Liver disease

EQS-News: HepaRegeniX publishes data for its first-in-class MKK4 inhibitor HRX-215 for the treatment of acute and chronic liver diseases in Cell

Retrieved on: 
Wednesday, April 10, 2024
Liver, Liver failure, DOI, Cell death, Regeneration, Clinical professor, Colorectal cancer, Transplant, Hepatectomy, Risk, Patient, MKK4, Mayo Clinic, Manuscript, Liver transplantation, Teaching hospital, Human, MAP, Liver regeneration, Hepatocyte, PHLF, Regenerative medicine, Safety, Hepatology, Liver disease, Dietary supplement

HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4).

Key Points: 
  • HRX-215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4).
  • "The positive results in terms of safety and tolerability confirm our intention to soon offer a drug that has the potential to revolutionize the treatment of severe liver diseases.
  • The data pave the way for further Phase II studies evaluating the efficacy of HRX-215 in humans," emphasizes Dr. Wolfgang Albrecht, COO of HepaRegeniX.
  • Further, HRX-215 was also able to protect hepatocytes from cell death in a model for acute liver injury.

MiNK Therapeutics Announces Promising Preclinical Activity of MiNK-215 Against Colorectal Cancer Liver Metastases at AACR

Retrieved on: 
Monday, April 8, 2024
TME, FAP, Cell, Immunotherapy, Colorectal cancer, Mink, Patient, Tumor microenvironment, Cancer, PST, AACR, MSS, Neoplasm, Therapy, CRC, Liver, Liver disease, Vaccine

The data presented at AACR demonstrate MiNK-215's potential to effectively combat colorectal liver metastases, offering hope for patients who have exhausted conventional treatment options,” said Dr. Jennifer Buell, President and Chief Executive Officer at MiNK.

Key Points: 
  • The data presented at AACR demonstrate MiNK-215's potential to effectively combat colorectal liver metastases, offering hope for patients who have exhausted conventional treatment options,” said Dr. Jennifer Buell, President and Chief Executive Officer at MiNK.
  • This collaboration holds promise in bolstering the anti-tumor response, particularly in the formidable realm of microsatellite stable colorectal cancer."
  • Liver mets have limited the efficacy of immunotherapy in patients with mismatch repair proficient/microsatellite-stable (pMMR/MSS) colorectal cancer (CRC).
  • MiNK's innovative iNKT cell therapy, MiNK-215, has shown the ability to remodel the immunosuppressive tumor microenvironment within the liver.

Protara Therapeutics Announces Alignment with FDA on Registrational Path Forward for IV Choline Chloride in Patients Dependent on Parenteral Nutrition

Retrieved on: 
Friday, April 5, 2024
Choline, Plasma, Liver, Nutritional science, Route of administration, Liver disease, Steatosis, Short bowel syndrome, Metabolism, Patient, Choline chloride, Cancer, ESPEN, Parenteral nutrition, Adolescence, Liver injury, Hepatology, Tubing (recreation), Fibrosis, Guideline, Society, Therapy, Copenhagen University Hospital, Safety, Pharmacokinetics, PN, FDA, ASPEN, Rigshospitalet, Food, Feeding tube, Extractive metallurgy

IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.

Key Points: 
  • IV Choline Chloride has the potential to become the first FDA-approved IV formulation of choline for the 40,000 PN patients in the U.S.
  • The Company plans to advance the development of IV Choline Chloride as a source of choline for adult and adolescent patients on long-term PN.
  • The FDA has granted IV Choline Chloride Orphan Drug Designation for the prevention of choline deficiency in PN patients.
  • “We look forward to advancing the clinical development of IV Choline Chloride, which we believe has the potential to become the first FDA approved IV choline therapy for patients dependent on PN.

