by Jakub Jarolím, Business Intelligence Department
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SOTIO Biotech
30/9/2021
July 2021 Review of news from the most innovative therapeutic areas and the business development transactions
Market
US stocks fell on concern a rebound of Covid cases would slow down economic growth
US stocks fell aggressively on concern a rebound in Covid cases would slow global economic growth. The selling picked up as the session went on, and the Dow Jones Industrial Average had its worst day since last October. NBI also experienced a 4% drop but recovered quickly.
Antibody-Drug Conjugates
Padcev received regular approval in US and added a new indication
FDA granted full approval to Padcev enfortumab vedotin-ejfv based on overall survival data from the confirmatory EV-301 trial. It also expanded the antibody-drug conjugate’s label to include patients with second-line locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy.
In 2019, FDA granted accelerated approval for locally advanced or metastatic urothelial cancer patients who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before or after surgery, or in a locally advanced or metastatic urothelial cancer setting.
Interleukin-15 and Interleukin-2
ImmunityBio’s novel immunotherapy NANR cancer vaccine is awarded a US patent
ImmunityBio announced it has been granted a patent by US Patent and Trademark Office for its proprietary NANT Cancer Vaccine (US Patent 11,071,774).
Cell Therapies
FDA granted Fast Track to Allogene’s ALLO-605 to treat relapsed or refractory multiple myeloma
Allogene announced that FDA granted Fast Track designation to ALLO-605, the Company’s next-generation AlloCAR T therapy targeting BCMA for the treatment of relapsed or refractory multiple myeloma.
The FDA granted Fast Track designation based on the potential of ALLO-605 to address the unmet need for patients who have failed other standard multiple myeloma therapies.
Other Innovative Treatment Areas
FDA approved Keytruda plus chemo for high-risk early-stage TNBC as neoadjuvant treatment
FDA approved Keytruda for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial.
KEYNOTE-522 showed that KEYTRUDA in combination with chemotherapy (carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide) before surgery and continued as a single agent after surgery significantly prolonged event-free survival (EFS) versus the same neoadjuvant chemotherapy regimens alone in patients with previously untreated stage II or stage III TNBC.
There was a 37% reduction in the risk of disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause. With this approval, Keytruda is now approved in the US for 30 indications.
Oncology Transactions
Amgen takes over multi-specific antibodies through up to $2.5 billion takeout of Teneobio
As multispecific therapies continue to gain traction, Amgen is building out its tool kit through its acquisition of TeneoBio for $900 million up front and $1.6 billion in milestones. Amgen is playing catch-up in hot immuno-oncology areas such as checkpoint inhibitors and CAR-Ts, but it has a first-mover advantage when it comes to bispecifics.
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