Herantis Pharma Plc – allocation of option rights

On April 13, 2022 Herantis Pharma Plc, Company release, 13 April 2022 at 5:35 p.m. EEST reported that the Board of Directors of Herantis Pharma Plc ("Herantis") has on 13 April 2022 decided to grant a maximum of 168,041 option rights entitling to shares to certain members of the management team under the option rights program 2021 I (Press release, Herantis Pharma, APR 13, 2022, View Source;allocation-of-option-rights,c3546223 [SID1234612136]). The option rights program is based on the authorization granted by the Annual General Meeting held on 15 April 2021 to issue a maximum of 975,000 option rights.

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The Board of Directors has in April 2021 resolved on issuance of a total of 961,221 option rights under the option rights program 2021 I. However, 369,262 of the issued option rights have subsequently been returned to the company as a result of the termination of employment or service relationship of certain persons. The Board of Directors have therefore decided on issuance of these new option rights under the option rights program 2021 I and within the limits of the authorization granted by the Annual General Meeting held on 15 April 2021. The total number of option rights granted and outstanding under the option rights program 2021 I after this issuance is 775,000.

The option rights will be offered without consideration. Each option right entitles to subscribe for one ordinary share in Herantis for a subscription price of EUR 2.60 per share. The subscription price corresponds to 126% of the volume weighted average share price during 10 trading days preceding the grant date of 13 April 2022 (30 March 2022–12 April 2022). The subscription price is higher than the subscription price of the company’s share in the company’s latest share issue against consideration preceding the option grant date.

Granted share options shall vest and become exercisable over a three-year period, with 1/3 becoming exercisable from 13 April 2023, with an annual vesting of 1/3 during the second year after the grant date, and with an annual vesting of 1/3 during the third year after the grant date. The options expire on 13 April 2027 or earlier subject to customary conditions.

OncoNano Medicine Announces Positive Preclinical Data for ONM-501 at AACR 2022 Annual Meeting

On April 13, 2022 OncoNano Medicine, Inc. reported positive results from a preclinical study of ONM-501, a novel dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications (Press release, OncoNano Medicine, APR 13, 2022, View Source [SID1234612135]). The data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, demonstrate the efficacy and tolerability of ONM-501 in animal models for multiple tumor types. ONM-501 is formulated with the core OncoNano OMNITM polymer technology consisting of STING-activating pH-sensitive micelles loaded with an endogenous agonist.

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"We are thrilled by the continued positive preclinical results for ONM-501. STING has consistently been a challenging pathway to target, so we are encouraged by the constellation of our impressive preclinical data showing anti-tumor efficacy and an adaptive response differentiated from cyclic dinucleotide (CDN) STING agonists," said Ruolan Han, Ph.D., Vice President of Nonclinical & Translational Medicine for OncoNano Medicine. "In preclinical studies to date, ONM-501 has demonstrated the ability to produce a burst and sustained activation of the STING signaling pathway that leads to a robust adaptive immune response with low systemic drug exposure and toxicity. We look forward to continuing our IND-enabling activities as we advance ONM-501 toward our first in human trial in early 2023."

ONM-501 was evaluated for anti-tumor efficacy and tolerability in multiple animal oncology models. The findings from multiple preclinical studies evidence the following about ONM-501:

STING activation was observed by measuring IFNB1 and CXCL10 mRNA in PBMCs from different species
Anti-tumor efficacy both as a monotherapy and in combination with anti-PD1 in both immune "hot" and "cold" tumor models
Anti-tumor effect mediated by host STING and dependent on CD8+ T cells
Ability to induce an abscopal effect – tumor inhibition was observed in both primary and distal tumors in the same animal
Ability to induce adaptive immune memory
Ability to inhibit lung metastasis in an immune "cold" triple negative orthotopic breast cancer 4T1 model
Unique nanoparticle formulation delivered intratumorally achieves high local drug retention, low systemic exposure and a potential for a reduced risk of toxicity
Presentation Overview

TITLE: ONM-501: A polyvalent STING agonist for oncology immunotherapy
PRESENTER: Qingtai Su, Ph.D., Senior Scientist, OncoNano Medicine

Kineta Unveils New Preclinical Data on its Anti-CD27 Agonist Lead Antibodies at AACR 2022

On April 13, 2022 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported the presentation of preclinical data on the company’s anti-CD27 agonist lead antibodies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, Kineta, APR 13, 2022, View Source;utm_medium=rss&utm_campaign=kineta-unveils-new-preclinical-data-on-its-anti-cd27-agonist-lead-antibodies-at-aacr-2022 [SID1234612134]). Thierry Guillaudeux, PhD, EVP Research and Development at Kineta, presented the company’s poster unveiling new preclinical data. Kineta is developing fully human anti-CD27 agonist antibodies for the treatment of blood cancers and solid tumors.

