Feliza Mirasol is the science editor for 

Feliza Mirasol

With the 31st annual BIO-Europe conference set to take place in Vienna, Austria, from Nov. 3–5, 2025, the event is anticipated to gather more than 5700 attendees from more than 3000 companies across the global biopharmaceutical industry. Produced by EBD Group, the conference has established itself as one of the largest forums for collaboration, licensing, and investment discussions in drug development and manufacturing, according to a company press release (1).

Partnering around the event has been underway since Sept. 22, 2025, and organizers expect more 30,000 one-to-one meetings, reflecting the growing demand for structured platforms that enable technology-driven collaborations.

For those in the biopharma industry, the scale of BIO-Europe illustrates how early partnerships have become critical to drug manufacturing and commercialization strategies. The event’s discussions will explore how companies can adapt development pipelines, improve clinical success rates, and secure the investment needed to advance new therapeutic modalities.

The Vienna program features a range of sessions designed to address current industry challenges and future directions. The opening plenary session, titled “

A symphony or a solo act? Europe’s role in biopharma’s future,

” will bring together IPSEN CEO David Loew and Ovid Therapeutics CEO and Chairman Jeremy Levin to debate whether Europe can maintain its competitive edge in healthcare innovation or risk ceding leadership to other global regions.

The financing environment for biopharma will be explored in “

From Roast to Billions: Biopharma Investment Landscape

,” where panelists from Jefferies International, Angelini Ventures, and Novo Holdings will examine how companies can secure funding in a tightening capital market, from venture rounds and initial public offerings to mergers and acquisitions. Funding is of particular relevance for technology-driven companies that require significant investment to scale advanced manufacturing platforms.

Meanwhile, in the therapeutic space, the session titled “

Scaling the melody of innovation for rare diseases

” will focus on development and commercialization hurdles for ultra-targeted therapies. Panelists from Ipsen, TVM Capital, and DEBRA Research will address regulatory and patient access complexities that shape the economics of manufacturing for rare conditions.

A day in the life of an experienced dealmaker

,” featuring experts from Bayer, IPSEN, and Forbion on the current state of life sciences transactions

Longevity: Stirring up investment and healthcare innovation

,” with WLAN Holding and Insilico Medicine exploring diagnostics, therapeutic pipelines, and the socio-economic realities of aging populations

Composing the next era of women’s health

,” with representatives from Freya Biosciences, ReproNovo, M Ventures, and the Bill & Melinda Gates Foundation on the intersection of investment, technology, and clinical innovation

How does hybrid engagement expand access?

The conference will conclude its in-person program with a networking reception at Vienna’s Hofburg Palace, hosted in collaboration with LISAvienna. To extend engagement, BIO-Europe will also offer two days of virtual partnering on Nov. 11–12, 2025. This hybrid format continues to broaden accessibility and ensures that companies can connect beyond geographic limitations, strengthening opportunities for cross-border collaborations, according to EBD Group in its release.

The relevance of BIO-Europe extends beyond the immediate networking value. By convening leaders from pharma, biotech, and investment communities, the conference highlights how drug development is increasingly dependent on partnerships that bridge scientific innovation, manufacturing capabilities, and commercialization expertise (2). For professionals focused on advancing biopharmaceutical technologies, the meeting provides insight into where investment is flowing, which therapeutic areas are prioritized, and how companies are navigating technical and regulatory bottlenecks.

As biomanufacturing becomes more complex—driven by cell and gene therapies, exosomes, and highly targeted biologics—the role of strategic partnerships underscored at BIO-Europe remains central to the industry’s ability to deliver next-generation medicines (1,3).

1. EBD Group. BIO-Europe 2025: Vienna Prepares to Welcome Global Biopharma Leaders. Press Release. Sept. 24, 2025. https://informaconnect.com/bioeurope/
2. Wu, X.; Knockaert, M.; Blasi, P. Collaborative Innovation During the Drug Discovery and Development Process. 

Cell and Gene Therapy Biomanufacturing Market—A Global and Regional Analysis: Focus on Product Type, Application, Usage, End User, and Region—Analysis and Forecast, 2025-2035

Articles

The 31st annual BIO-Europe conference in Vienna will gather over 5,700 attendees from more than 3,000 companies in the biopharmaceutical industry. The event emphasizes the importance of early partnerships in drug manufacturing and commercialization. Key sessions will address Europe's role in healthcare innovation, biopharma investment strategies, and challenges in rare disease therapies. The conference will also feature discussions on life sciences transactions, aging population healthcare, and women's health. A hybrid format, including virtual partnering, aims to enhance accessibility and foster cross-border collaborations.

