midastouch017
4 months ago
Compugen Announces FDA Clearance of IND for COM503 for the Treatment of Solid Tumors
https://finance.yahoo.com/news/compugen-announces-fda-clearance-ind-110000034.html
FDA clearance triggers a $30 million milestone payment from Gilead
Company on track to initiate a Phase 1 trial for COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics as monotherapy and in combination in advanced solid tumors in Q4 2024
HOLON, Israel, July 29, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a Phase 1 trial for COM503, a potential first-in-class, high affinity anti-IL-18 binding protein antibody licensed to Gilead Sciences, Inc. (Gilead). The IND clearance triggered a $30 million milestone payment from Gilead and Compugen is on track to initiate the Phase 1 trial in solid tumors, in the fourth quarter of 2024.
"We are thrilled to receive FDA IND clearance for COM503 which triggers a $30 million milestone payment from our partner Gilead, and the initiation of a Phase 1 trial will keep us on track to expedite COM503 development," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "We are excited about the potential of COM503, a differentiated antibody approach to harness cytokine biology for cancer therapeutics which we discovered through our computational discovery work at Compugen."
Dr. Cohen-Dayag added, "This achievement reflects our track record in execution and diversity in our pipeline, adding another clinical program discovered through our predictive computational discovery engine. In addition, it further strengthens our balance sheet with an expected cash runway sufficient to take us into 2027. We look forward to the initiation of the Phase 1 trial in the fourth quarter of this year, for which our preparation is well-advanced."
About COM503 Phase 1 trial
The Phase 1 trial is a first-in-human, dose escalation and dose expansion trial to assess the safety and tolerability of COM503 as a monotherapy and in combination with Gilead's anti-PD-1, zimberelimab in participants with advanced or metastatic solid tumors globally.
About the Compugen-Gilead license agreement
In 2023, Compugen and Gilead entered into a license agreement, pursuant to which Gilead was granted exclusive rights to develop and commercialize anti-IL-18 binding protein antibodies, including the COM503 drug candidate. Compugen is responsible for preclinical development and the anticipated first- in-human Phase 1 trial evaluating the safety and tolerability of COM503. Gilead will have the sole right to develop and commercialize COM503 thereafter. Gilead provided Compugen with a $60 million upfront payment and will make a $30 million payment for achievement of the milestone of IND clearance of COM503, the subject of this press release. Compugen will be eligible to receive up to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of up to $848 million. Compugen will also be eligible to receive single- digit to low double-digit tiered royalties on worldwide net sales.
midastouch017
5 months ago
Compugen to Present at Upcoming Antibody Industrial Symposium
https://finance.yahoo.com/news/compugen-present-upcoming-antibody-industrial-110000879.html
HOLON, Israel, June 17, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Pierre Ferré, Ph.D, SVP, Preclinical Development and Corporate Operations, Compugen will present a case study on clinical dose selection for TIGIT monospecific and bispecific antibodies at the Antibody Industrial Symposium taking place June 20-21, 2024, Montpellier, France.
Event: 12th Antibody Industrial Symposium, Montpellier, France
Date: Friday, June 21, 2024
Presenter: Pierre Ferré, Ph.D., SVP, Preclinical Development and Corporate Operations, Compugen
Presentation title: Case study on clinical dose selection for TIGIT monospecific and bispecific antibodies
midastouch017
6 months ago
Compugen to Receive Milestone Payment Triggered by Dosing of First Patient in the Second Phase 3 Trial Evaluating Rilvegostomig
https://finance.yahoo.com/news/compugen-receive-milestone-payment-triggered-110000791.html
Phase 3 trial evaluating rilvegostomig as monotherapy and in combination with AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan in first-line nonsquamous non-small cell lung cancer
Broadening the assessment of rilvegostomig reinforces Compugen's partnering strategy to expand opportunities for its pipeline
Compugen to receive $5 million milestone payment from AstraZeneca
HOLON, Israel, May 30, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it is entitled to receive a milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN) triggered by the dosing of the first patient in a Phase 3 trial evaluating rilvegostomig, AstraZeneca's PD-1/TIGIT bispecific antibody. The TIGIT component of rilvegostomig is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. Both rilvegostomig and COM902 are designed to have reduced Fc effector function.
