MediGene, BioNTech, BioNxt Solutions - New opportunities after the correction

BioNTech - Downturn ended for the time being

The Mainz-based biotechnology company BioNTech has lost over 75% of its share price since its high in August 2021. At that time, the share price was USD 464.00. After the Corona pandemic subsided and the resulting drastic decline in sales, the share price fell close to the USD 100 mark. Here the vaccine manufacturer's chart should find a bottom, at least in the short term. On the one hand, the relative strength indicator turned upwards and is about to generate a buy signal on a weekly basis; on the other hand, the trend-following indicator MACD has already formed positive divergences in recent weeks. The first trading target should be the high from 2020 at USD 131.00. The 200-week moving average is currently at USD 139.87.

The Mainz-based company received support for a successful bottoming from the United States. Together with partner OncoC4, they announced promising clinical Phase I/II data for their antibody candidate BNT316/ONC-392. This is intended for the treatment of difficult-to-treat non-small cell lung cancer. As non-small cell lung cancer accounts for 85% of all lung cancer cases, developing effective therapies for this form of cancer represents significant potential. The data presented demonstrate "encouraging signals of clinical anti-tumour activity as well as a manageable safety profile in patients with metastatic, PD-L1-resistant non-small cell lung cancer", BioNTech said. A final Phase III trial is already planned for the promising antibody candidate, which is expected to start in the third quarter of 2023.

The analysts at Goldman Sachs reiterated their "neutral" rating on BioNTech in their latest report and continue to see a price target of USD 140.

BioNxt Solutions - Significant approval

Since the beginning of the year, the shares of the German-Canadian biotech company BioNxt Solutions have performed much better than the Corona winner BioNTech. The share price performance is around 30%, whereby the annual high of CAD 0.83 from March was significantly higher. Since then, the Company, which is distinguished by its broadly diversified product portfolio, has corrected to CAD 0.58, but it lies on a prominent support zone. The steady news flow could create an attractive long-term entry opportunity here.

The life sciences accelerator focuses on next-generation drug formulations and drug delivery systems, diagnostic screening tests, and the manufacture and evaluation of new active pharmaceutical ingredients.

An important step was the recently announced approval for a European human bioavailability study of its rotigotine transdermal patch for treating Parkinson's disease. According to market researcher Research and Markets, the global market for transdermal skin patches was valued at just under USD 6.5 billion in 2020 and is expected to grow to around USD 20 billion by 2028.

The formulation of BioNxt Solutions is compared with an established branded product. The human trial is being conducted in Europe according to the highest standards of Good Clinical Practice (GCP) and the European Medicines Agency (EMA) guidelines on the quality of transdermal patches.

All transdermal patch samples for the clinical trial have already been manufactured. This important step was completed with the help of the innovative TDS platform technology of the wholly-owned German subsidiary, Vektor Pharma TF GmbH. Results are expected as early as 4 to 6 weeks after trial completion.

MediGene AG - Portfolio expanded

The Martinsried-based company wants to get back on "the radar of investors", as IR head Pamela Keck announced at the spring conference in Frankfurt. The Company is fully financed until the last quarter of the coming year and cooperates with BioNTech and the US National Cancer Institute.

The immuno-oncology platform company also announced the expansion of its pipeline to include neoantigens with programs targeting multiple KRAS mutations and HLAs. KRAS mutations are considered the most common oncogene mutations in hard-to-treat solid tumors and occur in approximately 30% of solid cancers such as pancreatic, colorectal, endometrial and non-small cell lung cancer. The global incidence of solid tumors harbouring KRAS mutations is estimated at over 300 000 patients.

"Our pipeline expansion to include neoantigens with multiple KRAS targets is an important step in our quest to develop first-in-class TCR-T therapies for patients with difficult-to-treat solid tumors", said Dr Selwyn Ho, Chief Executive Officer at MediGene. "We are pleased that this latest milestone further validates MediGene's proprietary end-to-end platform as the foundation for our highly specific, sensitive and potentially safer TCRs with optimal binding capabilities. These TCRs are combined with the PD1-41BB and/or CD40L-CD28 costimulatory switch receptors to enhance proliferation and longevity of TCR T cells and mitigate the immunosuppressive effects of the tumour microenvironment."

MediGene's shares have been in freefall since the February 2018 highs of EUR 19.40, losing around 92% of their value. At EUR 1.58, the share is trading close to a new low for the year.

After the sell-off of the past weeks, BioNTech could start to form a short-term bottom. The German-Canadian biotech company BioNxt Solutions received the necessary approval for a landmark study. MediGene is planning to expand its product pipeline.