Regeneron: Ahead of a Major EU Decision
Regeneron is an established biotechnology company. In addition to oncology, the company has a broad portfolio in ophthalmology, immunology and rare diseases.
The US group is currently advancing the further development of its cancer immunotherapy, Libtayo. Last week, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended a new dosing regimen. In future, following an initial twelve-week treatment period, the drug could be administered just every six weeks instead of every three weeks. The European Commission’s final decision is still pending.
For patients, this would be a considerable relief. Fewer infusion appointments mean less time spent and could reduce the burden of long-term cancer treatment. In addition, the committee recommends reducing infusion time at the existing dose from 30 to 15 minutes under certain conditions.
Libtayo is a so-called PD-1 inhibitor. The active substance helps the immune system recognise and attack cancer cells. In Europe, the drug is approved for certain forms of skin, lung and cervical cancer, among others. Particularly in advanced cutaneous squamous cell carcinomas, the therapy plays an important role.
The current recommendation does not initially extend the approved cancer indications. However, it could make an already established drug easier to use and strengthen its competitive position. At the same time, Regeneron is working on further combination therapies and new immuno-oncology agents. Cancer treatment remains an important part of its long-term growth strategy.
Vidac Pharma: Phase 2b Data Draw Closer, European Expansion Takes Shape
Anticipation is growing at Vidac Pharma. The biotech company will soon evaluate its Phase 2b study of VDA-1102 for actinic keratosis, a possible precursor to skin cancer. Vidac reported the completion of patient follow-up back in mid-September. Final data verification and statistical analysis will now follow. Positive results could decisively advance further clinical development.
The revolutionary aspect is the novel mechanism of action. Vidac targets the altered metabolism of diseased cells. The focus is on the enzyme hexokinase-2 (HK2), whose mitochondrial interactions the company aims to modulate. The goal is to normalise cellular metabolism and promote programmed cell death. The potential extends beyond actinic keratosis. VDA-1102 is also being developed to treat cutaneous T-cell lymphoma. In addition, Vidac is working on VDA-1275, another drug candidate targeting solid tumours.
The expansion of its European business could provide an additional tailwind. At the annual general meeting on September 30, shareholders approved a strategy to enter into a licensing agreement with Eutopos Pharma. The planned French group company will initially take on financing, development and marketing activities in Europe. Eutopos was selected for the Quest for Health innovation programme in Strasbourg back in July. This agreement could open up new access to investors, research partners and the European pharmaceutical market. However, a final licensing agreement has not yet been announced.
The combination of forthcoming study data and European expansion opens up attractive prospects for Vidac. If the efficacy and tolerability of VDA-1102 are confirmed, the company, with a market capitalisation of around EUR 20 million, could advance its clinical development on a broader organisational footing.
Krystal Biotech: More Than 80% of Skin Tumours Shrink
Krystal Biotech recently attracted attention with remarkable clinical data. The US biotechnology company reported initial results for its drug candidate KB113 in patients with Gorlin syndrome. This rare genetic disorder leads to a greatly increased risk of basal cell carcinomas. Affected patients can develop numerous skin tumours over their lives, often requiring repeated surgery.
The results of the small pilot study are promising. In three treated patients, shrinkage was observed in 69 of a total of 83 tumour lesions examined, equivalent to 83.1%. Not only did directly treated tumours respond, but 40 of 47 non-injected lesions also showed a reduction in size.
In each of the three patients, complete regression was also confirmed in a biopsied, previously treated skin lesion. All reported side effects were mild to moderate and transient.
KB113 uses virus-based technology to deliver the immune signalling molecules interleukin-2 and interleukin-12 directly into the tumour environment. This is intended to trigger an immune response that can reach potentially even untreated tumours.
Krystal already has commercial experience with its gene therapy Vyjuvek for a rare genetic skin disorder. The company can therefore draw on existing development and marketing structures.
The new data open up additional prospects in oncology. However, the study has so far included only three patients. Whether the results can be confirmed in larger studies remains an open question. According to its own statements, Krystal is already in discussions with the US Food and Drug Administration (FDA) about further clinical development.
Conclusion
Regeneron is strengthening its position in cancer treatment with a potential simplification of Libtayo treatment. Krystal Biotech is delivering impressive initial results in a rare skin tumour disease. Vidac Pharma, by contrast, is entering a critical phase: the forthcoming analysis of the Phase 2b study could show whether its novel approach to tumour metabolism proves clinically convincing. If this can be demonstrated, significantly broader development potential could open up for Vidac.
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