On October 6, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that they will provide an update on the clinical development program and commercial overview for duvelisib, an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, and discuss the company’s immuno-oncology development candidate, IPI-549, at its Research and Development (R&D) Day this morning from 8:00am (ET) to 11:45am (ET) in New York City (Press release, Infinity Pharmaceuticals, OCT 6, 2015, View Source;p=RssLanding&cat=news&id=2094363 [SID:1234507647]). During today’s presentations, Infinity will review its anticipated timelines for the development and commercialization of duvelisib. The company recently announced that the 120th patient has been enrolled in DYNAMO, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma (iNHL), and topline data from this study are anticipated in the third quarter of 2016. Infinity will also review the IPI-549 data presented at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) and discuss the planned Phase 1 study for IPI-549 in solid tumors.

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"We are entering into an exciting time for Infinity," stated Julian Adams, the company’s president, research and development. "During our R&D Day, we will provide a thorough review of our duvelisib program, including preclinical and clinical data that support our registration focused trials in iNHL and CLL, DYNAMO and DUO, respectively, and outline our clinical development strategy to further differentiate duvelisib. We are extremely pleased to have some of the top experts in leukemia, lymphoma and immuno-oncology to provide the physician’s perspective based on their knowledge and experience, and we also look forward to sharing the innovative science that led to IPI-549."

Today Infinity also announced that William (Bill) Bertrand has been appointed to the role of executive vice president, general counsel, effective October 19, 2015, reporting to Adelene Perkins, chair, president and chief executive officer.

"Bill has tremendous experience along the entire biotechnology value chain from preclinical through commercialization as the first and only general counsel of MedImmune and most recently, as the chief operating officer and general manager of Salix prior to its acquisition by Valeant this summer," stated Adelene Perkins, Infinity’s president and chief executive officer. "Bill will serve on Infinity’s senior executive leadership team and play an important role in helping us build the company and bring duvelisib to patients."

"During today’s R&D day, we look forward to sharing our vision for Infinity as well as providing an update on our development programs. With the recent completion of patient enrollment in DYNAMO, our ongoing duvelisib trials, the start of important new trials later this year, and the expansion of our pipeline with IPI-549, we are taking key steps toward our goal of delivering important new medicines to patients that could make a meaningful difference in their lives."

To listen to the live audio webcast and view the slide presentations, please visit the Investors/Media section of Infinity’s website, www.infi.com. A replay will also be available and archived on the site for approximately 90 days.

R&D Day Highlights

Duvelisib

120th patient enrolled in DYNAMO: In September, Infinity announced that the 120th patient had been enrolled in DYNAMO, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib (25 mg BID) in patients with iNHL whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint is overall response rate. Topline data is anticipated in the third quarter of 2016, and Infinity anticipates the submission of global regulatory filings by the end of 2016. This enrollment milestone triggered an obligation for AbbVie Inc. to pay Infinity a $130 million payment. AbbVie is Infinity’s global development and commercial partner for duvelisib in oncology.

DUO enrollment on track for completion by the end of 2015: Infinity expects that DUO, a Phase 3 randomized monotherapy study designed to evaluate the safety and efficacy of duvelisib (25mg BID) compared to ofatumumab in approximately 300 patients with relapsed/refractory chronic lymphocytic leukemia (CLL), will complete patient enrollment by the end of 2015. The primary endpoint of this study is progression-free survival.

Clinical study of duvelisib + venetoclax expected to begin by end of 2015: Infinity anticipates that AbbVie will initiate the first clinical study of duvelisib and venetoclax, a selective first-in-class BCL-2 inhibitor, by the end of 2015. This Phase 1b/2 trial of duvelisib and venetoclax will be designed to evaluate the safety and activity of the combination across a range of hematologic malignancies.

BRAVURA study expected to begin by the end of 2015: Infinity also announced plans to initiate BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL, in the fourth quarter of 2015. BRAVURA is designed to evaluate the safety and efficacy of duvelisib plus rituximab and bendamustine (RB) compared to placebo plus RB in approximately 600 patients. The primary endpoint is progression-free survival.

Infinity is planning to request advice from the U.S. Food and Drug Administration (FDA) to determine if BRAVURA, as designed, can serve as a confirmatory study if DYNAMO supports an accelerated approval.

