- Data from dose escalation study for CRB-701, a Nectin-4 ADC to treat solid tumors, on track for release in early 2024 along with start of
U.S. /EU Study - IND Submission for CRB-601, an αvβ8 Monoclonal Antibody to treat solid tumors, on track for Q4 2023
- Pre-clinical data for CRB-913, a peripherally restricted CB1 inverse agonist, published in Obesity and presented at Obesity Week
“The third quarter was a productive period for Corbus as data was presented for each of our three programs at relevant scientific conferences” said
Key Corporate and Program Updates:
- CRB-701 next generation Nectin-4 ADC
- The Phase 1 clinical trial with CRB-701 targeting Nectin-4 positive solid tumors is recruiting dose level 6 and is ongoing in
China . Early clinical experience will be shared in Q1 2024, which will coincide with the initiation of aU.S. /EU trial by Corbus. CRB-701 is designed to achieve an improved therapeutic index relative to PADCEV® (SeaGen/Astellas) and will be explored in urothelial cancer and other solid tumors. - Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The Nectin-4 ADC PADCEV® is approved for use in late metastatic urothelial cancer and recently received an expanded label from the
Food and Drug Administration based on accelerated approval for use in combination with KEYTRUDA® for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. - The first data characterizing the pre-clinical validation of CRB-701 was presented at the 2023
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics .- The poster, Development of CRB-701 (SYS6002): A novel site-specific Nectin-4 targeting ADC, provided an overview of the pre-clinical development and validation of the differentiating features of CRB-701, including site specific conjugation chemistry, a stable linker that leads to low payload release, and a novel Nectin-4 targeting monoclonal antibody with improved speed of internalization.
- The pre-clinical safety profile supports dosing at higher ADC exposures relative to enfortumab vedotin (PADCEV®).
- The poster, Development of CRB-701 (SYS6002): A novel site-specific Nectin-4 targeting ADC, provided an overview of the pre-clinical development and validation of the differentiating features of CRB-701, including site specific conjugation chemistry, a stable linker that leads to low payload release, and a novel Nectin-4 targeting monoclonal antibody with improved speed of internalization.
- The potential of CRB-701 was further highlighted in a “Meet the Expert” webinar hosted by Corbus that featured several notable oncology experts:
Daniel P. Petrylak , MD (Genitourinary,Yale School of Medicine ),Ari Rosenberg , MD (Head and Neck,University of Chicago ),Alexander Spira , MD, PhD, FACP (NSCLC,Virginia Cancer Specialists ), andParaic Kenny , PhD (Breast cancer, Translational Expert,Kabara Cancer Research Institute ).
- The Phase 1 clinical trial with CRB-701 targeting Nectin-4 positive solid tumors is recruiting dose level 6 and is ongoing in
- CRB-601 Anti- αvβ8 mAb blocking the activation of TGFβ expressed on cancer cells
- Corbus presented two posters at the 38th Annual Meeting of the
Society for Immunotherapy of Cancer (SITC) held onNovember 1 - 5, 2023 .- CRB-601, an integrin αvβ8 blocking antibody entering Phase I: pre-clinical and translational biomarkers for indication selection - which demonstrates anti-tumor activity, immunological changes, and biomarkers of response in mouse models. Results demonstrate the importance of protein detection of the integrin avb8 in selecting disease indications and that in both MC38 and EMT6 models tumor growth inhibition correlated with immune cell penetration into the tumor microenvironment.
- CRB-601, a selective integrin αvβ8-blocking antibody, prevents TGFβ activation, promotes immune cell remodeling, and exhibits potent antitumor activity – which assessed tumor growth inhibition of CRB-601+/- anti PD-1 in three tumor models, MC38, EMT6, and 4T1. Results showed CRB-601 advances immunotherapeutic strategies by antagonizing integrin αvβ8 and enhancing the efficacy of immune checkpoint inhibitors in vivo. This combination reveals the potential of such synergistic strategies in strengthening anti-tumor immunological responses, thereby emphasizing the promise of this combinatorial approach in advancing the domain of immunotherapy.
- The IND submission for CRB-601 is on track for the fourth quarter of 2023.
- Corbus presented two posters at the 38th Annual Meeting of the
- CRB-913 a highly peripherally restricted CB1 inverse agonist for the treatment of obesity
- A pre-clinical study was selected for an oral presentation and as a late breaking poster at the 2023
Obesity Week Conference held onOctober 14-17, 2023 . In addition, the study was just published in the November edition of Obesity, the scientific journal ofThe Obesity Society .- In this study, CRB-913, a highly peripherally restricted cannabinoid type-1 receptor (CB1) inverse agonist for the treatment of obesity, was evaluated as monotherapy and in combination with incretin analogs (tirzepatide, semaglutide, or liraglutide) in a diet induced-obesity (DIO) mouse model. CRB-913 demonstrated enhanced plasma exposure and a markedly reduced concentration in the brain compared to the first generation CB1 inverse agonist rimonabant. CRB-913 monotherapy yielded dose-dependent decrease in body weight in DIO mice that was further decreased in combination with tirzepatide, semaglutide, or liraglutide. Concomitantly, improvements were observed in body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and liver histology. All changes were statistically significant. Importantly, CRB-913 did not induce loss of lean muscle mass, a harmful phenomenon associated with incretin analogs.
- The authors of the publication concluded that CRB-913, in combination with incretin analogs, could potentially deliver meaningful improvements in obesity and related conditions.
