AstraZeneca's Calquence treads on Imbruvica's turf with second phase 3 CLL win

fiercepharma | June 06, 2019

AstraZeneca's Calquence treads on Imbruvica's turf with second phase 3 CLL win
AstraZeneca’s Calquence has been battling it out in mantle cell lymphoma since it won its first approval back in late 2017, but all along, the company has had its eye on another disease: chronic lymphocytic leukemia. And that’s where it’s scored its latest win. In a phase 3 trial, Calquence—combined with Roche’s Gazyva—beat out a regimen of chlorambucil chemotherapy and Gazyva at staving off disease progression in previously untreated CLL patients, AstraZeneca said Thursday. And the trial nailed a key secondary endpoint, too, showing solo Calquence could top the Gazyva-chemo combination at the same feat. The British drugmaker is keeping the details under wraps for now; they’ll debut at a future medical meeting. But in the meantime, later this month, the company plans to unveil full results from another Calquence CLL win that it top-lined in early May.

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The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion on modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology

Spotlight

The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion on modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology

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Zenas BioPharma Acquires Exclusive Worldwide Rights to Obexelimab from Xencor

Xencor, Zenas BioPharma | November 22, 2021

Xencor, Inc. a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, and Zenas BioPharma (“Zenas”), a global biopharmaceutical company based in the USA and China committed to the development and delivery of immune-based therapies, today announced that Zenas has acquired from Xencor exclusive worldwide rights to develop, manufacture and commercialize the investigational antibody obexelimab. Obexelimab is a potential first-in-class bifunctional antibody that targets CD19 with its variable domain and uses Xencor's XmAb® Immune Inhibitor Fc Domain to target FcγRIIb, a receptor that inhibits the function of B-cells, which are important components in the immune system. Xencor demonstrated through early-stage clinical studies that obexelimab effectively inhibits B-cell function without depleting the cells and generates an encouraging treatment effect in patients with multiple autoimmune diseases. “Zenas is advancing a broad pipeline of differentiated drug candidates that are intended to bring best-in-class innovation to patients with underserved medical needs. Today, we are pleased to add obexelimab to our portfolio, and based on its clinical profile, we believe it is positioned as a first-in-class candidate with the potential to treat numerous autoimmune diseases.” Hua Mu, Ph.D., MD, president and chief executive officer at Zenas “Obexelimab’s highly potent and broad blockade of B-cell activation—without depleting B cells—differentiates it from other B-cell targeting therapies, and it has demonstrated disease-modifying activity in settings where B-cell inhibition is a proven strategy,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “In Zenas BioPharma, we have found a partner committed to broadly and aggressively developing therapeutics like obexelimab for patients with autoimmune diseases, enabling Xencor’s continued focus on the growing opportunities provided by our XmAb bispecific antibody and cytokine pipeline.” Under the terms of the new agreement, Zenas will issue to Xencor a warrant giving Xencor the right to acquire additional Zenas equity, such that Xencor’s total equity in Zenas would be 15% of its fully diluted capitalization following the closing of Zenas’ next round of equity financing, subject to certain requirements. Xencor previously received equity in Zenas under a separate license agreement. Xencor is also eligible to receive up to $480 million based on the achievement of certain clinical development, regulatory and commercialization milestones and is eligible to receive tiered, mid-single digit to mid-teen percent royalties upon commercialization of obexelimab, dependent on geography. Zenas will have sole responsibility for advancing the research, development, regulatory and commercial activities of obexelimab worldwide. About Xencor, Inc. Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Currently, 22 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of proteins resulting in new mechanisms of therapeutic action. About Zenas BioPharma Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and delivery of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. Xencor Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to the development of obexelimab as a potential treatment for patients with autoimmune diseases; the commercial potential of obexelimab; the safety, tolerability, efficacy and pharmacokinetics of obexelimab; the quotations from Xencor’s president and chief executive officer; and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2020 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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Zealand Pharma strengthens executive team with new U.S. leadership

Globe newswire | June 15, 2020

Zealand Pharma, a biotechnology company changing lives with innovative peptide-based medicines, today announced the appointment of Frank Sanders as President of Zealand Pharma U.S. Frank will join Zealand on July 6, 2020. “I am pleased to welcome Frank Sanders to Zealand Pharma, and am confident that he will provide strong and experienced leadership for our U.S. organization,” said Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma. “Frank has more than 25 years of experience within commercial operations. He is well equipped to lead Zealand’s commercial operations to focus on growing existing sales of V-Go and to successfully launch four potential products beginning in 2021.” Frank has extensive experience in leading multidisciplinary operational teams to achieve successfully their growth strategies. He joins Zealand at a critical point in the company’s journey toward commercializing its proprietary products. Frank has worked in both start-up and established companies, where he has built, led and scaled organizations across sales, account management, marketing, pricing and contract strategy, operations, and patient support.

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ANDA approves Glenmark Pharmaceuticals for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg

Glenmark Pharmaceuticals Inc | October 19, 2020

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune®1 Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV. According to IQVIATM sales data for the 12 month period ending August 2020, the Rapamune® Tablets, 0.5 mg, 1 mg and 2 mg market2 achieved annual sales of approximately $119.7 million*. Glenmark's current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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