On May 30, 2024 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., reported the landmark overall survival (OS) analysis of camrelizumab and rivoceranib as a first-line treatment for unresectable hepatocellular carcinoma (uHCC) will be presented at an in-person poster presentation during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 1 (Press release, Elevar Therapeutics, MAY 30, 2024, View Source [SID1234643853]). The abstract can be viewed at asco.org/abstracts.

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"The CARES-310 final OS analysis confirmed statistically superior and clinically meaningful survival improvement with a manageable safety profile for the combination of camrelizumab and rivoceranib as a first-line treatment for patients suffering from unresectable hepatocellular carcinoma," said Saeho Chong, Elevar chief executive officer. "These data confirm that the novel combination therapy represents a clinically differentiated improvement to the standard of care in first-line treatments for uHCC."

"The CARES-310 landmark analysis reported the longest median overall survival for any treatment in a global Phase 3 trial in the uHCC setting," said Ahmed Omar Kaseb, M.D., professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. "The combination of camrelizumab and rivoceranib shows distinct promise to advance the standard of care for patients suffering with unresectable hepatocellular carcinoma."

The interim analysis of CARES-310 OS was completed after data cut-off on Feb. 8, 2022. For the final analysis, 16 months later, camrelizumab + rivoceranib continued to show clinically meaningful survival improvement compared with sorafenib, with manageable safety profile. The extended follow-up further confirmed the favorable benefit-to-risk profile of camrelizumab + rivoceranib, supporting it as a potential new first-line treatment option for uHCC.

In the final analysis, median OS was significantly prolonged with camrelizumab + rivoceranib vs. sorafenib (23.8 mo [95% CI 20.6-27.2] vs. 15.2 mo [95% CI 13.2-18.5]; hazard ratio 0.64 [95% CI 0.52-0.79]; 1-sided p < 0.0001). OS rate with camrelizumab + rivoceranib vs. sorafenib was 49.0% vs. 36.2% at 24 mo, and 37.7% vs. 24.8% at 36 mo. OS benefits with camrelizumab + rivoceranib were generally consistent across subgroups, regardless of geographical region, race and etiology.

CARES-310 was the first trial to demonstrate significant progression-free survival (PFS) and overall survival benefits with immunotherapy plus an anti-angiogenic tyrosine kinase inhibitor (TKI) over standard TKI as first-line treatment for uHCC.

ASCO 2024 CARES-310 Landmark Overall Survival In-Person Presentation The in-person poster presentation (abstract number 4110), titled "Camrelizumab plus rivoceranib vs sorafenib as first-line therapy for unresectable hepatocellular carcinoma (uHCC): Final overall survival analysis of the Phase 3 CARES-310 study," will be presented June 1 from 1:30 p.m. to 4:30 p.m. CT during the poster session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary. The abstract can be viewed at: asco.org/abstracts.

Additional ASCO (Free ASCO Whitepaper) 2024 CARES-310 Online Publication Additional data from CARES-310 will be available as an online publication. Abstract number e16197 is titled: "Role of neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte-ratio (PLR) in unresectable hepatocellular carcinoma (uHCC): Subgroup analysis of patients treated with camrelizumab (cam) + rivoceranib (rivo) in the CARES-310 trial." The abstract can be viewed at: asco.org/abstracts.

About Hepatocellular Carcinoma (HCC) HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About CARES-310 CARES 310 (NCT03764293) was a randomized, open-label, international Phase 3 study, which included 543 patients with unresectable or metastatic HCC who had not received prior systemic therapy. Patients were randomized 1:1 to receive the combination of camrelizumab + rivoceranib or sorafenib (400 mg orally twice daily), a standard-of-care first-line multi-kinase inhibitor treatment for uHCC. Camrelizumab was administered intravenously (190 mg) every two weeks and rivoceranib was administered orally (250 mg) once daily. The study was conducted at 95 study sites across 13 countries/regions, in which systemic treatment for uHCC independent of etiology, rivoceranib plus camrelizumab demonstrated statistically significant and clinically meaningful prolonged overall survival and progression-free survival, and improved overall response rate versus sorafenib. The co-primary endpoints were overall survival and progression-free survival. Secondary endpoints included objective response rate and duration of response.

About Camrelizumab Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer,

gastric cancer, and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for uHCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.

About Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese -territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.

