Lobe Sciences Announces Launch of Preclinical Study in Collaboration with the University of Miami Miller School of Medicine

(MENAFN – Newsfile Corp) Lobe Sciences Announces Launch of Preclinical Study in Collaboration with the University of Miami Miller School of Medicine

Vancouver, British Columbia–(Newsfile Corp. – November 30, 2020) – Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (” Lobe ” or the ” Company “) is pleased to announce the launch of preclinical research studies using psilocybin and N-Acetylcysteine (” NAC “) for the treatment of mild traumatic brain injury/concussion (” mTBI “) with post-traumatic stress disorder (” PTSD “). The study is in collaboration with a multidisciplinary team of scientists and physicians at the University of Miami Miller School of Medicine under the lead of Michael E. Hoffer, M.D., professor of otolaryngology and neurological surgery.

NAC has been shown to be safe and efficacious in a phase I human clinical study in treating military personnel who had suffered mTBI. The initial research focus is to demonstrate the safety and efficacy of the combination of psilocybin and NAC using broadly accepted rodent models. Final results are expected in 2021. Once this is established, more specific work can examine dose response, medicine uptake, and medicine levels. The research team at the Miller School of Medicine has conducted prior studies involving NAC with mTBI and has a license from the United States Drug Enforcement Administration to conduct research using Schedule I controlled substances, which includes psilocybin.

The Miller School of Medicine is an internationally recognized leader in medical research, ranked No. 39 among the top medical schools in the nation by Blue Ridge Institute for Medical Research. In 2019, the medical school submitted 1,968 research proposals and was awarded $149 million in research funding from the National Institutes of Health (NIH).

Advances in neuro-diagnostic assessment have revealed mild traumatic brain injury (concussion) is more common than previously thought and potentially associated with a host of negative health outcomes. The Centers for Disease Control (” CDC “) estimates that there are 3 million emergency room visits and over 230,000 hospitalizations due to TBI in any given year in the United States alone. Also, at the same time there are 5.3 million Americans living with the effects of mTBI (a 53% increase over ten years ago). The World Health Organization calls traumatic brain injury a “silent epidemic” that affects over 70 million individuals across the world. The United States Department of Defense estimates that over 345,000 individuals are affected by mTBI and that 20% of all service members who deploy suffer mTBI. mTBI and PTSD are significant health care issues that often co-occur and impact each other.

Dr. Hoffer, the principal investigator on the study, said, “This a very important extension of our work with NAC and other medicines to identify new treatments for mTBI and PTSD. We are hopeful that this new combination of psilocybin with NAC will lead us to better solutions for those suffering from mTBI and/or PTSD.”

Maghsoud Dariani, Chief Science Officer of Lobe said, “We are very excited to begin the preclinical studies in collaboration with Dr.

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LIDDS’ NanoZolid-TLR9 agonist demonstrates strong and durable preclinical anti-tumoral effect

UPPSALA, SWEDEN – LIDDS AB (publ) announces that intratumoral injection of NZ-TLR9, NanoZolid (NZ) formulation of a Toll-Like Receptor 9 (TLR9), results in strong antitumoral efficacy combined with prominent antitumoral immune responses in mouse tumor models. NZ-TLR9 forms an intratumoral depot which releases the TLR9 agonist for least 6 weeks and thus minimizes the need for repeated injections. Furthermore, we have identified both intratumoral- and plasma biomarkers needed to measure the activity of NZ-TLR9 in clinical trials.

LIDDS has completed a preclinical data package using a TLR9 agonist formulated with NanoZolid®(NZ-TLR9) showing that a single NZ-TLR9 injection is reducing tumor growth and improves the survival of mice, with increase of intratumoral cytotoxic T- cells and activated dendritic cells. The TLR9 agonist is released during at least 6 weeks with equal in vivo efficacy which minimizes the need for repeated injections, which are needed when using standard formulated TLR9 agonists. In addition, the study also identified plasma biomarkers which are suitable to measure the biological activity of NZ-TLR9 in coming clinical trial.

-I’m really happy to see our convincing preclinical data package with NanoZolid formulated TLR9, especially the six weeks of controlled release with strong anti-tumor effect. The results indicate that NanoZolid technology®, with controlled and sustained drug release, can be used to treat deep lying cancer tumors. These tumors are not suitable to be treated with standard TLR9 due to the necessity of weekly injections. The planning for a Phase I study treating solid tumors with intratumoral NZ-TLR9 is ongoing and we plan to start the study towards the second half of 2021, commented Monica Wallter, CEO of LIDDS.

