Europe peeking above the macro calamity

Behind the macro effects pulling on public market sentiments and the broader biotech sector, still the hunger for new technologies and investor opportunities remains strong. In Europe, much is happening behind the scenes that is being overlooked in the headline news. One major highlight of BIO-Europe this year is the spread of companies presenting, in fact 2023 is a record year on every measure, biopharma professionals, investors, business development opportunities, clinical trial updates and great networking.

At the base of the European biotech and pharma industry are the little remembered drug discovery and development players. While everyone is looking for the big clinical Phase III data news, regulatory approvals and M&A action, Europe’s earlier stage entrepreneurs continue to push ahead building value and creating answers to treating more and more diseases.

The platform players are breaking new boundaries, delivering novel therapeutic options for doctors and, of course, patients. Along the path to approval, the partnerships, licensing deals, M&A and fundraising activities will help to keep the European sector buzzing and busy.

For instance, iOmx Therapeutics AG, is developing next-generation immunotherapies by harnessing their deep tumor and myeloid biology insights, along with the iOTarg^TM versatile target screening platform and the comprehensive drug discovery & development expertise. The company's lead candidate, OMX-0407, a first-in-class oral salt-inducible kinase (SIK) inhibitor for the treatment of patients with previously treated inoperable solid tumors, entered the clinic this year.

“We are making excellent progress with our Phase I clinical trial,” said Dr. Apollon Papadimitriou, CEO of iOmx. The company translates unexplored immune evasion biology into a growing pipeline of biomarker-enabled therapeutic programs. “We are committed to shaping the future of cancer therapy, focusing on monotherapy approaches in a modality-agnostic fashion. All our compounds have the potential to treat cancers that are resistant to current immunotherapies," Papadimitriou added.

In another immuno-oncology platform approach, Medigene AG (FSE: MDG1) is focusing on the discovery and development of T cell immunotherapies to treat solid tumors. “Our approach to developing TCR-T therapies is holistic and focused on overcoming the challenges of treating solid tumors in the best possible way. Our End-to-End Platform, validated by partners such as BioNTech and 2seventy bio, offers multiple proprietary and exclusive TCR generation and optimization, as well as product enhancement technologies, and allows Medigene to create best-in-class, differentiated T cell receptor engineered T cell therapies that are optimized for safety, efficacy and durability,” said Selwyn Ho, CEO of Medigene.

The company is building a proprietary clinical pipeline and partnering other compounds discovered on the platform. “We are confident that by fully leveraging the capabilities of our End-to-End Platform, we will deliver significant value to patients,” he added.

Furthermore, in the cancer immunotherapy platform space, invIOs GmbH is developing individualized immunotherapies against solid tumors. Lead candidate APN401, currently in a Phase Ib clinical trial against various solid tumors, is a personalized cell therapy based on the proprietary EPiC technology platform. “EPiC enables the decentralized rapid processing of a patient’s fresh immune cells, meaning these cell therapies can be processed locally in a closed manufacturing system, a real benefit for doctors and patients,” said Peter Llewellyn-Davies, CEO of invIOs. Two other EPiC-based programs are in preclinical development.

invIOs is also developing INV501, a novel orally available small molecule candidate that can selectively enhance anti-tumor immune responses. The program has shown strong inhibition of tumor growth in preclinical models of hard-to-treat tumors – melanoma, breast cancer and glioblastoma and prolonged survival after end of treatment.

Taking a step away from immunotherapy platforms is LNAplus platform specialist Secarna Pharmaceuticals GmbH & Co. KG – the antisense drug discovery company focusing on the discovery and development of next-generation antisense oligonucleotide (ASO) therapies to treat challenging or previously undruggable targets. “The therapeutic opportunities we are developing could change the treatment paradigm for many patients that are running out of medical alternatives,” said Dr. Alexander Gebauer, CEO of Secarna. The proprietary platform and ASOs have been validated by several academic and industry collaborations and a broad proprietary pipeline of late-stage pre-clinical programs all addressing therapeutic areas of high unmet medical need including immuno-oncology and fibrotic/inflammatory diseases.
Reinforcing the strength of opportunities in the platform space, there is proof the partnership model works. Recently, we have seen several partnerships evolving, especially in the Antibody-drug conjugates (ADCs) space, with cash and longer-term investment commitments, too!

One such company is Heidelberg Pharma AG (FSE: HPHA), which has well developed partnerships with major Asian biopharma companies, namely Huadong Medicine and Takeda.  They are developing ADCs based on the payload amanitin with a unique mode of action addressing dormant tumor cells and resistance as two of the biggest challenges in oncology. “Leveraging our proprietary ATAC® technology, we have built a promising pipeline and look forward to discussing deal and partnering opportunities,” said Dr. George Badescu, CBO of Heidelberg Pharma.

