Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2024
Ivonescimab Monotherapy Achieved Statistically Significant & Clinically Meaningful Improvement over Pembrolizumab Monotherapy Head-to-Head in HARMONi-2 Phase III Trial in 1L Advanced NSCLC
Positive HARMONi-A Data Featured at ASCO and Published in JAMA Supporting Ivonescimab's First Regulatory Approval in
HARMONi and HARMONi-3 Enrollment Continues with HARMONi Planned to Complete Enrollment in Second Half of This Year
Raised
Five-Year Strategic Collaboration with MD Anderson to
Operational & Corporate Updates
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Our operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:
-
In
January 2023 , we closed our Collaboration and License Agreement with (Akeso Inc .Akeso , HKEX Code: 9926.HK) for ivonescimab (SMT112), with which over 1,800 patients have now been treated in clinical studies globally. At the initial time of the deal, Summit received rights to develop and commercialize ivonescimab inthe United States ,Canada ,Europe , andJapan .-
In
June 2024 , the agreement was amended and, as a result, expanded to also includeLatin America , includingMexico and all countries inCentral America ,South America , and theCaribbean , theMiddle East , andAfrica to Summit's license territories for ivonescimab.Akeso retains development and commercialization rights for the rest of the world, includingChina .
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In
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Since in-licensing ivonescimab, we have launched a late-stage clinical development program in non-small cell lung cancer (NSCLC) and are actively enrolling two registrational Phase III trials in the following proposed indications:
- HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC
who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI), with enrollment completion expected in the second half of 2024, and - HARMONi-3: Ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients, with the first patient having been treated in the fourth quarter of 2023.
- HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC
-
In late
May 2024 , positive results were announced from the Phase III HARMONi-A trial which were subsequently presented at the 2024 Annual Meeting of theAmerican Society of Clinical Oncology (ASCO 2024) and published in theJournal of the American Medical Association (JAMA). HARMONi-A, a single-region, randomized, double-blinded Phase III study in patients with NSCLCwho have progressed following an EGFR-TKI, achieved its primary endpoint of progression-free survival (PFS) for patients receiving ivonescimab in combination with doublet chemotherapy (pemetrexed and carboplatin). The HARMONi-A trial was conducted inChina and sponsored byAkeso with data generated and analyzed byAkeso . This is a clinical setting where PD-1 monoclonal antibodies have previously been unsuccessful in Phase III global clinical trials.-
Patients (n=322) experienced a 54% reduction in disease progression or death as compared to placebo plus doublet chemotherapy (HR: 0.46, 95% CI: 0.34 - 0.62; p<0.001). In a pre-specified subgroup PFS analysis of patients
who received a previous third-generation TKI, a hazard ratio of 0.48 was observed. The Phase III study was considered to have demonstrated a tolerable safety profile and a low discontinuation rate of ivonescimab for adverse events.
-
Patients (n=322) experienced a 54% reduction in disease progression or death as compared to placebo plus doublet chemotherapy (HR: 0.46, 95% CI: 0.34 - 0.62; p<0.001). In a pre-specified subgroup PFS analysis of patients
-
Additionally, on
May 30, 2024 ,Akeso announced that HARMONi-2, in which ivonescimab was administered as a monotherapy, resulted in a statistically significant improvement in PFS when compared to monotherapy pembrolizumab in patients with previously untreated advanced or metastatic NSCLC whose tumors had positive PD-L1 expression (PD-L1 tumor proportion score, or TPS, ≥1%). The PFS benefit was demonstrated across clinical subgroups, including those with PD-L1 low expression (PD-L1 TPS 1-49%), PD-L1 high expression (PD-L1 TPS ≥50%), squamous and non-squamous histologies, as well as other high-risk patients.-
These results are unprecedented as ivonescimab is the first known drug to achieve clinically meaningful efficacy benefit over pembrolizumab in a randomized Phase III clinical trial in NSCLC. The HARMONi-2 trial was conducted in
China and sponsored byAkeso with data generated and analyzed byAkeso . Previously,Akeso announced that it intends to release the results from this study at an upcoming medical conference later in the year.
