CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced final results from the Phase 2 CORE-001 clinical trial of its oncolytic immunotherapy candidate, cretostimogene, in combination with pembrolizumab for the treatment of BCG-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) with Carcinoma in Situ (CIS). The data will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting from May 31-June 4, in Chicago, IL.
Friday, May 24, 2024
ASCO24: An early look at cancer drug study results
BioPharma Dive is testing out a new format rounding up smaller updates from around the industry.
Today, we’re interrupting our usual rundown of industry news to highlight notable clinical trial updates ahead of next week’s American Society of Clinical Oncology’s annual meeting. On Thursday, conference organizers released abstracts, or snapshots, of most of the studies set to be presented at the meeting, which will be held in Chicago from May 31 to June 4.
Note: So-called late-breaking abstracts, which often feature particularly consequential trial findings, aren’t available until the day the relevant studies are presented. This year, that group includes anticipated data on Novartis’ therapy Scemblix in leukemia, GSK’s Blenrep in multiple myeloma and AstraZeneca and Daiichi Sankyo’s Enhertu treatment in breast cancer.
Abstract #9507: Analysts have closely tracked a dual-targeting antibody drug that Immunocore is developing for a type of skin cancer called cutaneous melanoma. Trial results included in an ASCO abstract showed that, among 31 evaluable people who previously received immunotherapy, Immunocore’s drug led to partial tumor responses in four, or 13%. Including study participants whose disease was considered stable, the so-called clinical benefit rate was 61%. Though slightly below analysts’ expectations, the data are roughly similar to the results for Bristol Myers Squibb’s Odualag in a comparable patient population. Immuncore recently began a Phase 3 trial of its drug, called brenetafusp.
Abstracts #5502, 9506: Drugmakers have hoped that targeting an immune cell protein called TIGIT could build on the success seen with “checkpoint” inhibitors like Merck & Co.’s Keytruda and Bristol Myers Squibb’s Opdivo. But trial results to date have been mixed and new data included in ASCO abstracts Thursday probably won’t settle any debates. On one hand, Phase 2 trial findings for Merck’s TIGIT-targeting drug vibostolimab coformulated with Keytruda shrank or eliminated tumors in a larger share of women with a type of endometrial cancer than Keytruda alone. On the other, data from a Phase 1/2 trial of Keytruda, vibostolimab and a third experimental immunotherapy called quavonlimab in advanced melanoma patients weren’t good enough for the Merck to continue enrolling patients.
Abstract #3508: An experimental cocktail of six drugs substantially extended survival and delayed tumor growth, compared to a standard therapy, in people with previously treated metastatic colon cancer, according to an ASCO abstract. The regimen includes two drugs developed by Arcus Biosciences: etrumadenant, a so-called adenosine receptor antagonist, and zimberelimab, a checkpoint inhibitor. Median overall survival among the 75 patients randomized to the cocktail was 19.7 months, versus 9.5 months for the 37 given Stivarga in the Phase 1b/2 study. Arcus is closely partnered with Gilead Sciences, although their focus has been on developing zimberelimab and another immunotherapy.
Abstract #5010: Johnson & Johnson is one of many companies now exploring radiopharmaceuticals, which deliver radiation directly to a tumor. Its first chance to break into the field could be JNJ-6420, a drug that executives already billed as a potential future blockbuster. J&J aims to show the drug can slow tumor progression in men whose prostate cancer has progressed after hormone therapies. Early-stage study results disclosed in an abstract show the company may need to manage safety concerns. While 46% of men treated with a select drug dose had a 50% decrease in a marker associated with improved survival, 61% experienced an adverse event graded as severe or medically significant. Four of the 67 patients who received J&J’s drug overall in the study died from adverse events.
Abstract #6502: Anyone looking for updated trial results on MorphoSys’ myelofibrosis drug pelabresib will have to wait for ASCO itself, as an abstract for the biotechnology company’s MANIFEST-2 study only includes previously presented data. The drug is at the center of Novartis’ pending $2.9 billion acquisition of MorphoSys, but there are questions about its safety after a Stat report highlighted multiple cases of acute myeloid leukemia developing in pelabresib-treated patients.
https://finance.yahoo.com/m/72385150-b2d0-347d-a532-a6248134727b/asco24%3A-an-early-look-at.html
Cue Health to lay off remaining employees, shut down
Cue Health will lay off the remainder of its staff this week, according to a filing with California’s Employment Development Department.