Vienna to host BIO-Europe 2025, connecting top biopharma companies for collaborations and pipeline development.

Global Biopharma Leaders to Shape Industry Outlook at BIO-Europe 2025

In a deal valued at approximately $4.9 billion, Pfizer is set to acquire Metsera, a US-based biotechnology company focused on next-generation therapies for obesity and cardiometabolic disease. The acquisition gives Pfizer a portfolio of differentiated oral and injectable incretin, non-incretin, and combination therapy candidates that boost its pipeline of obesity therapeutics, according to a Sept. 22, 2025 company press release (1).

The deal is expected to close in the fourth quarter of 2025, pending customary closing conditions. The boards of directors of both companies have unanimously approved the transaction, Pfizer reported in a company press release (1).

“Obesity is a large and growing space with [more than] 200 health conditions associated with it. The proposed acquisition of Metsera aligns with our focus on directing our investments to the most impactful opportunities and propels Pfizer into this key therapeutic area,” said Albert Bourla, chairman and chief executive officer, Pfizer in the release (1). “We are excited to apply our deep cardiometabolic experience and manufacturing and commercial infrastructure to accelerate a portfolio that includes potential best-in-class injectables, with clinical data differentiated by efficacy, tolerability, and durability supporting monthly dosing, with the aim to address the ongoing unmet needs associated with obesity and related diseases.”

Pfizer gets a portfolio of both injectable and oral therapeutic candidates with the acquisition, including Metsera’s key programs for MET-097i, MET-233i, two oral glucagon-like peptide-1 (GLP-1) receptor agonists, and additional preclinical nutrient-stimulated hormone therapeutics. MET-097i is an injectable incretin (GLP-1 receptor agonist) candidate that is being developed for both weekly and monthly administration. It is currently in Phase II development. MET-233i is a monthly amylin analog candidate being evaluated as both a monotherapy and in combination with MET-097i, for which it is in Phase I development.

Meanwhile, the two oral GLP-1 receptor agonist candidates are expected to begin clinical trials imminently. With the additional preclinical nutrient-stimulated hormone therapeutics, the companies aim to exploit alternative metabolic signaling pathways.

Why does this acquisition matter for development and manufacturing, and the competitive landscape?

This acquisition has multiple implications for bio/pharmaceutical drug development, including:

Dosing convenience and tolerability: Metsera’s efforts to reduce injection frequency by engineering molecules for weekly or monthly schedules respond to known patient and compliance challenges in obesity treatment.

Manufacturing scale and platform engineering: Metsera’s peptide engineering platform and ongoing preclinical programs suggest opportunities for optimizing manufacturability by, for example, improving bioavailability, durability, or peptide half-life. Such improvements can reduce cost of goods, support stable supply chains, and facilitate scaling up both injectable and oral formats, features that are of significant importance to developers and process engineers in the bio/pharma industry (2).

Regulatory and regulatory timing risks: The contingent payments depend on the initiation of the Phase III trial and regulatory approvals, so outcomes depend on successful clinical validation and regulatory pathways. This payment term reflects standard risk in pipeline acquisition but also underscores the importance of robust data, safety, and tolerability in the incretin/amylin fields.

Competitive positioning: The obesity drug field is crowded, with existing and emerging therapies based on GLP-1, amylin, or dual agonists (3). Pfizer’s acquisition of a company with both oral and injectable incretin/non-incretin agents helps it seek differentiation in efficacy, tolerability, durability, and administration route. The acquisition also shifts the dynamic of who owns promising assets in an area under pressure to deliver both clinical innovation and scalable manufacturing.

What is the strategic rationale behind this move, and what wider implications will it have?

Pfizer's acquisition of Metsera aligns with its strategy of directing capital to what it considers “the most impactful opportunities,” and, as Bourla emphasized, obesity is associated with more than 200 comorbid health conditions (1). For the broader industry, this deal illustrates the increasing value placed on companies that can integrate discovery, peptide engineering, and scalable manufacturing early in their pipeline. It spotlights how potential “best-in-class” profiles—that is, balancing efficacy, tolerability, duration of action, and manufacturing feasibility—are central to valuation in company exits or acquisitions.