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"Kineta’s anti-CD27 program was developed through our innate immunity expertise and the company’s proprietary PiiONEER platform. We have confirmed very exciting data with our lead anti-CD27 antibodies demonstrating their activity in inducing T cells as well as NK cell activation" said Dr. Guillaudeux. "We are encouraged with these preclinical data and believe that CD27 is an important immuno-oncology target for treating cancer patients with its capability of influencing both the innate and adaptive antitumor immune response ."

Key results from the AACR (Free AACR Whitepaper) poster presentation:

Evaluated 3 lead therapeutic antibodies from our library of 147 fully human anti-CD27 monoclonal antibodies generated in Trianni mice.
Confirmed lead antibodies’ binding potency and cross-reactivity with non-human primate CD27 but not with the murine CD27.
Lead candidates demonstrate strong agonist proprieties. They induce NK cell activation as well as T cell proliferation and activation after engagement of NFκ
Lead antibodies will be evaluated as a single agent or in combination with other immuno-therapies in vivo in solid and hematological mouse tumor models in hCD27-KI mice.
Click on the link below to access the poster

CD27 Publications – Poster Presentation at ESMO (Free ESMO Whitepaper) 2022

Presentation Details

Title: CD27 a new immuno-oncology target shaping innate and adaptive anti-tumor immune responses
Abstract Number: 5588
Presenter: Thierry Guillaudeux, PhD
Session Type: In-Person and e-Poster Presentation
Session Title: Therapeutic Antibodies 3
Session Time: April 13, 2022 9:00AM – 12:30PM Central Time
Location: Poster Section 39

Anti-CD27 mAb program: Kineta has developed a diverse set of anti-CD27 agonist antibodies. They are fully human monoclonal antibodies (mAbs) that demonstrate low nanomolar (nM) binding affinity to CD27 in humans. In preclinical studies, Kineta’s selected lead anti-CD27 agonist mAbs induce T cell proliferation and secretion of cytokines involved in T cell priming and recruitment, demonstrating the ability to potentiate new anti-tumor responses. Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q2 2022.

Portage Biotech Highlights Promising Data Presented on STING-Activating Therapy, PORT-5 (STI-001) at AACR 2022 Annual Meeting

On April 13, 2022 Portage Biotech Inc., (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported that data being presented in collaboration with Stimunity during the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting taking place April 8-13 in New Orleans, Louisiana (Press release, Portage Biotech, APR 13, 2022, View Source [SID1234612133]).

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Preclinical data shows that PORT-5 (STI-001), a stimulator of interferon genes (STING) agonist, cyclic guanosine monophosphate–adenosine monophosphate (cGAMP) packaged in a virus-like particle (VLP) developed with Stimunity, can be delivered systemically and achieve potent activation of the STING pathway preferentially in dendritic cells. The data will be presented in a late-breaking research session at the AACR (Free AACR Whitepaper) meeting on Wednesday, April 13.

"The promising results showcased in this presentation suggest that we are on the verge of developing a novel approach that could elevate the potential of STING-based therapies," said Dr. Ian Walters, chief executive officer of Portage Biotech. "The data shows that one or more targeted immunotherapy agents could be packaged within a virus-like particle to increase potency, while enabling a selective immune activation. We are glad to see these data showcased at an AACR (Free AACR Whitepaper) late-breaking session and look forward to working with our colleagues at Stimunity to further develop STING agonist treatments."

