Latest news with #Phase1
Business Wire
8 hours ago
- Business
- Business Wire
Sonoma Biotherapeutics Announces Poster Presentation at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress
SOUTH SAN FRANCISCO, Calif. & SEATTLE--(BUSINESS WIRE)-- Sonoma Biotherapeutics, Inc., a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases, will be sharing a poster presentation at the 2025 European Alliance of Associations for Rheumatology (EULAR) Congress, taking place in Barcelona on June 11-14, 2025. Details of the presentations are as follows: Poster Presentation Details: Title: 'REGULATE-RA: A Phase 1 Study of CAR-Treg Cells Targeting Citrullinated Proteins in Refractory Rheumatoid Arthritis: Interim Report of Patient Characteristics and Safety' Presenting Author: Sarah K. Baxter, MD, PhD Poster number: POS0034 Session: Clinical Poster Tours: Difficult to treat Rheumatoid Arthritis Date/ Time: Location: Poster Tour IV About Sonoma Biotherapeutics Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Treg cell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle. For more information, visit and follow on X, formerly Twitter, and LinkedIn.
National Post
22-05-2025
- Health
- National Post
Ventus Therapeutics to Present Phase 1 Results for VENT-03, a First-in-Class cGAS Inhibitor, at LUPUS 2025
Article content WALTHAM, Mass. & MONTREAL — Ventus Therapeutics, a clinical-stage biopharmaceutical company advancing two Phase 2 small-molecule programs for immunological, inflammatory, and neurological disorders, today announced the upcoming presentation of the Phase 1 safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) results of VENT-03 at the 16 th International Congress on Systemic Lupus Erythematosus (LUPUS 2025), taking place from May 21-24 in Toronto, Canada. Article content VENT-03 is the first oral small-molecule cyclic GMP-AMP synthase (cGAS) inhibitor to successfully complete a first-in-human Phase 1 study and was discovered using Ventus' proprietary ReSOLVE ® platform. Data from the Phase 1 study, initially announced in October 2024, showed that VENT-03 was safe and well tolerated at all tested dose levels with a favorable PK profile enabling once-daily dosing. Article content 'We are pleased to present at LUPUS 2025 the first reported Phase 1 results for a cGAS inhibitor, demonstrating that VENT-03 has the potential to become a first- and best-in-class therapy for lupus and other autoimmune disorders,' said Marcelo Bigal, M.D., Ph.D., President and CEO of Ventus. 'Ventus is eager to unlock the potential of cGAS inhibition across multiple autoimmune diseases, with the first Phase 2 trial evaluating VENT-03 in patients with lupus to commence later this year.' Article content The Phase 1, double-blind, placebo-controlled, first-in-human trial included 72 healthy adult volunteers across single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. The study results show that VENT-03 was safe and well tolerated up to single doses of 2000 mg once daily (QD) and multiple dosing of 900 mg QD for 10 days, which are substantially higher than our anticipated Phase 2 dose. The proportion of participants with adverse events (AEs) in the MAD cohorts was similar for VENT-03 and placebo (79% vs. 75%), and the vast majority of AEs in the study were mild and considered unrelated to the study drug. The PK profile of VENT-03 supports once-daily dosing with or without food, and the PD results demonstrate robust target engagement, supporting further clinical development. Article content 'More than five million people worldwide are estimated to have a form of lupus. These patients can experience disease progression and severe symptoms that can affect quality of life, and currently available treatment options may not be able to adequately address these symptoms for all patients,' said Mona Kotecha, M.D., Chief Medical Officer of Ventus. 'Through targeting cGAS, VENT-03 has the potential to become a safer and more effective treatment option for patients in need, addressing key unmet needs across multiple organ systems while providing the additional benefit of once-daily oral dosing. We look forward to sharing these results and to connecting with the wider lupus community at LUPUS 2025.' Article content Details of the poster presentation are as follows: Article content Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers of VENT-03, a Novel cGAS Inhibitor for the Treatment of Systemic Lupus Erythematosus Authors: Xavier Valencia, Kelly Pike, Loraine Warner, Conrad Winters, Jeanne Stewart, Ramsay Beveridge, Patrick Cyr, Nadine Fradet, Amandine Chefson, Ofer Spiegelstein Abstract Number: Poster 286 Session Date: May 22 nd Article content cGAS is an intracellular pattern recognition receptor that is activated after binding to double-stranded DNA (dsDNA) in the cytoplasm. The presence of dsDNA in the cytoplasm is often the result of cellular dysfunction, which is a hallmark of many autoimmune and inflammatory diseases. Activation of cGAS leads to cGAMP formation, activation of STING, pronounced inflammation, and tissue damage. In both patients and preclinical models of disease, the cGAS pathway has been shown to be a key driver of lupus and other inflammatory diseases, such as rheumatoid arthritis, systemic sclerosis, dermatomyositis, and Sjögren's disease. Article content Ventus Therapeutics is a clinical-stage biopharmaceutical company advancing two Phase 2 small-molecule programs for immunological, inflammatory, and neurological disorders. Using its proprietary drug discovery platform, ReSOLVE ®, the company has established a robust pipeline, including two wholly-owned programs. VENT-03 is a first-in-class, oral cGAS inhibitor expected to enter Phase 2 development for lupus in 2025. VENT-02 is a best-in-class, brain-penetrant, oral NLRP3 inhibitor in Phase 2 for Parkinson's disease, and is expected to enter Phase 2 development for osteoarthritis in obese patients later in 2025. