On January 6 2022 ONK Therapeutics, an innovative NK cell therapy platform company, reported the closing of its $21.5 million Series A financing, led by current investors Acorn Bioventures and ALSHC, who were joined by Cormorant Asset Management (Press release, ONK Therapeutics, JAN 6, 2022, View Source [SID1234598318]).

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The financing will enable ONK to maintain its strong momentum as it advances pre-clinical programs through comprehensive IND-enabling studies, including in-vivo proof-of-concept models across multiple programs. ONK will also continue progress towards a GMP manufacturing capability, as it optimizes both its proprietary cell engineering platform and process development.

ONK’s pipeline currently has three programs in pre-clinical development across both hematological malignancies and solid tumors. The Company is pioneering optimally engineered natural killer (NK) cell therapies, utilising a suite of engineering strategies to optimize cytotoxic potential, metabolic health and persistence of NK cells, while reducing the potential for their exhaustion in the tumor microenvironment. This is made possible through the Company’s ability to achieve unique proprietary gene edits.

ONK’s comprehensive owned and exclusively licensed patent estate covers CISH knockout (KO) in the field of human NK cells for the treatment of cancer, irrespective of the NK cell source; the expression of high affinity, membrane bound,TNF-related apoptosis-inducing ligand variants (TRAILv); and the deletion of checkpoint receptors in NK cells, including extracellular proteins CD96, TIGIT, Siglec-7 and PD-1.

These different strategies are being employed across the ONK pre-clinical product portfolio, including:

ONKT102, the Company’s lead program, an optimized affinity CD38 CAR (chimeric antigen receptor) NK cell therapy being developed for the treatment of patients with relapsed refractory multiple myeloma
ONKT104, a CLL-1 CAR-NK program targeting AML stem cells, which is advancing through later stages of its pre-clinical evaluation
ONKT103, which is being optimized to treat solid tumors such as Ovarian, Breast and Non-Small Cell Lung Cancer (NSCLC) and is based on tumor associated MUC-1 targeting CAR NK cells
In addition, these programs will explore incorporating further novel gene edits, such as CISH KO and TRAIL variants targeting DR5 or DR4.

ONK has also recently started two programs focused on the potential of highly functional CISH KO NK cells, namely:

ONKT105, exploring CISH KO cord blood derived NK cells
ONKT106, exploring CISH KO iPSC derived NK cells
The Company also continues to make significant progress on the manufacturing front, optimizing its process development, gene editing capability, efficient expansion techniques and its cryopreservation capability. In combination, these will support manufacturing as part of ONK’s progress towards GMP manufacturing of large numbers of NK cell therapy batches from a single cord.

Chris Nowers, ONK Therapeutics’ CEO said, "We thank our existing investors for their continued support and are pleased to welcome Cormorant Asset Management as a new investor and Andy Phillips to our Board, as we continue against our goal to optimally engineer, off-the-shelf, NK cell therapies to potentially cure patients with cancer. This financing will allow us to continue to deliver against our focused strategy, funding significant program progression, organizational development, and company growth. Within the next 18 months, we have the potential for multiple IND approvals to enable our evolution into a clinical-stage company."

Commenting on the investment, Isaac Manke, Ph.D., Partner at Acorn Bioventures said, "Over the 12 months of our investment, ONK Therapeutics has made excellent progress in advancing both its innovative next-generation NK cell therapy platform and across its exciting portfolio of pre-clinical assets. We are pleased to continue our support and to have introduced Cormorant Asset Management as a new investor to join with ourselves and founding investor ALSHC."

Andy Phillips, Ph.D., Managing Director at Cormorant Asset Management said, "We are impressed by the Company’s potential to make a highly innovative contribution to the quickly evolving field of NK cell therapies, which we believe have the opportunity to improve the lives of patients in need of new treatments for their disease. We are pleased to join the current investor groups in financing ONK as it looks forward to important proof of principle in vivo data and additional value catalyzing milestones."

On January 6, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the H.C. Wainwright BioConnect Conference on Thursday, January 13, 2022 at 7:00 AM ET (Press release, Ultragenyx Pharmaceutical, JAN 6, 2022, View Source [SID1234598335]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

On January 6, 2022 ImCheck Therapeutics reported that its Chief Executive Officer, Pierre d’Epenoux, will present a corporate overview on Monday, January 10th at 7:30 am Eastern Time/13:30 Central European Time during the 40th Annual J. P. Morgan Healthcare Conference being held virtually from January 10-13, 2022 (Press release, ImCheck Therapeutics, JAN 6, 2022, View Source [SID1234598355])

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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.