The layoffs, first reported by the The San Diego Union-Tribune, include all of Cue’s U.S. employees and company leadership.
Cue has undergone multiple rounds of layoffs in the past two years, announcing plans to cut nearly half of its staff earlier this month. The San Diego-based test maker had one product cleared by the Food and Drug Administration, a COVID-19 test, but the agency recently warned people to stop using it because of changes made to the test.
Cue, which built its business around a portable, molecular testing platform, grew quickly during the COVID-19 pandemic. The company struck agreements with Google and the NBA to provide COVID tests for both organizations and raised $200 million in an initial public offering in 2021. It also raised hundreds of millions of dollars through contracts with the Departments of Defense and Health and Human Services to provide COVID tests.
Cue’s fortunes changed when federal funding dried up and demand for COVID tests plummeted. Cue received de novo clearance for its COVID test in 2023, but it remained the company’s only FDA-cleared product.
By the end of 2023, Cue brought in just $70.9 million in revenue, down from $483.5 million the prior year. The company also began shedding employees through several rounds of cuts, including a 230-person layoff announced earlier this month and more than 200 people across two layoffs in January.
Cue’s sole product came under fire this month when the FDA sent a warning letter to the company regarding unauthorized changes to its COVID test and instructed people to not use the diagnostic.
Cue had initially planned a layoff of 190 U.S. employees effective July 1 and one additional employee on July 10, according to a California Worker Adjustment and Retraining Notification filing reviewed by MedTech Dive. The company sent an update on Monday to the state saying those people’s employment will end on May 24, along with all remaining U.S. employees, including company leadership. The decision was made by the company’s board “due to the fluid nature of this situation.”
CEO Ayub Khattak and CFO Aasim Javed resigned earlier this year.
https://finance.yahoo.com/m/52b3fff4-fbf7-33bc-9356-631f9b408b3f/cue-health-to-lay-off.html
'TriSalus Offers to Redeem Warrants'
-TriSalus Life Sciences® Inc. (“TriSalus” or the “Company”) (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, announced today that it has commenced an exchange offer (the “Offer”) and consent solicitation (the “Consent Solicitation”) relating to its warrants (the “Warrants”) identified in the Prospectus/Offer to Exchange (as defined below). The purpose of the Offer and Consent Solicitation is to simplify the Company’s capital structure and reduce the potential dilutive impact of the Warrants, thereby providing the Company with more flexibility for financing its operations in the future.
The Company is offering to all holders of each class of its Warrants, consisting of (i) its publicly-traded Warrants (the “Public Warrants”), (ii) certain Warrants issued in a private placement transaction occurring simultaneously with the closing of the initial public offering of the Company (the “Private Placement Warrants”), and (iii) certain Warrants issued for working capital requirements and payment of certain expenses of the Company (“Working Capital Warrants”), the opportunity to receive 0.30 shares of common stock of the Company, par value $0.0001 per share (“Common Stock”), in exchange for each Warrant tendered by the holder and exchanged pursuant to the Offer. Pursuant to the Offer, the Company is offering up to an aggregate of 4,264,532 shares of its Common Stock in exchange for the Warrants.
Concurrently with the Offer, the Company is also soliciting consents from holders of the Warrants to amend the warrant agreement that governs all of the Warrants (the “Warrant Agreement”) to permit the Company to require that all of the Exchange Warrants (as defined below) that are outstanding upon the closing of the Offer be exchanged, at the Company’s option (including the Company’s option to exchange all of the Exchange Warrants of one or more classes of Warrants without being obligated to exchange all of the Exchange Warrants of any other class of Warrants) into shares of Common Stock at a ratio of 0.27 shares of Common Stock per such Warrant, which is a ratio 10% less than the exchange ratio applicable to the Offer (such amendment, the “Warrant Amendment”). Parties representing approximately 34.8% of the Public Warrants have agreed to tender their Public Warrants in the Offer and to consent to the Warrant Amendment in the Consent Solicitation pursuant to tender and support agreements (each, a “Tender and Support Agreement”). Accordingly, if holders of an additional approximately 15.3% of the outstanding Public Warrants consent to the Warrant Amendment in the Consent Solicitation, and the other conditions described in the Prospectus/Offer to Exchange are satisfied or waived, then the Warrant Amendment will be adopted with respect to the Public Warrants. Although the Company has not received Tender and Support Agreements with respect to the Private Placement Warrants and Working Capital Warrants, assuming the Public Warrant Consent Threshold (as defined below) is met, the Warrant Amendment may be adopted with respect to either the Private Placement Warrants or the Working Capital Warrants if the Private Placement Warrant Consent Threshold or Working Capital Warrant Consent Threshold (each as defined below) is met, as applicable.
