On November 2, 2020 Genprex reported that quaratusugene ozeplasmid (Reqorsa) will be studied in two new trials, in which non-small cell lung cancer patients with specific molecular markers will receive its investigational drug combined with osimertinib (AstraZeneca’s Tagrisso) or pembrolizumab (Merck’s Keytruda) (Press release, Genprex, NOV 2, 2020, View Source [SID1234570032]).

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The Phase I/II trials, branded Acclaim, will begin in the first half of 2021. In Acclaim-1, late-stage, EGFR-mutated NSCLC patients who have progressed after treatment with the EGFR inhibitor osimertinib will receive quaratusugene ozeplasmid plus osimertinib. According to the company, the US Food and Drug Administration in January granted fast track designation to quaratusugene ozeplasmid for this indication.

In Acclaim-2, NSCLC patients who have PD-L1 expression in 1 percent to 49 percent of tumor cells and are considered to have low expression status will receive quaratusugene ozeplasmid in combination with the checkpoint inhibitor pembrolizumab.

In preclinical studies, quaratusugene ozeplasmid has been able to simultaneously inhibit the EGFR and AKT oncogenic kinase pathways in vitro and in vivo. In earlier studies, the investigational treatment also appeared to block mechanisms implicated in drug resistance.

On November 2, 2020 Pascal Biosciences, Inc. ("Pascal" or the "Company") (TSX VENTURE: PAS), a biotechnology company that specializes in cancer drug discovery and development, reported a non-brokered private placement (the "Private Placement") of up to 5,000,000 units (each a "Unit" respectively) at a price of $0.20 per Unit for gross proceeds of up to $1,000,000 (Press release, Pascal Biosciences, NOV 2, 2020, View Source [SID1234569775]). Each Unit will consist of one common share and one common share purchase warrant (each a "Warrant"). Each Warrant entitles the holder to purchase one additional common share of the Company
at a price of $0.35 per share for a period of twelve months from the date of closing, subject to an exercise acceleration clause. Under the exercise acceleration clause, which the Company may exercise once the Units are free of resale restrictions and if the Company’s shares are trading at or above a volume weighted average price of $0.50 for 10 consecutive trading days, the Warrants will expire upon 30 days from the date the Company provides notice in writing to the Warrant holders via a news release.

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Certain directors and officers of the Company intend to acquire the Units under the Private Placement. Any such participation would be considered to be a "related party transaction" as defined under Multilateral Instrument 61 -101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of any shares issued to, or the consideration paid by such persons, will exceed 25% of the Company’s market capitalization.

The proceeds from the sale of Units will be added to working capital in furtherance of the Company’s business. The securities to be issued under the placement will be subject to a four-month hold period and the Private Placement is subject to the acceptance of the TSX Venture Exchange.

On November 2, 2020 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that plans to propose to the extraordinary Shareholders’ Meeting, which is to be convened on November 27, 2020 and conducted as a virtual general meeting, in addition to the notification of loss pursuant to Section 92 par (Press release, Epigenomics, NOV 2, 2020, View Source [SID1234569749]). 1 AktG, the reduction of the share capital to EUR 5,891,230.00 and a further authorization to issue convertible bonds in a nominal amount of up to EUR 5.5 million.

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The capital reduction is to take place in two steps. First, the share capital shall be reduced by EUR 6.00 from EUR 47,129,846.00 to EUR 47,129,840.00 by withdrawing six treasury shares acquired free of charge. Secondly, the share capital of the Company shall be reduced by means of an ordinary capital reduction in accordance with Section 222 et seq. AktG by EUR 41,238,610.00 from EUR 47,129,840.00 to EUR 5,891,230.00. The ordinary capital reduction shall be carried out by combining the shares of the Company in the ratio 8:1. The ordinary capital reduction serves partly to cover losses and partly to allocate to the Company’s capital reserves.

The new authorization to issue convertible bonds with a nominal value of up to EUR 5.5 million, which is also to be proposed to the extraordinary General Shareholders’ Meeting, shall be limited until March 31, 2021. It stipulates a term of the convertible bonds of about three years. If the bonds have not been previously converted, there is a conversion obligation at the end of the term. The conversion price per no-par value share of the Company amounts to EUR 1.10. Under the authorization, conversion rights and obligations can accordingly be established for up to 5,000,000 new no-par value shares of the Company. There will be no adjustment of the conditions, in particular the conversion price, in the event of the capital reductions which will also be proposed to the extraordinary Shareholders’ Meeting. In the event that the authorization is exercised, the shareholders shall be granted the subscription right (subject to the exclusion of the subscription right for fractional amounts) and an over-subscription right. In accordance with the authorization, the convertible bonds will be issued at their nominal amount and will not bear interest.

In case that the authorization is exercised, the Company has today concluded a so-called backstop agreement with several shareholders, namely Deutsche Balaton Aktiengesellschaft and its affiliated companies. Under this agreement, Deutsche Balaton Aktiengesellschaft has undertaken, under certain conditions, to subscribe for or acquire new convertible bonds with a total nominal value of up to EUR 4 million if the authorization is exercised.

