On August 10, 2022 Scientists at City of Hope reported that, one of the largest cancer research and treatment organizations in the United States, may have developed a novel blood test that can be used to detect early-onset colorectal cancer, which has been on the rise in younger adults in recent years (Press release, City of Hope, AUG 10, 2022, View Source [SID1234618069]).

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"More research is needed, but this finding could help fill a void in the cancer prevention and early detection field, which does not currently have a noninvasive and accurate way to detect the presence of nonhereditary colorectal cancer in people younger than 50 years old," said Ajay Goel, Ph.D., M.S., professor and chair of the Department of Molecular Diagnostics and Experimental Therapeutics at City of Hope. "The study is significant because it is the first time a novel microRNA (miRNA) biomarker has been identified, developed and validated to detect early-onset colorectal cancer."

Colorectal cancer is the fourth most common cancer, according to the U.S. Centers for Disease Control and Prevention. The rate of colon or rectal cancers in people younger than 50 years old has been on the rise, an alarming trend, particularly because young people diagnosed with this nonhereditary form of colorectal cancer generally have more aggressive and advanced disease at diagnosis compared to late-onset colorectal cancer diagnosed in people 50 years or older. As a result, the recommendation to begin regular colorectal cancer screening has been moved to start five years earlier at age 45.

In the study, recently published in the journal Gastroenterology, researchers systematically conducted a genome-wide analysis to identify miRNA signatures by analyzing a large, publicly available dataset. They extrapolated the data of patients with either Stage 1 or 2 early-onset colorectal cancer (42) or patients with late-onset colorectal cancer (370). (MiRNAs regulate gene expression.) Scientists then validated the results using blood samples from 149 patients with early-onset colorectal cancer and compared the data with a control group of 110. While exciting, more research using larger patient cohorts must be performed before this novel liquid biopsy can be used in the clinic.

To enhance specificity and accuracy, the researchers eliminated all miRNA markers shared by people with early- and late-onset colorectal cancer to better identify patients with early-onset colorectal cancer. They were able to identify four miRNAs that, combined, create a signature biomarker which can be used to detect and diagnose the presence of early-onset colorectal cancer in younger adults.

"The goal would be to eventually be able to use this test as a part of an annual physical exam or every six months for people who are at high-risk for colorectal cancer due to the genes they inherited," Goel said. "Noninvasive fecal and blood tests that are currently available to people are not yet able to accurately detect early-onset colorectal cancer."

The study "A liquid biopsy signature for the detection of patients with early-onset colorectal cancer" was published in Gastroenterology. The research was supported by grants from the National Cancer Institute, National Institutes of Health (CA72851, CA181572, CA184792, CA202797 and CA227602) as well as from Fundación Mapfre Guanarterme.

On August 10, 2022 DCG Giving, a 501(c)(3) nonprofit part of the Dave Cantin Group, which is one of the largest financial advisory services companies for mergers and acquisitions, aims to improve cure rate and reduce side effects for children with cancer (Press release, Children’s Oncology Group, AUG 10, 2022, View Source [SID1234618068]).

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DCG Giving reported it has entered a partnership with the Children’s Oncology Group (COG) – the world’s largest organization devoted exclusively to childhood and adolescent cancer research and treatment. The goal of DCG Giving is to offer financial and structural support to COG’s local child and adolescent cancer programs and assist patients and their families across the country.

"We are proud to partner with COG, which is trailblazing the advancement for childhood and adolescent cancer research and treatment," said Executive Director Michael Weiner, MD. "Each of COG’s local programs is at the forefront of research and clinical care. These institutions are best equipped to address patient needs, and they are a part of a worldwide network that is united in the fight to cure and eradicate childhood cancer."

"We are excited for our new partnership with DCG Giving, and its ability to channel charitable donations from the automotive industry as well as other philanthropic organizations, foundations, and individuals, that will support COG’s incredible progress," said COG Chair Douglas S. Hawkins, MD. "We remain steadfast that the clinical research done by COG today will continue changing the lives of children and young adults, leading to more effective treatments for those fighting cancer in the future."

DCG Giving continually supports local pediatric cancer charities from coast to coast. Each one is a member of COG and has a track record of providing the best care to kids and families affected by cancer. Organizations that may benefit from this partnership to include the Dana-Farber Cancer Institute, New York-Presbyterian, Memorial Sloan Kettering Cancer Center, Texas Children’s Hospital, Geisinger Medical Center, Children’s Hospital of Philadelphia, Cincinnati Children’s Hospital Medical Center, Children’s Healthcare of Atlanta, Children’s Hospital Los Angeles, St. Jude Children’s Research Hospital, Seattle Children’s Hospital, and Johns Hopkins Children’s Center. To donate, visit View Source

On August 10, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta CAR T cell therapies for cancer, reported financial results and operational highlights for the second quarter ended June 30, 2022 (Press release, Adicet Bio, AUG 10, 2022, View Source [SID1234618067]).

