CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments. By FRANK VINLUAN CG Oncology, a company that turns viruses into cancer therapies, has raised $380 million to fund clinical development of a therapy that the company believes could become a new first-line treatment for certain bladder cancers. The stock offering marks the first biotech IPO of 2024. CG was able to raise much more than planned. In preliminary financial terms set earlier this week, the company projected selling 17 million shares in the range of $16 to $18 each, which would have raised $289 million at the pricing midpoint. When CG finalized the IPO terms late Thursday, it ended up offering 20 million shares priced at $19 apiece. Those shares will trade on ...
(“AOSAIKANG”) has completed the registration clinical phase III study of ASKB589, a bio-innovative drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer. ASKB589, a bio-innovation drug independently developed by AskGene Limited (“AskGene”), for the treatment of first-line advanced gastric cancer, has been administered to the first patient in China in the Phase III registration study: I. About the Registrational Clinical Phase III Study of ASKB589 The study is a multicenter, randomized, double-blind, standard treatment-controlled, efficacy-designed Phase III clinical study, which is planned to enroll 780 first-line gastric cancer patients in China, with the aim of evaluating the efficacy and efficacy of ASKB589 Injection or placebo in combination with CAPOX (oxaliplatin and capecitabine) and PD-1 inhibitor in the first-line treatment of CLDN18.2-positive unresectable locally advanced, recurrent or metastatic gastric and esophageal cancers, and to assess the efficacy and efficacy of the study. efficacy and safety ...
January 23, 2024 Pharmaceutical Executive Editorial Staff The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.Image credit: Dr_Microbe | stock.adobe.com Data from the Phase III EVOKE-01 trial (NCT05089734) show that Gilead Sciences, Inc’s Trodelvy (sacituzumab govitecan-hziy) did not achieve the primary endpoint of overall survival (OS) in patients with previously treated, metastatic non-small cell lung cancer (NSCLC).EVOKE-01 was comparing Trodelvy with docetaxel for the treatment of patients with metastatic or advanced NSCLC who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy. “The totality of our data gives us continued confidence in Trodelvy’s potential in metastatic NSCLC, and in our broader lung cancer clinical development program,” said Gilead Sciences Chief Medical Officer Merdad Parsey, MD, PhD, in a press release. “Treating metastatic NSCLC that has progressed on or ...
Cambridge, MA, Rotterdam, NL, Suzhou, CN – Jan 19, 2023 Harbour BioMed (the “Company”; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, announces a positive profit alert for the year ended December 31, 2023. As disclosed before, there was a turnaround from a loss of US$73.1 million for the six months ended June 30, 2022 to a profit of US$2.9 million for the six months ended June 30, 2023. Based on the preliminary review of the unaudited consolidated management accounts, it is expected that there will be a profit of approximately US$18 million for the year ended December 31, 2023, as compared to a loss of approximately US$137 million for the year ended December 31, 2022. This is the first time that the Company has recorded a net profit on its annual financial statements. The anticipated ...
For more than 2 years, Johnson & Johnson has been plotting its future as a two-sector company. In the wake of the company’s consumer healthcare spinoff last summer, the company’s fourth-quarter results offer plenty of signs of life from the new-look J&J.After wrapping up 2023 with a total haul of $85.2 billion, the company is heading into 2024 with “multiple catalysts for growth,” CEO Joaquin Duato said on J&J’s fourth-quarter and full-year earnings conference call. Across J&J’s innovative medicines portfolio, the company’s oncology and immunology medicines generated the lion’s share of sales in 2023’s fourth quarter, helping the unit achieve operational growth in the U.S. of 9.5% during the period. Worldwide, J&J’s pharma business reeled in $13.72 billion during the fourth quarter, a 4% increase from the same period in 2022.On the immunology front, J&J’s antibody blockbuster Stelara grew its market share and demonstrated continued strength in inflammatory bowel disease (IBD), J&J said in ...
