On June 29, 2021 Applied BioMath (www.appliedbiomath.com), an industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Ichnos Sciences for the development of a systems pharmacology model for a bispecific antibody in oncology (Press release, Applied BioMath, JUN 29, 2021, View Source [SID1234584488]). Applied BioMath will develop this model to help predict human pharmacokinetics (PK), efficacious dose ranges, first-in-human dose selection, and risk mitigation strategies for cytokine release with immune cell engagers in Oncology.

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"We look forward to collaborating with Applied BioMath and using our preclinical data to develop models which will support us in predicting model-derived PK parameters and optimum dosing regimens in the clinic," said Girish Gudi, Vice President, Global Head of Drug Metabolism and Clinical Pharmacology at Ichnos Sciences.

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about the mode of action of therapeutics with an understanding of human disease mechanisms. This approach employs proprietary algorithms and software designed specifically for systems pharmacology model development, simulation, and analysis. "One of the advantages of our modeling approach is the accuracy with which it translates from in vitro data and models to in vivo," said Dr. John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "By incorporating the mechanism of action into our model and leveraging the data available from all phases of R&D, we are able to translate and predict the human dose regimen and PK with far better accuracy than existing methods."

On June 29, 2021 Curaleaf International (formerly EMMAC Life Sciences Group), Europe’s largest vertically integrated cannabis company, reported that its wholly owned subsidiary, Adven GmbH ("Adven"), has announced a strategic partnership with Zambon GmbH, the German subsidiary of Zambon Spa, an Italian multinational pharmaceutical company, leading in Parkinson’s Diseases, Severe Respiratory Diseases and Pain (Press release, EMMAC Life Sciences, JUN 29, 2021, View Source [SID1234584505]). The aim of the agreement is to make medical cannabis treatments available to patients.The first treatment will be launched in Germany in Summer 2021.

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"We are delighted to be announcing this partnership with Zambon today, and to be working with a leading pharmaceutical company to create the first European pharmaceutical and medical cannabis partnership; we believe it is testament to our continued commitment to research-led product excellence at Curaleaf International," says Curaleaf International CEO, Antonio Costanzo. "We are looking forward to strengthening our collaboration and the creation of more such partnerships, where relevant pharmaceutical and medical cannabis expertise and excellence can be combined to advance the industry’s understanding of medical cannabis for the rapidly growing European patient community."

"Supporting therapies, like medical cannabis, are a meaningful addition to Zambon’s European portfolio. Our expertise in neurology and Curaleaf International’s knowledge of the pharmaceutical active processes of cannabinoids provide ideal conditions to bring innovative treatment to patients," says Marco Castino, Head of Region Europe in Zambon.

The market for medical cannabis in Germany

Since 2017, cannabis has been approved for therapeutic use in Germany and may be prescribed by doctors for serious illnesses. Germany is Europe’s largest market for medical cannabis. It is expected to be worth USD 2.1 billion[1] by 2025.

"We are constantly seeking ways to enhance the life of chronically neurologically ill patients with our products. Offering modern therapy approaches, such as co-medication, especially in view of the progression of these clinical pictures, is part of our vision to improve patients‘ lives" says Dirk Greshake, Zambon GmbH General Manager.

"As strategic partners, we are combining our experience and resources for the benefit of the patient. Together we want to advance the development of high-quality medicinal cannabis and have made it our mission to improve the quality of life of neurological patients who still have symptoms despite conventional therapy. With Zambon‘s many years of experience as a research company in the field of neurology and Adven GmbH, as part of Curleaf International, Europe’s largest vertically integrated medical cannabis company with its comprehensive expertise in the development and production of medicinal cannabis, we believe we have a unique partnership in place to address these patient requirements," explains Julian Vaterrodt, CEO of Adven GmbH.

On June 29, 2021 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported a commercialization partnership with San Diego-based human identification specialist Verogen that will provide customers of both companies with superior tools and comprehensive support for human identification (HID) workflows in their laboratories (Press release, Qiagen, JUN 29, 2021, View Source [SID1234586594]).

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The deal enables QIAGEN to offer Verogen’s preeminent HID sequencing and analysis solutions that run on MiSeq FGx sequencers from Illumina, decisively expanding QIAGEN’s forensics leadership that already covers sample collection and preparation, genetic testing analysis and workflow automation. The agreement grants QIAGEN the rights to distribute the Verogen portfolio globally – including kits based on the proprietary Verogen ForenSeq assay, the Verogen MiSeq FGx Sequencing System and the Universal Analysis Software – and covers an expansion of the partnership through future ForenSeq-based assays.

Verogen and QIAGEN will also cooperate to commercialize a menu of forensically validated workflows for next-generation sequencing (NGS) that combine Verogen’s library-prep products with QIAGEN’s QIAseq products, automation solutions and expertise. QIAGEN will market Verogen products globally alongside its portfolio of forensics instruments, kits and services. Financial details of the deal are not being disclosed.

