10 Aug Top Innovations in the Treatment of Methylmalonic Acidemia (MMA)
Methylmalonic Acidemia, a rare inherited disease that occurs in an estimated 1 in 50,000 to 100,000 people, is characterized by the inability of the body to process proteins and lipids effectively. This disease mostly affects infants leading to hypotonia, hepatomegaly and in severe cases failure to thrive. It also has several long-term complications such as developmental disability, chronic kidney disease and pancreatitis that can lead to death if left untreated.
Image Source: Newbornscreening.info
This disorder is caused due to mutations in the MMUT, MMAA, MMAB, MMADHC, and MCEE genes which also determine its severity and long-term implications. However, MMUT gene is the leading cause of the disease with over 60% of the cases being attributed to its malfunctioning. This gene is responsible for producing the enzyme named methylmalonyl CoA mutase which interacts with Vitamin B12 (cobalamin) to break down amino acids, lipids and cholesterol. Mutations in this gene can inhibit the production of this enzyme leading to accumulation of methylmalonyl CoA and other toxic compounds in vital organs.
In severe cases, no functional enzymes are produced leading to a condition called mut0. that has very poor outcomes. This disease follows an autosomal recessive pattern, with the parents acting as carriers of one copy of the mutated gene. An elevated C3 acylcarnitine is one of the indicators of this disease, other methods of diagnosis use genetic testing as well.
New Born screening is recommended and takes into account the final diagnosis in an infant with a positive newborn screening result. Owing to the extremely rare nature of this disease there are chances of a delayed diagnosis owing to very low awareness levels about this condition. Methylmalonic Acidemia usually starts manifesting when proteins are added to the diet during the first year of birth.
The current treatment approach is a low-protein, high-calorie diet that limits the intake of isoleucine, threonine, methionine, and valine with inclusion of supplements to treat carnitine deficiency. Cyanocobalamin supplements are the first line of treatment of this disorder although their efficacy in treating some forms of methylmalonyl acidemia is severely limited. Cobalamin (vitamin B12) injections and antibiotics are also used for treating certain cases. In extreme situations organ transplantations may be carried out and the donor organ may be able to produce a functional version of methylmalonic-CoA and aid its metabolism.
Those suffering from cobalamin-responsive variants show a better prognosis than those suffering from noncobalamin-responsive variants. No cure exists for the disorder as yet however recent scientific advancements along with increased research and development efforts have improved the life expectancy and quality of life of those affected.
We take a look at some of the most promising developments in this field.
Moderna, Inc. (NASDAQ: MRNA)
Market Cap: $4.39B; Current Share Price: 12.85 USD
Data by YCharts
Moderna is developing mRNA-3704 for the treatment of Methylmalonic Acidemia, which is currently undergoing a phase 1/2 open label study to evaluate its safety and efficacy. The company uses its proprietary mRNA platform to discover and create novel solutions across indications such as prophylactic vaccine development, personalized cancer vaccine, intra-tumoral immune-oncology and localized regenerative medicine to name a few.
The company has developed a unique mRNA sequence that codes for a protein, and encompasses knowledge of mRNA biology, chemistry, formulation & delivery, bioinformatics and protein engineering to address unmet needs in critical areas.
Image Source: Company
The Platform offers great flexibility and wide applicability; by changing the sequence of the genetic code it can combine different mRNA sequences for different proteins in a single mRNA medicine. It has a drug design studio, which can develop mRNA within a very short period of time, using a proprietary Sequence Designer module, bioinformatics algorithms and its modular synthesis robotics, making it a pioneering Digital Biotech Company™.
Image Source: Company
The company has built a robust and diverse network of strategic collaborations with pharmaceutical and biotechnology organisation, in addition to government entities and research organisations to leverage its mRNA platform for drug discovery and development. Some of its collaborations are with AstraZeneca (NYSE: AZN), Merck (NYSE: MRK), Vertex (NASDAQ: VRTX), BARDA, DARPA and Bill and Melinda gates foundation.