“Since our founding in 2022, Metsera has worked tirelessly to reduce the physical, emotional, and economic burdens of obesity with a portfolio of next-generation nutrient-stimulated hormone therapeutic candidates,” said Whit Bernard, co-founder and chief executive officer, Metsera, in the release. “Our team has invented and developed multiple injectable and oral candidate medicines and a category-leading peptide engineering platform, which together promise class-leading performance in a major sector of population health.”

Bernard added that “Today’s announcement sets a path for our portfolio to potentially transform the lives of hundreds of millions of people and represents an excellent outcome for our shareholders. We look forward to joining forces with Pfizer to leverage their global clinical, regulatory, manufacturing, and commercial capabilities to realize the promise of improved human health at scale.”

For industry professionals involved in manufacturing, formulation, regulatory affairs, and process development, the Metsera pipeline represents technical challenges (e.g., long half-life injectables, oral peptide stability, combination therapies) but also opportunities to improve supply chain resilience and cost efficiency. For drug development teams, the acquisition underscores the importance of achieving clinical differentiation, establishing durable safety profiles, and optimizing dosing intervals.

Pfizer to Acquire Metsera and Its Next-Generation Obesity Portfolio

. Press Release. Sept. 22, 2025.
2. Srai, J. S.; Badman, C.; Krumme, M.; et al. Future Supply Chains Enabled by Continuous Processing—Opportunities and Challenges. May 20-21, 2014 Continuous Manufacturing Symposium. 


3. Müller, T. D.; Clemmensen, C.; Finan, B.; et al. Anti-Obesity Therapy: from Rainbow Pills to Polyagonists. 

Pfizer is acquiring Metsera, a biotechnology company specializing in obesity and cardiometabolic disease therapies, for approximately $4.9 billion. This acquisition enhances Pfizer's pipeline with differentiated oral and injectable incretin and non-incretin therapies. The deal, expected to close in late 2025, aligns with Pfizer's strategic focus on impactful opportunities, particularly in obesity, which is linked to over 200 health conditions. Metsera's portfolio includes promising candidates like MET-097i and MET-233i, offering potential advancements in dosing convenience, manufacturing scalability, and competitive positioning in the obesity drug market.

Pfizer gains access to Metsera’s oral and injectable obesity candidates, underscoring innovation in drug development and scalable manufacturing.

Pfizer’s $4.9 Billion Acquisition of Metsera Enhances Obesity Drug Pipeline

US vaccine policy is expected to fundamentally shift on the back of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) Sept. 18, 2025 vote recommending that children receiving their first immunization dose against measles, mumps, rubella, and varicella (chickenpox) (MMRV) receive separate injections instead of the single, combined four-part vaccine. The decision was made via an 8-3 vote with one abstention, according to published reports (1,2).

The decision advises separating the MMR vaccine from the varicella vaccine for children four years old and younger, which, in other words, recommends against the use of the combined MMRV vaccine (marketed as Merck & Co.’s ProQuad, which was approved by FDA in 2005 [3]). ACIP recommendations typically determine which vaccines are provided free through the US government and influence state laws, as well as shape health insurance coverage.

What is the technical rationale behind ACIP’s decision?

The catalyst for this significant regulatory change appears rooted in epidemiological data concerning the incidence of febrile seizures. Panelists advocating for the split pointed to evidence indicating that the combined MMRV shot carries approximately double the rate of fever-related convulsions in the four-year-old-and-younger age group compared with the separate administration of the MMR and varicella shots (4).

Data indicate the combined shot yields roughly seven to eight febrile seizures per 10,000 children, versus roughly three to four per 10,000 for those receiving MMR and varicella separately. Receiving the MMRV vaccine can trigger an estimated one additional febrile seizure per every 2300 to 2600 children, compared with the MMR vaccine alone (5,6). While febrile seizures occur in 2% to 5% of young children, are generally common, and carry an excellent prognosis (7), some new panel members argued that reducing their incidence is a beneficial public health goal, citing research that suggests potential detrimental effects on neurodevelopment.

In counterpoint, committee member Cody Meissner, MD, professor of Pediatrics at Geisel School of Medicine, Dartmouth stated in one of the published reports, "It’s a very frightening experience, but I think people are very comfortable in saying that a febrile seizure is not associated with any sort of impaired performance or neurocognitive development or school problems" (1).

What concerns exist over patient adherence and disease risk?

