On September 26, 2022 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that Company leadership will participate in two upcoming investor conferences in October (Press release, ReCode Therapeutics, SEP 26, 2022, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-participate-in-upcoming-october-investor-conferences [SID1234621545]):

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Chardan’s 6th Annual Genetic Medicines Conference

BMO Biopharma Spotlight Series: Gene Editing & Therapeutics

On September 26, 2022 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (ANPC), a biotechnology company with operations in the United States and China focused on early cancer screening and detection, reported that on September 26, 2022, the Company and a group of nine institutional and individual investors (the "Investors") have signed legally binding agreements for the investment in the Company by the Investors of approximately $3.67 Million (Press release, Anpac Bio, SEP 26, 2022, View Source [SID1234621440]).

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Under the terms of the various Shares Purchase Agreements, the Investors will invest in a private offering, in the aggregate, $3.67 Million to purchase 36.7 million of the Company’s Class A shares. It is expected that the investment will be completed in late September 2022.

Dr. Chris Yu, Co-Chairman of the board and Co-CEO of the Company, commented: "This equity investment is important to the Company’s operations as well as research and development including its Class III medical device clinical trial. We believe the investments signal continued confidence in the long term and fundamental prospects of our Company and its technology. We are entering into the critical Class III medical device clinical trial at three well-known hospitals. The successful completion of this clinical trial and obtaining a Class III medical device license is very important to our efforts to commercialize our cancer detection technology and Company valuation. We believe we have a very strong innovation track record in addition to the world’s largest multi-cancer detection sample size (in the new generation cancer detection technology space) according to a 2021 report by US marketing and research firm Frost & Sullivan."

On September 26, 2022 Servier, an international pharmaceutical company, and Oncodesign Precision Medicine (OPM), a subsidiary of Oncodesign (ALONC – FR0011766229) specialized in precision medicine, reported that Servier has exercised its exclusive license option for their drug candidate, an inhibitor of the LRRK2 (Leucine-Rich-Repeat Kinase 2) kinase target (Press release, Servier, SEP 26, 2022, View Source [SID1234621437]).

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In March 2019, Servier and Oncodesign started a research and development collaboration on LRRK2 kinase inhibitors, from the OPM’s Nanocyclix platform, as potential therapeutic agents for Parkinson’s disease. This collaboration is based on the complementary expertise of Servier and OPM in neurodegenerative diseases and kinase inhibitors. In June 2021, the two companies announced the selection of a preclinical drug candidate. Servier expects to start a "Phase 1 study in healthy volunteers" before the end of 2022.

The exercise of the option triggers a €7 million milestone payment by Servier to OPM. In total, Servier could pay OPM up to €320 million in R&D, regulatory and commercial milestones, plus potential royalties on future sales.

Jan Hoflack, PhD, Chief Scientific Officer and Managing Director of Oncodesign and OPM, said: « The approval of the CTA dossier by the ANSM and the EC, and the exercise of the license option by Servier, precede the first evaluation in humans of our key LRRK2 inhibitor drug candidate. This drug candidate is the first molecule from our Nanocyclix technology to enter the clinic for therapeutic evaluation. LRRK2 is a well-known kinase in the pharmaceutical field since 2005. This kinase has proven to be very difficult to target with inhibitors but has the potential to slow the progression of Parkinson’s disease. This would be a major progress for patients suffering from this disease, for which only symptomatic treatments currently exist. Our collaboration with Servier, which started in 2019, led to the discovery of a promising drug candidate in less than 4 years, demonstrating the maturity of the Nanocyclix technology, our expertise in the kinase field, as well as Servier’s expertise in the neurosciences field, coupled with strong synergy and efficiency within the joint Servier/Oncodesign/OPM team. »

Philippe Genne, PhD, Chairman and CEO and founder of Oncodesign and OPM explains: « I am very pleased with the rapid and successful development of this collaboration with the Servier Group, a long-standing partner of our company. More than ever, this term has a meaning here, as this is the first compound from Oncodesign’s research to reach the clinical development stage. This project is also an important program in OPM’s growth strategy. We will be able to capitalise on this solid base for the promising development of this young and experienced biotech. There is still a long way to go before the candidate becomes a drug, but this step was crucial and announces further successes for the benefit of patients. »