The STING pathway is a well-recognized immune-boosting pathway that primes an anti-tumor T cell response and has long been an area of interest in cancer treatment, but limitations of small molecule therapies have stymied STING-activating therapies in clinical trials, due to lack of ability to target specific dendritic cells which leads to varied effects in different cells and an inefficient T cell response. Novel approaches are needed to overcome unwanted side effects associated with activation of this pathway in humans. The promising results from Portage and Stimunity show that PORT-5 (STI-001) can not only target specific dendritic cells but can be customized and targeted to specific cell and tumor types across the body and could offer a differentiating option compared to current treatments.

"This presentation is a recognition of the last two years of intense work on the preclinical package of our drug candidate STI-001 in collaboration with Nicolas Manel’s laboratory at Institut Curie / Inserm that demonstrates that packaging a therapeutic modality in a virus-like particle has the potential to unlock systemic delivery for STING via preferential dendritic cell targeting, which is unique in the field," said Sylvain Carlioz, CEO of Stimunity.

Presentation Details:

Abstract title: Cellular selectivity of STING stimulation determines priming of anti-tumor T cell responses
Abstract Number: 7829
Presenter: Bakhos Jneid, Institut Curie
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Date/Time: April 13, 2022, 9:00 a.m. – 12:30 p.m. CT
Location: Poster Section 16
Data Highlights:

Delivery of a well-characterized STING activator, cGAMP, by intra-tumoral injections of virus-like particles (cGAMP-VLP) leads to:
Differentiation of tumor-specific T cells
Decrease in tumor regulatory T cells (Tregs) that would otherwise suppress an immune response
Preferential targeting of dendritic cells leading to activation of tumor-specific T cells
Delivery of PORT-5 (STI-001) showed synergy when combined with an antibody that depletes Tregs, leading to complete and lasting tumor eradication
Additional synergy demonstrated when PORT-5 (STI-001) was combined with anti-PD1 treatments
Specific cell targeting of STING stimulation shapes the anti-tumor T cell response and reveals a therapeutic strategy with T cell modulators, which may address the current limitations of STING-based approaches in patients

Versant Ventures Launches Cimeio Therapeutics with $50 Million Series A

On April 13, 2022 Versant Ventures reported the debut of Cimeio Therapeutics, a biotechnology company developing a novel approach to cell therapies. Versant has made a $50 million Series A commitment to Cimeio, which is the most recent start-up to emerge from the firm’s Ridgeline Discovery Engine in Basel, Switzerland (Press release, Versant Ventures, APR 13, 2022, View Source [SID1234612132]).

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Cimeio’s platform has the potential to transform the treatment of patients with rare genetic diseases, hematologic malignancies and autoimmune disorders. The company’s initial focus is on a novel approach to hematopoietic stem cell (HSC) transplants and adoptive cell therapy (ACT).

HSC transplants are the only curative treatments for certain debilitating and life-threatening diseases, but many patients are ineligible due to the intensive chemotherapy and radiation conditioning required. While targeted therapeutics have recently emerged as alternatives to harsh conditioning agents, these have fallen short due to the absence of sufficiently selective targets. Furthermore, there are few options for salvaging unsuccessful transplants or for dealing with residual or recurring disease.

Cimeio seeks to transform HSC transplant and ACT eligibility and outcomes with its cell-shielding technology and precisely paired immunotherapies. The company’s proprietary immunotherapies deplete diseased cells, while its cell-shielding technology protects healthy transplanted cells and allows them to engraft. Because the transplanted cells are shielded, the immunotherapy can continue to be safely administered post-transplant to boost engraftment or to treat minimal residual disease.

"Our Shielded-Cell & Immunotherapy Pairs represent a fundamentally new approach to cellular therapy," said Cimeio CEO Thomas Fuchs. "We believe our technology platform has the potential to significantly improve HSC transplant, and will one day allow it to be given as an outpatient procedure in some circumstances."

"Making cell therapies effective and practical for large numbers of patients is an important element of Versant’s company creation activities, and we are confident that Cimeio is well-positioned to use its powerful platform to generate a pipeline of cellular and paired immunotherapy candidates for a range of diseases," added Alex Mayweg, Ph.D., Managing Director at Versant and a Cimeio board member.

Cimeio Technology Platform

Cimeio’s shielding technology was discovered and developed in the labs of founder Lukas Jeker, M.D., Ph.D., Professor at the Department of Biomedicine, University of Basel, Head of Experimental Transplantation Immunology & Nephrology at the Basel University Hospital, and Senior Vice President of Gene Editing at Cimeio.

