On August 1, 2022 Carterra, Inc., the world leader in innovative technologies enabling high-throughput biology, and La Jolla Institute for Immunology (LJI), a globally recognized non-profit research organization dedicated to understanding the power of the immune system to promote human health, reported that LJI has acquired a Carterra LSA instrument to enhance its antibody screening and characterization work (Press release, the La Jolla Institute, AUG 1, 2022, View Source [SID1234617216]).

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In 2020, while leading the pandemic response, LJI’s Coronavirus Immunotherapy Consortium (CoVIC) partnered with Carterra to screen and characterize hundreds of antibodies from all over the world, bringing academic, non-profit, and commercial laboratories together to discover the best antibody therapeutics against COVID-19. Funded by the Bill and Melinda Gates Foundation and led by Dr. Erica Ollmann Saphire, CoVIC’s goal is to find the most potent antibodies against COVID-19 and its variants, the results of which could guide the development of vaccines and therapeutics for today but that also protect against future pandemics. It was through this collaboration that LJI discovered the power and magnitude of the LSA’s capabilities. This body of work was published in Science in September 2021: View Source

"The LSA was key to mapping the epitope landscape of the SARS-CoV2 spike, using the 400 antibodies in the consortium. That information was instrumental to understanding which target sites are still effective against emerging variants of concern," said Erica Ollmann Saphire, Professor at La Jolla Institute for Immunology and Director of the CoVIC consortium. "Having seen what the LSA can do first-hand, through our collaboration with Carterra as part of the CoVIC, we now look forward to using this instrument to propel our own discovery efforts."

The LSA will support La Jolla Institute’s discovery efforts of broadly reactive antibodies against a number of pathogens, enabling rapid characterization of hundreds of antibodies in the early stages, followed by in-depth analysis of leads during later stages of discovery. The LSA will also enable the rapid characterization of sera samples from vaccine studies, in addition to autoimmune and cancer targets.

Carterra launched the LSA antibody discovery and characterization platform in 2018 and has quickly made it the standard in 17 of the 20 largest pharmaceutical companies, biotechs, CROs, and government labs such as the FDA and the NIAID of the NIH. The speed at which antibodies can now be identified and characterized as potential drugs by Carterra’s LSA has improved on traditional methods by generating results 100 times faster while using 99% less sample. Sensitivity for finding the rarest of antibodies in a complex matrix is also now best-in-class.

"We’re proud to see the benefit of Carterra’s LSA platform being brought to bear for global good," says Tim Germann, Chief Commercial Officer at Carterra. "Working with Erica and her team at LJI has been truly enlightening—they understand the importance of breaking down the old paradigm of slow and inefficient biologics discovery. Bringing the LSA to LJI represents their commitment to leading the effort to end the suffering from pandemics like Ebola and COVID-19."

Other highlights from Carterra’s success with the LSA platform include the following:

The LSA was a primary tool used by Eli Lilly and AbCellera in the discovery of bamlanivimab, the world’s first COVID-19 therapeutic and fastest biologic ever to reach clinical trials: View Source
In December of 2020, Carterra closed an equity round of financing from industry giant, PerkinElmer who is also now the exclusive distributor of the LSA platform in the Asia-Pacific and Oceania regions.

On August 1, 2022 Amphera B.V., a late-stage biotechnology company developing cell therapies to treat cancer, reported that the last patient has completed the active follow-up in the Phase II/III DENIM study of MesoPher cell therapy to treat pleural mesothelioma (Press release, Amphera, AUG 1, 2022, https://www.businesswire.com/news/home/20220801005324/en/Last-patient-completed-follow-up-period-in-Phase-IIIII-study-of-Amphera%E2%80%99s-MesoPher-cell-therapy-in-mesothelioma [SID1234617215]).

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Ilona Enninga PhD, COO of Amphera said: "Despite the challenges experienced during the pandemic, we were able to maintain strong enrolment to the study. The first patient was included in 2018, the last patient was included in June 2021 and completed the 12 month follow-up in June 2022. In total 176 patients were included. I would like to thank our investigators and the clinical study team for their exceptional efforts in keeping the study on track. We are now focused on database lock and subsequent statistical analysis."

