On December 5, 2022 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported promising clinical data from the Phase 1/2a first-in-human study of its DNA-based cancer immunotherapy, EVX-02 (Press release, Evaxion Biotech, DEC 5, 2022, View Source [SID1234624783]).

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In the clinical study, EVX-02 is given in combination with a checkpoint inhibitor and targets cancer mutations, neoantigens, in patients with resected melanoma. The Company reported encouraging interim safety and immunogenicity data from the Phase 1/2a study of its personalized DNA-based immunotherapy, EVX-02. The results are summarized below.

"We are thrilled to announce promising interim data from the first eight patients in our Phase 1/2a study of EVX-02. We believe that these results serve as validation of our DNA technology for personalized cancer immunotherapy. All patients demonstrated a specific T-cell immune response induced by the treatment, confirming the potential capabilities of our AI platform technology. And importantly, the treatment appeared to be well tolerated in all patients, with only very mild adverse events (AEs) observed," said CEO Per Norlén.

Personalized cancer immunotherapy, like EVX-02, is particularly challenging to produce because a new and unique drug is manufactured for each patient.

"This is a tremendous achievement. Our team has successfully completed this complex process, from biopsy, through genome sequencing, a selection of the most promising cancer targets through our AI platform technology, to manufacturing, quality testing, and drug product production and delivery. And they succeeded with every single step for each patient," says Mr. Norlén.
"The promising EVX-02 data, demonstrating both proof of mechanism and an encouraging safety profile, give us exactly what we need for our upcoming clinical trial of EVX-03 and our next-generation DNA technology."

Interim results in summary:

Safety: Treatment appeared to be well tolerated in all patients, with only very mild adverse events (AEs) observed in relation to EVX-02 treatment.
EVX-02 induced CD4+ and CD8+ specific T-cell responses in all patients, providing proof of mechanism for our DNA-delivery technology, in that the delivered EVX-02-DNA gave rise to immune reactions to its encoded neoantigen peptides.
The T-cell responses were robust and long-lasting.
A full clinical trial report for the EVX-02 Phase 1 study is expected in the second quarter of 2023.

On December 5, 2022 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported on December 2, 2022 filed with the SEC its financial results and related management’s discussion for the third quarter ended September 30, 2022 (Press release, Enlivex Therapeutics, DEC 5, 2022, View Source [SID1234624782]).

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"We are continuing to execute our stated operating plan across the different clinical verticals," said Oren Hershkovitz, Ph.D., Chief Executive Officer of Enlivex. "Our oncology program now includes two clinical trials that have initiated patient enrollment. These trials were initiated following a set of preclinical studies that provided strong a scientific rationale for the potential effect of Allocetra, alone and in combination with a PD1 checkpoint inhibitor, in patients with advanced solid tumors who have poor treatment alternatives."

Dr. Hershkovitz continued, "The IND clearance by the FDA of frozen-formulation Allocetra for treatment of patients with advanced solid tumors enables Enlivex to potentially add U.S.-based solid tumor patients to our ongoing study, as well as allow oncology investigators in the United States who are excited about the potential therapeutic effect of Allocetra in solid tumor patients to initiate investigator-initiated clinical trials in the United States subject to FDA’s clearance of cross-referencing INDs, thereby allowing Enlivex to potentially observe the potential clinical effect of Allocetra in a variety of different cancers and patient populations. Alongside our progress in oncology, we are pleased to have received clearance by several European regulatory agencies for the incorporation of Allocetra’s frozen formulation into our Phase II sepsis trial, alongside the expansion of the study’s target patient population to include various causes of sepsis in order to potentially accelerate Allocetra’s development and optimize our commercial prospects. In addition, we expect that our cash runway will extend beyond the various planned data readouts from our clinical trials, allowing us to focus on proper execution of our operating plan."

