Guangzhou Doublle Bioproduct gives a clinical and commercial update on its Adenolysin gene therapy asset for head and neck cancer as its seeks global partnersInitial results from our Phase III study of gene therapy in head and neck cancer are encouraging. Adenolysin can bring profound improvement for treatment of cancer patients in this indication.”— Dr Marilyn ZhouNEW YORK, NEW YORK, USA, June 10, 2021 /EINPresswire.com/ -- Guangzhou Doublle Bio-Product Co (“Doublle”), a Guangzhou, China-based company, announced that following a strategic review, it has appointed The Sage Group Inc to represent its Adenolysin gene therapy asset in a global search for commercial partners. Adenolysin is the first gene therapy product to reach a Phase III study in China.
Doublle also announced it will attend the BIO2021 Digital meeting from June 14-17, 2021, and welcomes interested companies to meet in the partnering sessions it will attend.
Adenolysin is a novel, late-stage gene therapy for treatment of head and neck cancer (exluding nasopharyngeal carcinoma). Adenolysin is a gene vector for intra-tumoral delivery of endostatin. Specifically, Adenolysin is a type 5 recombinant, replication-deficient, adenovirus vector carrying the human endostatin gene. Adenolysin can be used to directly introduce the gene into solid tumors and it continuously expresses the endostatin protein in host cells to limit vascularization for two weeks.
Intra-tumoral delivery of endostatin has been well known to inhibit tumor angiogenesis and prevent tumor cell growth. Adenolysin’s intra-tumoral delivery of recombinant endostatin yields higher bioavailability as evidenced by high plasma levels of endostatin for longer periods of time.
Adenolysin is a 1st in class cancer gene therapy combined with chemotherapy and other drugs.
Adenolysin is in a Phase III study at more than 20 centers and > 200 patients in China with late-stage head and neck excluding nasopharyngeal cancer. Results are due by the end of 2021 comparing chemotherapy alone (paclitaxel and cisplatin as the control) with chemotherapy plus Adenolysin as the active.
An interim Phase III analysis of 103 patients (76 active/27 control) shows Adenolysin achieved a statistically significant Overall Survival of p=0.043 in patients with multiple lesions and p=0.036 in patients with single lesions. This means that Adenolysin appears highly active and efficacious in treatment of head and neck cancer.
Doublle believes similar results and be achieved in the treatment of other tumor types including hepatocellular carcinoma, lung cancer, prostate cancer, stomach cancer.
Doublle operates a GMP manufacturing facility which is ICH, EMA, FDA regulation compliant.
Guangzhou Doublle seeks to collaborate with a development and commercialization partner for global or regional rights to Adenolysin outside of China.
Dr. Marilyn Zhou, CEO of Doublle, said “Initial results from patients recruited into our Phase III clinical study for patients with head and neck cancer (excluding nasopharyngeal) in China have been very encouraging in respect of improvement in overall survival, based on our interim results analysis. We expect final data readout later in 2021 and based on initial positive data in more than 100 patients, we have decided to appoint The Sage Group to seek global and/or regional partners for our Adenolysin asset. We believe that Adenolysin will bring profound improvement for global treatment of cancer patients in this indication”
For more information about Doublle and partnering opportunities for its Adenolysin asset, please contact:
Dr. Bill Mason
The Sage Group
The Old Black Barns
Lord’s Lane, Ousden CB8 8TX UK
Tel: +44 (0) 7785 950134
The Sage Group Inc.
1802 Route 31 North
New Jersey 08809 USA
Phone: +1 908 2306170
About Guangzhou Doublle Bioproduct Co
Guangzhou Doublle Bioproduct Co., Ltd. (“Doublle”) is an innovative biotechnology company headquartered at the International Business Incubator of Science Park in Guangzhou. Founded in May 2001 by a group of entrepreneurial returnees and led by a member of China’s 1000 Talents Program, Doublle focuses on discovering and developing innovative biologics with two Provincial Key Laboratories of anti-tumor drug research and development and a Municipal Key Laboratory focused on gene therapy.
Doublle has been a pioneer in anti-tumor gene therapy with 13 invention patents in China, 3 invention patents in USA and 7 invention patents in registration. And Doublle have built a rich product pipeline targeting gene therapy, oncology, and radiation protection.
Doublle has several lead product candidates including Adenolysin (E10A), E10B, E10D. Adenolysin is an innovative gene drug that is the first gene-based drug in a Phase III study in China.
Doublle also have other clinical stage assets including E10B and E10H. E10B is another gene therapy biologics and E10H is a cell therapy biologics.
Doublle believe the next generation of cancer treatment will utilize therapeutics both as gene therapy and in combination to attack multiple underlying mechanisms of cancer cell growth and survival
About The Sage Group, Inc.
The Sage Group Inc. is a leader in the provision of strategic and transactional advice to health care companies in the pharmaceutical, diagnostics, medical device, biotechnology and life science fields. Sage currently maintains offices in USA, Europe, Israel and Japan. Since its founding in 1994, The Sage Group has served more than 200 clients in the US, Europe and Asia, and completed numerous transactions including divestitures, alliances, acquisitions and financings with values ranging from $5 million to $500 million.
The Sage Group is an organization of experienced and successful executives who are committed to the service of the very vital and dynamic health care industry and its investors.
The range of services offered includes:
• Strategic alliances and licensing/partnering
• M&A, divestment, buy- and sell- side
• Global product and technology acquisition searches
• Strategic assessment and planning
• Due diligence, technology and molecule assessment, valuation
• New ventures, interim management
• Facilitating investment in R&D and/or company equity through introductions, network and brokering
The Sage Group's Principals, each an Executive Director, have been Founders, Chairmen, Presidents, CEO's and COO's of a number of emerging health care companies. These Principals have also held senior level management positions in large multi-national organizations. In addition to their management backgrounds, The Sage Group's Principals also have extensive experience in providing professional management consulting services to healthcare industry clients. All these experiences are being applied by The Sage Group to assist industry participants.
Dr. Bill Mason
The Sage Group
+44 7785 950134
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