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted, oral NLRP3 inhibitor in Phase 1, to Novo Nordisk A/S. For more information, please visit and engage with Ventus on LinkedIn. Article content Article content Article content Article content Article content Contacts Article content Media Dan Budwick 1AB dan@ Article content Article content
Reuters
22-05-2025
- Business
- Reuters
US ag sector should be on alert after last deal with China fell short
NAPERVILLE, Illinois, May 21 (Reuters) - Last week's U.S.-China trade truce has sparked speculation as to what a potential trade deal between the two rivals might look like. For the U.S. agriculture sector, the result would ideally be very different from the deal signed in January 2020 during Donald Trump's first U.S. presidency. That agreement, known as Phase 1, required China to significantly boost purchases of U.S. agricultural products. China ultimately came up short, but the structure of the deal itself was probably doomed from the start. It didn't help that enforcement and extension of the deal were practically nonexistent, especially as the U.S. presidency changed hands in 2021. U.S. officials recently suggested that China's failure to make good on Phase 1 purchase commitments be revisited. So let's re-examine the flaws of Phase 1 from an agricultural perspective, just in case a similar deal is proposed this time around. China's purchase commitments laid out by Phase 1 were based on dollar value, which immediately raised flags. The agreement suggested China would buy a record $36.5 billion in U.S. farm goods in 2020, some 50% above the pre-trade war average. A simple exercise can bring perspective. Soybeans, the top U.S. export of any kind to China, accounted for roughly half the value of all annual U.S. farm exports to China at the time. Given the average cost of exporting U.S. beans to China in 2019, when Phase 1 was formulated, the 2020 volume of shipments needed to jump 43% above the 2016 record. Where was this sudden, massive surge in Chinese soybean demand supposed to come from? Apparently, it never had to exist. China said from day one that it would purchase American goods per the deal based on market conditions, and that it had no intent to buy in excess. This clause basically deemed Phase 1 dead on arrival, but otherwise, a steep rise in global prices was the only possible way for the targets to be fulfilled. That eventually happened as global grain and oilseed prices neared or bested records in 2022. U.S. soybean shipments to China in 2022 were valued at a record $17.9 billion, up from $14.1 billion in 2020. But the 2022 volume was 12% lower than in 2020, meaning the high prices were masking a reduction in Chinese bookings. Phase 1 stated that China's increasing U.S. purchase trajectory was to continue from 2022 through 2025. China would have still fallen short of targets in 2022 despite the price levels, but the binding part of the deal seemingly expired after 2021. The Biden administration throughout its tenure was notoriously quiet on U.S.-China trade and enforcement of the Trump-era agreement, and Phase 1 essentially went dark after 2021. The concept of requiring China to purchase extreme volumes of U.S. farm goods conflicts with Trump's 'America First' agenda, as it overlooks domestic supply needs in favor of China. Another issue is that aside from being unrealistic, the Phase 1 purchasing targets seemed arbitrary. No explanation of the $36.5 billion goal was ever offered, but in hindsight, Trump's disdain for trade deficits could be a potential origin. The current state of U.S. agricultural trade with China is ugly. By value, U.S. farm exports to China in the first three months of 2025 were down 49% on the year, reaching some of the lowest levels within the last two decades. If China does agree to something that seems far-fetched, close attention is immediately warranted as Beijing seems to negotiate with back-pocket knowledge. No one thought China was smart to slap steep tariffs on U.S. soybeans in 2018, but Beijing likely knew something the rest of the world did not. Sweeping losses from disease across China's hog herd reduced feed demand and allowed Chinese buyers to avoid U.S. beans for a while, against sound calculations that they would not be able to do so. China may have also sensed that 2020 was going to be a wild ride. The World Health Organization one day before the signing of Phase 1 was already ringing alarm bells worldwide about a dangerous virus originating in China. This level of strategy that China has employed in recent trade conflicts should certainly raise the stakes for the U.S. side, which could perhaps benefit from a more sensible, sustainable approach to future negotiations. Karen Braun is a market analyst for Reuters. Views expressed above are her own.
