On July 20, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the company has established a joint venture with Immorna, a fast-growing biotechnology company focusing on the process development and optimization of mRNA and delivery vehicles and the research and development of new nucleic acid drugs, to develop and commercialize new drugs for the global market in the fields of cancer, infectious diseases, rare diseases, and other diseases, based on the mRNA technology and other technology platforms (Press release, Shanghai Junshi Bioscience, JUL 20, 2021, View Source [SID1234585313]).

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Immorna’s unique mRNA construction and established versatile process platform are suitable for the development of self-replicating mRNA as well as conventional non-replicating mRNA products, enabling the construction of a customized form of mRNA molecule for a specific disease. In terms of delivery vehicles, Immorna has developed several nanoliposome particles (LNP) suitable for different administration methods and has technical capabilities in the field of research and development of new non-LNP delivery vehicles.

Under the terms of the agreement, Junshi Biosciences will inject at most 799 million RMB in cash into the joint venture. The initial investment is 200 million RMB, of which 50 million RMB will be used to subscribe to 50% of the registered capital of the joint venture. Immorna will invest in the joint venture company with intellectual property rights involved in the mRNA technology platform. The 50 million RMB in the estimated asset value of the platform will be used to subscribe to other 50% of the registered capital of the joint venture company.

"As the mRNA Technology Platform gradually matures, its potential in a variety of fields—including infectious diseases, cancer, rare diseases, and other diseases—has become increasingly evident," says Dr. Ning Li, Chief Executive Officer of Junshi Biosciences. "This is highly consistent with the therapeutic areas covered by Junshi Biosciences’ R&D pipeline and our desire to explore the next generation of innovative therapeutics. Immorna has a wealth of experience and expertise in mRNA industrialization. We look forward to working together to develop more revolutionary therapeutics for patients worldwide through our mRNA Technology Platform with domestic intellectual property rights and promote public health on a global scale."

"Immorna is very pleased to reach a strategic collaboration agreement with Junshi Biosciences, under which a joint venture company has been created," says Dr. Zihao Wang, Chief Executive Officer of Immorna Therapeutics. "We are very confident that this new entity will allow us to take advantage of each other’s core competency, quickly and efficiently utilize the versatile mRNA platform technology in immunotherapy and infectious disease prevention, and continue our search for new directions of the application."

On July 20, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, reported the start of clinical development for its second program, a next generation autotaxin inhibitor designated IOA-289 (Press release, iOnctura, JUL 20, 2021, View Source [SID1234640246]). IOA-289 will be the first autotaxin inhibitor to be investigated in oncology.

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The Italian Medicines Agency (AIFA) has authorized a phase 1a dose-escalation study for IOA-289 in healthy volunteers. The healthy volunteer study prepares the way for a phase 1b trial of IOA-289, which iOnctura plans to conduct in patients with pancreatic cancer. iOnctura’s Phase Ib trial in pancreatic cancer is expected to begin in 2022.

"We are very excited to progress our highly differentiated autotaxin inhibitor, IOA-289, as our second clinical program," said Catherine Pickering, CEO of iOnctura. "This is another significant milestone for iOnctura demonstrating our strong development pipeline and capabilities of our team. We are looking forward to translating the promise demonstrated in our preclinical studies into humans."

In many types of cancer, including pancreatic cancer, high expression of autotaxin and the product it generates (lysophosphatidic acid – LPA) correlate with poor outcomes. IOA-289 has a unique chemistry and has demonstrated promising effects in several preclinical solid tumor models including pancreatic cancer. It has also exhibited greater potency and less toxicity than first-generation autotaxin inhibitors that have until now only been trialed in fibrotic disease indications.

The Phase 1a healthy volunteer study will involve a total of forty volunteers (2 receiving placebo, and 6 actively dosed in each of 5 dose escalation cohorts) and will explore a 10-fold dose-range of IOA-289. Topline data from the study are expected to be available in Q4 2021.

The short preparatory study in healthy volunteers will garner key information on the safety, pharmacokinetics and pharmacodynamics of IOA-289 enabling iOnctura to accelerate into a Phase 1b trial in pancreatic cancer.

On July 20, 2021 RemedyBio, an immunology focused discovery and development company, reported the final closing of an additional €8M ($9.4M) in equity financing from the EIC Fund, completing a €10.5M ($12.4M) funding award to the company by the EIC Accelerator (Press release, Remedy Biologics, JUL 20, 2021, View Source [SID1234644116]). This additional €8M financing complements the EIC grant funding of €2.5M ($3M) already awarded to RemedyBio in June 2020, to develop a Rapid Pandemic Response Platform based on its proprietary NanoreactorTM platform. This financing follows RemedyBio’s selection from almost 4,000 company proposals submitted to the EIC Accelerator in 2020.

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RemedyBio’s technology is designed to rapidly and simultaneously analyze millions of single immune cells from an individual sample. After succeeding in flagging powerful new antibodies against SARS-CoV-2 from the immune system of COVID-19 infected patients, the platform is now being tuned to respond to new variants and future diseases. The aim is to create a rapid passive therapy against new strains of COVID-19 and, primarily, to control future pandemics more rapidly, by making therapies for new viruses available in less than 90 days.

