On January 10, 2023 NKGen Biotech, a biotechnology company harnessing the power of the body’s immune system through the development of natural killer cell therapies, reported the appointment of Paul Y. Song, MD as Chief Executive Officer (CEO) and Vice Chairman of the Board of Directors, effective January 10, 2023 (Press release, NKMax America, JAN 10, 2023, View Source [SID1234626150]).

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"We are thrilled to welcome Paul as our new CEO and the experience, vision and leadership Paul brings to NKGen Biotech," said Sangwoo Park, Founder and Chairman of NKGen Biotech. "Paul will play a critical role in leading our company’s corporate strategy and the advancement of our potentially life-changing clinical portfolio in oncology and neurodegenerative disease. Paul’s passion for helping patients along with his focused expertise in NK cell therapeutics will provide NKGen with the guidance it needs to successfully meet its milestones and continue to show significant progress towards commercialization."

" I am honored to lead NKGen at this pivotal time as the Company advances its novel NK cell therapies through the clinic and in new disease indications," stated Paul Y. Song, MD, CEO of NKGen Biotech. "I strongly believe in the Company’s science and platform, unmatched manufacturing expertise, and talented leadership team making NKGen uniquely positioned to expand the overall NK cell therapy market well beyond oncology. NKGen has several key milestones on the immediate horizon in 2023 for both our autologous SNK01 and our allogeneic SNK02 NK cell therapy, and I am very optimistic that we will soon be able to show the true potential of our enhanced NK cell products to address a high unmet need for disease modifying treatment in advanced cancers and neurodegenerative diseases."

Dr. Song has nearly 25 years of experience as a biopharma executive, clinician, and translational medicine expert. Most recently, Dr. Song served as Co-founder and CEO at FuseBio Therapeutics, a company developing immune modulating therapies for cancer. Prior to FuseBio he was Chief Medical Officer at NKMax America leading the NK cell therapy clinical program strategy; CMO at Cynvenio Biosystems, a clinical stage genomic peripheral blood monitoring company; and CMO/Senior Advisor for Berg Health. Before joining the pharmaceutical industry, Dr. Song was an attending physician at Cedars-Sinai Medical Center’s Samuel Oschin Cancer Center.

Dr. Song is a board-certified Radiation Oncologist with expertise in translational medicine, clinical trials, and therapeutic development within oncology and immunology. He graduated with honors from the University of Chicago and received his M.D. degree from The George Washington University. Dr. Song completed his residency in radiation oncology at the University of Chicago where he served as Chief Resident and completed a brachytherapy fellowship at the Institute Gustave Roussy in Villejuif, France. He was also awarded an ASTRO research fellowship in 1995 for his research in radiation inducible gene therapy.

On January 10, 2023 NervianoMS reported that the targeted drug NMS-01940153E, a monopolar spindle 1 (MPS1) kinase inhibitor, has shown signs of clinical activity in a Phase I study of patients with relapsed or refractory unresectable hepatocellular carcinoma (HCC) (Press release, Nerviano Medical Sciences, JAN 10, 2023, View Source [SID1234626149]). The study findings were reported at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics.

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"We only treated 12 patients, but two of them achieved partial response. That means decreased tumor burden [of] at least 30 percent," said first author Maria Reig, MD, PhD, Professor and Head of the Barcelona Clinic Liver Cancer Unit at the Hospital Clinic of Barcelona at Barcelona University in Spain. Two further study patients (one for each dose level) had long-lasting stable disease, one of whom showed alpha-fetoprotein down modulation.

"NMS-01940153E represents a new type of treatment working in a very different way from the current options for treating liver cancer," Reig noted. It offered potential to help patients in the future. But she emphasized that the efficacy noted in this early study—primarily dose-finding and toxicity—needed to be confirmed.

The study reported that the experimental agent had shown orders of magnitude (two logs) higher anti-proliferative activity in HCC cell lines than sorafenib, lenvatinib, and regorafenib, which are kinase inhibitor drugs already being tried to treat HCC.

"Preclinical work demonstrated that NMS-01940153E was highly effective in preventing the proliferation of cancer cells, both on its own and in combination with other anti-cancer drugs. It seems more potent than other kinase inhibitors in liver cancer cells. And so we are testing it—as a single agent—in a Phase 1 clinical trial in liver cancer patients," said Reig, who noted the current standard for systemic treatment—immunotherapy—generally failed in three-quarters of all patients.

