Telix Pharmaceuticals and Applied Radiology Launch TelixU Medical Education Platform Focused on Radiopharmaceutical Research

On June 14, 2021 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported the launch of TelixU, a new educational platform focused on radiopharmaceutical research in partnership with leading medical imaging journal, Applied Radiology (Press release, Telix Pharmaceuticals, JUN 14, 2021, View Source [SID1234583973]). This website is specifically designed for healthcare professionals such as physicians and technologists, and features case studies, webinars, and technologist education.

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The launch of TelixU coincides with this year’s Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, and with over 20 sessions on gallium-68 (68Ga), the website will be a welcome resource for those looking for more information about prostate specific membrane antigen (PSMA) targeted radiopharmaceuticals. "We are proud to support SNMMI and their endeavors to educate physicians and their membership," says Colin Hayward, MBBS FFPM, Chief Medical Officer, Telix Pharmaceuticals. "Our participation in this year’s Virtual Annual Meeting is an ideal platform to introduce this valuable resource."

The Case Studies section provides peer-to-peer insight about PSMA PET/CT1 imaging, whilst ‘Technologist Education’ is a wide-ranging resource for anyone delivering PSMA imaging services and includes patient considerations, PET/CT imaging protocols, and operational and workflow resources.

"Applied Radiology is delighted to support Telix in this endeavor," said Kieran Anderson, Vice President and Group Publisher at Anderson Publishing Ltd., publishers of Applied Radiology and Applied Radiation Oncology. "We have a long history of working closely with key opinion leaders and industry. We develop high-quality, informative, and engaging content, and TelixU is the latest example, as it builds on our continued commitment to the medical imaging community."

TelixU is intended for healthcare professionals only.

About Anderson Publishing

Anderson Publishing, Ltd. is a leading medical communications and publishing company dedicated to producing high-quality, informative, and engaging content for the medical imaging and radiation oncology communities. Its primary brands include Applied Radiology, in publication since 1971, and Applied Radiation Oncology, in publication since 2012. Together, they reach a global audience of over 60,000 radiologists, nuclear medicine physicians, radiation oncologists, physicists, radiation therapists, nuclear medicine technologists, radiologic technologists, radiology administrators, and related imaging professionals.

Isofol raises SEK 500 million in oversubscribed rights issue and exercised over-allotment option

On June 14, 2021 Isofol Medical AB (publ) (Nasdaq First North Premier Growth Market: ISOFOL) ("Isofol" or the "Company") reported that fully guaranteed new share issue with preferential rights for the Company’s existing shareholders (the "Rights Issue"), which ended on June 10, 2021, was oversubscribed (Press release, Isofol Medical, JUN 14, 2021, View Source [SID1234583958]). Due to the strong demand from strategic investors, a directed issue with deviation from the shareholders’ preferential rights of approximately SEK 100 million (the "Over-Allotment Option") was exercised. Through the Rights Issue and the Over-Allotment Option, Isofol will receive proceeds amounting to approximately SEK 500 million before transaction costs.

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Not for publication, distribution or release, directly or indirectly, in whole or in part, within or into the United Kingdom, US, Canada, Japan, Australia, Hong Kong, New Zealand or any other jurisdiction in which such publication, distribution or release may be contravening to any applicable laws or rules. Additional restrictions are applicable, please see "Important information" in the end of this press release.

The result of the Rights Issue of maximum 62,524,474 shares shows that 61,550,652 new shares, corresponding to approximately 98.4 percent of the Rights Issue, have been subscribed for with subscription rights. Additionally, 27,532,079 shares were subscribed for without subscription rights of which 973,822 shares, corresponding to 1.6 percent of the Rights Issue, have been allotted to investors that have subscribed for shares without subscription rights. The Rights Issue is thus oversubscribed. Allotment of shares subscribed for without subscription rights has been made in accordance with the resolved allotment principles. Notice of allotment of shares subscribed for without subscription rights will only be sent to those who have been allotted shares. Payment shall be made in accordance with the instructions on the contract note. Nominee-registered shareholders will receive notice of allotment and payment in accordance with the procedures of each nominee.

Due to the oversubscription of the Rights Issue, the Board of Directors of Isofol has exercised the Over-Allotment Option to meet additional demand from strategic investors through a directed issue of 15,625,000 new shares. The Over-Allotment Option was directed to a few reputable investors, broadening Isofol’s shareholder base.

Isofol’s CEO, Ulf Jungnelius, comments: "We are very happy and satisfied with the strong support that both existing and new shareholders have shown us in the rights issue that made it possible to exercise the over-allotment option. The rights issue in combination with the over-allotment Option provides Isofol with the financial resources required to complete the global Phase III AGENT study and secure funding beyond the submission of the application with the FDA."

Following the Rights Issue and Over-Allotment Option, Isofol’s share capital will increase by approximately SEK 2,392,767.2 to approximately SEK 4,945,252.1 and the number of shares in Isofol will increase by 78,149,474 shares to 161,515,440 shares.

The shares subscribed for with subscription rights are expected to be registered with the Swedish Companies Registration Office (the "SCRO") on or about June 15, 2021 and are expected to begin trading on Nasdaq First North Premier Growth Market on June 18, 2021.

The shares subscribed for without subscription rights and through exercise of the Over-Allotment Option are expected to be registered with the SCRO on or about June 24, 2021 and are expected to begin trading on Nasdaq First North Premier Growth Market on June 30, 2021.

Advisors

Carnegie Investment Bank AB (publ) and Pareto Securities AB act as Joint Bookrunners in connection with the Rights Issue and the potential Over-Allotment Option. Vinge law firm acts as legal adviser to Isofol, and Schjødt law firm acts as legal adviser to the Joint Bookrunners. Ashurst LLP acts as legal adviser to the Joint Bookrunners as to US securities law.

