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Global CD276 Antibody Clinical Trials & Market Sales Forecast 2028

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    Report

  • 129 Pages
  • February 2023
  • Region: Global
  • Kuick Research
  • ID: 5739925

Report Highlights:

  •  Global CD276 Antibody Market Opportunity Assessment: > US$ 1 Billion
  • Global CD276 Antibody Expected Drug Approvals
  • Global CD276 Antibody Clinical Trials: > 30 Drugs In Trials 
  • Targeting CD276 Through Monotherapy, Combination & Targeted Therapy 
  • CD276 Antibodies Orphan & Priority Status Review
  • CD276 Antibody Clinical Trials By Company, Indication & Phase
  •  Insight On 25 Companies Involved in the Development of CD276 Antibodies

In the race to find a new therapeutic approach to cancer treatment, the pharmaceutical industry has been on the search for novel therapeutic modalities. Scavenging different targets that can fill a significant gap left by existing approaches has led to the discovery of another possible cancer immunotherapy target, CD276 or B7-H3 (B7 homolog 3 protein). This recently discovered immune checkpoint target has been turning heads in the pharma sector due to its association with tumorigenesis. With consistent innovations, the competition increases for developing techniques and technologies that will streamline and put biotech companies in the leading position for the drug discovery process.

Immune checkpoint inhibitors have been a novel therapeutic strategy that has proven to be the most successful in comparison to other immunotherapeutic approaches. After the introduction of PD-1 and CTLA-4 immune checkpoint inhibitors, there has been the question of what’s next. Researchers all over the world have constantly been addressing the demand for the discovery of the next big “magic drug” that the payers have been asking for. Vigorous research in the field, conducted over the years to discern more immune checkpoint targets has allowed the discovery of CD276.

Pharmaceutical companies have been accepting a dense and fast-evolving portfolio of regulations that have varied widely so as to move towards and together with the forwarding global standards. Even with little understanding of the therapeutic potential and physiological function of CD276, companies have been speeding up their drug approaches. This is where innovation and creative strategies play their part, with multinationals making future-proof regulation techniques and anticipating changes while also understanding the difference of requirements from market to market, they are steadily moving up this market of CD276 immune checkpoint inhibitors.

Now, as the researchers have been aiming to decipher the full potential of CD276, promising outcomes are also visible in the pre-clinical and clinical studies. For instance, Daiichi Sankyo’s CD276-directed DXd antibody-drug conjugate (ADC) DS-7300 is being developed in collaboration with Sarah Cannon Research Institute. The first-in-human data from its clinical study has shown promising early clinical activity in patients with several types of advanced solid tumors.

To date, there has been no CD276-directed therapies approved by the FDA for any kind of cancer treatment. But with CD276 gaining attention as an alternative target, it has been riding the prosperous wave of immune checkpoints in cancer immunotherapy. The market of CD276 directed inhibitors has faced some ups and downs over the years, for instance, up until mid of 2022, Omburtamab with iodine 131 (I- Omburtamab) was leading the clinical research and its developing company, YmAb Therapeutics also filled for Biologics License application, however, the US FDA rejected the BLA application on the basis that there was not enough evidence to support the drug’s overall survival benefit in the patient population.  Even with a minor setback, the company is still vigorously investigating to explore the use of Omburtamab in combination with other anti-cancer therapeutics. 

Being a unique and exceptionally different approach, the first drug to be approved in the market can be considered to dominate and overrule this market segment for a long period of time. Acting as a catalyst, the first approval might push forward the clinical pipeline for other drugs but for now, it can only be anticipated and guessed what more opportunities and windows this untouched market segment will bring. If compared to the success of the first approved immune checkpoint inhibitor, Ipilimumab, it is undoubtedly a possibility, that the market will witness the same blow as it did when Ipilimumab was launched.

Meanwhile, there are several drug candidates that have been steadily moving forward in their respective clinical trials hoping to be the first approved CD276 inhibitor. It is only a matter of time before a targeted drug therapy enters the commercial market but can be easily predicted that the marketed drug will certainly have an upper edge. Additionally, the combinational approach adopted by the industry and targeting several cancer indications can further help in market penetration and unleash astounding anti-cancer effects. Current leaders in the CD276 targeted checkpoint inhibitors include; Daiichi Sankyo, YmAb Therapeutics, AbbVie, BioAtla, Fate Therapeutics, MacroGenics, and several others.

There seems to be a growing emergence of CD276 therapies with initial sales of the first therapy to reach around US$ 100- US$150 Million during the initial 12 months of commercialization. Moreover, after the first approval, 2-3 more drugs can also be anticipated to enter the market in 4-5 years further increasing the market value by US$1 Billion in the next 5 years. this report sheds light on the growing potential of CD276 immune checkpoint inhibitors and why has it been the center of scientific development while also providing information on the currently ongoing clinical trials and the progress they have made in the field. Through this report, an understanding of the strategic initiatives taken by each leading company can be understood while also identifying potential new partners in the target market.