- In this study, CRB-913, a highly peripherally restricted cannabinoid type-1 receptor (CB1) inverse agonist for the treatment of obesity, was evaluated as monotherapy and in combination with incretin analogs (tirzepatide, semaglutide, or liraglutide) in a diet induced-obesity (DIO) mouse model. CRB-913 demonstrated enhanced plasma exposure and a markedly reduced concentration in the brain compared to the first generation CB1 inverse agonist rimonabant. CRB-913 monotherapy yielded dose-dependent decrease in body weight in DIO mice that was further decreased in combination with tirzepatide, semaglutide, or liraglutide. Concomitantly, improvements were observed in body fat content, leptinemia, insulin resistance, liver triglycerides, liver fat deposits, and liver histology. All changes were statistically significant. Importantly, CRB-913 did not induce loss of lean muscle mass, a harmful phenomenon associated with incretin analogs.
- A pre-clinical study was selected for an oral presentation and as a late breaking poster at the 2023
Financial Results for Quarter Ended
The Company reported a net loss of approximately
Operating expenses increased by
About Corbus
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's restructuring, trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the
INVESTOR CONTACT:
Chief Financial Officer
smoran@corbuspharma.com
Managing Director
bmackle@lifesciadvisors.com
Condensed Consolidated Balance Sheets (Unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 11,248,806 | $ | 17,002,715 | ||||
Investments | 17,484,437 | 42,194,296 | ||||||
Restricted cash | 192,475 | 192,475 | ||||||
Prepaid expenses and other current assets | 2,280,255 | 791,616 | ||||||
Total current assets | 31,205,973 | 60,181,102 | ||||||
Restricted cash | 477,425 | 477,425 | ||||||
Property and equipment, net | 1,120,793 | 1,613,815 | ||||||
Operating lease right of use assets | 3,277,943 | 3,884,252 | ||||||
Other assets | 201,271 | 155,346 | ||||||
Total assets | $ | 36,283,405 | $ | 66,311,940 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Notes payable | $ | — | $ | 353,323 | ||||
Accounts payable | 4,713,532 | 2,173,963 | ||||||
Accrued expenses | 7,545,781 | 5,999,252 | ||||||
Derivative liability | 36,868 | 36,868 | ||||||
Operating lease liabilities, current | 1,396,585 | 1,280,863 | ||||||
Current portion of long-term debt | 17,849,562 | 2,795,669 | ||||||
Total current liabilities | 31,542,328 | 12,639,938 | ||||||
Long-term debt, net of debt discount | — | 15,984,426 | ||||||
License agreement payable, noncurrent | 775,000 | — | ||||||
Other long-term liabilities | 44,410 | 22,205 | ||||||
Operating lease liabilities, noncurrent | 3,610,651 | 4,675,354 | ||||||
Total liabilities | 35,972,389 | 33,321,923 | ||||||
Stockholders’ equity | ||||||||
Preferred stock, | — | — | ||||||
Common stock, 4,423,683 and 4,171,297 shares issued and outstanding at | 442 | 417 | ||||||
Additional paid-in capital | 428,981,198 | 425,196,359 | ||||||
Accumulated deficit | (428,662,589 | ) | (392,080,667 | ) | ||||
Accumulated other comprehensive loss | (8,035 | ) | (126,092 | ) | ||||
Total stockholders’ equity | 311,016 | 32,990,017 | ||||||
Total liabilities and stockholders’ equity | $ | 36,283,405 | $ | 66,311,940 |
Condensed Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
(Unaudited) | ||||||||||||||||
For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 6,550,496 | $ | 4,108,190 | $ | 24,187,544 | $ | 9,894,068 | ||||||||
General and administrative | 2,937,442 | 4,073,266 | 10,786,410 | 14,144,557 | ||||||||||||
Litigation settlement | — | — | — | 5,000,000 | ||||||||||||
Total operating expenses | 9,487,938 | 8,181,456 | 34,973,954 | 29,038,625 | ||||||||||||
Operating loss | (9,487,938 | ) | (8,181,456 | ) | (34,973,954 | ) | (29,038,625 | ) | ||||||||
Other expense, net: | ||||||||||||||||
Other income (expense), net | 217,545 | 77,712 | 629,709 | (324,322 | ) | |||||||||||
Interest expense, net | (763,356 | ) | (541,889 | ) | (2,216,964 | ) | (1,491,137 | ) | ||||||||
Foreign currency exchange loss, net | (19,520 | ) | (136,087 | ) | (20,713 | ) | (613,766 | ) | ||||||||
Other expense, net | (565,331 | ) | (600,264 | ) | (1,607,968 | ) | (2,429,225 | ) | ||||||||
Net loss | $ | (10,053,269 | ) | $ | (8,781,720 | ) | $ | (36,581,922 | ) | $ | (31,467,850 | ) | ||||
Net loss per share, basic and diluted | $ | (2.27 | ) | $ | (2.11 | ) | $ | (8.52 | ) | $ | (7.55 | ) | ||||
Weighted average number of common shares outstanding, basic and diluted | 4,423,617 | 4,170,881 | 4,295,178 | 4,170,466 | ||||||||||||
Comprehensive loss: | ||||||||||||||||
Net loss | $ | (10,053,269 | ) | $ | (8,781,720 | ) | $ | (36,581,922 | ) | $ | (31,467,850 | ) | ||||
Other comprehensive income (loss): | ||||||||||||||||
Change in unrealized gain (loss) on marketable debt securities | 15,753 | (87,554 | ) | 118,057 | (144,429 | ) | ||||||||||
Total other comprehensive income (loss) | 15,753 | (87,554 | ) | 118,057 | (144,429 | ) | ||||||||||
Total comprehensive loss | $ | (10,037,516 | ) | $ | (8,869,274 | ) | $ | (36,463,865 | ) | $ | (31,612,279 | ) |
Source:
2023 GlobeNewswire, Inc., source