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"During the second quarter of 2022, we made significant progress, achieving a number of clinical and regulatory milestones," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We are particularly pleased with the positive clinical data from our lead product candidate ADI-001 presented at ASCO (Free ASCO Whitepaper) in June, and the Fast Track Designation by the FDA. We are excited to report that we are currently enrolling patients to dose level 4 (DL4) and are on track to potentially initiate at least one pivotal study during the first half of 2023. Our pipeline of preclinical programs is advancing, and we look forward to providing a more comprehensive update on several preclinical programs during the second half of 2022. With $304 million in cash and cash equivalents, as adjusted for the at-the-market transaction, we are capitalized into the first half of 2025 and expect to meet several meaningful milestones along the way, including during the second half of this year."

Second Quarter 2022 and Recent Operational Highlights:

Received FDA Fast Track Designation for lead candidate ADI-001. In April, Adicet announced the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to ADI-001, an investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).
Presented positive preclinical data at the ISCT Annual Meeting. In May, Adicet announced data from a preclinical evaluation of ADI-001 at the International Society for Cell and Gene Therapy (ISCT) Annual Meeting. The preclinical data showed that ADI-001 exhibited robust in vitro and in vivo tumor growth inhibition in multiple human lymphoma cell lines, with adaptive and innate activation pathways contributing to its anti-tumor activity. These cells demonstrated superior resilience to host versus graft targeting when compared to common gene-edited approaches.
Presented positive interim data from the Phase 1 study of ADI-001 at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. During the second quarter, Adicet presented positive data from the Phase 1 study of ADI-001 at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. As of the May 31, 2022 data-cut date, ADI-001 demonstrated 75% complete response (CR) and objective response rate (ORR) across all dose levels with favorable safety and tolerability profile in patients with relapsed/refractory high grade aggressive NHL.
Future development plans for ADI-001. In June, Adicet announced that given the safety profile to date, the Phase 1 study protocol was amended to include a new dose level – dose level 4 (DL4) (1E9 CAR+ cells) and a potential ADI-001 consolidation dosing at dose level 3 to finalize the recommended Phase 2 dose in the second half of 2022. The Company plans to provide at least one additional clinical update for the ADI-001 Phase 1 study in the second half of 2022. The Company also announced that it expects to discuss with the U.S. FDA and the European Medicines Agency (EMA) the design of two pivotal intent studies and a potential path to support a Biologics License Application (BLA) and Marketing Authorization Application (MAA) for ADI-001 and initiate at least one potentially pivotal study in the first half of 2023.
Moved Research & Development (R&D) operations to Redwood City, California; Establishing in-house manufacturing capacity. Adicet completed the move of its California operations to Redwood City, California for the purpose of establishing in-house manufacturing capabilities in the Redwood City facility to enable manufacturing for early clinical development of its potential clinical candidates. The manufacturing areas of the facility are expected to be operational in the fourth quarter of 2022.
Financial Results for Second Quarter 2022:

R&D Expenses: R&D expenses were $16.2 million for the three months ended June 30, 2022, compared to $10.6 million during the same period in 2021. The $5.6 million increase is primarily driven by a $2.5 million increase in payroll and personnel expenses resulting from an increase in headcount, a $1.4 million increase in contract manufacturing organization and other externally conducted R&D expense and a $0.7 million increase in contract research organization expense related to the Company’s Phase 1 trial. Payroll and personnel expenses for the three months ended June 30, 2022, includes $1.9 million of non-cash stock-based compensation expense compared to $0.8 million during the same period in 2021.
General and Administrative (G&A) Expenses: G&A expenses were $6.5 million for the three months ended June 30, 2022, compared to $5.0 million during the same period in 2021. The $1.5 million increase is primarily driven by an increase of $1.1 million of payroll and personnel expenses, which was partially offset by a $0.2 million decrease in professional service fees and a $0.2 million decrease in lab fees. Payroll and personnel expenses for the three months ended June 30, 2022, includes $2.4 million of non-cash stock-based compensation expense compared to $1.8 million during the same period in 2021.
Net Loss: Net loss attributable to common shareholders for the three months ended June 30, 2022 was $22.5 million, or a net loss of $0.56 per basic and diluted share, including non-cash stock-based compensation expense of $4.3 million, as compared to a net loss of $10.9 million during the same period in 2021, or a net loss of $0.34 per basic and diluted share, including non-cash stock-based compensation expense of $2.7 million.
Cash Position: Cash and cash equivalents were $260.6 million as of June 30, 2022, compared to $277.5 million as of December 31, 2021. On August 9, 2022, the Company sold an aggregate of 2,611,723 shares of the Company’s common stock at a purchase price of $17.23 per share under its existing at-the-market agreement. This resulted in aggregate gross proceeds to the Company of approximately $45.0 million, before deducting sales agent fees and expenses payable by the Company. The Company expects that current cash and cash equivalents of $304.3 million, adjusted for sales agent fees from the at-the-market transaction, will be sufficient to fund its operating expenses into the first half of 2025.