A key professional concern for vaccine manufacturers related to separating the vaccine regimen centers around the established benefit of combination vaccines in enhancing patient adherence to the childhood immunization schedule. Experts have warned that increasing the number of vaccinations required could threaten children’s health because it may likely increase the risk of non-compliance (8).

Preventable diseases, such as measles, mumps, rubella, and chickenpox, can be highly dangerous as evidenced by the fact that, prior to the measles vaccine in the 1960s, there were 48,000 annual hospitalizations (9). Opponents of the change emphasized that compliance risks outweigh the benefit of reducing the small incidence of febrile seizures.

"The disadvantage of giving two doses or, as was suggested, separating the two doses is that we know compliance falls. And the advantage of combination vaccines is that children and adults are more likely to complete the vaccine," Meissner said in the published report (1).

What impact will regulatory ambiguity and panel dynamics have on the industry?

Despite the new policy recommendation to split doses, the ACIP subsequently voted 8-1 not to change coverage for the combined MMRV shot within the Vaccines for Children (VFC) program. This subsequent vote to retain VFC coverage for the combined shot led to confusion among committee members regarding whether guidelines would differ based on the child's coverage. This contentious regulatory environment is furthermore heightened by the fact that Health and Human Services Secretary Robert F. Kennedy Jr., who has questioned vaccine safety, recently 

 and replaced them with handpicked advisers, some of whom lack documented vaccine expertise (10).

CDC officials estimate that the practical shift of the new policy may be limited because only about 15% of children in the relevant age group currently receive the four-part shot, according to the CDC, which noted that this figure is already influenced by its previous evaluation and communication of the seizure risk in 2008 and 2009. The ACIP is scheduled to continue its meetings, which will include discussions on COVID-19 vaccines and votes on hepatitis B vaccination timing.

CDC Panel Recommends Multiple Shots for Measles, Mumps, Rubella and Chickenpox Instead of Single Vaccine

. theguardian.com, Sept. 18, 2025 (accessed Sept. 19, 2025).
2. Gardner, J. 

CDC Panel Recommends Splitting Measles, Varicella Shots

, Sept. 18, 2025 (accessed Sept. 19, 2025).
3. FDA. ProQuad Label (accessed Sept. 19, 2025). 

https://www.fda.gov/media/119880/download


4. MacDonald, S. E.; Dover, D. C.; Simmonds, K. A.; Svenson, L. W. Risk of Febrile Seizures After First Dose of Measles-Mumps-Rubella-Varicella Vaccine: A Population-Based Cohort Study. 


5. Klein, N. P.; Fireman, B.; Yih, W. K.; et al. Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures. 

Information Sheet: Observed Rate of Vaccine Reactions Measles, Mumps and Rubella Vaccines

, May 2014.
7. Tiwari, A.; Meshram, R. J.; Kumar Singh, R. Febrile Seizures in Children: A Review. 


8. Ventola, C. L. Immunization in the United States: Recommendations, Barriers, and Measures to Improve Compliance. Part 1: Childhood Vaccinations. 

 (7), 426–436.
9. Wharton, M. E. Measles Elimination in the United States. 

Pharma Implications of Paul Offit’s Removal from Vaccine Advisory Committee

The CDC's Advisory Committee on Immunization Practices (ACIP) has recommended separating the MMR and varicella vaccines for children under four, moving away from the combined MMRV vaccine due to a higher incidence of febrile seizures. This decision, influenced by epidemiological data, aims to reduce seizure risk but raises concerns about potential non-compliance with vaccination schedules. Despite the recommendation, the ACIP voted to maintain coverage for the combined vaccine under the Vaccines for Children program, creating regulatory ambiguity. The policy shift's impact may be limited, as only 15% of children currently receive the combined shot.

CDC panel shifts vaccine policy by discouraging combined MMRV shot for young children due to increased febrile seizure risk.

CDC Panel’s Vote Separates MMRV Shot and What That Means

The shortlist for the CPHI Pharma Awards 2025 has been released, highlighting advances that reflect the evolving priorities of bio/pharmaceutical science and technology. Selected across 14 categories, the finalists represent progress in areas such as synthetic biology, artificial intelligence (AI) in formulation, patient access, and sustainable packaging, according to a Sept. 18, 2025 press release (1).

These awards serve as a barometer of the technologies and practices most likely to influence the industry’s next phase. They not only emphasize product innovation but also acknowledge leadership within the sector. Categories such as Future Leader and Women in Pharma highlight individuals whose technical expertise and vision are shaping the operational and cultural dimensions of pharmaceutical research and production.

