Global Roundup: Connect in Pharma, CanSino Biologics, HUTCHMED and More
The big Connect in Pharma conference is coming up and speakers plan to discuss digitization and strategies to bring the European supply chain home and CanSino Biologics, HUTCHMED and more have positive research news.
Connect in Pharma
The European pharmaceutical industry is coming together to focus on new methods that will remedy supply chain concerns and potentially improve innovations across the sector. Leaders will discuss key issues facing the industry and the means to overcome them.
European pharma leaders will gather in Geneva, Switzerland in September at the Connect in Pharma conference to discuss some of these concerns and brainstorm strategies to address them. Keynote speakers will focus on the need to maintain control of production lines and the prioritization of digitalization in order to ensure a strong future for the European industry.
Ahead of the conference, Jean-François Hilaire, executive vice president and president of advanced delivery systems at Recipharm, noted that decisions to shift production of key active pharmaceutical ingredients to factories in China and India have left the European pharmaceutical industry exposed to supply chain risks that the COVID-19 pandemic has highlighted. As a result, Hilaire pointed to a need to bring that production back to Europe in order to ensure a "more strategic resilience." Hilaire said this involves hurdles, including capital investment and regulatory approvals that could take years to overcome.
"We must retain the development and production of new, innovative products in Europe," Hilaire said.
Digitalization is a key part of any future roadmap in Europe, the speakers said. Christian Wölbeling, executive industry advisor and senior strategic account manager at Körber Pharma Software, discussed the strategic case for digital transformation and provided insights on how companies can create digital workflows and increase connectivity so systems can easily talk to each other. He said companies have multiple departments that are not always well-integrated.
"All these parts have data, and each system has its own silo. Without a common data platform, end-to-end tracking and tracing is inefficient and difficult," Wölbeling explained ahead of the conference.
Connect in Pharma will take place on September 14 and 15 in Geneva.
Elsewhere around the globe:
CanSino Biologics: Based in China, CanSino announced that it published a paper on the antibody persistence and safety of its nebulized inhaled Recombinant COVID-19 Vaccine on the preprint platform for biomedical research medRixv. Data from the report showed that a heterologous booster of CanSino's nebulized inhaled COVID-19 vaccine could elicit higher antibody levels against the original SARS-CoV-2 strain and the Omicron BA.1.1.529 variant in adults. Previous studies showed that CanSino's nebulized, inhaled COVID-19 vaccine requires only one-fifth or two-fifths of the dosage of the intramuscular injection version.
HUTCHMED: Also based in China, HUTCHMED announced a pivotal Phase III trial assessing fruquintinib as a potential treatment for patients with advanced, refractory metastatic colorectal cancer met its primary endpoint of overall survival. In addition to OS, a statistically-significant improvement in progression-free survival, a key secondary endpoint, was observed. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported studies. Full results will be submitted for presentation at an upcoming medical meeting.
HUTCHMED and its partner Immagene Biopharmaceuticals also announced that the first U.S. patient was dosed in a global Phase I trial of IMG-004, a non-covalent, reversible, third-generation Bruton Tyrosine Kinase inhibitor. The study will assess safety, tolerability, pharmacokinetics and pharmacodynamics.
LianBio: Based in Shanghai, with operations in New Jersey, LianBio completed enrollment in the Phase III EXPLORER-CN clinical study of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy. The study's primary endpoint is the change in the Valsalva left ventricular outflow tract (LVOT) gradient from baseline to week 30. Eligible patients are expected to continue in a long-term extension program.
Bionomics Limited: Based in Australia, Bionomics Limited received a research and development tax incentive valued at more than $2 million (Australian dollars). The Australian Government R&D tax incentive encourages companies to engage in R&D, benefiting Australia by providing a tax offset of up to 43.5% for eligible R&D activities.
CYTENA: BICO company CYTENA, which is based in Germany, launched a new instrument to streamline single-cell isolation in microbiology research. The next generation B.SIGHT is taking the company's automated single-cell isolation capabilities to the next level with special emphasis on handling bacteria, yeast and other microorganisms. CYTENA believes the new B.SIGHT will accelerate and automate microbial cloning workflows across the industry. It will also revolutionize the microbiome field by enabling scientists to streamline their microbiome work and accelerate their path toward transformative medicine.
SciSparc: Based in Israel, SciSparc Ltd. received approval from the Israeli Ministry of Health to conduct its clinical trial of SCI-210 in patients with autism spectrum disorder (ASD). The trial will investigate the effect of the company's drug candidate SCI-210, a proprietary combination of cannabidiol and CannAmide, compared to CBD monotherapy in ASD. The 20-week trial has three endpoints, the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician; and the effective therapeutic dose.
Captor Therapeutics: Poland's Captor selected CPT-6281 as a drug candidate for the CT-01 project, which will initially focus on the clinical development of the asset as a TPD treatment against hepatocellular carcinoma. CPT-6281 is on track to enter the clinical in 2023, the company said. The CT-01 series of molecular glues are compounds inducing degradation of Eukaryotic peptide chain release factor GTP-binding subunit ERF3A (GSPT1), Sal-like protein 4 (SALL4) and another undisclosed neo-substrate with an essential function in tumorigenesis.
Artios Pharma: Artios Pharma Limited, a U.K.-based company developing small molecules that target the DNA damage response process, initiated a Phase II study with ART4215, a small molecule inhibitor of polymerase theta (Polθ) in combination with Talzenna (talazoparib) in an expansion study for the treatment of BRCA deficient breast cancer. Polθ, a DNA polymerase, is a tumor-specific DDR target involved in microhomology-mediated end joining that is overexpressed in many tumors and found in low levels in healthy tissue, the company said. ART4215 is the first selective, oral, small molecule inhibitor of the Polθ polymerase domain to enter the clinic.