Logic Bio Therapeutics (NASDAQ: LOGC)
Market Cap: $251.99M; Current Share Price: 10.70 USD
Data by YCharts
Logic Bio Therapeutics, a gene-editing company that uses its GeneRide technology platform to develop solutions for rare diseases in pediatric patients was recently awarded an Orphan Drug Designation (ODD) status for its LB-001 a recombinant adeno-associated viral vector with human methylmalonyl-COA mutase (MUT) gene for the treatment of Methylmalonic Acidemia (MMA).
LB-001 developed using a proprietary promoterless, nuclease-free genome editing platform is likely to be filed for an Investigational New Drug License (IND) by the company in Q4,2019 with plans to start a Phase I/II clinical trial in 2020.
GeneRide, the company’s genome editing platform aims at creating long-lasting solutions for unmet medical needs through a single injection. It uses the natural DNA repair process, known as homologous recombination of natural cells to introduce transgene at a predetermined spot to the nuclei of the patient’s cells via an infusion. Currently it is using Stanford University’s library of synthetic, non-pathogenic, AAV vectors for its liver program.
Image Source: LogicBio
This technology offers numerous advantages over traditional therapeutic approaches; firstly by introducing the corrective gene into the patient’s genome at a precise point, it becomes an integral part of the DNA and leads to a more durable effect something that the conventional gene therapy does not offer.
Secondly, its platform is independent of exogenous (foreign) nucleases which reduce the risk of off-target cuts and fatal changes to the patient’s chromosomes. Since they do not use bacteria derived nucleases they eliminate the risk of provoking a strong defense by immune system and genotoxicities.
The third and most important advantage is that by eliminating the use of exogenous promoters which can change the expression of other genes including oncogenes, it reduces the risk of cancer and other genotoxicities.
Image Source: LogicBio
LB-001 is a GeneRide vector for pediatric patients who suffer from methylmalonic acidemia (MMA) which has demonstrated the ability to improve protein tolerance and growth and reduce toxic metabolites in mice during clinical studies. LB-can integrate a functioning version of the malfunctioning MUT gene into the genome of patients thereby offering a survival advantage over cells not expressing the transgene.
Its pipeline is at present focused on making innovative solutions for liver ailments such as Hemophilia B, AIATD and Crigler-Najjar with plans to extend the line to include Muscle and Central nervous system related disorders.
Translate Bio, Inc (NASDAQ: TBIO)
Market Cap: $411.14M; Current Share Price: 8.06 USD
Data by YCharts
Translate Bio is an mRNA focused biotechnology company that aims to transform the protein and gene dysfunction disease space. Its proprietary mRNA platform (MRTTM), can deliver encoded functional proteins to dysfunctional cells thereby restoring their functionality and balance. Through its proprietary technology, mRNA is encapsulated in a lipid nanoparticle and delivered to the target cell enabling the cell’s latent machinery to translate it and use it to improve protein function. MRT5201 is its lead candidate for for the treatment of OTC deficiency and other inherited metabolic disorders.
Image Source: Company
The Investigational New Drug Application (IND) submission for MRT5201, indicated for the treatment of OTC deficiency is currently on hold by the FDA for want of more clinical and non-clinical information, which the company seeks to address and bring to a quick resolution. In fact the company has already completed additional preclinical studies as instructed by the FDA and intends to file the data by Q4.2019.
In April 2019, Translate presented preclinical results from its trials, which demonstrate that the company’s unique liver deliver technology can effectively deliver mRNA therapeutics, as treatments for urea cycle disorders and organic acidemias. The studies have shown promising results in mouse models in disorders such as methylmalonic acidemia (MMA), ornithine transcarbamylase (OTC) deficiency and rgininosuccinate synthetase (ASS1) deficiency (citrullinemia).