The trial, called TROPION-Lung10, is evaluating the efficacy and safety of rilvegostomig as monotherapy and in combination with datopotamab deruxtecan (Dato-DXd), AstraZeneca and Daiichi Sankyo's (TSE: 4568) TROP2-directed antibody drug conjugate versus pembrolizumab as first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high PD-L1 expression (TC = 50%) and without actionable genomic alterations. The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo and is expected to enrol approximately 675 patients in more than 14 countries. Further details about TROPION-Lung10 are available on ClinicalTrials.gov, identifier: NCT06357533.
"We are very excited to see the advancement of rilvegostomig into its second Phase 3 trial by AstraZeneca in collaboration with Daiichi Sankyo, two global leaders in oncology," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "TROPION-Lung10 follows the start of the ARTEMIDE-Biliary01 Phase 3 trial evaluating rilvegostomig in biliary tract cancer, for which we received a $10 million milestone payment. Now, after dosing the first patient in this lung cancer trial, we are eligible to receive a $5 million milestone payment from AstraZeneca. Broadening the assessment of rilvegostomig reinforces our partnering strategy to expand opportunities for our pipeline and brings us closer to realizing potential future milestone payments and royalties."
The ARTEMIDE-Biliary01 Phase 3 trial is evaluating the efficacy and tolerability of rilvegostomig compared to placebo in combination with investigator's choice of chemotherapy in patients with biliary tract cancer after surgical resection with curative intent. Further details about the ARTEMIDE-Biliary01 trial are available on ClinicalTrials.gov, identifier: NCT06109779.
About the Compugen-AstraZeneca license agreement
In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen's monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. Compugen has received $35.5 million in upfront and milestone payments to date and is eligible to receive an additional $5 million milestone payment as described in this press release. Compugen is eligible to receive up to an aggregate milestone amount of $200 million in development and regulatory milestones for the first and second indications for the first product and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi- or multi-specific products are developed based on Compugen's monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.
Rilvegostomig (previously AZD2936) is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902. Rilvegostomig is in Phase 3 development by AstraZeneca through this license agreement. Both rilvegostomig and COM902 are designed to have reduced Fc effector function to avoid depletion of CD8+ T cells.
midastouch017
10 months ago
Compugen to Receive $10 Million Milestone Payment Following Dosing of First Patient in AstraZeneca Phase 3 Rilvegostomig Trial in Biliary Tract Cancer
https://finance.yahoo.com/news/compugen-receive-10-million-milestone-120500521.html
HOLON, Israel, Jan. 8, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that Compugen is entitled to receive a $10 million milestone payment from AstraZeneca (LSE/STO/Nasdaq: AZN), after the first patient was dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig. Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.
"I am delighted to see the advancement of the rilvegostomig Phase 3 trial by AstraZeneca, a global leader in oncology, which has dosed the first patient triggering a $10 million milestone payment to Compugen," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "Our license agreement with AstraZeneca is part of our strategy to broaden commercialization opportunities for our pipeline and specifically capitalize on the potentially emerging promise of bispecific therapies while maintaining our focus on the development of COM902 as part of the combination with COM701, our potential first-in-class anti-PVRIG antibody."
About the Compugen-AstraZeneca license agreement
In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen's monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. In addition to the $10 million milestone payment described in this press release, Compugen has received a $10 million upfront payment, and an additional $15.5 million in milestone payments to date, all out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi- or multi-specific therapies are developed based on Compugen's monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.
Further details about ARTEMIDE-Bil01 trial are available on ClinicalTrials.gov, identifier: NCT06109779
About Compugen
Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has developed two proprietary product candidates: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Compugen also has a clinical stage partnered program, rilvegostomig (previously AZD2936), a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of programs aiming to address various mechanisms of immune resistance, of which the most advanced program, COM503, is in IND enabling studies is licenced to Gilead. COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby freeing natural IL-18 in the tumor microenvironment to inhibit cancer growth. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN.
