On April 20, 2022 Monopteros Therapeutics Inc. ("Monopteros"), a clinical-stage biotechnology company developing MPT-0118, a first-in-class MALT1 inhibitor for the treatment of solid tumors, reported two presentations at the tumor immune microenvironment workshop of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), to be held in person in San Diego and virtually from April 21-22, 2022 (Press release, Monopteros Therapeutics, APR 20, 2022, View Source [SID1234612591]). These presentations demonstrate that highly activated immunosuppressive regulatory T cells (Tregs) in solid tumors have the potential to become interferon-gamma-producing effector T cells and that the occurrence of this reprogrammed state increases the clinical response to immune checkpoint therapy in cancer patients. Further, translational nonclinical results for MPT-0118, currently undergoing a phase 1 clinical trial (NCT04859777), are presented.

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"We are excited to present these results, which shed light on how a cold, unresponsive, and immunosuppressive tumor microenvironment can be modulated to respond to immunotherapy," said Peter Keller, President and CEO of Monopteros. "Our clinical candidate MPT-0118 is pioneering the novel mechanism of reprogramming tumor-infiltrating regulatory T cells, which is the key for opening up many cold tumors to immunotherapy."

Presentation Title: Spontaneous proinflammatory conversion of regulatory T cells (Treg) is associated with improved immune checkpoint inhibitor (CPI) response
Poster Number: 042
Presenter: Kevin Litchfield, PhD, University College of London
Presentation Date and Time: April 21, 5:20 to 6:20 pm PT
Results show that around 4% of Tregs in cancer are spontaneously producing interferon-gamma. This Treg population is associated with a higher probability of response to anti-PD-1 checkpoint inhibitor therapy in cancer patients. We further demonstrate that these reprogrammed Tregs are genetically related to a pool of highly activated PD1 and Lag3 positive Tregs.

Presentation Title: Reprogramming Regulatory T cells (Treg) Using a MALT1 Inhibitor for Cancer Therapy
Poster Number: 037
Presenter: Peter Keller, MSc, Monopteros Therapeutics
Presentation Date and Time: April 21, 5:20 to 6:20 pm PT
This poster was requested for resubmission from SITC (Free SITC Whitepaper)’s annual conference in 2021 and presents the data generated with clinical-stage MPT-0118 to reprogram regulatory T cells in mouse and human tissue and its preclinical anti-tumor effects.

Following the conference, the two presentations will be available in the Publications section of Monopteros’ website at www.monopterostx.com.

On April 20, 2022 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported data demonstrating that MN-166 (ibudilast) prevents metastasis in a uveal melanoma (UM) animal model was published in the journal Molecular Cancer Research (Press release, MediciNova, APR 20, 2022, View Source [SID1234612858]).

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The publication entitled "Uveal Melanoma Exosomes Induce a Prometastatic Microenvironment through Macrophage Migration Inhibitory Factor," was co-authored by MediciNova’s collaborators Dr. Grazia Ambrosini, Research Scientist at The Herbert Irving Comprehensive Cancer Center (HICCC), Columbia University Medical Center; Alex J. Rai, PhD, Associate Professor of Pathology and Cell Biology, Columbia University Irving Medical Center; Richard D. Carvajal, MD, Associate Professor of Medicine at Columbia Vagelos College of Physicians and Surgeons and co-director of the Precision Oncology and Systems Biology research program at the HICCC; and Gary Schwartz, MD, Professor of Oncology at Vagelos College of Physicians and Surgeons, Division Chief of Hematology/Oncology at Columbia University Irving Medical Center, and Deputy Director at the HICCC.

The publication describes a preclinical study which characterized the proteomic content of uveal melanoma exosomes and identified the presence of markers with metastatic properties. The study included an evaluation of MN-166 (ibudilast) in a metastatic uveal melanoma model.

Key take-aways in the publication include:

Uveal melanoma exosomes (UM-exo) induce activation of cell signaling pathways and the release of cytokines and growth factors from hepatocytes. These exosome-stimulated liver cells could in turn induce migration of UM cells.
The proinflammatory cytokine macrophage migration inhibitory factor (MIF) was over expressed in UM exosomes and was a major player in these mechanisms. MIF blockade inhibited UM cell migration in co-cultures with exosome-stimulated hepatocytes and prevented the development of metastases in vivo.
Most inhibitors of hepatocyte-derived cytokines and growth factors had little or partial effects in blocking UM cell migration toward exosome-stimulated hepatocytes.
The MIF inhibitor MN-166 (ibudilast) dramatically inhibited UM cell migration (p<0.001), suggesting that MIF plays a major role in the cell-to-cell cross-talk.
In the metastatic UM mouse model study,
Quantified bioluminescence signal intensity in the abdominal region was dramatically reduced by MN-166 (ibudilast) treatment (p<0.05) in the metastatic UM mouse model at Day 46.
Histological analysis of the liver tissues of control mice showed the presence of tumor cell clusters, which were not present in the liver tissues of mice treated with MN-166 (ibudilast).
MN-166 (ibudilast) prevented metastasis in the metastatic UM mouse model.
This study provided the first in vivo evidence that MIF inhibition may serve as a novel adjuvant drug therapy to prevent metastasis in uveal melanoma.
MIF inhibition with MN-166 (ibudilast) may prevent metastatic spread in uveal melanoma patients and help to address the unmet critical need for novel and effective adjuvant therapies.
Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc. commented, "We are very pleased that the details of the research data regarding MN-166 preventing metastasis in the metastatic UM mouse model study has been published. Cancer metastasis is often the major driver of cancer-related death rather than the primary cancer. We previously reported that MN-166 reduced levels of immune suppressive myeloid-derived suppressor cells (MDSCs) and enhanced CD8 T cell activity in the tumor microenvironment. The data from this metastatic UM model study suggested that treatment with MN-166 can potentially address significant unmet medical needs for novel and effective therapies for patients with UM at risk of metastasis. We are optimistic that MN-166 could help patients with UM and other malignancies."

