As the pandemic spreads further, the spotlight in the biotech sector remains on companies developing treatments for coronavirus. A slew of biotechs is evaluating their pipeline drugs and vaccines for the treatment of COVID-19 and updates from these companies continue to cheer investors in the hope of a possible treatment soon. Meanwhile, other pipeline and regulatory updates too were in the news.
Recap of the Week’s Most Important Stories:
Moderna Surges on Positive Vaccine Data: Moderna (MRNA - Free Report) announced positive interim data from a phase I study evaluating its mRNA-based coronavirus vaccine candidate, mRNA-1273. Data demonstrated that patients vaccinated with mRNA-1273 achieved levels of antibodies similar to or higher than those typically found in a patient who recovered from COVID-19 naturally.
The study is being conducted by the National Institute of Allergy and Infectious Diseases. The ongoing phase I study on mRNA-1273 is evaluating three doses of the candidate — 25 µg, 100 µg and 250 µg — in three patient groups — adults aged 18 to 55 years, older adults aged 56 to 70 years and elderly people aged 71 years and above — in nine separate cohorts.
Across all doses, all patients were seroconverted (developed specific antibodies against COVID-19 and the antibodies became detectable in the blood) by day 15 after a single dose. Meanwhile, patients after receiving two 25 µg doses of mRNA-1273 achieved levels of binding antibodies seen in convalescent sera (level of antibodies seen in blood samples of patients naturally recovered from COVID-19) at day 43.
Moreover, updated pre-clinical data showed that mRNA-1273 prevented viral replication in the lungs of a mouse challenge model. Shares were up on the positive data. The candidate was also granted Fast Track designation earlier this month.
The company also announced the pricing of an underwritten public offering of 17,600,000 shares of common stock at a price of $76.00 per share, before underwriting discounts and commissions.
Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Dynavax Up on COVID-19 Vaccine Update: Shares of Dynavax Technologies (DVAX - Free Report) surged after it announced that one or more of its collaboration partners will commence a phase I study of a potential COVID-19 vaccine as soon as July 2020. The company has established multiple research collaborations leveraging proprietary toll-like receptor 9 (TLR9) agonist adjuvant, CpG 1018, to support the development of coronavirus vaccines. Dynavax has filed patent applications for the use of CpG-1018 in the COVID-19 vaccine.
Sorrento Soars on Pipeline Update: Sorrento Therapeutics, Inc. (SRNE - Free Report) soared after it announced that its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in an in vitro virus infection experiment at a very low antibody concentration. The company aims to generate an antibody cocktail product that would act as a "protective shield" against coronavirus infection.
The cocktail is expected to remain effective even if virus mutations render a single antibody therapy less effective over time. STI-1499 completely neutralized the virus infectivity at a very low antibody dose, making it a prime candidate for further testing and development.
Incyte and MorphoSys Announce Positive Long-Term Data on Oncology Candidate: Incyte (INCY - Free Report) and partner MorphoSys AG (MOR - Free Report) announced updated results from the ongoing phase II L-MIND study evaluating the combination of tafasitamab and Revlimid in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). In the study, 80 patients receiving tafasitamab plus Revlimid were included in the efficacy analysis.
After a minimum of two years' follow-up, results from the L-MIND study are consistent with the primary analysis and confirm the durability of the response (DoR) and overall survival (OS) of tafasitamab in combination with Revlimid, followed by tafasitamab monotherapy in autologous stem cell transplantation (ASCT)-ineligible patients with r/r DLBCL. The combination showed an objective response rate (ORR) of 58.8% (47 out of 80 patients) and a complete response (CR) rate of 41.3% (33 out of 80 patients), following assessment by an independent review committee (IRC) at data cut-off. Median duration of response (mDOR) was 34.6 months, with median overall survival (mOS) of 31.6 months and median progression-free survival (mPFS) of 16.2 months.
Arbutus Announces Encouraging Data on Hepatitis B Treatment: Arbutus Biopharma (ABUS - Free Report) announced positive follow-up data from a phase Ia/Ibstudy (AB-729-001) in chronic HBV subjects on nucleos(t)ide therapy who received a single subcutaneous injection of 60 mg of AB-729, a proprietary GalNAc delivered RNAi compound. At week 12, the 60 mg single-dose achieved equivalent reductions in HBsAg as the 180 mg single dose.
Moreover, not only did AB-729 demonstrate robust HBsAg reduction, but it was generally safe and well tolerated with no abnormal transaminase values in any of the six subjects in this time span. The company is currently dosing chronic HBV subjects in a multi-dose cohort with 60 mg of AB-729.
The Nasdaq Biotechnology index lost 0.12% in the last five trading sessions. Among the biotech giants, Gilead lost 7.20% during this period. Over the past six months, shares of Regeneron have gained 61.98%. (See the last biotech stock roundup here: Biotech Stock Roundup: ALXN, MRNA Up on Coronavirus Treatment Updates, & More).
What's Next in Biotech?
Stay tuned for more pipeline updates, with a focus on treatments for the novel COVID-19.
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