More than five years after an FDA accelerated approval in a subtype of progressive colorectal cancer, Bristol Myers Squibb now has data supporting its checkpoint inhibitor doublet in newly diagnosed patients. But another approval may have to wait. The dual immunotherapy combo of Opdivo and Yervoy cut the risk of disease progression or death by 79% compared with chemotherapy—with or without targeted therapies—in patients newly diagnosed with metastatic colorectal cancer that was microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR). Investigators shared the results, from the CheckMate 8HW study, at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. After about two years of median follow-up, 72% of patients who received the anti-PD-1/CTLA-4 combo were alive without disease progression, versus 14% in the control group. The results “have potentially practice-changing implications” for previously untreated MSI-H/dMMR metastatic colorectal cancer, lead study author Thierry Andre, M.D., from the Sorbonne Université in Paris, said in a ...
The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) 2024 has been successfully concluded. CHIATAI TIANQING Pharmaceutical Group’s Class 1 innovative drugs Anrotinib (small molecule multi-targeted receptor tyrosine kinase inhibitor), Paianprilizumab (PD-1 inhibitor) and Behmosubaisumab (TQB2450, PD-L1 inhibitor) have been selected to be presented at the poster session this time with a total of 11 studies, which are related to the field of GI tumors with liver metastasis, esophageal cancer, hepatocellular carcinoma, tumors of the biliary tract system, and colorectal cancer. ALTER-G-001 is a multi-cohort, multi-center phase II study, and updated results from Cohort A were presented at this ASCO GI meeting. Patients in Cohort A were treated with 6 cycles (3 weeks each) of anilotinib (12 mg, po, qd, d1-14, q3w) + oxaliplatin (130 mg/m2, iv, d1, q3w) + capecitabine (850 mg/m2, po, bid, d1-14, q3w), and if liver metastases were not converted to resectable on ...
Eli Lilly’s attempt to wrestle a leukemia market from companies including AbbVie, AstraZeneca, BeiGene and Johnson & Johnson has analysts purring, with the GlobalData team tipping the drugmaker to capture 60% of demand and deliver $3 billion in annual sales. The GlobalData report covers the use of BTK inhibitors in the treatment of chronic lymphocytic leukemia (CLL). Pharmacyclics, now part of AbbVie, and J&J created the market with Imbruvica but now face a sea of threats, with the Inflation Reduction Act, increased competition and the looming prospect of generics pointing to a downward trajectory. AstraZeneca’s Calquence began challenging Imbruvica for the CLL market in 2019 and BeiGene’s Brukinsa joined the party last year. But the GlobalData analysts expect Lilly to come from behind to become the dominant force in CLL in the coming years. Lilly won accelerated FDA approval for Jaypirca in CLL last month. While the drugmaker, which acquired Jaypirca in its $8 billion ...
Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer. Image Credit: Adobe Stock Images/Crystal light The combination of Bristol Myers Squibb’s Opdivo (nivolumab) with Yervoy (ipilimumab) showed significant improvements in progression-free survival (PFS) as a first-line treatment for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC)in the Phase III CheckMate -8HW trial. The combination produced a 79% reduction in the risk of disease progression or death compared to chemotherapy, according to the trial. “Patients with MSI-H/dMMR metastatic colorectal cancer are less likely to benefit from chemotherapy,” said Thierry Andre, MD, head of the medical oncology department, Sorbonne University, Hospital Saint-Antoine, Paris, France, in a press release. “An impressive improvement in PFS and sustained benefit beginning at three months was observed with nivolumab plus ipilimumab versus chemotherapy in this trial. These results demonstrate ...
Pfizer’s Talzenna (talazoparib) has become the first targeted treatment to be recommended by the National Institute for Health and Care Excellence (NICE) to treat HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations. Patients eligible for the PARP inhibitor will have previously been treated with anthracycline or taxane chemotherapy, or both, unless these treatments are not suitable. Additionally, those with HR-positive breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for this.NICE’s final draft guidance, which reverses its earlier draft decision not to recommend Talzenna for this patient population, follows Pfizer’s offer of an increased discount of the treatment.The agency estimates that 300 breast cancer patients, who would otherwise be limited to chemotherapy and best supportive care, will benefit from the new recommendation. Stefano Podesta, oncology lead at Pfizer UK, said: “[The] decision is an important milestone for eligible patients with advanced-stage breast ...
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