On August 16, 2021 McKesson Corporation (NYSE:MCK) reported that the Company will host an Investor Day on December 8, 2021 in New York City (Press release, McKesson, AUG 16, 2021, View Source [SID1234586652]).

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A live audio webcast and presentation slides will be available on McKesson’s Investor Relations website at View Source Further details will be provided at a later date.

On August 16, 2021 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company with novel allogeneic stem cell platforms for delivery of oncolytic viruses, together with the University of Chicago and City of Hope, a world renowned NCI-Designated Comprehensive Cancer Center, based in Duarte, California, reported that it have entered into an exclusive worldwide licensing agreement for patents covering cutting edge therapies using an oncolytic adenovirus in combination with a clinical grade allogeneic neural stem cell line (Press release, Calidi Biotherapeutics, AUG 16, 2021, View Source [SID1234586651]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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City of Hope (COH) scientists, led by Dr. Karen Aboody in collaboration with Dr. Maciej Lesniak’s team at University of Chicago, and later Northwestern University, have used COH’s exclusive GMP grade immortalized, clonal human neural stem cell line, to selectively deliver an oncolytic adenovirus to tumor sites. Dr. Aboody and Dr. Lesniak, together with Dr. Rachael Mooney at COH, have spent 13 years in a passionate effort to translate promising pre-clinical results into the clinic, attaining FDA approval for commencing a first-in-human Phase-1 trial in recurrent glioma patients.

"We are very excited about the partnership and collaboration with Calidi Biotherapeutics. Their deep understanding and expertise using allogeneic stem cells as a delivery platform to protect, deliver, amplify, and potentiate oncolytic virotherapy, can potentially result in a significantly more effective treatment for cancer patients with invasive tumors," commented Dr. Karen Aboody, Professor, Department of Developmental and Stem Cell Biology, City of Hope National Medical Center & Beckman Research Institute.

"The first wave of Oncolytic Viruses were novel, but lacked the ability to efficiently deliver the virus to tumor sites, due to the human complement immune system inactivating the viruses, usually within one hour of patient injection, thus resulting in a lack of efficacy," stated Allan Camaisa, Co-Founder, Chairman and CEO of Calidi Biotherapeutics. "We believe this collaboration with City of Hope will allow us to implement Calidi’s proprietary techniques together with City of Hope’s novel approach to glioblastoma and other malignant tumors, using neural stem cells combined with an oncolytic adenovirus. This FDA approved Investigational New Drug (IND), planned for patient trials in the first quarter of 2022, increases Calidi’s drug pipeline and gives our company a tumor-tropic stem cell line to use for oncolytic virus delivery in cancer patients."

This exclusive license agreement, which was executed by the University of Chicago’s Polsky Center for Entrepeneurship and Innovation, transferred the COH/University of Chicago IND to Calidi for the commercial development of a licensed product. The agreement grants to Calidi commercial exclusivity in using neural stem cells with the adenovirus known as CRAd-pk-S-7 for oncolytic virotherapy.

"Calidi’s scientific and medical teams are very excited to contribute in the development of this promising technology that has significant potential to help many patients with advanced tumors," said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. "We are delighted to collaborate with the outstanding researchers and clinicians who developed this novel oncolytic virotherapy approach."

On August 16, 2021 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2021, as well as key clinical and corporate developments (Press release, Cel-Sci, AUG 16, 2021, View Source [SID1234586650]).

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Clinical and Corporate Developments include:

On June 28, 2021, CEL-SCI announced top line results from its 9.5 year global pivotal Phase 3 study for its immunotherapy Multikine (Leukocyte Interleukin, Injection)* in head and neck cancer. The Phase 3 results showed a long-term 5-year overall survival (OS) benefit in the treatment arm receiving Multikine treatment regimen followed by surgery and radiation. This survival benefit was statistically significant, robust and durable, with no safety issues, something not commonly seen with cancer drugs. In fact, the survival benefit increased over time and at 5-years the overall survival benefit reached an absolute 14.1% advantage for the Multikine treated arm over control (n=380, total study patients treated with surgery plus radiation): Multikine arm 62.7%, control arm 48.6% survival.
The OS benefit of 14.1% at 5 years for this treatment arm exceeded the >10% OS benefit set out for the study population as a whole in the protocol. The OS results for this treatment arm were significant (two-sided p=0.0236, HR=0.68) and the survival effect increased over time. The results from the Phase 3 cancer study proved that Multikine met all of the protocol required benefits stated in the study protocol in patients in the treatment arm receiving surgery and radiation as their standard therapies. Based on the results of this pivotal Phase 3 study, CEL-SCI intends to file a Biologic License Application with U.S. Food and Drug Administration (FDA) for approval of this indication. We are assembling the information required to request a pre-BLA (Biologics License Application) meeting with the FDA to discuss the adequacy of the study results to support a license application and receive FDA input on any other issues that would have to be addressed for an approval to be granted.
Worldwide there are approximately 890,000 newly diagnosed head and neck cancer patients of which CEL-SCI’s target population when filing for FDA approval is about 210,000 patients. That would mean that approximately 29,000 patients could be alive at 5-years if all 210,000 eligible patients received the Multikine treatment regimen followed by surgery and radiation compared to receiving surgery and radiation alone, the current treatment paradigm/SOC for these patients.
CEL-SCI is near completion of the expansion of its existing dedicated cGMP manufacturing facility for Multikine. The construction, which began in 2020, will double the current facility’s capacity to accommodate two shifts for increased production of Multikine.
CEL-SCI raised net proceeds of $53.6 million during the nine months ended June 30, 2021 through the sale of common stock and the exercise of warrants and options. As of June 30, 2021, CEL-SCI had $47.1 million in cash, cash equivalents and U.S. Treasury Bills.

"The results of this 10-year landmark study proved our novel concept of cancer treatment, 1) that the use of our investigational cancer immunotherapy Multikine before the usual first cancer treatments (as neoadjuvant treatment) should significantly increase survival and 2) that a cancer drug can have a very favorable safety profile. Our Phase 3 study results are the first sign of real progress in the treatment of advanced primary head and neck cancer in many decades. We estimate about 210,000 patients per year globally who could potentially benefit from this drug once approved. Our goal is to seek FDA approval based on the data from our recently concluded pivotal Phase 3 study," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported an operating loss of $27.7 million for the nine months ended June 30, 2021, versus an operating loss of $20.5 million for the nine months ended June 30, 2020. CEL-SCI reported an operating loss of $10.5 million for the quarter ended June 30, 2021, versus an operating loss of $7.0 million for the quarter ended June 30, 2020.

On August 16, 2021 HDT Bio Corp., a developer of immunotherapies for oncology and infectious diseases, reported an agreement with Korean biotech Quratis Inc. to co-develop HDT’s revolutionary COVID-19 vaccine (a next generation mRNA vaccine) for distribution in South Korea and neighboring countries (Press release, HDT Bio, AUG 16, 2021, View Source [SID1234586649]). HDT previously established a collaboration with Gennova Biopharmaceuticals in India, and it plans to announce similar deals in China and Brazil soon.

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"This agreement will enable Quratis to manufacture our next-generation COVID-19 vaccine and distribute it across much of East Asia," said HDT Bio CEO Steve Reed. "Today, we have advanced both HDT’s business prospects and its global health reach."

HDT Bio’s COVID-19 vaccine uses a proprietary Lipid InOrganic Nanoparticle (LIONTM) formulation to deliver immune-stimulating RNA fragments to targeted cells. The vaccine, currently in clinical trials to establish safety and efficacy, is significantly different from current mRNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine effectively activates the immune system at a much lower dose than current vaccines, enhancing safety and reducing manufacturing costs. Second, the HDT LION formulation system simplifies manufacture and enhances stability.

"Partnering with HDT Bio gives us a unique opportunity to fight COVID-19 with the world’s most advanced mRNA vaccine technology not only in Korea, but also in other nations in our region to help bring an end to this deadly pandemic," said Kwan Goo Cho, President of Quratis.

Quratis got an IND approval from Ministry of Food and Drug Safety for Phase I clinical trial of a COVID-19 vaccine in mid-July and is expected to begin evaluating QTP104 in a Phase 1 clinical trial shortly.

On August 16, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported recent presentations on two of its skin cancer gene expression profile tests at the 2021 American Academy of Dermatology (AAD) Summer Meeting, held Aug. 5-8, 2021 (Press release, Castle Biosciences, AUG 16, 2021, View Source [SID1234586648]).

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DecisionDx-Melanoma:

DecisionDx-Melanoma is Castle’s gene expression profile test that uses an individual patient’s tumor biology to predict the risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

"Integrating 31-gene expression profiling with clinicopathologic features improves prognostication of recurrence and metastasis in patients with stage I-III cutaneous melanoma" was presented by Nicholas Taylor, M.D., Ph.D., Zitelli and Brodland, P.C., Pittsburgh and Central Dermatology Center, Chapel Hill, N.C. in the Frontiers in Research, Science and Technology (FiRST) session on Saturday, Aug. 7.

