- Fitch Rates TransCanada PipeLines Limited’s Proposed Junior Subordinated Notes Offering ‘BBB-‘ Fitch Ratings
- TC Energy On Consideration Of U.S. Junior Subordinated Notes Offering By TransCanada PipeLines Limited MarketScreener
- TC Energy Brief: Announcing Consideration Of U.S. Junior Subordinated Notes Offering By TransCanada PipeLines Limited MarketScreener
Category: 3. Business
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Fitch Rates TransCanada PipeLines Limited's Proposed Junior Subordinated Notes Offering 'BBB-' – Fitch Ratings
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Global economic growth buoyed by signs of consumer upturn – S&P Global
- Global economic growth buoyed by signs of consumer upturn S&P Global
- JP Morgan: Global factory activity expands for second month in September Australian Manufacturing
- Global PMIs: Stockpiling continued in September – Standard Chartered FXStreet
- Global manufacturing PMI declines slightly in September bastillepost.com
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Efficacy, safety, and exploratory biomarker analysis of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: a prospective, single-arm, phase II trial | BMC Medicine
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Johnson Controls announces investment in data center liquid cooling company Accelsius
CORK, Ireland, Oct. 6, 2025 /PRNewswire/ -- Johnson Controls, the leader in smart, healthy and sustainable buildings, today announced a multi-million dollar strategic investment in Accelsius, a leader in two-phase, direct-to-chip liquid cooling technology for data centers. Two-phase solutions use 'phase change' from liquid to vapor to remove heat, enabling more efficient heat extraction with reduced energy consumption.
Cooling is among the most critical equipment in a data center, efficiently and reliably keeping the chips at the right temperature that are foundational to the digital economy and our everyday lives. However, with cooling systems accounting for 30% to 40% of a data center's total energy, deploying energy- and water-efficient cooling solutions is one of the industry's most pressing challenges.
"With the sharp growth in AI, cooling innovation has become a front-line imperative to meet the increasing demands of high-density data centers," said Austin Domenici, vice president and general manager, Johnson Controls Global Data Center Solutions. "Leveraging our leading capabilities, our mission is to drive the industry forward to unlock new levels of energy efficiency across the cooling chain."
"With power-dense AI workloads, data centers are moving to liquid cooling," said Josh Claman, CEO of Accelsius. "Our two-phase, direct-to-chip (D2C) cooling solutions use non-conductive fluids in highly efficient loops to stay ahead of the demanding power-dense AI and HPC workloads. This technology enables 35% OpEx savings over single-phase direct-to-chip and 8–17% total cost of ownership savings."
Johnson Controls has already pioneered a number of breakthrough innovations for data centers including its YORK® YVAM magnetic bearing chiller – a solution that consumes 40% less power annually as other available solutions with zero on-site water consumption, demonstrating how advanced technology can deliver sustainability and meaningful societal benefits. The technology was recently named to Fortune's "Change the World" list, and recognized as a data center leader, top innovator and top leader by ABI Research. In addition, the company recently launched its Silent-Aire Coolant Distribution Unit (CDU) platform offering a wide range of scalable cooling capacities from 500kW to over 10MW in flexible designs that can meet the needs of any data center. By adopting Johnson Controls' comprehensive thermal management solutions, owners and operators can significantly improve total facility efficiency, reducing non-IT energy consumption by more than 50% in most North American data center hubs.
About Johnson Controls:
At Johnson Controls (NYSE:JCI), we transform the environments where people live, work, learn and play. As the global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet.
Building on a proud history of nearly 140 years of innovation, we deliver the blueprint of the future for industries such as healthcare, schools, data centers, airports, stadiums, manufacturing and beyond through OpenBlue, our comprehensive digital offering.
Today, Johnson Controls offers the world`s largest portfolio of building technology and software as well as service solutions from some of the most trusted names in the industry.
Visit johnsoncontrols.com for more information and follow @Johnsoncontrols on social platforms.
About Accelsius
Founded by Innventure, Inc. (NASDAQ:INV), Accelsius empowers data center and edge operators to achieve their business, financial and sustainability goals through advanced cooling solutions. The proprietary NeuCool platform provides best-in-class thermal efficiencies through a safe, two-phase liquid cooling system that scales from single racks to entire data centers. For more information, visit accelsius.com or follow us on LinkedIn.
