On August 17, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported a business update and announced its second quarter 2023 financial results (Press release, Evaxion Biotech, AUG 17, 2023, View Source [SID1234634466]).

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"At Evaxion, we believe that AI-powered, personalized cancer vaccines have the potential to transform the care of patients with melanoma and other cancers. Early-stage clinical data reported at AACR (Free AACR Whitepaper) 2023 and ASCO (Free ASCO Whitepaper)23 indicated that patients treated with our vaccines, EVX-01 or EVX-02, in combination with a checkpoint inhibitor, experienced a treatment benefit, with good overall tolerability" said Per Norlén, Chief Executive Officer of Evaxion. "These data support the potential clinical utility for personalized cancer immunotherapy and the opportunity to advance our next-generation, DNA-based candidate, EVX-03, towards clinical trials in cancer patients."

"Additionally, at a time of positive industry data and renewed interest in personalized cancer vaccines, Evaxion is making excellent scientific progress. Utilization of two new, proprietary technologies, including the AI platform ObsERV, which enables identification of novel cancer antigens called ERVs, which are patient-specific cancer targets of viral origin, plus our novel genetic adjuvant, are believed to further enhance the efficacy of EVX-03," said Per, concluding, "On a separate note, we were pleased to present preclinical proof-of-concept data at the Gordon Conference showing that EVX-B1 can clear staphylococcus infections. Taken together, these clinical advances and proof-of-concept milestones highlight the potential for Evaxion’s AI-powered technology to address unmet medical needs in oncology and infectious diseases. The recent completion of an up to $20 million USD financing will support progression of our current studies and operations, while initiation of EVX-03 phase 1 activities are subject to additional funding."

Anticipated milestones

· Q4 2023 – Interim results of EVX-01 Phase 2 trial in melanoma

· Q4 2023 – Clinical trial application for EVX-03*

*Subject to additional funding in the range of $5-10 million secured before initiation

Recent Milestones (April to August 2023)

Completion of financing commitments totaling up to USD 20 million

[Press Release with hyperlink]. Evaxion announced completion of a financing commitment totaling up to $20 million with Global Growth Holding Limited, available in tranches over the next three years.

The financing is intended to cover the company’s working capital needs, including the advancement of EVX-03 to Phase 1 readiness.

Promising preclinical data presented at the Staphylococcal Diseases Gordon Research Conference

[Press Release with hyperlink]. Preclinical data showed EVX-B1, a vaccine against Staphylococcus aureus (S. aureus) containing AI-identified antigens, is highly protective against S. aureus disease in pre-clinical models and that EVX-B1 effectively clears S. aureus infections.

Promising early clinical data presented for EVX-01 and EVX-02

· EVX-01 presentation at ASCO (Free ASCO Whitepaper)23. Phase 1 results showed positive clinical responses in 8 out of 12 patients receiving EVX-01 in combination with a checkpoint inhibitor. The trial also met primary endpoints for tolerability and safety, with only mild AEs being related to EVX-01.

· EVX-02 presentation at AACR (Free AACR Whitepaper) 2023. Phase 1/2a results showed that all 10 patients with late stage melanoma who completed EVX-02 treatment demonstrated robust and treatment-specific immune responses and were relapse-free at their last assessment.

R&D Day Highlights Preclinical Data on genetic adjuvant technology

R&D Day 2023. In a series of talks from its scientists and collaborators, Evaxion provided an introduction to its proprietary genetic adjuvant technology developed to enhance the effectiveness of DNA and mRNA vaccines. The genetic adjuvant can be encoded into either DNA or mRNA vaccines to boost the immune response. Preclinical data show that the technology boosts both B cell and T cell immune responses, making it applicable to a wide range of vaccines, both for cancer and for infectious disease.

Second Quarter of 2023 Financial Results

· Cash position: As of June 30, 2023, cash and cash equivalents were $7.1 million as compared to $13.2 as of December 31, 2022. Operating spending for the second quarter of 2023 was offset by the proceeds from issue of shares and exercise of warrants. We expect that our existing cash and cash equivalents, will be sufficient to fund our operating expenses and capital expenditure requirements into December 2023.

· Research and Development expenses were $2.9 million for the quarter ended June 30, 2023 as compared to $4.1 million for the quarter ended June 30, 2022. The decrease in research and development expenses was primarily due to a decrease of $0.7 million in external costs related to finalized clinical trials and a decrease in employee-related costs of $0.5 million due to reduced headcount.