On August 10, 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 dosing of the first patient in a company-sponsored Phase 1/2 study evaluating a cryopreserved, readily available formulation of GDA-201 for the treatment of follicular and diffuse large B cell lymphomas (NCT05296525) (Press release, Gamida Cell, AUG 10, 2022, View Source [SID1234618066]).

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"We are excited to further advance the development of GDA-201, a NAM-enabled natural killer (NK) cell therapy candidate which we believe has the potential to be a new readily available, cryopreserved treatment option for cancer patients with relapsed/refractory lymphoma," said Ronit Simantov, M.D., chief medical and scientific officer of Gamida Cell. "Our NK cells elicited an adaptive immune response in patients in the previous investigator-sponsored study with the fresh formulation of GDA-201, potentially leading to durable remissions. We are truly grateful for the contribution of all the participants and clinical collaborators who will allow us to continue studying GDA-201 in this multi-center open label trial."

The Phase 1 portion of the study is a dose escalation phase, designed to evaluate the safety of GDA-201, and will include patients with follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma, marginal zone lymphoma or mantle cell lymphoma. The Phase 2 expansion phase is designed to evaluate the safety and efficacy of GDA-201 in 63 patients comprised of two cohorts of patients with either FL or DLBCL. The study will include patients who have relapsed or refractory lymphoma after at least two prior treatments, which may include CAR-T or stem cell transplant.

"Interest in NK cell therapies has increased in recent years as a potential alternative to current cell therapies, as NK cells have the potential to be effective in hematological and solid tumors while avoiding common safety issues," said Veronika Bachanova, M.D., Ph.D., University of Minnesota. "We are particularly excited about Gamida’s cryopreserved formulation of GDA-201, which has potential as a new treatment option for patients."

GDA-201 leverages Gamida Cell’s proprietary NAM (nicotinamide) technology platform to expand the number and functionality of NK cells to direct tumor cell killing properties and antibody-dependent cellular cytotoxicity (ADCC). In an investigator-sponsored Phase 1/2 study in patients with relapsed or refractory lymphoma, treatment with the fresh formulation of GDA-201 with rituximab demonstrated significant clinical activity. Of the 19 patients with non-Hodgkin lymphoma (NHL), 13 complete responses and one partial response were observed, with an overall response rate of 74% and a complete response rate of 68%. Two-year data on outcomes and cytokine biomarkers associated with survival data demonstrated a median duration of response of 16 months (range 5-36 months) and an overall survival at two years of 78% (95% CI, 51%–91%). In this study, GDA-201 was well-tolerated and no dose-limiting toxicities were observed in 19 patients with NHL and 16 patients with multiple myeloma. The most common Grade 3/4 adverse events were thrombocytopenia, hypertension, neutropenia, febrile neutropenia, and anemia. There were no incidents of cytokine release syndrome, neurotoxic events, graft versus host disease or marrow aplasia.

About NAM Technology

Our NAM-enabled technology, supported by positive Phase 3 data for omidubicel, 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, we can expand and metabolically modulate multiple cell types — including stem cells and NK 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.

About GDA-201

Gamida Cell applied the capabilities of its NAM-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard-of-care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves ADCC and tumor targeting of NK cells. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the currently ongoing GDA-201 Phase 1/2 clinical trial.

For more information about GDA-201, please visit View Source For more information on the Phase 1/2 clinical trial of GDA-201, please visit www.clinicaltrials.gov.

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On August 10, 2022 Exscientia (Nasdaq: EXAI), an AI-driven pharmatech company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner, reported that it will report financial results for the second quarter ended June 30, 2022, on Wednesday, August 17, 2022 after U.S. market close (Press release, Exscientia, AUG 10, 2022, View Source [SID1234618065]). Following the announcement, the Company will host a conference call and webcast at 1:30 p.m. BST / 8:30 a.m. ET on Thursday, August 18, 2022, to provide an overview of the Company’s pipeline and corporate strategy.

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A webcast of the live call can be accessed by visiting the "Investors and Media" section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialing +1 (888) 330 3292 (U.S.), +44 203 433 3846 (U.K.), +1 (646) 960 0857 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.