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Business Upturn
22-05-2025
- Business
- Business Upturn
Bicara Therapeutics Announces Publication of an Abstract with Updated Interim Data from Phase 1/1b Trial of Ficerafusp alfa in 1L R/M HNSCC at the 2025 ASCO Annual Meeting
BOSTON, May 22, 2025 (GLOBE NEWSWIRE) — Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the publication of an abstract with updated interim data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website. The company will host a conference call on Sunday, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET to present the fulsome dataset, including overall survival (OS) and duration of response (DOR) data, following an oral presentation of the data at the ASCO Annual Meeting. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers within the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). 'We are pleased to present the fulsome dataset from our Phase 1/1b trial of ficerafusp alfa in patients with recurrent/metastatic head and neck squamous cell carcinoma during our upcoming oral presentation at ASCO,' said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. 'The interim data featured in the ASCO abstract demonstrate encouraging signals that represent a meaningful improvement over historical benchmarks in patients with HPV-negative disease, a population with high unmet need and worse survival outcomes than those with HPV-positive disease. Notably, we're encouraged to see how ficerafusp alfa, specifically designed to drive tumor penetration within the tumor microenvironment, is leading to deep, and now, durable responses that appear to be translating to prolonged overall survival.' ASCO Presentation Details Christine Chung, MD, Chair, Department of Head and Neck-Endocrine Oncology and Program Leader of Head and Neck Oncology at Moffitt Cancer Center will present the fulsome dataset during an oral presentation at the 2025 ASCO Annual Meeting, on behalf of the patients and investigators who have contributed to this clinical trial. Title: Ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: Updated results from an expansion cohort of an open-label, multicenter, phase 1/1b trial Abstract #: 6017 Session Title: Rapid Oral Abstract Session Session Category: Rapid Oral Abstract Session Session Date and Time: 6/1/2025 12:12 – 12:18 p.m. CT Location: McCormick Place Convention Center Key highlights of the abstract include: Updated interim data (December 16, 2024 cutoff date) from the Phase 1/1b clinical trial of ficerafusp alfa in patients with 1L R/M HNSCC patients with a PD-L1 combined positive score (CPS) of ≥1. In the efficacy evaluable human papillomavirus (HPV)-negative population (n=28): 64% (18/28) objective response rate, including 21% (6/28) of patients who achieved a complete response. Median progression-free survival was 9.8 months (95% CI: 4.4–23.2) and the 12-month OS rate was 61% (95% CI: 40–76%). Median overall survival (mOS) and median DOR had not been reached yet, with mOS surpassing 20 months. Safety findings were consistent with the known safety profile of ficerafusp alfa plus pembrolizumab. Data from paired tumor biopsies demonstrated encouraging post-treatment downregulation of phospho-SMAD2, supporting targeted TGF-β inhibition. Company Conference Call Details Bicara Therapeutics will host a conference call and webcast on Sunday, June 1, 2025 at 3:00 p.m. CT / 4:00 p.m. ET. Individuals may register for the conference call by clicking the link here. Once registered, participants will receive dial-in details and unique PIN which will allow them to access the call. An audio webcast will be accessible through the Investor Relations section of the Bicara's website under Events and Presentations. Following the live webcast, an archived replay will also be available. About Head and Neck Squamous Cell Carcinoma Head and neck squamous cell carcinomas (HNSCCs) develop from the mucosal epithelium in the oral cavity, pharynx and larynx and are the most common malignancies that arise in the head and neck. HNSCC is one of the most common cancers in the United States and globally with a rising incidence anticipated to reach one million new global cases annually by 2030. Ten percent of HNSCC patients are diagnosed with metastatic disease and up to 30% develop a recurrence or metastases over time after receiving initial treatment for advanced HNSCC. Most cases of HNSCC are thought to result from accumulated mutations caused by carcinogenic exposures such as tobacco smoke or HPV infection. Approximately 80% of patients with R/M HNSCC are HPV-negative. These HPV-negative tumors often exhibit a recurrence pattern that is primarily local and are associated with severe morbidities, including fatal tumor bleeding, intense pain, difficulty swallowing, significant weight loss, and cachexia. This highlights a critical unmet need for therapies that have the potential to deliver durable anti-tumor responses, ultimately leading to meaningful improvements in patients' quality of life. About Ficerafusp Alfa Ficerafusp alfa is a first-in-class bifunctional antibody designed to drive tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this targeted mechanism, ficerafusp alfa reverses the fibrotic and immune-excluded tumor microenvironment driven by TGF-β signaling to enable tumor penetration that drives deep and durable responses. