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AI-designed monoclonal antibody ‘redirects’ the immune system

Drug Discovery World

Immuno-oncology company Aulos Bioscience has revealed interim results from an ongoing Phase I/II trial of monoclonal antibody AU-007 in solid tumours. AU-007 is a human IgG1 monoclonal antibody designed using artificial intelligence to harness the power of interleukin-2 (IL-2) to eradicate solid tumours.

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Merck wins regulatory approval for combination therapy to treat la/mUC

Pharmaceutical Technology

KEYTRUDA is an anti-PD-1 therapy developed by Merck, while Padcev has been developed by Astellas and Seagen. The combination therapy can be used to treat la/mUC patients who do not qualify for cisplatin-containing chemotherapy. The trial was jointly conducted by Seagen and Astellas.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Regulatory Considerations for Biologics. Section 351(a) is the traditional pathway for approving biologics under the PHS Act.

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Clinical Trials for Celiac Disease: Insights from Beyond Celiac’s Kate Avery

XTalks

When a person with celiac disease eats something that contains gluten, their immune system attacks their small intestine, damaging the lining and interfering with the absorption of nutrients from food. A blood test can detect antibodies to gluten, but a definitive diagnosis requires a biopsy of the small intestine.

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Hemogenyx Pharmaceuticals PLC Announces Update on CDX Antibody Development

The Pharma Data

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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ASP-2138 by Xencor for Metastatic Adenocarcinoma of The Pancreas: Likelihood of Approval

Pharmaceutical Technology

ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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ASP-2138 by Xencor for Gastric Cancer: Likelihood of Approval

Pharmaceutical Technology

ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. The drug candidate is being developed based on XmAb technology.

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