SOURCE Johnson Controls International plc
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Lessons from Hamburg Commissioner for Data Protection and Freedom of Information’s €492,000 Fine : Clyde & Co
A € 492,000 fine from the Hamburg Commissioner for Data Protection and Freedom of Information underscores the growing regulatory scrutiny of algorithmic decision-making and the critical importance of transparency and accountability in AI-driven processes. Not only EU GDPR but also the EU AI Act play a crucial role for user of AI (and its output) in decision-making.
1. Regulatory spotlight on algorithmic decisions
On 30 September 2025, the Hamburg Commissioner for Data Protection and Freedom of Information (HmbBfDI) published an interim report outlining administrative fines imposed for violations of the General Data Protection Regulation (Regulation (EU) 2016/679 – “GDPR”) during the current year (available here in German).
Among the cases highlighted, a financial services provider was fined nearly EUR 500,000 for failing to adequately fulfil its obligations under the GDPR. The case concerned the use of automated decision-making in credit card application processes, where applications were rejected despite applicants demonstrating good creditworthiness. The decisions in question were based on algorithms and were made without human oversight. When affected individuals requested information about the reasons for the rejection, the company failed to provide sufficient explanations, thereby breaching its information and access obligations under GDPR.
This enforcement action underlines the increasing regulatory scrutiny of algorithmic decision-making and the critical importance of transparency and accountability in AI-driven processes. In addition to the GDPR, the Artificial Intelligence Act (Regulation (EU) 2024/1689 – “AI Act”) will also be relevant in the future, as it contains further regulations, particularly regarding the use of high-risk AI systems, which complement the obligations of the GDPR.
2. Legal assessment
2.1 Article 22 GDPR
Under Article 22 (1) GDPR, individuals have the right not to be subject to decisions based solely on automated processing, including profiling, where such decisions produce legal effects or similarly significantly affect them. Exceptions apply only where the decision is necessary for entering into or performing a contract, authorised by Union or Member State law, or based on the data subject’s explicit consent.
In its landmark decision in SCHUFA Holding AG (C-634/21), the European Court of Justice (ECJ) clarified that credit scoring based on automated processing may fall within the scope of Article 22, particularly where the outcome significantly influences contractual decisions such as loan approvals. The ECJ emphasised that transparency obligations under Articles 13–15 GDPR are essential in such contexts, requiring controllers to provide:
- Meaningful information about the logic involved in the processing;
- The significance of the processing; and
- The envisaged consequences for the data subject.
As further analysed in our Insight on the ECJ’s decision concerning Dun & Bradstreet Austria GmbH (ECJ Ruling on Automated Decision-Making and Data Subject Access), the notion of “meaningful information about the logic involved” requires more than a generic description. It entails a level of detail that enables the data subject to understand the rationale behind the automated decision and to assess its fairness and impact.
In the Hamburg case, the company relied on automated systems to assess creditworthiness but failed to meet these informational obligations. The HmbBfDI found that the company did not adequately explain the logic behind its algorithmic decisions, nor did it provide sufficient access to the underlying rationale when requested. This lack of transparency constituted a breach of the GDPR and justified the imposition of a fine.
The case illustrates the practical implications of the ECJ’s rulings on SCHUFA and Dun & Bradstreet Austria GmbH, reinforcing that organisations deploying automated decision-making must ensure both legal justification and procedural transparency. Failure to do so may result in significant regulatory sanctions.
2.2 Beyond the GDPR: How Article 86 AI Act expands the right to explanation
When it comes to automated decision-making, companies do not only have to comply with the provisions of the GDPR, but also the AI Act. The AI Act introduces Article 86, which grants individuals the right to explanation when decisions are made using high-risk AI systems that significantly affect their rights, health, or safety. Article 86 AI Act will apply from 2 August 2026 on and complements the GDPR but differs in scope and emphasis:
- GDPR focuses on data protection and individual rights in automated processing.
- AI Act targets systemic risks and technical governance of AI systems, including transparency, human oversight, and documentation.