· General and Administrative expenses were $2.7 million for the quarter ended June 30, 2023 as compared to $2.1 million for the quarter ended June 30, 2022. The increase in general and administrative expenses was primarily due to an increase of $0.3 million in external costs related to overhead and professional fees and an increase in employee-related costs of $0.2 million. These increases are due to the timing of funding projects and business initiatives compared to 2022 and the expansion of the organization throughout 2022 to meet the requirements as a listed company.

· Net loss was $5.7 million for the quarter ended June 30, 2023 or ($0.21) per basic and diluted share as compared to a net loss of $4.8 million, or ($0.20) per basic and diluted share for the quarter ended June 30, 2022.

Webcast

Evaxion will host a webcast on Tuesday, August 22, at 8:00 a.m. EDT.

To access the webcast, please visit:

View Source

Notes and abbreviations:

ASCO23 = the 2023 Annual Meeting of the American Society for Clinical Oncology, AACR (Free AACR Whitepaper) 2023 = the 2023 Annual Meeting for the American Association for Cancer Research (AACR) (Free AACR Whitepaper), ERVs = endogenous retroviruses

On August 17, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported initial long-term safety and tumor control outcomes for patients with unresectable, recurrent, or locally advanced head and neck or skin tumors treated Alpha DaRT across four prospective trials conducted at several international institutions (Press release, Alpha Tau Medical, AUG 17, 2023, View Source [SID1234634465]).

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Between February 2017 and December 2022, 81 lesions in 71 patients were treated with Alpha DaRT in four prospective feasibility trials whose objective was to assess early toxicity and tumor response outcomes. The median follow-up was 14 months (range: 2-51 months). A complete response (CR) was observed in 89% of treated lesions (n=72), 10% (n=8) demonstrated a partial response, and one patient was not evaluable. The two-year actuarial local recurrence-free survival (LRFS) was 77% [95% CI: 63–87]. Variables including recurrent vs non-recurrent lesions, baseline tumor size, or histology did not impact long-term outcomes. Twenty percent of patients developed treatment-related acute grade 2 toxicity (such as dermatitis radiation, local pain at the treatment site or pruritus), which subsequently resolved with conservative treatment; there were no grade 3 or higher related acute toxicities. There was no grade 2 or higher late toxicities observed in this cohort, defined as toxicities occurring six months or later after Alpha DaRT treatment.

"We are excited to share these longer-term data on outcomes from treatment with Alpha DaRT," noted Uzi Sofer, Alpha Tau’s CEO. "We have seen continued encouraging outcomes for patients treated with Alpha DaRT, with 89% complete response rate and no grade 3 or higher toxicities, demonstrating outstanding potential for patients." Dr. Robert Den, Alpha Tau’s CMO, added, "These data answer an important question for Alpha Tau, namely, whether the strong short-term local responses we’ve seen will lead to long-term tumor control. The answer is a resounding yes, with a 77% durable tumor control rate at 2 years. We are looking forward to continued generation of additional data from our clinical trials, including our U.S. pivotal multicenter ReSTART trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy), our pancreatic cancer trial being conducted in Montreal, Canada, and other exciting trials underway or scheduled to launch soon."

Prof. Aron Popovtzer, Head of the Sharett Institute of Oncology at Hadassah Medical Center in Jerusalem, and a principal investigator in several of the trials, commented, "The ongoing and consistent strength of the results from treatment with Alpha DaRT speaks volumes about the transformative potential of Alpha DaRT for a broad array of patients with difficult-to-treat solid tumors."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On August 17, 2023 Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, reported the successful close of an oversubscribed $155 million Series B financing co-led by Redmile Group and Bain Capital Life Sciences (Press release, Abcuro, AUG 17, 2023, View Source [SID1234634463]).

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New and existing investors also participated in the financing including RA Capital Management, Samsara BioCapital, Sanofi Ventures, New Leaf Ventures, Pontifax, funds managed by Tekla Capital Management, LLC, funds and accounts managed by BlackRock, Mass General Brigham Ventures, Eurofarma, and Soleus Capital.

"Support from such a strong group of investors will allow us to complete our development programs in diseases where there are few to no treatment options available," said Alex Martin, Chief Executive Officer of Abcuro. "We are very motivated by the patients we serve and are excited by the clinical data we’ve seen to date. We’re committed to executing on our clinical trials including our registrational trial in inclusion body myositis."

