Junshi Biosciences and Coherus Expand Immuno-Oncology Collaboration to Include TIGIT-Targeted Antibody

  • Junshi Biosciences and Coherus plan to evaluate the toripalimab + JS006 combination
    in clinical trials in multiple tumor types
  • Combinations of PD-1 + TIGIT inhibitors have potential to expand checkpoint inhibitor utilization
    to new tumors and lines of therapy

SHANGHAI, China, and REDWOOD CITY, Calif., Jan. 10, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) today announced that Coherus has initiated the process to exercise its option to license JS006, Junshi Biosciences’ TIGIT-targeted antibody, in the United States and Canada, expanding the companies’ 2021 immuno-oncology collaboration agreement. Coherus will pay Junshi Biosciences $35 million upfront, up to $255 million in development regulatory and sales milestones, and an 18% royalty on net product revenue, subject to terms and conditions agreed between the parties. Closing of the transaction is expected to follow receipt of any applicable regulatory clearances. Antibodies blocking TIGIT (T cell immunoglobulin and ITIM domain) have shown potential for synergistic anti-tumor activity in combination with PD-1/PD-L1 inhibitors. In pre-clinical studies, JS006 has demonstrated excellent binding affinity and strong inhibition of the TIGIT pathway. Investigational new drug (IND) applications allowing clinical development of JS006 have been approved in Chinese Mainland and in the United States. A dose escalation, dose expansion clinical trial (NCT05061628) evaluating the safety, tolerability and pharmacokinetic properties of JS006 as monotherapy and in combination with PD-1 inhibitor toripalimab in patients with advanced solid tumors is ongoing.

“We are excited to extend our productive immuno-oncology collaboration with Coherus to include our anti-TIGIT monoclonal antibody JS006, after achieving several key milestones on toripalimab,” said Dr. Ning Li, CEO of Junshi Biosciences. “Following our ‘In China, For Global’ corporate strategy, we are actively conducting global clinical R&D programs in China, the U.S., Southeast Asia and European countries. We are grateful for the joint effort from our pre-clinical as well as clinical teams at the company’s innovation centers in China and the U.S. We believe the collaboration with Coherus will strengthen the development and commercialization of our products in the U.S. and Canada.”

“Since 2012, Junshi Biosciences has built a rich pipeline with complementary products in the area of immuno-oncology, which enable us to explore combination therapy of I-O drugs and combination of immunotherapy with other modalities, including traditional chemotherapy, radiotherapy, angiogenesis inhibitors and cytokine drugs, to provide patients with better treatment options,” said Dr. Sheng Yao, Senior Vice President of Junshi Biosciences. “The combination of anti-TIGIT and anti-PD-1 is quite promising with a potential to not only increase patients’ response to I-O therapy, but also expand the beneficial patient population. We look forward to working together with Coherus to quickly advance the combination therapy of JS006 with toripalimab across multiple tumor types.”

“TIGIT is a leading-edge immuno-oncology target with significant therapeutic potential across multiple major tumor types. The exercise of the option for JS006 marks the emergence of Coherus as an immuno-oncology development company with a rich clinical and preclinical pipeline of product candidates to drive long-term growth,” said Denny Lanfear, CEO of Coherus. “We are making rapid progress on our objective to become a leading immuno-oncology company, and the development of toripalimab combinations with therapeutics addressing novel targets such as TIGIT will allow us to access future growing markets. While toripalimab + JS006 is the first novel combination in our pipeline, our internal analytic, protein science and bioinformatics capabilities have generated additional toripalimab combination candidates. The first of these proprietary product candidates is expected to enter human clinical trials in 2023.”

“Blockade of the TIGIT pathway may be a crucial underlying mechanism for overcoming resistance to checkpoint inhibition. We believe the dual immuno-therapy approach of TIGIT with PD-1 could enhance PD-1 efficacy and create a new standard-of-care for multiple tumor types,” said Theresa LaVallee, Ph.D., Chief Development Officer at Coherus. “We recently reported that our PD-1 inhibitor, toripalimab, in combination with chemotherapy, extends both progression free survival and overall survival in patients with advanced non-small cell lung cancer. We look forward to working with our Junshi Biosciences colleagues to build upon this efficacy signal and to evaluate the potential of the JS006 and toripalimab combination to bring new, more efficacious immuno-oncology treatments forward for patients.”