"This financing from the EIC Fund will enable us to advance our technology development and therapeutic discovery activities, and forge collaborations with leading pharma partners and key clinical and research groups," said Daniel Crowley, CEO of RemedyBio. "We are delighted to have the support of the EIC Fund. It fills an important financing gap, supporting European companies with innovative technologies to create deep scientific programs and commercial partnerships. In our case, this will drive transformative biological insights and new therapy discoveries."

This investment will fund the significant development of RemedyBio’s innovative, proprietary Nanoreactor platform as well as advancing its key therapeutic pipeline assets. The Nanoreactor platform has been developed by RemedyBio, originating from intellectual property exclusively licensed from Dublin City University (DCU), following a decade-long R&D programme led by Dr. Paul Leonard, the company’s chief scientist and co-founder. The platform has created a step-change in the speed, scale and quality of single cell analysis and discovery, paving the way for powerful new antibodies and cell therapies. Its high-throughput identification capabilities open fresh insights into immune system interactions – driving a new era in precision medicine against viral diseases, cancer and auto-immune disorders.

"At Enterprise Ireland, we welcome this substantial EIC Fund investment in an Irish high potential start-up," said Garrett Murray, national director for Horizon Europe at Enterprise Ireland. "RemedyBio is a great example of an Irish company that has succeeded in winning competitive funding through the EIC and, in Ireland, through the Disruptive Technology Innovation Fund (DTIF) for oncology cell therapy applications, to help fund its development

and advance its scaling strategy. Enterprise Ireland is here to support and advise ambitious and innovative Irish start-ups considering application for competitive EIC financing as part of their funding journey."
Heidi Kakko, member of the Investment Committee of the European Innovation Council Fund said, "This financing round will enable Remedy Biologics to develop a Rapid COVID- 19 Passive Therapy Response Platform. We are glad the EIC Fund is supporting this breakthrough company, which is playing a pioneering role in creating new solutions in immune therapeutics. This shows how the EU contribution is crucial in tackling the Covid19 response."
About the EIC Fund
Established in June 2020, the European Innovation Council Fund (EIC Fund) is a breakthrough initiative of the European Commission to make direct equity and quasi- equity investments (between €500.000 and €15 million) in European high impact and deep tech start-ups and scale ups. The EIC Fund provides patient capital and invests in companies from any sector, across all EU countries and countries associated to Horizon 2020.
The EIC Fund aims to fill a critical financing gap and its main purpose is to have a high impact by accompanying companies with disruptive technologies in their growth. Its objective is to crowd in market players, further sharing risks by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The Fund pays particular attention to empower and support female founders as well as contributing to reduce the innovation divide among EU countries. www.eic.ec.europa.eu/investment-opportunities
About Enterprise Ireland
Enterprise Ireland (EI) services are geared towards helping Irish companies win international sales. These services include funding support, export assistance, development of competitiveness in international markets, R&D and assistance with R&D collaboration. EI also provides access to its global network of contacts. www.enterprise-ireland.com

On July 20, 2021 Imago BioSciences, Inc. ("Imago") (NASDAQ: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported the closing of $134.4 million in gross proceeds from its previously announced initial public offering and $20.0 million in gross proceeds from its concurrent private placement (Press release, Imago BioSciences, JUL 20, 2021, View Source [SID1234584970]).

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The initial public offering of 8,400,000 shares of common stock at a public offering price of $16.00 per share resulted in aggregate gross proceeds to Imago of $134.4 million, before deducting underwriting discounts, commissions and offering expenses. All of the shares in the initial public offering were offered by Imago.

Imago’s common stock is now listed on The Nasdaq Global Select Market under the ticker symbol "IMGO".

Jefferies, Cowen, Stifel and Guggenheim Securities acted as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the Securities and Exchange Commission and became effective on July 15, 2021. The offering of these securities is being made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by phone at 877-821-7388; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at [email protected].

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

On July 20, 2021 Agilent Technologies Inc. (NYSE: A) reported that the company’s PD-L1 IHC 22C3 pharmDx assay is now labeled for expanded use in patients with non-small cell lung cancer (NSCLC) in the European Union (Press release, Agilent, JUL 20, 2021, View Source [SID1234584988]). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo (cemiplimab). This announcement underscores Agilent’s continuing commitment to the development of IHC-based diagnostics for cancer therapy.

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"This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Lung cancer is the leading cause of cancer death overall and the 2nd most commonly diagnosed cancer in Europe.1 NSCLC makes up approximately 85% of all lung cancer cases.2 In Europe, the average five-year survival rate for lung cancer is less than 20%.3

"This expanded indication for PD-L1 IHC 22C3 pharmDx will enable pathologists in Europe to identify patients with NSCLC who may be eligible for treatment with Libtayo," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Anti-PD-1 immunotherapies such as Libtayo offer new treatment options for patients with advanced NSCLC.4 Sanofi and Regeneron developed Libtayo and partnered with Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1 expression in patients in the pivotal EMPOWER-Lung 1 (Study 1624) clinical trial.4

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.4