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). About Bicara Therapeutics Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara's lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit or follow us on LinkedIn or X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Bicara's clinical development of ficerafusp alfa in combination with pembrolizumab and presentation of updated results from an open-label, multicenter phase 1/1b trial of ficerafusp alfa with pembrolizumab in patients with recurrent or metastatic head and neck squamous cell carcinoma , and the expected therapeutic potential and clinical benefits of ficerafusp alfa, including potential efficacy, depth, durability and tolerability. The words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'expect,' 'estimate,' 'seek,' 'predict,' 'future,' 'project,' 'potential,' 'continue,' 'target' and similar words or expressions, or the negative thereof, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct and enrollment of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials and regulatory developments in the United States and foreign countries, whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission (SEC), including in Bicara's most recent Annual Report on Form 10-K, as well as any subsequent filings that Bicara makes with the SEC. In addition, forward-looking statements represent Bicara's views only as of today and should not be relied upon as representing its views as of any subsequent date. Bicara explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Contacts InvestorsRachel Frank [email protected]
New York Times
11-03-2025
- New York Times
Your Bag's Hidden Journey From Check-In to Plane
Visuals by Graham Dickie Text by Christine Chung Checking a bag is an exercise in trust. The hope? That you will be reunited painlessly with your possessions after many labor-intensive steps involving heavy machinery and numerous workers, often across multiple airports. While several million bags end up getting lost or damaged by U.S. airlines every year, the overwhelming majority of checked baggage (some 480 million bags in 2023) are returned to their owners. Checking your bag involves a significant amount of human effort: The average checked bag flown with Delta Air Lines is guided by nine people, including ticket agents and a handful of baggage handlers. We recently spent a day at LaGuardia Airport's Terminal C, to get an inside look at the journey of a bag checked with Delta. At the check-in counter Our bag was checked onto DL994, a daily flight departing LaGuardia at 12:59 p.m. and bound for Hartsfield-Jackson Atlanta International Airport. Ideally, checking a bag takes just a few minutes, barring long lines at the terminal. Customers begin the process at a self-service kiosk or at the counter with a ticket agent. (T.S.A. PreCheck travelers flying Delta can shave off more time by using Digital ID, a document-free process that relies on biometrics.)Bag tags are printed with essential information about your itinerary, including whether you have a tight connection. A chip with radio frequency identification technology is embedded in the tag — about the size of a nickel — and scanned at different points, providing regular location updates to the airline. After the tag is attached to the bag, a ticket agent takes the luggage and places it on the conveyor belt, which transports it to be screened by the Transportation Security Administration. T.S.A. screening Within a few minutes, the bag reaches T.S.A. screening. The agency uses C.T. scanning machines, which allow for 3-D analysis of a bag's contents. T.S.A. agents don't need to be present for this Delta and the overall airline industry, the number of passengers — and checked bags — has risen steadily in recent years. If a bag is flagged, it trundles on the conveyor belt over to a second room for additional screening. Here, T.S.A. agents may open it, breaking luggage locks if necessary, and pore over the contents to ensure there aren't weapons, explosives or other threats. Overstuffed bags can complicate this process, agents said. Duffel bags aren't easy to sift through, either. Agents will leave a notice of baggage inspection, playfully referred to as a 'T.S.A. love note.' The process for pets traveling as checked baggage differs. Pets don't travel on the conveyor belt and are screened by hand, a T.S.A. spokeswoman said. And the animals are loaded into the plane last and unloaded first upon arrival, a Delta spokeswoman said. Oversize luggage continues on the conveyor belt after screening, like other baggage. Ramp agents are constantly monitoring luggage flow on the conveyor belts. Jams can be caused by irregularly shaped or damaged bags and loose straps or zippers. Checked toolboxes, which can snag the belts, are also a culprit, T.S.A. agents said. Last year at LaGuardia, Delta handled four million checked bags on 81,000 flights, a spokeswoman said. Across its entire operations worldwide, Delta handled more than 145 million checked bags in 2024, about five million more than the previous year. The bag room The conveyor belt system at Terminal C is lengthy, clocking in at about three miles. The belts move the luggage from bag drop to screening and then to a carousel in the baggage room. Ramp agents then hoist the luggage into carts driven to the are loaded into carts and organized by whether they're local (to be picked up at the next destination), connecting or 'hot' — at LaGuardia, that refers to a bag that has a connection of less than an hour. Then ramp agents drive the carts to the planes. Agents can heft hundreds of bags daily. They take pride in the neatness and efficiency of their 'stack,' said Jordan Machado, a ramp department manager for Delta at LaGuardia. Stacking bags is 'a whole competition sport' among the ramp