BioNTech, Defence Therapeutics, Valneva - Will the fall bring a new boost?

BioNTech - New Omicron vaccine filed for approval

BioNTech, together with its US partner Pfizer, has developed a new variant of its COVID-19 vaccine that is explicitly adapted to the currently rampant Omicron variant. It is said to provide significantly better protection than the original version of the Comirnaty vaccine. The Company has now submitted applications for approval of the new vaccine variant to the US FDA and the European EMA.

At the same time, it was announced that the US government has already ordered 105 million doses of the new vaccine at a cost of USD 3.2 billion, with an option for an additional 195 million doses. Good news for the Company currently sitting on a mountain of USD 6.8 billion in cash with another USD 14.1 billion in receivables outstanding. The Company will report the exact figures for the 2nd quarter of the current fiscal year on August 8.

More decisive will be the outcome of patent lawsuits filed by competitors such as the Tübingen-based CureVac Group, which the Company is currently facing. Together with its American partner, the Mainz-based company is now taking aggressive action against the latter: The Company recently announced that it had filed a lawsuit with a district court in the US state of Massachusetts. In any case, analysts are positive and currently see a share price potential of over 40%.

Defence Therapeutics - Will a new study bring about the turnaround?

The last few months have been a tough test for investors in the Canadian biotech company Defence Therapeutics. The share lost ground disproportionately. The ADC specialists at Defence Therapeutics (ADC = Antibody Drug Conjugates, i.e. the antibody-drug combination in a "piggyback" process, similar to BioNTech's mRNA technology) opened the year with positive announcements.

For example, the final step of the preclinical phase for the breast cancer drug candidate AccuTOX™ was initiated. To this end, Eurofins Advinus Limited, a leading contract research organization, was contracted to conduct a GLP (Good Laboratory Practice) study. The Company has since announced numerous other research collaborations. These include the HUS Comprehensive Cancer Center, Finland's largest cancer treatment center.

Advanced in vivo studies, including a head-to-head comparison of Roche-developed T-DM1 ("Kadcyla") with AccumTM-T-DM1 developed on Defence Therapeutics' platform, or combined treatment with intratumoral injection of AccuTOX™ variants using different preclinical PDX (patient-derived xenograft) models in existing and as yet unestablished tumors, are currently taking place there.

The results are encouraging. It turns out that the agents developed using Accum™ technology are not only capable of preventing HPV (human papillomavirus) infections but even destroying existing tumors. If these results can be verified in clinical trials and possibly even transferred to other types of cancer, this would be a milestone. The share price is likely to react accordingly. In this respect, the current weakness with a market capitalization of only CAD 68 million should be considered an interesting entry opportunity.

Valneva - Will the approval bring the hoped-for rally?

Shareholders of the French vaccine manufacturer Valneva also need strong nerves and staying power. The share price has fallen by more than two-thirds since the high in November last year. At least the share price stabilized at just under EUR 10 in the face of good news. At the end of June, the EMA gave the green light to approve the vaccine in the EU.

It is thus the first true inactivated vaccine containing the complete, inactivated SARS-CoV2 virus. However, the preparation requires two adjuvants (boosters): Alum and CpG 1018. While Alum is a known aluminium salt, CpG 2018 consists of a single-stranded, short piece of DNA composed of 22 building blocks in which the nucleotides cytidine and guanosine are coupled. Utilizing the Toll-like receptor 9, this is recognized by the body as foreign DNA and thus stimulates the antibody response.

It is doubtful whether a vaccine that uses both aluminium, which is suspected of promoting the development of certain types of cancer, and a DNA strand as an effect enhancer will be more readily accepted by vaccine skeptics than an mRNA vaccine. After all, studies have shown that Valneva's vaccine has a stronger immune response than AstraZeneca's vaccine. Also, after the third vaccination, the agent is said to be more effective against the current Omicron variant than the unadapted version of BioNTech's Comirnaty product. The analysts at First Berlin raised the price target slightly from EUR 12 to EUR 12.50. The investment recommendation thus changed to "buy".

It should be a hot Corona autumn. At least the manufacturers of vaccines against the SARS-CoV2 virus should be pleased. After the bottoming of BioNTech shares, the paper is ready to attack again. Valneva, too, should finally get its foot off the brake again with the approval of its vaccine. Those willing to take a bigger risk should take a closer look at the share of Defence Therapeutics. The potential of the patented technologies is enormous and promises bold investors rich returns.