Ross Jeggo, PhD, Global Head of Neuroscience and Immuno-inflammation Therapeutic Area states: « The progress of the research and development program for this drug candidate in Parkinson’s disease is the result of the combined expertise of Servier and its partner Oncodesign. This collaboration reflects the Group’s commitment to focus its research on diseases with high medical needs, working closely with partners who share their know-how and technologies to create innovation synergies and accelerate the discovery of therapeutic solutions for the benefit of patients. »

About Parkinson’s disease

Parkinson’s disease is the most common neurodegenerative disorder responsible for motordysfunction, affecting 1% of the world’s population aged over 60[4]. In total, about 170,000 people are treated in France, with approximately 25,000 new cases reported[5] each year. It is a chronic disease with a progressive evolution of symptoms: slowed movements, tremors, rigidity. Parkinson’s disease is characterized by a progressive loss of dopaminergic neurons and by an accumulation of the protein α-synuclein in the brain. Current treatments, which are only symptomatic, are based on dopamine supplementation to compensate for the loss of dopaminergic neurons and reduce motor disorders, but their effectiveness diminishes with time. To date, there is no neuroprotective therapy able to slow down the progression of the disease. Modifying the course of the disease remains the main objective in the research and development of new treatments for Parkinson’s disease.

About the LRRK2 target

Parkinson’s disease is considered as an idiopathic disease, i.e. without a clearly identified origin in the vast majority of cases. Pathogenic mutations in LRRK2 protein are the most common monogenic form of Parkinson’s disease; a high level of LRRK2 protein activity is observed in these patients and also in idiopathic patients. The pathological features and clinical symptoms of an idiopathic patient and a patient with LRRK2 mutations are similar. LRRK2 is a multi-domain protein, which contains both kinase and GTPase enzymatic activities, where the pathogenic mutations are located. Inhibiting LRRK2 would therefore have neuroprotective potential, able to modify the progression of Parkinson’s disease. Last May, the first Phase I and Phase Ib clinical trials with other LRRK2 inhibitors showed very encouraging results. The collaboration program between Servier and OPM aims to develop a differentiating compound that addresses the major medical needs of Parkinson’s disease patients.

On September 26, 2022 Y-mAbs Therapeutics, Inc. ("Y-mAbs", NASDAQ: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Adium Pharma S.A. ("Adium") has submitted a regulatory filing for DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma to the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária ("Anvisa") (Press release, Y-mAbs Therapeutics, SEP 26, 2022, View Source [SID1234621434]).

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"We are very pleased with the regulatory capabilities of our partner Adium resulting in submission of DANYELZA for consideration of potential approval in Brazil. We believe this submission marks another important milestone in our aim to make DANYELZA globally available and address an unmet medical need for families in Brazil," said Thomas Gad, President, and Interim Chief Executive Officer. "If approved by Anvisa, we look forward to working closely with Adium on the production and logistic planning for DANYELZA to help ensure timely availability to patients in Brazil."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

About DANYELZA (naxitamab-gqgk)

In the United States, DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval by the U.S. Federal Drug Administration based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

On September 26, 2022 Innocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, and DURECT Corporation ( Nasdaq: DRRX) reported the recent commercial launch of POSIMIR (bupivacaine solution) in the United States (Press release, DURECT, SEP 26, 2022, https://www.durect.com/news/innocoll-and-durect-announce-u-s-launch-of-posimir/ [SID1234621433]). POSIMIR is an FDA-approved non-opioid, sustained-release local analgesic for the treatment of post-surgical pain in adults following arthroscopic subacromial decompression surgery.

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"We are excited to bring a potential cornerstone of multi-modal post-operative pain management to surgeons with the launch of POSIMIR," said Louis Pascarella, Chief Executive Officer of Innocoll. "The launch of POSIMIR establishes Innocoll as a leader in non-opioid pain management with two commercialized bupivacaine-based, sustained-release, non-opioid products and we look forward to bringing this new option to patients."