The company which was hitherto known as RaNA Therapeutics, acquired the messenger RNA (mRNA) therapy platform from Shire plc, to enhance its ability to correct a wide array of disease genotypes irrespective of mutations and overcome its limitations in accessing new targets. The company acquired Shire plc’s programs in cystic fibrosis and ornithine transcarbamylase (OTC) deficiency, a urea cycle disorder.
As part of its drug development initiative the company has two lead programs namely mRNA therapy for Cystic Fibrosis that seeks to restructure the CFTR pathway and restore its ability to produce healthy protein by replacing the defect in the CFTR gene irrespective of the type of mutation and OTC protein production in the liver for treating Ornithine transcarbamylase (OTC) deficiency, a singular genetic metabolism defect and a common urea-cycle disorder.
The company is also trying to leverage its mRNA technology platform for targeting disease in areas such as CNS disorders, ocular diseases and blood disorders. Its initial efforts are targeted towards restoring the expression of intracellular and transmembrane proteins, a relatively unexplored area with a huge unmet need.
The company has a licensing and collaboration agreement with Sanofi Pasteur for development of mRNA vaccines for up to five infectious disease pathogens. It received a $45 million upfront payment from Sanofi (NASDAQ: SNY) in lieu of the same.
Image Source: Company
In the pipeline are MRT5005, which can deliver mRNA encoded fully functional cystic fibrosis transmembrane conductance regulator (CFTR) protein to the lung. It received an orphan drug designation by the FDA in 2015 and is currently in clinical trials.
Selecta Biosciences, (NASDAQ: SELB)
Market Cap: $94.59M; Current Share Price: 1.92 USD
Data by YCharts
Selecta is leveraging its proprietary immune tolerance platform technology (ImmTOR), to create biologic therapies that can offer novel solutions for diseases, with large unmet medical needs. The company is targeting rare diseases that have a high immunogenicity, to create a pipeline aimed at therapeutic enzyme and gene therapy product candidates.
The company has promising results from its preclinical trials that demonstrate the ability of repeated co-administration of Anc80-Mut, a rationally engineered AAV vector encoding the methylmalonic CoA transgene, and ImmTOR™ was well-tolerated and led to complete inhibition of IgG antibodies as per a company statement. It also showed a sustained reduction of MMA levels, a higher liver cell DNA copy number and a normalized weight gain in mice models. This offers hope to patients with MMA.
In September 2018, the company entered collaboration with CureCN, a European consortium to develop an ImmTOR+AAV gene therapy combination product for the treatment of Criggler-Najjar Syndrome. CureCN is likely to carry out the preclinical toxicology studies in the first half of 2019, followed by a combination product candidate that will enter the clinic in the second half of the year.
Image Source: Company
The company’s proprietary ImmTOR therapy stimulates a selective immune tolerance, by prompting the dendritic cells to create T regulatory cells, which in turn make the immune system more responsive to biologic therapies. This mechanism is extremely important for gene therapies that use the adeno-associated virus (AAV) vectors, as neutralizing antibodies (Nabs) are created in response to AAV vector administration, which makes it impossible to repeat the process in patients who need multiple doses.
This technology is ground-breaking, as it allows for determining an optimal dose for patients who require multiple administrations, and also overcomes the problem of non-replicating AAV vectors, that lose their transgene expression as time passes and pediatric patients grow.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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for direct notifications, as I would hate to miss even one thought-provoking post.
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craft and eagerly anticipate your future posts.
Amidst the vastness of the digital world, it’s refreshing to come across a blogger who puts considerable effort into their work.
Your posts don’t just deliver knowledgeable takeaways but also provoke engaging discussions.
Count me in as a regular reader from this point forward.
Your blog has become a favorite for me, and I can’t help but check it frequently for fresh insights.
Each post is like a lesson in the topic at hand, conveyed with eloquence and charm.
Might you starting a subscription service or a periodic newsletter?
I would be delighted to get more of your knowledge directly to my inbox
The unique angle you bring to subjects is truly refreshing, it’s immensely appreciated in the modern internet landscape.
