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Regeneron’s Ebola Approval, and Other News: Biopharmacy Goods, Bads, Ugly (NASDAQ: REGN)




Regeneron Announces FDA Approval for Ebola REGN-EB3

Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) reports that the U.S. FDA has given Inmazeb approval to treat infections with Zaire Ebola virus in adult and pediatric patients, including newborns of mothers who test positive for infections. Did. Inmazeb is a combination of atortibimab, maftibimab, and odesibimab-ebgn. The company used the same technology used to develop the COVID-19 antibody combination in the development of this drug.

The company’s PALM test data was used to establish the safety and efficacy of Inmazeb. This randomized, multicenter, controlled trial began in 2018 in the Democratic Republic of the Congo and enrolled 681 patients. George D from Regeneron. Yancopoulos said: “With decades of investment in VelociSuite’s rapid response technology, the dedication of world-class scientists, the courageous contributions of healthcare providers and patients, and the remarkable cooperation between major international health institutions and governments, this is important. It was connected to the moment. “

The PALM trial was co-sponsored by WHO, Institut National de Recherche Biomdicale, and the National Institutes of Health. The trial was terminated prematurely because pre-specified interim analysis showed that the drug was superior to ZMapp and remdesivir in terms of mortality.

Adverse events that occurred in at least 10% of Inmazeb patients included rapid heartbeat, rapid breathing, and fever. Of these adverse events, only chills showed a higher frequency with Inmazeb than with ZMapp.

In July 2020, Regeneron announced a new agreement with the Biomedical Advanced Research and Development Authority (BARDA). Under this agreement, BARDA has agreed to REGN-EB3 as part of HHS’s goal of building national readiness for public health emergencies. BARDA works with the support of the Assistant Secretary’s Office for Preparation and Response within the US Department of Health and Human Services. The company is currently planning to deliver the agreed amount of drug over a six-year period.

Regeneron has worked with WHO, the US FDA, and other global organizations to develop Inmazeb under a compassionate usage protocol. The drug was included in a 4-arm PALM trial. The company offers Inmazeb for free in DRC via the MEURI protocol for compassionate use.

Inmazeb, formerly known as REGN-EB3, was developed using VelociSuite technology associated with the company’s Veloc Immune platform. The drug works by binding to different non-overlapping epitopes on the Zaire Ebola virus glycoprotein. It neutralizes the Ebola virus by interfering with the ability of the patient to infect and / or by involving other immune cells to target the infected cells and then eliminating them from the body. .. Inmazeb is given as a single weight-based intravenous infusion.

Analysts: Ebola virus treatment candidates do not bring profits to the company as approximately 20,000 people are rare diseases that require treatment. The market value in 2020 is $ 56 million. More than that amount was put into development under a compassionate usage protocol by government agencies. Regeneron has a market capitalization of $ 63.11 billion and a stock price of $ 599.74 as of the final closing date of October 16, 2020. The company has $ 2.22 billion in debt and $ 3.14 billion in cash. More than 88% of Regeneron’s stock is owned by the institution, but less than 7% of the general public. There are short-term interest rates of 2.05 million shares covered over the next two days.

Investment Papers: Stock prices have skyrocketed recently, but are still expected to rise significantly. The company also has many catalysts, including COVID-19 treatment, which has the potential to increase inventory.

Pluristem Received Cohort II Approval for Chronic Graft-versus-Host Disease Study

Pluristem Therapeutics Inc. (NASDAQ: PSTI) has announced that it will receive permission from the Safety Commission to conduct Phase I / II trials by initiating the recruitment of Cohort II. This study evaluates PLX-PAD cells for the treatment of steroid-resistant chronic graft-versus-host disease.

The potential of PLX-PAD cells in the treatment and symptom relief of patients with cGvHD is demonstrated by preliminary and previous preclinical data from Cohort I in Phase I / II trials. Yaky Yanai, CEO and President of Pluristem, said: “Pluristem is committed to contributing to the health and quality of life of our patients. We are undergoing a bone marrow transplant.”