-
These results are unprecedented as ivonescimab is the first known drug to achieve clinically meaningful efficacy benefit over pembrolizumab in a randomized Phase III clinical trial in NSCLC. The HARMONi-2 trial was conducted in
-
In
July 2024 , we announced a five-year strategic collaboration withThe University of Texas MD Anderson Cancer Center (MD Anderson) to accelerate the development of ivonescimab in several solid tumors across multiple clinical trials. Under the agreement, MD Anderson will lead multiple clinical trials to evaluate the safety and potential clinical benefit of ivonescimab, including the possibility of identifying biomarkers through additional research activities. Leveraging the clinical infrastructure and research expertise of MD Anderson, the collaboration is designed to quickly discover opportunities for ivonescimab, including several tumors outside of the current development plan. Early work may include certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer, as well as glioblastoma. -
During the quarter ended
June 30, 2024 , we also strengthened our Board of Directors with the appointment of two new members:-
In
April 2024 , the Company appointedMostafa Ronaghi , PhD, to its Board of Directors.Dr. Ronaghi is the Co-Founder and Executive Board Member of Cellanome. He was previously the Chief Technology Officer at Illumina, Inc. from 2008 to 2021. While at Illumina, in 2016,Dr. Ronaghi co-founded GRAIL, a next-gen liquid biopsy platform for cancer detection.Dr. Ronaghi holds a Ph.D. in Biotechnology fromRoyal Institute of Technology inStockholm, Sweden . -
In
June 2024 , the Company appointedJeff Huber to its Board of Directors.Mr. Huber is the Co-Founder andGeneral Partner ofTriatomic Capital Private LP , a venture capital firm. Prior to founding Triatomic,Mr. Huber was the Founding CEO and Vice Chairman ofGRAIL, Inc. Prior to GRAIL, he was a Senior Vice President at Alphabet Inc. (formerlyGoogle Inc. ).Mr. Huber holds a B.S. in Computer Engineering from theUniversity of Illinois and an M.B.A. fromHarvard Business School .
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In
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In
Financial Highlights
Cash and Cash Equivalents, Restricted Cash, & Short-term Investments
-
In
June 2024 , we received and accepted an unsolicited offer from an institutional investor to purchase 22,222,222 shares of the Company’s common stock at$9.00 per share, a premium to the closing price onFriday, May 31, 2024 , for aggregate gross and net proceeds to the Company of approximately$200.0 million .
-
On
August 6, 2024 , we intend to file a Form S-3 in order to register the above referenced 22.2 million shares that were purchased inJune 2024 .
-
Aggregate cash and cash equivalents, restricted cash, and short-term investments were
$325.8 million and$186.2 million atJune 30, 2024 andDecember 31, 2023 , respectively. Research and development tax credits were$1.3 million and$1.8 million atJune 30, 2024 andDecember 31, 2023 , respectively.
Updated Cash Guidance
- Based on the Company’s current operating plans and its existing cash, cash equivalents, and short-term investments, we updated our cash guidance. We believe we have sufficient cash to fund operations into the fourth quarter of 2025.
-
GAAP R&D expenses according to generally accepted accounting principles in the
U.S. (“GAAP”) were$30.8 million for the second quarter of 2024, compared to$9.5 million for the same period of the prior year.
-
Non-GAAP R&D expenses were
$27.3 million for the second quarter of 2024, compared to$8.8 million for the same period of the prior year.
-
GAAP Acquired IPR&D expenses were
$15.0 million for the second quarter of 2024, compared to zero for the same period of the prior year. Second quarter 2024 GAAP Acquired IPR&D expenses of$15.0 million related to our upfront consideration pursuant to theJune 2024 license agreement amendment withAkeso .
GAAP and Non-GAAP General and Administrative (G&A) Expenses
-
GAAP G&A expenses were
$14.0 million for the second quarter of 2024, compared to$6.3 million for the same period of the prior year.
-
Non-GAAP G&A expenses were
$6.4 million for the second quarter of 2024, compared to$5.2 million for the same period of the prior year.
GAAP and Non-GAAP Operating Expenses
-
GAAP operating expenses were
$59.8 million for the second quarter of 2024, compared to$15.8 million for the same period of the prior year. Second quarter 2024 GAAP R&D expenses included$15.0 million acquired in-process research and development expense related to our upfront consideration pursuant to theJune 2024 license agreement amendment withAkeso .
-
Non-GAAP operating expenses were
$33.7 million for the second quarter of 2024, compared to$13.9 million for the same period of the prior year. The increase is primarily due to expansion of clinical study and development costs related to ivonescimab and increases in people cost as we continue to build out our R&D team.