While the GDPR already implies a right to explanation through the above-mentioned Articles, Article 86 AI Act makes this even more explicit and ties it to high-risk AI systems listed in Annex III. It requires deployers to provide “clear and meaningful explanations of the role of the AI system in the decision-making procedure and the main elements of the decision taken.” This may also include AI systems used for decision-making in financial services as, among others, “AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score” also fall under the high-risk systems listed in Annex III of the AI Act (Annex III no. 5 (b) AI Act).
However, pursuant to Article 86 (3) AI Act, the right to explanation of individual decision-making in paragraph 1 shall only apply to the extent that it is not otherwise provided for under Union law. Articles 13 to 15, 22 GDPR already partially cover this right, meaning Article 86 (1) AI Act does not apply in these cases. This exclusion is, however, not absolute. The applicability of the provisions of the GDPR requires that an automated decision in individual cases pursuant to Art. 22 (1) GDPR be present. The characteristics of such automated decision are not identical to individual decisions based on the output of a high-risk AI system as required by Art. 86 (1) AI Act. Article 22 (1) of the GDPR only covers decisions “based solely on automated processing,” whereas for Article 86 (1) AI Act, decisions by the operator based solely on the output of AI systems are sufficient. The requirements for such decisions under Article 22 GDPR were further outlined by the SCHUFA ruling. In addition, the information referred to in Art. 86 (1) AI Act “on the role of the AI system in the decision-making process” goes beyond Art. 15 (1) lit. h of the GDPR and also beyond the requirements that the ECJ has formulated to date in the context of the right to information under the GDPR. This broader scope reflects the AI Act’s emphasis on system-level accountability and the need to explain not just the outcome, but the operational context of the AI system. Eventually, Article 86 (1) requires the relevant data to originate from a high-risk AI system, which in return is irrelevant for Article 22(1) GDPR.
Ultimately, Article 86 AI Act further protects the rights of data subjects. If an automated decision falls outside the scope of Article 22 GDPR, it may still be subject to Article 86 AI Act. This dual framework ensures that individuals are not left without recourse, even when automated decisions do not meet the strict criteria of the GDPR.
3. Practical takeaways
This case and the evolving legal landscape offer several key lessons:
- Transparency is non-negotiable: Companies must be able to explain automated decisions in a way that is understandable and meaningful to affected individuals.
- Documentation and oversight: Robust internal processes are essential to ensure compliance with both GDPR and the AI Act.
- Proactive engagement with regulators: Cooperation and remedial action can significantly mitigate penalties. In its press release, the HmbBfDI expressly highlighted the cooperation of the financial services provider. This was taken into account as a significant mitigating factor in determining the fine.
- Prepare for dual compliance: Businesses using AI systems should align their practices with both GDPR and AI Act, especially when deploying high-risk systems. This includes conducting impact assessments that address both data protection and AI-specific risks, and ensuring that explanations are tailored to the technical and legal context of each system.
As AI regulation matures, companies must move beyond technical compliance and embrace ethical and human-centric governance of automated decision-making. Even though automated decisions do not generally constitute a violation of the disclosure requirements under the GDPR and AI Act, companies should keep an eye on both sets of regulations (as well as future ones).
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Atebimetinib Plus Chemo Makes Case As Potential Frontline Option in Pancreatic Cancer
Atebimetinib (IMM-1-104) in combination with chemotherapy could represent a novel frontline treatment option for patients with metastatic pancreatic cancer, due to atebimetinib’s unique mechanism of action targeting MEK via intermittent deep cyclical inhibition, according to Martin F. Dietrich, MD, PhD.
Updated data from an ongoing phase 1/2 trial (NCT05585320) demonstrated that evaluable patients with treatment-naive metastatic pancreatic cancer who received atebimetinib in combination with modified gemcitabine and nab-paclitaxel (Abraxane; n = 34) experienced a 9-month overall survival (OS) rate of 86% and a median OS that was not reached.1 Additionally, the 9-month progression-free survival (PFS) rate was 53%. Conversely, prior data from the phase 3 MPACT trial (NCT00844649) had demonstrated that treatment with gemcitabine and nab-paclitaxel alone produced 9-month OS and PFS rates of approximately 47% and 29%, respectively.“First-line therapy for [patients with] pancreatic adenocarcinoma is heavily dependent on chemotherapy. We’ve [also] come to understand the central role of KRAS [mutations] in driving the vast majority of pancreatic adenocarcinoma,” Dietrich, a medical oncologist at The US Oncology Network Cancer Care Centers of Brevard and an assistant professor of internal medicine at the University of Central Florida College of Medicine in Orlando, said in an interview with OncLive®. “The idea is to see if targeted therapy could augment and potentially synergize with chemotherapy in the first-line setting.”