“Our Phase I/IIa clinical trial in Europe and the US with our lead candidate HDP-101 to treat multiple myeloma is well received by doctors and patients and is now progressing quickly through the dose escalation part. So far, it has been shown to be safe and well tolerated and we are expecting efficacy data next year. In parallel, we are expanding our ADC technology into a toolbox to develop the best possible ADCs for further targets and areas of application – to advance our own pipeline and our partners' programs and for the benefit of cancer patients worldwide,” he added.

In Belgium, Imcyse SA is developing next generation targeted antigen-specific immunotherapies for severe autoimmune diseases. The company gained backing from Pfizer, which has licensed worldwide rights to the preclinical Imotope™ program for rheumatoid arthritis (RA). Currently, Imcyse’s pipeline is drawing much attention for its Imotope™ IMCY-0098, a synthetic peptide based on insulin, in Phase 2 clinical trials as a Type 1 diabetes (T1D) treatment, with results of the Europe/US/Australia wide trial expected in the next 5 months. In addition, the Company completed enrolment and initial dosing in the Phase 1b portion of its adaptive Phase 1b/2 clinical trial of its Imotope™ IMCY-0141 in patients with relapsing-remitting multiple sclerosis (RRMS). Imotopes use modified autoantigen epitopes to induce T cell-mediated depletion of antigen presenting cells and pathogenic T cells driving the disease. “The basis of the Imotope approach is to prevent and potentially cure severe autoimmune diseases by reprogramming the patient’s own immune system; for instance, we aim to maintain insulin production to enable patients to live life less impacted by the disease,” noted Andrew Mackie, CBO of Imcyse. Other programs are in preclinical studies in diseases such as neuromyelitis optica.

As of today, there are many European companies with products on the market and revenues. Some of these companies have exciting clinical news in the coming months and quarters, which should spark interest from investors, potential partners, and smart bankers.

 MorphoSys AG (Xetra: MOR; Nasdaq: MOR) has long been regarded as a European bellwether, transforming from a scientific platform company into a hematology oncology specialist.  For 2023, the company expects sales between $85 million and $95 million for its marketed immunotherapy Monjuvi® (tafasitamab-cxix), a treatment for relapsed or refractory diffuse large B cell lymphoma (DLBCL). It’s largest and most immediate opportunity, however, lies with pelabresib, an investigational BET inhibitor, which could become a first-line therapy for myelofibrosis, a debilitating type of blood cancer with limited treatment options. Top-line results from the ongoing Phase III MANIFEST-2 trial with pelabresib are expected in the coming weeks, and an oral session at ASH 2023 in December will provide detailed findings from the trial. Jean-Paul Kress, MD, CEO of MorphoSys, notes: “We are focused on addressing the critical needs of cancer patients. With topline Phase III clinical results for pelabresib expected in the coming weeks, we hope to be able to bring an important new treatment option to patients with myelofibrosis.” MorphoSys is also developing tulmimetostat, a next-generation dual inhibitor of EZH2 and EZH1, which is in a Phase 1/2 clinical trial and recently received FDA fast-track designation for endometrial cancer.

InflaRx N.V. (Nasdaq: IFRX) is another European biotech which has made it to the market.  The company is developing potent and specific inhibitors of C5a and C5aR to treat a range of inflammation indications. Earlier this year, the company raised $46 million in a well-received follow-on round after receiving FDA Emergency Use Authorization for Gohibic (vilobelimab) for the treatment of critically ill COVID-19 patients. After the launch of Gohibic in the U.S. in June, InflaRx filed a market authorization application in Europe. Reporting third quarter results in early November, Dr. Thomas Taapken, CFO, noted: “This quarter was the first time that InflaRx has recorded sales revenues, an achievement that very few biotech companies reach. We are further expanding our commercial activities over the coming months as cases of severe COVID-19 are anticipated to increase over the winter months.” In addition to the anti-C5a antibody vilobelimab, the company is developing INF904, an orally administered small molecule inhibitor of C5aR, in a Phase I clinical trial to treat chronic autoimmune and inflammatory diseases.

Based on these few examples, it is clear Europe is well set for an exciting 2024, definitely, in platform development and clinical trial achievements, with a positive breeze! These past three years have been tough for all worldwide and now the dawn of a new paradigm in biotech and pharma deals is widely anticipated, presumably also helping to attract generalist investors once more to participate in public markets. On the venture capital side, so far this year we have seen over $2.9 billion raised in VC rounds, excluding VC debt and uncategorized equity rounds, in biotech companies, according to BioCentury’s BCIQ business intelligence and research tool. In 2022, the equivalent full year figure raised was $3.2 billion.