On May 30, 2024 Day One Biopharmaceuticals (Nasdaq: DAWN) ("Day One" or the "Company"), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported it sold its Priority Review Voucher ("PRV") for $108 million to an undisclosed buyer (Press release, Day One, MAY 30, 2024, View Source [SID1234643852]). The Company was awarded the PRV following the U.S. Food and Drug Administration ("FDA") accelerated approval of OJEMDA (tovorafenib).

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"The sale of the PRV delivers true non-dilutive capital to Day One and further strengthens our balance sheet as we continue executing on the launch of OJEMDA and investing in clinical development opportunities for children and adults living with cancer," said Charles York II, chief operating and financial officer of Day One.

Under the Rare Pediatric Disease Priority Review Voucher Program, FDA awards PRVs to sponsors of rare pediatric disease product applications that meet certain criteria. The program is intended to encourage development of new drugs and biologics for the prevention and treatment of rare diseases. A PRV can be redeemed to receive priority review of a subsequent marketing application for a different product, sold or transferred.

As part of the transaction, $8.1 million of the total consideration received from the sale of the PRV will be paid to Viracta Therapeutics, Inc. ("Viracta") to fully satisfy PRV related obligations of the Company’s license agreement with Viracta, dated December 16, 2019, as amended.

On May 30, 2024 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported that Richard A. Miller, M.D., president and chief executive officer, and Jeffrey Arcara, chief business officer, will conduct one-on-one meetings with investors and present a corporate overview at the Jefferies Global Health Conference, which is being held in New York from June 5-7, 2024 (Press release, Corvus Pharmaceuticals, MAY 30, 2024, View Source [SID1234643851]). The Company’s presentation will be on Wednesday, June 5 at 3:00 pm ET.

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A webcast of the presentation will be available live and for 90 days following the event. The webcast may be accessed via the investor relations section of the Corvus website.

On May 30, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN), a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported 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 (Press release, Compugen, MAY 30, 2024, View Source [SID1234643850]). 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.

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On May 30, 2024 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported that it has entered into a Supply Agreement with SpectronRx for the production of Cu-64 (Press release, Clarity Pharmaceuticals, MAY 30, 2024, View Source [SID1234643849]).

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Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited to bring an additional Cu-64 manufacturer to our extensive and reliable network of copper radioisotope suppliers. SpectronRx will be the first private supplier of Cu-64 to join our network in the US.

"Cu-64, with an ideal 12.7-hour half-life, is able to overcome the overwhelming supply restraints of other diagnostic isotopes, specifically Ga-68 with a half-life of ~1 hour and F-18 with a half-life of ~2 hours. Radiopharmaceutical products using these isotopes are severely limited and are associated with significant manufacturing and supply complications, driven by these very short half-lives. This leaves many patients around the world with no option of positron emission tomography (PET) imaging. This is well documented in the United States, the largest oncology market in the world, and the effects of these hurdles more heavily impact vulnerable populations, including African Americans and Veterans, who already experience much higher incidences of prostate cancer than the general population1, 2.

"Our focus at Clarity is to establish the most reliable, scalable, and logistically seamless supply chain in the radiopharmaceutical field to continue delivering our best-in-class products to patients and their clinicians on time. With our TCTs, we can avoid the myriad of challenges associated with the current generation of diagnostic isotopes, such as Ga-68 and F-18, which require local production due to their short half-lives.

"The unique properties of Cu-64 include the ability to produce commercially relevant volumes of this isotope daily, on centrally located cyclotrons. Cu-64 can then be manufactured into ready-to-use products with a shelf life that is measured in days rather than hours and supply the growing demand for PET imaging agents. Should an imaging site require 1, 10 or 100+ patient doses, we see a future where these quantities can be reliably supplied to any zip code in the United States, removing the burden of the current supply issues with Ga-68 and F-18 based products from practices and their patients.

"We are now actively recruiting and imaging patients for our first Phase III trial with 64Cu-SAR-bisPSMA in a pre-prostatectomy setting and planning our second Phase III trial in biochemically recurrent prostate cancer with this optimised product. With outstanding clinical trial data to date, we continue to implement our strategy for the commercial launch of 64Cu-SAR-bisPSMA, developing a seamless supply chain for this potential best-in-class agent."

The overarching Master Service Agreement and associated Cu-64 supply agreement are effective as of 30 May 2024. The initial supply from SpectronRx is expected to launch before the end of calendar year 2024. The Master Services Agreement is for an initial period of five years and the Cu-64 supply agreement is for an initial period of 3 years. Cancellation and extension provisions are aligned with industry standard rates.