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Effective URL: https://www.labiotech.eu/opinion/trends-clinical-research-2024/
Submission: On January 17 via manual from IN — Scanned from DE
Effective URL: https://www.labiotech.eu/opinion/trends-clinical-research-2024/
Submission: On January 17 via manual from IN — Scanned from DE
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Podcast Reports
Home Opinion What to expect from biotech clinical trials in the coming year
WHAT TO EXPECT FROM BIOTECH CLINICAL TRIALS IN THE COMING YEAR
Richard Staines, account director at Optimum Strategic Communications
11 minutesmins
December 18, 2023 -Updated: onJanuary 4, 2024
11 minutesmins
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There’s an air of cautious optimism about 2024, after a difficult few years
following the end of the pandemic when investment in pharma and biotech research
dropped substantially. After this significant reset, there’s now hope that in
2024, in line with emerging trends, the funds will be there for the vital
clinical research and cutting-edge technology that could redefine care for
diseases and conditions for which treatment options are limited or
non-existent.
Investors are still likely to be risk-averse, however, and the consensus is that
the bonanza seen during the pandemic is unlikely to return. But there are some
‘hot’ areas that are attracting investment because of recent successes such as
obesity and neurology.
Roche finished 2023 with a $2.7 billion buyout of obesity biotech Carmot
Therapeutics, which has a dual glucagon-like peptide-1 (GLP-1) and gastric
inhibitory polypeptide (GIP) agonist, ready for phase 2 development.
It’s aimed for treatment of obesity in patients with and without type 2
diabetes, and could be a direct competitor to Eli Lilly’s U.S. Food and Drug
Administration (FDA)-approved Zepbound, (tirzepatide) which has the same
mechanism of action, and Novo Nordisk’s GLP-1 Wegovy (semaglutide).
After around a decade of clinical trial failures, there has finally been
progress in recent years with a new generation of Alzheimer’s drug – first with
the FDA approval in 2021 of Biogen’s Aduhelm (aducanumab), and of Eisai’s
Leqembi (lecanemab) in 2023.
Dr. Jörg-Thomas Dierks, chief executive officer (CEO) of specialist neurology
pharmaceutical company Neuraxpharm, pointed out that these successes are just
the tip of the iceberg as both drugs can only slow progression of the disease.
He said: “Trying to address the many unmet medical needs that still persist in
this therapeutic area with new disruptive therapies like AI and cell and gene
therapies require high investment and consequently high risk. Nonetheless, it is
great to see that pre-pandemic investment flows have now recovered.”
In medtech, Anne Osdoit, partner at Sofinnova Partners, said that neurology is
likely to attract investment in 2024, in line with the trend in pharmaceutical
R&D.
She said: “Neurotechnology, particularly neurostimulation, is poised to reach
record-high investments, driven by deals focusing on pivotal clinical trials.
Orthopedics and cardiovascular (interventional heart failure specifically)
investments have also seen robust activity.”
Osdoit was cautious over the prospects for investment in digital health and
medtech.
“The tough investment environment we’ve been experiencing over the past 12
months means the deals that do happen involve the best scientific ideas, great
engineering and resilient, experienced teams. The medtech sector experienced a
35% drop in investment, to $3.7 billion across 276 deals in the first half of
2023, a significant decline from the previous year. This contraction is
attributed to a decrease in new investor-led financings, and a notable dip in
large financings over $200 million,” she said.
Renée Aguiar-Lucander, CEO of rare disease biotech Calliditas Therapeutics, said
capital markets will “remain difficult to navigate” for public biotechs in 2024.
She added: “For good data and significant catalysts, there is certainly an
ability to raise capital. The private market has been somewhat more resilient,
but even there, it has been challenging for many companies over the last couple
of years. Hopefully, as rates stabilize, there is more certainty around cost of
capital, facilitating funding.”
INNOVATIONS IN GENE EDITING AND RARE DISEASES
But there has been progress with closely-watched technologies such as gene
editing after the U.K. became the first country in the world to approve the
first CRISPR treatment for a disease.
The country’s Medicines and Healthcare products Regulatory Agency (MHRA)
approved Vertex/CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel), for
patients aged 12 and over for sickle cell disease (SCD) and
transfusion-dependent beta-thalassemia (TDBT).
This preceded a decision from the U.S. FDA, which approved Casgevy in December
2023, based on data from an ongoing single-arm trial in patients with SCD.
