On September 7, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported it has entered into a definitive agreement to acquire Ciitizen, a patient-centric consumer health tech company (Press release, Invitae, SEP 7, 2021, View Source [SID1234587385]). Backed by a16z, Section 32 and Verily, Ciitizen is working to build a global platform to help patients collect, organize, store and share their medical records digitally. The acquisition would enhance Invitae’s platform by providing patients an easy-to-use, centralized hub for their genomic and clinical information, which together comprise a powerful dataset with the potential to drive research and improve healthcare decision making.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Invitae is relentlessly pursuing a day when genetics is used routinely to improve healthcare for billions of people around the globe. We believe combining Ciitizen’s state-of-the-art, transparent and patient-consented platform with our technologies and services will accelerate our evolution into a genome information company that informs healthcare throughout one’s life. This would give us the ability to engage patients, create an innovative patient-centered data ecosystem and deliver better outcomes for everyone. Invitae views the acquisition of Ciitizen as an important part of its strategy to be the industry leader across the genetic testing, software and health information technology spaces," said Sean George, Ph.D., co-founder and CEO of Invitae.

"Ciitizen has already helped patients take ownership of their medical records to optimize therapy for themselves and contribute their data towards a variety of goals, including research on rare diseases," said Anil Sethi, CEO and founder of Ciitizen. "Patients leave a breadcrumb trail of records behind them, and we believe access to this real-world data is key to personalized therapeutics in the future. The combination of lifelong health history together with Invitae’s world-class genetic and data services would enable a digital ecosystem of personalized services for each patient. Democratization of patient-consented data is expected to improve outcomes by providing access to third-parties for whom the patient has granted consent. Unlike many health data companies, we operate on the premise that it’s the patient’s data, not ours."

Dr. George continued, "Genomics is currently a laboratory testing-based industry, but in the future it will look very much like an information industry. Developing an open-ended patient-centric platform of genomic, clinical and reported outcomes creates a thriving and purposeful network that truly advances healthcare. Patient control is the big differentiator at Ciitizen and at Invitae; and we believe combining forces is the right strategy for our businesses going forward."

Empowering patients to combine their genomic and clinical information to improve clinical care

Invitae is working to aggregate results from the world’s genetic tests into a single, easy-to-use service that makes genetic information accessible to all who can benefit from it – always with patient consent. Over the past five years, Invitae has completed 13 acquisitions that have expanded its testing menu, lowered the cost of its tests, improved its customer experience and enhanced its ability to attract partners. Invitae raised more than $1.4 billion since the beginning of 2021, in part to identify and acquire key assets that bring the company closer to delivering on its vision.

The addition of Ciitizen is expected to empower Invitae to more quickly extend its platform, adding a complementary patient service that streamlines the process of collecting and organizing health information from any source and uses machine learning to transform the unstructured (and largely untapped) health information to enable better care decisions, find clinical trials, and power research using real-world evidence. In addition, as the use of Invitae testing and the Ciitizen service expands, third-party access to consented genomic and other clinical data can be democratized to power a variety of applications that can enhance Invitae’s business and growth strategy.

Transaction Terms

Under the terms of the agreement, Invitae will acquire Ciitizen for approximately $325 million (subject to adjustment), consisting of (i) approximately $125 million in cash and (ii) approximately 7,070,000 shares of Invitae common stock (based upon a trailing average closing price prior to the agreement date). Invitae will also issue approximately $225 million in restricted stock units (RSUs) to new employees who join Invitae in connection with its acquisition of Ciitizen. These RSUs will be granted under Invitae’s 2015 Stock Incentive Plan, which is being amended and restated to increase a pool of shares of Invitae common stock thereunder which is used exclusively for the grant of inducement awards in compliance with New York Stock Exchange Rule 303A.08 ("Rule 303A.08"). These RSUs have been approved by the Invitae Board of Directors and will be made as an inducement material to each employee entering into employment with Invitae in reliance on the employment inducement exemption under Rule 303A.08. These RSUs will cover up to a total of approximately 8,125,000 shares of Invitae common stock (based upon a trailing average closing price prior to the agreement date) and will vest in tranches of one-third upon each of the first, second and third anniversaries of the date of grant, subject to acceleration in the event of a termination without cause by Invitae or a termination with good reason by a recipient. A total of 99 recipients will receive these RSUs, and Anil Sethi, the CEO and founder of Ciitizen, will receive RSUs with respect to approximately 2,011,000 shares of Invitae common stock.

