On December 10, 2019 Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter "Solasia") reported that it has entered into an exclusive license agreement with Maruho Co., Ltd. (Headquarters: Osaka, Japan, President & CEO: Koichi Takagi, hereinafter "Maruho") for commercialization of Solasia’s product SP-04 (PledOx, hereinafter "product"), a therapeutic agent for chemotherapy induced peripheral neuropathy (currently undergoing Phase III clinical trials; active ingredient name: calmangafodipir) in Japan (Press release, Solasia, DEC 10, 2019, View Source [SID1234552204]).

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Under the license agreement, Maruho will commercialize the product exclusively in Japan after Solasia completes development of the product. Based on the license agreement, Solasia will supply the product exclusively to Maruho, and Maruho will pay Solasia an upfront payment of 1.0 billion yen and milestone payments based on progress in development and marketing up to a total of 18.0 billion yen.

In addition to the above license agreement, Solasia and Maruho have entered into a capital alliance agreement whereby Maruho acquires Solasia shares by a third-party allotment with a view to maintain a close business relationship going forward.

Capital alliance format:

Acquisition of newly issued Solasia shares by Maruho in third-party allotment

Pay-in date:

December 26, 2019

Number of shares issued:

11,324,000 Solasia common stock

Issue price per share:

151 yen (closing price on December 9, 2019)

Total issue amount:

1,709,924,000 yen

Shareholding ratio after issue:

Maruho will hold 9.70% of outstanding shares in Solasia

Lock-up agreement:

Maruho must obtain prior consent from Solasia if transferring its shareholding before the day following the date of the initial announcement of the clinical trial results and others by Solasia after completion of the two Phase III trials of the product currently under way.

Solasia’s top shareholder, ITOCHU Corporation must obtain prior consent from Solasia if transferring its shareholding within one year of the pay-in date stated above.

Use of proceeds:

For in-licensing and development of new pipeline product SP-05.

Maruho specializes in dermatology and has contributed to improving the quality of life (QOL) of patients suffering from skin disorders caused by cancer treatment. This time, in order to further contribute to cancer patients and their families, Maruho decided to obtain the rights to commercialize the product. Solasia specializes in oncology in Asia, and 3 of their 4 existing and development products include drugs that treat the side effects of anticancer drugs. Solasia is yet to establish an in-house sales force in Japan. Therefore, in light of the steady progress of the phase III clinical trial for the product, Solasia decided to derive the commercialization rights to Maruho who share the common philosophy of the importance of improving patient QOL.

Koichi Takagi, President and CEO of Maruho, commented as follows:
"Solasia is a specialty pharmaceutical company in oncology. The company supports patients undergoing cancer treatment and their families by developing not only anticancer drugs, but also cancer supportive care products to improve patient QOL. In collaboration with Solasia, we will continue to do our best to help cancer patients and their families further by combining Solasia’s extensive knowledge in oncology with the experience we have gained in improving patient QOL."

Yoshihiro Arai, President and CEO of Solasia, commented as follows:
"Maruho is a leading company in Japan in the dermatology area that has gained from many years’ experience with cancer and other patients the insight that improving patient QOL is as important as treating the underlying disease. We are confident that Maruho, with its wealth of knowledge and experience in patient QOL, is the best partner for Solasia, as we can broadly share the expectations and importance of our development product SP-04 in the treatment of chemotherapy-induced peripheral neuropathy and work together to improve patient QOL.".

On December 10, 2019 ImmunOs Therapeutics AG, a Swiss bio-technology company and leading developer of a next generation innate immunity focused immunotherapy platform for cancer, reported the closing of a Series A financing of CHF 15 million (Press release, ImmunOs Therapeutics, DEC 10, 2019, View Source [SID1234552203]). The round was co-led by the Basel life sciences venture capital firm BioMedPartners and Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE), with the participation of Redalpine, Schroder Adveq, Wille Finance AG, BERNINA BioInvest Ltd alongside new private and existing investors. The financing will be used to complete the first-in-human trials with the company’s lead agent, iosH2, a potential new cancer treatment for both solid and liquid tumors. The funding will also be used to broaden the company’s novel immunotherapy iosH platform by advancing additional preclinical programs focusing on both cancer and auto-immunity.

