On October 11, 2021 Celsion GmbH, a wholly owned subsidiary of Celsion Corporation (NASDAQ: CLSN), a clinical-stage biotechnology company focused on DNA-based immunotherapy and next-generation vaccines, reported the journal Advanced Drug Delivery Reviews has published an article reviewing the history of ThermoDox, from animal studies through to the Phase III OPTIMA Study in advanced liver cancer (Press release, Celsion, OCT 11, 2021, View Source [SID1234591055]). Titled "Drug development of lyso-thermosensitive liposomal doxorubicin: Combining hyperthermia and thermosensitive drug delivery," the article was authored by Nicholas Borys, M.D., Executive Vice President and Chief Medical Officer of Celsion, and Mark W. Dewhirst, D.V.M., Ph.D., the Gustavo S. Montana Professor of Radiation Oncology and Vice Director for Basic Science of the Duke Cancer Institute at Duke University School of Medicine, and is available [here/link].

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ThermoDox features a novel mechanism of action that delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. ThermoDox is positioned for use with multiple heating technologies and has the potential to treat a broad range of cancers including metastatic liver, recurrent chest wall breast cancer and non-muscle invading bladder cancers. The article’s authors noted that ThermoDox is the first heat-activated formulation of a liposomal drug carrier to be utilized in human clinical trials.

According to Dr. Borys, "As our recent paper in Advanced Drug Delivery Reviews points out there was much learned regarding the application of ThermoDox with heat technology. The publication of this article helps to educate clinical researchers about the compelling results in early-stage studies we have achieved in multiple oncology targets (notably bladder and brain) during our years of work with ThermoDox, which may catalyze further investigation. While Celsion made a business decision to focus the company on other promising programs targeting important indications such as ovarian cancer and infectious diseases, I am pleased that Celsion GmbH will provide support for ThermoDox’s continued clinical evaluation and development. The work that is being initiated with the NIH is exciting and should open new paths of opportunity for ThermoDox."

Dr. Dewhirst added, "It is good to see important work continuing with ThermoDox. As heat delivery technology continues to improve, such as HIFU (High Intensity Focused Ultrasound), along with the availability of bladder heating technologies there is much potential for ThermoDox in a number of cancers, including the bladder or even the brain. The collaboration between the NIH and Celsion on ThermoDox is an exciting step toward better therapies for patients with cancer."

Celsion GmbH is also announcing a new Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health (NIH) to evaluate ThermoDox in two in vivo studies:

Evaluation of ThermoDox deployment in the rectal mucosa with endorectal heating. This preclinical study in a swine model seeks to explore the feasibility of the maximum tolerated dose of intravenous ThermoDox administration with endorectal heating of mucosa to assess the feasibility, depth of penetration and drug levels in the acute setting.

Evaluation of ThermoDox deployment in the bladder mucosa with endo-cavitary bladder heating. This preclinical study, also in a swine model, is intended to identify the feasibility of ThermoDox for bladder mucosal delivery utilizing a standard commercial bladder heating devices. To augment standard regimens, intra-cavitary mitomycin C will be co-administered with intravenous ThermoDox, along with heated bladder fluid in a closed circuit, in a regimen that simulates potential future clinical use.
Andreas Voss, M.D., Managing Director of Celsion GmbH, added, "This publication provides a comprehensive summary of the development of ThermoDox to date. While clinical studies in the first indication did not reveal its benefits the powerful proof of concept in vivo provides a strong rationale for the continued clinical development of ThermoDox. The ongoing preclinical and clinical studies will guide us towards clinical indications in which ThermoDox improves patient’s lives.

"In addition, I am highly encouraged by the interest shown to date by independent clinical researchers in investigating ThermoDox. The ability to safely deliver a potent yet toxic chemotherapeutic agent such as doxorubicin warrants such further work to identify the most promising targets. We are delighted the NIH also believes in the potential benefit of this work. While Celsion GmbH’s long-term objective is to seek partnerships to maximize the promise of ThermoDox, our overarching goal is to provide novel treatment options for patients with cancer."

ThermoDox is currently the subject of investigator-sponsored trials for several cancer indications, including:

A Phase I study led by the University Medical Center Utrecht in the Netherlands to determine the safety, tolerability and feasibility of ThermoDox in combination with Magnetic Resonance Guided High Intensity Focused Ultrasound hyperthermia and cyclophosphamide therapy for the local treatment of the primary tumor in metastatic breast cancer.

A Phase I study led by Oxford University in the UK to assess intravenous delivery of ThermoDox in combination with High Intensity Focused Ultrasound in pancreatic cancer.

On October 11, 2021 Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, reported that the clinical trial of ALK-1 antibody (GT90001C) and Nivolumab (Opdivo) combination therapy for the treatment of systemic therapy naïve patients with advanced hepatocellular carcinoma ("HCC") was approved by the National Medical Products Administration (the "NMPA") of China on October 9, 2021 (Press release, Suzhou Kintor Pharmaceuticals, OCT 11, 2021, View Source [SID1234591040]).

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ALK-1 antibody is a fully human IgG2 neutralizing monoclonal antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis. Kintor Pharma obtained an exclusive global license for all oncological applications for ALK-1 antibody from Pfizer, Inc., in February 2018.

