Pharmaceutical Industry 11 – 17 May: Ft UCB, Calla Lily Clinical Care and Palisade Bio
- UCB has expanded its strategic alliance with Cancer Research UK and Cancer Research Horizons to accelerate novel oncology candidates.
• Calla Lily Clinical Care has dosed the first patients in its NIHR funded Freedom clinical trial for its Callavid progesterone delivery platform.
• Palisade Bio has released further phase 1a/b analyses supporting the colon targeted profile of its investigational PDE4 inhibitor, PALI 2108.
Strategic Alliances Push Oncology Innovation Forward
UCB has entered a new multi project strategic alliance with Cancer Research UK and its innovation arm, Cancer Research Horizons, in a move designed to speed up the development of novel oncology candidates.
The agreement builds on a collaboration first announced in 2023 between UCB and Cancer Research UK’s Centre for Drug Development.
That earlier partnership has already helped advance two antibody drug candidates into ongoing clinical trials across the United Kingdom and European sites, giving the expanded alliance a strong foundation from which to grow.
The new framework broadens the scope of the relationship by bringing earlier stage discovery and preclinical programmes into the partnership.
For UCB, the attraction is clear. Cancer Research UK brings deep oncology knowledge, access to leading clinical investigators and substantial drug development capabilities. UCB, in turn, contributes its strengths in molecule discovery and therapeutic development.
Under the alliance, Cancer Research UK’s Centre for Drug Development and Cancer Research Horizons’ Therapeutic Innovation teams will work with UCB to progress selected therapeutics from research through to early clinical development.
For each project entering the alliance, the Centre for Drug Development will design, prepare, sponsor and run a phase 1/2 clinical trial.
UCB has already nominated two additional projects from its internal pipeline to join the partnership. Research and development costs will be shared, while UCB will retain exclusive rights to further develop and commercialise all programmes.
Cancer Research Horizons will receive undisclosed milestone and royalty payments linked to downstream progress.
The Director of the Centre for Drug Development at Cancer Research UK said the alliance reflects the organisation’s mission to translate exceptional science into life changing cancer treatments. By combining Cancer Research UK’s oncology expertise with UCB’s discovery strengths, the aim is to move promising therapeutics towards patients more efficiently.
UCB’s Executive Vice President and Chief Scientific Officer described the partnership as a strong example of strategic collaboration, highlighting the “unique synergy” created by combining clinical insight, oncology expertise and drug development capability.
Calla Lily Clinical Care Advances Women’s Health Trial
In women’s health, Calla Lily Clinical Care has reached a significant milestone by dosing the first patients in its Freedom clinical trial. The NIHR funded study is evaluating the company’s Callavid intravaginal drug delivery platform in women with luteal phase insufficiency.
Luteal phase insufficiency is a condition in which progesterone levels may be too low to support early pregnancy. It is associated with infertility and recurrent miscarriage, making effective progesterone support a major clinical and emotional issue for many women and couples.
The Freedom trial is assessing 400mg progesterone Callavid in patients diagnosed with luteal phase insufficiency. Callavid is being positioned as a potential first in class drug device combination for threatened miscarriage and for luteal phase support in assisted reproductive technologies, including IVF.
The scale of the challenge is significant. Estimates referenced in the Government’s renewed Women’s Health Strategy suggest the UK sees between 120,000 and 250,000 miscarriages each year. Current NICE guidance recommends 400mg micronised progesterone twice daily for women with a previous miscarriage who present with early pregnancy bleeding.
However, existing progesterone products can be difficult for patients to use. Traditional pessaries may leak, shift during use and require patients to remain horizontal after administration. At a time that is already stressful and emotionally charged, these practical challenges can add further anxiety.
Callavid has been designed to address these issues. Its patented, leak free, tampon like format aims to improve comfort, placement and consistency of drug absorption. The Freedom study will assess safety, user acceptability and progesterone absorption, helping to generate evidence around usability, adherence and clinical practicality.
The study is being led by Professor Siobhan Quenby MBE, Clinical Chief Investigator and Honorary Consultant at University Hospitals Coventry and Warwickshire NHS Trust.
She noted that clinicians regularly see the difficulties patients face with existing vaginal progesterone products, and described Callavid as a promising new option that could help ensure correct dosage delivery while giving women greater confidence in their treatment.
The Co founder and Chair of Calla Lily Clinical Care added a deeply personal perspective, explaining that as both a physician and entrepreneur, and someone who has experienced seven rounds of IVF, they understand how difficult progesterone treatment can be.
That lived experience has helped shape the company’s patient centred approach to innovation.
The Co founder and CEO said the dosing of the first patients marks a critical milestone, adding that Callavid could offer a differentiated delivery modality for a broad range of therapeutics in the pharmaceutical pipeline, while also creating new opportunities to extend the lifecycle of existing drugs.
