On May 24, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections, reported that its innate/adaptive immune activator, botensilimab, will be the subject of a late-breaking oral presentation at the upcoming ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in Barcelona, Spain (Press release, Agenus, MAY 24, 2022, View Source [SID1234614993]). In addition, Agenus also announced broad efficiencies expected to reduce costs by 20% and drive botensilimab’s accelerated development.

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"MSS colorectal cancer is one of the tumor types where single agent checkpoint inhibitors targeting PD-1/PD-L1 have not shown significant activity; in contrast, we are seeing deep and durable responses using botensilimab and balstilimab in these heavily pretreated MSS colorectal patients," said Anthony El-Khoueiry, MD, Phase I Program Director at the USC Norris Comprehensive Cancer Center, Keck Medicine of USC. "The activity noted with this combination warrants advancing the program with further trials".i

"The clinical activity of the combination of botensilimab and balstilimab in heavily pretreated metastatic MSS colorectal cancer is remarkable," said Dr. Steven O’Day, CMO of Agenus. "Prior PD1 and PDL1 antibodies, with or without CTLA-4, have failed in this same setting. These data in MSS CRC are further supported by emerging clinical data in a wide range of poorly responsive solid tumors. We look forward to advancing botensilimab alone and in combination in the second half of 2022."

Botensilimab is an immunotherapy with the potential to transform the treatment landscape. A growing body of evidence supports botensilimab’s broad activity in indications inadequately addressed by currently approved treatments, and Agenus is focusing additional resources to accelerate its development. In this regard, Agenus will:

Prioritize its clinical development programs.
Automate and implement Vision and AI capabilities, as part of effort to streamline discovery and development.
These measures will reduce Agenus’ operating expenses and allow the company to prioritize its high potential programs, while continuing to pursue creative financing mechanisms and/or potential partnerships.

Agenus will also continue to advance clinical collaborations designed to increase the potential value of botensilimab and other clinical programs in new indications and combinations. These studies are sponsored and executed by our partners, with drug supply and scientific support provided by Agenus. Internally, the company will continue to focus on botensilimab combinations which inform its use as a foundational therapy; these combinations include Agenus’ balstilimab (anti-PD-1), AGEN2373 (anti-CD137), and AGEN1571 (anti-ILT2) antibodies, as well as chemotherapy.

"As we enter a period of unprecedented regulatory and financial challenges for the biotech industry, Agenus is poised to differentiate our capabilities and comprehensive portfolio. The enthusiasm GI experts have shown, as evidenced by a prominent presentation at ESMO (Free ESMO Whitepaper) GI, is very heartening, as is the accelerated patient enrollment in our clinical trials. We believe the value of botensilimab to be unmatched relative to existing therapies and known development candidates, and we are moving with speed to bring this potentially revolutionary treatment to patients in need," CEO of Agenus, Dr. Garo Armen.

Agenus’ plans include initiation of three phase 2 studies in 2022 (MSS colorectal cancer, melanoma and pancreatic cancer).

About Botensilimab
Botensilimab (also known as AGEN1181) is a next-generation, Fc-enhanced, immunoglobulin G1 (IgG1) antibody which has shown significant activity in activating both the innate and adaptive immune response. It is also designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) inhibitory function from interacting with its ligands CD80 and CD86. The Fc region of the antibody was engineered to enhance immune activation and tumor killing, improve safety, and benefit a broader patient population versus first-generation anti CTLA-4 antibodies which act as a negative regulator of immune activation that is considered a foundational mechanism.

On May 24, 2022 ImaginAb, Inc., a market leading global biotechnology company focused on developing next generation immuno-oncology imaging agents and therapeutic radiopharmaceuticals (RPT), reported the signing of an exclusive license with [Yantai] DongCheng Pharmaceutical Group to commercialize ImaginAb’s CD8 ImmunoPET agent (zirconium Zr 89 crefmirlimab berdoxam) in the Greater China market (Press release, ImaginAb, MAY 24, 2022, View Source [SID1234615010]). Zirconium Zr 89 crefmirlimab berdoxam will be initially used in third party sponsored clinical trials with the intention of achieving market authorization.

