BUSINESS INSIGHTS, PHARMACY MARKET
Phio Pharmaceuticals Corp. | December 22, 2022
Phio Pharmaceuticals Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL™ compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi technology is designed to make immune cells more effective in killing tumor cells. PH-762 has been shown to reduce the expression of PD-1, a protein that inhibits T cells' ability to kill cancer cells. When administered intratumorally in preclinical models PH-762 primes an anti-tumor immune response, and inhibits tumor growth.
Phio is currently conducting a Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe. Phio expects to commence a US Phase 1b clinical trial early in the 2nd half of 2023. The initial US trial is expected to focus on the treatment of cutaneous squamous cell carcinoma and other selected cutaneous malignancies, following successful regulatory review of the IND.
"Therapeutic interventions for cSCC are limited, and there is increasing unmet medical need. As cSCC tumors comprise approximately 51% of the total incidence of solid tumors in the US, excluding basal cell cancers, we recognize the growing need for alternative therapies for cSCC," said Robert Bitterman, Phio's Principal Executive Officer and Executive Chairman. Mr. Bitterman has over 25 years of executive leadership experience in the pharmaceutical and biologic life science industry with a proven track record in operations, finance and investor relations.
"While monoclonal antibody therapies are available for the treatment of cSCC, mechanistically they only block the interaction between PD-1 and PD-L1 on the cell surface. PH-762 also has the potential to address PD-1 inside the T cell, essentially further enhancing the activity of the T cell to kill the tumor cells," said Dr. James Cardia, Phio's Vice President of Scientific Operations. Dr. Cardia led the team that discovered INTASYL.
"PH-762 has the potential to meet a significant medical need in patients who have failed to respond to mAbs, as well as those with resectable and metastatic solid tumors. Phio is committed to advancing the study of PH-762 to provide a meaningful therapy for patients with a broad range of solid tumors."
Dr. Mary Spellman, Phio's Medical and Clinical Development Advisor
INTASYL compounds are chemically modified siRNAs that are designed to provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy applications. In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial convenience to the prescriber and patient. Phio believes that INTASYL is the only self-delivering RNA interference technology focused on immuno-oncology therapeutics.
About Phio Pharmaceuticals
Phio Pharmaceuticals Corp. is a clinical stage biotechnology company whose proprietary INTASYL™ RNAi technology is designed to make immune cells more effective in killing tumor cells. Phio believes that INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems.
BUSINESS INSIGHTS, PHARMA TECH
Aequus Pharmaceuticals | December 21, 2022
Aequus Pharmaceuticals Inc. is pleased to announce that Health Canada has approved Zimed® PF for the reduction of elevated intraocular pressure in patients with open-angled glaucoma or ocular hypertension. Affecting more than 700,000 people in Canada, glaucoma is one of the leading causes of blindness in North America.
Zimed® PF is the first prostaglandin analog that is preservative free and offered in an easy-to-use multi-dose bottle in Canada. PGAs are commonly prescribed first-line to reduce IOP. The vast majority of medications currently available include preservatives such as Benzalkonium Chloride. Chronic exposure to BAK has been found to increase the likelihood of experiencing Ocular Surface Disease and reduce patient adherence.
“We have heard from the eyecare professionals that there is a need for preservative-free alternatives. The PGA market continues to grow year-over-year and we are excited to provide a new option for Canadian health care providers and their patients.”
Grant Larsen, CCO of Aequus Pharma
Zimed PF is contained in a unique multi-dose bottle that leverages a unidirectional valve and air filter technology to eliminates the need for a preservatives. In addition, this packaging format significantly reduces the amount of plastic used compared to single-use alternatives.
“Medicom is excited by this news and looks forward to launching Zimed® PF in the Canadian market with Aequus,” says Simon Martin, CEO of Medicom. “Globally we have seen the strong uptake for Zimed® PF and pleased it will soon be available to Canadian patients.”
Doug Janzen, CEO of Aequus Pharma said, “We want to thank Medicom for their support through the approval process with Health Canada. This is our third product we’ve brought to Canada in this partnership. We look forward to launching Zimed® PF in 2023 and providing Canadians with more treatment options.”
ABOUT AEQUUS PHARMACEUTICALS INC.
Aequus Pharmaceuticals Inc. is a specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus has grown its sales and marketing efforts to include several commercial products in ophthalmology and optometry. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license, remaining focused on highly specialized therapeutic areas.
Telix Pharmaceuticals Limited | November 23, 2022
Telix Pharmaceuticals Limited announces Illuccix® with up to 50mCi for radiolabeling is available for use on 100mCi gallium generators, an important development in radioisotope production.
High activity generators from Eckert & Ziegler Strahlen- und Medizintechnik AG increase activity from 50mCi to 100mCi and will be integral to expanding patient access to gallium-based radiopharmaceuticals as demand for PSMA-PET imaging in the United States continues to grow. This technology increases the number of daily elutions and activity in each elution, enabling hospitals and radiopharmacies to increase the number of daily doses produced, expand their service area and gain greater production efficiency.