RTÉ News
13-05-2025
- Business
- RTÉ News
What does US-China tariffs' truce mean for ongoing trade war?
By , University of Adelaide and Nathan Howard Gray, University of Adelaide Defying expectations, the United States and China have announced an important agreement to de-escalate bilateral trade tensions after talks in Geneva. The good news is their recent tariff increases will be slashed. The US has cut tariffs on Chinese imports from 145% to 30%, while China has reduced levies on US imports from 125% to 10%. This greatly eases major bilateral trade tensions, and explains why financial markets rallied. From RTÉ Radio 1's Today with Claire Byrne, Richard Curran from The Business on US and China agreement to slash tariffs The bad news is twofold. First, the remaining tariffs are still high by modern standards. The US average trade-weighted tariff rate was 2.2% on January 1 2025, while it is now estimated to be up to 17.8%. This makes it the highest tariff wall since the 1930s. Overall, it is very likely a new baseline has been set. Bilateral tariff-free trade belongs to a bygone era. Second, these tariff reductions will be in place for 90 days, while negotiations continue. Talks will likely include a long list of difficult-to-resolve issues. China's currency management policy and industrial subsidies system dominated by state-owned enterprises will be on the table. So will the many non-tariff barriers Beijing can turn on and off like a tap. China is offering to purchase unspecified quantities of US goods – in a repeat of a US-China "Phase 1 deal" from Trump's first presidency that was not implemented. On his first day in office in January, amid a blizzard of executive orders, Trump ordered a review of that deal's implementation. The review found China didn't follow through on the agriculture, finance and intellectual property protection commitments it had made. Unless the US has now decided to capitulate to Beijing's retaliatory actions, it is difficult to see the US being duped again. Failure to agree on these points would reveal the ugly truth that both countries continue to impose bilateral export controls on goods deemed sensitive, such as semiconductors (from the US to China) and processed critical minerals (from China to the US). Moreover, in its so-called "reciprocal" negotiations with other countries, the US is pressing trading partners to cut certain sensitive China-sourced goods from their exports destined for US markets. China is deeply unhappy about these US demands and has threatened to retaliate against trading partners that adopt them. A temporary truce Overall, the announcement is best viewed as a truce that does not shift the underlying structural reality that the US and China are locked into a long-term cycle of escalating strategic competition. That cycle will have its ups (the latest announcement) and downs (the tariff wars that preceded it). For now, both sides have agreed to announce victory and focus on other matters. For the US, this means ensuring there will be consumer goods on the shelves in time for Halloween and Christmas, albeit at inflated prices. For China, it means restoring some export market access to take pressure off its increasingly ailing economy. From RTÉ Radio 1's Brendan O'Connor Show, "the Chinese public wonder has America gone mad". Irish Times China correspondent Denis Staunton on Chinese reaction to the trade war with the US As neither side can vanquish the other, the likely long-term result is a frozen conflict. This will be punctuated by attempts to achieve "escalation dominance", as that will determine who emerges with better terms. Observers' opinions on where the balance currently lies are divided. Along the way, and to use a quote widely attributed to Winston Churchill, to "jaw-jaw is better than to war-war". Fasten your seat belts, there is more turbulence to come. Where does this leave everyone else? Significantly, the US has not (so far) changed its basic goals for all its bilateral trade deals. Its overarching aim is to cut the goods trade deficit by reducing goods imports and eliminating non-tariff barriers it says are "unfairly" prohibiting US exports. The US also wants to remove barriers to digital trade and investments by tech giants and "derisk" certain imports that it deems sensitive for national security reasons. The agreement between the US and UK last week clearly reflects these goals in operation. While the UK received some concessions, the remaining tariffs are higher, at 10% overall, than on April 2 and subject to US-imposed import quotas. Furthermore, the UK must open its market for certain