Optimum’s Year-End Review  

2023 was an exciting year for Optimum’s clients who overcame many of the market challenges to make significant strides forward with their vital life sciences research. Here are some of the highlights from what has been an exceptionally busy and successful year.

 

M&A & deals

Synaffix continued to build momentum – Lonza acquired the Netherlands-based biotech and its antibody-drug conjugate (ADC) technology for €100 million upfront and up to €60 million in additional performance-related payments.

The acquisition will further strengthen Lonza’s bioconjugates offering through the integration of Synaffix’s industry-leading, proprietary technology platform and R&D capabilities, including payload and site-specific linker technology.

Novo Holdings, the holding and investment company responsible for managing the assets and wealth of the Novo Nordisk Foundation, closed its acquisition of one of the world’s largest antibiotics specialists, Paratek Pharmaceuticals, in a US$462 million transaction. Novo Holdings, the holding and investment company responsible for managing the assets and wealth of the Novo Nordisk Foundation, closed its acquisition of the world’s largest antibiotics specialists, Paratek Pharmaceuticals, in a US$462 million transaction.

There was a major success for our client, the biotech investment firm Medicxi, when Eli Lilly made a $1.9 billion swoop for its portfolio company Versanis.

Neuraxpharm Group announced a tie-up with TG Therapeutics Inc. for the ex-U.S. commercialization of infused MS drug Briumvi (ublituximab).

Pheon Therapeutics, the antibody-drug conjugate (ADC) specialist, announced a deal with Biocytogen Pharmaceuticals (Beijing) Co., bringing in an antibody therapy developed using the latter’s RenMice platforms.  Pheon is developing next-generation ADCs for a wide range of hard-to-treat cancers.

In October, SpliceBio, a genetic medicines company harnessing protein splicing to develop next-generation gene therapies, signed an exclusive collaboration and licensing agreement with Spark Therapeutics to use SpliceBio’s protein splicing platform to develop a gene therapy for an undisclosed inherited retinal disease.

Engimmune, a developer of soluble T-cell receptor drugs (called ‘TCRs’) to tackle solid tumours, announced a collaboration with CSEM, the Swiss Technology Innovation Center, to use CSEM’s microfluidics technology to speed up the hunt for safe and effective TCR candidates.

Fundraising and investments

There were some eye-catching fundraising and investment deals from our clients.

Sofinnova Partners announced it had successfully closed its US$200 million (€190m) digital fund, significantly exceeding its target.

Specialist life sciences investor Vesalius Biocapital announced the closure of its fourth fund, securing over €95 million (US$101m) and attracting blue chip investors including the European Investment Fund (EIF).

Medicxi, the leading life sciences investment firm, made waves in July by launching its Medicxi IV fund, building on previous successful fundraisers.

In April, a US$105m Series C funding of cancer and fibrotic diseases biotech Alentis Therapeutics was co-led by our client Novo Holdings, along with Jeito Capital and RA Capital Management.

The Novo Nordisk Foundation gave a DKK 1 billion (around $143 million) grant to the Novo Nordisk Foundation Center for Basic Metabolic Research at the University of Copenhagen to support research towards innovative approaches to diagnosis, prevention, and treatment of cardiometabolic diseases.

Novo Holdings was among a group of investors that committed €443 million to the first close of Glentra Capital’s energy transition fund, Glentra Fund I. Based in Copenhagen and London, Glentra is a newly established investment firm with an ambition to accelerate the energy transition for a clean and sustainable future.

Acesion Pharma announced it had successfully closed an oversubscribed €45 million Series B financing round. The financing will be used to advance the clinical development of AP31969, an oral SK ion channel inhibitor optimised for chronic treatment of Atrial Fibrillation (AF). Earlier in 2023, Acesion demonstrated clinical proof-of-concept with AP30663, its first-in-class SK ion channel inhibitor for conversion of AF to normal sinus rhythm. More than half of patients on the phase II trial saw their sinus rhythm converted within 90 minutes of infusions starting.