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"Recent advances in the understanding of the innate immune system’s role in cancer provide a unique opportunity for ImmunOs Therapeutics and our partners. We value the ongoing support of all the current investors and welcome all the Series A round participants, specifically Pfizer Ventures and BioMedPartners, both of whom have demonstrated a strong commitment to the oncology field," said Sean R. Smith, CEO of ImmunOs Therapeutics AG.

Dr. Osiris Marroquin Belaunzaran, CSO and co-founder, added: "It is with great pleasure to see that our early research based on HLA open conformer modulation of immune cells is advancing toward a clinical drug candidate for human studies. Targeting the innate immune system to modulate the tumor microenvironment has been a key strategy for ImmunOs, and together with foundational approaches targeting the adaptive immune system such as PD-1 antibodies, we aim to produce a strong therapeutic benefit in difficult-to-treat cancer indications."

In conjunction with the financing, ImmunOs Therapeutics has expanded its Board of Directors to include four new members: Dr. Markus Hosang of BioMedPartners; Dr. Michael Baran of Pfizer Inc.; Dr. Reinhard Ambros, former head Novartis Venture Fund; and Dr. Daniel Vasella, former Chairman and CEO Novartis.

Dr. Markus Hosang noted: "At BioMedPartners, we have over the last 15 years very successfully invested in and brought forward several innovative early-stage cancer companies. We got particularly attracted by ImmunOs and its novel approach that also adds to existing treatment modalities and thus has the potential to provide novel medicines to cancer patients who do not obtain a long-term benefit from current therapies."

Dr. Michael Baran added: "Advances in understanding the role of the innate immune system is opening up opportunities to expand the potential of cancer immunotherapy. Pfizer Ventures is enthusiastic to support this emerging area through our investment in ImmunOs."

On December 10, 2019 Vedanta Biosciences, Inc. (Vedanta Biosciences, Vedanta or the Company), a clinical-stage biopharmaceutical company developing a new category of therapies for immune-mediated diseases based on defined bacterial consortia, reported the initiation of a first-in-patient clinical study of VE800 in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab) in patients with select types of advanced or metastatic cancer (Press release, Vedanta Biosciences, DEC 10, 2019, View Source [SID1234552202]). Vedanta also announced the formation of its Immuno-Oncology Scientific Advisory Board (SAB), which is comprised of experts in immunology, immuno-oncology and the microbiome, to support the planned clinical development of VE800.

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The study, which is being conducted at clinical centers in the United States, will evaluate the safety and tolerability and clinical activity of VE800 in combination with Opdivo, as measured by the confirmed overall response rate, in addition to other parameters. The open-label, non-randomized study will target enrollment of over 100 patients diagnosed with advanced or metastatic melanoma, gastric/gastroesophageal junction adenocarcinoma, or microsatellite-stable colorectal cancer. Eligible patients will receive daily VE800 dosing in combination with Opdivo. Topline results are anticipated in 2021.

"Despite unprecedented global investment in checkpoint inhibitors, there is still a major need for differentiated approaches to further enhance and expand responses in cancer," said Bernat Olle, Ph.D., co-founder and chief executive officer of Vedanta Biosciences. "The role the gut microbiota plays in influencing responses to immunotherapies has been ignored by previous approaches, so we are excited about the potential of microbiome modulation to open up an entirely new approach to cancer therapy."

VE800 is made up of 11 commensal bacterial strains that act in concert to activate cytotoxic CD8+ T cells, which are the vanguard of the immune system’s response to tumors and thus a key driver of effective immunotherapies. In preclinical studies, VE800 has been shown to enhance the ability of these T cells to infiltrate tumors, thereby promoting suppression of tumor growth and potentially enhancing survival. Preclinical data also suggest that VE800 may enhance the effects of checkpoint inhibitors.

Foundational work demonstrating VE800’s novel anti-tumor activity and cooperatively potentiated responses to checkpoint inhibitor therapies and various immune challenges was published in Nature by Vedanta and its scientific co-founder Kenya Honda, M.D., Ph.D., of Keio University School of Medicine. The research also showed that mice colonized with VE800 demonstrated enhanced therapeutic efficacy in a range of tumor models when VE800 was administered in conjunction with PD-1 or CTLA4 immune checkpoint inhibitors.