What can bio/pharma manufacturing and technology experts take away from these nominations?

This year’s shortlist underscores the growing integration of digital and sustainable practices into bio/pharmaceutical development pipelines. AI-enabled formulation tools are streamlining design and reducing experimental timelines, while circular packaging and sustainable processes point to an industry adapting its manufacturing models to meet both regulatory expectations and environmental goals (2–4).

“Across every category, the finalists are setting new standards in pharmaceutical innovation, sustainability, and patient impact,” said Tara Dougal, CPHI event director, Informa Markets, in the press release (1). “The CPHI Pharma Awards are a vital platform to spotlight the progress shaping the future of our industry.”

What do these awards mean for the industry’s global outlook?

The winners will be announced on Oct. 28 at the opening ceremony of CPHI Frankfurt 2025, which brings together professionals across the global supply chain. Recognition of these finalists highlights technologies and approaches that may soon influence manufacturing scalability, supply chain integration, and clinical development strategies.

CPHI Frankfurt will be held Oct. 28–30, 2025.

The 2025 finalists and their respective technologies/products by category include:

From Crystallization to Tablet: A scalable Platform for API Agglomeration”

 for mPredict Co-crystal Prediction Service

 for TAG Assisted Peptide Synthesis (TAPS).

 for Mono-Material Drug Delivery Demonstrator

 for Orgovyx—transforming prostate cancer care

 for room temperature-stable generic Posaconazole Injection using hydroxypropyl beta-cyclodextrin (HPβCD)

 for “Ullenistamab: A Targeted mAb for pancreatic cancer”.

Accord Healthcare for a decade of impact with International Health Partners (IHP)

 for elevating patient safety through intelligent design

 for enhancing access to affordable healthcare—HIV

 for “Resilient by Design: Farmak Group’s Ukrainian-Rooted Pharma Network Blueprint for Crisis-Proof Global Supply”

 and the Social Mobility Foundation for “Talent Without Barriers”.

 for its advanced peristomal barrier and adhesion cream

 for its Maggie Mix, which is a dual-chamber autoinjector with needle isolation technology (NIT)

 for launching the first biosimilar in an on-body injector

 for uniting sustainability and patient convenience in self-injection devices.

 for EUDRACAP colon, which, according to the company, is the world’s first functional ready-to-fill capsule for oral drug delivery to target the ileo-colonic region

 for modified supercritical anti-solvent (mSAS) particle engineering for stabilization of biomolecules

 for ReadiLYCOAT plant-based coating systems for enhanced oral dosage solutions

 for Innovaform innovation and formulation accelerator.

, senior manager, European Lab Services, 

 for EnzeneX: fully connected continuous manufacturing

 for GENEX, robotic, modular aseptic fill-finish platform

 for VectorBuilder’s gene drug manufacturing platform.

 for SCHOTT TOPPAC infuse—the next generation

 for TILE-X, a new generation gloveless aseptic fill-finish system

 for Vytal innovative ready-to-use snap-fit closure.

NunaBio for Custom: Cell-free, synthetic DNA—including high complexity sequences, multi kilobase length, and milligram scale—made in days to weeks

 for lipids for innovative drug formulation

 for integrated end-to-end supply chain platform

 for resilient chemical supply chains, supercharged by AI

 for TraceLink Orchestration Platform for Universal Solutions (OPUS).

 for leading the green chemical revolution, transforming industrial by-products into high-value green chemicals

 for the Enantios platform—enabling fast, label-free chiral analysis in solution

 for J.T.Baker Viral Inactivation Solution, an environmentally safer detergent for virus removal in bioprocessing

 for KinetiSol technology, a solvent-free, fusion-based technology that transforms poorly soluble drugs into high-bioavailability formulations

 for leading the way in next-generation propellants (NGPs)—commercial-ready capabilities in HFA152a and HFO1234ze propellants

 for Lean, Green, and Secure, a regulatory-ready, blister-free, syringe solution

 (BSI) for “Sustainability Grows on Trees: Producing QS-21, the Gold Standard Vaccine Adjuvant”.

, general manager, Bioprocessing, and head of Life Science Strategy, 

1. Informa Markets. CPHI Frankfurt Pharma Awards 2025 Finalists Announced. Press Release. Sept. 18, 2025. https://www.cphi.com/europe/en/cphi-celebration/awards.html
2. Ferreira, F. J. N.; Carneiro, A. S. AI-Driven Drug Discovery: A Comprehensive Review. 

