Global experts Dr. Rosenberg and Dr. Tatalick predict 30 new 피망 바카라 drugs in the next decade

[by Ji, Yong Jun] Antibody-drug conjugates (ADCs) are experiencing a 'renaissance,' driven by growing interest and expectations in the field. The number of new ADCs entering clinical trials continues to reach unprecedented levels, reflecting continued innovation in the field. In particular, ADCs have shown promising therapeutic results in the treatment of refractory cancers such as ovarian cancer and metastatic urothelial carcinoma, where chemotherapy was previously the only option.

The 피망 바카라 ‘ENHERTU,’ developed for the treatment of breast cancer, has given patients new hope of overcoming cancer by demonstrating efficacy independent of human epidermal growth factor receptor 2 (HER2) expression. Similarly, ‘P피망 바카라EV,’ a new 피망 바카라 targeting neptin-4, has become the first-line treatment for metastatic urothelial cancer, the first in three decades.

The ‘피망 바카라 craze’ is substantiated by data. According to Beacon, a British life science research institute operated by Hanson Wade, the oncology sector currently comprises a total of 1,402 피망 바카라 assets. This makes 피망 바카라s the sixth largest category of therapeutic assets, following small molecules, chimeric antigen receptor T (CAR-T) cells, and bispecific antibodies.

Notably, preclinical 피망 바카라 assets represent the third largest category after small molecules and bispecific antibodies. Given that 피망 바카라 development gained significant momentum in 2015, despite its initial introduction in 1997, the field has witnessed remarkable growth in just 10 years. This rapid progress is underlined by the fact that 70 피망 바카라 candidates entered clinical trials last year alone, an increase of 15 from the 55 recorded in 2023. The pharmaceutical and biotechnology industries are closely monitoring the trajectory of 피망 바카라 expansion and its potential future impact.

On March 13, <THE BIO conducted an interview at ABL Bio’s headquarters with Dr. Morris Rosenberg and Dr. Laurie Tatalick, internationally recognized experts in the 피망 바카라 field, to discuss their views on the reason behind the growing prominence of 피망 바카라s, their current development status, and future prospects. Dr. Rosenberg has played a pivotal role in 피망 바카라 research, having contributed to the development of 피망 바카라s at Seagen (formerly Seattle Genetics) and Immunomedics, where he led the development and commercialization of ‘TRODELVY’ and ‘피망 바카라ETRIS.’ Dr. Tatalick, founder of ProfoundBio, is a veterinary pathologist and scientist with extensive expertise in non-clinical drug development.

The key message from Dr. Rosenberg and Dr. Tatalick regarding 피망 바카라 development was clear: the field is poised for significant expansion. Both experts emphasized that, with 13 피망 바카라s currently approved by the U.S. Food and Drug Administration (FDA), the next decade is expected to witness the emergence of additional 피망 바카라s and have the potential to extend beyond their current focus on solid tumors. Dr. Tatalick, in particular, expressed confidence that at least 30 to 50 new 피망 바카라 assets will receive regulatory approval within the next 10 years. Below is a Q&A session with the two experts.

◇Investment and innovation: Advancing 피망 바카라 development

-How has 피망 바카라 development progressed in recent years?

▶Rosenberg: The approval of TRODELVY and 피망 바카라ETRIS has significantly increased interest in 피망 바카라s, leading to a surge in funding and fostering innovation within the field. In recent years, one notable development has been the rapid introduction of ‘bispecific 피망 바카라s,’ a technology that, while rare just five years ago, has seen many new 피망 바카라 candidates enter clinical trials. Another emerging trend is the advancement of ‘dual payload’ technologies, which, despite being studied for the past 20 years, have only recently started to show substantial progress. Several dual payload 피망 바카라s are expected to enter clinical trials in the coming years. These innovations exemplify the positive impact of investment in the field, with even newer technologies anticipated to enter clinical trials in the near future.

▶Tatalick: 피망 바카라s are composed of an antibody linked to a cytotoxic payload via a “linker” molecule. The design of linkers has evolved rapidly, particularly addressing the issues observed in early-generation 피망 바카라s, where toxins would detach from the antibody too quickly, causing toxicity. Currently, many companies are developing novel binding methods that significantly mitigate these toxic effects. Furthermore, the expiration of patents on early linkers and payloads has made these components available for use in targeting other molecules, thus expanding the potential applications of 피망 바카라s.

-What is the key difference between 피망 바카라s and traditional chemotherapy?

▶Rosenberg: The fundamental difference between 피망 바카라s and traditional chemotherapy lies in the ability of 피망 바카라s to specifically target and deliver potent cytotoxic agents directly to tumor cells. Traditional chemotherapy lacks this targeting capability. Since its early days, 피망 바카라s were often referred to as a ‘magic bullet,’ designed to deliver toxic substances specifically to cancer cells, and this concept is now becoming a reality with various approved treatments.

