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Synthetic Biologics, Inc. (SYN)

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Last Post: 9/26/2019 10:50:23 AM - Followers: 181 - Board type: Free - Posts Today: 0

Synthetic Biologics

Synthetics Biologics, Inc., a biotechnology company, focuses on development of novel anti-infective biologics and drug candidates targeting specific pathogens that cause serious infections and other diseases. The company?s product candidates include Trimesta, which has completed phase II clinical trials for the treatment of relapsing-remitting multiple sclerosis and cognitive dysfunction in multiple sclerosis; SYN-010 that is in preclinical stage for the treatment of constipation-predominant irritable bowel syndrome; SYN-004, which is in preclinical stage for the treatment of clostridium difficile infection prevention; SYN-005 that is in preclinical stage for the treatment of pertussis; SYN-001, which is in discovery stage for the treatment of acinetobacter infection; and SYN-007 that is in discovery stage for the treatment of irritable bowel syndrome. It has a sublicense agreement with Meda AB for the development and commercialization of Effirma (flupirtine) for fibromyalgia in the United States, Canada, and Japan. The company was formerly known as Adeona Pharmaceuticals, Inc. and changed its name to Synthetics Biologics, Inc. in February 2012. Synthetics Biologics, Inc. was founded in 2001 and is based in Rockville, Maryland.

As of November 2, 2015 the registrant had 90,810,086 shares of common stock outstanding.

management team rule

board of directors rule

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collaborators rule

The initiation of monocloncal antibody (mAb) development for the treatment of pertussis is the second of three infectious disease indications Synthetic Biologics intends to pursue as part of its August 2012 collaboration with Intrexon Corporation.

To further the development of this potential mAb therapy for pertussis, Synthetic Biologics has entered into an agreement with The University of Texas at Austin to license the rights to certain research and pending patents related to pertussis antibodies. These research efforts are being conducted at the Cockrell School of Engineering in the laboratory of Assistant Professor, Jennifer A. Maynard, Ph.D., the Laurence E. McMakin, Jr. Centennial Faculty Fellow in the McKetta Department of Chemical Engineering. Dr. Maynard brings to the project her expertise in defining the key neutralizing epitopes of pertussis toxin to optimize the potential efficacy of antibody therapeutics

SYN-001 rule

Acting as the body's army, antibodies are proteins, generally found in the bloodstream, that provide immunity in detecting and destroying pathogens, such as viruses and bacteria and their associated toxins. Monoclonal antibodies (mAbs) can also be designed and produced as therapeutic agents, utilizing protein engineering and recombinant production technologies. The mAbs being developed under the Synthetic Biologics’ collaboration with Intrexon are intended to supplement a patient's own immune system by providing the means to specifically and rapidly neutralize and/or clear specific pathogens and toxins of interest in a process known as “passive immunity”. Many pathogens that cause infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. Synthetic Biologics intends to utilize Intrexon’s comprehensive suite of proprietary mAb design and recombinant protein production technologies to efficiently create potent candidate mAbs, SYN-001, for human testing and use to specifically treat Acinetobacter.

infectious diseases collaboration with Intrexon rule

Many infectious diseases are innately resistant to, or over time have developed increased resistance to, antibiotics and other drugs. In August 2012, Synthetic Biologics announced a second worldwide exclusive channel collaboration with Intrexon Corporation. Using Intrexon’s comprehensive suite of proprietary technologies and processes, Synthetic Biologics intends to develop and commercialize a series of monoclonal antibody (mAb) therapies for the treatment of certain infectious diseases not adequately addressed by existing therapies.

partnered program rule

Effirma™ for Fibromyalgia

Synthetic Biologics has partnered the development of Effirma (flupirtine), a centrally-acting investigational oral drug, for the treatment of fibromyalgia syndrome with Meda AB. Effirma is a selective neuronal potassium channel opener that also has NMDA receptor antagonist properties. Effirma is a non-opioid, non-NSAID, non-steroidal, analgesic. Preclinical data and clinical experience suggest that Effirma should also be effective for neuropathic pain since it acts in the central nervous system via a mechanism of action distinguishable from most marketed analgesics. Effirma is especially attractive because it operates through non-opiate pain pathways, exhibits no known abuse potential, and lacks withdrawal effects. In addition, no tolerance to its antinocioceptive effects has been observed. One common link between neuroprotection, nocioception and Effirma may be the N-methyl-D-aspartic acid glutamate system, a major receptor subtype for the excitotoxic neurotransmitter, glutamate. Effirma has strong inhibitory actions on N-methyl-D-aspartic acid-mediated neurotransmission. Flupirtine was originally developed by Asta Medica (subsequently acquired by Meda AB) and has been approved and is marketed by Meda AB in Europe since 1984, as well as other countries, for the treatment of pain. It has never been approved by the FDA for any indication.

