New chemical entity

Junshi Biosciences Announces New Chemical Entity Application for Toripalimab Accepted by Australia’s TGA

Retrieved on: 
Saturday, December 2, 2023

Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.

Key Points: 
  • Additionally, the TGA has also granted an orphan drug designation to toripalimab for the treatment of NPC.
  • At present, seven other regulatory agencies have joined Project Orbis, including the TGA, Singapore Health Sciences Authority (HSA), Health Canada (HC), MHRA, etc.
  • Toripalimab for the treatment of NPC meets these application requirements and is the first domestic oncology drug to be included in Project Orbis.
  • Junshi Biosciences will explore the possibility of fast marketing in these countries and regions where the pathway is applicable.

Processa Pharmaceuticals Issues Letter to Shareholders Highlighting Corporate Strategy, Drug Pipeline, and Outlook

Retrieved on: 
Wednesday, November 29, 2023

That will not change under my direction, and much of my experience is in oncology and leading business transactions.

Key Points: 
  • That will not change under my direction, and much of my experience is in oncology and leading business transactions.
  • However, many issues and limitations are associated with the use of chemotherapy.
  • Many patients simply cannot tolerate a chemotherapy dose high enough to benefit from its use due to chemotherapy’s toxic side effects.
  • Working in our favor are deep management and R&D teams that have significant and direct experience in clinical drug development.

Enveric Biosciences Announces Presentation of Two Posters at Canadian Chemical Engineering Conference (CSChE 2023)

Retrieved on: 
Friday, November 24, 2023

Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced the presentation of two posters at the Canadian Chemical Engineering Conference (CSChE 2023) which was held October 29th to November 1, 2023.

Key Points: 
  • Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, today announced the presentation of two posters at the Canadian Chemical Engineering Conference (CSChE 2023) which was held October 29th to November 1, 2023.
  • First, the Enveric research team achieved the production of milligram quantities of pure compounds in small-scale batch fermentations.
  • The purified transamination products were converted to methamphetamine derivatives, including MDMA, by chemical reduction and N-methylation.
  • Using the synthetic biology platform, Enveric researchers were able to produce several previously undescribed, wholly novel products with important activities at target receptors.

Aclipse Therapeutics Expands Drug Development Pipeline with Signing of Exclusive, Worldwide License Agreement with Chong Kun Dang Pharmaceutical Corporation to Develop Potential Disease-Modifying Treatment for Gastroparesis

Retrieved on: 
Thursday, September 14, 2023

Lobeglitazone, given the development code “M107” by Aclipse, was developed by CKD and approved by South Korea’s Ministry of Food and Drug Safety for the treatment of Type 2 Diabetes Mellitus under the brand name, Duvie®.

Key Points: 
  • Lobeglitazone, given the development code “M107” by Aclipse, was developed by CKD and approved by South Korea’s Ministry of Food and Drug Safety for the treatment of Type 2 Diabetes Mellitus under the brand name, Duvie®.
  • Lobeglitazone has shown an extensive history of safety, having been dosed in over 3,600 patients and healthy volunteers during its development and post-marketing surveillance.
  • “The worldwide, exclusive license agreement with CKD expands the Aclipse drug development pipeline and advances the company into Phase 2 clinical development for this promising drug candidate,” said Raymond K. Houck, Chief Executive Officer of Aclipse.
  • “We look forward to continuing our partnership with Aclipse and to the further clinical and commercial development of lobeglitazone.”

CorMedix Inc. Announces Issuance of U.S. Patent Covering Lead Product Defencath

Retrieved on: 
Wednesday, August 30, 2023

11,738,120 with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters.

Key Points: 
  • 11,738,120 with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters.
  • This newly issued U.S. Patent, for which CorMedix previously announced the allowance of patent claims, reflects the unique and proprietary nature of DefenCath®, and will extend the Company’s current intellectual property protection with an expiration date of April 15, 2042.
  • The newly issued patent claims supplement CorMedix’s existing licensed U.S. Patent No.
  • 7,696,182, and provide an additional layer of patent protection for DefenCath.

Sathgen Therapeutics announces dosing of the first patient cohort with MSP008-22, a novel anti-cancer drug

Retrieved on: 
Thursday, July 20, 2023

MUMBAI, India, July 20, 2023 /PRNewswire/ -- Sathgen Therapeutics, a division of a leading chemicals conglomerate in India – Godavari Biorefineries Limited (GBL), has announced the completion of the first cohort in a Phase 1 clinical trial for their first-in-class New Chemical Entity, MSP008-22. The clinical trial program is managed by Clinexel Life Sciences, a renowned contract research organization in the health sector.

Key Points: 
  • Sathgen Therapeutics aims to develop MSP008-22 for difficult-to-treat cancers, starting with triple negative breast cancer (TNBC) and prostate cancer as proof-of-principle.
  • MSP008-22 effectively targets treatment-resistant cancer cells in preclinical models, and demonstrates an excellent safety profile with no serious adverse events in the first patient cohort.
  • Professor Sendurai Mani, Associate Director, Legorreta Cancer Center, Brown University, and Scientific Co-Founder, Sathgen Therapeutics, stated, "TNBC is responsible for 30% of breast cancer-related deaths.
  • With over 15 anti-cancer candidates in the pipeline, Sathgen Therapeutics remains committed to advancing cancer therapeutics.