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Ian Wilson, CEO of ImaginAb, said: "ImaginAb’s objective is to be a leading global imaging and radiotherapy company and, as such, China is an important market for our products. We are pleased to sign this exclusive license agreement and are looking forward to working with DongCheng to deliver our diagnostic imaging agent to cancer patients in China. DongCheng’s extensive experience in molecular imaging, combined with its technical experience and execution infrastructure make it an ideal development and commercial partner for ImaginAb in China. The addition of DongCheng to our customer portfolio provides additional support as we progress our business strategy and third-party validation of crefmirlimab berdoxam."

Grant Luo, CEO of [Yantai] DongCheng Pharmaceutical Group, commented: "By partnering with ImaginAb, we will be introducing to Greater China an ImmunoPET tracer to visualize cytotoxic CD8+ T cells in the tumor microenvironment, which has the potential to accurately select and monitor the appropriate population receiving immune checkpoint inhibitor treatment and further promote the effectiveness of immunotherapy treatments. In addition, we hope to collaborate with clinical experts and pharmaceutical companies through our nationwide Good Manufacturing Practice (GMP) nuclear pharmacies network, to help accelerate the clinical development and commercial launch of novel therapeutics with high clinical benefits and to address patients’ needs."

ImaginAb will receive license and milestone payments and up to double digit royalties for the CD8 ImmunoPET license and commercial partnership in the Greater China market. No other terms have been disclosed.

On May 24, 2023 Hervolution, an early-stage biotechnologycompany developing effective immunotherapies targeting the Human Endogenous Retroviruses (HERVs), reported that it has raised EUR 6M of Seed funding from private investors with the participation of the European Innovation Council (EIC) Fund (Press release, Hervolution Therapeutics, MAY 24, 2022, View Source [SID1234637206]). The financing will enable Hervolution to advance its lead drug candidate, IPT001, a first-in-class immunotherapy against solid tumors, into clinical development.

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Incubated at the BioInnovation Institute (BII) and seeded by the Novo Nordisk Foundation, Hervolution was established to develop immunotherapies designed to overcome the limitations of cancer vaccines. Hervolution is targeting the human endogenous retroviruses (HERVs) to treat cancer. HERVS are well recognized as tumor specific antigens, but until now, have been undruggable. Hervolution is targeting HERV tumor antigens with a powerful technology that stimulates both arms of the immune system, the humoral and the cellular response. The Company delivers the immunogen by using Adenoviral and RNA vectors.

Hervolution has generated robust pre-clinical, proof-of-concept data that demonstrate therapeutic potential for multiple oncology indications including pancreatic, ovarian, breast and prostate cancer. It plans to enter First-In-Human (FIH) trials in 2024.

To support its growth, Hervolution has appointed Dr Hamina Patel, MD, as Chief Medical Officer, and Dr Sven Rohmann, MD, PhD, MBA as Chairman of the Board of Directors.

Jordi Naval, Chief Executive Officer of Hervolution said: "Hervolution is shifting the paradigm in cancer immunotherapy and is at an exciting phase of growth. Our aim is tounlock the full potential of immunotherapy in cancer. We believe Hervolution can solve the limitations of current cancer vaccines, as our pre-clinical data has shown that our immunotherapy induces higher tumor control, survival rate and tumor efficacy, compared toother competing approaches. I am very pleased to welcome Sven and Hamina to Hervolution. Their expertise and track record of success will be invaluable as we accelerate the development of our lead candidate into clinical development."

Hermann Hauser, the EIC Fund Board member commented: "The EIC Fund has established itself as a strong force in EU deep-tech investments. This unique form of financing via EIC combining grants and equity – is proving itself highly attractive to Europe’s most promising start-ups."