GAAP and Non-GAAP Net Loss
-
GAAP net loss in the second quarter of 2024 and 2023 was
$60.4 million or$(0.09) per basic and diluted share, and$14.7 million or$(0.02) per basic and diluted share, respectively.
-
Non-GAAP net loss in the second quarter of 2024 and 2023 was
$34.3 million or$(0.05) per basic and diluted share, and$12.8 million or$(0.02) per basic and diluted share, respectively.
Use of Non-GAAP Financial Measures
This release includes measures that are not in accordance with
Second Quarter 2024 Earnings Call
Summit will host an earnings call this morning,
About Ivonescimab
Ivonescimab, known as SMT112 in Summit’s license territories,
This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC, 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et. al., SITC, 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.
Ivonescimab was engineered by
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3.
HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC
HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.
In addition,
HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC
HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including
About
Lung cancer is believed to impact approximately 600,000 people across
About
Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol "SMMT"). We are headquartered in
For more information, please visit https://www.smmttx.com and follow us on X @summitplc.
Summit Forward-looking Statements
Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with
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GAAP Condensed Consolidated Statements of Operations |
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(Unaudited) |
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(in millions, except per share data) |
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|
|
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Three Months Ended
|
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Six Months Ended
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2024 |
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2023 |
|
2024 |
|
2023 |
||||||||
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Research and development |
$ |
30.8 |
|
|
$ |
9.5 |
|
|
$ |
61.7 |
|
|
$ |
19.3 |
|
|
Acquired in-process research and development |
|
15.0 |
|
|
|
— |
|
|
|
15.0 |
|
|
|
520.9 |
|
|
General and administrative |
|
14.0 |
|
|
|
6.3 |
|
|
|
25.7 |
|
|
|
13.3 |
|
|
Total operating expenses |
|
59.8 |
|
|
|
15.8 |
|
|
|
102.4 |
|
|
|
553.5 |
|
|
Other operating income, net |
|
0.2 |
|
|
|
0.0 |
|
|
|
0.4 |
|
|
|
0.6 |
|
|
Operating loss |
|
(59.6 |
) |
|
|
(15.8 |
) |
|
|
(102.0 |
) |
|
|
(552.9 |
) |
|
Other (expense) income, net |
|
(0.8 |
) |
|
|
1.1 |
|
|
|
(1.9 |
) |
|
|
(4.1 |
) |
|
Net loss |
$ |
(60.4 |
) |
|
$ |
(14.7 |
) |
|
$ |
(103.9 |
) |
|
$ |
(557.0 |
) |
|
|
|
|
|
|
|
|
|
|||||||||
Net loss per share attributable to common shareholders per share, basic and diluted |
$ |
(0.09 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.15 |
) |
|
$ |
(1.03 |
) |
|
|
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GAAP Condensed Consolidated Balance Sheet Information |
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(in millions) |
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|
|
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||
|
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Unaudited
|
|
|
||
Cash and cash equivalents, restricted cash, and short-term investments |
|
$ |
325.8 |
|
$ |
186.2 |
Total assets |
|
$ |
341.9 |
|
$ |
202.9 |
Total liabilities |
|
$ |
146.8 |
|
$ |
125.3 |
Total stockholders' equity |
|
$ |
195.1 |
|
$ |
77.7 |
|
||||||||
GAAP Condensed Consolidated Statement of Cash Flows Information |
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(in millions) |
||||||||
|
|
|
||||||
|
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Unaudited |
||||||
|
|
Six Months Ended |
||||||
|
|
2024 |
|
2023 |
||||
Net cash used in operating activities |
|
$ |
(63.1 |
) |
|
$ |
(42.4 |
) |
Net cash used in investing activities |
|
|
(180.2 |
) |
|
|
(644.9 |
) |
Net cash provided by financing activities |
|
|
200.7 |
|
|
|
80.0 |
|
Effect of exchange rate changes on cash |
|
|
