On January 6, 2023, Keros Therapeutics, Inc. (the "Company") entered into a first amendment (the "Lease Amendment") to that certain indenture of lease, dated September 7, 2021 (as amended, the "Lease") with Revolution Labs Owner, LLC, a Delaware limited liability company (the "Landlord"), with respect to the Company’s office and laboratory space consisting of approximately 35,662 square feet located at 1050 Waltham Street, Lexington, Massachusetts (the "Premises") (Filing, 8-K, Keros Therapeutics, JAN 6, 2023, View Source [SID1234625970]).

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Under the terms of the Lease Amendment, the Company has agreed to the phased delivery of the Premises to the Company by the Landlord as follows: (i) the Landlord will deliver approximately 31,991 square feet of the Premises (the "Phase A Premises") on or before January 4, 2023 (the "Phase A Premises Commencement Date"), and (ii) the Landlord will deliver the additional approximately 3,671 rentable square feet of vivarium space (the "Phase B Premises") when the Landlord substantially completes work on the Phase B Premises, currently estimated to occur on or before May 1, 2023 (the "Phase B Premises Commencement Date").

Per the Lease Amendment, the term of the Lease will now commence on the Phase A Premises Commencement Date. The Lease has a term of eight years, measured from the Phase A Premises Commencement Date.

The Company’s obligation for the payment of base rent for the Phase A Premises begins on the date which is earlier to occur of (i) eight months following the Phase B Premises Commencement Date or (ii) 11 months following the Phase A Premises Commencement Date (such earlier date, the "Phase A Rent Commencement Date"). The Company’s obligation for the payment of base rent for the Phase B Premises begins on the date which is eight months following the Phase B Premises Commencement Date (the "Phase B Rent Commencement Date"). Base rent will initially be fixed at $202,084.66 per month, which will increase by approximately 3% per annum. From and after the Phase A Rent Commencement Date and until the occurrence of the Phase B Rent Commencement Date, the Company will be obligated to pay base rent at the per square foot rent for the Phase A Premises only. Upon the Phase B Rent Commencement Date, the Company will be obligated to pay the base rent for the entirety of the Premises. The Company will be obligated to pay the Landlord for certain costs, taxes and operating expenses as specified in the Lease.

The description of the Lease Amendment contained in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Lease Amendment, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ending March 31, 2023.

On January 6, 2023 Immunome presented its corporate presentation (Press release, Immunome, JAN 6, 2023, View Source [SID1234625968]).

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On January 6, 2023 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling and advanced medicinal chemistry technology, reported certain preliminary, unaudited financial results for the year ended December 31, 2022 (Press release, HTG Molecular Diagnostics, JAN 6, 2023, View Source [SID1234625966]).

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Total revenue for the full year 2022 is expected to be approximately $6.4 million, including approximately $2.7 million of HTG Transcriptome Panel (HTP) revenue representing 42% of our total revenue. Cash and cash equivalents are approximately $12.2 million as of December 31, 2022.

"While our full year revenue did not show the level of recovery anticipated in 2022, we believe that our Q4 and full year results reflect positive trends," said John Lubniewski, CEO of HTG. "First, we are encouraged to see revenue grow by nearly 95% from the third quarter to the fourth quarter of 2022. This revenue includes both orders from customers who have previously adopted our technology and are regularly reordering kits and services, as well as orders from new customers. The year-over-year revenue also reflects an increase from 2021 to 2022 of $1.3 million of HTP revenue, demonstrating growing demand for this potentially transformational product. Second, our preliminary cash and equivalents position shows a strengthened balance sheet. Considering recent revenue performance in our profiling business, we are focused on right-sizing this business, increasing efficiencies and minimizing spend without jeopardizing our ability to generate higher levels of profiling revenue or impacting our drug discovery milestones. As we look toward the rest of 2023, we are hopeful a leaner profiling business will continue to provide value to our customers, driving quality revenue and further adoption of our technology while supporting our therapeutics initiative."

The preliminary results set forth above are unaudited, are based on management’s initial review of the company’s results as of and for the year ended December 31, 2022 and are subject to revision based upon the company’s year-end closing procedures and the completion and external audit of the company’s year-end financial statements. Actual results may differ materially from these preliminary unaudited results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that company’s financial results are finalized, and such changes could be material. In addition, these preliminary unaudited results are not a comprehensive statement of the company’s financial results for the year ended December 31, 2022, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the company’s results for any future period.

The company expects to announce full 2022 financial results in advance of its quarterly conference call in March 2023.

On January 6, 2023 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200603 (Press release, HiFiBiO Therapeutics, JAN 6, 2023, View Source [SID1234625965]). HFB200603 is a novel monoclonal antibody against the immune checkpoint BTLA that blocks the interaction with its ligand, HVEM. HFB200603 is designed to reverse HVEM-mediated immune suppressive effects and induce the production of inflammatory cytokines in various solid tumors selected by HiFiBiO’s proprietary Drug Intelligence Science (DIS) platform.

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"The FDA’s clearance of our IND for HFB200603 marks our third consecutive successful IND for a therapeutic antibody targeting DIS defined solid tumors", said co-founder and CEO of HiFiBiO Therapeutics, Liang Schweizer, Ph.D. "This is continuing validation of the strength of our single cell-powered DIS platform to identify and develop novel drugs."