"The study demonstrated that DecisionDx-Melanoma added significant prognostic value for a patient beyond traditional staging," said Taylor. "The study further showed that the ability to integrate a patient’s unique tumor biology with their personal clinical and pathologic risk factors helped both patients and clinicians."

Study methods and findings:

DecisionDx-Melanoma’s 31-gene expression profile (31-GEP) has been validated to both identify patients at low risk of sentinel lymph node positivity and refine risk of recurrence prognosis.
A new integrated algorithm (i31-GEP ROR (risk of recurrence) for outcomes prediction) was developed (n=1581) and validated (n=523) using Cox regression and 10×4-fold cross-validation on patients with stage I-III cutaneous melanoma from multiple centers.
The final integrated outcomes prediction algorithm combined DecisionDx-Melanoma’s continuous 31-GEP score and patient-specific clinicopathologic risk factors, including Breslow thickness, ulceration, mitotic rate, age, tumor location, sentinel lymph node (SLN) status and/or the presence of microsatellites.
Compared to American Joint Committee on Cancer Eighth Edition (AJCC8) staging, the i31-GEP ROR algorithm for outcomes prediction significantly improved the classification of overall risk for five-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and melanoma-specific survival (MSS).
Integrating DecisionDx-Melanoma’s continuous 31-GEP score with clinicopathologic features improves risk stratification over staging guidelines alone.
Overall, the study demonstrated that DecisionDx-Melanoma’s i31-GEP ROR integrated test result was an independent, significant predictor of five-year RFS, DMFS and MSS, and that the i31-GEP ROR outcomes prediction algorithm provided an individualized risk estimate rather than an average, population-based risk estimate that can help personalize patient management decisions and overall risk assessments beyond standard melanoma staging.
DecisionDx-SCC:

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile (GEP) test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC), designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

"Risk assessment by the 40-gene expression profile (40-GEP) test further stratifies risk of metastasis in a subset of high-risk cutaneous squamous cell carcinoma (cSCC) patients meeting T1 staging criteria​" was presented by Aaron Farberg, M.D., Baylor University Medical Center, Dallas in the Frontiers in Research, Science and Technology (FiRST) session on Saturday, Aug. 7.

"As a physician, it is important that I leverage all of the information available to me to make the best decisions for the care of each patient," said Farberg. "This study demonstrated that by incorporating DecisionDx-SCC into their clinical practice, physicians can more confidently identify patients with a higher risk of metastasis, who may have otherwise been considered low-risk using traditional staging systems alone, which provides the ability to adjust their treatment plans for improved patient outcomes."

Study methods and findings:

Previous validation of the DecisionDx-SCC test in a high-risk SCC cohort (n=420, all high-risk or very- high risk by the National Comprehensive Cancer Network (NCCN) guidelines v1.2021 or meeting Appropriate Use Criteria for Mohs Micrographic Surgery) demonstrated independent prognostic value when the result was incorporated into existing risk assessment methods.
Using this validation cohort, the objective of this study was to determine whether DecisionDx-SCC could identify biologically risky tumors within a subset of NCCN high-risk tumors comprehensively staged as T1 by either American Joint Committee on Cancer Eighth Edition (AJCC8) or Brigham and Women’s Hospital (BWH) staging (AJCC8 cohort n=222; BWH cohort n=200).
Kaplan-Meier analysis demonstrated a statistically significant difference in three-year metastasis-free survival rates between DecisionDx-SCC risk groups:
AJCC8 T1 cases – Class 1: 95.2%, Class 2A: 81.4%, Class 2B: 50%; p<0.001
BWH T1 cases – Class 1: 96.6%, Class 2A: 84.9%, Class 2B: 55.6%; p<0.001
Within these T1 subsets, DecisionDx-SCC accurately identified metastatic cases in approximately 80% of the cases:
AJCC8 T1 cases: 78.6% ​of metastatic cases ​received a Class 2A (moderate biological risk of metastasis) or 2B (high biological risk of metastasis) DecisionDx-SCC result
BWH T1 cases: 78.9%​ of metastatic cases ​received a Class 2A or 2B DecisionDx-SCC result
Overall, the study demonstrated that DecisionDx-SCC accurately identified tumors at risk of metastasis and can be incorporated into clinical assessments with traditional clinicopathological risk factors to help inform patient surveillance and treatment decisions.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through June 30, 2021, DecisionDx-Melanoma has been ordered 78,277 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.