Table of Contents

1. CD276 - Emergence Of A New Era Of Immunotherapy

2. Introduction To CD276 Inhibitors
2.1 Role In Cancer Progression
2.2 The Need To Inhibit B7-H3/CD276

3. Clinical Approaches To Target CD276
3.1 Monoclonal Antibodies Against CD276
3.2 CAR-T Cell Therapy Against CD276
3.3 Multispecific (Bispecific & Trispecific) Antibodies & Killer Engagers Against CD276
3.4 Antibody Drug Conjugates Against CD276
3.5 Small Molecule Inhibitors Of CD276

4. Targeting CD276 As A Strategy For Cancer Treatment
4.1 As Targeted Therapy
4.2 As Monotherapy
4.3 As Combination Therapy

5. Global CD276 Antibody Market Assessment 2028
5.1 Expected Drug Approvals & Sales Assessment
5.2 Future Market Trend Analysis

6. FDA & EMA Designations In Promoting Development Of CD276 Antibody
6.1 Orphan Drug Designation
6.2 Priority Review

7. Global CD276 Antibody Clinical Trials Overview
7.1 By Company
7.2 By Country
7.3 By Indication
7.4 By Patient Segment
7.5 By Phase

8. Global CD276 Antibody Clinical Trials By Company, Indication & Phase
8.1 Research
8.2 Preclinical
8.3 Phase-I
8.4 Phase-I/II
8.5 Phase-II
8.6 Phase-II/III
8.7 Preregistration

9. Global CD276 Inhibitors Market Dynamics
9.1 Drivers & Opportunities
9.2 Challenges & Restraints

10. Competitive Landscape
10.1 Aleta Biotherapeutics
10.2 Antengene Corporation
10.3 Beijing Biocytogen
10.4 Beijing Mabworks Biotech
10.5 BioAtla
10.6 Bio-Thera Solutions
10.7 BoYuan RunSheng Pharma
10.8 Daiichi Sankyo Company
10.9 Elpis Biopharmaceuticals
10.10 Fate Therapeutics
10.11 I-MAB Biopharma
10.12 Innate Pharma
10.13 Invenra
10.14 MacroGenics
10.15 Memorial Sloan-Kettering Cancer Center
10.16 Minghui Pharmaceutical (Shanghai)
10.17 Nanjing Kati Medical Technology
10.18 PersonGen Biotherapeutics
10.19 Radiopharm Ventures
10.20 Seattle Childrens Therapeutics
10.21 Shanghai Hansoh Biomedical
10.22 Shattuck Labs
10.23 Takeda
10.24 TC BioPharm
10.25 TrueBinding
10.26 University Of Minnesota
10.27 Xencor
10.28 Y-Biologics

List of Figures
Figure 1-1: Global - Estimated Newl Cancer Cases & Deaths (Millions), 2020 & 2040
Figure 2-1: Role of CD276 With Respect To Cancer Cells
Figure 2-2: Role of CD276 With Respect To Cancer Tumor
Figure 2-3: B7-H3 Pathways & Their Effects
Figure 3-1: General Mechanism of Action Of Radiolabeled Antibodies
Figure 3-2: Mechanism of Action Of Blocking Monoclonal Antibodies
Figure 3-3: Mechanism of Action Of CD276 Directed CAR T Therapy
Figure 3-4: Mechanism of Action Of CD276 Directed Bispecific Antibody
Figure 3-5: Mechanism of Action Of CD276 Directed Bispecific NK Cell Engager
Figure 3-6: Mechanism of Action Of CD276 Directed Antibody Drug Conjugate
Figure 3-7: Mechanism of Action Of CD276 Directed Small Molecule Inhibitor
Figure 5-1: Global - First CD276 Antibody Sales Estimates After Approval (2024/2025)
Figure 5-2: Global - CD276 Antibody Sales Estimates (Million), 2028
Figure 6-1: Benefits Associated With FDA Orphan Drug Designation
Figure 6-2: Benefits Of PRIME Designation
Figure 7-1: Global -CD276 Antibody Clinical Pipeline By Company, 2023 till 2028
Figure 7-2: Global -CD276 Antibody Clinical Pipeline By Country, 2023 till 2028
Figure 7-3: Global -CD276 Antibody Clinical Pipeline By Indication, 2023 till 2028
Figure 7-4: Global - CD276 Antibody Clinical Pipeline By Patient Segment, 2023 till 2028
Figure 7-5: Global -CD276 Antibody Clinical Pipeline By Phase, 2023 till 2028
Figure 7-6: Global -CD276 Antibody Clinical Pipeline By Patient Segment, 2023 till 2028
Figure 9-1: Drivers & Opportunities In The CD276 Inhibitors Market
Figure 9-2: Challenges & Restraints Of The CD276 Inhibitors Market

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Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Aleta Biotherapeutics
  • Antengene Corporation
  • Beijing Biocytogen
  • Beijing Mabworks Biotech
  • BioAtla
  • Bio-Thera Solutions
  • BoYuan RunSheng Pharma
  • Daiichi Sankyo Company
  • Elpis Biopharmaceuticals
  • Fate Therapeutics
  • I-MAB Biopharma
  • Innate Pharma
  • Invenra
  • MacroGenics
  • Memorial Sloan-Kettering Cancer Center
  • Minghui Pharmaceutical (Shanghai)
  • Nanjing Kati Medical Technology
  • PersonGen Biotherapeutics
  • Radiopharm Ventures
  • Seattle Childrens Therapeutics
  • Shanghai Hansoh Biomedical
  • Shattuck Labs
  • Takeda
  • TC BioPharm
  • TrueBinding
  • University Of Minnesota
  • Xencor
  • Y-Biologics