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LONDON, UK / ACCESSWIRE / November 13, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) ("Infinity"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=INFI. The Company announced on November 10, 2017, Phase-1 clinical and translational data for IPI-549, its oral immuno-oncology development candidate. The data validated that IPI-549, dosed once daily (QD), was well tolerated and clinically active. So far, IPI-549 is believed to be the only selective PI3K-gamma inhibitor in clinical development. For immediate access to our complimentary reports, including today's coverage, register for free now at:
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Infinity, which is an innovative biopharmaceutical Company working towards developing new medicines for people with cancer, presented these findings in an oral presentation during the "Clinical Trials: New Agents" session at the 2017 Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting in National Harbor, Maryland, on November 10, 2017.
- IPI-549 is an investigational, orally-administered immuno-oncology development candidate, which selectively inhibits PI3K-gamma. In its pre-clinical studies, IPI-549 has shown to reprogram macrophages from a pro-tumor, M2, to an anti-tumor, M1, phenotype.
- Besides, it is capable of overcoming resistance to checkpoint inhibition and also to enhance the activity of checkpoint inhibitors.
- It is also believed that IPI-549 could have the potential to treat various solid tumors. It signifies a potentially additive, or synergistic, approach to restoring anti-tumor immunity in combination with other immunotherapies like checkpoint inhibitors.
- However, so far, the US Food and Drug Administration (FDA), or any other health authority has not evaluated the safety and efficacy profile of IPI-549.
Phase-1/1b Study Design
- Infinity is assessing IPI-549 as a monotherapy and in combination with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, in a Phase-1/1b study with nearly 200 patients with advanced solid tumors.
- The study is divided into four parts: (i) monotherapy dose escalation; (ii) monotherapy expansion; (iii) combination-dose escalation; and (iv) combination expansion.
- The combination expansion component of the study covers multiple cohorts for evaluating IPI-549 in patients with specific types of cancer, including patients with non-small cell lung cancer (NSCLC), melanoma, and head and neck squamous cell carcinoma (HNSCC), whose tumors show initial resistance, or initially respond to but subsequently develop resistance to immune checkpoint blockade therapy.
- It also includes a cohort of patients with triple negative breast cancer (TNBC) who have not been formerly treated with immune checkpoint blockade therapy; a cohort of patients with mesothelioma; and a cohort of patients with adrenocortical carcinoma.
- So far, Infinity has completed the monotherapy dose escalation part while the monotherapy expansion component of the study is underway.
- The Company expects to complete the combination dose escalation and start the combination expansion cohorts by the end of 2017.
Summary of Clinical Data Shared
- The monotherapy dose escalation study showed that IPI-549 treatment was well tolerated.
- A total of 19 patients were assessed for safety wherein no dose limiting toxicities were identified, and a maximum tolerated dose was not reached.
- Out of the total of 18 patients evaluated for activity, 44% (i.e. 8 out of 18) exhibited a clinical benefit. These were basically patients who remained on treatment for at least 16 weeks. The 44% included one partial response in a patient with advanced peritoneal mesothelioma who has remained on treatment for more than one year now.
- The study also validated the pharmacokinetic and pharmacodynamic properties of IPI-549, with near-complete and sustained inhibition of PI3K-gamma at doses at or above 20 mg QD, supporting once daily dosing of IPI-549.
- On the basis of these results, IPI-549 dosed at 60 mg QD was selected as the recommended monotherapy Phase-2 dose. Currently, the monotherapy expansion component of the study is in progress.
- No treatment-related serious adverse events or deaths were testified in the study. The majority side effects reported were Grade 1 or Grade 2.
Summary of Translational Data Shared
- Similarly, the peripheral blood samples from patients treated with IPI-549 were also analyzed to exemplify the mechanism of immune response.
- The data demonstrated that IPI-549 treatment lead to immune stimulation, with up-regulation of interferon-gamma responsive factors and reinvigoration of exhausted T cells across multiple tumor types and dose levels.
- Moreover, the initial translational data proved that a clinical benefit was associated with increased numbers of immuno-stimulated monocytes, which implied a biological correlation in patients who remained on treatment longer.
- Currently, Infinity is continuing its translational analyses. It expects to report additional findings in 2018.
David Hong, M.D., Deputy Chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas, MD Anderson Cancer Center, Houston, Texas, shared his views about the clinical and translational data. According to him, most of the patients enrolled in the Phase-1/1b study had advanced forms of cancer and had already undergone several therapies. Thus, the fact that 44% of the patients stayed on treatment for at least 16 weeks is an encouraging result. Also, there is one such patient with a partial response who has remained on treatment for more than a year and continues on study today.
Hong also expressed that there is a significant need for improved treatment options for patients, particularly for those who do not respond to, or develop resistance to, existing immunotherapies as well as for types of cancer where there is inadequate benefit from treatment with checkpoint inhibitors. Therefore, selective inhibition of PI3K-gamma is emerging as an exciting new approach to inducing an immune response. Looking forward, Hong intends to continue participating in this study.
Addition of Two New Cohorts to the Existing Study
Infinity also announced that it would add two additional cohorts to the combination expansion component of the study, one in mesothelioma and one in adrenocortical carcinoma (i.e. cancer of the adrenal gland).
These new cohorts have been driven by the partial response reported in a patient with mesothelioma in the monotherapy dose-escalation portion of the study and a partial response in a patient with adrenocortical carcinoma in the combination dose-escalation component of the study. Both these groups comprise under-served patient populations.
In this regard, Adelene Perkins, Chief Executive Officer (CEO) at Infinity, also shared her views. She stated that it is great that these clinical trials are flexible, as they allow the Company to be data-driven in adding additional cohorts in response to evidence of clinical activity and medical need. She agreed that currently patients with mesothelioma and adrenocortical carcinoma have limited effective treatment options. But fortunately, the early evidence of activity proves the potential of IPI-549 for improving outcomes for these patients.
At the same time, Perkins expressed her pleasure on the progress of the Phase-1/1b study of IPI-549. The results for the monotherapy expansion cohort as well as data from the combination dose escalation and disease-specific expansion cohorts are expected to be out in 2018.
Infinity's Expected Milestones for 2018
On the basis of the progress made in 2017, Infinity targets the following IPI-549 data milestones for 2018:
- It aims to report data from the monotherapy expansion component of the study in the first half of 2018.
- Data from the combination dose-escalation component of the study is expected to be reported in the first half of 2018.
- Moreover, initial data from the combination expansion component of the study would be reported in the first half of 2018.
- On the other hand, additional data from at least six combination expansion cohorts, with more mature clinical and translational data, including insights from paired tumor biopsies, would be announced in the second half of 2018.
Last Close Stock Review
At the closing bell, on Friday, November 10, 2017, Infinity Pharma's stock tumbled 13.93%, ending the trading session at $2.41. A total volume of 3.30 million shares have exchanged hands, which was higher than the 3-month average volume of 2.58 million shares. The Company's stock price skyrocketed 117.12% in the last three months, 38.51% in the past six months, and 88.28% in the previous twelve months. Moreover, the stock soared 78.52% since the start of the year. The stock currently has a market cap of $141.90 million.
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