The biotech space is brimming with big moves and important developments this morning. Here are some of the most important items you may have missed:
Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company, focuses on the discovery, development, and commercialization of Listeria monocytogenes (Lm) technology based immunotherapies in the United States. It is developing Axalimogene filolisbac and ADXS-Dual that are Lm-LLO immunotherapy product candidates for the treatment of human papilloma virus associated cancers, including cervical, and head and neck cancers.
The company is also developing Axalimogene filolisbac for the treatment of anal cancer; ADXS-PSA, an Lm-LLO immunotherapy product candidate, which is designed to target the prostate specific antigen associated with prostate cancer; and ADXS-NEO, an individualized Lm technology antigen delivery product candidate that is designed to create individualized therapies by activating the patient’s immune system to respond against multiple mutations or neoantigens. In addition, it is developing ADXS-HOT for generating potent anti-cancer immunity; and ADXS-HER2, an Lm technology antigen delivery product candidate that is designed to target HER2 expressing solid tumors, including human and canine osteosarcoma. The company has collaboration and licensing agreements with Bristol-Myers Squibb Company; Amgen Inc.; Sellas Life Science Group; Merck & Co., Inc.; MedImmune/AstraZeneca PLC; Especificos Stendhal SA de CV; Aratana Therapeutics Inc.; and Global BioPharma Inc. Advaxis, Inc. was founded in 2002 and is based in Princeton, New Jersey.
The company just announced it has commenced a Phase 1 trial with the dosing of the first patient with ADXS-NEO, an investigational personalized immunotherapy approach targeting personal neoantigens found by sequencing a patient’s own cancer cells. ADXS-NEO is being evaluated in an open-label, dose-escalation, multicenter Phase 1 clinical trial in the United States. According to the release, “The study is open to patients with metastatic non-small cell lung cancer (NSCLC), metastatic microsatellite stable colon cancer and metastatic squamous head and neck cancer. The first patient dosed is being treated for non-small cell lung cancer. ADXS-NEO is being developed in collaboration with Amgen. Advaxis is leading clinical development through proof-of-concept.”
NUTRIBAND ORD (OTCMKTS:NTRB) operates in the health supplement market. Its product line consists of an Energy Patch line; a Weight Management supplement patch line; and a Multivitamin Patch line.
This is a very speculative play that has the potential to be powered by its announcement out this morning that it has signed a Letter of Intent to acquire 100% of Carmel Biosciences, a pharmaceutical company that addresses critical needs in new drug and liquid reformulation for cardiovascular and metabolic therapies. Nutriband plans to complete the deal, valued at approximately $3.8 million, through payment of 450,000 restricted common shares of the Company’s stock. In December 2017, Carmel Biosciences received FDA approval for PREXXARTAN™, the first and only approved oral liquid dosage form of the angiotensin receptor blocker (ARB) valsartan in the United States.
According to the release, “PREXXARTAN™ (valsartan oral solution) is indicated for treatment of hypertension in adults and children six years and older. PREXXARTAN™ is also indicated for use as therapy for the treatment of heart failure (NYHA class II-IV). Additionally, PREXXARTAN™ has also been indicated for stable left ventricular failure or left ventricular dysfunction after myocardial infarction.”
“The Carmel Biosciences team combines a deep understanding of lipid biochemistry and clinical expertise in the cardiovascular and metabolic space,” stated Gareth Sheridan, CEO of Nutriband. “Carmel’s focus in the reformulation of drugs with a high degree of safety and efficacy allows improved access to patients who have difficulty swallowing tablets or capsules and provides enhanced usage of these widely acclaimed products.”
Keep in mind that this stock has an extremely tight float – sitting at just a tiny 2.3 million shares. If this news spreads and the stock gets some traction, a squeeze is not out of the question here.
Atara Biotherapeutics Inc (NASDAQ:ATRA) is an off-the-shelf T-cell immunotherapy company that has been a major momentum favorite so far in 2018.
The company just announced publication of new research findings advancing the understanding of Epstein-Barr Virus (EBV) infection in the multiple sclerosis (MS) brain. The research was carried out in collaboration with investigators at Stanford University School of Medicine and QIMR Berghofer Medical Research Institute. The findings are being reported in an article online and to be published in the July 2018 print issue of Neurology: Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology.
The company develops treatments for patients with cancer, autoimmune, and viral diseases in the United States. Right now, these guys are developing tabelecleucel, an advanced T-cell immunotherapy that is Phase III clinical trials for the treatment of rituximab-refractory epstein-barr virus (EBV) associated post-transplant lymphoproliferative disorder, as well as other EBV associated hematologic and solid tumors, including nasopharyngeal carcinoma. It is also developing ATA188 and autologous ATA190 that are in Phase I clinical trials for the treatment of multiple sclerosis; ATA520, a Phase I clinical trial product to treat Wilms tumor 1; and ATA230, which is Phase II clinical trials for refractory cytomegalovirus.
In addition, the company is developing ATA368 that is under preclinical development for HIV and cancers. It has license agreements with Memorial Sloan Kettering Cancer Center and Amgen, Inc.; and license, and research and development collaboration agreement with QIMR Berghofer Medical Research Institute. The company was founded in 2012 and is headquartered in South San Francisco, California.
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