On April 7, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported that Jeffrey L. Wade, Lexicon’s president and chief financial officer, will present at the 21st Annual Needham Virtual Healthcare Conference on Tuesday, April 12, 2022 at 8:45 a.m. ET (Press release, Lexicon Pharmaceuticals, APR 7, 2022, View Source [SID1234616369]).

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A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

On April 7, 2022 Kynos Therapeutics Ltd (Kynos or the Company), an immunemetabolic company with world-leading expertise in the kynurenine pathway and kynurenine 3monooxygenase (KMO) biology, reported that stealth mode with £9 million to finance its lead KMO inhibitor (KMOi) programme through Phase 1 clinical trials and to progress its innovative pipeline of first-in-class KMOi across key indications in inflammation, immunity and metabolism (Press release, Kynos Therapeutics, APR 7, 2022, View Source [SID1234615014]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Kynos is a spin-out from the University of Edinburgh (UoE), based on over a decade of research into KMO biology and its inhibitors. Its technology and KMOis were co-developed during a multi-year collaborative programme between the UoE founders and GSK. The collaboration concluded in 2019 and data packages and all rights and intellectual property were transferred to the UoE. GSK is eligible for a royalty should a medicine be registered.

The £6.5m initial venture financing round was led by Epidarex Capital, joined by IP Group and Scottish Enterprise. Kynos has also been awarded £2.5m through an Innovate UK grant to fund a first-time in human Phase 1 clinical trial of its lead KMOi, KNS366. Kynos has a completed INDenabling package and is preparing to start a single ascending dose study with biomarker analysis.

KMO plays a major role in the control of inflammation and metabolism, contributing to the regulation of the immune system. It is a mitochondrial enzyme that converts kynurenine into biologically active 3HK that damages cells. Blocking KMO reduces 3HK, protecting against tissue damage.

Kynos’s pipeline is focused on three key areas: in critical illness post-surgery; in conditions driven by inflammation; and in cancers where inflammation is preventing the immune system from fighting back. This financing will be used to build out its core team and to fund preclinical indication expansion studies as well as to initiate development of oral formulations of KMO inhibitors. These activities will run in parallel to the Innovate UK-funded Phase 1 clinical trial in humans.

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Kynos’s core founding team are leading experts in KMO biology and medicinal chemistry with clinical, translational and drug discovery experience: CEO Damian J Mole (Professor of Surgery and MRC Senior Clinical Fellow, the University of Edinburgh Centre for Inflammation Research; and CSO Scott Webster (Professor of Medicines Discovery, Centre for Cardiovascular Science, University of Edinburgh). The industry engagement and launch of the spin-out company have been supported by Edinburgh Innovations, the University of Edinburgh’s commercialisation service.

Professor Damian Mole, CEO of Kynos Therapeutics, said: "Our goal is to improve health and make a positive impact for patients, by developing our programme in the therapeutic area of inflammation and immunometabolism. We are very excited by the potential of our first-in-class KMO inhibitors and we are ready to enter the clinic with our lead asset.

"Our programmes are based on extensive industry collaborative research with a robust science base supported by multiple high impact publications. There are no approved or marketed medicines for our gateway indication, for which there is a significant unmet need."

Following the Financing Dr Elizabeth Roper, Partner at Epidarex Capital, and Dr Tassos Konstantinou, Investment Manager, Life Sciences at IP Group plc, have joined Kynos’s board of directors.

Dr Elizabeth Roper, Partner at Epidarex Capital and Kynos Investor Director, said: "Kynos has a first-in-class set of KMO inhibitors that we believe have potential in multiple therapeutic areas. We look forward to working closely with the team and the syndicate to progress these assets into the clinic and to realise the potential of Kynos’s world-class science."

Dr Sam Williams, Managing Partner of Life Sciences at IP Group plc, said: "KMO is rapidly becoming a target of great interest in drug discovery. IP Group is excited to support Kynos as it seeks to become a leading player in the KMO field and develop inhibitors with the potential to transform patients’ lives across multiple indications."

