BUSINESS INSIGHTS

Cyclenium Pharma and Vuja De Sciences Announce Oncology Drug Discovery Collaboration

Cyclenium Pharma | January 06, 2022

Cyclenium Pharma, Inc. an emerging pharmaceutical company specializing in the discovery and development of novel therapeutic agents based on their proprietary macrocyclic chemistry, and Vuja De Sciences, Inc. a biotechnology startup dedicated to discovering therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence, have announced today the signing of a drug discovery collaboration agreement. The companies will screen and optimize lead candidates to advance treatments uniquely suited for preventing cancer metastatic recurrence, the biggest unmet need in oncology.

The collaboration will exploit Vuja De’s proprietary anti-metastatic progression in vitro and ex vivo drug discovery screening platform and Cyclenium’s proprietary QUEST™ Library of next generation synthetic small-molecule macrocycles and associated optimization expertise to identify clinical candidates effective against dormant disseminated tumor cells for the prevention of metastatic cancer recurrence. Vuja De will be responsible for all screening efforts, while Cyclenium will be responsible for all medicinal chemistry efforts to generate new optimized macrocyclic compounds by employing its unique CMRT™ Technology.

We are very excited about entering this collaboration with Vuja De. We are confident that our CMRT™ Technology and proven success in the macrocycle area combined with the innovative anti-metastatic progression platform and excellent research team at Vuja De will enable the discovery and development of novel macrocyclic therapeutic agents to effectively control metastatic progression.”

 Helmut Thomas, Ph.D., President, Chief Executive Officer & Chief Scientific Officer of Cyclenium

“We highly appreciate Cyclenium’s expertise in the macrocycle area and their technology platform that is based on over 20 years of pioneering experience in small molecule macrocyclic chemistry,” said David Warshawsky, Ph.D., Chief Executive Officer of Vuja De. “We are very pleased to work with Cyclenium on identifying and developing novel game-changing drug candidates that prevent metastatic recurrence, the most urgent need of most cancer patients,” he added.

About Cyclenium Pharma
Cyclenium Pharma is an emerging, privately held pharmaceutical research and development company exploiting its proprietary next generation CMRT™ macrocyclic drug discovery technology for the discovery and development of novel small molecule therapeutic agents to address areas of unsatisfied medical need. Cyclenium is creating value through progression of internal programs in oncology, infectious diseases and inflammation/pain. In addition, Cyclenium is providing its extensive experience and exploring its CMRT-based QUEST™ screening library in risk-sharing partnerships with leading academic and research driven non-profit organizations, as well as collaborations with innovative pharmaceutical and biotechnology companies world-wide seeking to modulate unique and difficult disease targets in diverse therapeutic areas. 

About Vuja De Sciences
Vuja De is a biotechnology startup company dedicated to discovering and developing therapies that target the unique vulnerability of undetected disseminated tumor cells before they can cause deadly metastatic cancer recurrence. This vulnerability of DTCs stems from their dependence on a unique phenotype that includes stress adaptation, survival & dormancy, which we have coined “Metastatic Endurance”. ME enables DTCs to persist undetected at secondary sites like “ticking time-bombs” and eventually start to rapidly divide and form overt deadly tumors. We successfully created the first-ever cell-based and ex vivo drug screening platform that finds drugs that target ME. We are using the largely adolescent, orphan disease, osteosarcoma, as the best proof of concept model for developing anti metastatic progression drugs for many cancers such as breast, melanoma and kidney. We are testing repurposed drugs that have previously been in clinical trials, as well as novel preclinical drugs. 

About Osteosarcoma
Osteosarcoma is an aggressive cancer of the bone and is the most common type of bone cancer in children and teens. Since metastatic recurrence has shared biological mechanism in many other cancer types, therapies that show promise in osteosarcoma can be developed in parallel for many other cancer types, such as breast, kidney and melanoma. Despite successful control of the primary osteosarcoma tumors and follow-up chemotherapy, metastasis continues to be the most common cause of mortality. The last 30 years have brought little improvement in survival outcomes for children with osteosarcoma, despite intensification of therapy. Due to lack of improved outcomes, new approaches to therapy are highly needed. Furthermore, if targeted therapeutics are found to prevent metastasis in this cancer, a strong biological rationale would exist for the evaluation of such a therapy in other human cancers.

Spotlight

Pediatric populations represent the most diverse patient
groups in all of medicine. Factors such as individual
preferences, physiology, and dosage considerations all serve to complicate drug formulation aimed at pediatric care.

Spotlight

Pediatric populations represent the most diverse patient
groups in all of medicine. Factors such as individual
preferences, physiology, and dosage considerations all serve to complicate drug formulation aimed at pediatric care.

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BUSINESS INSIGHTS, PHARMACY MARKET

