On January 6, 2022 ATCC, the world’s premier biological materials management and standards organization, reported that it has been awarded a contract with Leidos Biomedical Research, Inc. (Leidos Biomed), current operator of the Frederick National Laboratory for Cancer Research, for the continued production, characterization and distribution of next-generation cancer models (NGCM) (Press release, Leidos, JAN 6, 2022, View Source [SID1234598373]). These models will be distributed solely by ATCC as part of the National Cancer Institute’s (NCI) Human Cancer Model Initiative (HCMI), an international consortium that is generating novel, next-generation, tumor-derived culture models annotated with genomic, clinical and biospecimen data. In consultation with the HCMI team at Leidos Biomed and the Center for Cancer Genomics (CCG) at NCI, the contract will add 70 additional NGCMs to HCMI’s current catalog of 182 models – all of which will be available as a community resource through its data portal.

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"We recognize that the industry needs more biologically relevant cancer models and are well positioned to ensure that this expanded collection of diverse NGCMs is available to the scientific community through the HCMI," said Raymond H. Cypess, D.V.M., Ph.D., chairman and CEO of ATCC.

NGCMs are invaluable for in vitro studies as they more closely mimic the in vivo disease characteristics. The new models from primary, metastatic and recurrent cancers will expand the types of cancers represented and increase the number of patient-derived tumors available for study. New cancer types potentially released under this contract include but are not limited to bladder, endometrial, head and neck, ovarian, pediatric, and rare cancer, as well as desmoid tumor, lymphoma, and neuroblastoma.

"ATCC is at the core of enabling breakthroughs in cancer research by collaborating with HCMI to provide well-characterized 2D and 3D models for R&D studies," said James Clinton, Lead Scientist at ATCC. "These patient-derived in vitro cancer models will include 2D conditionally reprogrammed cells (CRCs) and 3D neurospheres and organoids grown in a cellular matrix that better recapitulate the in vivo environment than adherent cell lines."

Using detailed methodologies and key technical inputs developed and shared by the HCMI Cancer Model Development Centers (CMDCs), scientists at ATCC have successfully replicated and compiled model-specific, easy-to-follow culture protocols and a video for the 3D model, containing everything that will be required to initiate, expand, and cryopreserve organoids embedded in 3D culture. They will also provide guidance and advice to fellow scientists working with NGCMs in their own laboratories.

"With this contract, ATCC will expand its commitment to the NCI’s mission to improve human health by providing the scientific community with in vitro tools like NGCMs to study cancer, identify and target novel therapies, and facilitate translational cancer research," said Joseph Leonelli, Ph.D., Senior Vice President of ATCC Federal Solutions. "We look forward to supporting HCMI’s efforts to prioritize the development of solutions to advance cancer research worldwide."

On January 6, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer and population sequencing, reported unaudited preliminary revenue for the fourth quarter and full year ended December 31, 2021 (Press release, Personalis, JAN 6, 2022, View Source [SID1234598336]).

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Personalis estimates revenue of approximately $20.7 million for the fourth quarter of 2021 and approximately $85.5 million for the full year of 2021.

Fourth Quarter Highlights

Preliminary revenue from biopharma and other customers is estimated to be $15.4 million in the fourth quarter of 2021 compared with $7.6 million in the fourth quarter of 2020, a 102% increase and a record quarter; preliminary revenue from biopharma and other customers includes estimated revenue from Natera at $5.8 million in the fourth quarter of 2021; preliminary revenue from biopharma customers excluding Natera at $9.6 million for the fourth quarter of 2021, a 26% increase compared with the fourth quarter of 2020
Preliminary revenue from the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) is estimated to be $5.3 million in the fourth quarter of 2021 compared with $12.6 million in the fourth quarter of 2020, a decrease of 58%
Launch of tumor-informed liquid biopsy assay, NeXT Personal (molecular residual disease) in December 2021; NeXT Personal delivers industry leading MRD sensitivity down to 1 part-per-million (PPM), which is expected to enable earlier detection across a broader set of cancers with low mutational burden and low-shedding cancers
Preliminary cash, cash equivalents, and short-term investments is estimated to be $287 million as of December 31, 2021
Full Year 2021 Revenue