After her talk in Barcelona, Reig said their investigational Mps1 kinase inhibitor had been shown to target cell division in what she described as one of the most lethal cancers. "The amazing thing is that it works in the cycle of mitosis," she said. "The key thing, here, is that expression of MPS-1 was demonstrated in several cancers—[and] also in HCC. However, until now we did not have data in hepatocellular carcinoma cell lines. [The] pre-clinical data that was presented was focused on that. We identified a new mechanism of action related to mitosis. This was used in the past for other tumors, but not in HCC."

When she was asked what was special about this particular kinase inhibitor that set it apart, she told Oncology Times it was the specific target that made the difference. "We are really, really interested in continuing with this research because [it] seems that it could act in an area that we have never seen before in HCC. Because patients [who] were failures for other treatments—sorafenib, lenvatinib, regorafenib—now have a good outcome with this component."

Patients with HCC enrolled in the study had a median age of 64 years and a median number of two prior systemic therapies. By the cut-off date (in August 2022), 10 patients had discontinued treatment, seven due to disease progression and two because of dose-limiting toxicities. Drug-related adverse events included neutropenia, chromaturia, thrombocytopenia, anemia, asthenia, and diarrhea.

Reig said neutropenia was the most frequent adverse event, defining the maximum tolerated dose. So, it was key in the management of patients, she said. But it was manageable. "The important thing [is] neutropenia recovered to Grade 1 in 9 days without [any] need to use treatment."

Reig said that, although their patients developed progression, many of them had good performance status and liver function. "For example, one of the patients lived 11 months after progression. So that means that after three failures, the fourth line of treatment [gave] the median survival (from the beginning of the study) [of] almost a year—something amazing."

The investigators concluded that the MPS1 inhibitor had shown preclinical and clinical activity in HCC and that the safety of the agent was manageable. In the ongoing Phase II study, it was currently under evaluation in patients with unresectable HCC previously treated with standard-of-care systemic therapy.

"I’m interested, but I’m really cautious," said Reig. "We are talking about a very early phase of development. The sign is here, but be cautious. Consider this drug only in the setting of a clinical trial."

On January 10, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company pioneering the development of monoclonal antibodies targeting various cancer types, reported the completion and closure of enrollment for the final cohort of patients involved in the Company’s Phase I trial to evaluate Pritumumab ("PTB") as a treatment for Brain Cancer (Press release, Nascent Biotech, JAN 10, 2023, https://www.nascentbiotech.com/nascent-enrolls-final-patient-cohort-in-phase-i-brain-cancer-trial/ [SID1234626148]).

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Following the completion of patient dosing in this fifth and final cohort, the Company’s Phase I trial will be complete. The Company will then prepare and submit research data to the FDA in preparation for the launch of its Phase 2 clinical research.

"Closing enrollment for this final cohort of our Phase I trial is a tremendous milestone that marks the start of our preparation for Phase II research," noted Nascent CEO, Sean Carrick. "This is a significant accomplishment in the advancement of our Biologic asset and in our mission to help future patients in their battle against this terrible disease."

PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy which seeks out only cancer cells while sparing healthy cells.

On January 10, 2023 Micronoma, the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, reported that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA) (Press release, Micronoma, JAN 10, 2023, View Source [SID1234626147]).

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As a result, Micronoma can expect continued guidance and prioritized reviews from the agency of its upcoming clinical trial and concomitant pre-market approval processes. The FDA based its Breakthrough Device decision on the ability of Micronoma’s technology to categorize lung nodules into high-risk or low risk of malignancy through a simple blood draw, even in the earliest stages of the disease, compared to the current standard of care.

Early detection of lung cancer can lead to a higher survival rate. In the U.S., lung cancer accounts for nearly 25% of all cancer-related deaths each year, with more people dying from lung cancer than from colon, breast, and prostate cancers combined (source: American Cancer Society).

"Receiving FDA Breakthrough Device Designation is a fantastic recognition by the agency and a great milestone for Micronoma," said Sandrine Miller-Montgomery, Micronoma CEO and co-founder. "While I have always had the utmost trust and admiration for my team, this is an objective recognition of the great science and rigorous work they have been conducting. The possibilities for the Oncobiota platform are endless, and while we are starting with lung cancer, we have active collaborations to pursue other cancer types for which early detection is critically unavailable. This designation is our first opportunity to expedite what we set out to do at our inception: significantly contribute to improving cancer patient care through early diagnosis."