The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close this month.

Conference Call and Webcast today at 8:30 a.m. ET / 5:30 a.m. PT

Management will host a conference call and webcast today at 8:30 a.m. ET / 5:30 a.m. PT to discuss the transaction. To register for the conference call, please use the link below. Upon registering, each participant will be provided with call details and a registrant ID.

Online registration: View Source

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

On September 7, 2021 Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS) ("Tiziana" or the "Company"), a biotechnology company focused on innovative therapeutics for oncology, inflammation, and infectious diseases, reported that it will host a conference call and audio webcast on Wednesday, September 8, at 4:15 p.m. ET to discuss its recently announced exclusive license agreement to evaluate Foralumab, the Company’s novel, fully human anti-CD3 monoclonal antibody, in conjunction with allogenic CAR T candidates for cancer treatment (Press release, Tiziana Life Sciences, SEP 7, 2021, View Source [SID1234587384]).

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For interested individuals unable to join the conference call, a dial-in replay of the call will be available until September 22, 2021 and can be accessed by dialing +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International) and entering replay pin number: 13722965.

About Foralumab

Foralumab (TZLS-401, formerly NI-0401), the only entirely human anti-CD3 mAb, shows reduced release of cytokines as compared to other anti-CD3 mAbs after IV administration in patients with Crohn’s disease with decreases in the classic side effects of cytokine release syndrome and improves the overall safety profile of Foralumab. In a humanized mouse model (NOD/SCID IL2γc-/-), it was shown that while targeting the T cell receptor, orally administered Foralumab modulates immune responses of the T cells, enhances regulatory T-cells (Tregs) and thus provides therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy (Ogura M. et al., 2017 Clin Immunol 183, 240-246). Based on animal studies, the nasal and oral administration of Foralumab offers the potential for the immunotherapy of autoimmune and inflammatory diseases in a safe manner by the induction of Tregs.

On September 7, 2021 Bio-Thera Solutions, Ltd. reported that it’s BAT6021 injection and BAT6005 injection of innovative drugs have been approved for clinical use, which means the new progress has been made in the field of tumor treatment (Press release, Shanghai Medicilon, SEP 7, 2021, View Source [SID1234587381]).

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In recent years, Medicilon has continued to expand and innovate in the cutting-edge field of biotechnology drug research and development, and has built a functional and well-equipped protein/antibody pharmacokinetic research platform and a biotechnology drug non-human primate safety evaluation technical service platform, which is flexible using various methods such as ELISA, ECL, TRFIA, CLIA, IF, IP, CoIP, qPCR, FACS, ELISpot, enzymology, etc., to support the preclinical research evaluation of various protein and antibody drugs.

About BAT6021
BAT6021 is a differentiated anti-TIGIT monoclonal antibody developed by Bio-Thera, which is intended to be developed for tumor treatment. TIGIT is an immunoglobulin superfamily protein that is highly expressed on the surface of activated NK cells, CD4+ T cells, CD8+ T cells and immunosuppressive Tregs. PVR, the main ligand of TIGIT, is highly expressed on the surface of a variety of solid tumor cells and dendritic cells. BAT6021 can block the combination of TIGIT and CD155 (PVR), thereby restoring the functions of T cells and NK cells. The differentiated BAT6021 has ADCC enhancement function, which can eliminate immunosuppressive Tregs cells through the enhanced ADCC function, and strengthen the combination of T cells and DC cells, thereby improving the response of antigen-specific T cells and improving the effect of tumor immunotherapy.

About BAT6005
BAT6005 is an anti-TIGIT monoclonal antibody developed by Bio-Thera, which is intended to be developed for tumor treatment. TIGIT is an immunoglobulin superfamily protein that is highly expressed on the surface of activated NK cells, CD4+ T cells, CD8+ T cells and immunosuppressive Tregs. PVR, the main ligand of TIGIT, is highly expressed on the surface of a variety of solid tumor cells and dendritic cells. BAT6005 can block the combination of TIGIT and CD155 (PVR), thereby restoring the functions of T cells and NK cells. In addition, BAT6005 has a normal ADCC effect function, which can eliminate immunosuppressive Tregs cells through ADCC function.