Preliminary revenue from biopharma and other customers is estimated to be $39.8 million for the full year of 2021 compared with $22.5 million for the full year of 2020, a 77% increase; preliminary revenue from biopharma and other customers includes estimated revenue from Natera at $8.6 million for the full year of 2021; preliminary revenue from biopharma customers excluding Natera at $31.2 million for the full year of 2021, a 39% increase
Preliminary revenue from the VA MVP is estimated to be $45.7 million for the full year of 2021 compared with $56.2 million for the full year of 2020, a decrease of 19%; VA MVP unfulfilled orders were approximately $7.6 million at December 31, 2021 and remaining unfulfilled orders are expected to be recognized as revenue from the first quarter through the third quarter of 2022, depending upon sample receipt volume and timing from the VA MVP
"I’m proud that preliminary revenue for our oncology business has exceeded $15 million in the fourth quarter of 2021 and was nearly $40 million for the full year 2021, despite all the headwinds from the COVID-19 pandemic. Customer orders from our oncology business were once again significantly above preliminary revenue estimates for both the fourth quarter and full year of 2021, which puts us in position to grow our oncology revenue by more than 50% in 2022 compared to 2021," said John West, Chief Executive Officer. "In addition, we recently launched NeXT Personal, our MRD liquid biopsy offering, which is expected to be an important growth driver for both biopharma and diagnostic test revenue in the future."

The above information is preliminary and subject to Personalis’ normal quarter and year-end accounting procedures and external audit by the company’s independent registered public accounting firm.

On January 6, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported a business update reviewing 2021 achievements and outlining the Company’s key business objectives for 2022 (Press release, Cyclacel, JAN 6, 2022, View Source [SID1234598356]).

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"This past year proved to be very productive for Cyclacel as we achieved our planned business objectives," said Spiro Rombotis, President and Chief Executive Officer. "First and foremost, we initiated two registration-directed, Phase 1/2 trials for our lead candidate fadraciclib, an oral CDK2/9 inhibitor. These studies are assessing fadraciclib activity across a range of solid tumors and hematological malignancies. In the solid tumor study we are enrolling patients at the third dose level using a schedule of twice daily dosing for five days, for 3 out of 4 weeks. In the leukemia study we are enrolling patients at the initial dosing level. We have also completed FDA review of an Investigational New Drug Application (IND) of CYC140, a differentiated oral PLK1 inhibitor, and received clearance to proceed with a registration-directed Phase 1/2 study in solid tumors. Finally, we strengthened our balance sheet in the year which provides a cash runway until early 2023."

"In early 2022 we expect to dose the first patient in our third, registration-directed, Phase 1/2 study, which will evaluate CYC140 across various solid tumors. We are currently planning our fourth registration-directed trial of CYC140 in hematological malignancies to follow soon thereafter. We also anticipate updates from collaborative, preclinical research studies providing valuable insights into which tumor histologies may be sensitive to CYC140’s mechanism of action. We anticipate reporting initial data for oral fadraciclib in solid tumors and lymphomas at a major medical meeting in the first half of 2022, which could be an exciting year for our company."

2021 Key Achievements

Seven patients with advanced solid tumors treated in the 065-101 study of oral fadraciclib
Three internationally recognized cancer treatment centers now enrolling in the 065-101 study selected for their expertise with tumor types of interest
First patient dosed in the 065-102 study of oral fadraciclib in patients with leukemia or myelodysplastic syndromes
Preclinical studies in progress to inform clinical development of fadraciclib
FDA clearance of our IND to proceed with 140-101, a streamlined, registration-directed, Phase 1/2 study of oral CYC140 in solid tumors
Preclinical studies in progress to support selection of histologies for CYC140 Phase 1/2 study
Raised $14.5 million in gross proceeds in a public offering in the first quarter of 2021
Key Business Objectives for 2022

