MedinCell | December 01, 2022
MedinCell has received an additional US$ 4 million payment from the Bill & Melinda Gates Foundation
This amount is intended to finance the next steps of MedinCell’s program mdc-WWM in readiness to initiate the first clinical trial end of 2023
It follows US$ 11,8 million already received as part of the two successive grants for a total of up to US$ 22,5 million from the Bill & Melinda Gates Foundation to finance the development of the program up to phase 1 completion
The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide
MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.
BUSINESS INSIGHTS, PHARMA TECH
Avacta | January 23, 2023
Avacta Group plc, a leading life sciences company focused on developing innovative, targeted oncology medicines and powerful diagnostics, recently announced that AVA6000 has maintained a very favorable safety profile in the fourth dose cohort of the ALS-6000-101 dose escalation phase 1 clinical trial. Furthermore, analysis of tumor samples acquired from six patients across multiple cohorts shows that doxorubicin is being released within the tumor tissue, supporting the pre|CISIONTM technology's tumor-targeting capability.
Patients in cohort 4 continue to tolerate AVA6000 well, with a significant decrease in the occurrence and severity of the commonly associated toxicities with the administration of traditional doxorubicin treatment. Nausea, vomiting, Alopecia, mucositis, myelosuppression, and cardiotoxicity are all among the typical toxicities. Notably, the typical drug-related cardiotoxicity of doxorubicin was not found even at the highest dosage levels in group 4, equivalent to more than double the standard dose of doxorubicin.
In order to confirm the release of the active chemotherapy, doxorubicin, in tumor tissue, several tumor biopsies acquired from patients in different cohorts have been analyzed. This analysis demonstrates that AVA6000 targets the release of doxorubicin to tumor tissue at therapeutic levels that are significantly higher than those detected in the bloodstream at the same time point.
To date, AVA6000 has been administered to 19 patients with advanced and/or metastatic solid tumors who were enrolled across four groups. Based on the very favorable safety profile of AVA6000 in the study thus far, the Safety Data Monitoring Committee (SDMC) has recommended that the study be extended to higher dose cohorts in order to identify a maximum tolerated dose (MTD) required to inform dosing levels for the phase 1b and future studies. The Company anticipates completing these additional cohorts within the first half of 2023.
Avacta is a healthcare group that promotes human health and well-being by creating new cancer treatments and powerful in vitro diagnostics. Its mission is to create the future of medicine by producing safe and effective medications as well as high-performance diagnostics using its unique Affimer® and pre|CISIONᵀᴹ platforms. By merging these two platforms, the Company is constructing a pipeline of innovative cancer therapeutics to fulfil its goal of developing successful treatments for all cancer patients, including those who do not react to current immunotherapies.
BUSINESS INSIGHTS, PHARMACY MARKET
AEON Biopharma | December 14, 2022
AEON Biopharma, Inc. a private clinical-stage biopharmaceutical company focused on the development of its proprietary botulinum toxin complex ABP-450 injection for therapeutic indications, and Priveterra Acquisition Corp. a special purpose acquisition company announced that they have entered into a definitive business combination agreement. Upon closing of the proposed transaction, the combined company will operate as AEON Biopharma, Inc. and is expected to list on Nasdaq under the ticker symbol
AEON Uniquely Positioned to Capitalize on Global Therapeutic Neurotoxin Opportunity Since its founding in 2019, AEON Biopharma has been led by Marc Forth, an Allergan plc veteran of 16 years and a former head of the BOTOX® Therapeutic franchise in the United States. AEON has assembled a seasoned team with expertise in neuroscience research, development, regulatory affairs, operations, manufacturing, and commercialization. Its executive team is comprised of industry leaders who have led new drug FDA approvals including multiple indications across multiple neurotoxin products.
The global therapeutic neurotoxin market is currently estimated to be $3.0 billion, of which the U.S. represents approximately 84%, and projected to grow to approximately $4.4 billion in 2027. BOTOX®, marketed by Abbvie, Inc., currently holds approximately 95% U.S. market share for therapeutic indications in the neurotoxin space.1 Other neurotoxin competitors have had success with aesthetic indications in the cash-pay consumer-driven market but have been unable to acquire meaningful market share for therapeutic indications due to the indirect influence of pricing dynamics for aesthetic indications that results in a minimal value proposition for both payors and providers. AEON intends to file a unique BLA for therapeutic indications that would be free of any effects on reimbursement that exist for all other toxin competitors that have both therapeutic and aesthetic indications approved under a single BLA.
Lead product candidate, ABP-450, is the same botulinum toxin approved and marketed for an aesthetic indication. Its 900 kDa molecular weight, similar to the market leader, will enable providers with a seamless transition to ABP-450 for therapeutic uses. Similar to the approved neurotoxins currently in the market, ABP-450’s commercial success does not depend upon patent protection, creating the possibility for an annuity-like construct of continued revenue generation, should ABP-450 be FDA approved.
AEON’s therapeutic-only focus also provides a differentiated business model designed to deliver enhanced value to payors and providers by permitting a traditional pharma pricing model that is not currently available to competitors that also market their products for aesthetic uses approved under a single BLA. The sole focus on therapeutics allows AEON to pursue an original BLA filing that would allow a unique commercial strategy that cannot be employed by other competitors.
About AEON Biopharma
AEON is a clinical stage biopharmaceutical company focused on developing ABP-450 injection for the treatment of debilitating medical conditions with an initial focus on the neurology and gastroenterology markets. The Company is dedicated to innovation in the rapidly expanding therapeutic botulinum toxin market and believes its therapeutic-only focus will allow AEON to advance safe and effective treatment options to patients, while delivering differentiated economics to payors and physicians. The Company continues to evaluate additional therapeutic indications for development based on a comprehensive product assessment process designed to identify those indications where it believes ABP-450 can attain clinical, regulatory, and commercial success.
About Priveterra Acquisition Corp.
Priveterra Acquisition Corp. is a blank-check company formed for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses in life sciences. Priveterra is sponsored by Robert Palmisano and Priveterra Capital, LLC.