It was a positive year for AMSilk GmbH, one of the world’s first industrial suppliers of high-performance biopolymers biotech-produced advanced materials based on spider silk proteins, raised an additional €25 million in an extended Series C financing led by existing investor ATHOS (AT Newtec) with participation from Novo Holdings, Cargill, and MIG Capital.

Emerging from stealth, Astraveus, a creator of modular, microfluidic cell factories that transform cell and gene therapy manufacturing, completed an oversubscribed €16.5 million seed financing led by AdBio partners, co-syndicated with M Ventures, Johnson & Johnson Innovation (JJDC, Inc.) and Bpifrance Large Venture.

AstronauTx, which aims to develop novel treatments for Alzheimer’s and other neurodegenerative disorders, closed a £48 million (US$61m) Series A financing. The company was launched in 2019 and spun out from UCL Business, the commercialisation company for University College London (UCL).

MinervaX, a privately held Danish biotech developing a novel prophylactic vaccine against Group B streptococcus, in October announced a €54 million upsized financing, including participation from existing investor Novo Holdings, among others.

Biocomposites delivered and exceeded its revenue expectations in a big step forward in its research and development in 2023, highlighting record sales growth and a huge increase in the number of patients it has supported to improve lives.

The BioInnovation Institute (BII), the international non-profit life sciences incubator, announced the first cohort of companies to enter the new accelerator start-up program at Deep Tech Lab – Quantum (DTL-Q). An independent accelerator, six companies have been selected for the DTL-Q, becoming the first to enter NATO’s Defence Innovation Accelerator for the North Atlantic (DIANA), which will be the inaugural program to run as part of Denmark’s contribution to the initiative.

Leucid Bio, a company developing next-generation Chimeric Antigen Receptor T-cell (CAR-T) therapies entered a commercial agreement to manufacture lead asset LEU011, a lateral CAR targeting NKG2D ligands for use in human studies.

Bionical continues to deliver in its commitment to improving patient outcomes and delivering better results with its clinical, commercial and digital services to life sciences companies in the UK and U.S.

 

Research success

Ariceum announced publication of positive results from a phase I/II trial of its radiopharmaceutical 177Lu-satoreotide tetraxetan (satoreotide) in patients with previously treated, progressive neuroendocrine tumours (NETs), in the European Journal of Nuclear Medicine and Molecular Imaging. The Phase I/II trial was initiated by Ipsen, and completed after Ariceum acquired satoreotide from the France-based pharma.

Vicore Pharma continued to blaze a trail in the rare respiratory disease Idiopathic Pulmonary Fibrosis (IPF), announcing an updated interim analysis from the phase IIa AIR trial, involving its C21 angiotensin II type 2 receptor agonist (ATRAG) class drug. Results showed C21 continued to demonstrate long-term efficacy at 36 weeks, improving lung function in this disease where lungs become progressively scarred. Approved drugs can only slow its onset.

Also in respiratory diseases, Verona Pharma announced data from the Phase III ENHANCE-1 trial testing nebulised ensifentrine in chronic obstructive pulmonary disease (COPD). Following a top-line readout late last year, Verona presented detailed data at the American Thoracic Society (ATS), including analyses from ENHANCE-1 and the almost identical ENHANCE-2 trial. Both hit their primary endpoints, improving lung function and reducing exacerbation risk, and formed the basis of an FDA filing asking for a full approval, paving the way for a regulatory decision in mid- 2024. Verona’s success saw CEO David Zaccardelli win the prestigious Executive of the Year 2023 award from SCRIP.

Calliditas Therapeutics in August announced pivotal results from its phase III study of Tarpeyo (budesonide), showing benefit in kidney function for patients with IgA nephropathy (IGAN). The data allowed Calliditas to ask the FDA for full approval for the drug, which is marketed conditionally under an accelerated approval.

