GT Biopharma Announces Preclinical Results For Its ROR1 TriKE™ As A Treatment For Prostate Cancer

On March 8, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical company focused on disruptive, target-directed Natural Killer (NK) cell engager immunotherapy technologies (TriKE) for cancer, reported preclinical results for its ROR1 TriKE product candidate as a prospective therapy for the treatment of prostate cancer (Press release, GT Biopharma, MAR 8, 2021, View Source [SID1234576198]).

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Tyrosine kinase transmembrane receptor ROR1 has recently been shown to be overexpressed on certain cancer cells, and appears to play a functional role in promoting migration/invasion and influencing the metastatic potential of various solid tumor cancers. Targeting ROR1 on cancer cells with TriKE and redirecting NK cells to attack and kill cancer cells expressing ROR1, could result in a therapeutic treatment that limits the metastatic potential and invasiveness of certain solid tumor cancers.

The ROR1 TriKE was evaluated in several preclinical models of prostate cancer, and was found to be effective at promoting NK cell killing of multiple prostate cancer cells including LnCAP, C4-2, PC-3, DU-145, VCaP and 22RV1. Significant NK cell activation and interferon gamma (IFNγ) production was also observed as a result of TriKE engagement and activation of the NK cell.

"We are pleased to report our ROR1 TriKE has passed this important preclinical milestone, and demonstrated effectiveness in promoting redirected and target-specific killing by NK cells," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "We plan to evaluate the ROR1 TriKE in additional IND-enabling preclinical studies with the goal of transitioning to a Phase I/II clinical trial."

Enlivex Receives Notice of Allowance for Japanese Patent Application Covering the use of Allocetra in Combination with CAR-T Therapies

On March 8, 2021 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company targeting diseased macrophages in patients with sepsis, COVID-19 and solid tumors, reported that the Japan Patent Office issued a notice of allowance for a new patent application (number 2017-543802) covering AllocetraTM, the Company’s immunotherapy product candidate (Press release, Enlivex Therapeutics, MAR 8, 2021, View Source [SID1234576197]). Upon issuance, the patent, titled "Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment", will provide added intellectual property protection in Japan with respect to certain methods, uses and pharmaceutical compositions for AllocetraTM in combination with CAR-T therapies. The company expects that this new patent will be issued in Japan in the second quarter of 2021.

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Enlivex is developing AllocetraTM as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with other therapeutic agents.

Lineage Cell Therapeutics Raises $35.9 Million From Sales of Marketable Securities Holdings and an At-the-Market Equity Offering

On March 8, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that it raised $11 million in new capital from sales of its holdings of marketable securities, including shares of OncoCyte Corporation (Nasdaq: OCX) and Hadasit Bio-Holdings (TASE: HDST), as well as $25 million in gross proceeds from its at-the-market ("ATM") offering (Press release, Lineage Cell Therapeutics, MAR 8, 2021, View Source [SID1234576196]). Lineage expects its approximately $57 million of cash and cash equivalents as of March 5, 2021 to fund operations well into 2023, by which time the Company expects to have achieved value-creating clinical and product development milestones. Lineage’s strengthened balance sheet also provides it with strategic flexibility in its ongoing partnership discussions.

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"During the past six months, appreciation in our share price and that of marketable securities we owned has provided us with opportunities to monetize our investments and raise additional capital through our ATM offering," stated Brian Culley, Lineage’s CEO. "These sales underscore that Lineage has created substantial value for its shareholders over time not only by advancing our product candidates toward later-stage clinical trials, but also by making and now harvesting significant early investments in OncoCyte and Hadasit and from aggressive and prudent expense reductions we previously reported. We expect that Lineage is now funded well into 2023, by which time we expect to have reached additional significant milestones, explored new areas to deploy our technology, and moved Lineage ever closer to our goal of becoming the preeminent allogeneic cell transplant company. Our stronger balance sheet also can provide us with optionality with respect to our ongoing partnership discussions."

Cash and cash equivalents as of December 31, 2020 were $32.6 million and reflected $5.1 million in gross proceeds from sales on the ATM (which excluded $0.3 million in cash in transit related to 2020 sales that settled in 2021) and $0.8 million in gross proceeds from sales of Hadasit shares during the fourth quarter. From January 1, 2021 through March 5, 2021, Lineage raised an additional $19.9 million in gross proceeds through the ATM offering (which included $0.3 million in cash in transit related to 2020 sales that settled in 2021), as well as $10.1 million in gross proceeds from sales of OncoCyte shares and $21,000 in gross proceeds from sales of Hadasit shares. Lineage incubated OncoCyte and funded its initial product development before spinning it out as a separate public company in January 2016. As of March 5, 2021, OncoCyte’s market capitalization was over $300 million and Lineage has realized $32.5 million in total sales of its OncoCyte shares over time. The Company continues to hold 1,122,401 shares of OncoCyte stock valued at approximately $4.2 million and 169,167 shares of Hadasit stock valued at approximately $330,000, in each case based on the closing prices of those shares on March 5, 2021. Previously, Lineage also incubated and funded the initial product development of AgeX Therapeutics (NYSE American: AGE), and subsequently spun it out as a separate public company in November 2018, ultimately raising nearly $50 million from sales of its securities. Lineage believes that its broad technology platform and intellectual property portfolio may allow it to create additional value for shareholders through the advancement of its own novel pipeline as well as through the incubation and development of other products and companies, and through strategic corporate partnerships.

