antibody-drug conjugate

ASH abstract drop backs Roche’s Polivy in first-line lymphoma

Roche trumpeted a top-line results of the POLARIX trial of its Polivy therapy in previously-untreated B-cell lymphoma, and a first look at the data suggests it is on track for approval in what could be a highly lucrative new market. An abstract of the results published ahead of the upcoming American Society of Haematology (ASH) …

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AZ/Daiichi partner with Merck on first-line lung cancer trial

The dominance of Merck & Co’s Keytruda in the treatment of previously-untreated non-small cell lung cancer (NSCLC) means it will be hard to dislodge – so AstraZeneca and Daiichi Sankyo have forged an alliance in the hope of piggy-backing on that success. AZ and Daiichi Sankyo have agreed to partner with Merck on a second …

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HER2 heats up as Seagen licenses RemeGen ADC for $2.6bn

Seagen is a specialist in antibody-drug conjugates, but has looked to Chinese biotech RemeGen for a HER2-targeting candidate that could challenge rival drugs from AstraZeneca/Daiichi Sankyo and Roche. The US company is paying $200 million upfront for rex-Asian rights to RemeGen’s disitamab vedotin, with another $2.4 billion in possible future payments tied to future successes …

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Armed with ph3 trial, Roche preps filing for Polivy in first-line DLBCL

Roche has the results it was hoping for in a phase 3 trial of Polivy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) – an indication it thinks could be worth up to $2 billion. The Swiss drugmaker reported top-line results from the POLARIX study this morning, showing that Polivy (polatuzumab vedotin) was able to …

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BMS pays $650m upfront for Eisai’s first ADC candidate for cancer

Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 billion.  BMS is making a hefty $650 million upfront payment to Eisai for global co-development and co-commercialisation rights to MORAb-202, which couples an anti-folate receptor …

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Ambrx tries another IPO as it chases down HER2 rivals

California biotech Ambrx Biopharma is hoping to raise $126 million from a listing on the New York Stock Exchange (NYSE) that will be used in part to fund clinical development of ARX-788, its HER2-targeting antibody drug conjugate (ADC). The Scripps Research spinout could be just 18 months away from licensee NovoCodex reporting results of a …

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Two new biotechs unveil $112M combined for antibody drug conjugates for cancer

The list of FDA-approved antibody drug conjugates (ADC) is growing, and two more biotech startups have emerged from stealth with new cash and new approaches to this type of cancer drug. Adcendo and Adcentrx raised a combined $112 from their Series A financings.

FDA approves ADC Therapeutics antibody drug conjugate in B-cell lymphoma

With FDA approval of Zynlonta, ADC Therapeutics can offer patients who have diffuse large B-cell lymphoma an option if CAR-T therapy doesn’t work. Additional clinical trials are underway that could expand use of the antibody drug conjugate to more cancer patients.

Enhertu cleared for NHS use via Cancer Drugs Fund

NICE has recommended the use of AstraZeneca and Daiichi Sankyo’s Enhertu in draft guidance, the first time the drug has been commissioned in any European country.  The UK health technology assessment (HTA) agency has backed Enhertu (trastuzumab deruxtecan) as a therapy for HER2 positive breast cancer which can’t be surgically removed or which has spread …

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Astellas, Seagen seek speedy reviews of Padcev in bladder cancer

The next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings.  One of the filings is to convert the ADC’s current conditional approval as a later-line therapy for urothelial cancer in patients …

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Boehringer buys NBE for €1.18bn, adding cancer ADC expertise

Boehringer Ingelheim has expanded its oncology focus for the second time this week by buying Swiss biotech NBE-Therapeutics, adding an antibody-drug conjugate (ADC) platform led by a drug for a hard-to-treat form of breast cancer. The German pharma group is paying €1.18 billion ($1.43bn) for all the shares in privately-held NBE, based in Basel, and …

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FDA sets May date for verdict on ADC’s lymphoma drug Lonca

ADC Therapeutics could claim its first product approval in the US next May, after the FDA started a priority review of lead drug Lonca for diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma. Lonca – short for loncastuximab tesirine (formerly ADCT-402) – is an antibody-drug conjugate that combines an antibody against CD19 …

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