"We are excited to bring our BTLA clinical candidate HFB200603 to patients and translate the promising preclinical data obtained in our labs into meaningful clinical benefit" shared Francisco Adrián, Ph.D., CSO of HiFiBiO Therapeutics. "HFB200603 has demonstrated its ability to stimulate tumor infiltrating lymphocytes and to potentiate the immunomodulatory effects of PD-1 blockade in human tumor cultures from different cancer types."

The planned Phase 1 clinical study will consist of an initial dose escalation followed by expansion cohorts, including combination treatment with Novartis’ Tislelizumab, in selected solid tumors identified through HiFiBiO DISTM platform.

HFB200603

HFB200603 was identified using HiFiBiO single cell platform as a single-digit nanomolar binder to human and cynomolgus BTLA, capable of blocking BTLA interaction with its ligand HVEM, reversing HVEM-mediated immune suppressive effects, and inducing the production of inflammatory cytokines in the tumor microenvironment of different human tumor types. HFB200603 synergizes with anti-PD-1 and demonstrates favorable developability, pharmacokinetic and safety profiles.

On January 6, 2023 – Genoscience Pharma, a clinical-stage biotech company developing unique lysosomotropic drug candidates for the treatment of cancer, fibrosis and autoimmune diseases through autophagy modulation, along with trial sponsor Grenoble University Hospital, reported the launch of the ABE-LIVER study (Press release, GenoScience, JAN 6, 2023, View Source [SID1234625964]). This phase 2b clinical trial will focus on first-line treatment of HepatoCellular Carcinoma (HCC) patients with Genoscience Pharma’s drug candidate ezurpimtrostat (GNS561). This is administered in conjunction with standard atezolizumab/bevacizumab treatment. The first patient received the initial treatment on January 2. Genoscience Pharma is providing ezurpimtrostat and operational support.

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Although standard treatment with atezolizumab (an anti-PDL1) / bevacizumab (an antiangiogenic agent) does produce some encouraging results, a tumor response is observed in only 30% of patients and the Progression-Free Survival (PFS) period remains short. Not only does ezurpimtrostat demonstrate intrinsic anti-tumor activity, but its addition to standard treatment also allows regulation of autophagy, a key mechanism involved in immune evasion in the case of immunotherapy.

"This trial is an important step both for Genoscience and for our product ezurpimtrostat, giving us an opportunity to demonstrate the efficacy of autophagy inhibition in oncology," said Professor Philippe Halfon, CEO of Genoscience Pharma. "We have high expectations for this trial, and we are delighted to be collaborating with Grenoble University Hospital, an institution involved in a number of major clinical trials in oncology, specifically promoting ABE-LIVER, thanks to its active network in the area of liver cancer."

ABE-LIVER is a multicenter, prospective, comparative, randomized and open phase 2b trial. The principal investigator is Dr. Gaël Roth, digestive oncologist and expert in primitive hepatic tumors at the Grenoble Alpes University Hospital (CHUGA). The main objective of this trial is to evaluate the efficacy of ezurpimtrostat in conjunction with standard treatment (atezolizumab-bevacizumab) compared to standard treatment alone, as the first-line treatment in patients fighting advanced HCC. The primary criteria is PFS. Between 187 and 196 patients will be enrolled in this trial, which will
take place in two stages: a preliminary safety phase involving 3–12 patients, followed by an expansion phase.

"Ezurpimtrostat could become a new weapon in our arsenal of treatments for a form of cancer that is still extremely aggressive and for which current treatments are only able to achieve a low fiveyear survival rate," said Professor Eric Raymond, medical director of Genoscience Pharma and head of medical oncology at the St-Joseph Hospital in Paris. "We are very optimistic and hope that by using an autophagy blocker we will be able to enhance the activity of immune checkpoint inhibitors. For patients, this means that the current treatments will become more effective."

"By targeting PPT-1, ezurpimtrostat exerts an anti-tumor effect by reducing the nutrient intake of tumor cells and sensitizes the tumor to immunotherapy by enhancing the expression of the Major Histocompatibility Complex (MHC-I) on the surface of the tumor cells. It also makes it possible to modulate the immune response through recolonization and activation of the CD8+ cytotoxic T-cells, rendering it a highly promising treatment strategy," added principal investigator Dr. Gaël Roth. "We are thrilled to have been able to start this trial, which involves most of the specialist liver cancer
centers in France. We are looking forward to evaluating the potential clinical impact of ezurpimtrostat in combination with atezolizumab-bevacizumab in HCC patients, whose treatment options are limited and whose prognosis remains very bleak at present."

The NCT05448677 trial is set to take place over three years, with intermediate results expected in 2024.

About HepatoCellular Carcinoma – HCC

With more than 900,000 new cases diagnosed each year, hepatocellular carcinoma is the fifth most common cancer in the world. Globally, it is the third most common cause of cancer-related deaths, responsible for around 830,000 deaths per year. Most hepatocellular carcinomas are not detected until they have reached an advanced stage. New treatment options are desperately needed for these patients. Hepatocellular carcinoma is the most common form of liver cancer, representing more than 75–85% of cases globally.

About ezurpimtrostat (GNS561)

Ezurpimtrostat is a human autophagy inhibitor whose activity is linked to the inhibition of PPT-1 (Palmitoyl Protein Thioesterase-1). Both in vitro and in vivo studies have found evidence of its high degree of tropism in the liver and powerful anti-tumor activity. Preliminary data from a phase 1b trial on primary and secondary liver tumors has confirmed that administration of ezurpimtrostat as a monotherapy is both feasible and well tolerated.