Moderna, Inc. | February 24, 2022
Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Thermo Fisher Scientific Inc. the world leader in serving science, today announced a 15-year strategic collaboration agreement to enable dedicated large-scale manufacturing in the U.S. of Spikevax®, Moderna’s COVID-19 vaccine, and other investigational mRNA medicines in its pipeline.
“Thermo Fisher continues to be a trusted partner, bringing a full range of products and services that have enabled us to deliver innovative medicines at an unprecedented speed and scale. We are pleased to further expand our collaboration with Thermo Fisher as a long-term manufacturing partner that will enable us to continue to build on our mRNA platform and pipeline.”
Juan Andres, Moderna's chief technical operations and quality officer
Over the past several years, Thermo Fisher has been partnering with Moderna to support its development pipeline with both clinical research and contract manufacturing services. This included the quick scale-up of aseptic fill-finish services and packaging of its COVID-19 vaccine. As part of this expanded agreement, Thermo Fisher will now provide dedicated capacity for a range of aseptic fill-finish services including lyophilized and liquid filling. In addition, the company will provide inspection, labeling and final packaging services.
"Moderna’s innovation in mRNA technology has been pivotal in the global response to the pandemic and we are proud and privileged to support Moderna over the last decade,” said Michel Lagarde, executive vice president and chief operating officer of Thermo Fisher Scientific. “In expanding our strategic partnership, Moderna will further leverage our scale and depth of capabilities to continue to transform its mRNA platform and bring new breakthrough medicines to patients around the world."
In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA) to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
BeiGene | February 18, 2022
BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines, today announced that BeiGene’s BTK inhibitor BRUKINSA received approval from Swissmedic for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior line of therapy, or for treatment-naïve patients who are not suited for standard chemo-immunotherapy. BRUKINSA had previously been granted orphan drug status.
“The authorization of BRUKINSA will bring a new option and an innovative medicine that has potential to offer deep and durable response for eligible patients with WM in Switzerland. BRUKINSA is a next-generation BTK inhibitor which has also provided meaningful improvements in tolerability for some patients with WM compared to ibrutinib, as treatment discontinuation remains a concern.”
Pr. Davide Rossi, Deputy Head of the Division of Hematology of the Oncology Institute of Southern Switzerland IOSI
Reto Kessler, Country Manager, Switzerland at BeiGene added, “This approval is a significant development for people living with WM in Switzerland and for BeiGene’s expansion in Europe. Our teams are committed to collaborating with the Federal Office of Public Health and healthcare professionals to ensure access to BRUKINSA for patients in Switzerland.”
The Marketing Authorization Application (MAA) is supported by data from the global Phase 3 ASPEN clinical trial, a Phase 3 randomized, open-label, multicenter trial (NCT03053440) that evaluated BRUKINSA compared to ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT). In the ASPEN trial, BRUKINSA demonstrated a numerically higher very good partial response (VGPR) rate and a favorable safety profile over ibrutinib, although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met. As assessed by independent review committee (IRC) per adaptation of the response criteria updated at the Sixth International Workshop on Waldenström’s Macroglobulinemia (IWWM), the combined complete response (CR) + VGPR rate in the overall intention-to-treat (ITT) population was 29% with BRUKINSA (95% CI: 20, 40), compared to 19% with ibrutinib (95% CI: 12, 30).
In the ASPEN trial, of the 101 patients with WM randomized and treated with BRUKINSA, four percent of patients discontinued due to adverse events, including cardiomegaly, neutropenia, plasma cell myeloma, and subdural hemorrhage. Adverse events leading to dose reduction occurred in 14% of patients, with the most common being neutropenia (3%) and diarrhea (2%).
The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.
About Waldenström’s Macroglobulinemia
WM is a rare B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin lymphomas.2 The disease usually affects older adults and is primarily found in bone marrow, although lymph nodes and the spleen may be involved.1 Throughout Europe, the estimated incidence rate of WM is approximately seven for every one million men and four for every one million women.2
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the U.S., European Union, China, Australia, Great Britain and Switzerland. Currently, more than 40 additional regulatory submissions are in review around the world.
BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.
In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.
BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,000 colleagues across five continents.
Cybin Inc. | January 28, 2022
Cybin Inc. a biotechnology company focused on progressing Psychedelics to Therapeutics™, is pleased to announce that Adelia Therapeutics Inc. a wholly-controlled subsidiary of Cybin, has achieved the milestones identified as Y1, Q4 (iv), Y1, Q4 (v) and Y2, Q1 (vi) as contemplated by the terms of a contribution agreement dated December 4, 2020 among Cybin, Cybin Corp., Cybin US Holdings Inc. a wholly-controlled subsidiary of Cybin, and all of the previous shareholders of Adelia.