Dr Sven Rohmann, newly appointed Chairman added: "I am thrilled to have joined the Board of Directors of Hervolution at this time of company expansion. The Company is working on cutting-edge technology at the forefront of cancer immunotherapies and I look forward to taking this technology into clinics."

Dr Patel has over 20 years of experience in the pharmaceutical industry with proven track record of leadership roles in clinical development, oncology and global commercialization, having previously held positions as Director of Drug Development, Oncology, at Johnson and Johnson, where she helped build a broad and differentiated portfolio of indications for the cancer drug VELCADE. Dr Rohmann is experienced in General Management and leadership and has a track record in raising funds for SMEs and public companies. He has extensive international experience in M&A, business and corporate development, clinical development, strategic marketing and portfolio management in small- and large-scale Venture Capital Financing at Merck, Novartis and MPM Bio IV NVS Strategic Fund.

The Seed round of EUR 6M includes private investors and a convertible loan from EICF. Hervolution is planning to raise an additional Series A to finance the pivot from preclinical to clinical development.

For further information, please contact:
Optimum Strategic Communications
Hollie Vile, Hana Malik, Eleanor Cooper
Tel: +44 20 3922 0891
Email: [email protected]

On May 24, 2022 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of stem cell-based delivery of oncolytic viruses, reported that it has been granted a new patent (No. US 11,285,194, Combination immunotherapy approach for treatment of cancer) by the U.S. Patent and Trademark Office (USPTO) related to its proprietary SuperNova (SNV) technology platform (Press release, Calidi Biotherapeutics, MAY 24, 2022, View Source [SID1234614974]). The enhanced oncolytic virotherapy delivery platform was designed to provide and improve therapeutic treatments for multiple cancer indications. Calidi’s product candidates are in the early stages of development and have not yet been approved by the U.S. Food and Drug Administration (FDA).

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The SNV platform is composed of allogeneic, adipose-derived mesenchymal stem cells (AD-MSC) loaded with an oncolytic agent, such as the vaccinia virus, and is anticipated to be used in combination with various immunotherapy agents, including blocking antibodies. The SNV platform is designed to shield oncolytic viral payloads from the immune system, thereby efficiently delivering immuno-oncology therapy directly to tumor sites.

"Calidi’s Supernova platform has been developed through years of research in stem cell delivery and potentiation of oncolytic viruses and has the potential to revolutionize the treatment of solid tumors," said Allan J. Camaisa, CEO and Chairman of Calidi. "The addition of this patent further strengthens our intellectual property position and solidifies the opportunity to use our platform technology in advancing therapeutic discovery and development through the FDA approval process."

The Calidi approach aims to induce a durable anti-tumor immune response. In pre-clinical studies, Calidi’s SNV platform-based product candidates have been shown to shield the oncolytic viruses from destruction by the patient’s immune system, supporting efficient viral replication within the stem cells prior to delivery to tumor sites. Once there, the viral payload selectively destroys tumor cells and stimulates the patient’s immune system to attack the tumor.

"Our outstanding team of doctors and scientists have invested years of intensive research and groundbreaking work to develop Calidi’s SNV platform technology," said Boris Minev, M.D., President, Medical and Scientific Affairs at Calidi, and a patent inventor. "This patent represents the culmination of their impressive expertise, dedication, and passion, and will help the company continue to advance its novel discovery programs."