Just as Bio-Thera adheres to the concept of "Innovation is only for life" and is committed to the research and development of a new generation of antibody drugs; Medicilon also regards "Innovation-driven, quality first" as its development philosophy, and is committed to provide a full range of pre-clinical new drug research services to global pharmaceutical companies, research institutions and scientific research. Similar ideas and visions have prompted the two parties to reach collaboration again and again and have successful results one by one. The collaboration between Medicilon and Bio-Thera is that like-minded people go to the future of human health, and it also shows Bio-Thera’s high recognition of Medicilon.

Medicilon has also repaid Bio-Thera’s trust with professional technology and rigorous attitude. From the beginning of the project, Medicilon has made every effort to promote the project with its rich project experience and high-quality and efficient R&D services. Through the collaboration, Medicilon has accumulated a lot of valuable R&D experiences.

The collaboration between Medicilon and Bio-Thera is continuing and we look forward to the joint efforts and mutual trust of both parties. The collaboration will bear more new drugs and promote the launch of more new biological drugs, which will benefit patients around the world!

The collaboration between Medicilon and Bio-Thera is continuing and we look forward to the joint efforts and mutual trust of both parties. The collaboration will bear more new drugs and promote the launch of more new biological drugs, which will benefit patients around the world!

On September 7, 2021 Emulate, Inc., a leading provider of next generation in vitro models, reported the close of an $82 million Series E financing round led by existing investor Northpond Ventures with additional participation from Perceptive Advisors (Press release, Emulate, SEP 7, 2021, View Source [SID1234587379]). With this investment, Emulate has raised nearly $225 million to date.

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"This fundraise is a testament to the fact that Emulate organ-chips are allowing the exploration of human biology like never before," said Jim Corbett, CEO of Emulate. "Over the last year, we have bolstered our leadership team, accelerated product development goals, and seen healthy growth in demand for our products. Several leading indicators validate our belief that organ-on-a-chip technology will dramatically transform the entire drug discovery and development pipeline and ultimately eliminate unnecessary animal testing."

Emulate develops and manufactures next-generation in vitro models that enable researchers to replicate and study human biology and disease, helping them understand and predict drug response with greater precision and detail than possible with conventional cell culture or animal-based methods. Organ-on-a-chip technology by Emulate provides flexible microenvironments containing tiny hollow channels lined with living cells and tissues that can be subjected to mechanical forces that mirror breathing or digestion in the human body. The technology is used by leading academic researchers, government entities, and many of the largest pharmaceutical companies to better understand the biology of human disease.

"We believe Emulate’s transformative technology is poised to accelerate innovation in the drug discovery and development process," said Sharon Kedar, CFA, Co-Founder and Partner at Northpond Ventures. "Our ongoing investment in Emulate reflects our confidence that organ-on-a-chip technology will be a key solution for preclinical testing of therapeutic compounds."

The funds raised through the Series E financing round will support a significant scale-up in research and development activities to facilitate the creation of new human-relevant organ-on-a-chip models in immunology, neuroinflammation, tumor modeling, and more. To help meet growing global demand, Emulate is extending operations in the Asia Pacific region with two new distributors.

"With biomedical research and pharmaceutical industries focused on leveraging the human immune system in the development of new biologic medicines, immunotherapies, and vaccines, human-relevant modeling methods are clearly essential to the success of development programs designed to improve human health," said Sam Chawla, Portfolio Manager at Perceptive. "The rapid growth in the adoption of Emulate organ-chip technology is a testament to the value they can provide to researchers seeking to understand the mechanisms of disease and treatment options."

Recently in the United States, the FDA Modernization Act and the Humane Research Act have been introduced in Congress calling on the support for alternatives to animal testing, citing scientific inadequacies and ethical concerns associated with animal models.

On September 7, 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, SEP 7, 2021, View Source [SID1234587373]). 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 30 August 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 19,301,886 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 3 September 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 20,495,414 B shares at an average share price of DKK 489.85 per B share equal to a transaction value of DKK 10,039,597,070.