On October 21, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has entered into a license agreement for worldwide non-exclusive rights of several Chugai’s antibody engineering technologies with Novo Nordisk A/S (Press release, Chugai, OCT 21, 2020, View Source [SID1234568712]).

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Under the terms of agreement, Novo Nordisk will receive the rights to use several Chugai’s antibody engineering technologies for their research activities and optional rights for the development and marketing of therapeutic antibodies applying those technologies. In return for the license, Chugai will receive a fee for technology access. In case Novo Nordisk creates a candidate antibody and exercises optional rights, Chugai will receive an upfront payment, milestone payments according to the development status, and royalty payment if the compound is launched as an approved antibody drug.

"Antibody engineering technology is one of Chugai’s core competencies and has led to the creation of innovative antibody drugs," said Dr. Junichi Nezu, Chugai’s Vice President, Head of Research Division. "We have high hopes that Novo Nordisk will utilize Chugai’s proprietary antibody engineering technologies to solve unmet medical needs and create novel medicines."

"With this agreement we have secured long-term access to antibody engineering technologies from Chugai which is one of the world leading companies within this field" added Lars Fogh Iversen, Senior Vice President, Global Research Technologies, Novo Nordisk. "Novo Nordisk is committed to protein-based therapeutics and access to premier technologies is essential to advancing the highest quality therapeutic programs."

On October 20, 2020 Xspray Pharma reported the company has based on the authorisation granted by the annual general meeting on 14 May 2020, and in accordance with that the Company indicated in a press release on 20 October 2020, successfully carried out a directed share issue at a subscription price of SEK 142.50 per share (the "Issue") (Press release, Xspray, OCT 20, 2020, View Source [SID1234650115]). The subscription price has been determined through an accelerated bookbuild transaction.

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A number of Swedish and international institutional investors, including Tredje AP-fonden, Handelsbanken Fonder, Andra AP-fonden, Swedbank Robur Fonder, Fjärde AP-fonden and TIN Ny Teknik have subscribed for shares in the Issue. The Company believes that using the flexibility provided by a non-pre-emptive placing is the most appropriate transaction structure in order to raise capital in a time- and cost-effective manner, whilst also further diversifying and strengthening the Company’s shareholder base.

The Company intends to use the net proceeds from the Issue to:

Enhance the Company’s financial position ahead of negotiating a deal pertaining to its lead product, HyNap-Dasa
Continue to expand the product portfolio
Complete the construction of its new manufacturing facility at a CMO in Malta
General corporate purposes
"The interest in Xspray is extremely motivating and we would like to thank the investors for their confidence in Xspray and our R&D. With the additional capital, we now have the financial strength required for our business development negotiations with potential partners for our most advanced project HyNap-Dasa. It will also allow us to speed up development of the next-in-line product candidates in our pipeline. We plan to start the study program with HyNap-Nilo already in Q1 2021 and to bring the exciting but not yet communicated subsequent product candidates forward in development. Furthermore, we are now able to finalize the expansion of our production capability in Malta allowing us to work at full speed with several products simultaneously," says Per Andersson, CEO Xspray Pharma.

The Issue is expected to raise proceeds for the Company of SEK 265 million, before transaction costs. The Issue will result in an increase in the number of shares in Xspray of 1,861,291, from 17,031,213 to 18,892,504, and an increase in the share capital by SEK 1,861,291 from SEK 17,031,213 to 18,892,504 resulting in a dilution of approximately 10%.

In connection with the Issue, the Company has agreed to a lock-up undertaking on future share issuance for a period of 90 days, subject to customary exceptions. In addition, the management and Board of Directors have undertaken not to sell any shares in Xspray during the same period subject to the right to sell shares to cover tax liabilities and to exercise holdings in the Company’s incentive program and customary exceptions.

Citigroup Global Markets Limited, Pareto Securities AB and Zonda Partners are acting as Joint Bookrunners in connection with the Issue. Vinge is acting as legal advisor to the Company and Baker McKenzie is acting as legal advisor to Citigroup Global Markets Limited, Pareto Securities AB and Zonda Partners.

On October 20, 2020 Chaperone, a new drug development bio venture, reported that it has completed attracting 26 billion won in Series C investment (Press release, Shaperon, OCT 20, 2020, View Source;idx=33&pNo=4&code=press_en [SID1234629322]).

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This investment includes follow-up investments from four existing investors, including Smilegate Investment, Yuanta Investment, and Seoul Investment Partners, as well as a total of nine investments, including POSCO Technology Investment, Moorim Capital, BNK Venture Investment, Albatros Investment, JX Partners, and Nova Healthcare. agency participated.

The amount by investor was 9 billion won by POSCO Technology Investment-Moorim Capital Investment Association and 7 billion won by Smilegate Investment, and other institutions were responsible for the rest.

