Immunovia and Global Pharmaceutical Company Agree on Early Termination of Lung Cancer Collaboration

On April 8, 2020 Immunovia AB (publ) ("Immunovia") reported that the company’s Lung Cancer collaboration with a global pharmaceutical company has been terminated (Press release, Immunovia, APR 8, 2020, View Source [SID1234556220]).

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Immunovia’s own early detection program in lung cancer continues as planned and the company has received the necessary fresh blood samples from the pharma partner for testing and analysis. Immunovia’s study is on track and will be finished in Q2 2020 as planned.

This is information that Immunovia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 8:45 CET on April 8, 2020.

Immutep’s Partner, EOC Pharma, Continues to Advance Efti in Breast Cancer

On April 8, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), reported that EOC Pharma ("EOC") and Immutep jointly discussed the current AIPAC results and confirmed plans to continue advancing Efti (designated as EOC202 in China) in metastatic breast cancer (Press release, Immutep, APR 8, 2020, View Source [SID1234556203]).

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The confirmation follows EOC Pharma’s analysis of the recently reported Progression Free Survival (PFS) data, including subgroup analysis, from Immutep’s phase IIb AIPAC study.

EOC Pharma is an oncology focused specialty pharmaceutical company headquartered in Shanghai, China, and is the exclusive licensee of efti from Immutep for the Chinese market. Under its agreement with Immutep, it will make further milestone payments to the Immutep if efti achieves specific development milestones as well as undisclosed royalties on sales and is also required to fund the Chinese development of efti.

EOC Pharma CEO, Xiaoming Zou, said: "Our analysis of the overall and subgroup data suggests there is a definite opportunity to progress efti for Chinese patients with metastatic breast cancer. The data allows us to more specifically address certain meaningful patient populations and maximize the chance of a benefit for those patient groups. We also look forward to entering a new phase of collaboration with our partner Immutep."

Immutep CEO, Marc Voigt stated: "We are very pleased about the discussions with EOC Pharma and their perspectives on efti in metastatic breast cancer and we look forward to further developing our collaboration with them."

EOC Pharma, has also confirmed it will continue to advance its ongoing phase I EOC202A1101 study of eftilagimod alpha ("efti" or "IMP321") in metastatic breast cancer in China. The last patient was enrolled and safely dosed in the EOC202A1101 study in February 2020. Data is expected to be reported from EOC202A1101 during 2020, with study completion in Q4 CY2020.

About the EOC202A1101 Trial

The EOC202A1101 study is taking place at the Fudan University Shanghai Cancer Center in China and is a single-center, open label, fixed dose-escalation phase I study in 12 metastatic breast carcinoma patients. The study is evaluating Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321"), in combination with chemotherapy agent, paclitaxel, in Chinese patients. Participants are receiving either 6 mg or 30 mg doses of efti over the six-month treatment period to determine the safety, tolerability and efficacy of the combination treatment, along with the appropriate dose for a potential phase II study. The Chinese IND application for EOC202 (efti) was approved by the Chinese National Medical Products Administration (NMPA) in December 2017.

Avectas Announces Issuance of U.S. Patent for Cell Engineering Technology by the U.S. Patent and Trademark Office

On April 8, 2020 Avectas reported that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 10,612,042, which is central to the company’s cell engineering technology, Solupore and expands Avectas’ global Intellectual Property portfolio (Press release, Avectas, APR 8, 2020, View Source [SID1234556221]). This patent covers an approach for delivering a payload, such as a protein and/or nucleic acid, across a plasma membrane of a cell.

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Avectas is a cell engineering technology business developing a unique delivery platform to enable the ex-vivo manufacture of gene-modified cell therapy products, which retain high in-vivo functionality. Avectas’ Solupore cell engineering technology has been developed to address challenges encountered with the manufacture of autologous and allogeneic cellular therapy products.

"Our patented cell engineering platform leverages a new mechanism to permeabilize the cell membrane and to enable the delivery of therapeutic molecules into the cell, enabling the production of functionally fitter cells to recognise and attack cancers," said Michael Maguire, Ph.D., Chief Executive Officer of Avectas. "This granted patent is an important component in our IP portfolio, protecting value in our cell engineering platform. We look forward to continuing the development of Solupore to address the tremendous need for a new cell engineering technology for next-generation cell therapies."

This announcement comes at a time when Avectas has recently announced several collaborations this year. In March, Avectas announced a collaboration with Vycellix to advance next-generation solutions for the optimized manufacture of cell and gene therapies. In February, Avectas entered a Collaboration agreement with the Centre for Commercialization of Regenerative Medicine (CCRM) based in Toronto, Canada to accelerate the translation of Avectas’ non-viral cell engineering platform (Solupore) into the clinic and in January Avectas joined the new NK Cell Centre of Excellence at Karolinska Institute as a partner.

About Solupore:

Solupore is a non-viral, cell engineering technology that permeabilizes the target cell membrane and allows efficient transport of cargo into cells whilst retaining very high levels of cell viability and functionality. The Solupore technology is designed for use with mRNA, DNA, and proteins, including gene-editing tools such as CRISPR and combination thereof. Solupore achieves excellent engineering efficiencies for delivery of these payloads to primary T cells and NK cells for immuno-oncology and gene editing applications.

Lilly Confirms Date and Conference Call for First-Quarter 2020 Financial Results Announcement

On April 8, 2020 Eli Lilly and Company (NYSE: LLY) reported that it will announce its first-quarter 2020 financial results on Thursday, April 23, 2020 (Press release, Eli Lilly, APR 8, 2020, View Source [SID1234556204]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

Idera Pharmaceuticals Announces Private Placement of up to $20.7 Million

ON April 7, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported entering into an agreement with a fund affiliated with an institutional investor providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of common stock together with accompanying warrants to purchase an additional shares of common stock, for aggregate gross proceeds of $5.0 million (Tranche 1). The price per share paid for the common stock was $1.52 per share (Press release, Idera Pharmaceuticals, APR 7, 2020, View Source [SID1234556169]). The common stock warrants have an exercise price of $2.28 per share, a term of three years and are exercisable after the Company receives stockholder approval and files a charter amendment to sufficiently increase the Company’s authorized shares of common stock to cover the exercise of the common stock warrants issuable under the agreement (Tranche 1 Initial Exercise Date).

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Pursuant to the agreement, the investor may, at their option, make a further investment of an additional $5.0 million to purchase shares of common stock (or common stock equivalents), together with accompanying common stock warrants to purchase additional shares of common stock (Tranche 2). The common stock purchase will be $1.76 per share. The common stock warrants, if issued, will have an exercise price of $2.71 per share, a term of three years and are exercisable after the later of their issuance date and the Tranche 1 Initial Exercise Date. Idera has the right to refuse Tranche 2 if, prior to receipt of notice from the investor, the closing price of Idera’s common stock is $3.01 or higher for any 20 consecutive days after June 30, 2020. The investor’s option to invest in Tranche 2 expires on December 30, 2020.

To the extent Tranche 2 is closed and inclusive of proceeds from the exercise of warrants issuable in this private placement, the Company may receive up to $20.7 million in gross proceeds. The Company plans to use the proceeds from the financing primarily to fund the completion, of the ongoing ILLUMINATE-301 clinical trial of its lead product, tilsotolimod, for the treatment of anti-PD-1 refractory metastatic melanoma. The Company also plans to use the subsequent proceeds, if exercised, to fund the potential NDA filing and commercial launch of tilsotolimod along with the ongoing ILLUMINATE-206 trial, and for general corporate purposes.

The shares of common stock (or common stock equivalents) and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

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.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.