Strong data from DSR® proof-of-concept studies in heart failure published in European Journal of Heart Failure

Retrieved on: 
Wednesday, April 3, 2024
Cardiorenal syndrome, Congestion, DSR, Brussels Stock Exchange, Liver disease, Associate, RED, Patient, NYHA, Mortality, Cancer, Fluid, Heart failure, European Journal, Diuretic, Overload, Syndrome, Yale University, Pharmaceutical industry

The publication can be accessed here .

Key Points: 
  • The publication can be accessed here .
  • Dr. Jeffrey Testani, Associate professor at Yale University and senior author of the publication commented: “Cardiorenal syndrome is a major clinical challenge in heart failure with a clear unmet need for therapies to effectively and durably address congestion and cardio-renal dysfunction.
  • Currently the mainstay of therapy for sodium avidity and congestion are the loop diuretics, which actually worsen sodium avidity and cardiorenal syndrome.
  • Diuretic-resistant heart failure and cardiorneal syndrome are large and growing markets both in the US and rest of world, with the clear need for novel treatments that can improve clinical outcomes beyond loop diuretics.

Chemomab to Host Virtual Key Opinion Leader Webinar on Primary Sclerosing Cholangitis on April 10, 2024

Retrieved on: 
Tuesday, April 2, 2024
Q&A, Primary sclerosing cholangitis, Liver disease, UC, UPMC, KOL, PSC, Doctor of Philosophy, Digestate, CCL24, Clinical trial, Therapy, CMMB, Liver, University of California, Davis, FDA, TEL, Pharmaceutical industry

TEL AVIV, Israel, April 02, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics to treat rare fibro-inflammatory diseases with high unmet need, today announced it will host a live key opinion leader (KOL) virtual event on primary sclerosing cholangitis (PSC) on Wednesday, April 10, 2024 at 10:00 AM ET. To register, click here.

Key Points: 
  • —“Breaking New Ground: Expert Perspectives on Primary Sclerosing Cholangitis” Will Feature Clinical, Academic and Patient Advocacy Leaders Discussing PSC Disease Management and Evolving Views on Clinical Development—
    TEL AVIV, Israel, April 02, 2024 (GLOBE NEWSWIRE) -- Chemomab Therapeutics Ltd. (Nasdaq: CMMB), (Chemomab), a clinical stage biotechnology company developing innovative therapeutics to treat rare fibro-inflammatory diseases with high unmet need, today announced it will host a live key opinion leader (KOL) virtual event on primary sclerosing cholangitis (PSC) on Wednesday, April 10, 2024 at 10:00 AM ET.
  • They will discuss the urgent need for new PSC treatments and emerging developments that could facilitate new drug approvals.
  • Chemomab’s co-founder, CEO & CSO Adi Mor, PhD and CMO Matt Frankel, MD, will provide an overview of the CM-101 Phase 2 PSC clinical trial that will report topline results midyear 2024.
  • CM-101 is a dual mechanism first-in-class monoclonal antibody that neutralizes CCL24, a soluble protein that is a key driver of inflammatory and fibrotic pathways central to PSC and other fibro-inflammatory diseases.

Gritstone bio Announces Positive Preliminary Progression-free Survival and Long-term Circulating Tumor DNA (ctDNA) Data from Phase 2 Portion of Ongoing Phase 2/3 Study of its Personalized Cancer Vaccine, GRANITE, in Front-line Metastatic Microsatellite St

Retrieved on: 
Monday, April 1, 2024
Lung cancer, Survival, Immunotherapy, Disease, Colorectal cancer, Progression-free survival, Medicine, Patient, Common, DNA, Aes, Cancer, Death, Doctor of Philosophy, Gritstone bio, MD, Kinetics, Induction chemotherapy, MSS, Circulating tumor DNA, VAF, Melanoma, PFS, Vaccine, Data, UCLA, Liver disease, Neoplasm, Pharmaceutical industry