goods while removing China-originating content from steel and pharmaceutical products destined for the US. As neither side can vanquish the other, the likely long-term result is a frozen conflict. For Washington's Pacific defence treaty allies, including Australia, nothing has changed. Potentially difficult negotiations with the Trump administration lie ahead, particularly if the US decides to use our security dependencies as leverage to wring concessions in trade. Japan has already disavowed linking security and trade, and their progress should be closely watched. The US has previously paused high tariffs on manufacturing nations in South-East Asia, particularly those used by other nations as export platforms to avoid China tariffs. Vietnam, Cambodia and others will face sustained uncertainty and increasingly difficult balancing acts. The economic stakes are higher for them. They, like the Japanese, are long-practised in the subtle arts of balancing the two giants. Still, juggling ties with both Washington and Beijing will become the act of an increasingly high-wire trapeze artist.
Associated Press
12-05-2025
- Business
- Associated Press
CytomX Announces Positive Interim Data From Phase 1 Dose Escalation Study of EpCAM Antibody Drug Conjugate (CX-2051) Candidate in Patients with Advanced Colorectal Cancer (CRC)
- 28% confirmed response rate (5/18) per RECIST v1.1 in unselected patientsacross doses prioritized for expansion (7.2, 8.6 and 10 mg/kg Q3W)- - 3 of 7 evaluable patients (43%) with confirmed responses at upper expansion dose (10 mg/kg Q3W) - - Median progression free survival of 5.8 months as of April 7th2025 data cutoff - - Encouraging initial safety profile with no dose limiting toxicities at data cutoff - - Planning Phase 2 study initiation in 1H 2026 - - Conference call on Monday, May 12 at 8:00 a.m. ET - SOUTH SAN FRANCISCO, Calif., May 12, 2025 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, today announced positive interim Phase 1 data for its EpCAM PROBODY® ADC candidate, CX-2051, in advanced, late-line CRC. The data are as of an April 7th 2025 data cutoff from the ongoing CTMX-2051-101 Phase 1 study. 'EpCAM is a high potential and broadly expressed cancer target that has been challenging to drug historically due to expression on normal tissues. We believe we have broken important new ground with our data announced today, which show potential for markedly improved outcomes for CRC patients,' said Sean McCarthy, D. Phil, chief executive officer and chairman of CytomX. 'CX-2051 is showing impressive, durable anti-tumor activity in late line metastatic CRC, an area of high unmet need and a very difficult tumor to treat. Furthermore, CX-2051 has been generally well tolerated, highlighting the power of CytomX PROBODY® masking technology.' Dr. McCarthy added, 'Importantly, we believe these results validate EpCAM as an oncology target and unlock a broad development opportunity for CX-2051 in CRC and potentially many other cancer types where EpCAM is expressed. We are excited to rapidly advance CX-2051 for the benefit of CRC patients and to explore the full potential of this novel ADC.' CX-2051 Phase 1a Interim Data Summary in Advanced, Late-line Colorectal Cancer Patient Characteristics: Efficacy Results: As of the data cutoff, 18 patients were efficacy-evaluable at the expansion doses of 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg Q3W. Safety Results: As of the data cutoff, 25 patients were evaluable for safety. CX-2051 Phase 1 Dose Expansions Initiated: CX-2051 Anticipated Milestones: CytomX Investor Event Information Additional details will be provided on the Company's Investor Call on May 12, 2025 at 8 a.m. EST. Participants may access the live webcast of the conference call from the Events and Presentations page of CytomX's website at Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. An archived replay of the webcast will be available on the company's website for at least 30 days. About CTMX-2051-101 Study Additional information about the CTMX-2051-101 study can be found here on About CX-2051 (EpCAM PROBODY® ADC) CX-2051 is an investigational masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM) and armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC, and was discovered in collaboration with ImmunoGen, now part of AbbVie. EpCAM (Epithelial Cell Adhesion Molecule) is a highly expressed but previously undruggable tumor antigen due to expression on normal tissues. CX-2051 is designed to open a therapeutic window for this high potential target and to deliver meaningful anti-cancer activity in solid tumors, including