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Synthetic Biologics, Inc. (SYN)

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Last Post: 2/24/2021 9:43:07 AM - Followers: 197 - 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: Synthetic Biologics to Report 2020 Year End Operational Highlights and Financial Results on March 4, 2021 02/25/2021 07:00:00 AM
SYN News: Amended Statement of Ownership (sc 13g/a) 02/22/2021 09:46:18 AM
SYN News: Prospectus Filed Pursuant to Rule 424(b)(5) (424b5) 02/19/2021 06:05:29 AM
SYN News: Amended Current Report Filing (8-k/a) 02/12/2021 06:11:05 PM
SYN News: Amended Statement of Ownership (sc 13g/a) 02/11/2021 06:01:39 AM
#8248   Fabulous splintered sunlight 02/24/21 09:43:07 AM
#8247   I have my own personal formula well I Dan Money 02/24/21 09:12:58 AM
#8246   I am also new here - why od splintered sunlight 02/24/21 08:52:27 AM
#8245   Hi I am new here but I see Dan Money 02/24/21 01:54:33 AM
#8244   Picked up the dip. Maybe a double bottom formed. SYN musicbynature 02/23/21 12:44:52 PM
#8243   Should hear something soon. Pull it off Lazar. Look musicbynature 02/17/21 07:01:31 PM
#8242   THis is why $SYN poppped https://pennystocks.com/featured/2021/02/16/top-penny-s SpotOnTrade 02/16/21 07:20:47 PM
#8241   No, what you saw was a stock heist BooDog 02/11/21 07:23:43 PM
#8240   Synthetic Biologics Announces Washington University School of Medicine BooDog 02/11/21 07:17:49 PM
#8239   I’ve also been seeing the constant heavy bids kevgan9 02/11/21 04:19:35 PM
#8238   Not sure if you've been watching the LII's BooDog 02/11/21 04:14:59 PM
#8237   Many companies raise capital for good reasons kevgan9 02/11/21 04:14:28 PM
#8236   I see APHA did the same thing around kevgan9 02/11/21 03:37:19 PM
#8235   I see more convertibles. And a raise BooDog 02/10/21 06:44:13 AM
#8234   New 52 week high comin kevgan9 02/09/21 04:34:55 PM
#8233   Good day here Batman412 01/25/21 09:47:35 AM
#8232   SYN 1$ Breakout Alert Gave you MKD Friday Stockexpertpro 01/25/21 08:35:31 AM
#8231   Looks liquid for nice size positions too... thanks Batman412 01/24/21 01:35:58 PM
#8230   "SYN latest O/S per 01-06-2021 Prospectus Supplement: 0210 01/24/21 01:32:24 PM
#8229   Thanks mate good break down.. any expected catalysts Batman412 01/24/21 01:18:27 PM
#8228   SYN Eco 101: Demand vs. Supply(37m low 0210 01/24/21 01:16:05 PM
#8227   Why is this moving higher and why was Batman412 01/23/21 06:03:26 PM
#8226   Androids Batman412 01/23/21 06:01:41 PM
#8225   Slow and steady it seems kevgan9 01/22/21 04:20:16 PM
#8224   * * $SYN Video Chart 01-12-2021 * * ClayTrader 01/12/21 06:05:38 PM
#8223   Happy I was buying in the .60$ 1trdmnymade 01/12/21 03:09:10 PM
#8222   A repeat of last week's fun run would slow_feet 01/12/21 01:04:57 PM
#8221   Big run coming, watch closely!! WatchingStocks 01/12/21 01:01:30 PM
#8220   UP UP and AWAY ... :) Bmaintz 01/11/21 07:17:38 PM
#8219   Lol bummer and thanks. Yeah looks like it’ll musicbynature 01/07/21 04:44:32 PM
#8218   It's an ATM, so SYN just tells them BooDog 01/07/21 01:01:41 PM
#8217   Was just going over this, so did the musicbynature 01/07/21 12:49:56 PM
#8216   Yeah same. Added some .70s earlier it was musicbynature 01/07/21 12:04:20 PM
#8215   And this is why we have stop loss. BooDog 01/07/21 10:14:57 AM
#8214   We have entered into an At Market Issuance BooDog 01/07/21 09:25:42 AM
#8213   I think with time this might turn out musicbynature 01/06/21 05:11:09 PM
#8212   Just took a bite here in the .82's. BooDog 01/06/21 12:30:25 PM
#8211   i'm out......no mas......next! Mikey 01/06/21 12:18:58 PM
#8210   They are teasing like crazy on the LII's. BooDog 01/06/21 12:17:28 PM
#8209   This could be their attempt to regain compliance BooDog 01/06/21 12:00:52 PM
#8208   Agree........i've fallen out of 'like' with this lil dog Mikey 01/06/21 11:55:55 AM
#8207   All under .40. Thinking we may see BooDog 01/06/21 11:54:23 AM
#8206   Synthetic Biologics 13D Filing From Custodian Ventures Shows Mikey 01/06/21 11:32:23 AM
#8205   Just the 13d that I can see... slow_feet 01/06/21 11:28:40 AM
#8204   sudden spike here...any news?? nuclear profitz 01/06/21 11:22:17 AM
#8203   That’s usually the way it works. SYN musicbynature 01/05/21 07:50:43 PM
#8202   The good ol’ one day GL kevgan9 01/05/21 05:36:02 PM
#8201   now have 1.07 avg.......had to avg down............maybe I Mikey 01/05/21 05:21:26 PM
#8200   Maybe for now but it’ll come back one day. SYN musicbynature 01/05/21 05:11:08 PM
#8199   Dont look good at all looks done to kevgan9 01/05/21 04:09:39 PM
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