About TLRs and TLR9
Toll-like receptors (TLRs) are key targets in the search for new treatments against cancer. TLRs are expressed on various immune cells, including dendritic cells, and upon activation they initiate the body’s immune response. TLR9 activation leads to an immunologically active tumor environment with recruitment of the cytotoxic T cells which are necessary for an antitumor response in immunotherapy. Thus, TLR9 agonists can convert immunologically “cold” tumors to immunologically “hot” tumors. The most promising target cancers for the TLR9 project are head and neck cancer, prostate cancer, sarcomas and lymphomas. These malignancies are diagnosed in around 2 million patients each year. The market for TLR agonists is expected to be worth hundreds of millions of dollars over the coming years.  

For additional information, please contact:
Monica Wallter, CEO LIDDS, +46 (0)737 07 09 22, [email protected]

This information is such that LIDDS AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above on October 26, 2020 at 08:30 CET.

LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology NanoZolid®. NanoZolid® is a clinically validated drug development technology and superior in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid

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Basilea presents preclinical data on anti-angiogenic activity of derazantinib at ENA 2020

Basel, Switzerland, October 26, 2020

Basilea Pharmaceutica Ltd. (SIX: BSLN) today reported that data on the anti-angiogenic activity of the fibroblast growth factor receptor (FGFR) inhibitor derazantinib were presented at the 32nd EORTC-NCI-AACR (ENA) Symposium on Molecular Targets and Cancer Therapeutics, that took place as a virtual event on 24-25 October, 2020. In addition to FGFR1-3 derazantinib also inhibits the vascular endothelial growth factor receptor 2 (VEGFR2). The presented data from several preclinical models demonstrate that derazantinib has an anti-angiogenic effect, which may contribute to its overall anti-tumor activity in FGFR-driven cancers.

The prevention of new blood vessel formation (anti-angiogenesis) is an established approach in cancer therapy as it deprives the growing tumor from oxygen and nutrients. VEGFR2 is a primary target for anti-angiogenic agents in the treatment of cancers.

Dr. Laurenz Kellenberger, Chief Scientific Officer, said: “Our development strategy for derazantinib is focused on strengthening the evidence for its differentiation versus other FGFR inhibitors. The preclinical data on derazantinib’s anti-angiogenic activity presented at the conference show that it may provide additional activity on top of its established primary anti-tumor effects in FGFR-positive solid tumors. Based on its unique kinase inhibition profile, we are exploring derazantinib’s potential for enhanced activity alone and in combination with other anti-cancer agents such as the anti-VEGFR2 antibody ramucirumab, or the PD-L1 immune checkpoint inhibitor atezolizumab within our ongoing clinical program FIDES.“

The following e-poster was presented at the EORTC-NCI-AACR Virtual Symposium 2020:

Presentation #

Authors/title

101

P. McSheehy, J. Boult, S. Robinson, F. Bachmann, M. El-Shemerly, L. Kellenberger, H. Lane

Derazantinib, an oral fibroblast growth factor receptor inhibitor, in phase-2 clinical development, shows anti-angiogenic activity in preclinical models

For further information, please visit https://event.eortc.org/ena2020

About derazantinib

Derazantinib is an investigational orally administered small-molecule FGFR inhibitor with strong activity against FGFR1, 2, and 3.1 FGFR kinases are key drivers of cell proliferation, differentiation and migration. FGFR genetic aberrations, e.g. gene fusions, mutations or amplifications, have been identified as potentially important therapeutic targets for various cancers, including intrahepatic cholangiocarcinoma (iCCA), urothelial, breast, gastric and lung cancers.2 In these cancers, FGFR genetic aberrations are found in a range of 5% to 30%.3
Derazantinib also inhibits the colony-stimulating-factor-1-receptor (CSF1R) kinase.1, 4 CSF1R-mediated signaling is important for the maintenance of tumor-promoting macrophages and therefore has been identified as a potential target for anti-cancer drugs.5 Preclinical data has shown that tumor macrophage depletion through CSF1R blockade renders tumors more responsive to T-cell checkpoint immunotherapy, including approaches targeting PD-1/PD-L1.67
Derazantinib has demonstrated antitumor activity and a manageable safety profile in a previous biomarker-driven phase 1/2 study in iCCA patients,8 and has received U.S. and EU orphan drug designation for iCCA. Basilea is currently conducting three clinical studies with derazantinib. The first study, FIDES-01, is a registrational phase 2 study in patients with inoperable or advanced iCCA. It comprises one cohort of patients with FGFR2 gene fusions and another cohort of patients with mutations or amplifications.

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