Building on clinical results announced in 2022, Futura Medical launched its Eroxon erectile dysfunction gel, with the product hitting retailers throughout the UK. It was the culmination of years of hard work and in July resulted in a partnership with GlaxoSmithKline spin-off Haleon in the U.S., where the gel was approved by the FDA.

4SC AG  announced data proving its maintenance therapy resminostat (Kinselby) is clinically proven to postpone disease progression in advanced cutaneous T-cell lymphoma (CTCL). The treatment has shown a statistically significant improvement in progression free survival of 97.6% compared to placebo, with a risk reduction of 38%. Furthermore, median time to next treatment (median TTNT) for those on 4SC’s drug versus placebo showed a huge improvement – of 8.8 months compared to 4.2 months. The company is actively preparing its Marketing Authorization Application in the EU, Switzerland, and the UK. In the U.S., the drug has been granted orphan designation. Discussions are planned with the FDA over marketing requirements in the U.S.

Cancer biotech iOnctura made progress on several fronts, including pioneering research describing the unique biological features of roginolisib, an oral first-in-class competitive allosteric modulator of PI3Kδ. The drug is in phase Ib/II development in solid tumours and blood cancers.

Lytix Biopharma AS made a splash at the European Society of Medical Oncology (ESMO) conference, with encouraging preliminary data from its ATLAS-IT-05 Phase II open label trial in 20 patients with stage III-IV melanoma refractory to treatment with PD1/PD-L1 inhibitors. A combination of Lytix’s LTX-315 and Keytruda demonstrated prolonged stabilization in this heavily pre-treated patient population with a disease control rate of 43%.

Cancer vaccine specialist IO Biotech completed enrolment in its pivotal Phase III trial of IO102-IO103, in combination with Merck & Co’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), in patients with advanced melanoma. After recruiting 380 patients, an interim analysis is expected in mid-2024 and readout of the progression free survival primary endpoint is expected in the second half of 2025.

STORM’s first-in-class investigational drug STC-15 became the first clinical stage molecule specifically targeting an RNA methyltransferase, reshaping the tumour microenvironment and activating anti-tumour immunity.

Versameb announced FDA clearance of IND applications for its lead candidate VMB-100 for the treatment of Stress Urinary Incontinence. A recent publication in the internationally recognized scientific journal, Molecular Therapy – Nucleic Acids, demonstrating the therapeutic potential of engineered IGF-I mRNA as a regenerative medicine with a favourable safety profile.

After a highly successful year, Poolbeg Pharma presented data at the American Society of Hematology (ASH) conference detailing how POLB 001 could be a potential therapy for Cytokine Release Syndrome (CRS) associated with cancer immunotherapies, such as T-cell engaging antibodies and CAR T cell therapies.

Mission Therapeutics has received Clinical Trial Authorization from the MHRA to begin a Phase 1, first-in-human study of MTX325, a potential disease-modifying therapy for Parkinson’s Disease.

Also in neurology, Alchemab Therapeutics, an antibody discovery company identifying naturally occurring antibodies from individuals resilient to disease, unveiled exciting data on ATLX-1088, its newly-discovered preclinical Alzheimer’s candidate. The drug targets CD33, a cell surface protein thought to play a key role in Alzheimer’s.

Rejuvenate, a Belgian firm advancing therapeutics to delay the onset of age-related diseases, completed a Phase 1b proof-of-mechanism trial into its lead candidate RJx-01, which it is developing as a treatment for sarcopenia.

 

Awards

At the LSX Lifestars Awards several of our clients were recognised, with Novo Holdings’ portfolio company Hemab clinching the Series B financing category. Amolyt, a portfolio company of our clients Novo Holdings and Sofinnova, won Biotech of the Year, while CorWave won the MedTech of the Year category. Ariceum scooped the Deal of the Year <€500m award and Renée Aguiar-Lucander, CEO of Calliditas, won the Women-led Business of the Year category.