Circularity in Primary Pharmaceutical Packaging: Uniting for Change

, June 16, 2025.
4. BioIndustry Association. 

Sustainability in Action: How Bioprocessing is Pioneering Sustainable Practices

The CPHI Pharma Awards 2025 shortlist showcases advancements in bio/pharmaceutical science and technology, emphasizing synthetic biology, AI in formulation, patient access, and sustainable packaging. These awards highlight the industry's evolving priorities, focusing on innovation, leadership, and sustainability. The finalists, selected across 14 categories, reflect the integration of digital and sustainable practices in development pipelines. The awards serve as a platform to recognize technologies and approaches that may influence manufacturing scalability, supply chain integration, and clinical development strategies, with winners to be announced at CPHI Frankfurt 2025.

Finalists for CPHI Frankfurt Pharma Awards 2025 showcase innovation in drug development, advanced manufacturing, and future industry leaders.

CPHI Frankfurt Reveals 2025 Pharma Awards Finalists for Bio/Pharma Development

Dan Williams, CEO of SynaptixBio emphasizes how small biotechs are using genetic research and partnerships to accelerate rare disease innovation in the final installment of his interview.

The Role of Genetic Advances and Partnerships in Rare Disease Drug Development (Part 3)

Because small biotechnology companies can leverage their agility and focus to drive innovation—where larger pharmaceutical firms may hesitate—small biotechs are playing a pivotal role in advancing treatments for rare diseases, says Dan Williams, PhD, CEO of SynaptixBio, in the third installment of his interview with 

According to Williams, whose company specializes in ultra-rare diseases, “small biotechs ... are able to move things forward ... [and] make decisions extremely quickly,” allowing them to respond rapidly to new data and research opportunities. A significant factor in rare disease research is the genetic basis of these conditions. “About 80% of rare diseases are genetic,” Williams notes, highlighting the impact of recent advances in genome sequencing on diagnostics and drug development.

How are genetic research and strategic partnerships propelling rare disease drugs?

Over the past decade, collaborations with academic institutions, such as the Children’s Hospital of Philadelphia, have deepened understanding of genetic components, accelerating the path from discovery to clinical trials, Williams explains. Despite their strengths, small biotechs face funding challenges. While grant opportunities are increasing in both the United States and United Kingdom, securing resources remains a major hurdle, Williams points out.

As rare disease treatments progress through clinical development, partnerships with larger pharmaceutical companies become essential. These collaborations bring the rigorous methodologies and resources needed to bring new therapies to market, says Williams. In addition, patient advocacy groups are also shaping the landscape, providing critical input on treatment priorities and quality of life improvements. As research momentum builds, the integration of genetic insights, agile biotech strategies, and collaborative partnerships is set to transform the future of rare disease therapeutics, he concludes.

Click the video above to view this interview.

Dan Williams, PhD, studied biochemistry and physiology at the University of Dundee, after which he worked his way up to senior scientist—managing a cell research group and preclinical development. Following this, he moved to drug development, focusing on the organization and management of both manufacturing and clinical trials. Williams then moved to Adaptimmune, developing cell therapies. He set up the development groups, project managing preclinical research and clinical trials, before becoming vice-president of Research Operations. From there, he moved to Meatable as chief product officer. Williams co-founded SynaptixBio in 2021.

Videos

Japan-based Nxera Pharma (Nxera) and Cancer Research UK announced on Sept. 17, 2025 that the first dosing of patients in a Phase IIa clinical trial (NCT05944237) has begun. The trial is meant to evaluate HTL0039732 (also known as NXE0039732), Nxera’s investigational small-molecule immunotherapy drug, in treating advanced solid tumors (1).

HTL0039732 is designed to block signaling through the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4). According to Nxera in a company press release, PGE2 acts in the tumor microenvironment to trigger cancer cells to evade the immune system (1). Unlike many existing immunotherapies, which rely on targeting immune checkpoints, EP4 antagonism addresses tumor-mediated immunosuppression within the microenvironment. This approach is of particular interest for drug developers seeking new strategies against cancers that historically respond poorly to current immunotherapies.

“The initiation of the Phase IIa trial marks a significant step forward in our efforts to bring this promising drug to patients with difficult-to-treat cancers,” said Matt Barnes, PhD, chief scientific officer and president of Nxera Pharma UK, in the press release (1). “The encouraging data from the Phase I study provide a strong foundation for continued clinical investigation, and we look forward to sharing further updates as the trial progresses.”