On May 6, 2010, Synthetic Biologics and Pipex, its wholly owned subsidiary, entered into a sublicense agreement with Meda AB, a multi-billion dollar international pharmaceutical company, pursuant to which Meda AB assumed all future development costs and may commercialize flupirtine for fibromyalgia in the United States. As consideration for such sublicense, Synthetic Biologics received an up-front payment of $2.5 million and is entitled to milestone payments of $5 million upon the FDA’s acceptance of the New Drug Application (NDA) for flupirtine for fibromyalgia and $10 million upon FDA approval of such NDA. Pursuant to the sublicense agreement, Synthetic Biologics will also receive a 7% royalty on net sales of flupirtine for fibromyalgia in the United States, Canada and Japan, with such royalties being shared equally with Synthetic Biologic’s licensor, McLean Hospital, a Harvard teaching hospital.

Flupirtine is approved and marketed by Meda AB and its distributors in Europe and other countries for indications other than fibromyalgia and has been prescribed to millions of patients worldwide. Synthetic Biologics believes that such substantial human experience with flupirtine should greatly assist the FDA in its evaluation of the safety of flupirtine upon review of an NDA of flupirtine for fibromyalgia. According to Meda’s 2010 Annual Report, flupirtine for fibromyalgia is currently in Phase II development.

Fibromyalgia is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, often accompanied by severe fatigue, insomnia and mood symptoms. According to the National Fibromyalgia Association, fibromyalgia affects an estimated 3-6% of the population worldwide, including an estimated 10 million patients in the U.S.

There are presently three FDA products approved for this indication in the United States – Lyrica®, Cymbalta® and Savella®. Flupirtine is differentiated from these products in that it employs a unique mode of action.



