GERMANTOWN, Md. - Orgenesis Inc . (NASDAQ: NASDAQ:ORGS), a global biotech company, has announced encouraging outcomes from a real-world study of its CD19 CAR-T therapy, ORG-101, in treating Acute Lymphoblastic Leukemia (B-cell ALL). The study showed high complete response rates of 82% in adults and 93% in pediatric patients, with a notably low incidence of severe Cytokine Release Syndrome (CRS) – only 2% in adults and 6% in children. CRS is a significant safety concern with existing CAR-T therapies, suggesting ORG-101 may offer a safer profile.
The data comes from a study of 233 patients at a leading hematology center in China. Orgenesis has adapted its CAR-T therapy to a decentralized production model, which could potentially reduce costs and increase access to advanced therapies. The company's GMP-Validated Platform supports this model, aiming to enhance production efficiency.
In light of these results, Harley Street Healthcare Group, in partnership with Orgenesis, plans to establish a Global Cancer Initiative to democratize access to advanced therapies and further clinical development. This initiative will reportedly focus on making cancer treatments more affordable and accessible worldwide.
Orgenesis is preparing to initiate a Phase 1/2 multicenter clinical study, with the first site at the General University Hospital of Patras in Greece. This move aligns with the company’s strategy to advance cell and gene therapies toward commercialization while leveraging regional partnerships to provide therapies to a larger patient population.
The company's CEO, Vered Caplan, expressed optimism about the clinical results and the potential of their decentralized cell processing platform to improve treatment access and affordability. Sanjeev Kumar, Chief Visionary Officer at Harley Street Healthcare Group, highlighted the initiative's commitment to addressing cancer's global impact and improving therapy affordability.
This announcement is based on a press release statement. Orgenesis continues to engage with regulatory bodies, including the FDA in the U.S., the Israeli MOH, and the Paul-Ehrlich-Institute in Germany, regarding ORG-101. The company emphasizes its dedication to bringing potentially life-saving treatments to patients worldwide.
In other recent news, Orgenesis Inc. has secured an additional $750,000 in funding from investor Jacob Safier, bringing the total loan amount to $1 million, with a maturity date set for December 31, 2024. The company has also formed a joint venture with Harley Street Healthcare Group (HSHG) to develop and commercialize wellness and longevity therapies worldwide, with HSHG committing to invest up to $10 million over the next three years into both Orgenesis and the venture. Orgenesis has also expanded its equity incentive plan by 9 million shares and elected five new directors to its board.
The company has also entered into a strategic collaboration with Germfree to make cell and gene therapy treatments more affordable and accessible. These recent developments aim to bolster the company's financial position and expand operations. Orgenesis's strategic moves underscore its efforts to secure necessary capital for its operations and to foster innovation in digital workflows and advanced quality management systems.
Please note that these are recent developments and do not offer a comprehensive view of the company's performance or future expectations. These facts are based on the company's SEC filings and other reliable sources.
InvestingPro Insights
Orgenesis Inc. (NASDAQ: ORGS) has caught the attention of the biotech industry with its recent study results for ORG-101, and its financial metrics provide additional context for investors evaluating the company's potential. According to InvestingPro data, Orgenesis has a market capitalization of $32.7 million, reflecting the scale of the company within the biotech sector. Despite challenging market conditions, Orgenesis has demonstrated a strong return over the last three months, with a 39.38% increase in its stock price, showcasing investor confidence in the company's growth prospects.
InvestingPro Tips indicate that Orgenesis is expected to experience net income growth this year, which could be a positive sign for potential investors. This anticipated growth aligns with the company's strategic initiatives, such as the Global Cancer Initiative and the upcoming Phase 1/2 multicenter clinical study for ORG-101. Moreover, the company is trading at a high revenue valuation multiple, which may suggest that investors are willing to pay a premium for its shares based on future growth expectations.
While Orgenesis does not pay a dividend to shareholders, the company's focus on advancing cell and gene therapies could present other forms of shareholder value, especially if these therapies successfully reach commercialization. For investors interested in a deeper dive, there are additional InvestingPro Tips available at: https://www.investing.com/pro/ORGS, providing a more comprehensive analysis of Orgenesis Inc.'s financial health and market position.
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