On August 30, 2021 Samyang Biopharm USA, Inc. (View Source) a subsidiary of Samyang Holdings Corp. (View Source), reported that the company has entered into a research collaboration with the Spanish National Research Council (CSIC), a state agency for scientific research and technological development (Press release, Samyang Biopharmaceuticals, AUG 30, 2021, View Source [SID1234587009]). The two organizations will work together to study the effect of NKG2D-ligand-containing vesicles and Samyang’s proprietary monoclonal antibody, SYB-010, on NKG2D receptor expression and NK cell function. Financial terms of the agreement were not released.

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"CSIC is the ideal partner for our early-stage discovery program with their proven scientific capability and successful track record in analyzing the immunomodulatory impact of antibodies. We look forward to future involvement within this collaboration" said Sean McKenna, Ph.D., Vice President of Research, Samyang Biopharm USA. "Partnering with CISC on SYB-010 will allow Samyang to advance our promising drug candidate."

SYB-010 is a monoclonal antibody targeting the human NKG2D-ligands, MCA/B, which has shown a clear immumodulatory effect in pre-clinical models. Treatment with this antibody markedly reduces tumor growth; while showing potential to also reduce the number of metastases and increasing overall animal survival. In 2019, Samyang acquired global rights for the development, manufacturing and commercialization of SYB-010 (formerly CuraB-10) from CanCure, LLC. More information on that collaboration can be found here. Samyang continues to develop this antibody both internally and through collaborations to enable future clinical programs.

"By combining our expertise in pre-clinical research that analyzes the immunomodulatory effect of drug candidates, we hope to confirm the potential of SYB-010 as a transformative cancer agent," said Drs. Valés-Gómez and Reyburn, Group Leaders at Spanish National Research Council. "We believe that this project is an important step in helping improve our overall understanding of the biology regulating this receptor and its ligands; and will allow us to foster further discovery and development efforts for Samyang."

"We believe that SYB-010 has great clinical potential and are pleased to be collaborating with CSIC whose breadth of experience in pre-clinical research will allow Samyang to advance this compound forward into the clinic," said Helen Hyun Jung Lee M.D., President/CEO, Samyang Biopharm USA, Inc. "Through this collaboration, we will benefit from our partner’s strong science expertise and enabling technologies to further influence and enhance our lead program and have the opportunity to evaluate the full potential of SYB-010 at this critical juncture."

On August 30, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, AUG 30, 2021, View Source [SID1234587027]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

Since the announcement 23 August 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 18,897,886 B shares of DKK 0.20 as treasury shares, corresponding to 0.8% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 27 August 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 20,091,414 B shares at an average share price of DKK 486.93 per B share equal to a transaction value of DKK 9,783,088,903.

On August 30, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its CAR-T (Chimeric Antigen Receptor-T cell) therapy, which is being developed in partnership with Moffitt Cancer Center (Moffitt) (Press release, Anixa Biosciences, AUG 30, 2021, View Source [SID1234586994]).

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Dr. Robert Wenham, Chair of Gynecological Oncology at Moffitt will lead the clinical trial.
This CAR-T therapy was developed by Dr. Jose Conejo-Garcia and his research team, when he was at the Wistar Institute. Dr. Conejo-Garcia is currently the Chairman of Immunology at Moffitt.
Anixa Biosciences has an exclusive worldwide license to the technology.
This technology is an autologous cell therapy. The therapeutic product is comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone receptor, and the target-binding domain is derived from its natural ligand, this technology is also known as CER-T (Chimeric Endocrine Receptor T-cell) therapy, a new type of CAR-T.
Dr. Amit Kumar, President and CEO of Anixa stated, "We are pleased that the FDA has authorized us to commence human clinical trials of our potentially paradigm-shifting therapy. Outcomes for women with late-stage ovarian cancer are poor, so if this approach demonstrates efficacy, it would have a dramatic impact on patients for whom there are no other options."

"This is a major milestone for our program. CAR-T therapy has had major successes in B-cell malignancies, but no clinical success in other types of tumors. We feel that our technology could be the first CAR-T approach that will demonstrate efficacy in a solid tumor indication, and we are looking forward to testing and verifying that assertion in human trials," said Dr. Wenham.

In addition to Drs. Wenham and Conejo-Garcia, other key members of the team at Moffitt include:

Dr. Marco Davila, Clinician and Director of the Cell Therapy Facility at Moffitt
Dr. Daniel Abate Daga, Assistant Director of the Cell Therapy Facility at Moffitt
Dr. Ana Marie Landin, Experimental Cell Therapy Manager at Moffitt
Dr. Theresa Boyle, Department of Pathology at Moffitt
Carrie Thomas, FDA Regulatory Liaison at Moffitt
Tam Jackson, Project Management Consultant
Scientists and Members of the Moffitt Cell Therapy Facility
Members of the Moffitt Alliance Relations Team

On August 30, 2021 Legend Biotech Corporation (NASDAQ: LEGN), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported that it will participate in the 19th Annual Morgan Stanley Virtual Global Healthcare Conference on Friday, September 10 (Press release, Legend Biotech, AUG 30, 2021, View Source [SID1234587010]). Ying Huang, Chief Executive Officer and Chief Financial Officer, will represent the Company in a session scheduled at 8:45 a.m. (Eastern Time).

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The webcast will be available to investors and other interested parties by accessing the Legend Biotech website at View Source

On August 30, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported CEO Jeff Wolf will host a conference call on Thursday, September 2nd at 11:00 A.M. Eastern Time to provide an update on the Company’s activities (Press release, Heat Biologics, AUG 30, 2021, View Source [SID1234587028]).

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The conference call may be accessed by dialing 844-602-0380 for U.S. callers or +1 862-298-0970 for international callers. A webcast of the call may be accessed at View Source or on the Company’s website at View Source

An audio replay of the call will be available through September 16, 2021, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and by entering the access code: 42602.