n January 26, 2021 Shaperon reported that it had signed a memorandum of understanding (MOU) with Selvion for cooperation in the joint development of new drugs for diagnosis and treatment of cancer (Press release, Shaperon, JAN 26, 2021, View Source;idx=38&pNo=3&code=press_en [SID1234629323]).

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Based on precision medicine technology, Cellvion is a bio company that is conducting clinical trials and development of new drugs such as medicines for diagnosis and treatment of intravascular inflammation, specific cancer, and complex contrast media for imaging surgery with leading university hospitals in Korea. We have production facilities that have obtained GMP (Good Manufacturing Practice) approval from the Ministry of Safety and Security.

In addition, in August, it obtained QP certification from the European EMA, and produced and supplied GMP clinical trial drugs to be used in the European phase 2 clinical trial of Chaperone’s COVID-19 treatment.

Through this agreement, Chaperon plans to accelerate the development of new drugs for diagnosing and treating cancer diseases, such as nanobody-based positron emission tomography (PET) diagnostic radiopharmaceuticals.

Chaperon’s own nanobody antibody technology has high antigen binding ability and stability as well as low immunogenicity, so it is attracting attention as a next-generation antibody treatment for the development of complex antibodies.

Based on this, Chaperone plans to develop a radiopharmaceutical diagnostic agent for PET diagnosis by applying nanobody technology targeting cancer cells or specific T-cell markers to determine the drug for immuno-anticancer drug treatment and determine whether to continue treatment with Cellvion.

In addition, the two companies plan to jointly conduct research and development of oral mucositis treatment mixed with ‘HY209’, which is currently being developed as a new drug candidate for atopic dermatitis.

Lee Myung-se, CEO of Chaperon, said, "We expect to accelerate the research and development of our nanobody antibody-based technology and inflammatory complex inhibitor new drug candidates through cooperation with Cellvion, which has excellent precision medicine technology."

Cellvion CEO Kwon Kim said, "We are sincerely pleased to have signed an MOU with Chaperone, which is leading the development of fundamental treatments for inflammatory and immune diseases, and expect that this agreement will fully exert synergy for the development of new drugs for diagnosis and treatment of cancer diseases. "he said.

Meanwhile, Chaperon is leading the research and development of inflammatory and immune disease treatments based on the theory of DAMPs (Damage-Associated Molecular Patterns) presented by CEO Seung-yong Sung for the first time in the world in ‘Nature Review Immunology,’ a world-renowned academic journal in the field of immunology. It is a bio-venture company.

In September 2020, Chaperone successfully attracted a series C investment of KRW 26 billion, and will lead the next-generation bio field as well as a new mechanism of inflammatory complex inhibitor for the treatment of major inflammatory diseases such as atopic dermatitis, Alzheimer’s disease, and ulcerative colitis. It is expanding its pipeline in various fields, including nanobody antibody-based immuno-oncology drugs.

On January 26, 2021 EXACT THERAPEUTICS AS ("EXACT-Tx" or the "Company"), a clinical stage precision medicine company utilizing Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported the appointment of Dr Hilary McElwaine-Johnn as Chief Medical Officer (Press release, Exact Therapeutics, JAN 26, 2021, View Source [SID1234578277]). Dr McElwaine-Johnn will be based at the newly opened London office of EXACT-Tx at the Translation & Innovation Hub (i-Hub) at White City.

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"We are delighted to welcome Hilary to EXACT Therapeutics AS where her unique experience in both therapeutics and drug delivery complemented by deep medical expertise will be pivotal in driving forward the development of ACT, both in the ongoing Phase I ACTIVATE study and beyond",

said Dr Rafiq Hasan, CEO of EXACT Therapeutics AS.

"Hilary joins EXACT-Tx at an exciting time as we expand our presence in the UK with the opening of our London office at the White City i-Hub in close proximity to the growing Imperial College campus".

Dr McElwaine-Johnn gained her medical degree from Imperial College, London and is a Member of the Royal College of Physicians and Faculty of Pharmaceutical Medicine. Following clinical roles in general internal medicine and oncology, she has pursued a highly successful career in the pharmaceutical industry. She has held a variety of senior medical positions including Vice President, Clinical, PowderMed Ltd (which was subsequently acquired by Pfizer), Chief Medical Officer of Vantia Ltd, PsiOxus Therapeutics Ltd and most recently Karus Therapeutics. During this time Hilary has gained extensive experience in drug development in both oncology and other therapeutic indications as well as delivery technologies complemented by a range of successful interactions with Regulatory Authorities, partner companies and fundraising activities.