FRESCO study expected to begin by the end of 2015: Infinity announced plans to initiate FRESCO, a Phase 2 study in patients with relapsed/refractory FL, in the fourth quarter of 2015. FRESCO is designed to evaluate the safety and efficacy of duvelisib plus rituximab versus rituximab in combination with chemotherapy in approximately 200 patients. The primary endpoint is progression-free survival.
IPI-549

IPI-549 demonstrates preclinical anti-tumor activity: Preclinical data show that IPI-549, a selective PI3K-gamma inhibitor for the treatment of solid tumors, has the potential to heighten an anti-cancer response by targeting macrophages in the immune-suppressive tumor microenvironment and may have the potential to treat a broad range of solid tumors. IPI-549 has demonstrated dose-dependent, single-agent, anti-tumor activity in multiple solid tumor models, including murine models of lung, colon and breast cancer. Additionally, mice treated with IPI-549 in combination with checkpoint inhibitors showed greater tumor growth inhibition than either treatment as a monotherapy. Preclinical in vivo data also demonstrated that T-cells are required for the anti-tumor activity of IPI-549, which is a hallmark of immunotherapy. These data were presented at CRI-CIMT-EATI-AACR – The Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September 2015.

First Phase 1 study of IPI-549 expected to begin in the first quarter of 2016: Infinity expects to file an Investigational New Drug (IND) Application for IPI-549 by the end of 2015 and begin a Phase 1 clinical study of IPI-549 in the first quarter of 2016. The Phase 1 study will be designed to explore the safety and activity of IPI-549 and include a dose escalation phase evaluating IPI-549 as a monotherapy as well as a dose-escalation phase evaluating IPI-549 in combination with anti–PD-1 antibody therapy. An expansion phase is planned in patients with selected solid tumors, including non-small cell lung cancer (NSCLC) and melanoma.
Corporate Updates

William Bertrand to join Infinity as executive vice president, general counsel: Infinity announced today that William Bertrand will join Infinity as executive vice president, general counsel, effective October 19, 2015. Prior to Infinity, Mr. Bertrand held various roles of increasingly responsibility at Salix Pharmaceuticals, Inc. (a subsidiary of Valeant Pharmaceuticals, Inc.) and most recently served as senior vice president, general manager at Salix where he was responsible for its commercial business as well as the transition and integration of Salix into Valeant. From 2001 to 2013, Mr. Bertrand held positions of increasing responsibility at MedImmune, Inc., serving as its first and only general counsel from 2003 to 2013, prior to and following its sale to AstraZeneca PLC in 2008. Prior to MedImmune, Mr. Bertrand served as associate general counsel at Pharmacia Corporation. He earned a B.S. in Biology from Wayne State University and a J.D. from the University of Wisconsin-Madison.

Infinity updates 2015 financial guidance: Due to changes in the anticipated timing of the initiation of planned clinical studies as well as slower than expected enrollment in DYNAMO+R, Infinity today provided the following updated financial guidance for 2015:
Revenue: Infinity expects revenue to range from $100 million to $120 million, compared to prior expectations of $105 million to $125 million.

Net Loss: Infinity expects net loss for 2015 to range from $125 million to $145 million, compared to prior expectations of $190 million to $210 million.

Cash and Investments: Infinity now expects to end 2015 with a year-end cash and investments balance ranging from $230 million to $250 million, compared to prior expectations of $145 million to $165 million. This year-end cash and investments includes the $130 million milestone payment from AbbVie associated with the completion of patient enrollment in DYNAMO.
Infinity plans to report its third quarter 2015 financial results in early November.

About Duvelisib

Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins with predominantly non-overlapping roles known to support the growth and survival of malignant B-cells.i Preclinical data suggest that PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K-delta play a role in the formation and maintenance of the supportive tumor microenvironment.ii Duvelisib is the only investigational PI3K-delta,gamma inhibitor in Phase 3 clinical development and has the potential to be a first-in-class treatment for certain types of hematologic malignancies, or blood cancers. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in oncology.

Duvelisib is being evaluated in registration-focused studies, including DYNAMO, a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma, and DUO, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia.

About IPI-549

IPI-549 is an orally administered immuno-oncology development candidate that selectively inhibits PI3K-gamma. IPI-549 inhibits immune suppressive macrophages within the tumor microenvironment, whereas other immunotherapies such as checkpoint modulators more directly target immune effector cell function. As such, IPI-549 may have the potential to treat a broad range of solid tumors and represents a potentially complementary approach to restoring anti-tumor immunity in combination with other immunotherapies such as checkpoint inhibitors.

Duvelisib and IPI-549 are investigational compounds and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On October 6, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported final survival data from the Phase III coBRIM study showing that Cotellic (cobimetinib), when used with Zelboraf (vemurafenib), helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live significantly longer (overall survival, OS) compared to Zelboraf alone (Press release, Hoffmann-La Roche , OCT 6, 2015, View Source [SID:1234507645]). Ongoing study monitoring did not identify any new safety signals. Long-term safety data are expected later this year.

