On August 15, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa") a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that, in conjunction with its partner Moffitt Cancer Center, it has commenced treatment of the first patient in the clinical trial of its novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, AUG 15, 2022, View Source [SID1234618393]).

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The study is a dose-escalation Phase 1 trial to determine safety and the maximum tolerated dose of follicle stimulating hormone receptor T-cells and to preliminarily assess efficacy. The study is being conducted at Moffitt Cancer Center and will consist of up to 48 patients.

The CAR-T approach used for Anixa’s therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs a specific antigen to recognize that is only present on target cancer cells in order to avoid negatively affecting healthy cells. The CER-T therapy being evaluated in Anixa’s Phase 1 study differs from traditional CAR-T in that it targets the follicle stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells in healthy adult females.

"We are pleased that the first patient has been treated in our ovarian cancer CAR-T clinical study," stated Amit Kumar, Ph.D., Chairman and CEO of Anixa Biosciences. "This is truly an exciting time for Anixa, as we have now begun treating patients in our second clinical trial. With our CAR-T study, we hope to determine whether our unique targeting approach will work in solid tumors—a difficult challenge for traditional CAR-T therapies."

Robert Wenham, M.D., MS, FACOG, FACS, the trial’s lead investigator and Chair of the Department of Gynecologic Oncology at Moffitt Cancer Center, added, "With limited treatment options for recurrent, chemo-resistant ovarian cancer, I am hopeful that this program can provide a unique opportunity to make a meaningful impact on patients of this devastating disease."

Jose R. Conejo-Garcia, M.D., Ph.D., Chair of the Department of Immunology at Moffitt Cancer Center and co-inventor of the CER-T technology, added, "It is exciting to see our novel FSHR-mediated CAR-T technology reaching patients, and if our unique CAR-T approach is successful, it could serve as a model for future targeted CAR-T therapies in other cancer types."

Dr. Conejo-Garcia and his research team developed the FSHR-mediated CAR-T technology when he was at the Wistar Institute where he contributed to report for the first time on the role of T-cell responses in the outcome of ovarian cancer patients. The clinical trial being conducted today is based on this pre-clinical work, originally published in Clinical Cancer Research. Anixa has an exclusive, world-wide license to this technology.

About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

On August 15, 2022 Lytix Biopharma AS ("Lytix" or the "Company"), a clinical-stage company with an in situ vaccination technology platform, reported data from its ATLAS-IT-04 trial in patients with progressive metastatic soft tissue sarcoma (STS) (Press release, Lytix Biopharma, AUG 15, 2022, View Source [SID1234618392]). The data from this Phase II proof of concept study shows that LTX-315 in combination with Adoptive Cell Therapy (ACT) was able to stabilize the disease in 3 out of 4 fully treated patients in this hard-to-treat patient population, and that the LTX-315 treatment generated tumor-specific T cells.

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The data is presented June 5th, 2022, as a poster at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, Chicago, IL, U.S.A.

The ATLAS-IT-04 trial was an open label, exploratory, Phase II trial assessing the effect of LTX-315 when used in combination with ACT in patients with metastatic STS. ACT with tumor infiltrating lymphocytes (TILs) is a potent treatment that can induce complete and durable tumor regression as documented in patients with melanoma. The use of ACT with TILs for patients with advanced STS has not previously been reported.

Patients with advanced stages of STS have few effective treatment options and respond poorly to current treatment as well as to immunotherapy tested in clinical trials. The trial design of ATLAS-IT-04 included intratumoral injections of LTX-315 ahead of surgical removal of tumors, followed by in vitro expansion of T cells as the first step. In a second step, the expanded T cells were infused back to the patients and the effect of LTX-315 on the tumor microenvironment was assessed.

LTX-315 is a first-in-class non-viral oncolytic molecule, representing a new and superior in situ therapeutic vaccination principle to boost the clonal expansion of T cells that kill tumor cells through a targeted immune response. In a recent Phase I/II study LTX-315 has been shown to increase TILs in malignant solid tumors after intratumoral injection.

The immune response data from the ATLAS-IT-04 trial demonstrates that the treatment induce both new and tumor-specific T cells which provides proof to the concept that LTX-315 generates an immune response that targets the tumor. Moreover, the data shows that LTX-315 induce expansion of a heterogenous pool of T-cell clones in blood, and a pool of these are also present in tumor tissue after treatment.

"This trial demonstrates that the combination of LTX-315 and ACT is not only feasible and tolerable, but that tumor-specific T cells can be expanded in vitro from tumors that have been pretreated with the oncolytic molecule LTX-315", Inge Marie Svane, PI and Professor at the National Center for Cancer Immune Therapy, Department of Oncology, Copenhagen University Hospital, comments.

She adds: "This combination therapy invokes tumor specific T cells that can be cultured and infused as part of an adoptive transfer regimen for several subtypes of soft tissue sarcoma, and its treatment schedule should be further optimized to achieve superior signs of efficacy."

The poster is presented June 5th at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting.