New Data Published from Women & Infants Hospital Demonstrate Utility of Predictive Immune Modeling in Ovarian Cancer

On March 8, 2021 Cofactor Genomics, the company bridging the precision medicine gap, reported new data published in Frontiers in Oncology1 by Women & Infants Hospital of Rhode Island (Press release, Cofactor Genomics, MAR 8, 2021, View Source [SID1234576190]). The data highlight the utility of Cofactor’s Predictive Immune Modeling technology in elucidating the immune landscape of epithelial ovarian cancer (EOC) for immunotherapy development, and to identify prognostic indicators of response to frontline chemotherapy.

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EOC is the most lethal of all gynecological malignancies, with more than 21,000 diagnoses and almost 14,000 deaths anticipated from the disease in the United States in 2020.2 Currently, several EOC clinical trials center upon immunotherapy;3 however, while melanoma and non-small cell lung cancer (NSCLC) patients have seen a great benefit from targeting immune checkpoint inhibitors, such cytotoxic T lymphocyte-associated protein-4 (CTLA-4) or programmed cell death protein 1 (PD-1), EOC patients have only exhibited response rates of 10 to 15 percent.4 Despite these poor response rates, evidence suggests that EOC is an immunogenic cancer,5,6 and in the paper, the team led by Jennifer Ribeiro, Ph.D., at Women & Infants Hospital outlined how these results lay the foundation for the development of better immunotherapy agents.

The primary investigator on the study, Dr. Ribeiro, stated, "This study offers new insights into high grade serous ovarian cancer that have the potential to make an impact in how patients are treated in the future. Using the ImmunoPrism platform, we have shown that immunological signatures are indeed related to patient outcomes in ovarian cancer."

In the study, the authors utilized the Cofactor Genomics ImmunoPrism platform to evaluate a cohort of high grade serous ovarian cancer (HGSOC) tumors to identify an immune-related gene expression model that may serve as a prognostic indicator of response to frontline chemotherapy. They found that the immunological markers CTLA-4, LAG-3, and Treg immune cells are more abundant in HGSOC patients with longer progression-free survival (PFS). Moreover, they investigated which immunological features in a tumor led to improved outcomes, which represent opportunities for novel immunotherapeutic approaches. The study also revealed that ICOS was significantly more highly expressed in patients with longer PFS, and strongly correlated with CTLA-4, PD-1, and specific subsets of immune cell infiltration. The results from the tumor cohort were confirmed using The Cancer Genome Atlas (TCGA) ovarian cancer dataset where high ICOS and LAG-3 levels were also significantly associated with longer survival.

The study builds on Cofactor’s previously presented work using its Predictive Immune Modeling technology to identify novel immune signals in other disease indications, including sarcoma, non-small cell lung cancer (NSCLC), and recurrent and metastatic squamous cell carcinoma of the head and neck (RM-HNSCC). The company has also announced a list of disease targets for diagnostic development and is current recruiting clinical partners: View Source

Pathios Therapeutics boosted by award of significant Innovate UK funding

On March 8, 2021 Pathios Therapeutics Limited ("Pathios"), an innovative biotech company focused on the development of first-in-class therapies for cancer, reported that it has been awarded £350K (approximately US$475K) in the form a Smart Grant from Innovate UK, the UK Government’s innovation agency, to accelerate their cancer immunotherapy programme targeting the innate immune checkpoint, GPR65 (Press release, Lifescience Newswire, MAR 8, 2021, View Source [SID1234576189]). Pathios will collaborate on this project with researchers from the Department of Oncology at The University of Oxford to develop the key tools required to enable the rapid translation of small-molecule GPR65 inhibitors for treatment-resistant melanoma.

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The advent of immunotherapy agents targeting T-cell checkpoints (PD-1/CTLA-4) has brought about significant improvements in the long-term survival of many melanoma patients. However, only a subset of patients receive sustained benefit from these treatments and it remains an ongoing challenge to identify additional therapies for the remaining non-responsive population.

Recent ground-breaking science suggests a key reason that some melanoma patients that do not respond well to anti-PD-1 therapies relates to the disarming of innate immune cells called tumour-associated macrophages (TAMs) by the acidic microenvironment that is inherent to advanced tumours. Activation of the pH-sensing receptor, GPR65, on TAMs by acidic pH leads to the suppression of a host of pro-inflammatory genes thereby shifting the characteristics of these cells from immune-stimulating to immunosuppressive(1). The importance of the GPR65 pathway in cancer is underscored by a small proportion of the population with inactivating polymorphisms showing stratified association with survival when analysed in The Cancer Genome Atlas (TCGA). Pathios’ ‘Macrophage Conditioning’ approach aims to deploy small-molecule GPR65 inhibitors to reverse pH-dependent immunosuppressive signalling in the vast majority of patients who do not carry this genetic change.

With this grant, Pathios will develop a range of tools to expedite the translation of small molecule GPR65 inhibitors for use in cancer immunotherapy. This will include the development of early clinical target engagement biomarkers as well as employing a range of bioinformatics techniques to identify those patients most likely to benefit from Pathios’ GPR65-targeted approach.

Stuart Hughes, Chief Executive Officer of Pathios: "We are delighted to have secured this highly competitive funding from Innovate UK to accelerate our programme against GPR65 and to continue to build our scientific links with cancer researchers at The University of Oxford. This award boosts our ongoing programme and is a significant endorsement of our novel approach to targeting the innate immune system in hard-to-treat cancers. We look forward to developing the tools that will drive forward our GPR65-based ‘Macrophage Conditioning’ technology and help deliver on the company’s goal to provide a first-in-class treatment approach for those melanoma patients who currently have limited treatment options".