Abcuro will use the proceeds from the financing to complete a Phase 2/3 registrational clinical trial evaluating ABC008, a first-in-class monoclonal antibody targeting killer cell lectin like receptor G1 (KLRG1), for the treatment of inclusion body myositis (IBM). The Company will also focus on completing a Phase 1/2 clinical trial of ABC008 in T cell large granular lymphocytic leukemia (T-LGLL), as well as initiating a Phase 1/2 clinical trial in T and NK cell lymphomas.

"IBM, like other autoimmune diseases, is progressive and devastating for patients. Targeting the depletion of cytotoxic T cells that express KLRG1 with ABC008 is a novel approach that has generated exciting early data in patients with IBM," said H. Jeffrey Wilkins, M.D., Chief Medical Officer of Abcuro. "These data are also supportive of using ABC008 in other diseases like T-LGLL in which cytotoxic T cells are pathogenic, and mature T and NK cell lymphomas in which KLRG1 expressing cells are malignant. We look forward to further advancing these programs in the clinic."

About KLRG1
Killer cell lectin like receptor G1 (KLRG1) is an immune checkpoint cell surface receptor selectively expressed on late-differentiated effector memory (TEM) and effector (TEMRA) T cells. In autoimmune disease, highly cytotoxic T cells that drive disease progression express KLRG1. Conversely, in cancer, tumor cells expressing ligands that bind to the KLRG1 receptor inhibit effector T cells and natural killer (NK) cells and downregulate anti-tumor immunity. KLRG1 is, therefore, a compelling target in immune modulation in both autoimmune diseases and cancer as it enables the precise targeting of clinically relevant cytotoxic T and NK cells, while sparing naïve, central memory and regulatory T cells which are required to maintain normal immune system homeostasis.

About ABC008
ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing naïve, regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. ABC008 is currently being evaluated in a Phase 2/3 registrational trial for inclusion body myositis (IBM) and in a Phase 1/2 trial for T cell large granular lymphocytic leukemia. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Designation to ABC008 for the treatment of IBM.

On August 17, 2023 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial and operational results for the six months ended June 30, 2023 (Press release, MediGene, AUG 17, 2023, View Source [SID1234634456]). The half-year 2023 earnings report can be found here.

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"In the first half of 2023, we have accomplished many significant milestones, and made substantial progress towards our strategic objectives", said Selwyn Ho, Chief Executive Officer at Medigene. "We advanced our IND / CTA enabling work on MDG1015 and expanded our pipeline into neoantigens targeting multiple KRAS mutations and HLAs in solid tumors. We also acquired a worldwide, exclusive license of a CD40L-CD28 costimulatory switch protein to further optimize the efficacy and safety profile of T cell receptor engineered T cell (TCR-T) therapies. With our expanding TCR-T therapy pipeline enhanced with two costimulatory switch proteins, bolstered by a robust IP portfolio, we are confident that we remain well on track to achieve our aim to develop best-in-class TCR-T therapies for patients suffering from difficult-to-treat solid tumors."

Financial and Corporate Highlights

The financial performance in the first half of 2023 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 3.1 million, primarily from the partnership with BioNTech. Reflecting the strong commitment towards advancing and expanding the pipeline, R&D expenses amounted to EUR 5.2 million.
The Executive Management Board, therefore, maintains its guidance for the fiscal year 2023 published in the annual report 2022 on March 29, 2023, in its entirety. Accordingly, the Executive Management Board expects revenue in 2023 to be between EUR 5 and 7 million. The Company expects R&D costs ranging from EUR 13 to 16 million. As of June 30, 2023, cash and cash equivalents and time deposits amounted to EUR 24.6 million (December 31, 2022: EUR 33.2 million). Based on current planning, the Company is financed until the fourth quarter of 2024.
In June, Medigene hosted an R&D Event to discuss the pipeline expansion and the evolution of its end-to-end platform. The replay as well as the accompanying slide deck can be found here.
In May, the Company has been issued a patent by the Japan Patent Office protecting its PD1-41BB switch receptor. In addition, the Company reported that it had been granted the patent protection of its T cell receptor targeting PRAME (PReferentially expressed Antigen of MElanoma) in Europe and China.
In April, the Company entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute to evaluate the use of Medigene’s proprietary T cell receptors in novel cell constructs.
In January, the Company announced the receipt of a USD 3 million milestone payment from its partner 2seventy bio, Inc.
During the reporting period, the Company has strengthened and complemented its executive leadership team with the addition of Pamela Keck as Head of Investor Relations & Corporate Communications and Kirsty Crame, MD as Head of Clinical Research & Development.