The ongoing trial, which is sponsored and managed by Cancer Research UK’s Center for Drug Development, is being led by Bristi Basu, PhD, of the University of Cambridge and Debashis Sarker, PhD, of King’s College London. The lead clinical site is Addenbrooke’s Hospital, Cambridge, UK, with additional enrollment at Experimental Cancer Medicine Center network locations.

The Phase IIa expansion will examine four tumor cohorts: microsatellite stable colorectal cancer, gastric or gastroesophageal junction adenocarcinoma, clear cell renal cell carcinoma, and metastatic castration-resistant prostate cancer. These tumor types represent areas of high unmet need, particularly in the context of immunotherapy resistance (2–5).

In an earlier Phase I study, patients with advanced, treatment-resistant solid tumors received HTL0039732 in combination with the checkpoint inhibitor atezolizumab. Results from this study included two confirmed partial responses in distinct tumor types, along with evidence of selective EP4 engagement without significant EP2 activity. These findings suggest that EP4 inhibition could complement existing immunotherapy modalities, potentially extending their reach into tumor types less responsive to current standards, according to Nxera.

“It is exciting to move to the next phase of assessing this new inhibitor of an important receptor EP4, which is implicated in suppression of the antitumor immune response,” said Basu in the release. “We hope that by combining it with immunotherapy, we will build on some of the promising early data we have seen in patients treated in the Phase I trial.”

What implications does the clinical development of HTL0039732 have on the broader oncology landscape?

From a drug development perspective, HTL0039732 exemplifies the trend toward small-molecule immuno-oncology approaches, offering oral administration and potential synergy with biologic checkpoint inhibitors. For drug manufacturers, the combination of small-molecule scalability with immunotherapy integration highlights the importance of flexible production strategies capable of supporting diverse treatment modalities.

“The dosing of the first patient in the Phase IIa trial of HTL0039732 is a significant step forward in the Center for Drug Development’s collaboration with Nxera Pharma, which exemplifies the power of partnership in accelerating the development of groundbreaking therapies,” said Lars Erwig, PhD, director of Cancer Research UK’s Center for Drug Development, in the release. “The need for novel immunotherapies is more pressing than ever, as many cancers continue to evade current treatments. We look forward to continuing this journey and bringing hope to patients and their families.”

As interest grows in targeting non-traditional immune pathways, the Phase IIa trial will be closely watched by those working in cancer drug research and manufacturing. Its outcomes could influence future strategies for integrating small molecules into immunotherapy pipelines and expanding therapeutic options for resistant solid tumors.

Nxera Pharma and Cancer Research UK Announce First Patient Dosed in Phase 2a Trial of Investigational Cancer Immunotherapy HTL0039732

. Press Release. Sept. 17, 2025.
2. Gandini, A.; Puglisi, S.; Pirrone, C.; et al. The Role of Immunotherapy in Microsatellites Stable Metastatic Colorectal Cancer: State of the Art and Future Perspectives. 


3. Chung, D. T.; Tung, D. S.; Dung, T. N. Harnessing Immune Checkpoint Inhibitors Against Gastric Cancer: Charting the Course to Expanded Therapeutic Benefit. 


4. Braun, D. A.; Bakouny, Z.; Hirsch, L.; et al. Beyond Conventional Immune-Checkpoint Inhibition—Novel Immunotherapies for Renal Cell Carcinoma. 


5. Bansal, D.; Reimers, M. A.; Knoche, E. M.; Pachynski, R. K. Immunotherapy and Immunotherapy Combinations in Metastatic Castration-Resistant Prostate Cancer. 

Japan-based Nxera Pharma and Cancer Research UK have initiated a Phase IIa clinical trial to evaluate HTL0039732, a small-molecule immunotherapy targeting the EP4 receptor, in advanced solid tumors. This trial, managed by Cancer Research UK, focuses on tumor types with high unmet needs, such as microsatellite stable colorectal cancer and metastatic castration-resistant prostate cancer. The drug's mechanism, which blocks PGE2 signaling, aims to overcome tumor-mediated immunosuppression. The trial's outcomes could influence future strategies for integrating small molecules into immunotherapy pipelines.

The Phase IIa study will test HTL0039732 in combination with immunotherapy to boost responses in resistant solid tumors and broaden treatment choices.