Cohort I consisted of 6 patients. These participants were injected twice with 150 million cells at weekly intervals. At a 3-month follow-up, provisional safety data showed that PLX-PAD cells were safe. In addition, no treatment-related side effects have been reported. Efficacy data showed that improvement in symptoms was reported by 4 of 6 patients. This improvement reduced the severity of cGvHD and significantly reduced the steroid dose required for some patients.

This data served as a basis for initiating registration with Cohort II. This cohort recruits 14 patients. These patients receive four injections of 150 million cells.

Pluristem Therapeutics is a regenerative medicine company. Primarily engaged in the development of new placenta-based cell therapy product candidates. The company’s PLX cell product candidates are believed to work by releasing a range of therapeutic proteins in response to ischemia, inflammation, muscle trauma, radiation damage, and hematological damage.

Analysis: Pluristem’s cGvHD candidates correspond to markets estimated to reach $ 360 million in 2016, $ 510 million in 2021, and $ 640 million with a 6% CAGR in 2026. I will. The market is crowded with a few players in the more advanced stages of development. Candidates may help the company to demonstrate the effectiveness of the platform for many manageable illnesses. The company has a market capitalization of $ 272.92 million and a share price of $ 10.68 as of October 16, 2020. Prices are high for nearly 52 weeks, with short-term interest rates above 6% covering over the next two days. The public holds more than 60% of the shares, and insiders hold nearly 30% of the shares. The company’s cash balance was $ 45.78 million, its liabilities were $ 1.58 million, and its cash burn in the previous fiscal year (until June 2020) was $ 29.5 million.

Investment Paper: This positive news is expected to be a positive catalyst for stock prices. The company also has a strong development pipeline to support rising stock prices.

Anaptys Bio announces positive data from Phase 3 immunodrimab trials

AnaptysBio, Inc. (ANAB) has released positive top-line data from an interim analysis of Phase 2 clinical trials of imcydrimab. The study aims to evaluate the performance of candidate drugs in the treatment of moderate to severe systemic pustular psoriasis, a rare, life-threatening inflammatory disease for which there is no approved treatment.

The GALLOP trial enrolled eight patients with an average baseline value of 9 in the modified Japanese Dermatological Association severity index. Paul F. Lizzul, Chief Medical Officer of Anaptys Bio, said: In doing so, it provides potential therapeutic interventions for these patients with unmet medical needs. “

The primary endpoint of the study was improvement of the CGI scale on day 29. Six out of eight patients achieved this goal. The remaining two patients withdrew from the study before day 29 and were considered to have failed their primary objectives. The mJDA-SI score dropped by an average of 29% on day 8 and 54% on day 29. Genotyping showed homozygous wild-type IL-36RN, CARD14, and AP1S3 alleles in all eight patients. It is widely applicable to pustular diseases regardless of genetic factors.

Analysis: AnaptysBio imsidolimab is working on a market that is expected to reach $ 13.1 billion with a CAGR of 7.3% by 2025. The company has a market capitalization of $ 657.47 million as of October 16, 2020, a share price of $ 24.08, and a 52-week range between $ 10 and $ 39.48. There are large short-term interest rates of nearly 25% or 4.5 million shares covered in 16 days. Institutional investors hold more than 68% of the shares, hedge funds hold more than 23%, and PE / VC companies hold 7.45%. Insiders hold less than 2% of the shares and there are no visible public shares. The company had a cash balance of $ 377.88 million and a cash burn of $ 16.1 million in the previous fiscal year. Wall Street is strangely neutral to the company with a price target of $ 21.57, which is lower than its current price.

Investment Papers: Stocks are currently trading well below the 52-week lows. The company is also working on a variety of other trails, including ECLIPSE for chronic sinusitis with nasal polyps.

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Disclosure: I / we do not have a position on any of the shares mentioned and do not plan to open a position within 72 hours. This article was written by myself and expresses my opinion. I have no compensation for it (from other than Seeking Alpha). We have no business relationship with the companies listed in this article.

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