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SYN News: Securities Registration: Employee Benefit Plan (s-8) 09/26/2019 05:05:45 PM
SYN News: Synthetic Biologics Strengthens U.S. Patent Coverage of SYN-010, Intended for the Novel Treatment of Irritable Bowel Syndrome... 09/26/2019 07:00:00 AM
SYN News: Current Report Filing (8-k) 09/06/2019 06:03:48 AM
SYN News: Statement of Changes in Beneficial Ownership (4) 08/26/2019 05:01:01 PM
SYN News: Quarterly Report (10-q) 08/08/2019 04:38:13 PM
#8128   News: $SYN Synthetic Biologics Strengthens U.S. Patent Coverage whytestocks 09/26/19 10:50:23 AM
#8127   Took some of these 40s maybe I'm just BooDog 08/13/19 02:50:33 PM
#8126   Just about time for a swing imo. BooDog 04/12/19 12:15:59 PM
#8125   $SYN Momentum may be trying to push. BooDog 03/26/19 12:42:40 PM
#8124   $SYN very low vol today. The key to SpotOnTrade 03/22/19 04:37:13 PM
#8123   Love all this positive talk, once it goes Bmaintz 03/22/19 04:29:22 PM
#8122   Augustafriends from ORIONS Money Stocks said, " $SYN SpotOnTrade 03/22/19 03:19:54 PM
#8121   Patience is a virtue $SYN https://www.azquotes.com/picture-quotes/quote-suc SpotOnTrade 03/22/19 01:22:06 PM
#8120   Synthetic Biologics NYSE $SYN Upgraded H.C. Wainwright SpotOnTrade 03/22/19 01:18:57 PM
#8119   $SYN Undervalued Biotech Pipeline SpotOnTrade 03/22/19 12:17:20 PM
#8118   Can anyone tell me if SYN stock cheap theRASPYone 03/22/19 01:35:04 AM
#8117   $SYN was over $100.00 per share a few SpotOnTrade 03/21/19 07:30:45 PM
#8116   Synthetic Biologics, Inc. $SYN Pioneering Cutting-edge Research into SpotOnTrade 03/21/19 07:10:31 PM
#8115   $SYN the numbers are beautiful. If we get SpotOnTrade 03/21/19 06:46:33 PM
#8114   $SYN The Sleeping Giant Has Awaken SpotOnTrade 03/21/19 06:43:05 PM
#8113   $SYN 1 Year target from Yahoo Finance $3.63 SpotOnTrade 03/21/19 06:17:07 PM
#8112   Yeah right lol. $SYN Loading SpotOnTrade 03/21/19 03:55:50 PM
#8111   Keep in mind lots of open gaps a theRASPYone 03/21/19 03:21:13 PM
#8110   Gains traction soon imo, and with a low BooDog 03/21/19 03:05:45 PM
#8109   Wow Slappy getting buck wild! Analyst shouldn't even theRASPYone 03/21/19 02:58:20 PM
#8108   Solid support here $.72 $SYN SpotOnTrade 03/21/19 01:15:06 PM
#8107   $SYN higher lows. beautiful chart SpotOnTrade 03/21/19 12:31:02 PM
#8106   $SYN Video SYN-010 is intended to act primarily SpotOnTrade 03/21/19 11:59:29 AM
#8105   $SYN SYN-010 is a proprietary, modified-release formulation of SpotOnTrade 03/21/19 11:56:34 AM
#8104   $SYN Gap filled. SpotOnTrade 03/21/19 11:30:56 AM
#8103   $SYN at the bottom for sure. 52-Week Range SpotOnTrade 03/21/19 11:19:51 AM
#8102   $SYN has $28.92 Million Cash Synthetic Biologics, Inc SpotOnTrade 03/21/19 10:34:32 AM
#8101   $SYN 1 analysts included in the consensus. The SpotOnTrade 03/21/19 10:15:02 AM
#8100   $SYN 2nd Resistance Point 1.03 SpotOnTrade 03/21/19 10:11:40 AM
#8099   $SYN In the last 3 months, 1 ranked SpotOnTrade 03/21/19 10:06:27 AM
#8098   $SYN from Augustafriends https://twitter.com/augustafriends/status/1108328648795 SpotOnTrade 03/21/19 09:51:24 AM
#8097   Shouldn't this Phase 2b be done by now? theRASPYone 03/21/19 02:44:45 AM
#8096   Clay has posted videos here before. Apparently some theRASPYone 03/21/19 02:31:08 AM
#8095   * * $SYN Video Chart 03-14-2019 * * ClayTrader 03/14/19 05:39:25 PM
#8094   Need to get some of that low floater BooDog 03/14/19 10:45:36 AM
#8093   https://www.nasdaq.com/symbol/syn/institutional-holdings beambe 03/07/19 03:32:19 PM
#8092   good Volume beambe 03/07/19 03:18:30 PM
#8091   Now that's a spike in volume. BooDog 03/07/19 03:03:04 PM
#8090   Low float. Not sure if anyone around BooDog 02/28/19 06:49:00 AM
#8089   Nice looking chart imo. BooDog 02/27/19 03:53:19 PM
#8088   cc the 27th, with a webcast. https://ih.advfn.com/stock-market/AMEX/synthetic-b BooDog 02/20/19 06:39:01 AM
#8087   Interesting indeed. BooDog 02/06/19 07:36:25 AM
#8086   This is a pure lotto pick stock, but Wisest Dick 01/29/19 06:08:04 AM
#8085   Up .08 on 5x normal volume?? Theboy56 01/17/19 03:55:56 PM
#8084   What are they smoking?? Theboy56 01/11/19 10:39:11 AM
#8083   The current Price Target for SYN is $4.42. BooDog 01/10/19 12:40:46 PM
#8082   Synthetic Biologics Announces First Two Patients Enrolled in BooDog 01/03/19 08:35:38 AM
#8080   More comedy relief: Who funds their Ph3 first? WBillCody 12/18/18 05:21:28 PM
#8079   Now that the news has sunk in, hopefully jsb330 11/26/18 04:39:00 AM
#8078   https://finmercury.com/2018/11/23/synthetic-biologics-inc-syn-is-now-on-a-buy-li jsb330 11/24/18 01:08:55 AM