On February 15, 2023 Emergent BioSolutions (NYSE: EBS) reported that it has entered into an agreement to sell its travel health business to Bavarian Nordic (BVNRY) for a total value of up to $380 million, including potential future milestone payments (Press release, Emergent BioSolutions, FEB 15, 2023, View Source [SID1234627255]). Under the terms of the definitive agreement, Bavarian Nordic will acquire the rights to VIVOTIF, indicated for the active immunization to prevent typhoid fever, and VAXCHORA, indicated for the active immunization to prevent cholera, as well as the development-stage chikungunya vaccine candidate CHIKV VLP. Bavarian Nordic will also acquire Emergent’s manufacturing site in Bern, Switzerland, and development facilities in San Diego, California. Approximately 280 current Emergent employees are expected to join Bavarian Nordic as part of the transaction.

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"This agreement enables these important vaccines to continue to get to patients and customers who need them while allowing us to further sharpen our focus on protecting and enhancing life through our core products and contract manufacturing services businesses," said Robert G. Kramer, Emergent president and chief executive officer. "I want to thank our Emergent teammates who will be joining Bavarian Nordic for their dedication to developing and delivering these products that address global health needs."

The sale of its travel health business builds on Emergent’s previously announced strategic prioritization of its medical countermeasure products, such as ACAM2000 (Smallpox (Vaccinia) Vaccine, Live), TEMBEXA (brincidofovir), RSDL (Reactive Skin Decontamination Lotion Kit), several anthrax products, and opioid overdose reversal medicine NARCAN (naloxone HCl) Nasal Spray, and contract development and manufacturing services businesses. Together, these actions will improve profitability and position Emergent for steady, sustainable growth over the long term.

Emergent will further discuss this transaction during the conference call associated with the announcement of its fourth quarter and full year 2022 financial results scheduled for post-market close on February 27, 2023.

Transaction Details
Upon closing of the transaction, Bavarian Nordic will pay Emergent $270 million in upfront cash consideration. Additionally, Bavarian Nordic will pay Emergent up to $30 million in sales-based milestones associated with the commercial products and up to $80 million in development-based milestones associated with the CHIKV VLP program. The transaction is expected to close in the second quarter of 2023, subject to regulatory clearance and customary closing conditions.

For Emergent BioSolutions, Wells Fargo Securities, LLC served as financial advisor, and Barnes & Thornburg LLP served as legal counsel for this transaction.

On February 15, 2023 Eurofins Viracor LLC, part of the Eurofins network of companies, and a leader in testing for infectious disease, immunology, and allergy, reported the launch of a ground-breaking test that can assess the expansion and persistence of Chimeric Antigen Receptor T-Cell (CAR-T) therapy in patients with pre-B cell acute lymphoblastic leukemia and B cell lymphomas (Press release, Eurofins Scientific Longjumeau, FEB 15, 2023, View Source [SID1234627284]).

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The test, based on a method developed by Eurofins Viracor, is designed to help clinicians better understand how CAR-T therapy is performing for their patients. CAR-T therapy is a revolutionary form of immunotherapy that uses genetically engineered T-cells to attack cancer cells and has shown promising results in treating a variety of cancers.

Research has demonstrated that the persistence and expansion of CAR-T therapy are important indicators of how long the therapy is likely to remain effective in the patient. The test is designed to provide clinicians with an accurate and comprehensive assessment of the CAR-T cell population in the patient’s body and may offer insights to therapy effectiveness.

The launch of this test marks an important step forward in the evaluation and management of CAR-T therapy in cancer patients. It is expected to be a valuable tool in helping clinicians to make more informed decisions about the best course of treatment for their patients.

On February 15, 2023 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) reported a regulatory update on the clinical development plan of Tedopi, an immunotherapy activating tumor specific T-cells, in phase 3 in monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) after checkpoint inhibitor failure (ICI) (Press release, OSE Immunotherapeutics, FEB 15, 2023, View Source [SID1234627283]).