About JS006
JS006 is a recombinant humanized IgG4κ monoclonal antibody specifically against human TIGIT, developed independently by Junshi Biosciences. Including back-up candidates, the JS006 program encompasses molecules with silent and active Fc functions. According to the results of preclinical studies, JS006 can specifically block the TIGIT-PVR pathway. Expressed by T cells and NK cells, TIGIT can be engaged and activated by PVR family ligands highly expressed on tumor cells and suppressive immune cells to directly inhibit the killing effect of T cells and NK cells directed at tumor cells. A number of pre-clinical and clinical studies have showed that activation of the TIGIT pathway could be a crucial underlying mechanism for the resistance to PD-1 blockade therapy. Combination of TIGIT and PD-1/PD-L1 antibodies showed a synergistic potential to enhance antitumor response to overcome anti-PD-1 resistance and broaden the cancer patient population that can benefit from immunotherapy.

In early 2021, JS006 was approved for clinical trials in both China and the United States. In the same year, Junshi Biosciences commenced a phase I trial to evaluate the safety and tolerability of JS006 as monotherapy and in combination with toripalimab in patients with advanced tumors who have failed standard therapies. Junshi Biosciences and Coherus are planning late-stage clinical development of JS006 in combination with toripalimab in North America.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promote the immune system’s ability to attack and kill tumor cells.
More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are 4 approved indications for toripalimab in China:

  1. unresectable or metastatic melanoma after failure of standard systemic therapy;
  2. recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
  3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
  4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.

The first three indications have been included in the National Reimbursement Drug List (NRDL) (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.
In addition, two supplemental New Drug Applications (NDAs) for toripalimab are currently under review by the National Medical Products Administration (NMPA) in China:

  • in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC).
  • in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with no EGFR or ALK sensitizing mutations.

In the United States, the FDA has granted priority review for the toripalimab biologics license application (BLA) for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which has no FDA-approved immuno-oncology treatment options. The FDA has assigned a Prescription Drug User Fee Act target action date for April 2022 for the toripalimab BLA. The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for the treatment of esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Junshi Biosciences and Coherus plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising 45 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company building a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. A biologics license application for toripalimab for the treatment of metastatic or recurrent nasopharyngeal carcinoma is currently under priority review by the FDA, with a target action date of April 2022. Toripalimab is also being evaluated in pivotal clinical trials for the treatment of cancers of the lung, breast, liver, skin, kidney, stomach, esophagus, and bladder.

Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta® in the United States, and expects to launch the FDA-approved Humira® biosimilar YUSIMRY™ (adalimumab-aqvh) in the United States in 2023. The FDA is currently reviewing the biologics license application for CHS-201, a biosimilar of Lucentis® (ranibizumab), with a target action date of August 2022. Coherus is also developing CHS-305, a biosimilar of Avastin® (bevacizumab).

Junshi Biosciences Contact Information

IR Team:
Junshi Biosciences
+ 86 021-2250 0300

Solebury Trout
Bob Ai
+ 1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
+ 86 021-6105 8800

Coherus Contact Information
McDavid Stilwell
Chief Financial Officer
Coherus BioSciences, Inc.

Cheston Turbyfill
Coherus BioSciences, Inc.

Kelli Perkins
Red House

General Fusion achieves critical technology milestone for practical fusion power

Successful performance of plasma compression prototype confirms path to commercialization

General Fusion’s plasma compression prototype

General Fusion has successfully achieved several aggressive performance goals on its prototype compression system, demonstrating a critical element of the company’s Magnetized Target Fusion technology.