Palisade Bio Strengthens the Case for Colon Targeted IBD Therapy
Palisade Bio has also added to the clinical momentum, releasing further phase 1a/b analyses of its investigational PDE4 inhibitor prodrug, PALI 2108.
The latest findings provide additional evidence of colon targeted delivery, sustained active metabolite exposure and pharmacological activity consistent with once daily dosing.
The company reported delayed ileocolonic activation, high tissue to plasma exposure and steady state concentrations of the active metabolite, PALI 0008, remaining above IC90 throughout the dosing interval.
These data build on earlier results that showed rapid improvements across clinical, histological and biomarker measures in ulcerative colitis.
According to Palisade, steady state analyses showed pre dose trough concentrations of PALI 0008 exceeded the IC90 threshold and were approximately 20 percent higher than single dose Cmax. This suggests continuous target inhibition across the dosing period. The metabolite reached steady state within roughly 48 hours and demonstrated an extended half life.
The tissue to plasma ratio of around six fold also supports preferential localisation of drug activity to the intestinal mucosa. Importantly, transcriptional effects were observed in colonic tissue but not in peripheral blood, reinforcing the colon selective nature of the drug’s activity.
Biomarker changes aligned with PDE4 inhibition, including decreased mucosal PDE4B expression, increased cAMP, reductions in lymphocytes and marked decreases in faecal calprotectin. Histological improvements were also observed across multiple indices.
Treatment with PALI 2108 also produced colon selective suppression of inflammatory and fibrotic pathways, including JAK STAT, NF κB, TNF α and TGF β signalling. For inflammatory bowel disease, where effective local activity and reduced systemic exposure are highly desirable, these findings are likely to be watched closely.
The President and Chief Medical Officer of Palisade Bio said the additional pharmacokinetic and translational analyses further characterise the differentiated profile of PALI 2108, which has been designed to be selectively bioactivated in the ileum and colon.
The company highlighted sustained trough levels of PALI 0008 above the IC90 threshold throughout the dosing interval, a profile it says compares favourably with currently approved systemic PDE4 inhibitors.
Previously reported phase 1a/b data showed consistent pharmacodynamic activity and clinical benefit, with all patients achieving clinical response and 40 percent achieving clinical remission.
Palisade said the accumulating evidence supports continued development of PALI 2108 as a next generation PDE4 inhibitor for inflammatory bowel disease.
What This Means for Pharmaceutical Manufacturing and Production
Together, these developments point to a pharmaceutical manufacturing landscape that is becoming more specialised, more targeted and more closely linked to clinical usability.
For manufacturers, the direction is clear. The next generation of pharmaceutical products is not only about discovering active compounds, but also about delivering them more precisely, supporting better patient adherence and building production models that can handle complex drug device combinations, biologics, prodrugs and targeted delivery systems.
UCB’s alliance with Cancer Research UK highlights the growing importance of integrated research and development pipelines, where discovery, preclinical work and early clinical trials are connected more tightly.
Calla Lily Clinical Care’s Callavid platform demonstrates how manufacturing must increasingly account for human factors, comfort and real world use. Palisade Bio’s PALI 2108 data shows the value of designing medicines that act where they are needed, with delivery and activation engineered into the product itself.
This raises the bar for pharmaceutical production. Companies will need robust quality systems, adaptable manufacturing processes and stronger collaboration between scientists, clinicians, device engineers and regulatory teams.
In practice, the boundary between medicine, device and delivery platform is becoming less rigid, and that has major implications for how products are developed, tested, manufactured and scaled.
Conclusion: A Clear Signal of Where Pharmaceutical Innovation Is Heading
The latest updates from UCB, Cancer Research UK, Calla Lily Clinical Care and Palisade Bio show a sector moving with purpose across several major fronts.
In oncology, strategic alliances are being used to bring promising science closer to the clinic. In women’s health, patient centred drug delivery is being given the attention it has too often lacked. In inflammatory bowel disease, targeted activation and localised therapeutic activity are shaping the next wave of treatment development.
Although these programmes sit in different therapeutic areas, they share a common theme. Pharmaceutical innovation is becoming more precise, more collaborative and more closely shaped around the patient experience.
For patients, clinicians and manufacturers alike, that is where the significance lies. These are not isolated announcements. They are part of a broader movement towards medicines that are not only scientifically advanced, but also better designed for the realities of treatment, production and long term clinical value.
News Credits:
UCB and Cancer Research UK form expanded alliance to advance novel cancer therapies
Calla Lily Clinical Care begins dosing in trial of intravaginal platform for threatened miscarriage
Palisade Bio reports phase 1a/b data showing colon‑targeted exposure
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