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Infinity Announces Completion Of Target Enrollment In DUO™, A Phase 3 Study Evaluating Duvelisib In Chronic Lymphocytic Leukemia

On November 17, 2015 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it has reached target enrollment of 300 patients in DUO, a randomized Phase 3 monotherapy study evaluating the safety and efficacy of duvelisib compared to ofatumumab (an anti-CD20 antibody) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) (Press release, Infinity Pharmaceuticals, NOV 17, 2015, View Source [SID:1234508269]).

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The primary endpoint of this study is progression free survival (PFS). Duvelisib is an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma. Infinity is jointly developing duvelisib with AbbVie, its strategic development and commercialization partner for duvelisib in oncology.

"Reaching this enrollment milestone for DUO is an important achievement for Infinity and the duvelisib development program. We are grateful for the support of the DUO investigators, and most importantly the patients and their families, for their participation in this study. We would also like to thank the Infinity and AbbVie teams for their hard work in ensuring completion of enrollment in this trial," said Julian Adams, Ph.D., president, research and development at Infinity. "This achievement follows the recent completion of patient enrollment in DYNAMO, our registration-focused study of duvelisib in indolent non-Hodgkin lymphoma. We look forward to seeing the data from both of these studies, which could enable us to move forward with global regulatory filings."

Infinity recently completed patient enrollment in DYNAMO, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib in approximately 120 patients with indolent non-Hodgkin lymphoma (iNHL) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study is overall response rate. Topline data from the study are anticipated in the third quarter of 2016. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to duvelisib for both the treatment of patients with follicular lymphoma (FL), the most common form of iNHL, who have received at least two prior therapies and for the treatment of patients with CLL who have received at least one prior therapy.

The DYNAMO and DUO studies are part of DUETTS, a broad clinical development program evaluating duvelisib in patients with iNHL and CLL. In addition to DYNAMO and DUO, Infinity is enrolling patients in CONTEMPO, a Phase 1b/2 study in treatment-naïve patients with follicular lymphoma, and SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory to or has relapsed while receiving a Bruton’s tyrosine kinase (BTK) inhibitor. Infinity expects three additional clinical studies to be initiated this year: BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL; FRESCO, a Phase 2 study in patients with relapsed/refractory follicular lymphoma; and the first clinical study of duvelisib in combination with venetoclax, AbbVie’s first-in-class investigational B-cell lymphoma-2 (BCL-2) selective inhibitor. Infinity is planning to close enrollment in DYNAMO+R, a Phase 3 study in patients with previously treated follicular lymphoma and is planning to meet with the FDA to ascertain that BRAVURA can serve as a confirmatory study if DYNAMO supports an accelerated approval.

Additional information on clinical studies of duvelisib is available at View Source or at www.clinicaltrials.gov.

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, and DUO, a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

Xenetic Biosciences, Inc. Enters Into Asset Purchase Agreement With Financing Component for the Rights to Develop, Market and License Oncologic Drug Candidate Virexxa™

On November 16, 2015 Xenetic Biosciences, Inc. (OTCQB:XBIO) (the "Company"), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported that it has entered into an Asset Purchase Agreement (the "APA") with AS Kevelt, an Estonian biotech company ("Kevelt") and OJSC Pharmsynthez ("Pharmsynthez", and together with Kevelt, "Sellers") (Press release, Xenetic Biosciences, NOV 16, 2015, View Source [SID1234537823]). Pursuant to the APA, the Sellers will transfer to the Company certain intellectual property rights with respect to Virexxa, and the Company will receive the worldwide rights to develop, market and license Virexxa for all uses, except for certain excluded uses within the Commonwealth of Independent States (the "CIS"), in exchange for 111.5 million shares of Company common stock and certain other consideration. Virexxa is a Phase II oncology drug candidate which is under investigation for the treatment of certain endometrial cancers. As part of this total consideration, the Company will also acquire Kevelt’s U.S. Orphan Drug designation for the use of Virexxa in the treatment of progesterone receptor negative endometrial cancer in conjunction with progesterone therapy.

The APA also contains a financing component wherein the Company will receive from Pharmsynthez up to $3.5 million in bridge financing and a commitment of an additional $6.5 million in financing as part of a planned capital raise of at least $15 million and up-list to a national securities exchange.

"This transaction provides us with our first U.S. FDA IND-enabled clinical candidate for an orphan cancer indication," said M. Scott Maguire, Chief Executive Officer of Xenetic Biosciences. "Virexxa with orphan designation in the U.S. adds to our Phase II portfolio which also includes ErepoXen, our long-acting anemia drug candidate. As well as expanding our pipeline, the Company is pleased to receive financial commitments of up to $10M to fund our further development, as well as financial commitments to back our planned uplisting to a national securities exchange, an objective that remains a priority for the Company’s board."

This press release is not intended to describe this transaction in its entirety and the reader should refer to SEC form 8-K and related exhibits filed on November 16, 2015 for a complete description of this APA transaction.

About Virexxa

Virexxa (sodium cridanimod) is a small-molecule immunomodulator and interferon inducer which, in preliminary studies, has been shown to increase progesterone receptor (PrR) expression in endometrial tissue. Restoration of PrR expression may re-sensitize endometrial tumor tissue to progestin therapy in previously unresponsive tumors.

Virexxa is under investigation in a U.S. FDA IND-enabled Phase 2 open-label, multi-center, single arm study of sodium cridanimod in progesterone receptor negative recurrent or persistent endometrial carcinoma. This study will investigate the effect of sodium cridanimod on the levels of PrR in tumor tissue and how this effect correlates to a patient’s clinical response to progestin therapy.

Endometrial cancer is the most common gynecological malignancy and represents a major health concern, as overall five-year survival rates have not improved over the past three decades. Endometrial cancer patients whose tumors no longer express progesterone receptors are not candidates for progestin-based therapy. Virexxa may improve sensitivity to progestin therapy in subjects with advanced or recurrent PrR -negative tumors.

For more information:
clinicaltrials.gov/show/NCT02064725

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Infinity Announces Completion Of Target Enrollment In DUO™, A Phase 3 Study Evaluating Duvelisib In Chronic Lymphocytic Leukemia

Xenetic Biosciences, Inc. Enters Into Asset Purchase Agreement With Financing Component for the Rights to Develop, Market and License Oncologic Drug Candidate Virexxa™

10-Q – Quarterly report [Sections 13 or 15(d)]

10-Q – Quarterly report [Sections 13 or 15(d)]

10-Q – Quarterly report [Sections 13 or 15(d)]