Pursuant to the terms of the Transaction Agreement, Class B common shares in the capital of the Acquiror shall be issued to the Adelia Shareholders, in satisfaction of the $551,171.99 due to them on meeting a portion of the relevant milestones, at an effective issue price determined in accordance with the Transaction Agreement and applicable securities law. The Class B Shares issued by the Acquiror to the Adelia Shareholders are exchangeable for common shares in the capital of Cybin on a 10 Cybin Shares for 1 Class B Share basis, at the option of the holder thereof, subject to customary adjustments. No Class B Shares were exchangeable prior to December 14, 2021, and not more than: (i) 33 1/3% of the Class B Shares will be exchangeable prior to December 14, 2022; (ii) 66 2/3% of the Class B Shares will be exchangeable prior to December 14, 2023; and (iii) thereafter, 100% of the Class B Shares will be exchangeable.
Cybin is a leading ethical biotechnology company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics™ by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Adelia is a wholly-controlled subsidiary of the Company, that aims to develop medicinal psychedelics with improved dosing efficacy and therapeutic indices to address unmet medical needs. Adelia’s primary focus is on the development of treatment regimens consisting of proprietary psychedelic molecules and related clinical protocols. This proprietary development strategy is based on chemical modifications to the known and well understood tryptamine derivatives that significantly modify their pharmacokinetic properties without changing their therapeutic potential. These proprietary approaches seek to minimize inter-patient variability by better controlling drug metabolism without loss of efficacy that together have been shown to produce more predictable and favorable patient outcomes.
CELL AND GENE THERAPY
Caris Life Sciences | April 11, 2022
Caris Life Sciences®(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, to present findings that provide a deeper understanding that tumor expression of genes related to extent of drug exposure, stratified by p53 status, is associated with clinical outcomes on the common chemotherapeutic regimens used to treat metastatic colorectal cancer (CRC). These results will be presented at the 2022 American Association for Cancer Research (AACR) Annual Meeting being held April 8 - 13, 2022 in New Orleans, Louisiana.
The research with poster titled, "Prognostic and predictive drug-induced gene signatures for colorectal cancer patients personalized based on p53 status and treatment with FOLFOX, 5-FU, oxaliplatin or irinotecan" (Abstract #1231), was led by Wafik El-Deiry, M.D., Ph.D., FACP, Director of Brown University's Legorreta Cancer Center, Associate Dean at the Warren Alpert Medical School, a member of Caris' Precision Oncology Alliance (POA). Caris' POA is a growing network of leading cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research. This work is being presented in New Orleans by Lindsey Carlsen, a Pathobiology graduate student in the EL-DEIRY Lab at Brown.
The goal of this study was to identify predictive biomarkers for chemotherapies used in CRC. The study used CRC cell lines to identify differentially expressed genes following 5-fluorouracil, irinotecan, or oxaliplatin treatment and stratified the signatures based on p53 status. From these in vitro studies, the researchers then examined whether these genes and gene signatures could predict CRC patient outcomes following chemotherapy (FOLFOX, 5-fluorouracil, irinotecan or oxaliplatin). 2,983 wild-type and 6,229 loss-of-function p53 CRC patient samples were analyzed by DNA/RNA next-generation sequencing at Caris Life Sciences. Real-world survival outcomes were inferred from insurance claims data and Kaplan-Meier estimates. Both prognostic and non-prognostic gene expression had a significant effect on survival outcomes following specific drug treatments.
This study helps us understand the importance that gene signatures have in demonstrating an enhanced predictive ability compared to individual transcripts, Bridging basic and clinical research, this research allows us to better understand which therapies are more likely to benefit CRC patients."
The study found that tumor expression of genes related to drug exposure can predict outcomes after chemotherapy treatment:
High EGR1 and FOS mRNA independently predict response to FOLFOX in patients with wild-type p53 tumors.
Low CCNB1 mRNA correlates with good prognosis of CRC patients with tumors harboring TP53 loss of function mutations.
Low expression of BTG2 predicts better prognosis in patients with MSI-High TP53 mutated tumors.
Gene signatures may demonstrate enhanced predictive ability as compared to individual transcript effects.
Caris' comprehensive molecular profiling assesses whole exome (DNA), whole transcriptome (RNA) and protein expression, providing an unmatched resource and the ideal path forward to conduct the translational research to accelerate discovery for detection, diagnosis, monitoring, therapy selection and drug development to improve the human condition.
About Caris Life Sciences
Caris Life Sciences® (Caris) is the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare and improve patient outcomes. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced artificial intelligence (AI) and machine learning algorithms, Caris has created the large-scale clinico-genomic database and cognitive computing needed to analyze and unravel the molecular complexity of disease. This information provides an unmatched resource and the ideal path forward to conduct the basic, fundamental research to accelerate discovery for detection, diagnosis, monitoring, therapy selection and drug development to improve the human condition.