VANCOUVER, British Columbia, Jan. 10, 2022 (GLOBE NEWSWIRE) — General Fusion announced today it has successfully achieved several aggressive performance goals of a prototype system for its Fusion Demonstration Plant (FDP). The company’s plasma compression prototype, located at its Vancouver, Canada laboratory, is being used to demonstrate a critical element of its proprietary Magnetized Target Fusion (MTF) technology. This important milestone marks another significant step toward General Fusion’s goal of creating practical and commercially viable fusion power.

Commissioned in early 2021, the prototype machine drives a forceful, but precisely shaped, symmetric collapse of a large liquid vortex cavity in tens of milliseconds. The forces involved in the full-scale FDP compression system will be immense, pushing the limits of material science, fluid dynamics, and mechanical design. Achieving this milestone with the prototype significantly reduces engineering and technical risks for General Fusion’s FDP. It will use a collapsing liquid metal cavity to heat and compress plasma fuel to fusion conditions at 100 million degrees Celsius.

The idea of using a collapsing liquid metal cavity to create fusion has been around for decades, but General Fusion has been able to bring new enabling technologies such as high-speed digital control systems, additive manufacturing, and advanced composite materials to make this concept viable and to de-risk its implementation in the FDP. Driving a rapid, smooth, and spherically shaped collapse of a cavity created inside a rotating liquid has been a difficult engineering challenge that General Fusion has now demonstrated in this prototype machine. It is the pathfinder for a larger prototype being built in 2022 to validate further refinements to various engineering aspects of this technology.

“Net energy production is essential, but not really the ultimate goal of commercializing fusion energy, which is building economical, carbon-free fusion power plants,” said Christofer Mowry, CEO, General Fusion. “Our unique technology, two decades in the making, solves the long-standing challenges of building practical fusion power plants for the world’s energy markets struggling to move away from fossil fuels. The successful performance of this important prototype validates we are on the path to success.”

General Fusion’s unique MTF technology overcomes several key challenges of creating practical fusion energy. MTF will economically create fusion conditions, efficiently convert fusion energy into carbon-free electricity, protect the fusion machine from burning fusion plasma, and produce enough fusion fuel for its own use. General Fusion’s prototype compression system validates one of the most critical parts of its MTF technology because a mechanically collapsed liquid cavity is a cornerstone for MTF overcoming all these challenges.

About General Fusion
General Fusion is pursuing the fastest and most practical path to commercial fusion energy and is based in Vancouver, Canada, with locations in London, U.K., and Oak Ridge, Tennessee, U.S.A. The company was established in 2002 and is funded by a global syndicate of leading energy venture capital firms, industry leaders, and technology pioneers. Learn more at www.generalfusion.com.

General Fusion Media Relations

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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a8d18aac-c6fb-4486-ad73-6d0c0ea1cb81

2022 A4BET® Worldwide Domain & Trademark Sale

BEIJING and LONDON and PARIS and SAN FRANCISCO, Jan. 10, 2022 (GLOBE NEWSWIRE) — After overwhelming demand, creative offers and global inquires from it’s recent September 2021 billion dollar auction, A4BET® is announcing a time sensitive bidding process to acquire this rare, unique, valuable name.

A4BET® covers everything from A-Z!

The sale of A4BET® includes:

1.) United States Trademark & Patent Office transfer( 6th year renewal period )

2.) A4BET.com domain

3.) A4BET® animated character

4.) A4BET® social media sites: Facebook, Instagram, LinkedIn, Pinterest, Twitter & YouTube

A4BET® is a 21st century neologism for the word alphabet that is short, powerful and easy to remember. A4BET® is a United States Patent & Trademark Office registered “pseudo mark” for the word alphabet.

The esoteric centurion shuns traditional measures when valuing a name. A4BET® is unlike any name for the word alphabet in United States Patent & Trademark Department history. A history that spans more than 200 years.

In an exclusive interview, A4BET® founder & neologist C.C. Alexander ll says,

“A4BET® is the perfect turn-key solution for all industries including bitcoin, blockchain, casinos, conglomerates, entrepreneurs, established companies and start-ups to create value and increase their bottomline. A4BET® is a unique simple way to take advantage of listing the many services companies offer in one convenient place. A4BET® is not only a turn-key solution, but comes with a character. The A4BET® character represents massive exponential perpetual ancillary possibilities. The A4BET® domain & trademark cannot be duplicated. A4BET® is one of the most flexible names in the world. It is simply one-of-a-kind.”