The work that led to the Breakthrough Device Designation is based on the findings of Micronoma’s co-founders, published in the scientific journals Nature and Cell. These discoveries were then validated in a large, lung-specific cohort, as described in a manuscript shared with the FDA and under review at a high-impact journal.

When an imaging test (e.g., low-dose CT scan (LDCT)) shows an indeterminate lung nodule in a patient, the current standard of care is to keep the patient under surveillance with additional imaging (e.g., more LDCTs, PET-CT scans). Then, if suspicion remains, they are sent for a lung biopsy. However, since 95% of imaged lung nodules turn out to be benign, the current patient journey can be a slow and risky one, with potentially invasive but unnecessary tissue biopsies. In contrast, with a simple blood draw, Micronoma’s OncobiotaLUNG diagnostic assay can help clinicians determine a high-risk versus low risk of malignancy for the detected lung nodules, with diagnostic performance that matches or exceeds the current standard of care.

On January 10, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), hepatocellular carcinoma ("HCC"), and other chronic liver diseases, reported that its research collaborator, Carlos Perez-Stable, PhD, from the University of Miami Miller School of Medicine and Miami Veterans Affairs/Research, today presented new findings from a preclinical study on the Company’s lead drug candidate, rencofilstat, a potent inhibitor of cyclophilins, in a presentation at the 2023 State of Florida Cancer Symposium in Tampa, Florida (Press release, Hepion Pharmaceuticals, JAN 10, 2023, View Source [SID1234626146]).

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The presentation, entitled "A New Strategy to Increase Proteotoxic Stress in Prostate Cancer," highlighted a preclinical study which investigated the killing of cultured prostate cancer cells by rencofilstat in combination with a proteasome inhibitor, ixazomib. Proteosome inhibitors are a class of anti-cancer agents that are used for the treatment of multiple myeloma and other blood cancers. They kill cancer cells by inducing a process called proteotoxic stress. There has been long-standing interest in expanding the use of proteosome inhibitors for solid tumors, but clinical trials to date have not shown durable anti-tumor efficacy. The present study showed that rencofilstat could synergistically increase the proteotoxic stress and in vitro cancer killing properties of ixazomib. These results suggest that the addition of rencofilstat could expand the use of proteosome inhibitors for existing applications, or possibly for other cancers, such as prostate cancer.

In this preclinical study, rencofilstat and ixazomib were applied at low concentrations to several types of prostate cancer cell lines, and also to non-cancerous prostate cells. Neither drug alone at low concentrations caused proteotoxic stress or killed the cells. However, in combination they induced sustained proteotoxic stress and killed 70% – 90% of the cancer cells (4 different cell lines) over two days. In contrast, the drug combination caused only mild, transient stress and no killing of the non-cancer cells.

"The selective killing of several cancer cell lines by this drug combination without killing the non-cancer cells occurred because cancer cells are especially susceptible to proteotoxic stress due to their aggressive growth and high demand for proteins," said Dr. Perez-Stable. "Certain isoforms of cyclophilins participate in the efficient synthesis and function of proteins and contribute significantly to cancer cell growth. Inhibiting those cyclophilins with rencofilstat and impairing protein turnover with ixazomib together stressed the cells beyond a threshold and triggered their death."

"Dr. Perez-Stable’s findings open up new opportunities, in addition to our Phase 2 trials in NASH, for investigation of potential cancer treatments and therapeutic use of rencofilstat," said Daren Ure, PhD, Hepion’s Chief Scientific Officer. "The findings are similar to those of a previous, independent study in which cyclophilin inhibition in combination with the proteosome inhibitor, carfilzomib, synergistically killed multiple myeloma cells.1 A synergistic anti-cancer effect also has been observed in a liver cancer study in mice with a combination of rencofilstat and a checkpoint inhibitor, anti-PD1 antibody. Thus, evidence is accumulating that rencofilstat could potentiate the anti-cancer activities of multiple agents, through multiple mechanisms, and across a variety of cancer types. This makes us very optimistic that rencofilstat will have tremendous versatility as an anti-cancer agent."

Reference

1Nature Medicine, 2021 27(3):491-503. doi: 10.1038/s41591-021-01232-w