Abcuro Announces $155 Million Oversubscribed Series B Financing to Further Advance Autoimmune Pipeline

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.

Medigene Reports Second Quarter and Six Months 2023 Financial Results and Provides Corporate Update

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

Interim Report 2023

On August 16, 2023 Hutchison China MediTech reported its interim report 2023 (Presentation, Hutchison China MediTech, AUG 16, 2023, View Source [SID1234634837]).

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Corporate overview

On August 16, 2023 Iovance Biotherapeutics presented its corporate presentation (Presentation, Iovance Biotherapeutics, AUG 16, 2023, View Source [SID1234634500]).

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PDS Biotech Announces Data from IMMUNOCERV Phase 2 Trial Investigating PDS0101 and Chemoradiotherapy in Cervical Cancer to be Featured in Oral Presentation at the ASTRO 2023 Annual Meeting

On August 16, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB) (PDS Biotech or the Company), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary T cell activating platforms, reported that data from the IMMUNOCERV Phase 2 clinical trial investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the treatment of locally advanced cervical cancer will be featured in an oral presentation at the American Society for Radiation Oncology (ASTRO 2023) Annual Meeting (Press release, PDS Biotechnology, AUG 16, 2023, View Source [SID1234634479]). ASTRO 2023 is being held October 1-4, 2023, in San Diego, CA.

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The abstract, titled "HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation," will report on the levels of circulating HPV-positive cell-free DNA (HPV-cfDNA) in the blood of 47 cervical cancer patients during and after CRT treatment, including subjects in the IMMUNOCERV study who received PDS0101 in addition to CRT. The research is designed to evaluate the relationship between the levels of circulating HPV viral DNA and the extent of disease, clinical staging, and treatment response in patients with HPV-positive cervical cancer. The findings will be presented by Dr. Aaron Seo, MD, Ph.D., The University of Texas MD Anderson Cancer Center.

"We are pleased that PDS0101 is being evaluated in this cutting-edge approach to better understand the patients’ prognosis and the mechanism by which PDS0101 may impact clinical outcomes in cervical cancer, and we look forward to Dr. Seo’s presentation at ASTRO 2023," stated Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "Examination of HPV-cfDNA in this larger cohort of patients will also provide additional insights to the IMMUNOCERV data presented at SITC (Free SITC Whitepaper) 2022, which suggested that PDS0101 promotes the induction of multifunctional CD8 killer T cells that were associated with declines in circulating tumor DNA and 100% (9/9) clinical response with greater than 60% tumor shrinkage at mid-point evaluation in high-risk cervical cancer patients."

The IMMUNOCERV Phase 2 study is investigating PDS0101 in combination with standard-of-care CRT in the treatment of patients with large tumors over 5 cm in size and/or cancer that has spread to the lymph nodes.

Presentation Details:
Abstract #: 55593
Abstract Title: HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation
Presenter: Aaron Seo
Author Block: Aaron Seo, Weihong Xiao, Olsi Gjyshi, Kyoko Court, Tatiana Cisneros Napravnik, Aradhana Venkatesan, Erica Lynn, Julie Sammouri, Lauren Colbert, Anuja Jhingran, Melissa Joyner, Lilie Lin, Maura Gillison, Ann Klopp
Scientific Session Number: SS 02
Scientific Session Title: GYN 1: Integrating the Next Wave of Biomarkers for Future Gynecologic Clinical Trials
Session Date/Time: October 1, 8:00AM-9:00AM