Kerry Sharp, Director of Growth Investments at Scottish Enterprise said: "Scotland is globally renowned for its strengths in life sciences because of our innovative companies, incredible talent and world-class universities. Supporting companies in this sector, such as Kynos Therapeutics, to progress its ground-breaking medical research is a priority for Scottish Enterprise. Kynos is developing an innovative portfolio of first-in-class medicines and this funding will help deliver therapies for patients impacted by inflammatory conditions."

On April 7, 2022 LTZ Therapeutics – an immunotherapy-focused biotech company, co-founded by seasoned drug developers Robert Li Ph.D, Martin Treder Ph.D and Jianhui Zhou Ph.D – reported it has raised $17 million in pre-Series A financing led by K2 Venture Partners, with participation from Qiming Venture Partners and Tigermed (Press release, LTZ Therapeutics, APR 7, 2022, View Source;other-complex-diseases-301519601.html [SID1234611831]). The proceeds from the financing will be used to develop the company’s three-pronged platform, establish its initial pipeline and to further build LTZ’s operations team.

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"We are excited and grateful for the support from our syndicate of investors in this pre-Series A round who recognize the transformative potential of our therapeutic platform," said Robert Li, co-founder and CEO of LTZ. "More fundamental knowledge of the underlying tumor biology and the tumor microenvironment is essential to develop therapies capable of overcoming resistance and relapse as well as boosting anti-tumor immunity. LTZ’s strategy is built on closing this opportunity space using a three-pronged platform to reduce immunosuppression, re-program innate immunity and modulate adaptive immunity. In addition to our stellar group of investors, we are thrilled to welcome our new scientific advisory board members, further validating our approach to improve clinical outcomes in patients with cancer and other complex diseases."

Members of LTZ’s newly formed scientific advisory board all share a common thread, previously holding key leadership roles at Genentech, including former VP of Protein Sciences Sarah Hymowitz Ph.D, prior VP of Development Sciences Greg Cosma Ph.D and former ED of Oncology Biomarkers Lukas Amler Ph.D.

"LTZ’s novel approach holds great promise in the identification of targets with its three-pronged platform and the creation of a solid, diverse and sustainable portfolio," said Yunhai Wang, Partner at K2 Venture Partners. "Immunotherapy has become a game-changer in cancer treatment since the approval of immune checkpoint inhibitors. What this experienced, global team brings forward is strong leadership in the development of next-generation immunotherapy, from early R&D to clinical development. We look forward to partnering with LTZ to accelerate the progress of developing therapies that have the potential to positively impact the lives of patients."

"With a seasoned founding team possessing sharp insight into targeted biology and platform versatility, we are enthusiastic about the great potential of LTZ’s transformative therapeutics platform for patients, breaking new ground in the biotech industry in both China and worldwide," said Kan Chen, Partner at Qiming Venture Partners.

"We are particularly excited about the founding team’s depth of industry knowledge and diverse experience as well as the highly targeted and sustainable approach LTZ is taking to develop novel immunotherapies for the treatment of cancer and other diseases with unmet clinical need," said Dr. Tianrong Ji, Chief Investment Officer at Tigermed.

On April 7, 2022 PerkinElmer, Inc., a global leader committed to innovating for a healthier world, reported that it will be at The American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 8-13 in New Orleans (booths #1009, #1851 and #909), alongside its partner companies showcasing how genomic and cellular solutions for cancer research can be used to study its mechanisms, improve biomarker discovery, and help drive targeted, therapeutic discovery leading to new methods for diagnosing and treating the disease (Press release, PerkinElmer, APR 7, 2022, View Source [SID1234611659]). PerkinElmer has expanded and customized its therapeutics portfolio to support researchers in their workflow, which includes biomarker analysis, functional drug screening, gene editing and modulation as well as target sequencing, reagents for proteogenomics, spatial biology and flow cytometry, viral vectors, in vivo and cellular imaging, multimode plate readers and complementary assay technologies, and automated cell counters.