A4BET® founder & neologist C.C. Alexander ll also states,

“Black ideas matter. Why is there not one Black-owned idea the world knows on a first name basis in 2022? A4BET® is the perfect platform for change. Blacks are more than consumers. Blacks also have great ideas. Great ideas for the world to share. A4BET® can mean all for better equality today. This is one example of what A4BET® represents. Product is worth more than talent. A4BET® is both. Any entity monetizing A4BET® regardless of country, industry, language or platform will immediately increase their bottomline.”

The word alphabet is define as a collection of letters that represent the English language. An “alpha bet” means investment above benchmark.

A4BET® founder & neologist C.C. Alexander ll concludes,

”A4BET® provides a perpetual platform to always keep things simple, memorable and worth people’s time. No one was ever bored into buying anything. People never pay real attention to marketing; but they’ll always pay attention to interesting. A4BET® is interesting.”

The A4BET® worldwide sale ends January 31, 2022.


*All bids must be submitted by 12 p.m. eastern standard time January 31, 2022


* ( C.C.G.I.P.- collaboration, compensation, geometric, indemnity, perpetual )






A4BET® is a United States Patent & Trademark Office trademark that provides a website featuring technology that enable users to access information that is available on the internet. A4BET® is the “pseudo mark” for the word alphabet…the most important word in the dictionary.

British Fishing Tackle & Bait Scales Order Fulfillment Processing 250% with Descartes Ecommerce WMS

CHIPPENHAM, United Kingdom, Jan. 10, 2022 (GLOBE NEWSWIRE) — Descartes Systems Group (Nasdaq: DSGX) (TSX: DSG), the global leader in uniting logistics-intensive businesses in commerce, announced that UK-based sports and hobbies retailer Fishing Tackle & Bait has successfully transformed its international fulfillment capabilities with Descartes’ cloud-based ecommerce warehouse management solution (WMS). With Descartes, the multi-channel merchant scaled order processing capacity by 250% without adding labour. In addition, it was able to virtually eliminate miss-picked items and overselling of inventory, and reduced customer service queries by more than 70%.

“Our business was originally a classic brick-and-mortar retail store, but we soon realized we had to broaden our distribution strategy and participate in marketplaces like Amazon and eBay to ensure future growth not only in the UK but also in Ireland, Europe and North America,” said David Burleigh, Director of Fishing Tackle & Bait. “With COVID, we suddenly experienced an incredible spike in sales of over 250%. With only manual processes in place, we soon faced inaccurate stock levels and disappointed customers who were waiting for their deliveries. We were considering hiring additional staff when our ecommerce platform provider, IRP Commerce, recommended the Descartes ecommerce WMS to us. Now we’re extremely proud of our current logistics operations and our ability to better control over our customers’ delivery experiences.”

Part of Descartes’ ecommerce solution suite, the Descartes ecommerce WMS solution helps direct-to-consumer brands and ecommerce retailers rapidly scale in combination with providing an improved customer experience. The solution helps ensure that retailers can ship on time, ship the right items, reduce risks of overselling existing inventory, and have greater transparency into warehouse operations. The Descartes ecommerce WMS solution has integrations into major ecommerce platforms to accelerate implementation and time to value. Order information is automatically available to be executed via mobile driven multi-order pick-and-pack strategies and then fed into parcel shipment systems.

“We’re pleased that Fishing Tackle & Bait is able to deliver a highly satisfying online buying and delivery experience to their customers,” said Dirk Haschke, VP & General Manager, Ecommerce at Descartes. “Our scalable ecommerce WMS offers efficient and intelligent processes that eliminate key warehouse management problem areas for online retailers. Fishing Tackle & Bait’s ecommerce success demonstrates the importance of automated order fulfillment for growing multi-channel merchants that want to stay ahead of their competition and retain satisfied customers.”