Dr McElwaine-Johnn commented:

"I am excited to be joining EXACT Therapeutics in London to be part of a dynamic and innovative organization exploring the potential of the ACT platform to transform clinical practice across indications, particularly in the management of patients with cancer. With a strong preclinical evidence base and clinical development of ACT already underway, I am looking forward to working with the clinical community in further investigating this exciting approach to ultrasound mediated therapeutic targeting."

About ACT

• ACT is a proprietary formulation consisting of microbubbles and microdroplets that are activated through the application of ultrasound with the consequent increase in targeted delivery of a co-administered therapeutic agent.

ACT is supported by a strong and broad preclinical package demonstrating therapeutic enhancement in multiple oncology models (pancreatic, breast, colon, prostate) as well as blood-brain barrier penetration.

• Initial focus of the company is oncology, however the ACT platform has potential across therapeutic areas (infectious diseases, CNS, immunotherapy) and product classes.

On January 26, 2021 Nirogy reported that it will narrow its lactate transporter inhibitor candidates down to one for preclinical development and IND-enabling studies (Press release, Nirogy Therapeutics, JAN 26, 2021, View Source [SID1234577594]).

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After years working under the radar, Nirogy Therapeutics is offcially launching with $16.5 million and a mission to drug a family of membrane proteins called solute carriers. The proceeds will see the company’s lead cancer program through phase 1, CEO Vincent Sandanayaka, Ph.D., said.

Solute carriers are embedded in the cell membrane and control the movement of metabolites such as glucose, cholesterol and amino acids in and out of cells or to the right locations within cells. They’re the gatekeepers of processes like nutrient uptake and metabolite disposal, which go awry in many diseases. Nirogy’s lead program targets lactate transporters to take out cancer with a one-two punch.
Unlike healthy cells, cancer cells consume a large amount of glucose and produce lots of lactic acid as a waste product that they expel into the tumor microenvironment through lactate transporters. Tumors with high levels of lactate are a hostile environment for immune cells, so they tamp down anti-tumor immunity.

"If we block these transporters, we can directly kill cancer cells and simultaneously activate anti-tumor immunity," Sandanayaka said. Nirogy hopes to move its lead program into the clinic in 2022.

"We recognize the potential of the Nirogy team and its proprietary drug discovery engine in SLCTs, which could yield over 450 potential druggable targets and open up new treatment modalities for a number of life-threatening diseases," said Dennis McWilliams, a partner at Santé Ventures, in a statement. Santé led the series A round alongside Sporos.

Despite being an attractive drug target, solute carriers have been largely untapped due to technology challenges.

"These are highly complex proteins bound to cell membranes. If we take them out of the cell membrane, their functional state is destroyed and therefore, it’s very hard to design drugs against them," Sandanayaka said.

Others have drugged solute carriers before, but approached them individually rather than as a family with shared characteristics. Like Jnana Therapeutics, another biotech working to drug solute carriers, Nirogy built technology to go after these targets.

RELATED:
Jnana Roche, take aim at metabolite transporters in $40M discovery deal.

"Our team’s strength in computational modeling, medicinal chemistry and cancer biology has enabled us to overcome the challenge of drugging these critical untapped targets," Sandanayaka said in the statement.

Solute carriers aren’t all Jnana and Nirogy have in common. Both companies’ names are derived from Sanskrit: Jnana means "knowledge," while Nirogy means "without illness."

"Our vision is to create a path to really end patient suffering," Sandanayaka said.

Over the next year, Nirogy will narrow its lactate transporter inhibitor candidates down to one for preclinical development and IND-enabling studies. Though the compound on its own acts as a combination of targeted therapy and an immunotherapy drug, it could be added to other cancer-fghting agents to boost their effcacy, Sandanayaka said.

So far, it’s looked at combining its prospects with anti-PD1 and anti-CTLA4 immunotherapies in mouse models of triple- negative breast cancer, melanoma and colorectal cancer.