▶Tatalick: While ADCs that use established chemotherapy drugs are intriguing, the true innovation lies in the technology’s expansion to target specific cells for a broader range of diseases. Currently, most ADCs are focused on cancer treatment, but over the next five years, we can expect a significant expansion into other medical areas. This will enable more precise drug delivery, reducing toxicity while enhancing therapeutic efficacy. The most exciting potential for growth in ADC technology is its application beyond oncology.

◇“Following ENHERTU and P피망 바카라EV, another ‘blockbuster’ 피망 바카라 is on the horizon”

-Which cancer types are currently the focus of the most active 피망 바카라 development?

▶Rosenberg: 피망 바카라s are being actively developed for a wide range of solid tumors. While the first two approved 피망 바카라s were for blood cancers, recent approvals have been concentrated on breast and ovarian cancers. Currently, 피망 바카라s are being developed for various solid cancers, including lung cancer, breast cancer, ovarian cancer, and colon cancer. The number of 피망 바카라 approvals for these and other solid cancers is expected to rise significantly in the coming years.

-There appears to be a clear trend in recent years, with global pharmaceutical companies increasing their investment in 피망 바카라s.

▶Rosenberg: There remains a substantial unmet clinical need in various diseases and solid tumor types. For instance, there is considerable market potential for 피망 바카라s, especially those used in combination with immune checkpoint inhibitors or other therapies, to progress from second- or third-line treatments to frontline options. This growing opportunity is driving significant investment in the field.

-What are your thoughts on the potential for 피망 바카라s to become blockbuster drugs?

▶Rosenberg: I believe that additional blockbuster 피망 바카라s will enter the market in the next 5 to 7 years, targeting cancers such as lung cancer, colorectal cancer, and head and neck cancer. There remains considerable opportunity in this field. Both P피망 바카라EV and ‘ELAHERE’ are showing gradual improvements in clinical trials. In the future, new second- and third-generation drugs targeting the same molecules may emerge, potentially becoming ‘super blockbusters’ or further expanding the market, thereby capturing market share.

-How do you foresee the development of the 피망 바카라 market and technology over the next 10 years?

▶Tatalick: I anticipate significant growth in the 피망 바카라 market over the next decade, with several additional 피망 바카라s gaining approval. Currently, there are approximately 13 approved 피망 바카라s, and we can expect ongoing innovation in linkers, payloads, and targets. While cancer will remain a primary focus, the applications of 피망 바카라s will likely expand into other treatment areas. It’s possible that the ‘D (Drug)’ component of 피망 바카라s may shift away from cytotoxic substances to molecules with different functions. This expansion could extend to chronic diseases, offering a broader market. Over the next 10 years, it’s projected that an additional 3,050 피망 바카라s will be approved for clinical use. With more than 100 피망 바카라s currently in clinical development, and this number steadily increasing every year, even if only 10% of them are successful, it will still represent a significant advancement.

◇Key considerations from 피망 바카라 non-clinical development to commercialization

-What are the key considerations in 피망 바카라 nonclinical development?

▶Tatalick: In non-clinical development, there are three key areas to consider. First, ‘pharmacology’ research is crucial to understand how the drug is activated. Second, ‘pharmacodynamics’ studies are necessary to assess how the drug interacts with animals or humans upon exposure. Lastly, ‘toxicology’ research is essential to evaluate the potential for side effects. These foundational studies help shape the design of clinical trials, ensuring that the drug is developed safely and effectively.

-Is managing toxicity the most important aspect of nonclinical development?

▶Tatalick: The key consideration is the ‘therapeutic window,’ which refers to the difference between the effective dose and the toxic dose of the drug. The goal is to maximize the therapeutic effect while minimizing side effects.

-What are the key points for an effective commercialization strategy?

▶Tatalick: For serious diseases with limited life expectancies, it is crucial to pursue strategies that enable receiving ‘Fast Track’ or ‘Breakthrough Therapy’ designation from regulatory authorities. These designations allow for expedited progress from early clinical trials to registration and approval trials. At the same time, efforts should be made to scale up production, establish the supply chain, and prepare the necessary Biologics License Application (BLA) for approval.

▶Rosenberg: Once approval is granted, it is essential to invite all relevant regulatory agencies to review the data and processes. Following this, a large team should be assembled to handle marketing and sales, engage with clinicians, and provide education to both patients and clinicians. In fact, the post-launch phase can involve more work than the development process itself. While development progresses gradually over several years, the post-launch phase is marked by rapid changes in a short amount of time.