EMERYVILLE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced positive preliminary data from the ongoing, signal seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE, its personalized neoantigen cancer vaccine, in front-line metastatic microsatellite stable colorectal cancer (MSS-CRC). The randomized, controlled, open-label study is designed to quantify the clinical benefit of maintenance therapy with GRANITE (GRT-C901/GRT-R902) in combination with immune checkpoint blockade in addition to fluoropyrimidine/bevacizumab versus fluoropyrimidine/bevacizumab alone. Overall progression free survival (PFS) data show an early trend in benefit for GRANITE patients (HR=0.82, [95% CI, 0.34-1.67]; 62% censored) and extended PFS benefit in high-risk patients (HR=0.52 [95% CI, 0.15-1.38]; 44% censored), in whom progression occurs faster. Circulating tumor DNA (ctDNA) analysis over several months of treatment shows the expected relationship with disease progression and favors GRANITE, while short-term ctDNA response analysis (molecular response as defined per protocol) did not demonstrate a difference between study arms. Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).

Key Points: 
  • Gritstone bio successfully manufactured GRANITE product candidate for every eligible patient (i.e., 100% vaccine manufacturing success rate).
  • “Today's preliminary Phase 2 results are highly encouraging and represent the first randomized trial evidence, albeit early, that a personalized neoantigen-directed vaccine can potentially drive efficacy in a metastatic ‘cold’ tumor.
  • Fortunately, long-term analysis demonstrates the expected correlation of ctDNA with clinical benefit and favors GRANITE patients.
  • This analysis was performed on 44 patients who received study treatment (control and GRANITE arms) and have available baseline ctDNA data.

Surrozen Announces Safety, Pharmacodynamic and Liver Function Data for SZN-043

Retrieved on: 
Monday, April 1, 2024
MELD, Metabolism, Regeneration, Dicarboxylic acid, Survival, Liver disease, PD, Safety, Patient, History, Alkaline phosphatase, CYP1A2, Crosstalk (biology), ASGR1, Pharmacokinetics, Therapy, ALP, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. (“Surrozen” or the “Company”) (Nasdaq: SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt Pathway for tissue repair and regeneration, today provided an update on the Phase 1a clinical trial of SZN-043 in healthy volunteers and patients with cirrhosis.   The Phase 1a study was completed in February 2024. SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function.   The observed safety and pharmacodynamic activity were the basis for the Company’s previous announcement that it planned to initiate enrollment in the Phase 1b study in alcohol-associated hepatitis.

Key Points: 
  • SZN-043 demonstrated acceptable safety and tolerability in all subjects, with evidence of target engagement, Wnt signal activation and effects on liver function.
  • The observed safety and pharmacodynamic activity were the basis for the Company’s previous announcement that it planned to initiate enrollment in the Phase 1b study in alcohol-associated hepatitis.
  • The randomized, placebo-controlled Phase 1a trial enrolled a total of 48 subjects, including 40 healthy volunteers and 8 patients with cirrhosis and a history of liver disease.
  • Cirrhotic patients also showed evidence of liver function effects after treatment with SZN-043 as measured by HepQuant which is a test that measures cholate clearance, a liver specific function that quantifies liver function.

Adagene Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Friday, March 29, 2024
Head, Immunotherapy, HNSCC, Patient, Roche, Lead, Immunoglobulin G, Neoplasm, CRC, Audit committee, PD-1, Observation, Bioinformatics, Colorectal cancer, SAN, Information technology, Pembrolizumab, PRS, Safety, PD-L1, Compensated emancipation, Annual report, Apoptosis, Cervical cancer, Part, Merck, Senior, Bevacizumab, MSS, GAAP, ASCO, PFS, MTD, Liver disease, HCC, Therapeutic index, Endometrial cancer, Progression-free survival, ADS, Net, Regulatory T cell, Research and development, Liver, Pharmaceutical industry

SAN DIEGO and SUZHOU, China, March 29, 2024 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based therapies, today reported financial results for the full year 2023 and provided corporate updates.

