BUSINESS INSIGHTS, PHARMA TECH
Northstar and Inhibrx | January 09, 2023
NorthStar Medical Radioisotopes, LLC, announced a collaboration with Inhibrx, Inc., to develop and produce new radiopharmaceuticals for cancer treatment.
Inhibrx will develop a new generation of targeted alpha treatments utilizing its improved single-domain antibodies (sdAbs). With a long history of sdAb innovation, it has created a library of sdAbs targeting tumor-associated antigens. Its high binding affinity and specificity for tumor cells or antigen-expressing cells within the tumor microenvironment make sdAbs an ideal biological targeting agent for radioisotope delivery. In addition, alpha-emitting radioisotopes have a small range of activity and high energy transfer, allowing for the targeted destruction of cancer cells with minimum damage to adjacent healthy tissue.
NorthStar is expanding its position as an industry leader in the rapidly-growing field of therapeutic radioisotopes, and it is now prepared to become the first commercial-scale manufacturer of non-carrier added (n.c.a.) actinium-225 (Ac-225) and copper-67 (Cu-67).
Under the terms of this agreement, NorthStar will provide the supply of Ac-225 and access to its comprehensive radiopharmaceutical contract development and manufacturing organization (CDMO) services to assist the development of a predetermined number of Inhibrx's novel biologic medicines. NorthStar will also prepare Inhibrx patient dosages for clinical studies and, upon approval, may manufacture and supply radionuclides for its commercial use.
About NorthStar Medical Radioisotopes, LLC
NorthStar Medical Radioisotopes is a commercial-stage nuclear medicine company with a mission to provide patients with global access to game-changing radiopharmaceuticals. The company uses ecologically preferable technologies to create, manufacture, and distribute diagnostic imaging and therapeutic radiopharmaceuticals. It is the only commercial U.S. producer of molybdenum-99, an essential diagnostic imaging radioisotope (Mo-99). The FDA-approved RadioGenix® System (technetium Tc 99m generator) uses US-manufactured, non-uranium-based Mo-99 as the source material to generate technetium-99m (Tc-99m), which is used to assess heart disease and cancer.
Douglas Pharmaceuticals | January 27, 2023
A clinical advisory board has been established to support Douglas Pharmaceuticals' lead program R-107, an oral extended-release dose of racemic ketamine being developed as an adjunctive or stand-alone therapy for treatment-resistant depression.
Douglas Pharmaceuticals is a New Zealand-based pharmaceutical company specializing in the development of specialty generic and repurposed medications (TRD).
Peter Surman, Chief Scientific Officer expressed, "We are very excited to bring together a group of world-class experts in the field of psychiatry, to help guide our late-stage development of R-107." "We believe their deep knowledge in the field, insights and contributions will be instrumental in charting an efficient course through pivotal clinical studies in TRD," he added.
(Source – Cision PR Newswire)
Some of the members of the clinical advisory board are as follows:
• Prof. Paul Glue [MB, ChB (Otago), MD (Bristol), FRCPsych]
• Prof. Alan F. Schatzberg, [MD] • Prof. Sanjay J. Mathew [MD]
• Prof. Allan Young [MB, ChB, MPhil, Ph.D., FRCP (Edin.), FRCPC, FRCPsych]
• Prof. Wiesław J. Cubała, [MD, PhD]
• Prof. Colleen Loo [MBBS (Hons), FRANZCP, MD]
About Douglas Pharmaceuticals
New Zealand's largest private pharmaceutical and healthcare firm, Douglas Pharmaceuticals, employs over 700 people and exports to over 40 countries. The company provides creative, competitive, and high-quality healthcare solutions to 'improve lives'. It designs, manufactures, and distributes unique and generic products, preferring those with significant intellectual property and technological complexity in high-unmet need sectors. The company's presence in international markets continues to grow, exposing New Zealand to the world. It is dedicated to improving people's health all around the globe. Some of the products that the company works with cutting-edge partners to develop, make, market, and distribute are pharmaceuticals, nutraceuticals, automated compliance systems, and consumer healthcare items.
BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.