— |
|
|
|
0.7 |
|
Decrease in cash and cash equivalents |
|
$ |
(42.6 |
) |
|
$ |
(606.6 |
) |
|
||||||||||||||||
Schedule Reconciling Selected Non-GAAP Financial Measures |
||||||||||||||||
(Unaudited) |
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(in millions, except per share data) |
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|
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|
|||||||||||||
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Three Months Ended
|
Six Months Ended
|
||||||||||||||
|
2024 |
2023 |
2024 |
2023 |
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Reconciliation of GAAP to |
|
|
|
|
||||||||||||
|
$ |
30.8 |
|
$ |
9.5 |
|
$ |
61.7 |
|
$ |
19.3 |
|
||||
Stock-based compensation (Note 1) |
|
(3.5 |
) |
|
(0.7 |
) |
|
(5.9 |
) |
|
(1.8 |
) |
||||
|
$ |
27.3 |
|
$ |
8.8 |
|
$ |
55.8 |
|
$ |
17.5 |
|
||||
|
|
|
|
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Reconciliation of GAAP to Non-GAAP General and Administrative Expenses |
|
|
|
|
||||||||||||
GAAP General and administrative |
$ |
14.0 |
|
$ |
6.3 |
|
$ |
25.7 |
|
$ |
13.3 |
|
||||
Stock-based compensation (Note 1) |
|
(7.6 |
) |
|
(1.1 |
) |
|
(14.7 |
) |
|
(2.8 |
) |
||||
Non-GAAP General and administrative |
$ |
6.4 |
|
$ |
5.2 |
|
$ |
11.0 |
|
$ |
10.5 |
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|
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|
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Reconciliation of GAAP to |
|
|
|
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GAAP Acquired In-process research and development |
$ |
15.0 |
|
$ |
— |
|
$ |
15.0 |
|
$ |
520.9 |
|
||||
Acquired In-process research and development (Note 2) |
|
(15.0 |
) |
|
— |
|
|
(15.0 |
) |
|
(520.9 |
) |
||||
Non-GAAP Acquired In-process research and development |
$ |
— |
|
$ |
— |
|
$ |
— |
|
$ |
— |
|
||||
|
|
|
|
|
||||||||||||
Reconciliation of GAAP Net Loss to Non-GAAP Net Loss |
|
|
|
|
||||||||||||
GAAP Net Loss |
$ |
(60.4 |
) |
$ |
(14.7 |
) |
$ |
(103.9 |
) |
$ |
(557.0 |
) |
||||
Stock-based compensation (Note 1) |
|
11.1 |
|
|
1.9 |
|
|
20.6 |
|
|
4.6 |
|
||||
Acquired In-process research and development (Note 2) |
|
15.0 |
|
|
— |
|
|
15.0 |
|
|
520.9 |
|
||||
Non-GAAP Net Loss |
$ |
(34.3 |
) |
$ |
(12.8 |
) |
$ |
(68.3 |
) |
$ |
(31.5 |
) |
||||
|
|
|
|
|
||||||||||||
Reconciliation of GAAP Net Loss to Non-GAAP Net Loss Per Common Share |
|
|
|
|
||||||||||||
GAAP Net Loss Per Basic and Diluted Common Share |
$ |
(0.09 |
) |
$ |
(0.02 |
) |
$ |
(0.15 |
) |
$ |
(1.03 |
) |
||||
Stock-based compensation (Note 1) |
|
0.02 |
|
|
— |
|
|
0.03 |
|
|
0.01 |
|
||||
Acquired In-process research and development (Note 2) |
|
0.02 |
|
|
— |
|
|
0.02 |
|
|
0.97 |
|
||||
Non-GAAP Net loss Per Basic and Diluted Common Share |
$ |
(0.05 |
) |
$ |
(0.02 |
) |
$ |
(0.10 |
) |
$ |
(0.05 |
) |
||||
Basic and Diluted Common Shares |
|
707.9 |
|
|
697.7 |
|
|
704.8 |
|
|
538.8 |
|
||||
|
||||||||||||||||||||
Schedule Reconciling Selected Non-GAAP Financial Measures |
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(in millions) |
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Unaudited |
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|
Three Months Ended |
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|
|
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||||||||||
Reconciliation of GAAP to Non-GAAP Operating Expenses |
|
|
|
|
|
|||||||||||||||
GAAP Operating expenses |
$ |
59.8 |
|
$ |
42.6 |
|
$ |
36.4 |
|
$ |
20.8 |
|
$ |
15.8 |
|
|||||
Stock-based compensation (Note 1) |
|
(11.1 |
) |
|
(9.5 |
) |
|
(8.7 |
) |
|
(0.7 |
) |
|
(1.9 |
) |
|||||
Acquired In-process research and development (Note 2) |
|
(15.0 |
) |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|||||
Non-GAAP Operating Expense |
$ |
33.7 |
|
$ |
33.1 |
|
$ |
27.7 |
|
$ |
20.1 |
|
$ |
13.9 |
|
|||||
|
|
|
|
|
|
|||||||||||||||
Reconciliation of GAAP Net Loss to Non-GAAP Net Loss |
|
|
|
|
|
|||||||||||||||
GAAP Net Loss |
$ |
(60.4 |
) |
$ |
(43.5 |
) |
$ |
(36.6 |
) |
$ |
(21.3 |
) |
$ |
(14.7 |
) |
|||||
Stock-based compensation (Note 1) |
|
11.1 |
|
|
9.5 |
|
|
8.7 |
|
|
0.7 |
|
|
1.9 |
|
|||||
Acquired In-process research and development (Note 2) |
|