The phase II clinical trial of the combination therapy of ALK-1 antibody and Nivolumab on patients with advanced HCC has started on May 7, 2019 in Taiwan, China ("Taiwan phase II clinical trial"), evaluated the efficacy and safety of ALK-1 antibody in combination with Nivolumab in patients with advanced HCC who were progressed on or intolerant to first-line therapy with Sorafenib or Lenvatinib. The preliminary data of the ongoing Taiwan phase II clinical trial was released at the ASCO (Free ASCO Whitepaper) GI 2021 (held between January 15 – 17, 2021), and showed positive efficacy and safety results. The overall response rate ("ORR") was 40%.

On 11 February 2021, the investigational new drug application of multiregional phase II clinical trial of combination therapy of ALK-1 antibody and Nivolumab for the second-line treatment of advanced HCC was greenlighted by the United States Food and Drug Administration.

Dr. Youzhi Tong, founder, Chairman and CEO of Kintor Pharma, commented, "Liver cancer has been ranked no. 4 in terms of incident rate and no. 2 in terms of mortality rate in China, and HCC accounts for 75-85% of liver cancer. ALK-1 antibody was in-licensed from Pfizer, which has made Kintor the leader in the clinical development of this anti-cancer angiogenesis inhibitor with the first-in-class potential globally. ALK-1 antibody, in combination with Nivolumab, has demonstrated very positive results in the clinical trial of treating HCC patients who failed sorafenib or Lenvatinib. Currently we are in co-development with Alphamab to test ALK-1’s combo therapy with KN046 bispecific for treating a bunch of solid tumors including HCC. NMPA’s formal approval of ALK-1 antibody in combination with Nivolumab as the first-line treatment of HCC, which provides a great opportunity for this combo therapy as a potential standard of care for HCC. If successful, the market prospect and commercial value are very promising."

On October 11, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) reported the appointment of Mari Scheiffele as EVP and President, Specialty Care International, effective November 1st 2021 (Press release, Ipsen, OCT 11, 2021, View Source [SID1234591038]). Based in Boulogne, France, she will be reporting directly to David Loew, CEO, Ipsen, and serve on the Executive Leadership Team.

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"Along with the ELT, we are very pleased to welcome Mari to Ipsen. Her diverse experience will be critical in developing our three key therapeutic areas, Oncology, Rare Disease and Neuroscience, by continuing to strengthen Ipsen’s international commercial presence in over 115 countries, excluding North America. Mari also brings valuable capabilities in transformation which she built over the course of her previous roles at Novartis and McKinsey. We are looking forward to working closely with her," said David Loew, CEO, Ipsen.

Mari brings 20 years of healthcare leadership experience, from across the industry, having worked in the US, Europe and in Japan. She joins Ipsen from Novartis where she has been in both global strategic and country operational roles, first in Japan and then in the UK. Most recently, Mari has been General Manager, Novartis Oncology UK & Ireland where with a focus on patient-centricity, evidence-based medicine, and partnership, she has driven a successful business transformation.

In addition to her depth in Oncology, Mari has worked in other specialty care environments such as ophthalmology, neuroscience and immunology. Prior to Novartis, Mari was a partner at McKinsey & Company in New York and in Switzerland in Pharmaceuticals and Medical Products.

"I’m delighted to be joining Ipsen at such an exciting time," said Mari Scheiffele. "Ipsen has an inspiring strategy, strong growth and a fantastic culture of collaboration, and excellence. I look forward to working with my new colleagues on Ipsen’s International team, across its broad reach of markets, to bring Ipsen’s transformative innovations to patients around the World."

Mari speaks English, Finnish and Japanese and holds a doctorate in neuroscience from Harvard Medical School.

On October 10, 2021 MobileODT reported that we are Finalist in the Hospital Diagnostics category for a UCSF 2021 Health Award (Press release, MobileODT, OCT 10, 2021, https://www.mobileodt.com/various/mobileodt-selected-as-ucsf-2021-health-awards-finalist/ [SID1234591048]). The UCSF Health Awards honor outstanding health technologies and innovations dramatically transforming healthcare.

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MobileODT was selected out of thousands of companies, through rigorous judgment rounds, performed by over 300 judges from all over the world. We are extremely honored by this selection, which is a testament to the impact that our technology is making on women’s health.

On October 10, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed offering and sale in the United States of shares of Evotec represented by American Depositary Shares ("ADSs") (Press release, Evotec, OCT 10, 2021, View Source;announcements/press-releases/p/evotec-se-files-registration-statement-for-proposed-offering-of-american-depositary-shares-6102 [SID1234591046]). The Registration Statement has not yet become effective and the final number of ADSs to be offered and their price have not yet been determined.

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Evotec’s shares are listed on the regulated market of the Frankfurt Stock Exchange in Germany with additional admission obligations of the Prime Standard Segment. Evotec has applied for a secondary listing of the ADSs on the Nasdaq Global Select Market in the United States under the ticker symbol "EVO". The new shares underlying the ADSs will be issued from Evotec’s authorised capital.

The ADSs will be issued under Evotec’s revised ADS program, which continues to be administered by JP Morgan Chase Bank, N.A. BofA Securities and Morgan Stanley are acting as lead joint book-running managers for the offering. Citigroup, Jefferies, Cowen and RBC Capital Markets are acting as joint book-running managers for the offering.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus, when available, may be obtained from BofA Securities, NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department or by email at [email protected], Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected].

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities law of any such state or jurisdiction.