Immuron Naval Medical Research Center responds to FDA Hold for Campylobacter ETEC Therapeutic

  Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company that has developed two commercially available oral immunotherapeutic products for the treatment of gut mediated diseases, today announces that a response letter has been submitted to the US Food and Drug Administration (FDA). Immuron has previously reported feedback was received from the FDA following a review of the Investigational New Drug (IND) application (ASX announcement July 26, 2022) of a new oral therapeutic targeting Campylobacter and ETEC developed in collaboration with Immuron. The FDA informed the NMRC that based on its review of the nonclinical data, the agency was placing a clinical hold on the clinical trials of the new oral therapeutic under the IND application.

The Sponsor Investigator and Principal Investigator from Johns Hopkins University (JHU) Bloomberg School of Public Health and personnel from the Naval Medical Research Center (NMRC) and Immuron participated in a virtual meeting with the FDA on the 2 December 2022 to discuss the clinical hold and advise on a path forward to address the safety concerns and supporting data associated with this new product. The FDA provided written guidance to the NMRC following the meeting on the 20 December 2022. NMRC, JHU and Immuron have now addressed the specific concerns of the FDA clinical hold and a response letter has been submitted. The agency will provide feedback on the clinical hold in 30 calendar days from receipt of the NMRC information package.

https://finance.yahoo.com/news/immuron-us-dod-naval-medical-110000867.html

Aurinia: Patent for LUPKYNIS® in Treatment of Lupus

 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that the United States Patent and Trademark Office (USPTO) has allowed a method of use patent application titled IMPROVED PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS. Aurinia’s newly allowed U.S. Patent Application (No. 17/713,140) reflects the unique and proprietary dosing regimen of its currently marketed product, LUPKYNIS. Specifically, this patent further refines the method of using LUPKYNIS in combination with mycophenolate mofetil (MMF) and corticosteroids using eGFR as a method of pharmacodynamically dosing the product in patients with lupus nephritis. The newly allowed application provides patent coverage that supplements Aurinia’s existing U.S. Patent No. 10,286,036, which is listed in the Orange Book and claims an FDA-approved method of using LUPKYNIS. The claims in this additional patent add further specificity on dosing consistent with the FDA approved product label. This patent has the potential to provide an additional layer of patent protection for LUPKYNIS up to 2037. The Company intends to list this newly allowed patent in the Orange Book once issued.

In addition, Aurinia is also announcing that it has recently received a Notice of Intention to Grant from the European Patent Office (EPO) for a patent application that has similar claims to Aurinia’s existing method of use U.S. Patent No. 10,286,036. This European patent application was pursued through the Patent Cooperation Treaty (PCT) process. Once issued, this patent could provide protection up to 2037 across Europe.

https://finance.yahoo.com/news/aurinia-pharmaceuticals-announces-allowance-refined-210000337.html

Merck to Stop Trial of KEYTRUDA Plus Enzalutamide and Androgen Deprivation Therapy in Prostate Cancer

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that it will stop the Phase 3 KEYNOTE-991 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee which reviewed data from a planned interim analysis. At the interim analysis, KEYTRUDA in combination with enzalutamide and ADT did not demonstrate an improvement in overall survival (OS) or radiographic progression-free survival (rPFS), the trial’s dual primary endpoints, compared to placebo plus enzalutamide and ADT. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. No new safety signals were identified; however, the combination was associated with a higher incidence of Grade 3-5 adverse events and serious adverse events compared to the control arm. Merck is informing study investigators of the decision and advises patients in the study to speak to their physician regarding treatment. Data from this study will be presented at an upcoming medical meeting.

https://finance.yahoo.com/news/merck-announces-keynote-991-trial-115000134.html

Merck KEYTRUDA Plus Chemo Significantly Improved Overall Survival in Biliary Cancer

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 KEYNOTE-966 trial. In the final analysis of this trial, KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.

https://finance.yahoo.com/news/merck-keytruda-pembrolizumab-plus-chemotherapy-114500666.html

Cidara, Melinta: AdComm Urges Approval of Rezafungin for Candidemia and Invasive Candidiasis

 FDA decision expected by PDUFA target action date of March 22, 2023

If approved, rezafungin will be the first new drug for the treatment of candidemia and invasive candidiasis in over a decade

https://finance.yahoo.com/news/cidara-therapeutics-melinta-therapeutics-announce-120000219.html

First Wave: Adrulipase Intellectual Property Portfolio Expanded

 First Wave BioPharma, Inc. (NASDAQ: FWBI) (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, announced today the company has filed a U.S. Provisional Patent application involving composition of matter improvements designed to enhance adrulipase’s delayed release profile. This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase.

Expansion of the adrulipase patent estate follows the recent submission of an Investigational New Drug (IND) amendment seeking authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical trial evaluating an enhanced enteric microgranule delivery formulation of adrulipase as a treatment for exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.

https://finance.yahoo.com/news/first-wave-biopharma-announces-expansion-120000431.html

Openness To Medical Cannabis Is Mostly Fairly Low

 Almost 100,000 new patients were estimated to be able to legally access medical cannabis in the United Kingdom and Europe in 2022, according to a report by industry analysts Prohibition Partners, bringing the region’s total number of medical users to around 342,000. This figure is expected to surpass 500,000 in 2023, as more countries introduce access to legalized medical cannabis and existing markets mature.

According to the researchers' latest report, in 2022, the Spanish government legalized the use of medical cannabis for select conditions through the country’s public health system, while in Ukraine, the Minister of Health said he intends to legalize cannabis for medical purposes as part of the country’s efforts to treat trauma from the war. The trend is also being seen in Latin America, with Costa Rica and Panama having adopted medical cannabis laws for the first time, while in Asia, Malaysia’s Ministry of Health stated its intention to legalize the medical drug.

Medical cannabis is sometimes prescribed to people to ease the symptoms of certain medical conditions. According to the NHS, in the United Kingdom it is currently only prescribed to children and adults with rare, severe forms of epilepsy, to adults with vomiting or nausea caused by chemotherapy, and by people with muscle stiffness and spasms caused by multiple sclerosis (MS). In terms of medical side effects, experts say that abuse of the drug can increase the risk of psychosis and anxiety.

Despite the drug’s ability to relieve pain and improve quality of life, access remains limited for many, as bureaucratic barriers and laws mean it can be difficult to get a hold of.

Stigma remains around the topic in many countries, particularly since the United States’ war on drugs campaign in the 70s, with perceptions slow to change.

But, as Statista's Anna Fleck details below, both cultural and individuals’ views around the use of medical cannabis vary from country to country.

As Fleck showd in the chart above, pulling from Statista’s Consumer Insight survey, in Spain and France, only 22 and 23 percent of respondents, respectively, said they would be open to trying the medical version of the drug.

This is even lower in South Korea, where only 13 percent would consider using it.

Germany and Poland are among the more receptive of the polled countries, at 39 percent and 46 percent. In Germany, the topic has been in the public eye of late, as the country is currently looking whether to fully legalize cannabis for adults, including recreationally, with plans to have a draft cannabis law drawn up by the end of 2023. Medical marajuana has been legal in the country since 2017 for seriously ill patients.

Susanne Casper, CEO of the pharmaceutical company Linnea SA, tells the writers of the report that as recreational marajuana becomes legalized in more countries, it will be important that it does not wipe out the medical marajuana market, which has high standards for regulations in terms of reliable potency and dosing, and offers the benefit that it can usually be partially covered by health insurance, benefiting patients.

https://www.zerohedge.com/medical/openness-medical-cannabis-mostly-fairly-low