15.0 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|||||
Non-GAAP Net Loss |
$ |
(34.3 |
) |
$ |
(34.0 |
) |
$ |
(27.9 |
) |
$ |
(20.6 |
) |
$ |
(12.8 |
) |
|||||
|
|
|
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Notes on our Non-GAAP Financial Information
Non-GAAP financial measures adjust GAAP financial measures for the items listed below. These Non-GAAP measures should be viewed in addition to, and not as a substitute for Summit's reported GAAP results, and may be different from Non-GAAP measures used by other companies. In addition, these Non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Summit management uses these non-GAAP measures for internal budgeting and forecasting purposes and to evaluate Summit’s financial performance. Summit management believes the presentation of these Non-GAAP measures is useful to investors for comparing prior periods and analyzing ongoing business trends and operating results.
Each of non-
Note 1: Stock-based compensation is a non-cash charge and costs calculated for this expense can vary year-over-year depending on the stock price of awards on the date of grant as well as the timing of compensation award arrangements.
Note 2: Acquired in-process research and development represents a one-time charge associated with the Company's in-licensing of ivonescimab from
Appendix: Glossary of Critical Terms Contained Herein
Affinity – Affinity is the strength of binding of a molecule, such as a protein or antibody, to another molecule, such as a ligand.
Avidity – Avidity is the accumulated strength of multiple binding interactions.
Angiogenesis – Angiogenesis is the development, formation, and maintenance of blood vessel structures. Without sufficient blood flow, tissue may experience hypoxia (insufficient oxygen) or lack of nutrition, which may cause cell death.5
Cooperative binding – Cooperative binding occurs when the number of binding sites on the molecule that can be occupied by a specific ligand (e.g., protein) is impacted by the ligand’s concentration. For example, this can be due to an affinity for the ligand that depends on the amount of ligand bound or the binding strength of the molecule to one ligand based on the concentration of another ligand, increasing the chance of another ligand binding to the compound.6
Immunotherapy – Immunotherapy is a type of treatment, including cancer treatments, that help a person’s immune system fight cancer. Examples include anti-PD-1 therapies.7
Intracranial - Within the cranium or skull.
PD-1 – Programmed cell Death protein 1 is a protein on the surface of T cells and other cells. PD-1 plays a key role in reducing the regulation of ineffective or harmful immune responses and maintaining immune tolerance. However, with respect to cancer tumor cells, PD-1 can act as a stopping mechanism (a brake or checkpoint) by binding to PD-L1 ligands that exist on tumor cells and preventing the T cells from targeting cancerous tumor cells.8
PD-L1 – Programmed cell Death Ligand 1 is expressed by cancerous tumor cells as an adaptive immune mechanism to escape anti-tumor responses, thus believed to suppress the immune system’s response to the presence of cancer cells.9
PD-L1 TPS – PD-L1 Tumor Proportion Score represents the percentage of tumor cells that express PD-L1 proteins.
PFS – Progression-Free Survival.
RANO –Response Assessment in Neuro-Oncology, the standard for assessing the response of a brain or spinal cord tumor to therapy.
SQ-NSCLC – Non-small cell lung cancer tumors of squamous histology.
T Cells – T cells are a type of white blood cell that is a component of the immune system that, in general, fights against infection and harmful cells like tumor cells.10
Tetravalent – A tetravalent molecule has four binding sites or regions.
Tumor Microenvironment – The tumor microenvironment is the ecosystem that surrounds a tumor inside the body. It includes immune cells, the extracellular matrix, blood vessels and other cells, like fibroblasts. A tumor and its microenvironment constantly interact and influence each other, either positively or negatively.11
VEGF – Vascular Endothelial Growth Factor is a signaling protein that promotes angiogenesis.12
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