About Fishing Tackle & Bait LTD

About 10 years ago, David Burleigh bought the business that is now known as Fishing Tackle & Bait LTD. In the beginning a brick-and-mortar retail store with only a small handful of staff, David – with an eye to modernization and bringing the business to a broader audience – took his trade digital with a marketplace strategy on eBay and Amazon, followed by their first ecommerce site, built on Shopify. Today, the business is one of the largest independently-owned retailers in the UK. Learn more at https://www.fishingtackleandbait.co.uk/.

About Descartes

Descartes (Nasdaq: DSGX) (TSX: DSG) is the global leader in providing on-demand, software-as-a-service solutions focused on improving the productivity, performance and security of logistics-intensive businesses. Customers use our modular, software-as-a-service solutions to route, schedule, track and measure delivery resources; plan, allocate and execute shipments; rate, audit and pay transportation invoices; access global trade data; file customs and security documents for imports and exports; and complete numerous other logistics processes by participating in the world’s largest, collaborative multimodal logistics community. Our headquarters are in Waterloo, Ontario, Canada and we have offices and partners around the world. Learn more at www.descartes.com, and connect with us on LinkedIn and Twitter.

Global Media Contact
Andra Schaz                                                       
Tel: +49 (0)89 961 60 61 66                            

Cautionary Statement Regarding Forward-Looking Statements

This release contains forward-looking information within the meaning of applicable securities laws (“forward-looking statements”) that relate to Descartes’ solution offering and potential benefits derived therefrom including potential efficiency gains and potential productivity improvements; and other matters. Such forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, performance or achievements to differ materially from the anticipated results, performance or achievements or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, the factors and assumptions discussed in the section entitled, “Certain Factors That May Affect Future Results” in documents filed with the Securities and Exchange Commission, the Ontario Securities Commission and other securities commissions across Canada including Descartes most recently filed management’s discussion and analysis. If any such risks actually occur, they could materially adversely affect our business, financial condition or results of operations. In that case, the trading price of our common shares could decline, perhaps materially. Readers are cautioned not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Forward-looking statements are provided for the purposes of providing information about management’s current expectations and plans relating to the future. Readers are cautioned that such information may not be appropriate for other purposes. We do not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.

Khondrion completes enrolment in KHENERGYZE Phase IIb trial evaluating sonlicromanol in adult patients with MELAS spectrum disorders

Khondrion completes enrolment in KHENERGYZE Phase IIb trial evaluating sonlicromanol in adult patients with MELAS spectrum disorders

NIJMEGEN, the Netherlands – 10 January 2022: Khondrion, a clinical stage biopharmaceutical company discovering and developing therapies targeting primary mitochondrial diseases, today announced that the last patient has been dosed with sonlicromanol in the KHENERGYZE Phase IIb clinical study. Sonlicromanol is Khondrion’s wholly-owned, lead asset being developed to treat a range of mitochondrial diseases in children and adults. Topline data from KHENERGYZE is expected in the third quarter of 2022.

The study’s primary objective is to evaluate the dose-effect of sonlicromanol on the attention domain score of cognitive functioning, as assessed by the computerised Cogstate visual identification test. Cognitive impairment is becoming increasingly recognised in mitochondrial disease patients and can have a significant and debilitating impact on many aspects of their lives. Sonlicromanol’s potential to counteract cognitive decline is supported by preclinical research and results from a completed Phase IIa study, which showed a significant improvement in attention and mood related outcomes in patients treated with sonlicromanol compared to placebo.

Prof. Dr. Jan Smeitink, Chief Executive Officer at Khondrion, said: Completing enrolment in our Phase IIb study is an important milestone and brings us another step closer to providing an urgent and much needed disease-modifying therapy to patients with severe and debilitating mitochondrial diseases. I would like to express my gratitude to all the patients and their families for their participation in this trial, and to the investigators and wider team, whose dedication has been vital in advancing this important clinical programme. We look forward to receiving results from the trial later in the year.”