In 2024, clinical research into CRISPR-derived technologies, base editing and
prime editing, is expted to gather pace. In late 2023, there were the first
clinical results from Verve Therapeutics’ VERVE-101, a base editing therapy
which permanently deactivates the gene PCSK9, and was the first therapy of this
kind in the clinic in 2022.
This controls the level of low-density lipoprotein (LDL) “bad” cholesterol
associated with heart disease – a readout from the company’s phase 1b trial in
patients with high-risk heterozygous familial hypercholesterolemia (HeFH),
established atherosclerotic cardiovascular disease and uncontrolled LDL levels
on standard oral therapy.
Three patients out of 10 saw their LDL cholesterol levels cut but one patient
experienced a myocardial infarction the day after receiving the treatment,
considered potentially related to the dosing.
Another patient suffered a fatal cardiac arrest around five weeks after
treatment, although this was determined to be caused by underlying ischaemic
heart disease rather than the treatment.
The safety data were of concern to investors but the efficacy data has been seen
as a proof-of-concept for this iteration of CRISPR gene editing.
Clinical trials of another CRISPR variant, prime editing, are also expected to
begin in 2024, in the quest for gene editing therapies that are more accurate
and with fewer or no off-target editing events.
Jean-Philippe Combal, CEO of gene therapy biotech Vivet Therapeutics, added that
approved treatments for hemophilia A and B will generate “significant commercial
momentum” for proven adeno-associated virus (AAV) gene therapy technology.
AAVs are now well established as a gene therapy vector, and have proven to be
safe and effective in the clinic, and have been on the market since 2017.
Their major drawback is they can only carry smaller genes (around 2,000 bases),
although there are hopes this could be improved as the technology develops.
Combal added: “In Duchenne muscular dystrophy, Sarepta, Pfizer, Solid and
RGNXBIO will lead the way for new clinical data, and in Wilson’s disease our own
Gateway clinical trial is ongoing.”
Data for ocular, CNS and hearing loss disorder, AAV gene therapies could drive
financing rounds, while refinements to the technology could improve
manufacturing yield and reduce costs.
Overall, rare diseases will continue to attract clinical research in 2024,
continuing a long-term trend, according to Calliditas’ Aguiar-Lucander,
including genetic and pediatric diseases such as Duchenne muscular dystrophy,
Alport syndrome and amyotrophic lateral sclerosis.
She said: “Rare disease research has grown significantly over the last 15 years,
and there seems to be an unabated interest and need for new medications for
patients with rare diseases. Less than 10% of rare diseases have so far been
addressed with medications, so there is a substantial unmet medical need.”
INVESTMENT AND PROGRESS IN CANCER RESEARCH: A KEY CLINICAL TREND IN 2024
Oncology is an area that has always attracted research investment, with some
arguing in the past that this came at the expense of other disease areas such as
infectious diseases.
According to a 2023 analysis by contract research giant IQVIA, oncology trial
starts are at historically high levels, and global spending on cancer medicines
has increased annually by an average of 5% over the past five years. This is
expected to continue in the coming years, according to IQVIA.
Mai-Britt Zocca, founder and CEO of IO Biotech, a specialist in cancer vaccines,
added: “There’s no doubt the funding environment continues to be challenging,
but companies with strong clinical data will be able to attract what they need
to progress clinical trials and make regulatory submissions. However, I think
it’s going to be harder for companies with early pipeline assets.”
Dr John Maher, chief scientific officer at cancer cell therapy biotech, Leucid
Bio, said there was a surprising lack of funding for research into the area,
despite a high profile success in the clinic from a group led by Franco
Locatelli, in the Ospedale Pediatrico Bambino Gesù in Rome, Italy.
Maher said: “It surprises me that funding remains somewhat tight in the current
climate. The transformational data achieved by the Locatelli group in solid
tumor patients really should have translated into a large bounce for the field,
but the message doesn’t seem to have quite permeated as yet.”
Leucid’s Dr Maher added that in the field of CAR-T Immunotherapy, where a
patient’s T-cells are genetically manipulated to fight cancer, further progress
will be made in solid tumors following the findings from the Italian study.
“I remain firmly optimistic that the field will continue to advance steadily,
and we will see more impressive developments in 2024,” Maher said.
