Category: antibody-drug conjugate
Astellas has agreed a $1.36 billion partnership with US biotech Sutro Biopharma for a series of antibody-drug conjugates for cancer, focusing on applications in patients who don’t respond to current immunotherapies. The alliance includes an upfront payment of $90 million, backed by $422.5 million in possible milestone payments apiece for up to three development programmes […]
ADC Therapeutics is looking to add a second approved antibody-drug conjugate to its portfolio after reporting strong phase 2 results with camidanlumab tesirine (cami) in relapsed/refractory Hodgkin lymphoma at the EHA annual meeting. In the study, 70% of patients treated with the CD25-targeting ADC had a response to therapy, with 33% of them having a […]
Eisai’s first-ever attempt at developing an antibody-drug conjugate for cancer was rewarded with a $3.1 billion licensing deal from Bristol-Myers Squibb, and new data reported at ASCO has given a glimpse into its potential. Farletuzumab ecteribulin – also known as MORAb-202 – is being developed to treat tumours that overexpress folate receptor alpha (FRα), and […]
During the annual meeting of the American Society of Clinical Oncology, AstraZeneca and Daiichi Sankyo reported pivotal clinical trial data showing that their partnered cancer drug Enhertu can treat a group of patients previously thought to be out of reach for a targeted therapy. The results suggest use of this FDA-approved drug could significantly expand […]
AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after the showing the drug extended survival in patients with HER2-low metastatic breast cancer. The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved […]
A US jury has decided that Daiichi Sankyo and AstraZeneca’s breast cancer drug Enhertu infringes a patent held by US biotech Seagen, awarding almost $42 million in damages. Seagen claims Enhertu (trastuzumab deruxtecan) – an antibody-drug conjugate (ADC) targeting HER2 – infringes a patient it holds (No. 10,808,039) covering ADCs that include auristatin compounds coupled […]
Roche has moved a step closer to extending the use of its B-cell lymphoma therapy Polivy into the first-line setting, after getting a recommendation for approval in the EU from EMA advisors. The CHMP backed Polivy (polatuzumab vedotin) for previously-untreated diffuse large B-cell lymphoma (DLBCL) in combination with R-CHP chemotherapy (rituximab, cyclophosphamide, doxorubicin, and prednisone) […]
Antibody drug conjugates have made scientific and regulatory progress in recent years. Sanofi is partnering with ADC specialist Seagen in a multi-drug alliance that keeps the pharmaceutical giant in the mix of this growing field of cancer therapies.
ImmunoGenAlmost four years after backing out of an antibody-drug conjugate (ADC) alliance with ImmunoGen, Eli Lilly has come back to the table with a new, wide-ranging deal worth up to $1.7 billion. Like the earlier agreement, the new deal is focused on one of ImmunoGen’s payload technologies, the toxic molecules that add a cell-killing punch […]
Astellas and Seagen’s Padcev is on course to move further up the treatment pathway in bladder cancer, thanks to a positive readout in the EV-103 clinical trial. Padcev (enfortumab vedotin) is already approved as a second-line therapy for urothelial carcinoma (UC) after cisplatin chemotherapy and immunotherapy with checkpoint inhibitors, but Seagen and Astellas are working […]
The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. Teliso-V (telisotuzumab vedotin) is pitching to become the first targeted cancer treatment for people with non-small cell lung cancer (NSCLC) whose tumours overexpress c-Met. The c-Met protein thought […]
Daiichi Sankyo has been granted breakthrough status by the FDA for patritumab deruxtecan, a HER3-targeted antibody-drug conjugate (ADC) in clinical trials for lung cancer. The designation – which is awarded to therapies that could represent a significant improvement over standard of care in either efficacy, safety, or both – has been awarded on the strength […]
Antibody drug conjugates deliver a targeted strike to tumors, but the toxic payloads of these therapies can still reach healthy tissue. Mythic Therapeutics’ FateControl technology ensures that more of an ADC’s drug payload reaches the tumor, and CEO Alex Nichols is steering the startup out of stealth with $103 million and a lead program in lung […]
AstraZeneca and Daiichi Sankyo have reported new data with their antibody-drug conjugate for triple-negative breast cancer (TNBC), as they build a case to challenge Gilead’s already-marketed Trodelvy. New data from the TROPION-PanTumor01 study of datopotamab deruxtecan (Dato-DXd) showed a 34% objective response rate (ORR) with AZ and Daiichi’s drug when used as a therapy for […]
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) […]
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 […]
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 […]
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 […]
ProfoundBio is developing a type of targeted cancer therapy called antibody drug conjugates. As the biotech looks ahead to clinical trials, it has raised more than $55 million in Series A funding.
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 […]
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 […]
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.
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.
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 […]
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 […]
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 […]
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 […]