by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
17/1/2022
December 2021 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
The Nasdaq Biotech Index has the same value as in January 2021
The NBI added 0% during 2021, compared to S&P500 27% or Dow Jones’ 19%. The market kept setting new highs despite plenty of challenges, including rising inflation, global supply chain disruptions and outbreaks of more contagious variants of the Covid-19 virus.
Antibody-Drug Conjugates
Immunogen announced positive pivotal trial data of mirvetuximab in ovarian cancer
ImmunoGen announced positive results from its pivotal trial of mirvetuximab in ovarian cancer. Immunogen announced positive top-line data from the pivotal SORAYA trial.
The trial evaluates the safety and efficacy of mirvetuximab soravtansine monotherapy in patients with FRα-high platinum-resistant ovarian cancer who have been previously treated with Avastin.
Interleukin-15 and Interleukin-2
SOTIO partnered with Merck on IL-15 superagonist combined with Keytruda
Nektar presented Phase 1 data of its NKTR-255 in hematologic malignancies
Nektar Therapeutics announced two data presentations from the dose-escalation portion of its ongoing Phase 1 study of NKTR-255 in patients with relapsed/refractory hematologic malignancies at ASH Meeting.
Cell Therapies
Phase 3 data of CD-19 targeting CAR-Tliso-cel show significant improvement in DLBCL
Liso-cel significantly improves outcomes in second-line DLBCL
BMS announced the first disclosure of results from a prespecified interim analysis of the pivotal TRANSFORM study, a global randomized Phase 3 trial evaluating Breyanzi(liso-cel), a CD19-directed CAR-T cell therapy as a second-line treatment in adults with relapsed or refractory large B-cell lymphoma.
It compared the outcomes to the standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus autologous hematopoietic stem cell transplant.
Other Innovative Treatment Areas
FDA approves Keytruda in adjuvant setting for melanoma
FDA approves Keytruda in adjuvant setting for melanoma
FDA approved Keytruda pembrolizumab from Merck & Co. for the adjuvant treatment of stage IIB or IIC melanoma in patients aged 12 years and older. The approval is based on interim data from the Phase 3 Keynote-716 trial, where Keytruda reduced the risk of disease recurrence or death by 35% compared to placebo.
FDA also expanded the drug’s indication as an adjuvant treatment in stage III melanoma to include patients 12 years and older. Keytruda was the first anti-PD-1 therapy to be approved in metastatic melanoma in 2014. The Keynote-716 results were reported at ESMO last September.
Oncology Transactions
Amunix signs takeover pact with Sanofi worth $1 billion targeting immune-oncology platforms
Sanofi announced that it has entered into an agreement to acquire Amunix Pharmaceuticals, an immuno-oncology company leveraging its proprietary, clinically validated XTEN and innovative universal protease-releasable masking technology platform, Pro-XTENT, to discover and develop transformative T-cell engagers (TCE) and cytokine therapies for patients with cancer.
Amunix’s pipeline, which includes lead candidate, AMX-818, a masked HER2-directed TCE, offers a strong strategic fit with Sanofi’s focus on developing potentially transformative cancer therapies in immuno-oncology.
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