"This combination brings together Verogen’s innovative NGS workflows with QIAGEN’s leading portfolio of Sample to Insight solutions, creating the most comprehensive product offering for forensics applications," said Thierry Bernard, Chief Executive Officer at QIAGEN. "The partnership will drive the adoption of NGS in human identification as it will enable our customers to gain even better insights from their casework samples. This will ultimately strengthen justice systems all over the world."

"Our mission is to empower the human identification community with innovative tools that can deliver an identification, not just a DNA profile," said Brett Williams, Chief Executive Officer at Verogen. "This partnership with QIAGEN will make it easier for laboratories to provide more impactful answers. By combining Verogen’s industry-leading NGS-based product portfolio with QIAGEN’s gold-standard extraction, assay and automation solutions, we will accelerate adoption and use of NGS in forensics."

NGS is used in many biotechnological fields, from cancer research to rare-disease testing. In forensics, it opens completely new opportunities for criminal casework, missing persons and disaster-victim identification. While traditional STR-profiling requires a suspect or a database hit to compare with a crime sample, NGS provides additional intelligence options such as estimation of externally visible characteristics like hair or eye color, thereby elevating DNA testing from a passive forensic support to a proactive investigational technique.

Experts expect the market for NGS in forensics to grow at a double-digit rate annually because of its promising applications.

This collaboration of market leaders addresses important hurdles in areas like workflow integration, automation and vendor support that have slowed adoption of NGS in forensics. The partnership bolsters the workflow solutions offered by QIAGEN and Verogen by offering forensic customers a new level of end-to-end support across the globe, from sample collection to data interpretation and analysis.

QIAGEN is a world leader in HID and forensic testing. It offers a full range of forensic-grade chemistries and high-quality instruments, such as the new EZ2 Connect Fx that address the challenges of crime scene investigation and more. Covering every step from sample to insight, QIAGEN has shaped the development of forensic standards, supporting criminal justice and missing persons identification. QIAGEN’s top-quality forensics products and services are helping customers unlock vital molecular insights to make improvements in life possible.

On June 29, 2021 Carmot Therapeutics, Inc. (Berkeley, CA), a clinical-stage biotechnology company applying its proprietary therapeutic platform, Chemotype Evolution (CE), to discover and develop disease-modifying therapies in metabolic disease and cancer, reported that in connection with the recent U.S. Food and Drug Administration (FDA) approval and commercial launch of Amgen’s LUMAKRAS (sotorasib), Carmot is eligible to receive royalty payments from future sales (Press release, Carmot, JUN 29, 2021, View Source [SID1234584452]).

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FDA recently approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. LUMAKRAS has received accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Amgen and Carmot Therapeutics entered into a research collaboration and license agreement announced in 2014 with objectives that included identification of KRASG12C targeted therapeutics. Within this collaboration, Carmot and Amgen successfully applied Chemotype Evolution to identify novel binding sites and covalent inhibitors of KRASG12C. Amgen then built on those findings to develop LUMAKRAS. Under the terms of the agreement Carmot is entitled to research funding, milestone payments and a royalty on commercial sales of products emerging from the collaboration.

"The rapid development of LUMAKRAS illustrates the value of Chemotype Evolution and its ability to complement structure-based drug design and medicinal chemistry," commented Stig K. Hansen, PhD, Carmot’s co-founder and Chief Executive Officer. "Chemotype Evolution is a transformative technology that can accelerate the discovery of drugs for challenging targets. KRAS was deemed an undruggable target for decades, but Chemotype Evolution combined with published findings, enabled Carmot and Amgen to rapidly gain novel insights that aided Amgen in the discovery of AMG 510, now LUMAKRAS.

More broadly, we have greatly expanded the capabilities of Chemotype Evolution and used it to develop a portfolio of programs in metabolic disease and cancer. Just as Chemotype Evolution provided critical new insights into KRAS function, Carmot has used the technology to generate deep insights in other disease areas".

On June 29, 2021 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology both in vivo and ex vivo, reported the pricing of an underwritten public offering of 4,137,931 shares of its common stock at a public offering price of $145.00 per share (Press release, Intellia Therapeutics, JUN 29, 2021, View Source [SID1234584471]). Intellia also granted the underwriters a 30-day option to purchase up to an additional 620,689 shares of its common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $600 million, excluding any exercise of the underwriters’ option to purchase additional shares. All of the shares in the offering are to be sold by Intellia.

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Goldman Sachs & Co. LLC, Jefferies, SVB Leerink, and Barclays are acting as joint book-running managers for the offering. Truist Securities is acting as co-manager for the offering. The offering is expected to close on or about July 2, 2021, subject to customary closing conditions.

The shares of common stock are being offered by Intellia pursuant to an effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on June 28, 2021. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, from: Goldman Sachs & Co. LLC, by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; or Jefferies LLC, by mail at 520 Madison Avenue, 2nd Floor, New York, NY 10022, Attention: Equity Syndicate Prospectus Department, by telephone at (877) 547-6340, or by email at [email protected]; SVB Leerink LLC, by mail at One Federal Street, 37th Floor, Boston, MA 02110, Attention: Syndicate Department, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Barclays Capital Inc., by mail at c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.