In the interview, Dietrich discussed the present limitations of frontline chemotherapy for the treatment of patients with advanced/metastatic pancreatic cancer, the early-phase data that have been reported with the agent in this disease setting, and its future in the space.
OncLive: What are the current first-line chemotherapy regimens for patients with advanced/metastatic pancreatic cancer, and what are their limitations?
Dietrich: The current first-line standard of care for [patients with] pancreatic adenocarcinoma is dependent on the use of chemotherapy. We have a number of regimens that can be used, and they have to be tailored to the individual patient’s performance status and organ function. One of the standard regimens is gemcitabine [plus] nab-paclitaxel. It’s a doublet of 2 mechanisms that are used together, and it’s generally felt to be a bit milder [in terms of toxicity], but it also has limitations in regard to efficacy. The overall response rate [ORR] was [23%] with a [median] PFS of [5.5] months and a median OS of [8.5 months in the MPACT trial].2
We have 2 additional triplet regimens. We started out over 10 years ago with FOLFIRINOX [irinotecan plus oxaliplatin, leucovorin, and 5-fluorouracil (5-FU)], based on phase 2 data in France [NCT00112658]. We saw an ORR of 31.6%, a median PFS of [4.6 months], and a median OS of [11.1 months].3
Most recently, we had the readout of the [phase 3] NAPOLI-3 study [NCT04083235] that established NALIRIFOX [irinotecan liposome (Onivyde) with oxaliplatin, 5-FU, and leucovorin] against gemcitabine plus nab-paclitaxel. The ORR was 41.8% [95% CI, 36.8%-46.9%] and the [median] OS was 11.1 months [95% CI, 10.0-12.1].4
It’s a heavily chemotherapy-dependent treatment [paradigm]. We don’t have any more targeted therapies [approved] in the first-line setting. The limitations [of chemotherapy] are typically that although [these regimens] may be effective immediately, the concern is durability, not only from a standpoint of efficacy but also from a standpoint of cumulative toxicity. For nab-paclitaxel, we typically worry about cumulative neuropathy, in addition to cytopenias. For FOLFIRINOX and NALIRIFOX, the adverse effects [AEs] of concern are neuropathy from a different angle: the oxaliplatin-induced neurotoxicity. It is very different mechanistically from nab-paclitaxel, but similarly impactful.
There’s a lot of room for improvement [on frontline chemotherapy]. Unfortunately, many patients do not qualify for treatment at all, and there are also a lot of limitations with the durability of these therapies.
What is the mechanism of action of atebimetinib, and would you consider it to be novel, given its specificity for targeting MEK?
Atebimetinib has a unique mechanism of action. We have had MAP kinase inhibitors for a long time in the clinic, but their concept was very different. They were aiming at chronic suppression of MAP kinase signaling via direct targeting of MEK. We’ve had significant challenges, both in melanoma [as well as] colorectal and lung cancers where they are approved, with concerns for modulation of the immune system, fevers, and liver function test abnormalities. [These agents have also been] implicated in vascular integrity and vascular events.
The idea [with atebimetinib] is to target a very well-established and important pathway through a novel mechanism. The mechanism here is an intermittent deep inhibition mechanism that is labeled deep cyclical inhibition. This essentially allows for 2 things: We shut off the pathway long enough to allow for a synergistic effect on the efficacy side, but not long enough to induce significant traditional toxicities associated with MAP kinase inhibition.
[It’s a] very interesting concept. We never thought about this. We always thought ‘more is better,’ and the stronger the inhibition of a pathway target, the better. However, this doesn’t necessarily seem to be the case, and at least from the preliminary data that we have, both on a toxicity and efficacy side, the concept seems to be very promising.
How does the administration method of atebimetinib differentiate it from agents such as systemic chemotherapy?