Elsewhere in cancer, Catherine Pickering, CEO of iOnctura noted progress in the
first-line setting for many cancers, noting that some have a five year survival
rate of 95% thanks to the latest therapies.
But she added: “A key trend in clinical research for 2024 will be a shifting
focus to acquired and adaptive resistance. More and more companies, iOnctura
included, are focusing on characterizing the mechanisms behind this resistance
using validated multi-omic approaches at the intersection of biology /
immunology and computer science. As resistance mechanisms are uncovered,
companies will be looking to intelligently combine different drugs to overcome
them.”
IO Biotech’s Mai-Britt Zocca added that cancer vaccines could play a role in
improving response rates to checkpoint inhibitors by modulating the tumor
micro-environment and making it less immunosuppressive.
In 2024, IO Biotech expects an interim analysis of a phase 3 trial for its
immune-modulating vaccine IO102-IO103, combination with U.S. based Merck & Co’s
anti-PD-1 checkpoint inhibitor, Keytruda (pembrolizumab).
While new modalities are making the headlines, there has been a resurgence in
interest in small molecules as cancer drugs.
They are often available as patient-friendly oral therapies that don’t require
hospital visits to administer.
There are other technical advantages as they can pass through cell membranes to
reach targets within the cell. They tend to be cheaper to manufacture and can be
easy to store without need for refrigeration.
Jerry McMahon, CEO of STORM Therapeutics, said: “Small molecules are back at the
forefront, especially with novel chemistries that do not rely upon catalytic
inhibition of the target. Inhibition or modulation of RNA represents a new
frontier for small molecules.”
RECRUITMENT CHALLENGES IN CLINICAL TRIALS IN 2024
After the continuing geopolitical turmoil in 2023, there are challenges with
research regions affected by war and like many industries, pharma and biotech
will be hoping for stability in 2024, as they search for places to recruit
patients for clinical trials.
The ongoing issue of clinical trial recruitment will continue, according to
industry experts.
Paul Little, CEO of Vesper Bio, a company which specializes in sortilin receptor
biology and has its lead programme focused on frontotemporal dementia, outlined
the challenges of trial recruitment for rare diseases.
He said: “Site visits can be challenging and upsetting for patients, so allowing
patients to self-dose at home and minimize the need to interrupt their, and
their caregiver’s day is important. To overcome this, it is critical to build a
network of contract research organizations, key opinion leaders and patient
groups, with whom you can work closely with, to optimize your clinical trial
design, while always keeping the patient in mind.”
Meanwhile, iOnctura’s Catherine Pickering welcomed U.S. legislation contained in
spending legislation (Consolidated Appropriations Act, 2023), aimed at
increasing representation of groups on clinical trials who have been
historically omitted from clinical research, such as women and ethnic minority
patients.
The U.S. National Institutes of Health (NIH) and numerous other healthcare
figures have raised concerns that decades of testing drugs primarily on white
men, means there are gaps in knowledge about how drugs work in large parts of
the population.
Pickering said: “[The] FDA will require diversity plans for all phase 3 clinical
trials conducted in the U.S.. This will start to shape the clinical trial
landscape in 2024. Historically, women and racial and ethnic minorities have
been underrepresented in clinical trials. It is a positive move that companies
are being encouraged to address this.”
THE RISE OF AI: A TOP TREND IN CLINICAL RESEARCH IN 2024
Edward Kliphuis, partner at Sofinnova Partners, said artificial intelligence
will continue to shape clinical research in 2024 and beyond, helping to
interpret the vast amounts of health data that is emerging from various
technologies.
At the same time, use of wearable devices will allow health monitoring to grow
substantially, creating a far more personalized healthcare experience.
A key development has been the rise of generative artificial intelligence
(GenAI), which is capable of generating text, images or other media, Kliphuis
said. This can be used to create a whole ecosystem of sophisticated,
patient-centric health management tools, he added.
He said: “We expect the collaboration between tech companies and healthcare
providers to deepen, leveraging GenAI to create more sophisticated,
patient-centric health-management tools. This collaboration is expected to
bridge the gap between data collection and practical healthcare delivery, making
digital health solutions more integral to everyday healthcare practices.”
24 top innovations for 2024
24 scientific discoveries from academic teams around the world selected by the
global R&D community
Review the list
Explore other topics: Artificial intelligenceCancerClinical trialinvestment
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