Your ability to dissect complex concepts and present them in a user-friendly way is an ability that should be celebrated.
I eagerly await your next article and the conversations they’ll foster.
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The readership you’re cultivating here is proof to your
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I’ll be following along closely.
Having dedicated several hours navigating the myriad
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a beacon of knowledge. Not once have I encountered such a trove of intriguing content that resonate on a profound level.
Your ability for elucidating complex subjects with simplicity and acuity is admirable.
I’m patiently waiting for your upcoming article, knowing it will enrich my
understanding even further.
In our modern age of information, where information overload is common, your blog emerges as a cornerstone of
genuine content creation. It’s a rarity to discover a space of
the web that adheres to cultivating mindful learning.
Your eloquently written posts ignite a yearning for understanding that many of us seek.
Please let me know if there’s an option to sign up for direct notifications, as I wouldn’t want to miss any thought-provoking article.
Your online presence is the epitome of what passionate
writing is all about. Each entry you create is filled with valuable takeaways and deep insights that
make me reflect long after I’ve read them. Your narrative is a much-needed addition to the sometimes chaotic digital landscape.
Should you decide to an exclusive community, count me as an eager participant to join. Your content is
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Your blog serves as a beacon in the sometimes turbulent seas of online content.
Your deep dives into diverse subjects are not only educational but also
extremely absorbing. I admire the way you meld detailed study with narrative storytelling, creating posts that are
equally informative and entertaining. If there’s a way
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your latest musings.
As a content creator, I’m spurred by the passion you inject into each article.
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خوب مقاله. منروبهرو میشوم|در حال گذراندن |
عالی سایت دارید اینجا.. پیدا
کردنش سخت است} کیفیت مانند شما این روزها.
به طور جدی از امثال شما قدردانی می کنم!
مراقب باش!!|
این وبسایت توسط پسر عمویم توصیه
شد. به خاطر داشته باش. من به شما می گویم، من قطعاهمزمان با عصبانیت در حالی که |نگرانی|مسائل} که آنها به وضوحدر مورد
نگرانی هایی که فقط نمی دانند.
شما توانستید به بالا ضربه بزنید و همه چیز را بدون داشتن عوارض جانبی مشخص کردید، مردم
شما در واقع آن را {به نظر میآید} خیلی آسان همراه با ارائهتان اما من در جستجو
این مهم بودن در واقع یک چیز که احساس
میکنم شاید به هیچ وجه فهمیدن.
برای من
مداوم من پستها کوچکتر را میخواندم که هم انگیزه آنها را روشن
میکرد، و این نیز اتفاق میافتد.
با این قطعه نوشته که دارم اکنون میخوانم.
وبسایتها در شبکه. میخواهم
توصیه میکنم این سایت!
روی وبسایت شما.|
وبلاگ شیرین! من آن را در حین جستجو در یاهو نیوز پیدا کردم.
آیا نکات در مورد نحوه قرار گرفتن در لیست یاهو نیوز دارید؟ مدتی است که تلاش می کنم اما به نظر
می رسد هرگز به آنجا نرسیدم! قدردانی کنید|
عالی سایت. Lots of مفید اطلاعات در اینجا.
من آن را برای چند دوستان ارسال میکنم و همچنین در
خوشمزه به اشتراک میگذارند. و البته، ممنونم عرق شما!|
فوق العاده انتشار، بسیار آموزنده.
معجبم چرا دیگر متخصصان این بخش {نمیدانند} میفهمند.
نوشتن خود را باید ادامه.من مطمئن هستم}، شما پایگاه خوانندگان بسیار
بزرگی دارید!|
ضرب عالی ! وقتی وبسایت خود را اصلاح میکنید، میخواهم شاگردی کنم، چگونه میتوانم برای وبلاگ سایت مشترک
شوم؟ حساب aided روشن و شفاف ایده| آشنا بودم.