Atebimetinib is an oral [agent]. It’s a different delivery of a therapy. It has a very interesting pharmacokinetic [profile]. We see an on/off activity off the MAP kinase pathway, but it seems to be enough to suppress tumor growth and avoid the escape pathways that we see with other MAP kinase [inhibitors]. It also avoids some of the typical MAP kinase AEs such as pyrexia.
What are the key design elements of the phase 1/2 trial evaluating atebimetinib in first-line pancreatic cancer?
This was a multicohort analysis that looked at atebimetinib in [patients with] pancreatic adenocarcinoma in 2 [groups]: in combination with gemcitabine and nab-paclitaxel and [in combination with] modified FOLFIRINOX [mFOLFIRINOX], as well as in combination with pembrolizumab [Keytruda] for [patients with] melanoma, [in combination with dabrafenib (Tafinlar) for patients with BRAF-mutated melanoma, and in combination with cemiplimab-rwlc (Libtayo) for patients with unresectable or metastatic, RAS-mutant non–small cell lung cancer].5 This is a broad investigation. It reflects how important the MAP kinase pathway is, either in the up-front propagation of cancer growth or in the resistance setting, so there’s broad interest [in atebimetinib].
Focusing on the benchmarks here in pancreatic adenocarcinoma, I believe it’s most important to understand the limitation that OS hasn’t exceeded 1 year in any significant way and the durability [of response] remains the main challenge [with chemotherapy alone]. We have early data [with atebimetinib], and they are data that we can contextualize very well historically against the efficacy data both for the doublet and the triplet chemotherapies. For practical purposes, the mFOLFIRINOX [data] are a more internationally accessible standard, [and the regimen] is in many ways similar to NALIRIFOX.
How did the early efficacy data with atebimetinib compare with historical benchmarks?
When we look at data from phase 1, and especially the results from the [phase] 2a part of the study, they set some very competitive benchmarks in the first-line setting for the use of atebimetinib in combination with chemotherapy. We saw that 94% of patients were alive at the 6-month high mark. This is a substantial increase in durability over the historical expectations.4
We [also] saw 70% of patients progression-free at 6 months, which signifies that the addition of atebimetinib is adding to the durability of the [chemotherapy] regimen in the first-line setting. This is certainly something that we don’t see with any of the other first-line chemotherapy regimens. There is a significant breakout of the survival curves.
We’ve seen some nice early responses that we would like to follow. The ORR was [approximately] double what we would typically see with first-line pancreatic adenocarcinoma treatment with gemcitabine and nab-paclitaxel, [and] many of these responses [were] deep and durable.
What has been observed regarding safety with the addition of atebimetinib to chemotherapy?
There’s always [a point] where we have to balance efficacy and safety. It’s very interesting to see that although we do see a mild increase in toxicity with gemcitabine and nab-paclitaxel being a backbone that is significantly better tolerated than our triplets, we don’t really see substantial increases when we look at the addition of atebimetinib in the first-line setting. This was a very favorable ratio of benefit to risk with this treatment, and certainly a de-escalation of toxicity from mFOLFIRINOX and NALIRIFOX.
It is also important to recognize that when we look at these datasets, the study looked at patients with less favorable [disease factors and characteristics]. They were typically older. We saw a patient population that was generally demonstrating all features of high-risk disease: CA 19-9 elevation, significantly high levels of liver and lung metastases, and a strong subset of peritoneal metastases. This was, if anything, a less favorable patient population in which these data were produced. [These findings] require verification in a prospective study, side-by-side with chemotherapy in a randomized fashion, but the first signal here [is] certainly incredibly strong.
What are the next steps that are needed in order for the combination to move forward?
It’s very clear that we have to do more for patients. There are 2 factors: One is the efficacy of the first-line therapy, and the other is the significant drop-off in the number of patients who are able to receive second-line [therapy]. The second-line options after exhausting first-line therapy, especially if patients start on a triplet in the first-line setting, [are sparse]. I believe that’s where atebimetinib is going to find a wide-open treatment opportunity.
This is a new mechanism, one that historically doesn’t have a side-by-side comparison. We’re using a well-established pathway in pancreatic adenocarcinoma, but with a new way of approaching it through intermittent deep cyclical inhibition that allows for a gain in efficacy, as the data would suggest, without a significant increase in toxicity. Most of the toxicity experience will remain defined here by the underlying chemotherapy backbone.