On May 24, 2022 LIDDS AB (publ) reported that Interim Report January – March 2022 (Press release, Lidds, MAY 24, 2022, View Source [SID1234614994])

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Net sales amounted to 0.6 (0.6) MSEK
The operating result for the period was -9.8 (-10.8) MSEK
The net result was -9.8 (-10.8) MSEK corresponding to earnings per share of SEK -0.29 (-0.36)
Cash flow from operating activities amounted to -6.1 (-11.7) MSEK
Cash and cash equivalents amounted to 27.5 (23.3) MSEK

Significant events January – March
The R&D project with J&J has moved into the next phase.
A financing agreement of up to 40.8 MSEK signed with Nice&Green

Significant events after the reporting period
Max Mitteregger and Johan Lund are proposed as new member of LIDDS Board of Directors. Max Mitteregger will in connection with the appointment to LIDDS’ Board of Directors acquire shares at a total value of 4.5 MSEK. It is proposed that this will be done through a directed share issue of 750,000 shares at a subscription price of 6 SEK, which corresponds to LIDDS’ share price at Nasdaq First North Growth Market at the time for a binding commitment to subscribe for the shares. The directed share issue is subject to approval by the Annual General Meeting of shareholders.

CEO comment
In the beginning of 2022, we have had several important announcements. Early January, we announced that the research collaboration with Johnson & Johnson Enterprise Innovation Inc (J&J) continued into the next stage. It is of utmost importance that the cooperation continues to develop well. The collaboration with J&J is an important part of our development goals to be able to offer drugs that make an important difference in patients’ lives. We want to be part of developing products that improves the situation for patients, caregivers and society at large through improved treatment results, increased quality of life and efficient use of resources.

We also presented the next step in the development of our project nanodotax which isNanoZolid-formulated docetaxel. We will conduct a shorter clinical study to evaluate the immunological effects observed in the clinical Phase I study NZ-DTX-001. The study showed activation of systemic inflammatory biomarkers that are believed to improve conditions for treatment with so-called checkpoint inhibitors. Preliminary results indicate that local treatment with nanodotax could stimulate patients’ immune systems in such a way that it could attack even distant metastases. Based on the positive results in the phase I study, we chose to take over the sponsorship of the previously approved investigator sponsored trial in patients with prostate cancer. We expect to be able to start recruiting patients quite soon and I look forward to the results as the study will provide important insights into the mechanism of action and how the project will be further advanced in the clinical development regarding patient group and indication.

I note that there is great interest in TLR9-targeted treatment as Regeneron Pharmaceuticals has announced its intention to acquire Checkmate Pharmaceuticals. Checkmate’s product in development is a TLR9 agonist which is basically the same as our nanoimod product but without the long-lasting effect. We are convinced that the solution for good treatment results lies in a long-acting and continuous TLR9 activation. The deal is a good indication of the interest among pharmaceutical companies for intratumoral administration in general and more specifically of TLR9-targeted treatment as a new tool in the treatment of various cancers.

In order to be able to continue the positive development of the project portfolio, secured financing is of great importance. Therefore, we announced in February that LIDDS has entered into a convertible loan agreement with Nice & Green, a Swiss specialist investor with valuable experience from the life science sector. The agreement stipulates that Nice & Green has committed to subscribe for convertibles with a nominal value of up to SEK 40.8 million. The agreement gives LIDDS the opportunity, but no obligation, to use the agreed financing for the next 18 months. This is very important for the company because it gives us flexibility.

I am happy to have been able to meet both shareholders and other stakeholders during the first months of the year. We did this both at the Fight Cancer Day organized by Redeye in January and at the much-appreciated Capital Markets Day (CMD) that we held in March. The focus at the CMD was on our research and development – the heart of the company. I appreciate your commitment and interest and look forward to meeting you again. In June, we will have reason to spread the word about LIDDS further as we attend the US BIO International Convention in San Diego. The conference is one of the most important industry congresses with internationally renowned keynote speakers and brings together a large number of market-leading players from around the world. As a further step in strengthening the knowledge about LIDDS, the website has also been updated with new design, content and better functions to make it easier for our visitors.

My focus in the future is to manage the good foundation we carefully laid out for the company in 2021 and the beginning of 2022. We will accelerate the work of developing effective solutions for local drug administration and develop projects that generate the greatest opportunities for future collaborations and agreements.