First patient to be dosed with oral CYC140 in the 140-101 solid tumor study
Initial data from Phase 1 dose escalation of the 065-101 solid tumor study of oral fadraciclib
First patient to be dosed with oral CYC140 in the 140-102 leukemia study
Commence Phase 2 proof of concept stage in the 065-101 solid tumor study of oral fadraciclib
Initial data from Phase 1 dose-escalation of the 065-102 leukemia study of oral fadraciclib
Commence Phase 2 proof of concept stage of oral fadraciclib in the 065-102 leukemia study

On January 6, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported an agreement with the Broad Institute to make available a whole exome target enrichment panel to enable next-generation sequencing (NGS) in canine genomics research (Press release, Twist Bioscience, JAN 6, 2022, View Source [SID1234598374]). The panel, known as the Twist Alliance Canine Exome Panel, is available for order today and will begin shipping in February 2022.

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The Twist Alliance Canine Exome is the most current commercial exome-scale assay available for canine NGS research, and is based on updated content from CanFam v3.1. The panel was collaboratively designed with the Vertebrate Genomics Group at the Broad Institute by leveraging Twist’s rapid, iterative and flexible NGS platform to provide a rapid, off-the-shelf solution covering all coding exons of canine genes. In addition to exon-centric content, the assay includes regions of known importance in human cancers. When used with Twist’s robust end-to-end target enrichment workflows it enables cost-effective comparative studies between human and canine genomics to drive further insight into both human and canine health.

"In addition to the benefits to dogs from research using our canine exome panels, there may also be implications for human health, as both canines and humans suffer from similar inherited diseases, such as cancer, heart disease, rheumatoid arthritis and autoimmune disorders," said Emily M. Leproust, PhD, chief executive officer and co-founder of Twist Bioscience. "We are excited to expand our solutions in veterinary medicine, with the launch today of the Twist Alliance Canine Exome Panel."

About Twist Alliance Panels

In partnership with leading research institutions from around the world, Twist has curated a collection of high-quality target enrichment panels for applications ranging from carrier screening to cancer diagnostics and whole exome sequencing. The Twist Alliance Panels combine the strengths of precise, highly uniform oligonucleotide synthesis with the specialty expertise of leading scientific research partners.

Well designed, custom target enrichment panels enable increased sequencing depth on target genes while reducing overall sequencing. This allows for more sensitive detection of target sequences and higher confidence variant detection.

On January 6, 2022 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has entered into a License Agreement granting the exclusive rights for global research, development, manufacture and sale of the investigational anticancer agent H3B-8800 to a subsidiary of Roivant Sciences Ltd. (Nasdaq: ROIV, Headquarters: London, U.K., "Roivant") (Press release, Eisai, JAN 6, 2022, View Source [SID1234598214]). H3B-8800 (Roivant’s Development Code: RVT-2001) is a splicing modulator compound, discovered by Eisai’s U.S. research subsidiary H3 Biomedicine Inc., which is undergoing development as an investigational anticancer agent.

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H3B-8800 is an orally available small molecule modulator of splicing factor 3B subunit 1 (SF3B1), discovered by H3 Biomedicine Inc. Splicing occurs to remove introns that are base sequence of pre-messenger RNA (mRNA), unneeded for protein synthesis, in the process of synthesizing proteins based on the genetic code. Mutations in splicing factor-encoding genes are observed in multiple hematological malignancies and solid tumors. SF3B1 is a particularly frequent gene mutation in splicing factors.1,2 H3B-8800 binds to SF3B1, and demonstrated significant antitumor activity in preclinical models by modulating the disruption of mRNA splicing in cancer.3 Eisai and H3 Biomedicine Inc. are currently conducting a Phase I clinical trial of H3B-8800 in the U.S. and Europe in patients with myelodysplastic syndrome carrying SF3B1 mutations.

Under the terms of the agreement, Eisai will receive a contractual up-front payment, development, and regulatory milestone payments for H3B-8800, and will also receive a certain amount of royalties on sales revenue of H3B-8800 after the launch.

Roivant is a biopharmaceutical company with a unique business model. Roivant builds and launches subsidiaries, called "Vants" which conduct efficient clinical development in diverse therapeutic areas. Eisai believes that this License Agreement with Roivant will lead to the maximization of the value of H3B-8800. Eisai will continue to accelerate its discovery of new medicines based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.