On August 15, 2022 Ginkgo Bioworks Holdings, Inc. (NYSE: DNA) ("Ginkgo"), the leading horizontal platform for cell programming, reported its results for the second quarter ended June 30, 2022 (Press release, Ginkgo Bioworks, AUG 15, 2022, View Source [SID1234618389]). The update, including a webcast slide presentation with additional details on the second quarter and supplemental financial information, will be available at investors.ginkgobioworks.com.

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"We delivered a strong quarter across both our cell programming and biosecurity businesses," said Jason Kelly, co-founder and CEO of Ginkgo. "We added 13 new Cell Programs and more than doubled our second-quarter Foundry revenue year-over-year. We executed well on our biosecurity business through the remainder of the school year and are seeing traction across this business with longer-term, diversified biosecurity opportunities, including being awarded a new contract from the CDC to continue our pathogen monitoring work in airports. We are excited about our recently announced transactions with Zymergen and Bayer, which we expect to significantly improve our platform and drive future value. Our strong cash balance of approximately $1.4 billion affords us the ability to play offense when compelling opportunities arise, while we remain focused on our cash runway and can consider multiple levers as we drive towards profitability."

Recent Business Highlights & Strategic Positioning

Generated Foundry revenue of $44 million in Q2 2022, representing 105% growth over the comparable prior year period, including a previously announced equity milestone from the successful completion of the third productivity target in our collaboration with Cronos Group Inc.
Added 13 new Cell Programs to the Foundry platform in Q2 2022, representing 86% growth over the comparable prior year period
Concentric by Ginkgo, Ginkgo’s biosecurity and public health offering, had another strong quarter, producing $100 million in revenue in Q2 2022
Concentric was recently awarded the contract to continue CDC’s traveler-based SARS-CoV-2 genomic surveillance program, which we expect will expand inbound pathogen monitoring at ports of entry, building on our partnership over the last year with XpresCheck
On July 24, 2022, Ginkgo entered into a definitive agreement to acquire Zymergen in an all-stock transaction
The merger is expected to improve the capacity, capabilities, and efficiency of Ginkgo’s platform for its diverse customer base and enable new growth opportunities across many end markets
The transaction is expected to close by Q1 2023, subject to approval by Zymergen’s stockholders, receipt of regulatory approvals, and satisfaction or waiver of other closing conditions
Also on July 24, 2022, Ginkgo entered into a definitive agreement to acquire Bayer’s West Sacramento agricultural biologicals R&D facility
As part of the transaction, Bayer will be entering into a multi-year partnership with Ginkgo, representing Ginkgo’s largest ever cell programming contract (in terms of R&D service fees) and with the potential to earn downstream value in the form of royalties on net sales from products developed under the partnership
The transaction is expected to close in Q4 2022, subject to regulatory approvals and customary closing conditions
Added Dr. Kathy Hopinkah Hannan to the Ginkgo Board of Directors
Dr. Hannan brings over thirty years of experience as a senior C-Suite executive, corporate advisor, independent board director and strategist leading significant operations and high priority initiatives
Second Quarter 2022 Financial Highlights

Second quarter 2022 Total revenue of $145 million, up from $44 million in the comparable prior year period, an increase of 231%
Second quarter 2022 Foundry revenue of $44 million, up from $22 million in the comparable prior year period, an increase of 105%. Second quarter 2022 Foundry revenue included downstream value share revenue related to the equity milestone achievement by Cronos Group Inc.
Second quarter 2022 Biosecurity revenue of $100 million with a gross profit margin of 36%
Second quarter 2022 Loss from operations of $(647) million (inclusive of stock-based compensation expense of $607 million), compared to Loss from operations of $(60) million in the comparable prior year period. The stock-based compensation expense primarily relates to the continued GAAP accounting for the modification of restricted stock units issued prior to becoming a public company, as disclosed in our annual report on Form 10-K filed with the SEC on March 29, 2022
Second quarter 2022 Adjusted EBITDA of $(23) million, improved from $(38) million in the comparable prior year period
Cash and cash equivalents balance as of the end of the second quarter of approximately $1.4 billion puts Ginkgo in a strong financial position to pursue its strategic objectives
Full Year 2022 Guidance

Ginkgo continues to expect to add 60 new Cell Programs to the Foundry platform in 2022
Ginkgo further revised its expectation for Total revenue from $375 – $390 million to $425 –$440 million in 2022
Ginkgo continues to expect Foundry revenue of $165 – $180 million in 2022
While Biosecurity remains an uncertain business, based on strong year-to-date performance Ginkgo now expects Biosecurity revenue in 2022 of at least $260 million
Conference Call Details

Ginkgo will host a videoconference today, Monday, August 15, 2022, beginning at 4:30 p.m. ET. The presentation will include an overview of the second quarter financial performance, recent business updates, a discussion on Ginkgo’s outlook, as well as a moderated question and answer session.

To ask a question ahead of the presentation, please submit your questions to @Ginkgo on Twitter (hashtag #GinkgoResults) or by sending an e-mail to [email protected].