This presents opportunities, [including potential] combination options independent of the chemotherapy regimen. If you think about [how] we would normally like to offer fit and performance status–eligible patients a triplet in the first-line setting to maximize outcomes, maybe there’s an opportunity here of giving targeted therapy with atebimetinib plus chemotherapy to achieve equal or better outcomes than we see with the triplet therapies [alone]. A global, randomized prospective phase 3 study [expected to launch by the end of 2025] will answer these questions in more clarity.1
References
- Immuneering announces extraordinary 86% overall survival at 9 months in first-line pancreatic cancer patients treated with atebimetinib + mGnP. News release. Immuneering. September 24, 2025. Accessed October 2, 2025. https://ir.immuneering.com/news-releases/news-release-details/immuneering-announces-extraordinary-86-overall-survival-9-months
- Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-1703. doi:10.1056/NEJMoa1304369
- Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-1825. doi:10.1056/NEJMoa1011923
- Wainberg ZA, Melisi D, Macarulla T, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023;402(10409):1272-1281. doi:10.1016/S0140-6736(23)01366-1
- Immuneering announces clinical supply agreement with Regeneron Pharmaceuticals to evaluate IMM-1-104 in combination with Libtayo (cemiplimab). News release. Immuneering. February 6, 2025. Accessed October 2, 2025. https://ir.immuneering.com/news-releases/news-release-details/immuneering-announces-clinical-supply-agreement-regeneron
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Mondi shares tumble to 12-year low after flagging ‘challenging’ conditions
Shares in global paper producer Mondi have plunged to a 12-year low after reporting weak demand and lower prices weighing on trading over recent months.
The company, which is listed on London’s FTSE 100 index, said “challenging” conditions were set to persist for the rest of the year.
This reflected lower selling prices of paper and pulp dragging on its sales, as well as weaker demand and intense competition affecting the division.
Mondi said it had extended planned maintenance shuts at some of its sites in response to lower levels of demand.
It also told investors it was reorganising the business from three divisions to two in order to cut costs and speed up decision-making.
The tougher conditions were expected to persist for the rest of the year “as demand-side confidence remains fragile, key markets remain in oversupply and current selling prices are lower”, according to the company.
“Trading conditions in the third quarter were challenging, with softer volumes and declining prices across most pulp and paper grades,” Mondi’s chief executive, Andrew King, said.
But he said the company was “relentlessly focused” on managing what it can control in order to “navigate current headwinds”.
Shares in Mondi, which employs about 24,000 people globally, tumbled by around 15% on Monday to hit the lowest price since 2013.
Dan Coatsworth, head of markets for AJ Bell, said: “Packaging companies are economic bellwethers.
“A strong economy normally implies a steady flow of goods around the world; a weakening economy often leads to reduced demand for goods and therefore for the packaging that holds them.
“Mondi has issued a shocker of a trading update, causing its share price to slump and hit a 12-year low.
“Mondi is well versed to operating in a cyclical market and there are a few levers it can pull, such as extending maintenance shutdowns.
“However, investors are clearly worried about the bigger picture and whether we’re in for a sustained period of weakness.”
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Data from First-in-Human Clinical Studies of the Hyalex Freestyle Knee Implant to be Presented at the ICRS Congress 2025
LEXINGTON, Mass., Oct. 6, 2025 /PRNewswire/ — Hyalex Orthopaedics, a privately held medical device company developing joint preservation technologies based on the transformative HYALEX Hydrosurf™ materials platform, today announced that data from the company’s first-in-human clinical studies of its HYALEX Freestyle™ Knee Implant will be highlighted in a presentation at the International Cartilage Regeneration and Joint Preservation Society (ICRS) Congress 2025. Presented data will include findings from the company’s U.S.-based Early Feasibility Study (EFS) and its Poland-based first-in-human trial. The ICRS Congress 2025 is taking place October 11-14, 2025, in Boston, MA.
Details of the HYALEX Freestyle™ Knee Implant presentation are as follows:
Title: First-in-human Study of a Synthetic Cartilage Implant to Treat Painful Knee Cartilage Lesions
Presenting Author: Sabrina M. Strickland, M.D., Orthopedic Surgeon at Hospital for Special Surgery, New York, NY.