Research & Development Highlights:

In June, the Company announced its pipeline expansion into neoantigens with KRAS (Kirsten rat sarcoma viral oncogene homolog) as the first target in its MDG10xx program, a TCR-T therapy being developed in combination with the company’s PD1-41BB switch receptor technology. The first KRAS antigens and HLAs (human leukocyte antigens) of the library target are KRAS G12V-A11 (MDG2011), KRAS G12V-A03 (MDG2012), and KRAS G12D-A11 (MDG2021).
In June, the Company presented an overview on elevated activity of TCR-T therapies when combining Medigene´s PD1-41BB costimulatory switch receptor with T cell receptors (TCRs) targeting different antigens at the Immuno-Oncology-Summit Europe.
In May, the Company expanded its portfolio of product enhancement technologies by acquiring the worldwide, exclusive license of the CD40L-CD28 costimulatory switch protein.
In April, the first MDG1015 pre-clinical data was presented at the American Academy of Cancer Research 2023 Annual Meeting showing the potential for significant benefits of MDG1015 in improving long-term anti-tumor effects by mitigating the immunosuppressive tumor microenvironment. The MDG1015 program will be the first clinical trial in which the ‑PD1-‑41BB costimulatory switch receptor is applied in the clinic. The program is progressing as planned and IND/CTA filing is expected in H2 2024 in line with the Company’s clinical development guidance.
Conference Call and Webcast

The Company will host a conference call and webcast today at 3 pm CET / 9 am ET. A Q&A session will follow management’s formal presentation.

Full details for the conference call and webcast are as follows:

Date August 17, 2023
Time 3 pm CET (9 am ET)
Registration
Conference Call:

View Source 1585591&linkSecurityString=250613ca4
Webcast: Join the live webcast here
Conference ID: 20230660

Participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call with the above registration link for the conference call.

Please dial in 10 minutes ahead of time to ensure a timely start of the conference call.

Following the call, an archived webcast will be accessible on the Investors & Media section of the Medigene website: View Source

On August 16, 2023 Sprint Bioscience AB (publ) reported it has licensed the global rights to its cancer program VADA (VRK1) to Day One Biopharmaceuticals Inc. The total potential value of the agreement amounts to US$ 316 million plus single-digit royalties on sales of a future drug from the program. Upon entering into the agreement, Sprint Bioscience will receive an upfront payment of US$ 3 million. In addition, Sprint Bioscience will project-lead the program and be reimbursed for continuing preclinical research and development activities in the coming two years.

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"We are very proud to present that Sprint Bioscience has entered into a license agreement with Day One Biopharmaceuticals. This agreement is yet another confirmation that the work we do within the company is of the highest international class. The VADA (VRK1) program has generated great interest in the industry globally and we have chosen Day One as a partner since we are convinced that they are well suited to take the program forward. The collaboration with Day One gives us a great opportunity to realize our strategy to become a profitable growth company that extends and improves the lives of cancer patients.", says Mathias Skalmstad, acting CEO and CFO of Sprint Bioscience.

In addition to the upfront payment and research funding, Sprint Bioscience is entitled to payments linked to predefined milestones during the program’s continued development, its regulatory process, and commercialization of a potential drug. The total value of these payments is up to US$ 313 million.

The chosen partner, Day One Biopharmaceuticals Inc., is a clinical-stage American biopharmaceutical company, listed on the Nasdaq Global Select Market (Nasdaq: DAWN). With a clear focus on both solving the urgent needs of children with cancer and developing and commercializing targeted therapies for patients of all ages, Day One is judged to be a highly attractive partner for Sprint Bioscience’s VADA (VRK1) program.

About VADA
The VADA program targets the protein vaccinia-related kinase 1 (VRK1). The program aims to develop drugs targeting a family of proteins involved in the cell’s response to DNA damage (DNA damage response, DDR) and control of the cell cycle. Elevated levels of this protein family are found in a range of cancers and are correlated with poorer survival. VRK1 inhibitors have the potential to work in combination with other targeted treatments, radiotherapy or chemotherapy.

(Press release, Sprint Bioscience, AUG 16, 2023, View Source [SID1234660964])