The complete agenda, together with explanations and more detailed information on registration for the extraordinary General Shareholders’ Meeting, can be found in the invitation, which is expected to be published in the Federal Gazette on November 5, 2020 and will also be available at View Source

On November 2, 2020 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported a definitive license agreement with Endo Ventures Limited, a subsidiary of Endo International plc (NASDAQ: ENDP) plc, for the registration and commercialization of arfolitixorin on an exclusive basis in Canada (Press release, Isofol Medical, NOV 2, 2020, View Source [SID1234569744]). With the consent of Isofol, Endo Ventures Limited has designated Paladin Labs Inc., an operating company of Endo, to be responsible for seeking regulatory approval for arfolitixorin in Canada and after receipt of such approval, to be responsible for the commercialization of arfolitixorin in Canada, including distribution, marketing, medical affairs, pricing and reimbursement activities. Isofol may receive up to $US 23.05 million** (SEK 205 million**) as upfront, development, regulatory and sales-based milestone payments. In addition, Isofol will receive tiered royalties on net sales in solid double-digit figures.

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The license agreement is focused on the registration and commercialization of arfolitixorin as first-line treatment for metastatic colorectal cancer (mCRC) patients in Canada. Isofol will be responsible for supplying the drug to Endo and will retain all international development rights.

"This licensing agreement between Isofol and Endo is a strong validation of the potential for arfolitixorin to address the large unmet medical need for patients treated for CRC. The collaboration will allow Canadian patients access to arfolitixorin upon receipt of the requisite regulatory approval, advancing the treatment regimens of difficult to treat cancers and also demonstrates our commitment to advance the quality of cancer care worldwide. Endo, through Paladin, has a very successful track record of commercializing innovative pharmaceutical products in Canada and our collaboration with them will be an invaluable component of our strategy to ensure global access to arfolitixorin," said Ulf Jungnelius, M.D, CEO of Isofol.

Isofol will remain as global sponsor of the AGENT study and Endo will be responsible for registrational filing and pursuing potential regulatory approval. Paladin will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Canada. Furthermore, Isofol will receive solid double-digit tiered royalty rates on future net sales applicable for the deal.

"Arfolitixorin is an important addition to our portfolio of innovative oncology therapies," said Livio Di Francesco, Vice President and General Manager of Paladin. "Colorectal cancer is the third most common cancer affecting nearly 27 thousand Canadians annually***. Paladin is dedicated to bringing new treatment options to Canadians, such as arfolitixorin, which could potentially provide an additional therapeutic option to patients undergoing chemotherapy treatment for metastatic colorectal cancer."

Isofol’s drug candidate arfolitixorin is being evaluated in the ongoing global Phase III AGENT study, as a first-line treatment for mCRC. The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan in over 90 clinics that are open worldwide.

** The amount given in SEK is subject to exchange rate

*** Canadian Cancer Society (www.cancer.ca/en/cancer-information/cancer-type/colorectal/statistics)

Isofol was advised on the transaction by Shadow Lake Group Inc., and Setterwalls Law Firm.

Invitation to a conference call and webcast on November 2, 2020 at 15:00 (CET)
Isofol invites investors, analysts and media to a conference call in connection with the licensing agreement with Endo/Paladin. The presentation will be held by CEO Ulf Jungnelius in English and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the webcast. No preregistration is needed.

On November 2, 2020 PerkinElmer, Inc. (NYSE: PKI) ("PerkinElmer") and Horizon Discovery Group plc (LSE: HZD) ("Horizon") reported that they have reached an agreement on the terms of a recommended all cash offer whereby PerkinElmer will acquire Horizon for approximately $383 million (£296 million) (Press release, PerkinElmer, NOV 2, 2020, View Source [SID1234569742]). The transaction has a total enterprise value of approximately $368 million (£284 million), is expected to close in the first quarter of 2021 subject to customary closing conditions.

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With this investment, PerkinElmer will expand its portfolio of leading, automated life sciences discovery and applied genomics solutions to include gene editing and gene modulation tools. The acquisition will enable PerkinElmer to better partner with academic and pharma/biopharma scientists to help meet today’s research challenges. It will also provide an opportunity to provide important tools for exploring next generation cell engineering and customized cell lines for relevant biological models – important for the future of precision medicine.

Headquartered in Cambridge, UK, Horizon is a leading provider of CRISPR and RNAi reagents, cell models, cell engineering and base editing offerings which help scientists better understand gene function, genetic disease drivers and biotherapeutics delivery. Horizon has approximately 400 employees across multiple countries, including the UK, the US and Japan and reported revenue from continuing operations of $75.5 million (£58.3 million) in 2019.

PerkinElmer’s discovery and applied genomics solutions feature a range of immunoassay platforms, high content screening (HCS) and in vivo imaging, along with microfluidics, robotic liquid handling technologies and next-generation sequencing library preparation kits.

Unifying PerkinElmer’s and Horizon’s complementary offerings across the genotypic and phenotypic approaches for drug discovery and development will help researchers accelerate decision making with better information, automated workflows and greater quality and control over data.

Commenting on the agreement, Prahlad Singh, President and Chief Executive Officer, PerkinElmer said, "One of the key fundamentals for molecular research and drug discovery is being able to knock down a gene or function and explore the results to discover actionable insights and new clinical trial candidates faster. We’re excited to team up with Horizon to not only add CRISPR and RNAi capabilities into our existing portfolio, but also to leverage our combined life sciences screening and applied genomics solutions to help propel the next phase of cell and gene research for precision medicine. PerkinElmer leads with science and creates total solutions to bring today’s leading innovations together for our customers, while also working at the cutting edge of what’s next. Today’s announcement delivers on both of these fronts."

In total, PerkinElmer’s life sciences solutions span across early-stage research, drug discovery, drug development and QA/QC for drug manufacturing. For more information please visit: View Source

In terms of financial impact, PerkinElmer expects the acquisition to be modestly accretive to non-GAAP earnings in year-one following the close, and the Company forecasts Horizon’s business to be attractively positioned in markets that are projected to grow at a compound annual growth rate of high-single digits over the next few years.