"We were able to specifically edit a cell surface receptor in a way that completely prevented antibody binding while keeping the receptor functional. This type of epitope editing could allow the shielding of any cell surface receptor, which gives our technology much broader application than removing a target entirely," said Dr. Jeker.

Cimeio uses gene editing tools to insert novel protein variants into HSCs or other types of cells, allowing the cells to maintain their function while making them resistant to depletion by the paired immunotherapy. Cimeio’s platform has effectively shielded cells from depletion mediated by antibodies, T-cell engagers, ADCs, and CAR-T cells in preclinical studies. The company is advancing its first programs towards clinical development in 2023.

Leadership and Operating Plans

Cimeio has built a leadership team of disease area and cell therapy veterans, and has assembled a scientific advisory board of gene editing and HSC transplant experts.

Management

Thomas Fuchs, CEO. Mr. Fuchs joined Cimeio from Genentech/Roche where he led its Hematology Franchise and was responsible for the portfolio strategy and life cycle management for the disease area.
Stefanie Urlinger, Ph.D., SVP Biology. Dr. Urlinger is a protein engineering expert who has led the discovery of dozens of antibodies during her time at Morphosys and iOmx, and works closely with academic founder Dr. Jeker.
Lukas Jeker, M.D., Ph.D., SVP Gene Editing. Dr. Jeker is a world leader in the field of applied genome editing and Professor of Experimental Transplantation Immunology & Nephrology at the University of Basel. Earlier in his career he conducted research in the lab of Jeff Bluestone at the University of California San Francisco as a post-doc and later an Assistant Adjunct Professor.
Daniel Stark, Ph.D., Chief Manufacturing Officer. Dr. Stark formerly was head of Manufacturing Science and Technology (MSAT) at Novartis Cell & Gene Therapies, where he oversaw CMC for Kymriah and Novartis’ pipeline of cellular therapies.
Thomas Winkler, M.D., CMO. Dr. Winkler is a physician-scientist who spent 11 years conducting basic and clinical research related to various benign and malignant hematological diseases, stem cell biology, and regenerative medicine at the National Institute of Health in Bethesda, MD, and later led early stage and pivotal studies at Agios and AstraZeneca.
Tristan Imbert, CFO. Mr. Imbert previously was Senior Vice President and CFO of Novartis Gene Therapies, where he oversaw the scale up and commercialization of Zolgensma.
SAB

Chairman Fyodor Urnov, Ph.D., is Scientific Director at the Innovative Genomics Institute and Professor at the University of California, Berkeley. Dr. Urnov’s research is focused on development and advancement to the clinic of novel approaches to treat human disease using CRISPR-based genome and epigenome editing.
Jeff Bluestone, Ph.D., President and CEO of Sonoma BioTherapeutics. Dr. Bluestone is one of the leading immunologists in the field of T cell activation and immune tolerance research that has led to the development of multiple immunotherapies.
Toni Cathomen, Ph.D., Director at the Institute for Transfusion Medicine and Gene Therapy and a Professor at the University of Freiburg. Dr. Cathomen’s research is focused on improving CRISPR-Cas platforms for therapeutic applications in human stem cells.
Corey Cutler, M.D., M.P.H., Medical Director of the Stem Cell Transplantation Program at the Dana Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School. Dr. Cutler’s research is focused on developing novel methods of acute and chronic graft-versus-host disease (GVHD) prophylaxis and therapy, transplant for the myelodysplastic syndromes, and decision theory in stem cell transplantation.
Suneet Agarwal, M.D., Ph.D., Co-Program Leader for the Stem Cell Transplant Center at the Dana-Farber/Boston Children’s Cancer and Blood Disorders Center and Associate Professor of Pediatrics at the Harvard Medical School. Dr. Agarwal’s research is focused on developing innovative therapies using novel medications or a patient’s own cells to treat genetic blood disorders.
Cimeio is located in Boston, MA, and Basel, Switzerland, and is rapidly expanding its research and CMC teams to advance its three lead programs and expand its portfolio. Cimeio also has active research collaborations with Dr. Jeker’s lab, with Matt Porteus, M.D., Ph.D., at Stanford University, and with Dr. Cathomen’s research group.