Third Quarter 2022 Financial Results:

Research and development expenses were $4.2 million for the three months ended September 30, 2022, as compared to $2.7 million for the same period in 2021. 56% of the increase was associated with expenses relating to clinical studies, pre-clinical studies, an increase in the number of Allocetra doses that were manufactured and inventoried, and lease payments and overhead expenses with respect to our new manufacturing plant. 23% of the increase was associated with an increase in salaries as a result of hiring additional R&D personnel and certain pay increases for existing R&D personnel.

General and administrative expenses were $1.5 million for the three months ended September 30, 2022, as compared to $1.1 million for the same period in 2021. 31% of the increase was associated with expenses relating to salaries of newly recruited management team members, 21% to an increase in intellectual property regulatory expenses, and 9% in non-cash share-based compensation expense. For the nine month period ending September 30, 2022, compensation paid to executive and non-executive board members, in the aggregate, decreased by $346,000

Net loss for the three months ended September 30, 2022 was $5.7 million, as compared to a net loss of $3.4 million for the three months ended September 30, 2021. This increase resulted primarily from clinical studies, pre-clinical studies and an increase in the number of Allocetra TM doses that were manufactured and inventoried, as well as from an increase in salaries as a result of hiring additional R&D personnel and certain pay increases for existing R&D personnel. Additionally, net loss increased for the three months ended September 30, 2022 due to non-operating losses associated with changes in the fair value of marketable securities and currency fluctuations on cash and cash equivalents and deposits denominated in New Israeli Shekels, as compared to a non-operating gain for the three months ended September 30, 2021.

As of September 30, 2022, Enlivex had cash and cash equivalents of $57.7 million. The Company believes its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements through the third quarter of 2024.

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

On December 5, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the publication of a retrospective analysis of patients who underwent a percutaneous hepatic perfusion procedure (PHP) with CHEMOSAT for the treatment of either inoperable intrahepatic cholangiocarinomas (iCCA) or extrahepatic cholangiocarinoma (eCCA) with liver metastases (Press release, Delcath Systems, DEC 5, 2022, View Source [SID1234624781]).

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The article, New perspectives in unresectable cholangiocarcinoma? Evaluation of chemosaturation with percutaneous hepatic perfusion as a palliative treatment option by Dr. Cornelia L. A. Dewald, et al, was a retrospective analysis of 17 patients who underwent a total of 42 PHP procedures between October 2014 and September 2020 at the Hannover Medical School in Germany. The aim of the retrospective, monocentric study was to analyze PHP as a palliative treatment for unresectable liver dominant CCA.

16 of the 17 patients were evaluable for response as one patient died without follow-up imaging 13 weeks after the first PHP with no identifiable relationship to the PHP treatment. After the first PHP, one patient (6%) presented with a complete response (CR). Three patients (18%) had a partial response (PR) in the first follow-up exam and seven patients (44%) presented with stable disease (SD). Five patients (31%) had progressive disease (PD), one of which was limited to extrahepatic progression only. In total, in 17 treated patients an overall response rate (ORR) of 25% and a disease control rate (DCR) of 75% was achieved. Two patients with PR, six patients with SD and the patient with PD limited to extrahepatic progression received further PHP treatments. In the subsequent follow-up exams, the overall best therapy response in these patients was PR in 78% and SD in 22%. One patient was treated in total with 8 PHP treatments within 30 months.

The median progression free survival (PFS) was 3.5 (95% CI:2.2–7.4) months with a similar median hepatic PFS of 3.6 [95% CI: 2.6–9.5] months. Calculated from first diagnosis of iCCA (or CCA liver metastases), the median survival was 27.6 [95% CI: 16.5–37] months. From first PHP, a median survival of 9.9 [95% CI: 3.8–21] months was observed, with a 1-year survival rate of 41%. For context, the authors noted that for inoperable CCA, the treatment options are limited and a median survival of 2.5 – 6 months is to be expected, which can be extended to approximately 12 months under first-line chemotherapy with gemcitabine and cisplatin. In this study all patients were previously treated with at least systemic therapy and the authors note that the results of their analyses confirms the potential for survival extension by PHP treatment even after the exhaustion of systemic therapies.