"We are pleased that Innocoll, with its dedicated hospital sales and marketing organization, has launched POSIMIR in the United States and recorded its first sales," added James E. Brown, President and Chief Executive Officer of DURECT Corporation. "Bringing a new non-opioid analgesic option with POSIMIR is a welcome next step in the evolution of pain management for patients."

Per the terms of the collaboration between Innocoll and DURECT, Innocoll will make a $2 million payment to DURECT triggered by the first commercial sale of POSIMIR. Previously, in August 2022, DURECT was issued a new patent by the US Patent Office, extending US patent coverage of POSIMIR to at least 2041, resulting in an $8 million milestone payment by Innocoll to DURECT. These payments are in addition to the $4 million upfront license fee received in January 2022. As the launch progresses, DURECT will receive tiered, low double-digit to mid-teen royalties on net product sales in the United States, as well as additional milestone payments up to $122 million in the aggregate, depending on the achievement of certain commercial, regulatory and intellectual property milestone payments with respect to POSIMIR.

In addition to the exclusive right to develop and commercialize POSIMIR in the United States, Innocoll also has been granted the right to conduct additional development activities to expand the approved indications for POSIMIR, and DURECT’s contract manufacturing supply agreement for POSIMIR has been assigned to Innocoll. DURECT retains all commercial rights to POSIMIR throughout the rest of the world.

About POSIMIR
POSIMIR (bupivacaine solution) for infiltration use is a novel and proprietary product that combines the strength of 660 mg of bupivacaine base with the innovative SABER platform technology, enabling continuous sustained delivery of a non-opioid local analgesic over 3 days in adults. POSIMIR contains more bupivacaine than any other approved single-dose sustained-release bupivacaine product. At the end of surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more.

Indications and Usage
POSIMIR (bupivacaine solution) for infiltration use is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.

Limitations of Use
Safety and effectiveness have not been established in other surgical procedures, including soft tissue surgical procedures, other orthopedic procedures, including for intra-articular administration, and boney procedures, or when used for neuraxial or peripheral nerve blockade.

Full Prescribing Information, including the Boxed Warning, is available at www.POSIMIR.com

Important Safety Information
BOXED WARNING: Risk of Potential Adverse Embolic Effects Resulting From Inadvertent Intravascaular Injection. Inadvertent intravascular injection could cause POSIMIR droplets to be deposited in the pulmonary and other capillary beds. Administer POSIMIR into the subacromial space at the end of arthroscopic shoulder surgery. Direct arthroscopic visualization must be used to confirm proper placement of the needle tip before injecting POSIMIR.

In POSIMIR clinical studies, no inadvertent intravascular injections were observed. Do not inject POSIMIR intravascularly.

POSIMIR is contraindicated in patients with a known hypersensitivity to any amide local anesthetic, or other components of POSIMIR, as well as in patients undergoing obstetrical paracervical block anesthesia. There is a risk of joint cartilage necrosis with unapproved intra-articular use of POSIMIR. Unintended intravascular injection of POSIMIR may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. As with other local anesthetics, patients should be monitored for central nervous system, cardiovascular, and allergic reactions. Avoid additional use of local anesthetics within 168 hours following administration of POSIMIR. Cases of methemoglobinemia have been reported in association with use of local anesthetics. There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. POSIMIR should be used cautiously in patients with impaired hepatic and cardiovascular function. Adverse events reported with an incidence greater than or equal to 10% and greater than control following POSIMIR administration in shoulder surgery were dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting. Adverse events reported with an incidence greater than or equal to 10% and greater than control following POSIMIR administration in soft tissue surgical procedures were anemia, bradycardia, constipation, C-reactive protein increased, diarrhea, dizziness, dysgeusia, headache, nausea, post-procedural contusion (bruising), procedural pain, pruritus, pyrexia, somnolence, surgical site bleeding, visible bruising and vomiting.