DirectRx Announces Rebranding Specialty Pharmacy Services

DirectRx Pharmacy | February 15, 2023

On February 14, 2023, DirectRx, a leading national specialty pharmacy committed to serving individual patients with chronic and complex health needs, announced the launch of a new website and a suite of team member training programs. The new website emphasizes the company's dedication to working with patients and prescribers to provide the best possible care. The training programs are designed to assist team members in developing professionally. The DirectRx website emphasizes the company's concern for patients and dedication to collaborating with doctors to offer the highest quality care. The new additions to the website consist of a Prescribers tab highlighting the key ways in which DirectRx collaborates with its prescriber partners; a manufacturers tab highlighting the company's "industry best" time-to-fill, adherence and conversion rates; and an interactive Careers tab to help grow the DirectRx team. Additionally, DirectRx has launched new training and development programs for team members to help them improve their skill set and stay with the firm longer. The new programs include pharmacy technicians in training, account managers in training and regional patient care coordinators in training. The specialty pharmacy is also expanding its managerial positions, including a customer service manager role and others. DirectRx's Director, Alban Ivezaj, commented, "We're very excited to launch our new website as we feel it better captures our commitment to compassionate patient care and the best-in-class services we offer to our provider partners." He added, "As a result of that commitment, DirectRx has experienced significant growth across all regions of the U.S. - including servicing all 50 states and a 26 percent increase in the number of patients we serviced in 2022." (Source – Globe Newswire) About DirectRx Pharmacy Founded in 1985, DirectRx is an independent pharmacy committed to providing patients with exceptional, individualized pharmaceutical care. With the belief that communication and teamwork are crucial to achieving good treatment outcomes, the physician, patient, and pharmacist form a circle of integrated services and coordinated care, so there are no gaps in patient care between physician and pharmacist. It stands apart from the competition due to its concern and commitment to providing unmatched customer service. The company is accredited by ACHC, NABP, WBENC and URAC. Since its establishment over three decades ago, the company has expanded to 49 states.

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BUSINESS INSIGHTS, PHARMACY MARKET

Hovione and Laxxon Medical Establish an Agreement for the cGMP Production of 3D Screen Printed Pharmaceutical Applications

PRNewswire | March 23, 2023

Hovione and Laxxon Medical announced a strategic collaboration to advance the use of 3D screen printing technologies for the pharmaceutical industry. This partnership combines Laxxon´s expertise in 3D screen printing, based on their SPID®-Technology, with Hovione's product & process development, engineering and manufacturing expertise in pharmaceutical applications. Under the terms of the agreement, Hovione will establish the Laxxon Medical 3D screen printing technology at Hovione's cGMP production sites first in Portugal and later in the USA. The 3D technology displays numerous advantages including the potential to produce unique or customized dosage forms with characteristics that cannot be achieved with conventional dosage forms, the ability to create tablets of any shape and size, the option to easily adjust the number of active substances and individual components in the composition of the tablet and even to set the dosage individually for each patient for personalized medicines. "Laxxon is thrilled to establish a long-term partnership with Hovione." said Klaus Kuehne, COO of Laxxon Medical. "This partnership will serve as a great accelerator in establishing 3D screen printing within the pharmaceutical industry thus accelerating our ability to serve our customers." "Hovione has a global reputation for their pharmaceutical innovation services, expertise and market access. This agreement marks a significant milestone for Laxxon in terms of our own market strategy and development efforts." said Helmut Kerschbaumer, Laxxon's CEO. "We are looking forward to collaborating with Hovione to promote innovation through 3D screen printing." "We find the Laxxon Medical 3D printing technology to be very innovative and enabling. It not only allows for the customization and production of drug products with complex shapes and structures as well as unique API release characteristics but it also has the potential to reduce the time and cost of drug development" says Dr. Jean-Luc Herbeaux, Hovione´s CEO. He adds "Hovione has a track record of turning emerging pharmaceutical production technologies into reliable and scalable offerings at both developmental and commercial scales. We are excited at the prospect of supporting Laxxon in industrializing its 3D printing technology and make it accessible to a greater number of pharmaceutical and medical device companies." With this partnership the platform will be available from early development phases to routine commercial manufacturing. About Hovione Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) Hovione has a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

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RESEARCH, PHARMA TECH

Positive Results for Ambrx’s Proprietary Anti-PSMA ADC, ARX517, in Prostate Cancer

Ambrx | February 21, 2023

Ambrx Biopharma Inc., recently released positive preliminary results from its current Phase 1 trial, APEX-01 (NCT04662580), which is examining ARX517, Ambrx's patented anti-PSMA ADC, in patients with prostate cancer. Patients with advanced prostate cancer who have progressed on at least two prior FDA-approved treatments are enrolled in the Phase 1, first-in-human, open label dose escalation and dose expansion experiment known as APEX-01. In the US, APEX-01 is the only clinical trial that uses an ADC to treat PSMA. The trials revealed • No grade ≥3 treatment-related adverse events (AEs) or drug-related serious adverse events (SAEs) have been reported in the 22 individuals who were evaluable for safety. ARX517 was well-tolerated otherwise with grade 1 or 2 treatment-related adverse events were observed. It is yet to reach the maximum tolerated dose (MTD) • Starting with the second to lowest dose of 0.64 mg/kg, PSA reductions of > 30% have been seen in Cohorts 2-5 • 3 (100%) patients in Cohort 6 (2.0 mg/kg dosage) had a PSA level reduction of at least 50%. PSA levels were reduced by more than 90% in 2 out of 3 patients. At the initial on-treatment scan, soft tissue measurable disease was found in 1 of the 3 patients, and showed a partial RECIST v1.1 response • In Cohort 7, three patients received doses with no DLTs Daniel J. O’Connor, CEO of Ambrx, said, “While recent advances have considerably reduced the number of men who die from prostate cancer, it remains the second-most common form of death from cancer in the United States. Approximately 1 man in 41 will die of prostate cancer. Thus, there remains an urgent need for better treatments, in particular for men with advanced prostate cancer.” He further added, “We are very pleased to see a significant reduction of greater than 50% in PSA levels in the first three patients at 2.0 mg/kg, two of which went on to see a greater than 90% PSA level reduction, without any serious drug-related adverse events.” (Source – Business Wire) About Ambrx Ambrx Inc., is a clinical-stage biopharmaceutical company. It develops precision biologics using an extended genetic code. Synthetic amino acids are incorporated into proteins using Ambrx technology, which is carried out entirely within a living cell. Precision Biologics, a novel therapeutic class with significant potential uses these synthesized amino acids.

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