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CorMedix Inc. Completes Sale of $1.3 Million of NOL Tax Benefits Through The New Jersey Economic Development Authority Program

On June 10, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that it has completed the sale of $1.3 million of its available tax benefits to an unrelated, profitable New Jersey corporation through the New Jersey Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer program for the State Fiscal Year 2020 (Press release, CorMedix, JUN 10, 2021, View Source [SID1234583811]). As a result, the Company has received approximately $1.3 million in cash proceeds from the sale of these NOL tax benefits.

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The New Jersey Technology Business Tax Certificate Transfer (NOL) program enables qualified, unprofitable NJ-based technology or biotechnology companied with fewer than 225 U.S. employees to sell a percentage of net operating losses and research and development (R&D) tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn their tax losses and credits into cash proceeds to fund growth and operations, including research and development or other allowable expenditures. CorMedix is one of 49 early-stage companies to share in approximately $54.5 million of tax credit transfers approved by NJEDA for the 2020 period.

Notable Labs to Attend BIO Digital 2021 Highlighting Predictive Technology Platform for Oncology

On June 10, 2021 Notable Labs Inc., a leader in technology-powered life science with a proprietary platform for predicting patient outcomes and accelerating precision drug development, reported that it will be attending BIO Digital 2021, a key international biotech partnering event held virtually on June 14-18 (Press release, Notable Labs, JUN 10, 2021, View Source [SID1234583810]).

During the conference Notable will be seeking partnering opportunities to partner on and in-license investigational treatments for hematological cancers. Notable’s focus is to achieve and accelerate their development by targeting patient populations who will respond based on its prediction technology platform.

Dr. Thomas Bock, CEO of Notable said, "This conference comes at a pivotal time to expand our collaboration with current and prospective partners and leverage the recent progress we achieved for our prediction platform capabilities." Matt De Silva, Founder and Executive Chairman of the board added, "In the past months we have advanced and grown extremely fast, propelling our insights across drug classes and diseases. We are thrilled to share that excitement with potential new collaborators."

The BIO Digital conference provides access to almost 3,000 US and international life science companies. The virtual gathering of the global biotech industry provides access to key partners via BIO’s One-on-One Partnering, critical education including policy, industry trends, breakthrough therapies, and patient access.

HiberCell Initiates Phase 1a Clinical Trial of HC-5404-FU, an ER Stress Modulator

On June 10, 2021 HiberCell, a biotechnology company dedicated to overcoming foundational barriers that prevent patients from living longer, cancer-free lives, reported the initiation of a Phase 1a multicenter, open-label, dose escalation trial of its orally administered HC-5404-FU in patients with selected metastatic solid tumors (Press release, HiberCell, JUN 10, 2021, View Source;utm_medium=rss&utm_campaign=hibercell-initiates-phase-1a-clinical-trial-of-hc-5404-fu-an-er-stress-modulator [SID1234583809]). HC-5404-FU is an endoplasmic reticulum (ER) stress modulator, and the Investigational New Drug (IND) application received the greenlight from the U.S. Food and Drug Administration (FDA) in late 2020.

The Phase 1a trial is designed as a dose escalation study across patients with specific tumor types, inclusive of renal cell carcinoma (RCC), gastric cancer (GC), breast cancer (MBC), and small-cell lung cancer (SCLC). The primary endpoints are to establish HC-5404-FU’s Maximum Tolerated Dose (MTD) and to monitor its safety and tolerability in patients with selected, advanced solid tumors. The secondary endpoints are intended to determine the pharmacokinetic (PK) parameters of HC-5404-FU and to preliminarily assess potential antitumor activity, as evaluated by overall response rate (ORR), duration of response (DOR) progression-free survival (PFS), time to treatment failure (TTF) and overall survival (OS). ORR, DOR, PFS and TTF will be assessed per immune-related Response Evaluation Criteria in Solid Tumors (iRECIST). Exploratory objectives of the study include immunophenotyping of peripheral blood cells and evaluation of local antitumor effects, microenvironment changes, and associated pharmacodynamic (PD) markers in tumor biopsies by multiplex immunohistochemistry (IHC).

"While targeted therapy and immunotherapy have extended the timeline horizon for cancer patients with solid tumors, stress-mediated tumor recurrence, therapeutic resistance, and cancer relapse remain significant barriers in the management of advanced cancer," said Alan Rigby, PhD, Chief Executive Officer at HiberCell. "The initiation of this first-in-human study is a significant milestone for HiberCell as we move our platform of stress modulators into the clinic."