Forward-Looking Statement
This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements relating to the recruitment of subjects to the ARTEMIDE-Bil01 trial. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value; and the general market, political and economic conditions in the countries in which Compugen operates, including Israel; and the effect of the evolving nature of the recent war in Gaza between Israel and Hamas. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
Company contact:
Yvonne Naughton, Ph.D.
Head of Investor Relations and Corporate Communications
Email: ir@cgen.com
Tel: +1 (628) 241-0071
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/compugen-to-receive-10-million-milestone-payment-following-dosing-of-first-patient-in-astrazeneca-phase-3-rilvegostomig-trial-in-biliary-tract-cancer-302028318.html
SOURCE Compugen
midastouch017
10 months ago
Compugen Regains Compliance with Nasdaq Minimum Bid Price Requirement
https://finance.yahoo.com/news/compugen-regains-compliance-nasdaq-minimum-120000043.html
HOLON, Israel, Jan. 8, 2024 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, announced today that on January 4, 2024, it received a notification letter (the "Notification Letter") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company that it had regained compliance with the minimum bid price requirement set forth in the Nasdaq Listing Rule 5550(a)(2) (the "Minimum Bid Price Requirement").
As announced on November 3, 2023, the Company was notified that its ordinary shares failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by the Minimum Bid Price Requirement. To regain compliance with the Minimum Bid Price Requirement, the closing bid of the Company's ordinary shares needed to be at least $1.00 for a minimum of 10 consecutive business days.
The Notification Letter confirmed that the Company evidenced a closing bid price at or greater than the $1.00 per ordinary share minimum requirement for the last 10 consecutive business days from December 19, 2023 to January 3, 2024 and that the Company has regained compliance with the Minimum Bid Price Requirement.
midastouch017
11 months ago
Compugen to Host Conference Call to Discuss Exclusive License Agreement with Gilead for COM503, Novel Immuno-Oncology Pre-Clinical Program Harnessing IL-18 Biology
https://finance.yahoo.com/news/compugen-host-conference-call-discuss-120500402.html
Conference call today, December 19, 2023, 8:30 AM ET to discuss the license agreement
HOLON, Israel, Dec. 19, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced that it will host a conference call at 8:30 AM ET today, to discuss the exclusive license agreement with Gilead announced today, for the development and commercialization of its anti-IL-18 binding protein program including COM503, a pre-clinical potential first-in-class high affinity antibody targeting IL-18 binding protein with potential to treat multiple tumor types.
Conference Call Details
To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen's website, located at the following link.
Following the live webcast, a replay will be available on the Company's website.
midastouch017
11 months ago
Compugen will be Eligible to Receive $10 Million Milestone Payment upon Dosing of First Patient in AstraZeneca Phase 3 Rilvegostomig Trial in Biliary Tract Cancer
Dosing of first patient in Phase 3 trial of rilvegostomig, a PD-1/TIGIT bispecific antibody, will trigger $10 million milestone payment from AstraZeneca
HOLON, Israel, Dec. 19, 2023 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today announced it will be eligible to receive a milestone payment of $10 million from AstraZeneca (LSE/STO/Nasdaq: AZN), when the first patient is dosed in AstraZeneca's ARTEMIDE-Bil01 trial with rilvegostomig. Rilvegostomig is a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical-stage anti-TIGIT antibody, COM902. The ARTEMIDE-Bil01 trial is expected to recruit about 750 subjects in more than 20 countries with biliary tract cancer who will be randomized to receive rilvegostomig or placebo with investigator choice chemotherapy as adjuvant treatment after resection with curative intent.
"I am delighted to see the advancement of rilvegostomig into Phase 3 by AstraZeneca, a global leader in oncology," said Anat Cohen-Dayag, Ph.D., President, and Chief Executive Officer of Compugen. "I believe that the progress of the rilvegostomig clinical program in this Phase 3 trial along with the Phase 1 and 2 trials in additional indications, demonstrates the commitment to explore the potential of this bispecific antibody, where the TIGIT component is derived from our anti-TIGIT antibody COM902."
