OS Therapies’s HER2-immunotherapy met the primary endpoint in a Phase IIb trial in patients with recurrent, fully resected, lung metastatic (METS) osteosarcoma.
The Phase IIb trial (NCT04974008) met its primary endpoint seeing 12-month event-free survival (EFS) in 33% of patients treated it when measured against previously published historical control groups who saw only 20%. An event in this case is defined as the recurrence of metastatic osteosarcoma.
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The company also added that all patients who achieved the primary 12-month EFS endpoint remain alive. At the same time, the trial met its secondary endpoint in overall survival at the one-year and two-year marks.
After announcing the data on 15 January, the companies stock jumped 68% from $4.16 at market close on 14 January to a high of $7.00 on 15 January. The stock price dropped back down to close at $4.36.
OST-HER2 is targeted immunotherapy treatment bioengineered form of the bacteria Listeria monocytogenes (Lm) to trigger a strong immune response against cancer cells expressing HER2 with the goal of preventing metastasis whilst delaying recurrence and destroying tumours expressing HER2 alone and in combination with other therapies to increase overall survival.
Robert Petit, chief medical and scientific officer at OS Therapies, said: “We are extremely pleased with these results of our Phase IIb clinical trial because they show that OST-HER2-treated patients achieved the primary endpoint of 12-month EFS in a statistically significantly higher ratio than comparable historical controls, in addition to increasing the likelihood of 1-year and 2-year survival as compared with comparable historical controls.
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By GlobalData“The strong safety profile shown in this study also supports the use of OST-HER2 in this incredibly difficult-to-treat population that has no currently approved therapies.”
The trial recruited 39 patients at 21 centres between the ages of 12 to 39 into a single arm. All were dosed 16 times, once every three weeks for 48 weeks, with a four-week follow-up final visit.
The announcement follows after the US Food and Drug Administration (FDA) granted OST-HER2 rare pediatric disease designation for osteosarcoma in 2021, granting OS Therapies a priority review voucher. The company has confirmed it intends to sell the voucher after the approval of OST-HER2.
Paul Romness, CEO of OS Therapies, said: “The achievement of the primary endpoint in the OST-HER2 Phase IIb is a tremendous success that opens the possibility, for the first time, of meaningful therapy for patients suffering from osteosarcoma with lung metastases after resection. This is a leap forward in the development of OST-HER2 and we are pleased that our regulatory strategy is consistent with the FDA’s recent draft guidance update for accelerated approvals.
“With these positive data in hand, we are preparing to engage with the US FDA on an accelerated pathway for approval in this extremely challenging indication.”
Elsewhere in the field of paediatric oncology therapies, the University of Birmingham has launched the global ‘Glo-BNHL’ clinical trial assessing new therapies to treat patients with B-cell non-Hodgkin lymphoma.