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and for glioblastoma, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) is being evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

On April 20, 2022 ArcticZymes Technologies reported that it will attend the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), which will take place from the 23rd to 26th of April in Lisbon, Portugal (Press release, Biotec Pharmacon, APR 20, 2022, View Source [SID1234612575]).

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Our team is looking forward to meeting you at booth 2-11.1 located in Pavilion 3 to discuss your needs and share the latest development on our enzymes!

On April 20, 2022 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, reported it has partnered with oncology development expert Gilad Gordon, MD to assist the Company in developing its next-generation LADR drugs toward first-in-human clinical trials (Press release, CytRx, APR 20, 2022, View Source [SID1234612592]).

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Dr. Gordon is President of ORRA Group, LLC, a consultancy focused on assisting companies in drug development efforts, particularly in oncology. Dr. Gordon brings 30 years of experience in the development of oncology therapeutics, having led clinical teams in multi-national Phase I through Phase III trials. Throughout his career, Dr. Gordon has participated in the filing of over 50 Investigational New Drug ("IND") applications, has had responsibility for hundreds of clinical trials in cancer and has been responsible for the final market approvals of approximately five cancer therapeutics that went on to help cancer patients. In addition, Dr. Gordon was a senior member of the management team that sold Inviragen, Inc. to Takeda Pharmaceutical Company Limited for $250 million and has been involved in raising more than $2 billion through IPOs, venture funding and other partnership programs.

CytRx CEO Dr. Stephen Snowdy commented:

"We are really excited to have someone with Dr. Gordon’s experience in developing cancer therapies working with us to move our next-generation LADR drugs closer to saving lives. CytRx is committed to moving these cancer assets toward IND filing as quickly and capital-efficiently as possible and is working hard to find the most expedient path possible. The difficult market environment has not impacted our confidence in LADR or our resolve to unlock shareholder value through advancement of our LADR-based drugs."

Dr. Gordon added:

"Globally, there are 17 million new cancer cases per year, and 10 million deaths due to cancer. Additional treatments for this disease are desperately needed. CytRx’s unique LADR backbone allows for the targeting of drugs to tumors, and subsequent concentration and release of drugs in the tumor, which is expected to reduce toxicity and increase efficacy. This elegant approach has the added benefit of being based on small molecules, which offers advantages in manufacturing and toxicity relative to large molecules, such as antibodies or liposomal particles. The first LADR drug, Aldoxorubicin, has provided validation of the LADR approach in multiple clinical trials, allowing several-fold higher dosing of doxorubicin than would be possible without the LADR backbone, and is in late-stage clinical trials for pancreatic cancer. Most importantly, the preclinical data on the next-generation LADR drugs is very impressive, and I look forward to helping guide these products through clinical testing and the regulatory process."

Dr. Gordon attended Harvard College and received his MD from Harvard Medical School. He is Board-certified in Internal Medicine and received his Master of Business Administration from the University of Washington. He is a Clinical Associate Professor of Medicine at the University of Colorado.

On April 20, 2022 EpiAxis Therapeutics reported that it was thrilled to attend and present at the ACCESS CHINA Biotech Forum Spring Showcase 2022 earlier this month (Press release, EpiAxis Therapeutics, APR 20, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-therapeutics-presents-access-china [SID1234612827]).

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ACCESS CHINA Biotech Forum is one of the largest corporate access events in China. It provides opportunities for business development, licensing deals and commercial collaborations to global biopharmas. It has been held every quarter since 2020 and has been bringing together international and Chinese biotech BDs and CEOs over the past two years.

The 2022 ACCESS CHINA forum was held online from 18-19 April 2022, attracting more than 1000 participants from China pharma and biotech companies.

EpiAxis CEO Dr Jeremy Chrisp presented during the US and Australia biotech Company Roadshows sessions. His video presentation focused on overcoming resistance to standard of care cancer treatments with novel epigenetic cancer therapies.

Dr Chrisp explained that the primary focus at EpiAxis Therapeutics is the initial treatment and subsequent prevention of recurrence of cancer using proprietary LSD1 inhibitors.

"We are seeking capital to allow us to complete our program to advance one of our therapeutics into the clinic," Dr Chrisp said. "We believe LSD1 is the pivotal enzyme controlling cancer regression. Our thesis is directed towards inhibiting nuclear LSD1 and we believe it allows us to reprogram cancer cells and immune cells to offer a new way to treat aggressive cancer."