"The ability of bacterial consortia to mediate immune activity, including potential anti-cancer activity, is an exciting area for investigation in indications with some of the highest unmet medical need," said Hassane M. Zarour, M.D., co-leader of the Cancer Immunology and Immunotherapy Program of the Hillman Cancer Center, University of Pittsburgh, and a member of Vedanta’s newly formed Immuno-Oncology SAB. "We see enormous potential for this class of drugs to improve cancer patients’ outcomes."

Vedanta’s newly announced Immuno-Oncology SAB will work closely with the Company’s scientific co-founders and leadership to further support the clinical development of VE800. The SAB includes:

Antoni Ribas, M.D., Ph.D.is a leading translational and clinical researcher in immuno-oncology with a focus on malignant melanoma. He is a professor of medicine, surgery and molecular and medical pharmacology at the University of California Los Angeles (UCLA), director of the tumor immunology program at the Jonsson Comprehensive Cancer Center, director of the Parker Institute for Cancer Immunotherapy Center at UCLA, chair of the Melanoma Committee at SWOG and president-elect 2019-2020 of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
Josep Tabernero, M.D., Ph.D. is a researcher focused on gastrointestinal cancers and cancer genetics. At Vall D’Hebron Institute of Oncology (VHIO), he is director of clinical research, co-director of the research unit for molecular therapy of cancer, head of the gastrointestinal and endocrine tumors group, and head of the medical oncology department of Vall d’Hebron University Hospital. He is also president of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper).
Hassane Zarour, M.D. is a researcher with expertise in melanoma and skin lesions, immunotherapy and cancer vaccines. At the University of Pittsburgh Medical Center, he is a professor of medicine, immunology and dermatology, co-leader of the melanoma program and the James W. and Frances G. McGlothlin chair in melanoma immunotherapy research.
Diwakar Davar, MBBS, M.Sc. is a leader in microbiome science and using the microbiome to treat melanoma. He is an assistant professor of medicine at the University of Pittsburgh Medical Center.
Bertrand Routy, M.D., Ph.D. is recognized as one of the first researchers to demonstrate the negative impact of antibiotics and the microbiome on the efficacy of checkpoint inhibitor therapy. He is an assistant professor of hematology-oncology and director of the laboratory of immunotherapy / oncomicrobiome at the Centre hospitalier de l’Université de Montréal (CHUM).
Dan Littman, M.D., Ph.D. is a scientific co-founder of Vedanta and a leader in T cell biology, including differentiation and lineage specification. He is the Helen L. and Martin S. Kimmel professor of molecular immunology and pathology and professor in the department of microbiology at the Skirball Institute of Biomolecular Medicine at New York University Langone School of Medicine.
Sasha Rudensky, Ph.D. is a scientific co-founder of Vedanta and a leader in molecular mechanisms of CD4 T cell differentiation, particularly regulatory T cells. He is chair of the immunology program at Sloan Kettering Institute (SKI) and director of the Ludwig Center at Memorial Sloan Kettering (MSK).
About VE800

VE800 is Vedanta Biosciences’ proprietary, orally administered immuno-oncology product candidate. It is produced from pure, non-pathogenic clonal bacterial cell banks, which yield a standardized drug product in powdered form. VE800 consists of a rationally-defined bacterial consortium of 11 commensal strains that, acting in concert, activate cytotoxic CD8+ T cells, a type of white blood cell that is the predominant effector in cancer immunotherapy. In preclinical studies, VE800 has been shown to enhance the ability of these T cells to infiltrate tumors, thereby promoting suppression of tumor growth and enhancing survival. Preclinical data also suggest that VE800 may enhance the effects of checkpoint inhibitors. Vedanta is evaluating VE800 as a potential treatment for patients with advanced or metastatic cancers.

On December 10, 2019 Geron Corporation (Nasdaq: GERN) reported that two posters related to imetelstat, the Company’s first-in-class telomerase inhibitor, were presented at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando, Florida on December 8 and 9 (Press release, Geron, DEC 10, 2019, View Source [SID1234552199]). Both posters are available on Geron’s website at www.geron.com/r-d/publications.