Session: 14.3 “Fixation & Integration”
Session Date/Time: Monday, October 13, 2025, at 3:45 p.m. Eastern Time
Presentation Date/Time: Monday, October 13, 2025, at 4:10 p.m. Eastern Time
The HYALEX Freestyle Knee Implant is designed to enable patients suffering from cartilage damage and early osteoarthritis of the femoral condyle(s) to regain an active lifestyle by replicating the function and structure of natural cartilage. Dr. Strickland will present preliminary findings from the company’s first-in-human studies of the HYALEX Freestyle Knee Implant, which represent the first clinical applications of the transformative implant technology.
Hyalex recently announced that it is expanding its U.S.-based EFS, as well as its ex-U.S. first-in-human study, to a global pivotal trial, which is currently enrolling patients. This trial expansion was allowed based on the U.S. Food and Drug Administration’s approval of Hyalex’s supplemental Investigational Device Exemption (IDE) application for the HYALEX Freestyle Knee Implant, supporting the company’s continued efforts to bring this next-generation orthopedic solution to patients in need.
To learn more about the HYALEX Freestyle Knee EFS, please visit https://clinicaltrials.gov/study/NCT06368700.
About Hyalex Orthopaedics
Hyalex is a privately held medical device company headquartered in Lexington, MA, developing transformational joint preservation technologies for diseased and damaged joints. The HYALEX Hydrosurf™ materials platform is protected by more than 17 patents and trademarks worldwide. The HYALEX Freestyle Knee system has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration for a clinical trial in the United States.
For more information: www.hyalex.com
Contact Information:
Tim Brons
Vida Strategic Partners (media)
646-319-8981
[email protected]SOURCE Hyalex Orthopaedics
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European Markets Retreat as French Crisis Deepens
European markets retreat amid political uncertainty
European shares have taken a step back after touching record highs, with the STOXX Europe 600 closing 0.1% lower at 570.1. The retreat comes as investors digest renewed political uncertainty in France and reassess valuations following the strong rally seen in recent weeks.
The mixed performance across sectors highlights the divergent forces at play. While technology and energy sectors managed to post gains, banks and consumer discretionary stocks faced selling pressure. This sector rotation suggests investors are carefully selecting where to deploy capital in the current environment.
Market breadth remained relatively weak throughout the session, with decliners outnumbering advancers across most European bourses. The subdued tone reflects caution ahead of key economic data releases and ongoing geopolitical developments that continue to shape investor sentiment.
The intraday record high for the STOXX 600 demonstrates that the underlying bullish trend remains intact despite the pullback. However, the inability to hold these gains suggests some profit-taking may be underway as traders lock in recent profits.
French political turmoil weighs on sentiment
France has emerged as the primary source of market concern, with the CAC 40 falling 0.7% following Prime Minister Sebastien Lecornu’s appointment of Roland Lescure as finance minister. The political reshuffling has reignited concerns about France’s fiscal trajectory and policy stability.
The broader impact extended beyond French equities, with the euro weakening to below 87p against sterling, marking its lowest level since mid-September. French bond yields surged more than 10 basis points as investors demanded higher compensation for political risk.
Eurozone banks bore the brunt of the selloff, declining 0.6% as a sector. Société Générale, Crédit Agricole and BNP Paribas all posted notable losses as investors reassessed their exposure to French financial institutions amid the political uncertainty.
The political crisis in France serves as a reminder of the fragility of European politics and its potential to disrupt markets. With France being the eurozone’s second-largest economy, any prolonged instability could have wider implications for European growth and monetary policy.
Oil and gold provide support
Despite the broader market weakness, commodities provided a bright spot. Oil and gas stocks rose 0.8% after OPEC+ announced a smaller-than-expected production increase, supporting crude prices and benefiting energy majors.
BP shares climbed as much as 1.8% while Shell advanced 1.1%, helping to cushion the FTSE 100’s decline from record highs. The oil majors’ performance demonstrates their continued ability to respond positively to supply-side developments in the energy market.