No significant complications occurred during the PHP treatments. Significant, but transient and clinically manageable, hemotoxicity was reported with grade 3/4 thrombocytopenia after 50%, anemia after 26% and leukopenia after 21% of the PHP treatments. There were no PHP-related deaths. The authors stated that the toxicity rates were consistent both with previously published PHP values and with first-line systemic therapy with gemcitabine/cisplatin in CCA.

The authors highlighted the increasing importance of locoregional forms of therapy in the treatment of CCA and that the new edition of the German S3 cancer guideline "Diagnostics and Therapy of Hepatocellular Carcinoma and Biliary Carcinomas" now includes PHP with melphalan for the treatment of inoperable iCCA or eCCA liver metastases. Based on the results of this study the authors concluded that for patients with inoperable, treatment-refractory iCCA and CCA liver metastases PHP is an effective and safe treatment option that has the potential to prolong life in a palliative setting.

CCA are the second most common primary liver tumors, with an incidence of approximately 1.6 per 100,000 in the US and Europe, the majority of which are either iCCA or eCCA which become liver dominant. Radical surgical resection to tumor-free margins is the only curative therapy for non-metastatic CCA. Particularly in the case of iCCA however, due to long asymptomatic phases which often lead to an advanced tumor stage at initial diagnosis, less than 30–40% of patients are operable and there is a high risk of recurrence at 40–80% after surgical tumor resection.

On December 5, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that it will host an investor conference call to provide an update on CPI-818 data that will be presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, along with an update on the Company’s development programs (Press release, Corvus Pharmaceuticals, DEC 5, 2022, View Source [SID1234624780]). The conference call and webcast will be held on Monday, December 12 from 4:30 pm – 5:30 pm Eastern Time.

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The event will cover updated results from the Phase 1/1b trial of CPI-818, the Company’s ITK inhibitor, which is being studied for the treatment of immune disorders such as T cell lymphomas, autoimmune and allergic diseases. The investor call will be hosted by Corvus management: Richard A. Miller, M.D., co-founder, president, and chief executive officer, and James T. Rosenbaum, M.D., Senior Vice President of Research.

Details regarding the ASH (Free ASH Whitepaper) poster presentation, which will be available in the poster hall and via the virtual event platform, are as follows:

Date and Time: Monday, December 12, 2022, 6:00 pm CT

Title: ITK Inhibitor Induces Dose-Dependent Th1 Skewing in Normal T Cells and Is Active in Refractory T Cell Lymphomas

Poster #: 3993

Presenter: Ryan Wilcox, M.D., Ph.D., Section Head, Lymphoma & Myeloma, and Associate Professor, Department of Internal Medicine, Division of Hematology/Oncology, University of Michigan

Conference Call, Webcast and Presentation Slides
The conference call can be accessed by dialing 1- 877-300-8521 (toll-free domestic) or 1- 412-317-6026 (international) and using the conference ID 10172958. The live webcast, which will include presentation slides, may be accessed via the investor relations section of the Corvus website at www.corvuspharma.com. A replay of the webcast will be available for 90 days.

On December 5, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that the details of its investor webcast being held on Monday, December 12, 2022 at 8:00 a.m. ET (7:00 a.m. CT) to discuss updated clinical data from its on-going Phase 2 APEX trial evaluating bezuclastinib in patients with Advanced Systemic Mastocytosis being presented at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Cogent Biosciences, DEC 5, 2022, View Source [SID1234624779]).

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The event will be led by Andrew Robbins, Cogent’s President and CEO, and will include a presentation by Daniel J. DeAngelo, M.D., Ph.D., Chief of the Division of Leukemia at the Dana-Farber Cancer Institute. The speakers and additional members of Cogent leadership will be available during the Question & Answer session.

The live webcast of the event can be accessed on the Investors and Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.