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HOW: PerkinElmer’s newly and widely expanded cancer discovery portfolio comprised of solutions across its Life Sciences, Applied Genomics, OMNI, Horizon Discovery, SIRION Biotech, Nexcelom and BioLegend businesses supports researchers and clinicians in identifying more successful target drug candidates faster, as well as helps clinicians better understand and manage the unique treatment journey of each patient.

Solutions on hand include:

JANUS G3 Blood iQ workstation, the first step in a seamless, efficient, and traceable workflow for the genetic analysis of cell free DNA (cfDNA) from fractionated blood. As part of this process, the chemagicTM 360 instrument, isolates cfDNA from the plasma to enable biomarkers to be studied for signs of cancer.
HIVE scRNAseq solution, developed by Honeycomb Biotechnologies, for single-cell isolation and analysis leverages a portable handheld device for the capture, storage and RNA-seq library prep of a diverse range of cell types, requires no specialized instrumentation, and expands opportunities for laboratories pursuing basic, translational, preclinical, and clinical cancer research.
BioLegend’s pre-titrated TotalSeq Universal Cocktails contain more than 115 antibodies for comprehensive single cell profiling, Ce3D Tissue Clearing Reagents add a new dimension to cancer research through integrated validation of fluorescent antibodies with Ce3D Tissue Clearing solutions, and LEGENDplex bead-based immunoassays are used for analyzing anti-cancer responses.
Vega widefield preclinical ultrasound system, the latest addition to PerkinElmer’s in vivo instruments portfolio. The hands-free, high throughput imaging system is the first-of-its-kind automated ultrasound platform designed to accelerate non-invasive preclinical research and drug development studies of cancer and other diseases.
Ready-to-use HTRF and AlphaLISA assay kits for CHO HCP impurities detection and quantification are an industry first in high-throughput, no-wash assays designed to contribute to the development, manufacture and quality control of safer, more effective biotherapeutics.
These products are for research use only. Not for use in diagnostic procedures.

WHY: "Today’s cancer researchers and clinicians are increasingly looking to decode immune system responses and regulation, as well as solid tumor response and progression, in order to move more fully towards the promise of precision medicine," said Alan Fletcher, senior vice president life science at PerkinElmer. "Understanding the rapid pace of innovation in cancer research and the desire to ultimately eradicate the disease, PerkinElmer has developed a unique portfolio comprised of tools, technologies, reagents and detection capabilities spanning from genomics to biomarker discovery and beyond, designed to meet these demands and accelerate cancer research and discovery."

On April 7, 2022 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the first quarter ended February 28, 2022 and provided a corporate update (Press release, Nurix Therapeutics, APR 7, 2022, View Source [SID1234611643]).

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"In the first quarter, we have made both clinical and regulatory advances in each of our four drug programs including our lead BTK degrader NX-2127 which position us well to provide important proof of concept data across our pipeline throughout the remainder of 2022," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "With the recent dosing of our first patient in the DeTIL-0255 Phase 1 program, we have expanded the reach of our protein modulation platform to now include drug-enhanced cell therapy."

Recent Business Highlights

Dosed first patient in the Phase 1 trial of DeTIL-0255: Nurix announced the dosing of its first patient in the Phase 1 trial of its drug-enhanced TIL product, DeTIL-0255, which is being conducted at several sites in the United States and includes patients with advanced gynecologic cancers, including ovarian cancer, cervical cancer, and endometrial cancer. This announcement marked a major milestone for Nurix with its first cell therapy successfully manufactured and administered to a patient. It also represents the first application of targeted protein modulation in the field of cell therapy.
Awarded Innovation Passport for NX-1607: The UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, for NX-1607 for the treatment of patients with advanced solid tumors. The Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP) which aims to accelerate time to market and facilitate patient access to novel drugs to treat serious and life-threatening diseases.
Upcoming Program Highlights*

NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory drug (IMiD) activity for the treatment of patients with relapsed or refractory B-cell malignancies. Nurix is conducting its Phase 1 clinical trial of NX-2127 at multiple clinical sites in the United States. Preclinical data highlighting NX-2127’s dual activity will be presented in a poster titled "Concurrent degradation of BTK and IMiD neosubstrates by NX-2127 enhances multiple mechanisms of tumor killing" at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which will be held from April 8-13, 2022. Detailed clinical results from the Phase 1a portion of the trial will be presented in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without IMiD activity for certain B-cell malignancies and autoimmune diseases. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to begin dosing patients in the United Kingdom in the first half of 2022 and to have initial safety and pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1a portion of the study in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).
NX-1607: Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B) for immuno-oncology indications including a range of solid tumor types. Nurix is evaluating NX-1607 in an ongoing, Phase 1 dose escalation and expansion trial in adults with a variety of oncology indications at multiple clinical sites in the United Kingdom and expects to have initial PK/PD data from the Phase 1a stage of the study, including biomarker and safety data, in mid-2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix is evaluating DeTIL-0255 in a Phase 1 trial in adults with gynecological malignancies including ovarian cancer, cervical cancer, and endometrial cancer. Preclinical data supporting our drug-enhanced cell therapy program will be presented in a poster titled "Ex-vivo inhibition of CBL-B with a novel small molecule inhibitor, NX-0255, enhances persistence and anti-tumor activity of adoptively transferred CD8+ T cells in mouse tumor models" at the upcoming AACR (Free AACR Whitepaper) Annual Meeting, which will be held from April 8-13, 2022. Nurix anticipates providing a clinical update from the run-in portion of the DeTIL-0255 Phase 1 study in the second half of 2022. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107739).
* Expected timing of events throughout the press release are based on calendar year quarters.

Fiscal First Quarter 2022 Financial Highlights

Collaboration revenue for the three months ended February 28, 2022 was $9.6 million compared to $5.0 million for the three months ended February 28, 2021. The increase was primarily due to the recognition of revenue as a cumulative catch up for activities satisfied in previous periods as we achieved certain research milestones under our collaborations with Gilead and Sanofi. The increase was also due to increased effort resulting in a higher percentage of completion of performance obligations under our collaboration with Gilead and Sanofi in the current period. In the three months ended February 28, 2022, Nurix achieved a research milestone under its collaboration with Gilead and received a payment of $6.0 million in the second quarter of 2022. Similarly, in the three months ended February 28, 2022, Nurix achieved a research milestone under its collaboration with Sanofi and anticipates a payment of $2.0 million in the second quarter of 2022.

Research and development expenses for the three months ended February 28, 2022 were $43.1 million compared to $23.0 million for the three months ended February 28, 2021. The increase was primarily related to an increase of $7.6 million in compensation and related personnel costs and an increase of $2.3 million in non-cash stock-based compensation expense attributable to higher headcount. There was also an increase of $8.6 million in supplies, contract research, contract manufacturing and clinical trial costs.

General and administrative expenses for the three months ended February 28, 2022 were $9.2 million compared to $6.5 million for the three months ended February 28, 2021. The increase was primarily related to an increase of $0.4 million in compensation related expenses and an increase of $1.1 million in non-cash stock-based compensation expense attributable to higher headcount. There was also an increase of $1.1 million in professional service expenses, including legal and accounting expenses related to infrastructure improvements.

Net loss for the three months ended February 28, 2022 was $42.5 million, or ($0.95) per share, compared to a net loss of $24.3 million for the three months ended February 28, 2021, or ($0.63) per share.

Cash, cash equivalents and investments: As of February 28, 2022, Nurix had cash, cash equivalents and investments of $385.7 million compared to $432.9 million as of November 30, 2021. The decrease was primarily attributable to the net operating loss for the three months ended February 28, 2022.