Targovax to present and attend at upcoming investor and scientific conferences

On March 8, 2021 Targovax ASA, reported that members of its executive management team is invited to present and participate at upcoming conferences (Press release, Targovax, MAR 8, 2021, View Source [SID1234576177]).

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H.C. Wainwright Annual Global Life Sciences Conference, virtual
Date: 9 March 2021
Presenter: Øystein Soug (CEO)
Time: 13:00 CET

Carnegie Healthcare Seminar, virtual
Date: 12 March 2021
Presenter: Øystein Soug (CEO)
Time: 12:45 CET

Roth Capital 33rd Annual Conference, virtual
Date: 15-17 March 2021
1×1 meetings

Tumor Myeloid Microenvironment Directed Therapeutics, virtual
Date: 17 March
Presenter: Victor Levitsky (CSO)
Time: 22:45 CET

European Biotech Investor Days 2021, virtual
Date: 7-8 April 2021
Presenter: Øystein Soug (CEO)
Time: To be scheduled

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.

Pathios Therapeutics boosted by award of significant Innovate UK funding

On March 8, 2021 Pathios Therapeutics reported that it will team up with researchers at The University of Oxford to accelerate cancer immunotherapies targeting GPR65 on immunosuppressive macrophages (Press release, Pathios Therapeutics, MAR 8, 2021, View Source [SID1234576178]).

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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. 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.

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".

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.

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."