Sathgen Therapeutics announces dosing of the first patient cohort with MSP008-22, a novel anti-cancer drug

Retrieved on: 
Thursday, July 20, 2023

MUMBAI, India, July 20, 2023 /PRNewswire/ -- Sathgen Therapeutics, a division of a leading chemicals conglomerate in India – Godavari Biorefineries Limited (GBL), has announced the completion of the first cohort in a Phase 1 clinical trial for their first-in-class New Chemical Entity, MSP008-22. The clinical trial program is managed by Clinexel Life Sciences, a renowned contract research organization in the health sector.

Key Points: 
  • Sathgen Therapeutics aims to develop MSP008-22 for difficult-to-treat cancers, starting with triple negative breast cancer (TNBC) and prostate cancer as proof-of-principle.
  • MSP008-22 effectively targets treatment-resistant cancer cells in preclinical models, and demonstrates an excellent safety profile with no serious adverse events in the first patient cohort.
  • Professor Sendurai Mani, Associate Director, Legorreta Cancer Center, Brown University, and Scientific Co-Founder, Sathgen Therapeutics, stated, "TNBC is responsible for 30% of breast cancer-related deaths.
  • With over 15 anti-cancer candidates in the pipeline, Sathgen Therapeutics remains committed to advancing cancer therapeutics.

Visiox Pharma Licenses OMLONTI®

Retrieved on: 
Wednesday, July 19, 2023

Visiox plans to launch OMLONTI in early 2024, followed by once-daily PDP-716 (brimonidine) 0.35%, positioning the company to become a leader in glaucoma, a disease with significant impact on patients.

Key Points: 
  • Visiox plans to launch OMLONTI in early 2024, followed by once-daily PDP-716 (brimonidine) 0.35%, positioning the company to become a leader in glaucoma, a disease with significant impact on patients.
  • "We believe this is a compelling transaction, as it expands our addressable market opportunity enhancing our long-term growth and profitability."
  • The strategic license provides exclusive rights in the U.S. for product manufacturing and commercialization of OMLONTI®.
  • Santen will receive an equity stake in Visiox as an upfront payment, and remains eligible to receive sales milestone payments, as well as royalties on net sales of OMLONTI® in the U.S.

ConSynance Therapeutics Reports Positive Phase 1 Results for CSTI-500 in Prader-Willi Syndrome Patients

Retrieved on: 
Tuesday, May 30, 2023

ConSynance Therapeutics, Inc., an emerging biopharmaceutical firm focused on developing novel therapies for rare central nervous system (CNS) disorders, today announced positive results from its Phase 1 trial for CSTI-500, a potential groundbreaking treatment for Prader-Willi Syndrome (PWS).

Key Points: 
  • ConSynance Therapeutics, Inc., an emerging biopharmaceutical firm focused on developing novel therapies for rare central nervous system (CNS) disorders, today announced positive results from its Phase 1 trial for CSTI-500, a potential groundbreaking treatment for Prader-Willi Syndrome (PWS).
  • With these compelling findings, CSTI-500 is now poised to advance into a Phase 2 clinical trial.
  • The robust pharmacokinetic and safety data of CSTI-500 in PWS patients provide strong support to proceed to a Phase 2 study.
  • This feature has the potential to safely and effectively mitigate hyperphagia and temper outbursts, two prominent neuropsychiatric symptoms in PWS patients.

FSD Pharma Completes Dosing of First Cohort in Phase I Clinical Trial of Lucid-MS, a New Drug Candidate for the Treatment of Multiple Sclerosis: Safety Review Committee Recommends Commencing Dosing of Second Cohort

Retrieved on: 
Wednesday, May 10, 2023

The clinical trial (ClinicalTrials.gov Identifier: NCT05821387 ), being conducted by FSD Pharma through the Company’s wholly owned subsidiary Lucid Psycheceuticals, is a first-in-human study evaluating Lucid-MS, a small molecule inhibitor of hypercitrullination, as a novel drug candidate for the treatment of Multiple Sclerosis (“MS”).

Key Points: 
  • The clinical trial (ClinicalTrials.gov Identifier: NCT05821387 ), being conducted by FSD Pharma through the Company’s wholly owned subsidiary Lucid Psycheceuticals, is a first-in-human study evaluating Lucid-MS, a small molecule inhibitor of hypercitrullination, as a novel drug candidate for the treatment of Multiple Sclerosis (“MS”).
  • “Our clinical development team and international advisory committee are delighted at the progress of this milestone and completing dosing the first cohort,” said Dr. Lakshmi Kotra, CEO of Lucid Psycheceuticals.
  • Each SAD and MAD cohort will enroll eight participants (for a total of 56 participants) randomized to six active and two placebo groups.
  • Based on current evidence, Lucid-MS is non-immunomodulatory agent, an important distinction in the potential for developing new, safe options for treating MS.