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments:

"We are pleased with the positive outcomes from the US Food & Drug Administration (FDA) Type C Meeting following the supportive European Medicines Agency (EMA) advice, as we are actively preparing a confirmatory phase 3 trial to support the regulatory registration of Tedopi.

Leveraging on the positive data on efficacy, safety and quality of life from the initial phase 3 randomized trial in third line post-chemotherapy followed by an immune checkpoint inhibitor (ICI), we are committed in advancing the clinical development for Tedopi as a potential new standard of care in monotherapy in second line for advanced or metastatic lung cancer patients in secondary resistance to ICI now used in first line. No therapeutic options have yet been approved to date in this patient population with high unmet medical needs."

Positive recommendations from the US Food and Drug Administration (FDA) "Type C" meeting following the European Medicines Agency (EMA) scientific advice for the confirmatory phase 3 trial in second line treatment

Both Agencies supported the continuation of the clinical development for Tedopi through a new confirmatory phase 3 clinical trial versus standard of care in second line treatment for HLA-A2+ patients in advanced in non-small cell lung cancer (NSCLC).

OSE Immunotherapeutics is thus progressing on the protocol development for the next confirmatory phase 3 pivotal trial to support the regulatory registration of Tedopi in second line. This upcoming phase 3 is planned for HLA-A2+ patients with secondary resistance to immunotherapy (IO) after a first line of chemo-IO followed by failure to maintenance IO of at least 12 weeks (defined as the threshold for secondary/acquired resistance by international expert consensus recommendations). The protocol design is developed with the support of the international NSCLC clinician experts’ group which were already involved in the previous phase 3 ATALANTE trial.

Positive clinical data from the initial phase 3 trial ATALANTE in third line treatment

Tedopi is the first cancer vaccine to show positive and clinically meaningful efficacy results associated with a better safety and quality of life profile in monotherapy versus active comparator (chemotherapy-based standard of care) in third line with secondary resistance to ICI in advanced or metastatic NSCLC.

– Significant overall survival (primary endpoint) (p=0.017) with 44.4% overall survival rate at 1 year with Tedopi versus 27.5% with chemotherapy;

– Significant better safety profile with less severe (Grade 3-5) adverse events (11% with Tedopi versus 35% with chemotherapy, p<0.05);

– Significant better quality of life (Global health status: p=0.045; Role Functioning: p=0.025).

The results from the first phase 3 trial (ATALANTE) in a clearly defined target population are based on a strong biological rationale: increased specific T-cell responses induced by Tedopi’s innovative mechanism of action correlated to the overall survival in HLA-A2+ NSCLC patients. The direct activation of tumor specific T-cells by Tedopi differs from ICI releasing the break of immune response.

Ongoing compassionate use* programs in third line treatment in secondary resistance post-sequential chemotherapy and immunotherapy

OSE Immunotherapeutics is committed to provide Tedopi through cohort early access and nominative compassionate use programs across European countries to address patients’ needs alongside physicians’ engagement.

The French National Authority for Health issued a negative decision on the cohort early access program in third line treatment related to the COVID crisis which led to the suspension of patient inclusion in the previous phase 3 ATALANTE and the consecutive primary analysis on a population of interest with secondary resistance.

Patients can benefit from Tedopi through compassionate use programs in third or further lines of treatment (post chemotherapy and immunotherapy) currently approved in France, Italy and Spain, confirming thereby the significant medical need for new therapeutic alternatives.

On-going combination studies of Tedopi

Tedopi is currently being evaluated in phase 2 combination trials in three indications:

– Non-Small Cell Lung Cancer: Tedopi plus docetaxel or Tedopi plus nivolumab or docetaxel alone, in second-line treatment in metastatic NSCLC, progressing after first-line chemo-immunotherapy (CombiTED study: NCT04884282, 105 patients planned, sponsor: FoRT);

– Pancreatic cancer: Tedopi plus FOLFIRI vs FOLFIRI as maintenance treatment in patients with advanced or metastatic pancreatic adenocarcinoma with no progression after 8 cycles of FOLFIRINOX (TEDOPaM study: NCT03806309, 106 patients planned, sponsor: GERCOR);

– Ovarian cancer: Tedopi alone or in combination with pembrolizumab vs best supportive care as maintenance treatment in platinum-sensitive recurrent ovarian cancer patients (TEDOVA study: NCT04713514, 180 patients planned, sponsor: ARCAGY-GINECO).

