NantKwest publicizes initiation of second era COVID-19 vaccine candidate
NantKwest Inc. (NK) announced that it has dosed the primary participant for its scientific trial of hAd5-COVID-19. The vaccine candidate makes use of a second-generation adenovirus to ship a number of proteins of the SARS-CoV-2. The trial is presently enrolling wholesome grownup members of as much as age 55. The primary goal of the trial is to look at the security and reactogenicity of two doses of hAd5-COVID-19.
NantKwest is collaborating with ImmunityBio for creating this vaccine candidate. It’s an engineered serotype vaccine and goals to work by delivering each the spike protein and nucleocapsid protein by twin constructs of SARS-CoV-2. Dr. Patrick Quickly-Shiong, Chairman and CEO of ImmunityBio and NantKwest. “We imagine this twin focusing on is a key benefit that will result in the stimulation of each T-cell-mediated and antibody-mediated immunity to SARS-CoV-2, which is a vital differentiator from different vaccine candidates that solely goal the spike protein.”
hAd5-COVID-19 intends to generate B and T cell reminiscence to the COVID-19 antigens and long-term immunity to the virus. At present a lot of the COVID-19 vaccines being trialed are designed to offer solely the monovalent spike protein on the floor of the virus to provide blocking antibodies.
The vaccine candidate has been developed utilizing ImmunityBio’s novel human adenovirus vector. This know-how allows the vaccine to be reengineered for growing the immunogenicity of the COVID insert. The vector has proven preliminary security in additional than 125 sufferers unfold throughout 13 Part I and a pair of trials until date. In line with the information generated by Nationwide Most cancers Institute scientific research, the vector triggers antigen-specific T-cell immunity in sufferers, even when pre-existing adenoviral immunity is there.
The first endpoint of the trial is to review the security and reactogenicity of two doses of the vaccine. The businesses are additionally engaged on creating totally different administration codecs for hAd5 comparable to oral, intranasal and inhalational. NantKwest struck the take care of ImmunityBio in August 2020 and each will share improvement, manufacturing, advertising and marketing and commercialization prices.
ImmunityBio is a late-clinical-stage immunotherapy firm. It develops innovative immunotherapies for treating infectious illnesses and cancers. The corporate has three fundamental applied sciences in its portfolio that are artificial immunomodulators, antibody cytokine fusion proteins and second-generation human adenovirus applied sciences.
NantKwest is a clinical-stage, immunotherapy firm. It primarily focuses on creating scientific dose types of off-the-shelf pure killer cell therapies. This know-how works by demolishing most cancers and virally contaminated cells. Part 1 scientific trials have corroborated the security and efficiency in opposition to a wide selection of cancers. The corporate has strong improvement applications with emphasis on immune-oncology applications.
Evaluation: One other participant on the COVID-19 bandwagon, marketplace for which is unfathomable presently. NantKWest is a ~$867 million firm at a inventory worth of $8.58, halfway between a 52 week vary of $1.05 and $15.70. Main shareholding is over 63% by insiders, almost 22% and 15% by the general public and establishments respectively. Wall Road analysts are impartial with a median rating of three.5/5 and a worth goal of $13. 4.85 million shorted shares are to be lined in 4 days. The corporate has a debt of $12.55 million, and money stability of $110.62 million, which is sweet for about 18 months contemplating money burn of $67 million in fiscal 2019 and $71 million within the TTM. The corporate had income of $236,000 in 2015, whereas the 2020 estimate is $26,000.
Funding Thesis: The corporate has strong liquidity place and really low leverage, permitting it to undertake formidable tasks. Its inventory has been a multibagger and is predicted to retain the efficiency.
Protagonist Therapeutics receives orphan drug standing for PTG-300
Protagonist Therapeutics Inc. (PTGX) announced that its lead product candidate PTG-300 has been awarded orphan drug designation for treating polycythemia vera. PTG-300 already holds the same designation awarded by the FDA in the USA for this indication. The corporate is presently enrolling sufferers with polycythemia vera for a Part 2 research of PTG-300.
The designation is awarded by the European Fee on the advice of the EMA Committee for Orphan Medicinal Merchandise. Samuel Saks, M.D., Protagonist Chief Medical Officer mentioned, “Completion of enrollment for the continued research of fifty sufferers is predicted in mid-2021. A pivotal research is predicted to start within the second half of 2021, pending our deliberate discussions with regulatory companies.”