عالی امتیاز در مجموع، شما به سادگی
بردید یک خواننده جدید. چه چیزی ممکن است
شما توصیه میکنید درباره پست خود} چندروز پیش؟ آیا مثبت؟|
آیا اشکالی ندارید که چند از مقالات شما را تا زمانی که اعتبار و
منابع را به سایت شما ارائه میدهم
نقل کنم؟ وبلاگ من در دقیقاً یکسان منطقه مورد علاقه شماست
و بازدیدکنندگان من واقعا از 101 سود میبرند.
بسیاری از اطلاعاتی که در اینجا {ارائه میدهید}.
لطفاً به من اطلاع دهید اگر این خیلی
خوب با شماست. با احترام!|
با داشتن این همه محتوا آیا تا به حال با مسائل سرقت
ادبی یا نقض حق چاپ مواجه شده اید؟ وب سایت من دارای محتوای کاملاً منحصر به فرد زیادی
است که من خودم یا خودم نوشته} یا برون سپاری کرده ام، اما به نظر می رسد بسیاری از آن ها هستند.
نمایش آن در سرتاسر وب بدون
مجوز من. آیا هیچ راه حل برای کمک به توقف بیان|گفتن} و راه که
میگویی. میسازید آن را سرگرمکننده میکنید و به آن ادامه میدهید مواظب تا آن را عاقلانه نگه دارید}
. من نمیتوانم صبر کنم تا از شما بخوانم بسیار
بیشتر. این است در واقع یک عالی وب سایت.|
اگر کسی نیاز دارد با جدیدترین فناوریها بهروز شود سپس باید به دیدن این سایت بروید و هر روز به روز باشید.|
من معجب بودم که آیا تا به حال {به این فکر میکنید
که} ساختار سایت خود را تغییر دهید؟ بسیار خوب نوشته شده است؛ من عاشق چیزی
هستم که باید بگویی اما شاید بتوانید کمی بیشتر
در مسیر محتوا قرار دهید تا مردم بتوانند بهتر با آن ارتباط برقرار کنند.
فقط برای داشتن یک یا 2 تصاویر متن
بسیار زیادی دارید. شاید بتوانید آن را بهتر از هم جدا کنید؟|
خیلی به زودی این سایت در میان همه وبلاگ بازدیدکنندگان
مشهور خواهد شد. ، به دلیل اینکه
محتوا است، خوشایند است}|
اگر کسی آرزو دارد نظر متخصص درباره راهاندازی
وبلاگ سپس مشاوره به او برای بازدید این صفحه، ادامه دهید خوب کار.|
اجناس عالی از شما مرد. من مطالب شما را قبلاً درک کرده ام و شما فقط خیلی عالی} عالی.
من واقعاً آنچه را که در اینجا به
دست آوردهاید، واقعاً، واقعاً آنچه را که شما} و نحوه بیان
آن را دوست دارم. شما آن را لذتبخش میکنید و همچنان مراقب
هستید تا آن را معقول نگه دارید.
من نمیتونم صبر کنم تا بسیار بیشتر از شما بخونم.
این در واقع یک برد فوق العاده استderful| فوق العاده} وب سایت.|
ضرب باعظمت ! من میخواهمدر حالی که سایت خود را اصلاح میکنید، چگونه میتوان برای یک وبلاگ سایت؟
حساب به من کمک کرد یک معامله قابل اجرا.
من کمیآشنای} با این پخش شما ارائه
روشن شفاف ایده|
معمولا من در وبلاگها آموختم مقاله
میکنم، هر چند میخواهم بگویم که این
نوشته بسیار مجبور تلاش و آن
را انجام دهم! طعم نوشتن شما مرا متعجب کرده است.
ممنونم، بسیار عالی مقاله.|
این وبسایت توسط پسر عمویم} پیشنهاد شد.
من نه مثبت یا نه این قرار داده نوشته شده است بسیار هوشمندانه نوشته شده است.