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"Overall survival is the gold standard endpoint in oncology, and the results we’ve seen in coBRIM show how the combination of Cotellic and Zelboraf can help people with BRAF V600 mutation-positive advanced melanoma live longer than Zelboraf alone," said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. "We are currently working with health authorities in their review of the Cotellic marketing applications and hope to bring this combination to people with advanced melanoma around the world in the coming months."

The coBRIM overall survival results will be presented at an upcoming medical meeting. Cotellic received approval in Switzerland in August for use in combination with Zelboraf as a treatment for patients with advanced melanoma. Last month, the EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Cotellic in combination with Zelboraf; a decision by the European Commission is expected by the end of 2015. A decision from the U.S. Food and Drug Administration (FDA) on Roche’s new drug application is expected by November 11, 2015.

About melanoma
Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer.1,2 A V600 mutation of the BRAF protein occurs in approximately half of melanomas, and should therefore be tested to identify the best treatment option.3 When melanoma is diagnosed early, it is generally a curable disease,4,5 but most people with advanced melanoma have a poor prognosis.2 More than 232,000 people worldwide are currently diagnosed with melanoma each year.6 In recent years, there have been significant advances in treatment for metastatic melanoma, and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years.7

About Cotellic and Zelboraf in combination
Zelboraf was the first approved treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by a validated test, such as Roche’s cobas 4800 BRAF Mutation Test. Zelboraf is not indicated for use in patients with wild-type BRAF melanoma. Cotellic (cobimetinib) is designed to selectively block the activity of MEK8, one of a series of proteins inside cells that make up the MAPK signaling pathway that helps regulate cell division and survival.9 In the majority of patients, resistance to BRAF-inhibitor monotherapy will eventually occur through re-activation of the MAPK pathway via MEK.10 Cotellic was developed to overcome resistance to BRAF-inhibition and prevent re-activation of the pathway. Cotellic binds to MEK, while Zelboraf binds to mutant BRAF, to interrupt abnormal signalling that can cause tumours to grow.11,12
Cotellic is also being investigated in combination with several investigational medicines, including immunotherapy, in several tumour types such as non-small cell lung cancer and colorectal cancer. Cotellic was discovered by Exelixis Inc. and is being developed by Roche in collaboration with Exelixis.

On October 6, 2015 OncoResponse, an immuno-oncology antibody discovery company, has been launched jointly by The University of Texas MD Anderson Cancer Center and Theraclone Sciences, of Seattle, Washington (Press release, OncoResponse, OCT 6, 2015, View Source [SID1234516434]).

OncoResponse will use Theraclone’s I-STAR immune repertoire screening technology to identify therapeutic antibodies against novel targets from immuno-oncology treated patients. I-STAR technology rapidly screens antibodies made by the human immune system to identify those with exceptional reactivity that may lead to cancer treatment development. MD Anderson will provide access to samples and physiologic, prognostic and genotypic data from patients that have responded well to cancer immunotherapies, along with oncology and translational medicine expertise.

"The immune system of patients who have responded exceptionally well to cancer immunotherapies may hold the key within their memory repertoire as to what gives them an edge over other patients with less robust immune responses. It could provide us with a way to increase success rates in treating cancer," said Clifford J. Stocks, CEO of Theraclone and interim CEO of OncoResponse. "I-STAR immune repertoire screening technology has the unique capability to identify rare cancer-fighting antibodies and new targets. We’re extremely excited to have teamed up with MD Anderson experts to make a difference in the lives of patients with cancer and their families."

"Immunotherapy will continue to be of utmost significance for our patients who rely on us to provide them with the very latest in treatment options," said Ronald DePinho, M.D., president of MD Anderson. "Through strategic alliances, we aim for more timely delivery of therapies that will enhance their quality of life and successfully treat their disease."

The new company announced the closing of a $9.5 million Series A financing co-led by ARCH Venture Partners, Canaan Partners and MD Anderson. William Marsh Rice University and Alexandria Real Estate Equities also participated.

The OncoResponse launch is the latest in collaborative efforts by MD Anderson that are facilitating further development of a biotech hub in Houston, attracting blue chip investors such as ARCH, Canaan and others. They represent a growing trend in alliances between the pharmaceutical industry and biomedical research and healthcare institutions.

"With MD Anderson, OncoResponse has partnered with an institution and people with countless years of experience in research and treatment in oncology. We’ll gain access to data, information and the immune system memory cells from those patients who are elite responders to cancer immunotherapies. That, coupled with the experience of the Theraclone team, who has overseen the discovery and development of several relevant product candidates from the I-STAR technology in multiple therapeutic area, make OncoResponse a sound investment," commented Steve Gillis, Ph.D., managing director of ARCH Venture Partners.