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the official website of the antibody society

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You are here: Home / Archives for Phase 3 pipeline

Antibody Drug Conjugates – Clinical Progress

June 1, 2016 by Joost Melis

square logo ADCIn the second half of May several companies reported important progress on their therapeutic ADC products. The Dutch pharmaceutical company Synthon initiated the second phase of the ongoing phase I clinical trial with its investigational anti-HER2 ADC SYD985. During the first part patients with solid tumors of any origin were enrolled. Promising results were obtained in this dose-finding part of the trial in 33 cancer patients who were dosed with between 0.3 and 2.4 mg/kg of SYD985 every three weeks. Very high response rates and durable responses were observed  at doses from 1.2 mg/kg onwards in patients whose cancers were refractory to HER2-targeted agents, including Herceptin® and Kadcyla®. The second part will see 48 additional heavily pre-treated patients with HER2-positive breast cancer enrolled into the Phase I trial. This marked a significant next step in the development of SYD985, the frontrunner of the company’s duocarmycin-based ADC platform.

Additionally, Seattle Genetics announced initiation of a pivotal phase III clinical trial, CASCADE, evaluating vadastuximab talirine (SGN-CD33A) in combination with azacitidine (Vidaza) or decitabine (Dacogen) in older patients with newly diagnosed acute myeloid leukemia (AML). SGN-CD33A is an ADC targeting CD33 comprising an engineered cysteine antibody (EC-mAb) stably linked to a pyrrolobenzodiazepine (PBD) dimer. CD33 is expressed on leukemic blasts in nearly all AML patients and expression is generally consistent regardless of age, cytogenetic abnormalities or underlying mutations. Azacitidine and decitabine are hypomethylating agents (HMAs) commonly used in the treatment of older AML patients. The phase III CASCADE study is a randomized, double-blinded, placebo-controlled, global clinical trial. Patients will be randomized on a 1:1 ratio to be treated with an HMA plus SGN-CD33A or an HMA plus placebo. The secondary endpoints include the comparison of composite complete remission rate, event-free and leukemia-free survival, duration of response, safety, and 30- and 60-day mortality rates. This phase III trial will enroll approximately 500 patients globally.

Filed Under: Ab news, ADC, Clinical pipeline, Phase 3 pipeline

Overview of the antibody therapeutics clinical pipeline now available!

March 8, 2016 by Janice Reichert

mabs-coverAntibody therapeutics research and development by the biopharmaceutical industry has undergone remarkable expansion in the past ~ 5 years. Over 100 novel antibodies entered first clinical studies in 2015, and the overall clinical pipeline now includes ~480 antibodies. Importantly for patients, these molecules are progressing through the phases of clinical testing, and being approved for marketing. Over 50 antibody therapeutics for a variety of diseases are in Phase 3 studies. A record number (9 new products) were granted first marketing approvals in the United States or European Union in 2015, and the evidence suggests that a larger number may be approved in 2016. A new presentation now available to Society members shows the number of novel antibodies that entered clinical studies recently, how many are in the three clinical phases, and which antibodies might be approved in 2016. Log in to get the presentation. Not a member? Please join!

Filed Under: Ab news, Phase 3 pipeline Tagged With: antibody therapeutics, clinical pipeline

‘Antibodies to watch in 2016’ now free

February 8, 2016 by Janice Reichert

The current late-stage clinical pipeline includes over 50 antibody therapeutics that are listed in the latest installment of the ‘Antibodies to watch’ article series. ‘Antibodies to watch in 2016’ is now freely available on the mAbs website.

Find the article here

mAbs is a journal of the Society, and a special subscription rate of US $63 is available for Society members. To receive the special rate, contact the publisher Taylor & Francis at 1 (800) 354-1420 (Fax: (215) 207-0046) or customerservice@taylorandfrancis.com

Filed Under: Ab news, Phase 3 pipeline Tagged With: antibodies, clinical, pipeline

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