Oregovomab

SEOUL, South Korea, Aug. 23, 2024 /PRNewswire/ -- CanariaBio Inc, a leading late-stage biotechnology company, announces the successful completion of enrollment of 88 patients in a randomized Phase 2 study of oregovomab in combination with chemotherapy (paclitaxel and carboplatin) as neo-adjuvant treatment of patients with newly diagnosed advanced epithelial ovarian cancer. This trial, known as FLORA-6 (NCT05605535) is a Phase 2, double-blinded, placebo-controlled, multi centered clinical trial in neo-adjuvant setting in patients with newly diagnosed advanced epithelial ovarian cancer. The study will assess 12 months progression free survival (PFS) rate, PFS, overall survival (OS), disease control rate, the immunological and early humoral response of concomitant oregovomab and chemotherapy. Ovarian cancer is known for its high recurrence rate. Despite numerous clinical trials conducted, the development of an effective and specific treatment has proven challenging due to treatment resistance, toxicity, and limited efficacy. In this difficult landscape, oregovomab has the potential of emerging as a promising immunotherapeutic agent. About Oregovomab Oregovomab is a murine monoclonal antibody against CA 125, a biomarker commonly found in ovarian cancer. Indirect immunization with oregovomab interacts with immune modulating properties of infused paclitaxel and carboplatin resulting in synergistic clinical benefits as observed in a Phase II trial (Gynecology Oncology (2020) 156:523-529). Oregovomab is currently undergoing multiple clinical trials for the treatment of ovarian cancer in various setting including a Phase 3 study (NCT04498117, NCT05605535, NCT05335993, NCT05407584, NCT04938583) About CanariaBio Inc. CanariaBio Inc. is a Korean biopharmaceutical company focused on the development and commercialization of immunotherapies for cancer. CanariaBio's technology platform includes a portfolio of tumor antigen specific monoclonal immunoglobulins targeting CA-125, MUC1, PSA and Her2/neu. The company is exploring the therapeutic potential of these antibodies as indirect immunizers in combination with other immune modulating drugs or drug combinations to address unmet medical needs in oncology. Forward Looking Statements This press release includes forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. The information in this release is provided only as of the date of this release and the company undertakes no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law. SOURCE CanariaBio Inc.

Recently, the United States has announced the first 10 drug prices after negotiations under the Inflation Reduction Act (IRA). Among these drugs, the price reduction for at least 9 of them is at least 50%. Among them, the reduction in the price of diabetes treatment drugs is particularly significant: Merck's Januvia price was reduced by 79%, from $527 per month to $113; Novo Nordisk's Fiasp, a treatment drug for type 1 diabetes, was reduced by 76%, from $495 per month to $119; AstraZeneca's Farxiga (dapagliflozin) was reduced by 68%. The First List of Drug Prices Negotiated under the US IRA Act Drug Name Original Price (Monthly) Negotiated Price (Monthly) Reduction Rate Januvia 527 113 0.79 Fiasp 495 119 0.76 Farxiga (Dapagliflozin) - - 0.68   According to a research report, the implementation of the first round of drug negotiations under the US IRA Act has resulted in price reductions ranging from 38% to 79% for the covered drugs. However, due to the fact that these drugs generally have a high list price and high rebate business model, it is expected that the negotiated price reduction will have a net impact on the actual product price of around 10% to 20%. Currently, these negotiated prices only apply to Medicare patients and not to patients with commercial insurance, thus having a limited short-term financial impact on the originator pharmaceutical companies.   From a long-term perspective, the IRA negotiated price reduction may lead to a shorter peak return period for individual products, prompting pharmaceutical companies to be more inclined to develop drugs with broad indications as their initial indications. Considering the long R&D cycle, in the case of a shortened peak return period, large pharmaceutical companies may accelerate their acquisition and merger activities. Based on this, the research report maintains its "outperform" rating for the domestic innovative pharmaceutical industry and recommends actively following companies that have overseas commercialization or licensing potential.   Analysis of the Impact of the First Round of Drug Negotiations under the US IRA Act Reduction in Drug Prices Impact of Net Price for Actual Products Target User Short-Term Financial Impact 38%-79% 10%-20% Medicare Patient Limited   In fact, in recent years, the internationalization process of China's innovative drugs has been accelerating. For example, on August 9, Merck & Co., a multinational pharmaceutical company, announced that it plans to acquire CN201, a dual antibody drug in development by Tongrun Biotech, for up to $1.3 billion in total transaction value, which is intended for the treatment of cancer and autoimmune diseases.   On June 14, Yasen Pharmaceuticals announced that it will license Orebactin (trade name: Nerivac) to Takeda, according to the agreement, Yasen Pharmaceuticals will receive a $100 million option payment, and is eligible to receive up to $1.2 billion in option exercise fees and additional potential milestone payments, as well as double-digit percentage royalties based on annual sales. According to industry statistics, in 2023, a total of 156 drugs were licensed out overseas, with a total transaction value of $35 billion, of which 78 projects belong to domestic enterprises going global.   Entering 2024, the number of outbound licensing transactions is still growing. Just in the first half of this year, the pharmaceutical industry has seen more than 30 outbound License-out authorizations, involving small molecules, monoclonal antibodies, and other categories. On the commercialization front, by the end of 2023, a total of six innovative drugs developed in China had been approved for the US market, and the number of approvals has shown an upward trend, with the number of approvals from 2019 to 2023 being 1, 2, and 3.   The Process of China's Innovative Pharmaceuticals Industry Going Global and Its Collaboration Event Involved Companies Transaction Amount Remarks Merck Acquires Tongrun Bio's Bispecific Antibody New Drug CN201 Merck, Tongrun Bio $1.3 Billion For the treatment of cancer and autoimmune diseases Ascentage Pharma Licenses Oregovomab to Takeda Ascentage Pharma, Takeda Up to $1.3 Billion Includes option payments, royalties and milestone payments Outbound Licensing of Chinese Drugs Domestic Companies $35 Billion 2023 data, 78 projects are outbound projects of domestic companies Innovative Drugs Listed in the US Market by China - - Number of approvals from 2019 to 2023 is 1, 2, 3 respectively   The report indicates that collaborating to expand overseas markets is an ideal choice for Chinese pharmaceutical companies. For the internationalization of innovative drugs, the following factors should be given priority: the potential peak sales of the drug, innovative drugs with a larger number of patients in the target indications are likely to have higher peak sales; drugs with a smaller patient base even if approved, the elasticity of performance and market capitalization is relatively limited; the clinical efficacy and the order of marketing authorization, drugs with the potential of being the best-in-class or me-better are expected to capture a higher market share, and drugs with earlier marketing authorization have certain first-mover advantages; the strength of overseas partners, considering that the dominant force in global innovative drug commercialization is still traditional pharmaceutical giants, drugs licensed to these leading companies are expected to have higher peak sales. Companies worth paying attention to include Yifan Pharmaceutical, Maiwei Biotech, and Hengrui Pharmaceutical.