to co-promote the products.

"Amgen is excited to collaborate with Daiichi Sankyo as we seek to drive adoption and build confidence in biosimilars as a means of enhancing patient access to more affordable therapeutic options worldwide," said Scott Foraker, vice president and general manager of Biosimilars at Amgen.

Amgen will retain all additional distribution and commercialization rights for the biosimilar programs outside of Japan. Specific financial terms of the agreement were not disclosed.

TARIS Biomedical® Initiates Phase 1b Clinical Trial of TAR-200 (GemRIS™) in Patients with Muscle-Invasive Bladder Cancer

On July 13, 2016 TARIS Biomedical LLC, a company developing powerful and targeted new treatments for millions of patients suffering from difficult-to-treat bladder diseases, reported the initiation of a Phase 1b clinical trial of TAR-200 (GemRIS) in patients with muscle-invasive bladder cancer (MIBC) (Press release, TARIS Biomedical, JUL 13, 2016, View Source [SID:1234513867]). TAR-200, a drug-device combination product utilizing the TARIS System, is designed to release gemcitabine continuously into the bladder over 7 days. TARIS also announced that Christopher J. Cutie, M.D., MBA, has been promoted to Chief Medical Officer to oversee all of TARIS’ clinical programs.

"Patients diagnosed with muscle-invasive bladder cancer often require complex treatment regimens, including systemic chemotherapy and radical cystectomy (complete surgical removal of the urinary bladder), a life-altering operation associated with significant morbidity and, in some cases, death. Unfortunately, one or both of these treatments are not suitable for many patients suffering from this potentially lethal disease," said Dr. Cutie. "TAR-200 has the potential to address patients underserved by the current standard of care."

"To our knowledge, this is the first time any drug has ever been continuously delivered into the bladder to treat a bladder tumor over such an extended period. We are excited about this novel treatment approach and look forward to seeing the results of this study," said Purnanand Sarma, Ph.D., President and Chief Executive Officer of TARIS. "Launching our first clinical trial in oncology is a significant milestone for TARIS. Building on the momentum from our Allergan transaction announced in 2014, we are rapidly expanding the organization and plan to move multiple programs into the clinic in the coming 12-18 months. We are pleased to recognize Dr. Cutie’s superb leadership of our clinical programs with his promotion to Chief Medical Officer."

About the TAR-200 Phase 1b Trial
The Phase 1b open-label study will assess whether continuous, local exposure to gemcitabine using TAR-200 is safe and tolerable in patients with MIBC. The study will also assess the preliminary efficacy in this patient population. The study will be conducted at multiple sites in the U.S. and expects to enroll up to 20 patients after the diagnosis of MIBC and before radical cystectomy.

About TAR-200
TAR-200 (GemRIS) is TARIS’ first program in bladder cancer. TAR-200 is a drug-device combination product designed to release gemcitabine continuously into the bladder over 7 days. Gemcitabine is commonly used to treat multiple cancers alone and in combination with other chemotherapeutic drugs.1 TARIS believes TAR-200 has the potential to set a new standard of care in bladder cancer, with enhanced efficacy and minimal systemic side effects compared to current approaches. TARIS is developing TAR-200 to address unmet needs in both muscle invasive and non-muscle invasive bladder cancer.

About Muscle Invasive Bladder Cancer
Bladder cancer affects roughly 2.7 million people worldwide, including nearly 600,000 in the United States.2 The National Cancer Institute estimates that there will be a total of nearly 77,000 new cases and 16,000 deaths due to this disease in 2016.3 When measured as a cumulative lifetime per patient cost, the expense to treat bladder cancer exceeds all other forms of cancer.4 The estimated U.S. national expenditure on bladder cancer was $4.3 billion in 2014.5

Muscle Invasive Bladder Cancer (MIBC) is an advanced form of the disease, representing 25-30% of the newly diagnosed cases. MIBC tumors, which have progressed into the muscle of the bladder wall and potentially beyond, may lead to metastases and death. The standard of care for treatment of MIBC includes radical cystectomy, or complete removal of the bladder, with or without neoadjuvant chemotherapy. Radical cystectomy is a major, life changing procedure and many patients are medically unfit and/or unwilling to undergo the procedure.

Loxo Oncology Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-101

On July 13, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), "for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments (Press release, Loxo Oncology, JUL 13, 2016, View Source [SID:1234513860]).

"We’re pleased to have been granted Breakthrough Therapy Designation for LOXO-101 and look forward to working more closely with the FDA to bring this therapy to patients with TRK fusion cancers," said Josh Bilenker, M.D., chief executive officer at Loxo Oncology. "Data presented to date from the ongoing adult and pediatric studies of LOXO-101 have demonstrated durable anti-tumor activity across TRK fusion cancers, further validating LOXO-101’s potential to address the unmet medical need among patients with these genetically defined cancers. We remain on track to provide an enrollment update regarding the LOXO-101 Phase 2 trial in the second half of 2016."

The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

The LOXO-101 Breakthrough Therapy Designation application included data from the ongoing Phase 1 dose-escalation study of LOXO-101 in adult patients with advanced solid tumors, the ongoing Phase 1 pediatric study of LOXO-101 in patients with advanced solid tumors or primary CNS tumors, and the ongoing Phase 2 basket trial of LOXO-101 in adult cancer patients whose tumors harbor TRK fusions.

About LOXO-101
LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions and a Phase 1 trial in pediatric patients. For additional information about the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov or www.loxooncologytrials.com. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.