* Compassionate use is a treatment option that allows for the use of an unauthorized medicine. Under strict conditions, products in development can be made available to nominative patients who have a disease with no satisfactory authorized therapies and who cannot enter clinical trials (https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use).

On February 15, 2023 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2022, as well as key clinical and corporate developments (Press release, Cel-Sci, FEB 15, 2023, View Source [SID1234627282]).

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Clinical and Corporate Developments include:

Multikine completely cleared cancer in 5 people with advanced head and neck cancer (locally advanced primary squamous cell carcinoma (SCC) of the head & neck (HN)) and 40 patients were partial responders whose tumors were reduced by more than 30% after 3 weeks of treatment with Multikine and prior to standard of care treatment.
Complete early tumor responses in 3 weeks have never before been reported in the scientific literature for locally advanced primary head and neck cancer according to medical experts and none were seen in the control group.
These data, from CEL-SCI’s Phase 3 head and neck cancer study, were presented by Dr. Philip Lavin in a video that was made public in October 2022. Dr. Lavin is a well-known biostatistician with a long history of supporting clinical trials for product registrations, reimbursements, and public health advancement. He has served on the faculty of Harvard Medical School at the Harvard School of Public Health for over 25 years and advised the U.S. Food and Drug Administration (FDA) from 1983 through 2015 on product approvals.
Images were presented in the video that clearly show tumors in patients’ oral cavity prior to treatment with Multikine and the disappearance of these tumors before any subsequent standard of care treatment, confirmed at surgery. The presentation and images can be seen here: LINK
During the fiscal 2023 first quarter, CEL-SCI focused on assembling the vast body of clinical documentation of a Biologic License Application (BLA) required to obtain FDA approval for commercial marketing of Multikine. Data to be submitted from the Company’s Phase 3 global head and neck cancer of 928 patients include the following:
The Multikine-treated study population who received surgery and radiotherapy as their standard of care treatment showed significant advantages over the control group;
Nearly four years (46.5 months) median overall survival improvement;
62.7% of Multikine patients were alive after five years vs. 48.6% in the control;
Complete tumor disappearance in five patients in just 3 weeks before surgery; and
Histopathology analysis showed evidence of Multikine’s mechanism of action at work.
Data from the Company’s Phase 3 study have already been presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) annual meetings in 2022. CEL-SCI continues to submit additional abstracts and manuscripts to peer-reviewed scientific journals and conferences for publishing and presentation. In fact, one of those submissions, which includes data CEL-SCI believes to be very important, is expected to be made public in the near future.
The Company’s Multikine manufacturing facility is being prepared for inspection by the FDA in advance of Multikine’s commercial launch, pending FDA approval of a BLA.
As of December 31, 2022, CEL-SCI had $18 million in cash and cash equivalents.
"We are hyper-focused on readying the vast body of data required to achieve a BLA approval from the FDA. Due to the unprecedented size, scope, length of study and nature of our Phase 3 study and the fact that Multikine is intended as a first-line treatment for primary, advanced head and neck cancer, the BLA submission has required tremendous time and effort, including expansion of the team to include independent medical and regulatory experts. We have shown a survival benefit for head and neck cancer patients with an immunotherapy given before surgery—this has never before been done. We are therefore starting from scratch. We remain highly energized and optimistic in our effort, because we believe Multikine can change the paradigm on cancer treatment and help a large number of patients. We look forward to providing updates as we reach milestones in the coming months," stated CEL-SCI CEO, Geert Kersten.

Financial Results

The Company incurred a net operating loss of approximately $7.7 million for the three months ended December 31, 2022. This net operating loss consists of significant non-cash expenses including approximately $1.7 million in stock-based employee compensation, approximately $1.0 million in depreciation and amortization expense and approximately $0.2 million in other non-cash expenses. The net cash expenditures for the quarter were approximately $4.7 million.