Stress is omnipresent in cancer. Endoplasmic reticulum (ER) mediated stress resulting from activation of the unfolded protein response (UPR) pathway creates an immunosuppressive tumor microenvironment, while simultaneously endowing cancer cells with survival advantages. Protein kinase R–like endoplasmic reticulum kinase (PERK) is a primary UPR sensor that plays a central role in tumor angiogenesis and survival. Modulation of the PERK pathway in a hypoxic or nutrient deprived, ‘stressed’ environment leads to cell apoptosis and tumor growth inhibition. HC-5404-FU is a highly selective, potent PERK inhibitor (PERKi) oral candidate with demonstrable monotherapy anti-tumor activity.

"In preclinical studies across species, HC-5404-FU was well tolerated. Beyond HC-5404-FU, our PERK drug discovery and chemistry campaign has identified several potent, selective, drug-like compounds. These and other data in support of inhibiting PERK in cancer have published in a recently accepted manuscript in Bioorganic Medicinal Chemistry Letters (Calvo et al., Bioorg. Med. Chem. Lett. 43 (2021), 128058)," said José Iglesias, MD, Consultant Chief Medical Officer at HiberCell. "We are excited to move HC-5404-FU into the clinic. Its mechanism of action allows us to explore several novel possibilities to interdict tumor growth, given the observed synergy with immunotherapeutic and antiangiogenic agents."

Transactions with shares and linked securities in Genmab A/S made by managerial employees and their closely associated persons

On June 10, 2021 Genmab A/S (Nasdaq: GMAB) reported that In accordance with Article 19 of Regulation No. 596/2014 on Market Abuse and Implementing Regulation 2016/523, this document discloses the data of the transactions made in Genmab A/S (Nasdaq: GMAB) made by managerial employees and their closely associated persons (Press release, Genmab, JUN 10, 2021, View Source [SID1234583808]).

The company’s managerial employees and their closely associated persons have given Genmab A/S power of attorney on their behalf to publish trading in Genmab shares by the company’s managerial employees and their closely associated persons.

Synthekine Announces $107.5 Million Oversubscribed Series B Financing to Support Lead Programs to Clinical Proof of Concept, Advance Preclinical Programs and Platform

On June 10, 2021 Synthekine Inc., an engineered cytokine therapeutics company, reported that it has closed an oversubscribed $107.5 million Series B financing (Press release, Synthekine, JUN 10, 2021, View Source [SID1234583807]). The round was co-led by Deerfield Management and Janus Henderson Investors, with participation from RA Capital Management, Rock Springs Capital, Omega Funds, TCG X, Lilly Asia Ventures, and an undisclosed leading healthcare investor. Existing investors The Column Group, Samsara BioCapital, Canaan Partners, and Emerson Collective also participated in the round.

"Synthekine was founded two years ago to advance cytokine science and create optimized therapeutics in this important space. In that time, we have advanced two highly differentiated programs to IND-enabling development, expanded our pre-clinical pipeline of selective cytokine therapeutics through both internal development and licensing, and built a world-class team," said Debanjan Ray, chief executive officer of Synthekine. "We are grateful for the support from this highly distinguished group of biotech investors and the continued support from our Series A investors. The proceeds of this financing put Synthekine in a position to generate clinical data with our lead programs, advance our preclinical pipeline towards clinical investigation, and mature our unique cytokine engineering platforms."

Synthekine’s therapeutic pipeline is led by its selective IL-2 partial agonist, STK-012, and its orthogonal IL-2 and CD-19 CAR-T system, STK-009 and SYNCAR-001. At AACR (Free AACR Whitepaper) 2021, data presented showed STK-012 induced potent anti-tumor activity while avoiding the toxicities that have hindered the development of IL-2 therapeutics, including vascular leak syndrome (VLS). Previously at ASH (Free ASH Whitepaper) 2020, data presented showed STK-009 drove expansion of SYNCAR-001 in vivo, leading to deeper and more durable responses in pre-clinical models. Synthekine expects to move both programs into clinical investigation within the next year, with proceeds from the financing supporting clinical proof-of-concept data.

In addition to supporting advancement of Synthekine’s clinical pipeline, the financing will enable the company to advance additional programs toward clinical investigation. These include cytokine partial agonist programs for IL-10, IL-12 and IL-22 licensed by Synthekine in April 2021 from a new agreement with Stanford University through research conducted in the laboratory of Chris Garcia, PhD. While most cytokines are pleiotropic and drive a range of signaling responses across multiple cell types, which limits their potential as therapeutics, Synthekine’s partial agonists are tuned to trigger signaling in specific cell types, unlocking therapeutic benefit while avoiding toxicity.

Proceeds from this financing will also support the advancement of the company’s proprietary synthekine platform to pre-clinical proof of concept. This new class of cytokine therapeutics uses surrogate VHH agonists, in lieu of modified cytokines, to dimerize cytokine receptors and elicit biased signaling activities. Synthekine is building a modular approach with libraries of VHH agonists and is researching potential combinations that could have therapeutic application in oncology, immunology, and inflammation.