Protagonist is presently working in the direction of the design of a pivotal research. The corporate had not too long ago reported early scientific outcomes for the drug candidate which corroborated its potential to assist a broad vary of polycythemia vera sufferers.
Polycythemia vera is a myeloproliferative neoplasm. Its fundamental characteristic is elevated manufacturing of purple blood cells. PTG-300 is an injectable artificial peptide mimetic of the pure hormone hepcidin. It’s being developed for treating varied blood problems.
Protagonist Therapeutics is a scientific stage firm. It presently has three product candidates in several phases of improvement. These are PTG-300, PTG-200 and PN-943. PTG-200 is an orally delivered, gut-restricted, interleukin-23 receptor particular antagonist peptide whereas PN-943 is an orally delivered, gut-restricted alpha-4-beta-7 integrin particular antagonist peptide.
Evaluation: Protagonist’s orphan drug is focusing on a market of polycythemia vera (PV) market that was value ~$952 million in 2017 and rising. Almost 60% of the market share was of Jakafi, the primary competitor within the second-line remedy of PV. Wall Road analysts are very bullish, scoring a median of 4.5/5 and a worth goal of $31.75 for the close to 52 week excessive inventory presently at $19.95. Market capitalization is ~$744 million with over 66% development in 52 weeks. Main shareholders are establishments with over 58% holding and hedge funds with over 33% shares. Money burn of $80.8 million in fiscal 2019 and $92 million within the TTM, and a money stability of ~$209 million together with income estimate of $14.24 million for 2020 suggests a money runway of about 30 months.
Funding Thesis: The corporate has robust but targeted improvement pipeline, making certain a number of catalysts over a time frame. It additionally studies persistently strong quarterly outcomes. Nevertheless, the buyers might look ahead to a pullback in its inventory worth.
Genmab studies optimistic knowledge from Part 2 CASSIOPEIA research
Genmab A/S (GMAB) announced optimistic knowledge from the second a part of the Part 3 CASSIOPEIA research. The trial is designed to evaluate using daratumumab monotherapy as upkeep remedy versus remark (no remedy) for sufferers with newly identified a number of myeloma eligible for autologous stem cell transplant. The research is being carried out by the French Intergroupe Francophone du Myelome in cooperation with Janssen Analysis & Improvement and the Dutch-Belgian Cooperative Trial Group for Hematology Oncology.
The trial met the first endpoint of bettering development free survival. It confirmed 47 % decline within the danger of development or dying in sufferers handled with daratumumab. Jan van de Winkel, Ph.D., Chief Government Officer of Genmab mentioned, “Following the optimistic knowledge from the primary a part of the CASSIOPEIA research, we’re very happy to see this profit. We’re appreciative of the efforts of the IFM, of HOVON and of Janssen for his or her work on this research.”
CASSIOPEIA Research is a randomized, open-label, multicenter trial. It has recruited 1,085 eligible sufferers. The primary a part of the research randomized the sufferers and administered induction and consolidation remedy with daratumumab mixed with bortezomib, thalidomide and dexamethasone (VTd) or VTd alone.
The second a part of the research sufferers with response had been randomized to be given upkeep remedy of daratumumab 16 mg/kg each 8 weeks for as much as 2 years versus no additional remedy.
DARZALEX or daratumumab is the primary monoclonal antibody (mAb) to obtain the US FDA approval for treating a number of myeloma.
Evaluation: Genmab is a ~$23 billion firm at a worth of $35.67, close to 52 week excessive. The corporate in collaboration with Janssen targets the massive MM market that can be worth ~$31 billion by 2026, rising at a CAGR of 6% from ~19.5 billion in 2018. The corporate’s income estimates for 2020 and 2021 are $1.53 billion and $1.24 billion respectively. Money reserve is $1.93 billion, whereas money burn was $409.5 million in fiscal 2019 and $489.8 million within the TTM.
Funding Thesis: As Genmab is presently embroiled in authorized tussle with Johnson & Johnson over most cancers remedy and the inventory has proven steep rise within the current previous, it’s value to attend and watch.
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