With this investment as an opportunity, Chaperon is currently in phase 2 clinical trial for atopic dermatitis treatment in Korea and phase 2 clinical trial for COVID-19 treatment in Europe, as well as septicemia treatment that has completed phase 1 clinical trial and phase 1 clinical trial. It plans to accelerate the development and commercialization of Alzheimer’s dementia and ulcerative colitis treatments. In addition, the development of nanobody therapeutics, which are alpaca-derived fragment antibodies that overcome the limitations of existing antibodies, will also be accelerated.

To this end, Lee Myung-se, who recently served as CEO of Eli Lilly Philippines and Korea representative director of Abbott and Mundipharma, has been recruited as co-CEO, and co-CEO Seung-Yong Sung, the founder, is promoting global commercialization in the technology and business fields.

The NLRP3 inflammatory complex inhibitor being developed by Chaperon is a newly emerging target in new drug development to the extent that less than 10 bio companies around the world have substances that have entered the clinical stage, and multinational pharmaceutical companies are highly interested in it.

While competitive substances inhibit only IL-1β, Chaperone’s new drug substance simultaneously controls the initiation and amplification steps of the inflammatory complex, suppressing a wide range of inflammatory factors such as IL-1β, IL-6, and TNF-α, resulting in various inflammatory factors. It is more effective for acute chronic inflammatory diseases and shows the fastest clinical stage compared to competitors.

Co-CEO Lee Myung-se said, "With the goal of an IPO in 2021, we will materialize commercialization through global open innovation based on the world’s first GPCR receptor-modulating inflammatory complex inhibitor and nanobody platform technology established by only a handful of companies in the world."

On October 20, 2020 Ankarys Therapeutics Inc. (Ankarys), Applied StemCell, Inc. (ASC), and HebeCell Corp. (HebeCell) reported that they have entered into a strategic collaboration to co-develop allogeneic induced pluripotent stem cell (iPSC)-derived chimeric antigen receptor (CAR) NK cell therapeutics targeting hematological malignancies (Press release, HebeCell, OCT 20, 2020, View Source [SID1234571033]).

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The collaboration will leverage Ankarys’ cGMP iPSC lines, proprietary CAR constructs, and FailSafe cell engineering technology. Ankarys will lead the Canadian CTA/US IND-enabling studies and launch a Phase I clinical trial in Canada and US.

ASC will use its proprietary TARGATT gene editing technology to insert the proprietary CAR constructs into Ankarys’ iPSC lines.

HebeCell will differentiate the CAR expressing iPSCs into NK cells using its proprietary 3D bioreactor platform and will be the manufacturing partner for the collaboration throughout the preclinical, clinical, and commercialization phases of the product.

"Our unique TARGATT gene insertion technology has multiple applications in immunotherapy and regenerative Medicine" said Dr. Ruby Yanru Tsai, Chief Executive Officer and Co-Founder of ASC. "I am very excited to see TARGATT technology being used in generating iPSC-derived CAR-NK therapeutic products."

Dr. Allen Feng, the Founder and Chief Scientific Officer of HebeCell added "We are thrilled to start this collaboration with Ankarys and ASC as all three companies have a shared goal of achieving the unmet needs in the immuno-oncology field,"

"This collaborative partnership builds on the unique complementary strengths and resources to rapidly deploy off-the-shelf CAR-NK products for all patients." Dr. Armand Keating, Founder of Ankarys said. "We are excited to be working with ASC and HebeCell, and believe our platform technologies will alter the NK cell therapy field by delivering cost effective allogeneic therapies worldwide."

On October 20, 2020 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that the Phase 2 clinical trial of PDS0101 in combination with standard of care chemoradiotherapy (CRT) for treatment of locally advanced cervical cancer is now open (Press release, PDS Biotechnology, OCT 20, 2020, View Source [SID1234570260]).

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This Phase 2 trial is being led by Ann H. Klopp, M.D., Ph.D., Associate Professor of Radiation Oncology and Olsi Gjyshi, M.D., Ph.D., Resident in Radiation Oncology at The University of Texas MD Anderson Cancer Center. The trial will investigate the anti-tumor efficacy and safety of the PDS0101-CRT combination, and their correlation with critical biomarkers of immune response, in approximately 35 patients.

"We are excited to have initiated this Phase 2 human study of PDS0101 administered with the current standard of care. We believe that the demonstrated potential of PDS0101 to activate the immune system to induce tumor-targeting T-cells provides strong potential to present improved treatments to patients with cervical cancer," commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.

Dr. Lauren Wood, PDS Biotech’s Chief Medical Officer, will serve as PDS Biotech’s intermediary. The study is being performed pursuant to an Investigator Initiated Study Agreement between PDS Biotech and MD Anderson.