Key Points: 
  • Both confirmed PRs are sustained after more than one year with repeat dosing while maintaining robust safety profiles.
  • Observation of these clinical activities triggered further expansion into the second stage of the Simon’s 2-stage design for this dose level.
  • Net loss attributable to Adagene Inc.’s shareholders was US$18.9 million for the year ended December 31, 2023, compared to US$80.0 million in 2022.
  • The company encourages investors and others to review its financial information in its entirety and not rely on a single financial measure.

Sequana Medical announces 2023 Full Year Results and 2024 Outlook

Retrieved on: 
Thursday, March 28, 2024
Cardiorenal syndrome, Cirrhosis, Partner, Congestion, American Medical Association, Ascites, DSR, Brussels Stock Exchange, Liver disease, RED, Patient, Peritoneal dialysis, 2.0, Mouse, Sheep, Cancer, Heart, Heart failure, PMA, US FDA, Safety, File, CPT9, Overload, Catheter, ISO, THT, FDA, Animal, Pharmaceutical industry

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.

Key Points: 
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.
  • Furthermore, the alfapump can benefit from attractive pricing and leverage its FDA breakthrough device designation to enhance its reimbursement position.
  • Following this equity placement, the €3.0 million convertible loan agreement entered in February 2024 by Partners in Equity and Rosetta Capital will be mandatorily converted into new shares.
  • A day-100 meeting is scheduled with the FDA on April 9th 2024.

SEQUANA MEDICAL ANNOUNCES NEW SHARE CAPITAL AMOUNT AND NEW NUMBER OF SHARES

Retrieved on: 
Tuesday, March 26, 2024
Brussels Stock Exchange, Exercise, Liver disease, Finance Secretary (India), Cancer, Disclosure, Heart failure, Overload, Consultant, Security (finance)

Ghent, Belgium, 26 March 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, announces today that in the context of the private placement of new shares that was announced and priced on 20 March 2024, with pricing announced on 21 March 2024, by means of a private placement through an accelerated bookbuilding procedure of new shares, the Company's share capital has increased on 25 March 2024 from EUR 2,926,295.90 to EUR 3,720,562.60 and the number of issued and outstanding shares has increased from 28,242,753 to 35,909,420 shares, through the issuance of a total of 7,666,667 new shares.

Key Points: 
  • Ghent, Belgium, 26 March 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, announces today that in the context of the private placement of new shares that was announced and priced on 20 March 2024, with pricing announced on 21 March 2024, by means of a private placement through an accelerated bookbuilding procedure of new shares, the Company's share capital has increased on 25 March 2024 from EUR 2,926,295.90 to EUR 3,720,562.60 and the number of issued and outstanding shares has increased from 28,242,753 to 35,909,420 shares, through the issuance of a total of 7,666,667 new shares.
  • The total current number of outstanding subscription rights amounts to 5,032,452, which entitles their holders (if exercised) to subscribe to 4,792,765 new shares with voting rights in total, namely:
    up to 261,895 new shares can be issued upon the exercise of 90,780 share options that are still outstanding under the 'Executive Share Options' plan for staff members and consultants of the Company, entitling the holder thereof to acquire ca.
  • upon the exercise of 10 warrants (each warrant having the form of a subscription right) that are still outstanding that have been issued by the extraordinary shareholders meeting of 27 May 2022 (the "Bootstrap Warrants");
    up to 161,404 new shares can be issued to Kreos Capital VII Aggregator SCSp.
  • upon the exercise of 875,000 warrants (each warrant having the form of a subscription right) that are still outstanding that have been issued by the extraordinary shareholders meeting of 10 February 2023 (the "Kreos Warrants")1; and
    This announcement is made in accordance with Article 15 of the Belgian Act of 2 May 2007 on the disclosure of major participations in issuers of which shares are admitted to trading on a regulated market and regarding miscellaneous provisions.