eli lilly & co (LLY) Key Developments
Immunocore Limited and Eli Lilly and Company Enters Clinical Trial Collaboration in Melanoma
Jun 29 15
Immunocore Limited and Eli Lilly and Company announced that they have entered into an immunotherapy-based clinical trial collaboration to explore the utility of Immunocore’s lead T-cell receptor based investigational therapeutic, IMCgp100, in combination with Lilly’s galunisertib (LY2157299) and merestinib (LY2801653) for the treatment of melanoma. The goal of the collaboration is to identify combination regimens that provide synergies in efficacy and durability in patients with metastatic cutaneous and uveal melanomas. Under the terms of the agreement, Immunocore and Lilly will conduct a Phase Ib/II clinical study evaluating the safety and preliminary efficacy of IMCgp100 in combination with galunisertib in metastatic cutaneous melanoma. A second Phase Ib/II study will be conducted combining IMCgp100 with merestinib in metastatic uveal melanoma. Lilly will act as trial sponsor. These studies are anticipated to begin in 2016. No financial terms were disclosed. IMCgp100 and galunisertib are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body’s own immune system in fighting cancer and whose mechanisms of action have the potential to be complementary. IMCgp100 is Immunocore’s most advanced Immune mobilising mTCR Against Cancer molecules (ImmTAC), which are a novel class of bi-specific biologic drugs based on T-cell receptors (TCRs) with ultra-high affinity for intracellular and extracellular cancer targets. Lilly’s galunisertib is a small molecule inhibitor of TGF beta R1 kinase that in vitro selectively blocks TGF beta signaling. TGF beta promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread in the body. Merestinib is Lilly’s small molecule multi-kinase inhibitor that in vitro selectively blocks signaling of MET, MST1R (RON), AXL, and MKNK1/2.
Adocia and Eli Lilly Report Positive Phase 1b Topline Results on the Post-Meal Effect of Ultra-Rapid BioChaperone Lispro in Patients with Type 1 Diabetes
Jun 26 15
Adocia and Eli Lilly and Company announced the completion of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia’s proprietary technology BioChaperone, which is designed to accelerate insulin absorption. This completed study, part of the Adocia-Lilly partnership, aimed to compare the effects of BioChaperone Lispro and Humalog® (insulin lispro rDNA origin) when injected at mealtime on post-prandial glycemic control in type 1 diabetes patients. While commercialized fast-acting insulin analogs are injected five to 15 minutes before or immediately after a meal, an ultra-rapid insulin may allow injection at the time of the meal, or even after the start of a meal while improving post-prandial glycemic control. In this crossover, randomized, double-blind meal study, 38 people with type 1 diabetes received a 0.2 U/kg dose of either BioChaperone Lispro or Humalog just prior to a standardized meal. The primary endpoint was a comparison of the post-meal glycemic excursions over the first two hours (Delta-AUC-BG(0-2h)). BioChaperone Lispro was associated with a 61% reduction in post-prandial glucose excursion over the first two hours compared to Humalog (Delta-AUC-BG(0-2h) ratio = 0.39; 95%-CI 0.28 to 0.52; p<0.0001). The study also provides confirmation of the ultra-rapid pharmacokinetic profile of BioChaperone Lispro. These results are consistent with previous clinical findings from NCT021466511 demonstrating BioChaperone Lispro has a significantly faster rate of insulin lispro absorption than Humalog with an increase in the early insulin exposure of 168% at the same dose (AUClispro_0-30min ratio = 2.68; 95%-CI 2.18 to 3.30; p<0.0001). In terms of safety, BioChaperone Lispro and Humalog led to similar numbers of hypoglycemia episodes. No local reactions were seen on the site of administration for either treatment.