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Trials in Progress Poster Presentation

Title: IMerge: A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) That Is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment (Abstract #4248)

The poster described key aspects of the IMerge Phase 2/3 clinical trial, including: the trial design; patient eligibility criteria; primary, secondary and exploratory endpoints; and the status of the trial. The poster also included a summary of previously presented data from the Phase 2 portion of the IMerge trial.

IMerge is an ongoing global two-part Phase 2/3 clinical trial of imetelstat in red blood cell (RBC) transfusion dependent patients with Low or Intermediate-1 risk, or lower risk myelodysplastic syndromes (MDS), who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint for the IMerge Phase 2/3 clinical trial is 8-week RBC transfusion independence (TI), which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions.

IMerge Phase 3 Trial Now Enrolling

The IMerge Phase 3 is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial. The trial will enroll non-del(5q) lower risk MDS patients who are naïve to treatment with hypomethylating agents (HMAs) and lenalidomide. The primary and secondary endpoints remain the same as the Phase 2 portion of the trial. Approximately 90 sites are planned to participate in 12 countries across North America, Europe, Middle East and Asia. Enrollment opened in August 2019, and the first patient was dosed in October 2019.

To learn more about the IMerge Phase 3 clinical trial and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov (NCT02598661).

IMerge Phase 2 Data Summary

Imetelstat treatment showed meaningful and durable transfusion independence in 38 non-del(5q) lower risk MDS patients who were naïve to HMAs and lenalidomide.
42% (16/38) of patients achieved ≥8-week RBC-TI
29% (11/38) of patients achieved ≥24-week RBC-TI
Median duration of TI was 85.9 weeks (range: 8.0-140.9)
68% (26/38) of patients achieved HI-E, or improvement in red blood cell count, as measured by either transfusion reduction or a rise in hemoglobin:
All 26 patients had a reduction of at least four RBC units over eight weeks compared with prior transfusion burden
12 patients had a hemoglobin increase of at least 1.5 g/dL lasting at least eight weeks
Mean relative reduction in transfusion burden from baseline was 68%
Transfusion independence was observed across different MDS patient subgroups.
Biomarker data suggested potential impact on malignant clone and disease modification by imetelstat treatment.
No new safety signals were identified. Reversible cytopenias were the most frequent adverse events.
Non-Clinical Data Poster Presentation

Title: Combination Treatment with Imetelstat, a Telomerase Inhibitor, and Ruxolitinib Depletes Myelofibrosis Hematopoietic Stem Cells and Progenitor Cells (Abstract #2963)

This poster presentation described results from early, nonclinical experiments on the potential effect of combining imetelstat and ruxolitinib on malignant myelofibrosis (MF) cells. The experiments explored the hypothesis that, due to different mechanisms of action, a combination of imetelstat and ruxolitinib might create a treatment regimen for MF that could be more efficacious than using either drug alone in reducing both malignant progenitor and stem cells. Ruxolitinib is a janus kinase (JAK) inhibitor that inhibits proliferation of malignant progenitor cells without eliminating malignant stem cells. Imetelstat is a telomerase inhibitor that selectively depletes malignant progenitor and stem cells.

In the experiments, the sequential treatment of ruxolitinib followed by imetelstat had additive inhibitory activity resulting in greater reductions in both malignant progenitor and stem cells when compared to simultaneous treatment or either drug alone. Furthermore, the sequential treatment regimen did not affect normal hematopoietic progenitor and stem cells. As stated in the poster, these non-clinical findings suggest that sequential treatment of ruxolitinib followed by imetelstat represents a potentially effective treatment that may eliminate both malignant MF progenitor and stem cells.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS), and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis (MF). Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.

On December 10, 2019 Omeros Corporation (Nasdaq: OMER) reported an upcoming presentation directed to its novel cancer immunotherapy target GPR174 at the European Society for Medical Oncology 2019 Immuno-Oncology Congress, which is being held December 11-14, 2019 in Geneva, Switzerland (Press release, Omeros, DEC 10, 2019, View Source [SID1234552198]).

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In addition to previously presented ex vivo human and in vivo animal studies, the presentation will include new findings from human T-cells demonstrating that GPR174 inhibition results in downregulation of checkpoint and tumor promoting factors.

The poster (#108P) will be presented on December 12, 2019, at 12:15 PM local time by Marc Gavin, Ph.D., Omeros’ Director of Immunology.