AstraZeneca and Daiichi Sankyo win new breakthrough therapy designation for Enhertu

AstraZeneca/Daiichi-Sankyo

The HER2-directed antibody-drug conjugate Enertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA.

Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY).

The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.

Of the five breakthrough therapy designations for the drug, three are for breast cancer, while the other two are in lung and gastric cancers, respectively.

In particular, the designation covers adults who have received prior systemic therapy for metastatic breast cancer or who have experienced disease recurrence within six months of finishing adjuvant chemotherapy.

In addition, the designation specifies that patients with hormone receptor (HR) positive breast cancer have received or be inelig…

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Novartis partners with Carisma Therapeutics on manufacturing HER2-targeted CAR-M cell therapy

Novartis (NYSE:NVS) has inked a deal with the biopharma Carisma Therapeutics focused on the production of human epidermal growth factor receptor 2 (HER2)-targeted chimeric antigen receptor macrophages (CAR-M) to potentially treat solid tumors.

Carisma is headquartered in Philadelphia.

As part of the deal, Carisma will shift manufacturing to a Novartis cell therapy site in Morris Plains, New Jersey.

Novartis anticipates clinical manufacturing to begin in 2023.

Get the full story from our sister site, Drug Discovery & Development. 

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Novartis partners with Carisma Therapeutics on manufacturing HER2-targeted CAR-M cell therapy

Novartis (NYSE:NVS) has inked a deal with the biopharma Carisma Therapeutics focused on the production of human epidermal growth factor receptor 2 (HER2)-targeted chimeric antigen receptor macrophages (CAR-M) to potentially treat solid tumors.

Carisma is headquartered in Philadelphia.

As part of the deal, Carisma will shift manufacturing to a Novartis cell therapy site in Morris Plains, New Jersey.

Novartis anticipates clinical manufacturing to begin in 2023.

Novartis has worked to expand its contract manufacturing business. Last year, the company announced that it had an agreement with BioNTech (Nasdaq:BNTX) to fill COVID-19 vaccine vials in Europe.

Novartis has also helped Roche (SWX:ROG) manufacture the arthritis drug Actemra.

In 2017, Novartis became the first company to win FDA approval for a gene therapy with the authorization of Kymriah (tisagenlecleucel) for some pediatric and young adult patients with a form of acute lymphob…

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