Why Is Sensei Biotherapeutics (SNSE) Stock Down
Sensei Biotherapeutics (NASDAQ:SNSE) stock is falling on Friday after it failed to impress investors with its latest Phase 1/2 clinical trial data for SNS-101.
SNS-101 is a human monoclonal antibody targeting the immune checkpoint VISTA. The company notes this has it being developed to treat solid cancer tumors.
The bad news for Sensei Biotherapeutics comes from its results in this trial. The company notes that only a few patients of the 34 treated showed signs of improvement.
https://investorplace.com/2024/05/why-is-sensei-biotherapeutics-snse-stock-down-40-today/
ASCO 2024: Merus positive Phase II data for head and neck cancer antibody
Among abstracts announced yesterday by the American Society of Clinical Oncology (ASCO) is positive data from a Phase II trial by Netherlands-based Merus.
The Phase II study is evaluating petosemtamab in combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) as a first-line treatment for metastatic head and neck squamous cell carcinoma (HNSCC).
The abstracts were released after market closed on 23 May and shares in Merus rose by 15% in premarket trading.
The abstract reveals that as of last November’s data cutoff, 10 patients were evaluated for efficacy. Among them, there was one complete response, five partial responses, and three instances of stable disease, leaving only one patient unresponsive to treatment. Additionally, among the 26 patients enrolled by the cutoff date, the regimen demonstrated a favourable safety profile with no significant overlapping toxicities, as noted by the study investigators. Updated findings will be presented at the upcoming ASCO 2024 annual meeting.
Merus will also be presenting two more abstracts at the meeting, which kicks off next week. On 2 June, the company will present data from the Phase I trial of monotherapy MCLA-145 in combination with Keytruda. A 3 June abstract will describe the efficacy and safety of MCLA-129, an anti-EGFR/c-MET bispecific antibody, in non-small-cell lung cancer (NSCLC) with c-MET exon 14 skipping mutations (METex14).
Petosemtamab targets epidermal growth factor receptor (EGFR) and leucine-rich repeat-containing G-protein coupled receptor 5 (LGR5). EGFR is a known oncogenic driver in HNSCC, and the LGR5 is a receptor expressed on cancer stem cells, including in HNSCC. According to GlobalData’s Pharma Intelligence Center, petosemtamab is forecast to generate $713m in sales in 2030.
GlobalData is the parent company of Pharmaceutical Technology.
In February 2024, Merus teamed up with Gilead for the discovery of dual tumour-associated antigens targeting trispecific antibodies – antibodies that can target three different antigens simultaneously.
In the announcement accompanying the abstract, CEO of Merus Bill Lundberg said: “We believe petosemtamab continues to demonstrate potential best in class safety and efficacy in head and neck cancer. We are encouraged with the well tolerated safety profile of the combination of petosemtamab and pembrolizumab, particularly with a low rate of Grade 3 or greater adverse events, and a low rate of infusion-related reactions observed.”
Other abstracts coming from the meeting include positive initial results from an ongoing Phase I/II trial investigating Verastem Oncology’s kinase inhibitor avutometinib for the treatment of pancreatic cancer.
Verastem Starts Rolling Submission in Ovarian Cancer Treatment
Plan to complete NDA submission with the mature RAMP 201 dataset, anticipated to include 12 months of follow-up, in the second half of 2024
Plan to present the mature dataset from RAMP 201 at a medical conference in the second half of 2024
Avutometinib and defactinib combination have continued to show robust and durable response rates in ongoing RAMP 201 trial in patients with recurrent low-grade serous ovarian cancer
Company to host investor conference call and webcast on Friday, May 24, 2024 at 8:00 am EDT to provide update on RAMP 201 and rolling NDA submission
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