Sonlicromanol is a first-in-class, oral small molecule targeting key underlying mechanisms of mitochondrial disease based on its unique triple mode of action: redox modulation to help restore the cell’s metabolism, radical trapping preventing ferroptotic cell death, and mPGES-1 inhibition resulting in anti-inflammatory effects. In Phase I and Phase IIa studies, sonlicromanol showed a good safety and tolerability profile well beyond target therapeutic dosing levels.

KHENERGYZE is a double-blind, randomised, placebo-controlled, multi-centre, three-way cross-over study examining cognitive function in adult patients with a specific genetically confirmed DNA mutation in the mitochondrial transfer RNALeu(UUR) (MT-TL1m.3243A>G). This mutation is responsible for MELAS spectrum disorders, including MELAS (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes), MIDD (maternally inherited diabetes and deafness) syndromes, and mixed phenotypes.

Sonlicromanol’s development programme also includes two other ongoing clinical studies: the KHENEREXT Phase IIb open label extension study, examining the long-term safety and efficacy of sonlicromanol in adult patients who have completed the KHENERGYZE study, and the KHENERGYC Phase II study in children.

Further details of the KHENERGYZE study are available on clinicaltrials.gov.


Khondrion BV
Prof. Dr. Jan Smeitink, CEO
E-mail: info@khondrion.com
Tel: +31-24-7635000

Consilium Strategic Communications
Mary-Jane Elliott, David Daley, Melissa Gardiner
E-mail: khondrion@consilium-comms.com
Tel: +44 20 3709 5700

About Khondrion
Khondrion is a clinical stage biopharmaceutical company developing therapies for patients with inherited mitochondrial diseases. Based on proprietary science and a deep biological understanding of mitochondrial dysfunction, the company is advancing its lead drug candidate sonlicromanol, a first-in-class, oral small molecule targeting key underlying mechanisms of mitochondrial disease based on the drug’s unique triple mode of action.

One of the most advanced disease-modifying drug candidates for mitochondrial disease in development, sonlicromanol is currently being tested in a Phase IIb trial and a 12-month open-label extension study in adult patients with MELAS (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) spectrum disorders, as well as in a 6-month Phase II study in children with genetically confirmed primary mitochondrial diseases and who suffer from motor symptoms. The compound has been granted orphan drug designations for the treatment of MELAS, Leigh disease and patients with maternally inherited diabetes and deafness (MIDD) in Europe, and for all inherited mitochondrial respiratory chain disorders in the US. It has also been granted a Rare Pediatric Disease designation in the US for the treatment of MELAS. Sonlicromanol and other compounds from Khondrion’s proprietary library have the potential to be developed for a wide range of diseases and conditions with the aim of benefiting patients whose daily lives are severely impacted by mitochondrial impairment.

For more information visit www.khondrion.com.

About mitochondrial disease
Mitochondrial disease occurs when mitochondria, found within all cells of the human body and responsible for producing the energy necessary for cells to function, are defective. This can result in a wide range of serious and debilitating illnesses occurring shortly after birth or later in life. Signs and symptoms of these can include cognitive problems, learning disabilities, blindness, deafness, heart failure, diabetes, fatigue, intolerance to exercise, muscle weakness and gait problems, and stunted growth. Orphan diseases of the oxidative phosphorylation system like Leigh disease, MELAS (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes) spectrum disorders including MIDD (maternally inherited diabetes and deafness), and other respiratory chain / oxidative phosphorylation disorders, are all examples of mitochondrial disease. MELAS spectrum disorders are some of the most frequently observed primary mitochondrial diseases, in which all patients are characterised by an underlying point mutation (m.3243A>G) in the maternally inherited MTTL1 gene.

MeMed raises $93M to accelerate commercialization of its host immune-response product portfolio

MeMed raises $93M to accelerate commercialization of its
host immune-response product portfolio

MeMed BV® test recently cleared for use by US FDA to aid in distinguishing between bacterial and viral infection on the point-of-need platform MeMed Key®

HAIFA, Israel; BOSTON, MA; January 10th, 2022 – MeMed, a leader in host response technologies, today announces a $93 million private financing round, bringing total funding in the Company to over $200 million, including support from the U.S. Department of Defense and EU Commission. Funds will be used to scale up manufacturing, accelerate commercialization and expand MeMed’s pioneering host immune response product portfolio.