On January 26, 2021 Boston-based Nirogy Therapeutics Inc. reported $16.5 million series A round is meant to enable a pipeline of small-molecule drugs targeting the solute carrier family of transporter proteins (SLCTs) embedded in the cell membrane, and let the firm bring its front oncology runner to the clinic in 2022 (Press release, Nirogy Therapeutics, JAN 26, 2021, View Source [SID1234577568]).

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"The first thing we’re going to do is select the lead compound for preclinical devel-opment" and start IND-enabling studies, founder, president and CEO Vincent Sandanayaka told BioWorld. Nirogy’s technology allows a "one-two punch" in pill form against cancer, he said, directly killing disease cells and activating the immune system at the same time. Early work suggests that the strategy could work well against triple-negative breast cancer (TNBC), melanoma and colorectal cancer – all challenging indications.

SLCTs, dubbed gatekeepers of physiological functions, are involved in nutrient uptake and metabolite disposal. They represent a largely underexplored source of new therapeutic targets, Nirogy pointed out. Fewer than 20 of more than 450 transporters are targeted by current drugs, leaving a bounty of others, many of which are orphan targets of which the biologi-cal function and substrate specificity are unknown.

Nirogy’s research starts with identifying a target of interest and building homology models based on known structural data, deploying in-house mutational studies and computational capabilities. Once a reasonable model has been established, the firm does virtual screening of compound databases and available tool compounds while developing physiologically rel-evant biological assays to come up with lead compounds. What Nirogy calls a "synchronous lead optimization strategy" lets the company quickly find leads to test in mouse models. Transla-tional bioinformatics helps select relevant mouse models, so that mechanisms of action can be better understood.

Monocarboxylate transporters (MCTs) make up a subfamily of SLCTs consisting of 14 metabolite transporters. Of those, MCT1 and MCT4 are key isoforms that transport lactate metabolite bidirectionally in and out of cells. Nirogy’s lead program targets lactate transporters (LTs) for cancer. Unlike normal cells, cancer cells consume large amounts of glucose and excrete a huge excess of lactic acid to the tumor microenvironment by way of LTs for their rapid growth and survival, the company noted.

Lactate-rich tumors create a hostile environment for immune cells, thereby knocking down antitumor immunity. LT inhibitors in the Nirogy hopper have shown robust antitumor efficacy in preclinical models as monotherapy and combo therapy. The pipeline includes a second transporter target in cancer and a third program in immunology. Another indication in the firm’s crosshairs is rheumatoid arthritis. There’s an effort in inflam-mation, too.
Taking its name from the Sanskrit word meaning "without illness," Nirogy has five full-time employees and over the next five or six months expects to increase the headcount to 15 to 20. The firm was founded in 2014 and received seed money in 2019.

Aggressive, recurrent and difficult to treat, TNBC has been the subject of much research lately. TNBC accounted for 12% of breast cancers diagnosed in the U.S. from 2012 to 2016, with a five-year survival rate 8% to 16% lower than hormone recep-tor-positive disease, a paper in The Cancer Journal pointed out. "However, preventive and screening strategies remain tailored to the demographics of less lethal luminal cancers," the authors said. The illness "disproportionately affects African American women and carriers of germline BRCA and PALB2 mutations," they noted. "Even controlling for treatment delays, stage, and socioeconomic factors, African Americans with TNBC remain nearly twice as likely to die of their disease."

Some encouraging news recently came out of the melano-ma space, with researchers at Dana Farber Cancer Institute, Brigham and Women’s Hospital, and the Broad Institute of MIT and Harvard reporting a study finding that, four years after pa-tients with melanoma were treated with a personalized cancer vaccine, the immune response generated stayed strong and effective. The vaccine is called Neovax, and the research was published in Nature Medicine.

More has lately been discovered about colorectal cancer as well. Scientists at the University of Virginia found that one side of the colon ages biologically faster than the other in African Americans and people of European descent, which is why those populations are more likely to suffer the disease at an earlier age. In African Americans, however, the right side ages signifi-cantly faster, explaining why African Americas are more likely to develop cancerous lesions on that side. The research was published in the Journal of the National Cancer Institute.