"As the only commercially available kit that can take advantage of high activity generators for up to 50mCi radiolabeling, Illuccix gives hospitals, pharmacies, and physicians added confidence that their dose scheduling needs – and the needs of their patients – can be met today and in the future as the potential of 68Ga PSMA-11 is realized in the diagnostic market. We are pleased to continue our collaborative relationships with IRE ELiT and EZAG to continue to make 68Ga PSMA-11 accessible and convenient to use for customers across the United States."
Dr. Christian Behrenbruch, Group CEO and Managing Director of Telix
Jay Simon, Managing Director of Eckert and Ziegler North America said, "The high activity GalliaPharm® generator may allow for broader availability and expanded service areas. It is about delivering doses when and where they are needed, whether you're a remotely located clinic, a busy metropolitan hospital or a pharmacy. We are pleased to be working with Telix to harness this innovation to maximize the efficiency for our customers and ultimately, their patients."
Jean Bonnet, Head of Sales, Strategy and Marketing at IRE Group said, "While current generator technology is sufficient to meet today's demands, the rollout of the higher activity 100mCi generators are future-proofing the ability to meet demand in a market which is growing exponentially. The use of high activity generators has the potential to increase daily elutions and increase the activity in each elution. When radiolabeled up to 50mCi with Illuccix, the result could potentially provide more flexibilitty in meeting the growing demand for 68Ga radiopharmaceuticals while giving customers the benefit of greater dose scheduling flexibility and efficient production."
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange.
BUSINESS INSIGHTS, PHARMACY MARKET
Novo Nordisk & ATLATL | December 06, 2022
Novo Nordisk Research Centre China and ATLATL jointly announce the winners of EntreStar program. Hangzhou DNano MetaBio and Modit Medicine stood out among all participants and won the awards.
The two winners will be given priority access to one of ATLATL’s nation-wide facilities in China, and a prize of CNY 500K RMB each to pay for the ATLATL facilities and services. They are also entitled to mentoring by relevant experts of Novo Nordisk. There will be no strings attached for the two companies.
Founded in 2022, Hangzhou DNano MetaBio Technology has been focusing on the design of nucleic acid nanocarriers with customized functions and great potential in clinical translation. The team has rich experience in nucleic acid structure design, which enables them to accurately regulate the organ-targeting ability and the on-demand drug release performance of the nanocarriers.
“It’s our great honour to participate in EntreStar. We look forward to exploring collaboration opportunities with the community. Meanwhile, it is very much appreciated that we can receive guidance and help from Novo Nordisk’s experts in relevant fields, so that our company can develop in a healthy way.”
Dr. Baoquan DING, President & Chief Scientist of DNano expressed his hopes in the award ceremony,
Modit Medicine Inc., founded in 2022, is a biotech company focusing on RNA editing and therapeutics. The company owns cutting-edge and propriety RNA modification and editing methodologies and is devoted to the development of novel platform technologies. Instead of manipulating DNA sequences, technologies of Modit Medicine Inc. correct genetic errors at the RNA level, thereby providing opportunities for safe, efficacious and innovative therapeutics to treat human rare diseases, cancers, etc.
Dr. Chengqi YI, Founder of Modit Medicine and Boya Professor of Peking University, commented on his participation, “By participating in the EntreStar program, Modit Medicine Inc. hopes to learn from global pharma about their insights on technology platform and marketing strategies in gene therapy, as well as to seek and form potential collaborations with Novo Nordisk. We also appreciate advice and suggestions from ATLATL about useful tips for start-up companies to connect with government and industry.”
Dr. Dan HAN, President of NNRCC, shared her remarks: “We see great potential in the novel concepts proposed by DNano and Modit. By leveraging knowledge and experiences in our global organisation, we hope that Novo Nordisk can help pushing their research projects forward more effectively. As a Novo Nordisk affiliate in China, we partner with brilliant minds via INNOVO® program to facilitate translational research, with EntreStar initiative as its latest addition.”
Dr. Pengcheng ZHU, Founder of ATLATL Innovation Center, commented on the role ATLATL plays: “It is my greatest pleasure to help make the EntreStar winners thrive at ATLATL’s platform, with access to global resources, such as our partners like Novo Nordisk. The ATLATL Innovation Center is a world-class scientific hub for the life sciences. We streamline the elements of R&D to improve resource utilization, and revolutionize the traditional asset-heavy investment model into an asset-light operation model. I am looking forward to collaborating with even more leading biopharmaceuticals and bringing success to these talented people.”
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 49,300 people in 80 countries and markets its products in around 170 countries.
Novo Nordisk Research Centre China founded in 1997, takes pride in being the first research centre established by a multinational pharmaceutical company in China. With a focus on protein and peptide therapeutics, NNRCC has full capabilities and rich experiences in drug discovery research.
The ATLATL Innovation Center is a world-class scientific hub for global life sciences. ATLATL streamlines the elements of R&D to improve resource utilization and revolutionizes the traditional asset-heavy investment model into an asset-light operation model. This much more time and cost-efficient model originated in Boston and continues to be optimized from 2017 onwards in China. ATLATL provides not only state-of-the-art facilities and professional operational management but also many R&D platforms staffed with scientists and project managers specializing in various fields. By collaborating with leading biopharma ATLATL integrates global resources to stimulate innovative developments. ATLATL currently has R&D platforms in Beijing, Shanghai, Suzhou, etc., leveraging the uniqueness of each site to help innovators quickly reach the next milestone.