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NeoImmuneTech Announces First Clinical Trial Application Authorization Received in the EU for its Phase 2 Study of NT-I7 (efineptakin alfa) and Opdivo® (nivolumab)

On June 8, 2021 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported the first Clinical Trial Application (CTA) authorization in the European Union (EU) (Press release, NeoImmuneTech, JUN 8, 2021, View Source [SID1234583718]). This authorization comes from Italy’s Agenzia Italiana Del Farmaco (AIFA) for the company’s ongoing Phase 2 study of NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with Bristol-Myers Squibb Company’s (NYSE: BMY) Opdivo (nivolumab), a PD-1 blocking antibody, versus nivolumab monotherapy.

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"We are excited to expand our investigation of NT-I7 as a potential therapeutic for cancers and other immune-mediated illnesses into the EU," said NgocDiep Le, M.D., Ph.D., Executive VP and Chief Medical Officer of NeoImmuneTech. "This authorization marks a significant milestone for the development of NT-I7 and provides the opportunity to include additional patients in this study whose treatment outcomes may be improved with the use of NT-I7."

This ongoing Phase 2, randomized, proof-of-principle study is to evaluate preliminary anti-tumor activity of NT-I7 and nivolumab, compared with nivolumab alone, in patients with previously treated advanced or metastatic gastric or gastro-esophageal junction (GEJ) cancer, or esophageal adenocarcinoma, and to assess safety and tolerability of the combination in these patients. AIFA’s CTA authorization is for the phase 2 part of the study, upon successful completion of the dose escalation phase. The results of this study will be used to further clinical development of this combination in selected clinical settings and tumor types. More information on this trial can be found at www.clinicaltrials.gov, identifier: NCT04594811

Opdivo is a registered trademark of Bristol Myers Squibb.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

Histogen Announces $6.5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

On June 8, 2021 Histogen Inc. (Nasdaq: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, reported that it has entered into definitive agreements with several institutional and accredited investors, for the purchase and sale of 5,977,300 shares of its common stock, at a purchase price of $1.10 per share, in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Conatus Pharmaceuticals, JUN 8, 2021, View Source [SID1234583717]). Histogen also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 4,781,840 shares of its common stock. The closing of the offering is expected to occur on or about June 9, 2021, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.00 per share, will be exercisable immediately upon issuance and will expire five and one-half years from the date of issuance.

The gross proceeds from this offering are expected to be approximately $6.5 million, before deducting placement agent’s fees and other offering expenses. Histogen intends to use the net proceeds from this offering for working capital and general corporate purposes, including expenses related to the clinical development of its pipeline programs, further research and development, capital expenditures and general and administrative expenses.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) are being offered by Histogen pursuant to a "shelf" registration statement on Form S-3 (File No. 333-248074) previously filed with the Securities and Exchange Commission (the "SEC") on August 17, 2020 and declared effective by the SEC on August 26, 2020. The offering of the shares of common stock will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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.

Orion and the Blood Service launch collaboration to develop new CAR T-cell cancer therapy

On June 8, 2021 Orion Corporation and the Finnish Red Cross Blood Service reported that they have concluded an agreement on research collaboration with the aim of developing chimeric antigen receptor (CAR) T-cell therapy (Press release, Orion , JUN 8, 2021, View Source [SID1234583716]).

Cancer immunotherapies, with CAR T-cell therapy as one form of therapy, have introduced entirely new possibilities for cancer treatment. In CAR T-cell therapy, the patient’s own white blood cells are genetically modified to attack the cancer and kill it. CAR T-cells are currently used to treat certain haematological cancers.

The first T-cell therapies received marketing authorisation in the USA in 2017 and in Finland in 2019 for the treatment of recurrent acute lymphocytic leukaemia and B-cell lymphoma. Despite the good treatment results, development needs have been identified in CAR T-cell therapies, which is why research related to CAR-T cell therapy is being pursued.

The Blood Service has considerable experience in cell research, in the supply of cord blood and stem cell grafts classified as tissue products, and in the preparation of ATMP cell products classified as medicinal products. The Blood Service also has expertise and the necessary clean rooms for the research and high-quality production of therapeutic cells.

Orion has a solid research infrastructure and has introduced several proprietary drugs to the market in different therapy areas. Orion’s oncology therapy area researches and develops novel proprietary drugs for the treatment of cancer. In recent years, Orion has expanded its research activities to include immuno-oncology therapies.

New possibilities for cancer treatment

The research collaboration is based on new innovations to improve the structure of the CAR T-cell product. Matti Korhonen, Senior Medical Officer, who leads the research at the Blood Service, believes that the collaboration offers a great opportunity to develop new cell therapy products for patient care. According to Oliver Cooper, Ph.D., director of Discovery Sciences at Orion’s R&D, Orion’s drug development expertise will provide the necessary momentum for this project.