Gold miners also rallied as the precious metal hit a record high above $3,900.00 per ounce. Fresnillo surged 2.7%, Endeavour Mining gained 1.4%, and Hochschild Mining posted solid gains as investors sought safe-haven assets amid the political uncertainty.
The technology sector also managed to buck the downward trend, rising 0.5%. ASML, the Dutch semiconductor equipment maker, advanced 1.6% as investors continued to favour companies with strong growth prospects and exposure to artificial intelligence (AI) trends.
UK markets pull back from record highs
The FTSE 100 retreated 0.2% from its record high as the British pound fell 0.3% to around $1.34. The pullback comes after a strong run that has seen UK equities outperform many of their European counterparts in recent months.
UK bond yields rose in tandem with their European counterparts, with 30-year gilt yields climbing more than 5 basis points. The broad-based selling in sovereign debt markets reflected concerns about fiscal sustainability and the impact of political instability on government borrowing costs.
The pound’s weakness against the US dollar provided some support for FTSE 100 multinational companies that generate significant overseas revenues. However, this currency tailwind was insufficient to prevent the index from pulling back from its recent peak.
Market breadth in London was mixed, with gains in energy and mining stocks offset by weakness in financial services and consumer discretionary names. This sector rotation suggests investors are repositioning portfolios rather than engaging in wholesale selling.
Corporate movers highlight mixed performance
Individual company moves painted a picture of divergent fortunes across sectors. SEB, the French small domestic appliance maker, plunged 22.3% after slashing its full-year sales and profit guidance, highlighting ongoing challenges in the consumer goods sector.
Aston Martin shares dropped as much as 11% after the luxury carmaker warned that 2025 earnings would miss expectations. The disappointing outlook underscores the difficulties facing premium automotive brands as consumer spending patterns shift.
Mondi fell approximately 14% following weak third-quarter (Q3) results and news of a delayed project. The forestry and packaging group’s troubles reflect broader concerns about industrial demand and the impact of economic uncertainty on capital-intensive businesses.
On the positive side, Speedy Hire jumped 12% on news of a new partnership with ProService, while Shawbrook confirmed plans for a London initial public offering (IPO) seeking a valuation near £2 billion. These corporate actions demonstrate that dealmaking and growth initiatives continue despite market volatility.
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Start-up Heidi secures US$65 million to expand AI healthcare in Hong Kong, Singapore
Australian healthcare technology start-up Heidi has secured US$65 million in a new funding round, as it aims to expand its workforce and establish offices in Hong Kong and Singapore to capitalise on the growing demand for medical artificial intelligence technology in the region.
The company is valued at US$465 million following its series B round announced on Monday, led by Point72 Private Investments, a global alternative asset manager.
The six-year-old start-up planned to build a team of about 15 to 20 people in Hong Kong and Singapore by the end of next year, depending on market traction, with a central office to be established in one of the two cities, according to CEO and co-founder Thomas Kelly.
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Heidi’s self-developed AI-enabled platform was designed to transcribe consultations between medical professionals and patients into clinical notes to reduce doctors’ administrative workloads. This would allow them to focus more on patient care and enhance hospital operational efficiency, the company said.
Heidi’s AI platform has been designed to transcribe consultations between doctors and patients into clinical notes to reduce doctors’ administrative workloads. Photo: Handout alt=Heidi’s AI platform has been designed to transcribe consultations between doctors and patients into clinical notes to reduce doctors’ administrative workloads. Photo: Handout>
Hong Kong has a large patient population but a relatively small number of doctors, according to Kelly, a former doctor. “If we can increase the capacity of clinicians, it’s going to make a much bigger impact than in places like Australia,” he said.
Heidi said its data showed nearly 20,000 and 55,000 consultations had been conducted through its platforms in Hong Kong and Singapore, respectively. “That was before we’d even launched here,” Kelly said.
Regulatory bodies and governments in Hong Kong and Singapore were enthusiastic about using AI in healthcare, actively promoting initiatives such as AI applications in hospitals because “they see the economic and social value of faster, cheaper and better healthcare”, he said.
Heidi’s expansion into Asia is part of its broader global strategy. The company said it planned to use the new funding to further develop its products and grow its workforce in the US, UK and Canada, while also expanding use of its products in France, Spain, Germany, Ireland and South Africa.
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