CRC. About CytomX Therapeutics CytomX is a clinical-stage, oncology-focused biopharmaceutical company focused on developing novel conditionally activated, masked biologics designed to be localized to the tumor microenvironment. By pioneering a novel pipeline of localized biologics, powered by its PROBODY® therapeutic platform, CytomX's vision is to create safer, more effective therapies for the treatment of cancer. CytomX's robust and differentiated pipeline comprises therapeutic candidates across multiple treatment modalities including antibody-drug conjugates (ADCs), T-cell engagers, and immune modulators such as cytokines. CytomX's clinical-stage pipeline includes CX-2051 and CX-801. CX-2051 is a masked, conditionally activated ADC directed toward epithelial cell adhesion molecule (EpCAM), armed with a topoisomerase-1 inhibitor payload. CX-2051 has potential applicability across multiple EpCAM-expressing epithelial cancers, including CRC. CX-801 is a masked interferon alpha-2b PROBODY® cytokine with broad potential applicability in traditionally immuno-oncology sensitive as well as insensitive (cold) tumors. CytomX has established strategic collaborations with multiple leaders in oncology, including Amgen, Astellas, Bristol Myers Squibb, Regeneron and Moderna. For more information about CytomX and how it is working to make conditionally activated treatments the new standard-of-care in the fight against cancer, visit and follow us on LinkedIn and X (formerly Twitter). CytomX Therapeutics Forward-Looking Statements This press release includes forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements, including those related to CX-2051. Accordingly, you should not rely on any of these forward-looking statements, including those relating to the potential benefits, safety and efficacy or progress of CytomX's or any of its collaborative partners' product candidates, including CX-2051 and CX-801, the potential benefits or applications of CytomX's PROBODY® therapeutic platform, CytomX's or its collaborative partners' ability to develop and advance product candidates into and successfully complete clinical trials, including the ongoing and planned clinical trials of CX-2051 and CX-801 and the timing of initial and ongoing data availability for our clinical trials, including CX-2051 and CX-801, and other development milestones. Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include: the unproven nature of CytomX's novel PROBODY® therapeutic technology; uncertainties around the Company's ability to raise sufficient funds to carry out its planned research and development; CytomX's clinical trial product candidates are in the initial stages of clinical development and its other product candidates are currently in preclinical development, and the process by which preclinical and clinical development could potentially lead to an approved product is long and subject to significant risks and uncertainties, including the possibility that the results of preclinical research and early clinical trials, including initial CX-2051 results, may not be predictive of future results; the possibility that CytomX's clinical trials will not be successful; the possibility that current preclinical research may not result in additional product candidates; CytomX's dependence on the success of CX-2051 and CX-801; CytomX's reliance on third parties for the manufacture of the Company's product candidates; possible regulatory developments in the United States and foreign countries, including China and the European Union; and the risk that we may incur higher costs than expected for research and development or unexpected costs and expenses or may not obtain expected savings from our announced restructuring. Additional applicable risks and uncertainties include those relating to our preclinical research and development, clinical development, and other risks identified under the heading 'Risk Factors' included in CytomX's Quarterly Report on Form 10-Q filed with the SEC on May 12, 2025. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise. PROBODY is a U.S. registered trademark of CytomX Therapeutics, Inc. All other trademarks are the properties of their respective owners. Company Contact: Chris Ogden SVP, Chief Financial Officer [email protected] Investor Contact: Precision AQ (formerly Stern Investor Relations) Stephanie Ascher [email protected] Media Contact: Redhouse Communications Teri Dahlman [email protected] 1 Lonsurf®, Fruzaqla®, Stivarga® package inserts 2 Disease Control Rate: Patients achieving a best response of stable disease, partial response, or complete response.