"Targeted immunotherapy has opened up entirely new possibilities for the treatment of cancer, and it is important to advance this development in Finland, too. I also believe that as a result of the development work, more and more patients will be able to benefit from this effective treatment," says Matti Korhonen

Project managers Satu Juhila from Orion and Jan Koski from the Blood Service say that the collaboration has got off to a good start: "Both parties are very enthusiastic regarding the opportunities of the collaboration and about advancing the development of cell therapy in Finland. We believe that the collaboration will provide plenty of new opportunities for the development of cell therapy products."

InflaRx Doses First Patient in Multicenter Phase II Clinical Trial in Cutaneous Squamous Cell Carcinoma with Vilobelimab

On June 8, 2021 InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported the enrollment of the first patient in an open-label, multicenter Phase II clinical study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC) (Press release, InflaRx, JUN 8, 2021, View Source [SID1234583715]).

The Phase II clinical trial is expected to enroll approximately 70 patients at sites in Europe, the U.S. and elsewhere. The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess the safety and antitumor activity of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm.

Dr. Korinna Pilz, Global Head of Clinical Research and Development at InflaRx, said: "We are pleased to initiate the first clinical trial to evaluate vilobelimab in cancer. Scientific data suggest C5a involvement in tumor formation and progression, as well as in immunosuppression. Additionally, there is pre-clinical evidence of synergies between PD-1 and C5a/C5aR inhibitors in inducing anti-tumor responses. Based on this, we believe that vilobelimab has the potential alone and in combination with the PD-1 checkpoint inhibitor pembrolizumab to treat the advanced stages of this potentially deadly skin cancer."

The C5a/C5aR pathway has been implied as a potential driver for tumorigenesis, metastases and avoidance of immune cell destruction, particularly in the context of cSCC.

Several independent pre-clinical studies showed that the combination of a C5a or C5aR pathway inhibitor with inhibition of the PD-1/PD-L1 axis leads to an antitumoral effect, which was stronger than inhibition of one of the axes alone. This provides a pre-clinical rationale for the combined blockade of PD-1 and C5a to restore antitumor immune responses and to inhibit tumor cell growth.

About cutaneous squamous cell carcinoma (cSCC)

cSCC is the second most common form of skin cancer and, if caught early, it is generally curable. In the U.S. alone, according to the Skin Cancer Foundation, an estimated 1.8 million cases are diagnosed each year, which translates to about 205 cases diagnosed every hour. The incidence of cSCC has increased up to 200 percent in the past three decades. Over 15,000 people in the U.S. die each year from this disease. Approximately 5% of patients with cSCC develop locally advanced or metastatic disease. These forms of cSCC have a poor prognosis with low survival rates.

About vilobelimab (IFX-1):

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response in pre-clinical studies. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum and COVID-19 pneumonia.

EISAI RECEIVES SPECIAL PRIZE AT PLATINUM CAREER AWARD 2021

On June 8, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has received a special prize at the Platinum Career Award 2021 (Press release, Eisai, JUN 8, 2021, View Source [SID1234583714]). The awards ceremony was held via online at the symposium on June 8, 2021.

The Platinum Career Award was established in 2019 with the aim of commending companies that aspire to provide opportunities for employees to develop their career and play an active role, in order to realize career paths that Japanese employees are aiming for in the era of the 100 years’ life. (This event was held with sponsorship and planning by Mitsubishi Research Institute, Inc., planning by Mitsubishi UFJ Trust and Banking Corporation, support by the Ministry of Health, Labour and Welfare, Japan, and Tokyo Stock Exchange, Inc., and cooperation from TOYO KEIZAI INC.). Eisai received a special prize dedicated to companies that are implementing "new working styles initiated to adjust with the era of Corona (COVID-19 Pandemic)".

Eisai defines our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," in the articles of incorporation, which we call our human health care (hhc) philosophy.

Eisai will enhance the development of self-reliant talents, so that each and every employee who sympathize with its corporate philosophy can adapt themselves to any changes and contribute to the creation of new social value through working independently with high motivation. By promoting work and learning style reforms to achieve this goal, Eisai attempts to transition from a company-led career development style to a proactive career development style based on the diversity of values of individual employees and their willingness to take on challenges. In addition, Eisai will work on expanding the range of individual discretion in choosing work locations and working hours, as well as implementing new measures for utilizing IT tools in terms of both hardware and software, such as efficiently providing training opportunities for all employees to independently learn new skills and acquire new working experiences, adopting a special paid leave system that can be used for self-development and social contribution activities, and promoting online dialogue between members inside and outside the organization.

Eisai will make continuous efforts based on the hhc philosophy to further contribute to increasing the benefits of patients and their families around the world.