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TIL for Advanced Melanoma Approved
First T-cell therapy approved by FDA. Iovance’s Amtagvi is the first individualised tumor lymphocyte (TIL) therapy on the market. Advanced melanoma patients with BRAF V600 tumor mutation treated with a PD-1 and BRAF inhibitors qualify for this new therapy at a $515, 000 per patient wholesale acquisition cost.
Amtagvi is made using individual patients’ immune cells (TIL) collected from their resected tumor, expanded externally and infused back into the patients’ body. Prior to Amtagvi, solid tumors were impossible to target by CAR-T cells due to their lack of appropriate cell-surface biomarkers. Not so with TIL cells, they able to identify cancer biomarkers naturally.
At the drug’s launch Iovance will operate from 30 centers, and plan to expand soon to 50 designated centers. The average manufacturing turnaround time is 34 days. For more details see the reports below:
FierceBiotech Link
PharmaTell Studio Link
PharmaTell Studio Link
PharmaTell Studio Link
Magrolimab Discontinued for Blood Cancer
Gilead has ended the development of a CD47 medication for blood
cancer.
The FDA requested a partial clinical hold on magrolimab in solid tumor trials, four phase 2 studies, following deaths in blood cancer patients.
In response to futility analyses and increased death reports, Gilead abandoned plans to develop the antibody in blood cancer. Patients with triple-negative breast cancer and colorectal cancer can re-consent to receiving magrolimab if clinically benefiting.
Gilead is now ‘reviewing the benefit-risk of magrolimab across all ongoing trials’. Magrolimab’s setbacks date back to an early 2022 partial clinical hold and are a part of a wider negative results in CD47 therapeutics. For more details see the reports below:
Link:
Fierce Biotech Link
PharmaTell Studio Link
PharmaTell Studio Link
BioTech Financing
2023 saw a significant increase in biotech bankruptcies, with a record high of 28 companies filing for bankruptcy in the United States.
This surge can be attributed to various factors, including the disruption of cash flow and depleted funds due to the COVID-19 pandemic, the inability to keep pace with industry advancements, high investment requirements, project failures, financial challenges, and the impact of rising interest rates on fund-raising. The trend is new for the biotech world, as bankruptcy is not a common occurrence in an industry that is primarily equity financed. The economic environment has led to companies winding down operations, selling assets, or filing for bankruptcy. In addition, the challenging financing environment is continuing to affect valuations and deal-making activity across the sector. For more details see the reports below.
Link:
The Street Link
BioSpace Link
Hot Start-ups for 2024
Some of the trending, promising biotech startups of the year include:
1. Eligo Bioscience: A company focused on developing precision antimicrobials to reshape the microbiome.
2. Calluna Pharma: A biopharmaceutical company dedicated to developing innovative treatments for cancer and autoimmune diseases.
3. Casualy: CausalyA platform that uses causal AI to accelerate research and development in healthcare and life sciences.
4. Complement Therapeutics: A company working on developing innovative therapies for the treatment of severe diseases related to the complement system.
5. Enveda Biosciences: Focused on the discovery and development of next-generation medicines using a platform that combines data from multiple sources.
6. Redesign Science: Utilizes Al to build machine learning systems for drug development.
7. Capsan Therapeutics: Developing therapies for cancer and other serious diseases using a proprietary drug discovery platform.
8. Ribon Therapeutics: A biopharmaceutical company targeting stress support pathways in cancer.
9. MoMa Therapeutics: A biotechnology company harnessing the power of molecular machines to provide better precision treatments.
10. NotCo: Using AI and deep learning to eliminate the need for animals in the food production process.
References include:
SeedTable Link
Biotech Startups Link