Bispecific Antibody Drug Conjugates Clinical Trials FDA Approval Commercial Launch Market Forecast 2029

First Bispecific Antibody Drug Conjugate Is Expected To Be Available In Market By 2029 Says Kuick Research

/EIN News/ -- Delhi, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Global Bispecific Antibody Drug Conjugates Clinical Trials, Regulatory Approvals & Future Market Opportunity Outlook 2029 Report:

• Report Answers Question On Why There Exist Need For Bispecific Antibody Drug Conjugates
• First Bispecific Antibody Drug Conjugates Commercial Approval Expected By 2029
• Insight On Bispecific Antibody Drug Conjugates In Clinical Trials : > 60 Drug Conjugates
• China Dominating Bispecific Antibody Drug Conjugates Clinical Trials: > 35 Drug Conjugates
• Majority Of Bispecific Antibody Drug Conjugates For Breast Cancer
• Bispecific Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication and Phase
• Bispecific Antibody Drug Conjugates In Combination Therapy By Indication and Clinical Phase
• Key Companies Involved In Development Of Bispecific Antibody Drug Conjugates

Download Report: https://www.kuickresearch.com/report-bispecific-antibody-drug-conjugates

The global bispecific antibody drug conjugates (BsADCs) segment is experiencing a surge of interests and investment, despite being in its early stages. This innovative therapeutic approach, which combines the targeting precision of bispecific antibodies with the potent cytotoxicity of traditional antibody-drug conjugates (ADCs), is garnering attention from both pharmaceutical companies and nimble biotechnology firms. Early-phase and preclinical candidates dominate the industry landscape, which is indicative of the cutting-edge nature of this technology.
         
While the majority of BsADC programs are still in their initial stages, a select few have significant strides towards late-stage development. Notably, 2 candidates, Alhamab Oncology's JSKN003 (anti-HER2) and Sichuan Baili Pharmaceutical's BL-B01D1, also known as Zalontamab Brengitecan (EGFR×HER3) have advanced to phase 3 clinical trials for solid tumors. In China, phase 3 clinical studies for BL-B01D1 are being conducted for the treatment of several malignancies and their subtypes, including breast and lung cancer. On the other hand, JSKN003 is currently undergoing phase 3 clinical trials in China as a therapy for breast cancer.

Industry watchers are keeping a close eye on these pioneers since their advancements may lead to the first BsADC approvals and establish significant industry precedents. Additionally, the Chinese National Medical Products Administration designated BL-B01D1 as a breakthrough therapy, granting it exceptional benefits from the national drug regulatory body, including an accelerated market approval.

In recent months, the BsADC segment has been a hub of collaborative activity, with multiple partnerships establishing throughout drug development stages. Biocytogen and ABL Bio have partnered in the early stage discovery space to take advantage of their complementary backgrounds in antibody engineering and development. The goal of this collaboration is to find new BsADC candidates with better safety and effectiveness profiles rapidly.

The BsADC ecosystem has also been significantly shaped by licensing agreements. A noteworthy instance is the recent agreement between Biocytogen and SOTIO Biotech, which permits SOTIO to license several bispecific antibodies produced by Biocytogen utilizing its exclusive RenLite® platform in order to produce next-generation ADCs using its exclusive ADC platform. These types of partnerships enable the pooling  of resources and expertise, which could accelerate the progression of promising treatments through the development stages. 

Collaborations in clinical trials are becoming another significant trend, especially to investigate combination of drugs. Pharmaceutical companies are increasingly recognizing the potential of BsADCs to synergize with other treatment modalities, such as checkpoint inhibitors or targeted therapies. A clinical trial partnership and supply agreement has been signed by Xuanzhu Biopharma and Innovent Bio to assess the efficacy of KM-501 (anti-HER2 BsADC) in combination with Sintilimab, an anti-PD-1 monoclonal antibody, for the treatment of solid tumors. These clinical trials collaborations may open up new avenues for treatment and expand the number of patients who can be treated with BsADC therapies.

As regulatory agencies become more familiar with BsADCs, an increasing number of candidates are receiving clearance to enter clinical trials. Doma Bio announced in July and August of 2024 that the US FDA had approved their BsADC candidates, DM001 and DM005, to begin phase I clinical studies for solid tumors. It is anticipated that this trend will pick up speed in the upcoming years, resulting in a more sizable pipeline of BsADCs undergoing active clinical development.

Companies are vying for patents to safeguard their technological breakthroughs, which is adding complexity to the already sophisticated intellectual property landscape surrounding BsADCs. For example, the United States Patent and Trademark Office (USPTO) has granted a patent to Biocytogen for their independently created RenLite® completely human common light chain mouse platform, which the company has utilized to generate BsADCs.

Looking ahead, as more candidates advance through clinical development, the BsADC market is expected to experience substantial growth. The results of ongoing and upcoming late-stage clinical trials will play a pivotal role in determining the regulatory outlook and investor confidence surrounding this new drug class. As the BsADC field evolves, it is likely to see further specialization and diversification. Some companies may focus on developing platforms technologies for BsADC development, while others concentrate on advancing candidates for specific indications or targeting combinations. This diversity may result in a thriving ecosystem of players, each contributing uniquely to the advancement of BsADC therapeutics.

Neeraj Chawla
                    Research Head
                    Kuick Research
                    neeraj@kuickresearch.com
                    https://www.kuickresearch.com