A webcast link is available on Ginkgo’s Investor Relations website and a replay will be made available following the presentation.

On August 15, 2022 Personalis, Inc. has reported a collaboration with BC Cancer to deploy a personalized liquid biopsy-based research use only (RUO) assay for a study of patients with colorectal and pancreatic cancers (Press release, Personalis, AUG 15, 2022, View Source [SID1234618388]). The research efforts will deploy Personalis’ NeXT Personal, which has demonstrated high sensitivity for detecting circulating tumor DNA (ctDNA) from a patient’s blood sample, to determine the best time to draw blood for ctDNA sampling for molecular residual disease (MRD) detection. MRD describes a very small number of cancer cells that remain in the body during or after treatment.

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Identification and tracking of MRD is an emerging focus in the clinical care of patients with gastrointestinal cancers such as colorectal and pancreatic cancer, which may improve overall clinical management throughout a patient’s journey. Researchers are also hoping to show that ctDNA is useful in identifying cancer progression before the current standard of care tests and use the data to do an economic analysis to assess cost-effectiveness for healthcare systems.

"ctDNA surveillance may allow earlier detection of cancer recurrence or progression, and therefore earlier intervention, which may improve patient survival," said Dr. Jonathan Loree, Medical Oncologist at BC Cancer and Assistant Professor at the University of British Columbia. "In addition, because utilizing ctDNA for ongoing clinical management has the potential to reduce healthcare expenditures, our partnered research with Personalis will assess the costs of ctDNA-based surveillance compared to MRI/CT based surveillance."

"We believe the clinical management of cancer can substantially improve with early determination of patient response and by accurately informing changes to treatment regimens. Such determinations offer the potential to avoid unnecessary toxicities, improve cost-effectiveness, and increase survival," said Dr. Richard Chen, MD, Chief Medical Officer and Senior Vice President of R&D at Personalis. "By collaborating with researchers at BC Cancer on this multifaceted study, we hope to accelerate advances in oncology practice via ultra-sensitive MRD detection."

Approximately 220 patients will be recruited for this study from across British Columbia to assess how ctDNA can improve cancer care delivery.

About NeXT Personal

NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants that can emerge and change over time, especially under therapeutic pressure.

On August 15, 2022 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2022, as well as key clinical and corporate developments (Press release, Cel-Sci, AUG 15, 2022, View Source [SID1234618387]).

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Clinical and Corporate Developments include:

The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) published two abstracts related to CEL-SCI’s pivotal randomized controlled Phase 3 Multikine (Leukocyte Interleukin, Injection)* head and neck cancer clinical trial for presentation at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois. The abstract titles are:

"Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only." – View Source

"Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study." – View Source

Multikine is given for three weeks after cancer diagnosis, but before surgery and other treatments. In the peer-reviewed abstract presented at ASCO (Free ASCO Whitepaper), a clear survival advantage for patients treated with Multikine prior to surgery in the surgery-plus-radiation arm of the IT-MATTERS study was described. The survival advantage was driven by objective data derived from patients in the intent-to-treat (ITT) population who had a significant number of early complete and partial tumor responses which occurred prior to surgery. Five patients in the study had their tumors completely disappear (confirmed by pathology) before surgery. In the ITT population as a whole, 8.5% of all Multikine-treated patients had a tumor response before surgery, but not a single tumor response before surgery was seen in the ITT control group before surgery, statistically a highly significant finding (p-value of less than 0.00000000001). This indicates that the likelihood of seeing these results by chance is less than 1 in ten billion. These results confirm findings from the Phase 1 and 2 studies with Multikine and provide direct evidence of Multikine’s anticancer activity.

Additional results from the Phase 3 study of Multikine in advanced primary head and neck cancer have been submitted to the U.S. government clinical trial website www.clinicaltrials.gov. That data is expected to be released to the public in the near future.

CEL-SCI’s dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures Multikine is now undergoing validation following the completion of its commercial scale build out during the first quarter of 2022. The construction was designed to ensure the facility will be compliant with all U.S. Food and Drug Administration’s (FDA) GMP and European regulations.
"Advanced primary squamous cell carcinoma (cancer) of the head and neck is a horrible disease for which FDA has not approved a new treatment in many decades. Many leading drugs have failed in studies for the treatment of advanced primary head and neck cancer. Our Phase 3 study shows an almost 4-year median survival benefit for the patients who received Multikine treatment before surgery and radiation. We believe that this represents a meaningful clinical impact for those patients for whom no treatment has imparted a significant survival benefit in decades. We are looking forward to additional peer-reviewed publications of this data," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported an operating loss of $27.1 million for the nine months ended June 30, 2022 versus an operating loss of $27.7 million for the nine months ended June 30, 2021. Net cash used during the nine months ended June 30, 2022 was $13.3 million. This represents a decrease of $0.7 million compared to the nine months ended June 30, 2021. CEL-SCI reported an operating loss of $8.7 million for the three months ended June 30, 2022 versus an operating loss of $10.5 million for the three months ended June 30, 2021.