MeMed’s technology suite decodes the body’s immune response within minutes, providing physicians with important patient management solutions that tackle key clinical dilemmas. The U.S. Food and Drug Administration (FDA) recently granted a landmark clearance for the use of the MeMed BV® test on the point-of-need platform MeMed Key®, to help healthcare providers distinguish between bacterial and viral infections in both children and adults. MeMed has also developed the MeMed COVID-19 Severity™ test for predicting severe outcomes in COVID-19 patients, which has been cleared for use in Europe.

The latest financing brings together new and existing investors including Horizons Ventures, Shavit Capital, Social Capital, La Maison Partners, Touchwood Capital, Caesara Medical Holdings, Union Tech Ventures, ClaI Insurance, Phoenix Insurance, Poalim Equity and Western Technology Investment.

Eran Eden, MeMed’s co-founder and CEO, said: “This new investment will enable MeMed to expand operations with a focus on the U.S. We are grateful to our investors for their support and will leverage the funds, the recent FDA clearance, and our growing network of partnerships to provide broad patient access to our technology, as well as expand our product portfolio of pioneering host response solutions.”

Patrick Zhang, Horizons Ventures, said: “We strongly believe that MeMed’s strategy of using host immune response technologies is a significant advance in the improvement of two major issues in healthcare today: the rise of antimicrobial resistance due to unnecessary prescription of antibiotics and effectively triaging patients infected with COVID-19. We look forward to playing a role in how MeMed, a category leader in this area, is transforming the way diseases are diagnosed and treated to improve patient healthcare across the globe.”

About MeMed
Our mission is to translate the immune system’s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. For additional information on MeMed, please visit http://www.me-med.com.

MeMed Contacts:
Media: Will Harris, VP Marketing, MeMed

IR: Kfir Emmer, CFO, MeMed

Media Contacts:
Consilium Strategic Communications


Nyxoah Provides General Corporate Update

Nyxoah Provides General Corporate Update

Transformational 2021 positions Nyxoah for further clinical, regulatory, and commercial milestones in 2022

Mont-Saint-Guibert, Belgium – January 10, 2022, 7:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today provided a general corporate update.

2021 Highlights

  • Implanted first U.S. patient in the DREAM IDE pivotal study in December 2020; there are currently 15 active and enrolling patient sites in the U.S., with implants expected to be completed in Q1 2022
  • Secured CE Mark MR conditional labeling for the Genio® system in January, ensuring that implanted patients can undergo full-body 1.5T and 3T MRI diagnostic scans
  • Raised $97.8 million in a Nasdaq initial public offering in July, successfully completing Nyxoah’s second IPO after previously raising $100 million in the September 2020 Euronext Brussels IPO
  • Granted U.S. FDA Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate in September; engaged in sprint discussions with FDA regarding the IDE study for CCC patients in the U.S., which Nyxoah hopes to commence in the second half of 2022
  • Received expanded CE Mark indication to treat CCC patients in October, thus increasing Nyxoah’s total addressable market by at least 30% and thereby enabling patients not to have to undergo a Drug-Induced Sleep Endoscopy (DISE) procedure prior to Genio® implantation
  • Made strong commercial progress in Germany after obtaining a dedicated DRG code in January
  • Obtained DRG coding in Switzerland in March and secured first revenue in Spain; submitted reimbursement files in other key European markets
  • Entered exclusive licensing agreement with Vanderbilt University in February to develop next generation neurostimulation technologies, specifically a stimulator focused on the Ansa Cervicalis, which innervates the palatoglossus and/or the palatopharyngeus muscle; this collaboration has thus far resulted in initial prototyping discussions, and Nyxoah expects to make further progress on this project in 2022
  • Appointed Loic Moreau as Chief Financial Officer effective January 1, 2022, replacing Fabian Suarez, who is pursuing a new opportunity as CEO of a startup MedTech company
  • Announced the appointment of Rita Johnson-Mills to the Board of Directors in August