Rob Meijer, CEO of Amphera said: "This is another significant milestone in the development of MesoPher after the promising efficacy results in pancreatic cancer reported earlier this year. The DENIM study is designed to be pivotal following discussions with the regulators. We plan to report topline results early in Q4 2022. The results are expected to be the basis for an EMA Marketing Authorization Application in H1 2023, starting the process of bringing this new therapy to mesothelioma patients."

The DENIM (DENdritic cell Immunotherapy for Mesothelioma) study is a randomised open-label Phase II/III study of patients with pleural mesothelioma. The objectives are to assess the efficacy and anti-tumour activity of MesoPher as maintenance treatment after chemotherapy. Patients received 3 bi-weekly injections of MesoPher, plus two further injections of MesoPher after 4 and 7 months. Patients in the control arm received best supportive care alone. The primary endpoint of the study is overall survival.

In Q4 2022, Amphera will also present the survival data of the expansion cohort of 28 patients in the Phase II REACtiVe study of MesoPher in resected pancreatic cancer. The promising results of the first cohort were recently published in the European Journal of Cancer (View Source(22)00159-9/fulltext).

On August 1, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in an upcoming investor conference (Press release, Zymeworks, AUG 1, 2022, View Source [SID1234617214]):

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Citi’s 17th Annual BioPharma Conference. Zymeworks will participate in one-on-one meetings and management will participate in a fireside chat on September 7th in Boston, MA.
2022 Wells Fargo Healthcare Conference. Zymeworks will participate in one-on-one meetings and management will participate in a fireside chat on September 8th in Boston, MA.
Morgan Stanley 20th Annual Global Healthcare Conference. Zymeworks will participate in one-on-one meetings on September 13th and 14th in New York, NY.
H.C. Wainwright 24th Annual Global Investment Conference. Zymeworks will virtually participate in one-on-one meetings on September 13th and 14th and will make available a pre-recorded presentation on September 12th.
The presentation and fireside chats will be available on Zymeworks’ website at View Source

On August 1, 2022 As part of its continued commitment to expand the benefits of next-generation sequencing (NGS), Thermo Fisher Scientific reported that it is now accepting submissions for the fifth round of the Oncomine Clinical Research Grant program (Press release, Thermo Fisher Scientific, AUG 1, 2022, View Source [SID1234617213]). The program supports clinical and translational research that advances the use of genomic testing to unlock the promise of precision medicine for more cancer patients.

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The program awards independent clinical research teams with financial support worth up to $200,000 in reagents and general funding. Since its introduction in 2020, the Oncomine Clinical Research Grant program has provided support to more than 20 unique research projects across 11 countries in areas including hematology-oncology, immuno-oncology, liquid biopsy and gene fusion detection.

"NGS has the power to transform cancer treatment by matching patients with the right therapy quickly, but more research is needed to investigate new applications with the potential to address areas of unmet diagnostic need," said Jose Luis Costa, Ph.D., director of medical affairs for clinical next-generation sequencing and oncology at Thermo Fisher. "We launched the Oncomine Clinical Research Grant program to help fill this gap by supporting the next discoveries in genomic research that may advance precision oncology and improve patients’ lives in the future."

Spring 2022 Grant Recipients Named

Following the last call for proposals in the spring, the following researchers and projects have been selected as the latest grant recipients:

Matias Avila, B. Pharm., Ph.D., University of Navarra, Pamplona, Spain — "Mutational Analysis of Bile cfDNA for the Early Diagnosis of Biliopancreatic Tumors"
Wendy Erber, M.D., The University of Western Australia, Crawley, Australia — "Genomic Profiling and Disease Monitoring Using Plasma Cell-Free DNA in Acute Myeloid Leukemia"
Xiuning Le, M.D., Ph.D., MD Anderson Cancer Center, Houston, U.S. — "ctDNA Analysis to Understand Resistance and Response to Osimertinib Ramucirumab Combination Therapy in EGFR Mutant Non-Small Cell Lung Cancer"
Nir Peled, M.D., Ph.D., FCCP, Shaare Zedek Medical Center, Jerusalem, Israel — "Liquid Biopsy in Suspected Lung Cancer Solitary Pulmonary Nodules"
Two years into the program, studies supported by the grant are already delivering insights with the future potential to improve patient outcomes. Pathologist Brandon Sheffield, M.D., and his team at William Osler Health System leveraged the Oncomine Clinical Research Grant he received in 2020 to demonstrate cost-effectiveness and better care through rapid in-house genomic profiling in a community oncology practice. The Osler team’s findings were recently published in Current Oncology.

"Community hospitals, where the majority of cancer patients are treated, often rely on outsourced testing or single-gene testing – both of which significantly slow time to results," said Dr. Sheffield. "The Oncomine Clinical Research Grant accelerated our ability to demonstrate the benefits of bringing user-friendly, rapid NGS in-house to help clinical teams make fast and objective treatment decisions that benefit their patients."

Grant applications are open through Sept. 26, 2022. For more information on the Oncomine Clinical Research Grant Program and how to submit proposals, please visit www.oncomine.com/grants.

On August 1, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) for omidubicel for the treatment of patients with blood cancers in need of an allogenic hematopoietic stem cell transplant (Press release, Gamida Cell, AUG 1, 2022, View Source [SID1234617212]). Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations.

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The FDA granted Priority Review for the BLA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. The FDA grants Priority Review to product applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. At this time, the FDA has indicated that it is not planning an advisory committee meeting as part of the BLA review.

"The FDA’s acceptance of our BLA with Priority Review signifies a critical milestone in our mission to deliver a new stem cell therapy option for patients in need of a donor for an allogeneic stem cell transplant," said Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are encouraged by the positive and sustained follow-up results from patients participating in the Phase 3 trial of omidubicel, including a positive overall survival trend one-year out from treatment. These results provide promising rationale that, if approved, omidubicel could become a treatment of choice for patients in need of an allo-HSCT transplant. We look forward to working with the FDA throughout the review process to bring omidubicel to patients as quickly as possible."

Upon FDA approval, omidubicel will be manufactured at the Gamida Cell owned manufacturing facility in Israel. This is a newly constructed, state-of-the-art, modular facility which allows for additional capacity to be added to address growing demand. Batches from this facility were used to support the BLA for omidubicel and the facility is currently manufacturing clinical batches.

The omidubicel BLA is supported by the statistically significant results from Gamida Cell’s pivotal Phase 3 study, the results of which were published in Blood, the official journal of the American Society of Hematology (ASH) (Free ASH Whitepaper). Results for the study’s primary endpoint, the median time to neutrophil engraftment in patients with hematologic malignancies undergoing allogeneic bone marrow transplant with omidubicel compared to standard umbilical cord blood (UCB), demonstrated a median time to neutrophil engraftment of 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p < 0.001). The secondary endpoints of this Phase 3 study were all achieved and were statistically significant. These secondary endpoints were platelet engraftment, the rate of infection, and days alive and out of hospital. Omidubicel was generally well tolerated in the Phase 3 study.

The full Blood manuscript is available here: View Source

In 2019, approximately 8,000 patients who were 12 years old and up with hematologic malignancies underwent an allogeneic stem cell transplant in the United States.1 Unfortunately, it is estimated that another 1,200 patients were eligible for transplant but could not find a donor source.2 If approved, omidubicel has the potential to improve outcomes for patients based on transplanter feedback and to potentially increase access for patients to get to transplant. If approved, omidubicel has the potential to treat approximately 2,000 – 2,500 patients each year in the U.S.

Conference Call Information

Gamida Cell will host a conference call today, August 1, 2022, at 8:00 a.m. ET to discuss this update. To access the conference call, please register here and please be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit View Source

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.