مطمئن میشوم آن را نشانکگذاری میکنم و برمیگردم تا از مفید بیشتر مفید بیشتر.
بابت پست متشکرم. حتما برمی
گردم.|
با تشکر for ones را تخصص داشتم، همانطور که بارگذاری مجدد وبسایت بسیاری از بارها قبل از
من میتوانستم آن را درست بارگیری کنم.
میدانستم که آیا میزبان وب شما خوب است؟ نه اینکه
من، اما زمانهای بارگیری گاهی روی قرارگیری شما در Google تأثیر میگذارد و میتواند به کیفیت در صورت تبلیغات و بازاریابی با Adwords.
به هر حال من این RSS را به e-mail خود اضافه میکنم
و میتوانم به دنبال بسیار چیزهای دیگر جذاب شما
باشم. محتوای | هیجان انگیز}. مطمئن شوید این را دوباره به زودی به روز کنید.|
آنچه من نمیدانم این است که در واقع
چگونه شما دیگر نیستید واقعا خیلی بیشتر بهطور منظم-ترجیح از شما ممکن است
اکنون. تو خیلی باهوشی. میدانید بنابراین بهطور قابلتوجهی ارتباط با این موضوع، من را
به نظر من باور آن را از {تصور کنید} زوایای بسیار زیاد|تعدادی|بسیاری از} تعدادی.
مانند زنان و مردان نه علاقهمند به جز این است یکی است کاری} برای انجام با گاگای بانو!
شخصی چیزهای بی نظیر است. همیشه مواظب!|
عجب! بالاخره من یک وبلاگ دریافت کردم که از آنجا
میتوانم واقعاً |در واقع|درست|واقعاً}
گرفت مفید داده درباره مطالعه و دانش من.|
وقتی کسی بند را می نویسد، تصویر یک کاربر را در ذهن خود
سلام، آره این قطعه نوشتاری در واقع سریع و من چیزهای زیادی از آن درباره وبلاگ نویسی یاد گرفتم.
با تشکر. برای من، از این
فرصت من دارم این عالی آموزنده مقاله را اینجا در خانه
خود میخوانم. .|
سلام، همهچیز اینجا صدا پیش میرود و البته همه اطلاعات را به اشتراک
میگذارند، این در واقع خوب، به نوشتن ادامه دهید.|
A impressive! من همین الان این را برای یک دوست که بود یککوچکی تحقیق در مورد این.
و برای من در واقع خرید صبحانه به این دلیل که برای او پیدا
کردم روده بر شدن از خنده. بنابراین
{اجازه دهید} این را دوباره بنویسم ….
از شما برای وعده غذایی!!
اما بله، {تشکر} از اینکه زمان را صرف بحث و گفتگو در مورد} این موضوع در اینجا در
وب سایت.|
اوه این وبلاگ عالی دوست دارم
مقالات شما را میخوانم|مطالعه میکنم.
{بمانید|به کار {خوب|عالی} ادامه دهید!
{میدانید|میفهمید|میدانید|میشناسید|از قبل میدانید}، {بسیاری|بسیاری
از|خیلیها} {مردم هستند|افراد هستند|افراد} {شکار|جستجو|نگاه میکنند} {در اطراف|دور میگردند} برای این {اطلاعات|اطلاعات}، {میتوانید|میتوانید} بسیار به آنها {کمک|کمک کنید}.
|
{سلام|هیا|هی|هی|روز بخیر|سلام|سلام|سلام|سلام|سلام}!
من می دانم که این تا حدی خارج
از موضوع است {با این حال،|با این وجود|اما|اما} فکر می کردم بپرسم.
آیا علاقه مند به {تبادل|تجارت} پیوندها هستید
یا ممکن است مهمان {نوشتن|نویسنده} یک
وبلاگ {مقاله|پست} باشید یا بالعکس؟ {وبسایت|سایت|وبلاگ} من {میگذرد|بحث میکند|آدرس|پوشش میدهد}
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