“2021 was a transformational year for Nyxoah as we achieved several important clinical, regulatory, commercial, and financial accomplishments and set ourselves up for continued progress in 2022 and beyond,” said Olivier Taelman, CEO of Nyxoah. “On the clinical front, we announced that our BETTER SLEEP clinical trial achieved a statistically significant mean reduction in the Apnea Hypopnea Index (AHI) from baseline to six months post implantation for the entire cohort as well as for the subgroup of patients with Complete Concentric Collapse (CCC) of the soft palate. We will be submitting the full data set for journal publication and look forward to discussing more fully once the data are published, hopefully in the first half of 2022. We are extremely encouraged by the data generated by BETTER SLEEP, which were used by our notified body DEKRA to expand our CE Mark indication to include CCC patients as well as by FDA in granting us Breakthrough Device Designation for the treatment of CCC patients in the U.S. We are also excited to partner with Dr. David Kent and his team at Vanderbilt University on the development of a next generation device that stimulates the Ansa Cervicalis, which Dr. Kent’s research suggests could be another effective way to treat OSA patients, and we look forward to advancing our work in creating a stimulator that leverages this novel approach.”

Mr. Taelman continued, “As we begin 2022, our primary clinical focus is on our DREAM U.S. IDE pivotal study in which patient enrollment and implants are well underway, and we still expect to complete our target of 134 implants by the end of Q1 2022. We continue to generate great enthusiasm from physicians and patients as we activate more sites and enroll more patients, and we are seeing implant rates accelerating as we move into the new year. We have also been encouraged by our sprint discussions with FDA regarding our IDE trial for CCC patients in the U.S., which we hope to commence in the second half of 2022. From a commercial standpoint, we have made tremendous progress in our key geographic markets, securing DRG codes in Germany and Switzerland, obtaining hospital reimbursement in Spain and awaiting reimbursement decisions in Belgium, the Netherlands, and the Nordic countries. Our commercial strategy centers on the concept of going deep as opposed to going wide; in other words, we want to focus our strategy on key Centers of Excellence with high levels of clinical expertise and patient care, large patient pools, and well-coordinated clinical and administrative infrastructures. This strategy, combined with our ability to treat CCC patients, has enabled us to gain meaningful market share in Germany, and we expect to exit 2022 as the market leader in that important country.”

Mr. Taelman concluded, “As proud and excited as we are of our significant accomplishments in 2021, we have our sights set much higher for 2022. Aiding our efforts is a strong balance sheet that we bolstered in July with close to $100 million raised in our Nasdaq IPO, less than one year after raising close to $100 million in our Euronext IPO in September 2020. This liquidity gives us ample flexibility to complete the DREAM study, conduct the ACCCESS study, invest further in our existing commercial operations, and begin to build out a U.S. commercial operation in anticipation of launch following FDA approval. We are extremely well positioned to execute on our clinical, regulatory, and commercial initiatives, and we look forward to providing further updates on our progress as the year unfolds.”

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

For more information, please visit http://www.nyxoah.com/

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements 
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Loic Moreau, Chief Financial Officer
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
+1 917 749 1494

Gilmartin Group 
Vivian Cervantes



Heavy floods leave over 30,000 displaced in northern Sumatra, Indonesia

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Global Voices

An aerial photo of flooding in the Aceh region last week after days of heavy downpour. Via YouTube. After a week of heavy rain on the island of Sumatra in Indonesia, more than 32,000 people have been displaced, and three children have died. Many more people are unaccounted for across the region. Torrential rains overtook the island on December 31, 2021, causing destructive flash floods in four districts. Since then, persistent rain has left parts of Northern Sumatra underwater. In pictures: Heavy rainfall causes floods in Indonesia’s North Aceh pic.twitter.com/9eIHugdLOh — TRT World Now (@TRTW… Continue reading “Heavy floods leave over 30,000 displaced in northern Sumatra, Indonesia”