About the Compugen-AstraZeneca license agreement
In 2018, Compugen and AstraZeneca entered into an agreement by which Compugen provided an exclusive license to AstraZeneca to use Compugen's monospecific antibodies that bind to TIGIT, including COM902, for the development of bispecific and multispecific antibody products, excluding such bispecific and multispecific antibodies that also bind to PVRIG, PVRL2 and/or TIGIT. AstraZeneca is responsible for all research, development, and commercial activities. AstraZeneca has the right to create multiple products under this license. In addition to the $10 million milestone payment described here which Compugen will be eligible to receive on dosing of the first patient in the Phase 3 ARTEMIDE-Bil01 trial, Compugen has received a $10 million upfront payment, and an additional $15.5 million in milestone payments to date, all out of up to an aggregate milestone amount of $200 million that the Company is eligible to receive in development, regulatory and commercial milestones for the first product, as well as tiered royalties on future product sales. If additional bi- or multi-specific products are developed based on Compugen's monospecific antibodies that bind to TIGIT, additional milestones and royalties would be due to Compugen.
Further details about ARTEMIDE-Bil01 trial are available on ClinicalTrials.gov, identifier: NCT06109779.
midastouch017
11 months ago
Gilead and Compugen Announce Exclusive License Agreement for Novel Pre-Clinical Immunotherapy Program
https://finance.yahoo.com/news/gilead-compugen-announce-exclusive-license-120000324.html
– Gilead Will Have Exclusive Rights to Later Stage Development and Commercialization of Anti-IL18 Binding Protein Antibodies with Potential to Treat Various Tumor Types –
– Gilead to Make $60 Million Upfront Payment and $30 Million in a Near Term Milestone Payment with a Total Deal Value of up to $848 Million –
FOSTER CITY, Calif. & HOLON, Israel, December 19, 2023--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced an agreement with Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, headquartered in Holon, Israel, to exclusively license its potential first-in-class, pre-clinical antibody program against IL-18 binding protein, including the COM503 drug candidate.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231218814564/en/
Compugen utilizes its broadly applicable predictive computational discovery capabilities to identify new drug targets and biological pathways for developing novel cancer immunotherapies. COM503 is a potential first-in-class, high affinity antibody which blocks the interaction between IL-18 binding protein and IL-18, thereby releasing natural IL-18 in the tumor microenvironment and inhibiting cancer growth.
"We are very pleased to add COM503 to our pipeline of investigational immuno-oncology therapies that have the potential to transform care for patients with cancer," said Flavius Martin, M.D., Executive Vice President, Research, Gilead Sciences. "We believe that this collaboration complements our strategy of developing modalities which promote immune-mediated tumor killing and may enable new combination therapies with programs in our growing oncology portfolio."
"We are delighted to enter into this collaboration with Gilead and believe that Gilead’s confidence in our differentiated approach to harness cytokine biology for cancer therapeutics speaks to the quality of our computational discovery capabilities as well as our ability to translate our novel discoveries into investigational drugs in the clinic and we look forward to working together to bring new treatment options to patients," said Anat Cohen-Dayag, Ph.D., President, and CEO at Compugen. "IL-18 is one of the rare cytokines which is naturally inhibited by an endogenous binding protein, presenting a unique opportunity to use a blocking antibody to increase the local concentrations of IL-18 within the tumor where it can potentiate anti-tumor immune responses, thereby potentially overcoming the limitations of systemically administered cytokines."
Terms of the Partnership
Under the terms of the agreement, Compugen will be responsible for the ongoing pre-clinical development and the future Phase 1 study of COM503. Thereafter, Gilead will have the sole right to develop and commercialize COM503.
Gilead will make Compugen an upfront payment of $60 million and $30 million in a near term milestone payment subject to IND clearance of COM503 expected in 2024. Compugen will also be eligible to receive up to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of $848 million. Compugen will also be eligible to receive single-digit to low double-digit tiered royalties on worldwide net sales.
Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Compugen is expected to reduce Gilead’s GAAP and non-GAAP 2023 EPS by approximately $0.03 - $0.05.
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