For further information, please contact

This is information that Isofol Medical AB (publ) 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 10:00 CEST on June 14, 2021.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

The U.S. FDA Approved IND Application to Investigate Combination of Asieris’ APL-1202 and BeiGene’s Tislelizumab as Neoadjuvant Therapy for MIBC Patients

On June 14, 2021 Asieris Pharmaceuticals (Asieris) reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of oral APL-1202 in combination with BeiGene’s tislelizumab as neoadjuvant therapy in patients with muscle invasive bladder cancer (MIBC) (Press release, Asieris Pharmaceuticals, JUN 14, 2021, View Source [SID1234583974]). Asieris will accelerate the initiation of the clinical trial enrollment in the U.S. and also file a Clinical Trial Application (CTA) to the National Medical Products Administration (NMPA) of China in the near future.

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This is an open-label, multi-center Phase I/II clinical study with the following objectives: to evaluate the safety in MIBC patients; to determine the RP2D (recommended Phase 2 dose), and to assess efficacy as neoadjuvant therapy for MIBC.

APL-1202 is an orally available reversible MetAP2 Inhibitor with anti-angiogenic, anti-tumor activities and can also modulate tumor immune microenvironment. It is currently in Phase III/pivotal clinical trials in China, either as single agent as first-line treatment for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), or in combination with a chemotherapy as second-line treatment in patients with intermediate and high-risk chemo-refractory NMIBC. Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. The China National Medical Products Administration (NMPA) has granted tislelizumab approval in three indications, including full approval for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy; and conditional approval for the treatment of patients with classical Hodgkin’s lymphoma (cHL) who received at least two prior therapies and for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Full approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

According to the 2020 Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Urothelial Carcinoma, the Level I recommendation for MIBC is that patients who tolerate cisplatin undergo radical cystectomy (RC) after neoadjuvant chemotherapy. The commonly used chemotherapy regimen is gemcitabine plus cisplatin (GC). However, cisplatin can cause serious side effects such as renal dysfunction, peripheral neuropathy, and bone marrow suppression, and some patients are intolerant. Patients with intolerance to cisplatin don’t have any preoperative/neoadjuvant therapy that can bring survival benefits.

"We are very pleased that FDA approved the IND application for oral APL-1202 in combination with tislelizumab as a neoadjuvant therapy in MIBC patients," said Dr. Xue Yong, MD, PhD, Chief Medical Officer at Asieris. "The approval is expected to accelerate the clinical development, and Asieris will conitnue to explore cutting-edge technologies and therapeutics in our focused areas to meet the urgent medical needs and establish an outstanding portfolio that covers diagnosis and treatment to benefit more patients. "

RAPT Therapeutics Announces Proposed Public Offering of Common Stock

On June 14, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported that it has commenced an underwritten public offering of $125 million of its common stock (Press release, RAPT Therapeutics, JUN 14, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-proposed-public-offering-common [SID1234585134]). In addition, RAPT expects the underwriters to be granted a 30-day option to purchase up to an additional $18.75 million of its common stock on the same terms and conditions. All of the shares of common stock are being offered by RAPT. The proposed offering is subject to market conditions, and there can be no assurance as to whether or when the proposed offering may be completed or as to the actual size or terms of the proposed offering.

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J.P. Morgan, SVB Leerink and Piper Sandler are acting as joint lead book-running managers for the proposed offering. Cantor is acting as book-running manager for the proposed offering.

The offering is being made pursuant to a shelf registration statement, including a base prospectus, filed by RAPT with the Securities and Exchange Commission (SEC), which was declared effective by the SEC on November 16, 2020. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. When available, electronic copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by telephone at (866) 803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by email at [email protected] or by telephone at (800) 808-7525, ext. 6105; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by email at [email protected] or by telephone at (800) 747-3924.

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 the registration or qualification under the securities laws of any such state or jurisdiction.

Evotec partners with CEBINA to launch Danube Labs, a partnership to develop cutting edge biotechnology projects sourced from Central and Eastern European Universities and Research Institutions

On June 14, 2021 CEBINA GmbH, Central European Biotech Incubator and Accelerator, reported the launch of Danube Labs, a partnership with Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) to fast-track early-stage academic research to drug discovery and development (Press release, Evotec, JUN 14, 2021, View Source;announcements/press-releases/p/evotec-partners-with-cebina-to-launch-danube-labs-a-partnership-to-develop-cutting-edge-biotechnology-projects-sourced-from-central-and-eastern-european-universities-and-research-institutions-6070 [SID1234583941]). The joint project, financed by a dedicated group of private investors, will identify, and develop academic projects into mature therapeutic product development opportunities, primed for biotech company formation or partnering. Danube Labs aims to create up to 8 new biotech companies over 4 years, and is supported by CEBINA Bridge Capital Limited, a private fund established in Gibraltar and committed to providing a minimum investment of € 10 m.

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"We are excited to join forces with Evotec to expand our mission to transform promising research and early-stage drug discovery projects from Central and Eastern Europe into mature projects attractive for forming new companies that will be embedded in the biotech ecosystem CEBINA has created. This partnership brings together great entrepreneurial expertise and experience in drug development that, we believe, will enable us to generate breakthrough therapeutics," commented Eszter Nagy, MD PhD, founder and CEO&CSO of CEBINA.

"Danube Labs represents the latest of Evotec’s BRIDGE partnerships, where we explore exciting academic science with the aim to accelerate the translation of early-stage drug discovery from academia to patients," commented Mark Slack, PhD, VP Academic Partnerships at Evotec. "Through our partnership with CEBINA, we see the opportunity to seek out and validate promising innovative research in Central and Eastern Europe".