Our Biggest #Biotech Alert Yet? Full Details

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When you find a mix of strong management, novel therapy, solid portfolio of patents, Cash in the bank, and one of the biggest biotech investors in history…would you think to pay attention? Many would and today we’re looking at a company with all of the above!

Last night we brought you the full report on our newest biotech feature, MabVax Therapeutics Holdings, Inc. (NASDAQ:MBVX) and it’s been the above characteristics which have helped to propel some incredibly strong momentum in the market. On the heels of its most recent shareholder update, MBVX continues to reach for higher highs and today could be set for yet another BIG GREEN day for this biotech.

If you’ve been waiting in the wings for something, MBVX could be just that. If you haven’t checked out our full report, you can do so below. Pull up MBVX this morning, pull up your level two and if you choose, be ready to trade at the opening bell. We’ll see you there!


 

MabVax Therapeutics Holdings, Inc. (NASDAQ:MBVX)

Let’s get right to it because MBVX has a lot going on. Just for starters, MBVX has a portfolio of fully human antibodies that are being developed to address unmet medical needs in several difficult to treat cancers such as pancreatic, small cell lung, sarcoma, ovarian, and breast cancer. It’s currently conducting two Phase 1 clinical trials with the lead antibody assets, MVT-5873 and MVT-2163. MVT-5873 is being tested as a therapeutic agent in patients with advanced pancreatic cancer while MVT-2163 is being tested as an imaging agent in patients with pancreatic cancer.

This sounds exciting but what does it all mean? If you are unfamiliar with the science behind novel therapies, you should become familiar with what they target and why they are targeted. So without getting to long winded on the science (because there is a lot behind it), let’s at least cover what antibodies are and why they are important…it should help everyone have a better understanding of the huge opportunity MBVX has in front of it:

Antibodies are a group of specialized proteins produced by the immune system. Their purpose is to bind to foreign antigens such as viruses, bacteria, or foreign proteins and alert the immune system to clear the invading pathogen from the host. Antibodies are produced by B-cells, and each B-cell is capable of producing a unique antibody that can bind to a single, unique epitope (a specific area of an antigen/foreign substance).

MBVX is utilizing fully human monoclonal antibodies derived from a novel means of production. The company is developing fully human mAbs that are directed against an antigen that is highly expressed on certain types of cancer while having a very limited expression in normal tissues, which should avoid any “on-target, off-cancer” effects. In addition, the high specificity to a unique cancer antigen means that the antibodies could be used as efficient vehicles for delivering cytotoxic payloads specifically to tumors.

Lead Antibody Product: HuMab-5B1

Due to the properties of MabVax’s HuMab-5B1 antibody, drug development is not limited to a single cancer type and what that could mean is BIG OPPORTUNITY for MBVX. Let’s explain: According to the company, the 5B1 antibody has demonstrated high specificity, strong ties to, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers! No one trick pony by any stretch of the imagination.

HuMab-5B1 antibody is fully human and was discovered from the immune response of patients with cancer vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In fact, MBVX states that the antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer. Furthermore, key observations from patient outcomes included:

A. Seven Stage IV patients vaccinated in 4Q08 and six are still alive (median: 197 weeks post-vaccination)

B. Patient from whom derived the HuMab-5B1 antibody remained disease free at 5+ years

And the initial response from HuMab-5B1 has opened up a HUGE pipeline for MBVX, all in different phases of testing & trials. MVT-5873 and MVT-2163 are furthest in the cycle with both expected to give early readouts THIS QUARTER!

Why Now?

We always talk about timing, right? For MBVX not only doesn’t timing present itself with the early readouts of the first two therapies in the company’s pipeline but also due to the fact that MBVX has just recently done a uplisting to the NASDAQ exchange! MabVax Therapeutics uplisted from the over-the-counter market to the Nasdaq Capital Market, effective August 17th…that’s less than 1 month ago!

With many bigger institutions limited and even restricted from investing in companies that are not on an exchange like NASDAQ or NYSE, OR if they are under a certain price, this up-listing now opens some BIG DOORS for MBVX to attract a whole new group of large firms!

Also, speaking of BIG DOORS, MBVX’s transparency and experienced management has also attracted to likes of Billionaire biotech investor, Dr. Phillip Frost! Dr. Frost and OPKO Health (OPK) have increased stake in MBVX via the just-completed capital raise. Just take a look through the SEC filings from April 2015 to now and you should notice that Dr. Frost and OPKO hold roughly a 15% stake in MBVX!

Other Key Highlights:

A. MBVX’s long list of patent to date covers composition of the vaccine, methods of treatment, chemical modification of antigens, and synthesis.

11 issued patents and 3 pending applications in the U.S.

– Issued patents covering monovalent and polyvalent vaccines, methods of manufacture,
methods of use
– 2 pending applications covering monoclonal antibodies

14 international patents and 3 pending applications
– Issued patents covering monovalent and polyvalent vaccines, methods of manufacture,
methods of use
– 2 pending applications covering monoclonal antibodies

Orphan drug designation available for vaccine and antibody products
– Received U.S. FDA ODD in Sept 2014 for neuroblastoma vaccine

B. Well Versed, Highly Experience Leadership Team
Board Of Directors

C. Closed on $9.4M financing
MBVX: Uplist to Nasdaq Complete; Company Raised $9.4 million; Preliminary Data for HuMab-5B1 Looks Encouraging

D. Near Term Opportunity To Address Pancreatic Cancer Market
Trial initiated July of 2016 in subjects with stage 3 and 4 metastatic pancreatic cancer with progressive disease having failed prior treatment.
-First subject has completed the multiple image assessment
-Current result bodes well for target specificity validation
-MVT-5873 and MVT-2163 interim program milestones anticipated late 3Q2016 and full
Phase I readout mid-2017

Direct Access To MBVX September Corporate Presentation

Nothing Like We’ve Ever Seen!

Our focus as of late, has been on alerts that usually trend below $1. Obviously MBVX is higher than that, however due to the timing of everything a quick look at the chart will show that the market has begun to take notice. Over the last few weeks MBVX has seen an increase in both price and momentum. On the heels of its most recent shareholder update (here), MBVX has managed to hit levels that it hasn’t since April…and that was during a time BEFORE all of this was going on with MBVX!

With obvious increase in activity in the market, a bullish chart, major developments anticipated for the near term (as soon as this and next quarter – Q3 & Q4), AND the recent uplisting, this could be THE TIME to have MBVX on your screen!

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