Eli Lilly and Sarah Cannon Research Institute Partner to Co-Develop New Cancer Therapy
Jun 25 15
Eli Lilly and Company and Sarah Cannon Research Institute have announced a strategic partnership to co-develop an investigational oncology compound, LY3023414, a PI3K/mTOR dual inhibitor. Under the agreement, SCRI will collaborate with Lilly to provide clinical development expertise and program design, as well as medical oversight and trial management. Patient enrollment for the initial Phase II clinical trial is underway. The partnership supports the development of this novel targeted cancer therapy, including flexible and efficient program design and implementation, as well as more rapid patient enrollment to clinical trials by accessing SCRI's large network of patients.
UK Court Rules in Favor of Eli Lilly and Company in Alimta Vitamin Regimen Patent Lawsuit
Jun 25 15
Eli Lilly and Company announced that the Court of Appeal has ruled that the Alimta® (pemetrexed disodium) vitamin regimen patent would be indirectly infringed by a generic competitor that had stated its intent to market certain alternative salt forms of pemetrexed in the United Kingdom prior to the UK patent's expiration in June 2021. Specifically, the Court of Appeal held that commercialization of these alternative salt forms in the products as proposed would constitute indirect infringement by supplying an essential means for putting the patented invention into effect. The decision came in the case of Actavis v. Eli Lilly and company. The Court of Appeal also held there was no difference between the law in the UK and that in France, Italy and Spain as it relates to indirect infringement, and so reversed the High Court's decision granting declarations of noninfringement over the Alimta vitamin regimen patents in those countries. Actavis may seek permission to appeal the decision to the UK Supreme Court. In addition, Actavis has stated it may ask the High Court to decide whether a different proposed product would infringe the patent. The Court of Appeal has ruled that the High Court will need to decide whether it will hear this new claim. If the High Court decides to hear Actavis' case on the different proposed product, Lilly will defend the case vigorously.
Boehringer Ingelheim and Eli Lilly and Company Announce Encouraging Data from Phase III Diabetes Trial
Jun 19 15
Boehringer Ingelheim and Eli Lilly and Company have announced data from a Phase III clinical trial of empagliflozin in combination with metformin, which reduced blood glucose levels in adults with type 2 diabetes, or T2D. The 24-week study compared dual therapy of empagliflozin and metformin to monotherapy of either empagliflozin or metformin in patients with T2D. The primary endpoint of this study of 1,364 randomised adults with T2D was change from baseline in HbA1c at 24 weeks. Patients enrolled in this study were not receiving any glucose lowering therapy for at least 12 weeks prior to the start of the trial and had a mean baseline HbA1c of approximately 8.7%. All four empagliflozin and metformin combination doses showed statistically significant reductions in HbA1c vs. the individual components of empagliflozin or metformin. Statistical models showed the following estimated average HbA1c level reductions from baseline: Empagliflozin 12.5 mg bid/metformin 1000 mg bid: 2.08%; Empagliflozin 12.5 mg bid/metformin 500 mg bid: 1.93%; Empagliflozin 5 mg bid/metformin 1000 mg bid: 2.07%; Empagliflozin 5 mg bid/metformin 500 mg bid: 1.98%; Empagliflozin 25 mg qd: 1.36%; Empagliflozin 10 mg qd: 1.35%; Metformin 1000 mg bid: 1.75%; and Metformin 500 mg bid: 1.18%. Changes from baseline in fasting plasma glucose (FPG) and weight were exploratory analyses. Patients in this study had a mean baseline FPG of approximately 169.6 mg/dL. The empagliflozin and metformin combinations resulted in larger reductions in FPG versus either empagliflozin or metformin alone. The empagliflozin and metformin combinations also resulted in a statistically significant reduction in weight versus metformin monotherapy. The overall frequency of adverse events (AEs) was consistent across all patient groups (56.7% - 66.3%). The percentage of patients with confirmed hypoglycaemic AEs (glucose 70mg/dL and/or requiring assistance) was low in all groups (0% -1.8%); none required assistance. Initial combination treatment with empagliflozin and metformin was part of an investigational trial. The fixed dose combination of empagliflozin and metformin hydrochloride (Synjardy) was approved for the treatment of T2D in adults on 27 May 2015 in the European Union, but is not approved for first line use.