Sandanayaka said his firm’s approach, developed in-house, is "very different from everyone else, to our knowledge," but Nir-ogy is not entirely alone in the space. Jnana Therapeutics Inc., also of Boston, pulled down a $50 million series A financing in October 2019 backed by Polaris Partners, Avalon Ventures, Versant Ventures, Abbvie Ventures LLC and Pfizer Inc. In the summer of last year, Jnana bagged a deal with Basel, Switzer-land-based Roche Holding AG that brought $40 million up front and potentially upward of $1 billion more in research funding, preclinical, development and commercial milestones, as well as sales royalties, in the multitarget deal.

The Nirogy financing was co-led by Santé Ventures and Sporos. Dennis McWilliams of Santé and Joseph Kekst of Sporos will join Nirogy’s board, and Casey Cunningham of Santé will join Nirogy’s scientific advisory board.

On January 26, 2021 Nirogy Therapeutics, based in Boston, reported that launched with a $16.5 million Series A financing round (Press release, Nirogy Therapeutics, JAN 26, 2021, View Source [SID1234577567]). The round was co-led by Santé Ventures and Sporos.

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Nirogy is focusing on small-molecule drugs that target the solute carrier family of transporter proteins (SLCTs). These proteins are embedded in the cell membrane and act as gatekeepers of a number of functions, including nutrient uptake and metabolite disposal. The lead programs are targeting cancer.

"Cellular transporters, which are central to many aspects of cell biology and dysregulated in myriad diseases, have not been effectively targeted due to the complex structures of SLCTs," said Vincent Sandanayaka, founder, president and chief executive officer of Nirogy. "Our team’s strength in computational modeling, medicinal chemistry and cancer biology has enabled us to overcome the challenge of drugging these critical untapped targets. We are fortunate to have a world-class scientific advisory board, highly committed investor partners and a dedicated team with proven scientific and drug development expertise."

The lead program targets lactate transporters for cancer therapy. The company believes it will be able to take this compound into clinical trials in 2022. Cancer cells utilize large amounts of glucose, while excreting a huge additional quantity of lactic acid into the tumor microenvironment by way of lactate transporters. Tumors that are lactate-rich create a hostile environment for immune cells, which suppressed anti-tumor immunity. In preclinical research, the company’s lactate transport inhibitors demonstrated robust anti-tumor efficacy, either by themselves or in combination with other drugs.

Nirogy’s pipeline includes two other compounds, the second also a transporter target for cancer and the third in immunology.

As part of the financing, Dennis McWilliams of Santé Ventures and Joseph Kekst of Sporos are joining Nirogy’s board of directors.

"We recognize the potential of the Nirogy team and its proprietary drug discovery engine in SLCTs, which could yield over 450 potential druggable targets and open up new treatment modalities for a number of life-threatening diseases," said McWilliams.

SLCTs have been attractive drug targets, in theory, but have largely been unexplored and certainly unexploited so far.

Sandanayaka noted that, "These are highly complex proteins bound to cell membranes. If we take them out of the cell membrane, their functional state is destroyed and therefore, it’s very hard to design drugs against them."

For example, in 2017, France-based Genoscience Pharma began investigating its own SLCT, GNS561. In November 2020, the company announced it had successfully completed its Phase Ib trial of GNS561 in primary and secondary liver cancer patients. It expects to begin Phase II trials this year. GNS561 is a palmitoyl protein thioesterase-1 (PPT-1) inhibitor that blocks autophagy, which is activated in tumor cells in response to specific conditions. Autophagy is how the body cleans out damaged cells in order to regenerate newer, healthier cells. GNS561 is able to enter the lysosomes and bind to its target, inhibiting activity on late-stage autophagy, which causes tumor cell death.

Last Friday, January 23, Nirogy announced it was awarded a $2 million NIH/NCI SBIR grant to develop dual monocarboxylate transport inhibitors (dMCTi) for triple negative breast cancer (TNBC). dMCTi blocks lactate excretion to the tumor microenvironment, and in preliminary research, has shown it has potent activity against multiple TNBC cell lines.
"We are delighted to receive this highly competitive award from NIH/NCI under its small business innovation research grant program," said Sandanayaka. "We are appreciative of the continued support from NCI for our breast cancer program. I believe that this award attests to the validity of our science strategy to target the untapped class of solute carrier transporters (SLCT) family of proteins for cancer, and the progress we have made so far in this breast cancer program."