During the three months ended December 31, 2022, research and development expenses decreased by approximately $0.7 million, or 11%, compared to the three months ended December 31, 2021. Major components of this decrease include approximately $0.9 million in employee stock compensation expense and $0.4 million in costs related to the Phase 3 clinical study. These decreases are offset by increases in costs incurred to prepare for the potential commercial sale of Multikine of approximately $0.4 million and other research and development costs of approximately $0.2 million.

During the three months ended December 31, 2022, general and administrative expenses decreased by approximately $0.5 million, or 18%, compared to the three months ended December 31, 2021.

On February 15, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the initiation of a new study to examine patient preference for Shield, Guardant Health’s blood test to screen for colorectal cancer (CRC), and if having the option of a blood test improves patient adherence to screening (Press release, Guardant Health, FEB 15, 2023, View Source [SID1234627281]). The study will be conducted by the Center for Asian Health Equity – University of Chicago Medicine (CAHE-UCM).

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In this study, Understanding Patient Preference on Colorectal Cancer Screening Options (U-Screen), led by University of Chicago physician-scientist and colorectal cancer specialist Dr. Karen Kim, patients receiving care at Federally Qualified Health Centers (FQHC) who fail to complete guideline-recommended screening will have the option to complete their screening with a Shield blood test. Shield test performance was recently clinically validated by the ECLIPSE Study — one of the largest cancer screening studies of its kind — and achieved 83% sensitivity for the detection of CRC.1

Screening for colorectal cancer has been shown to improve survival rates, yet one in three adults have not completed the recommended CRC screening.2,3 Adherence to CRC screening is particularly low among minority populations: only 59% of individuals aged 50 and older who are Hispanic and 65% of individuals who are Black/African American are up to date with recommended screenings.4 Screening rates are even lower in FQHCs, where only 40 % of eligible patients were screened for CRC in 2020.5

There are significant barriers associated with established CRC screening methods — such as a colonoscopy or a stool-based test — including patient preferences, time and difficulty to complete the procedure.6 With a simple blood draw, the Shield test overcomes these barriers because it requires no special preparation, no sedation, no dietary changes, no extra time away from family or work, and it can be completed as part of any patient office visit.7 Since the launch of the Shield test, it has shown approximately 90% adherence demonstrating the value of blood-based screening in a real-world clinical setting.8

"Failing to complete recommended screening is a significant factor contributing to the high rate of cancer-related deaths in underserved populations," said AmirAli Talasaz, Guardant Health co-CEO. "We believe patient access to a highly accurate blood test can increase overall compliance to screening, which is critical to improving CRC outcomes, and we are excited to partner with CAHE-UCM on such an important study."

According to Dr. Kim, the Sara and Harold Lincoln Thompson Professor of Medicine, Vice Provost for Research, and founder of the Center for Asian Health Equity – University of Chicago Medicine, "This study will use an implementation science approach to help us better understand patient and provider preferences for colorectal cancer screening so we can increase screening and reduce the unnecessary burden of colorectal cancer among all populations."

About the U-Screen Study (NCT05536713)

The study will enroll people between the ages of 45 and 75 who are at average risk of developing CRC and have failed to complete guideline-recommended screening. Up to 2,400 patients will be enrolled during the three-year study period at three Federally Qualified Health Centers (FQHC), which have multiple clinics in Illinois and Indiana and provide primary care services to racial/ethnic minority and low-income populations.

About the Shield Test

The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA). Specifically, the test uses a multi-modal approach to identify specific characteristics of the DNA that may indicate the presence of cancer.

The clinical performance of the Shield assay was validated using an analyzed set of over ten thousand patient samples in a screening study. The test demonstrated 83% sensitivity in detecting individuals with CRC. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. This test also demonstrated 13% sensitivity in detecting advanced adenomas.

Shield is commercially available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer. Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation.

More information about the Shield test is available at bloodbasedscreening.com.