agents, Mr. Machado said. Onto the tarmac and onto the plane Ramp agents face a number of challenges inherent to the job: noisy conditions, inclement weather and strain on the body. Delta refers to these employees as 'industrial athletes.' For each departure at Terminal C, there's a handful of agents handling luggage: a pair pulling the bags off the belt and a trio getting the bags loaded onto the plane and prepping it for takeoff. For DL994, ramp agents began loading bags into the plane's cargo hold shortly after noon. The number of bags that can fit depends on the type of plane and on stacking strategy, like a game of Tetris. Each bag is scanned again as it enters the are loaded into different bins depending on factors that include connection time and whether the passenger is in a priority cabin. (Upon arrival, this generally means that elite Delta fliers will get their bags unloaded first.) Graham Dickie/The New York Times
Associated Press
20-02-2025
- Business
- Associated Press
FibroGen Announces the Sale of FibroGen China to AstraZeneca for Approximately $160 Million
Purchase price represents enterprise value of $85 million plus FibroGen net cash held in China at closing, currently estimated to be approximately $75 million Upon close, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company's capital structure Company's cash runway extended into 2027 Company to continue to advance its oncology pipeline, with the initiation of the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) in 2Q 2025 Preliminary unaudited cash, cash equivalents, and accounts receivable of $121.1 million as of December 31, 2024 FibroGen to host conference call and webcast presentation today at 8:30 AM ET SAN FRANCISCO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the sale of its China subsidiary to AstraZeneca for approximately $160 million. 'Today, we announced the sale of FibroGen China to AstraZeneca, our long-time strategic partner for roxadustat in China, bolstering our company on several fronts. It strengthens our financial position, meaningfully extending our cash runway into 2027, and enables us to continue progressing the clinical development program for FG-3246, our first-in-class, CD46 targeting antibody drug conjugate, and FG-3180, our companion PET imaging agent, in mCRPC,' said Thane Wettig, Chief Executive Officer of FibroGen. 'After a thorough evaluation of alternatives, we believe selling our China operations and repaying our term loan is in the best interest of FibroGen's stakeholders. We are grateful for our China colleagues, and in particular Christine Chung, our Head of China Operations, for their unwavering commitment to patients and successful commercialization of roxadustat in China. Now, we turn the page to the next exciting chapter for FibroGen.' Under the terms of the agreement, FibroGen will receive an enterprise value of $85 million plus FibroGen net cash held in China at closing, currently estimated to be approximately $75 million, totaling approximately $160 million. The transaction is expected to close by mid-2025, pending customary closing conditions, including regulatory review in China. Following the close of the transaction, FibroGen will repay its term loan facility to investment funds managed by Morgan Stanley Tactical Value, further simplifying the Company's capital structure. The combined transactions are expected to extend the Company's cash runway into 2027. Upon closing, AstraZeneca will obtain all rights to roxadustat in China. Roxadustat is the category leader in brand value share for the treatment of anemia in chronic kidney disease with a pending regulatory decision for chemotherapy-induced anemia. FibroGen maintains its rights to roxadustat in the U.S. and in all markets not licensed to Astellas. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS), a high-value indication with significant unmet medical need. The Company is planning for an FDA meeting in the second quarter of 2025 to determine the potential next steps for the development program for roxadustat in the U.S. In addition, FibroGen continues to advance the clinical development of its lead asset, FG-3246, and its companion PET imaging agent, FG-3180, with the initiation of the Phase 2 monotherapy trial of FG-3246 in patients with mCRPC expected in the second quarter of 2025. BofA Securities, Inc. is acting as exclusive financial advisor and Ropes & Gray LLP is acting as legal advisor to FibroGen on this transaction. Conference Call and Webcast Presentation FibroGen management team will host a conference call and webcast presentation today, February 20, 2025 at 8:30 a.m. ET to discuss the sale of FibroGen China. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen's website. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit Forward-Looking Statements This release contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the net cash portion of the purchase price and closing of the sale of FibroGen China as well as the payoff of the Morgan Stanley Tactical Value term loan, use of proceeds, and statements regarding the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund FibroGen's operating plans into 2027, and statements about FibroGen's plans and objectives. These forward-looking statements are typically identified by use of terms such as 'may,' 'will', 'should,' 'on track,' 'could,' 'expect,' 'plan,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'continue' and similar words, although some forward-looking statements are expressed differently. FibroGen's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
