On January 19, 2021 Prescient Therapeutics (PTX) reported that three internal development programs for its immune receptor technology platform, OmniCAR (Press release, Prescient Therapeutics, JAN 19, 2021, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-asxptx-to-begin-three-next-gen-car-t-programs [SID1234574088]).

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OmniCAR is a next-generation CAR T therapy platform that offers multiple advantages over its predecessor such as control, safety, flexibility and efficacy.

CAR T is a form of immunotherapy that uses T-cells to directly target cancer cells, however, it has some limitations. As a result, OmniCAR is believed to be a more safe and effective treatment when treating cancers such as Acute Myeloid Leukemia (AML), breast, ovarian and gastric cancers and glioblastoma multiforme (GBM).

Essentially, AML causes patients to become extremely ill, which makes them unable to tolerate the vigorous nature of CAR T therapy. The disease is also known to rapidly mutate mid-therapy, which causes single CAR Ts to be ineffective.

Other downsides of CAR T therapy when treating solid tumours include its inability to overcome an immunosuppressive tumour microenvironment and the inability of T-cells to reach tumour sites and penetrate physical barriers.

When considering GBM and its rapidly progressive nature, CAR Ts ability to only target a single antigen makes it an ineffective treatment option.

Following a strategic review by Prescient and its scientific advisory board, it has been realised that using the OmniCAR technology to treat these cancers may have significant benefits over the conventional CAR T therapy.

Benefits include titration for improved safety, the ability to switch antigen targeting; co-arming CAR T against multiple antigens simultaneously, persistent dosing and improved efficacy.

The development programs are OmniCAR CD33 and CLL-1 for AML, OmniCAR Her2 for Her2+ solid tumours including breast, ovarian and gastric cancers, and OmniCAR Her2 and EGFRviii for GBM.

"We are delighted to select these internal programs as truly differentiated, next-generation CAR T products for Prescient. Each of the programs represents a tremendous market opportunity," Prescient Therapeutics Managing Director and CEO Steven Yatomi-Clarke said.

"Furthermore, Prescient will continue to seek collaborations with external parties on additional opportunities where OmniCAR can create additional next-generation CAR therapies with partners," he added.

Not only are the programs aimed at demonstrating the unique features and advantages of OmniCAR in treating patients, but they’ll also potentially move OmniCAR towards clinical programs.

Company shares are up 5 per cent and trading at 8.4 cents at 11:10 am AEDT.

On January 19, 2021 Incyte (Nasdaq:INCY) reported that it has scheduled its fourth quarter and year-end 2020 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, February 9, 2021 (Press release, Incyte, JAN 19, 2021, View Source [SID1234574087]).

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The schedule for the press release and conference call/webcast is as follows:

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13715042.

The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

On January 18, 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, JAN 18, 2021, View Source [SID1234577311]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 5 February 2020.

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Under the programme initiated 3 November 2020, Novo Nordisk will repurchase B shares for an amount up to DKK 2.7 billion in the period from 4 November 2020 to 1 February 2021.

With the transactions stated above, Novo Nordisk owns a total of 38,738,659 B shares of DKK 0.20 as treasury shares, corresponding to 1.6% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 5 February 2020. As of 15 January 2021, Novo Nordisk has since 5 February 2020 repurchased a total of 38,800,522 B shares at an average share price of DKK 425.00 per B share equal to a transaction value of DKK 16,490,383,717.

On January 18, 2021 MonTa Biosciences reported it was awarded with positive feedback from the regulatory agency in Denmark to initiate phase I study on our lead candidate MBS8. The study will start later in Q1 with dosing of solid tumor patients in a dose-escalation study (Press release, MonTa Biosciences, JAN 18, 2021, View Source [SID1234575255]). The primary endpoint is to establish the recommended phase 2 dose level, for which the second part of the study, the expansion stage, will include a larger group of different solid tumor patients.

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On January 18, 2021 Sana Biotechnology reported that filed with the U.S. Securities and Exchange Commission (SEC) to launch an initial public offering (IPO) worth $150 million (Press release, Sana Biotechnology, JAN 18, 2021, View Source [SID1234574125]). But that number doesn’t quite reflect the company’s likely market valuation, which is expected to be between $9 billion and $12 billion.

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Based in Seattle, Washington, Sana focuses on in vivo and ex vivo cell engineering platforms to develop therapies for cancer, diabetes, cardiovascular disease, CNS disorders, and genetic diseases. Despite its lofty valuation, the company does not yet have any drugs in the clinic, although it expects to submit Investigational New Drug (IND) applications in 2022 and 2023.

Launched in 2019, the company raised $700 million in June 2020 in its initial financing. Those funds were used to advance its discovery and development programs.

It was founded by the former chief executive officer of Juno Therapeutics, Hans Bishop. Sana’s initial investments came from Flagship Pioneering, ARCH Venture Partners, and F-Prime Capital. In addition to that initial investment, investors included the Canada Pension Plan Investment Board, Baillie Gifford, Alaska Permanent Fund, the Public Sector Pension Investment Board, Bezos Expeditions, GV, Omega Funds, Altitude Life Science Ventures, and several unnamed institutional investors.

In a June 2020 statement, chief executive officer Steve Harr said, "Sana is dedicated to modulating genes in cells as well as replacing damaged cells in the body. I am proud of our progress to date in turning our technologies into potential therapies for serious diseases such as cancer, central nervous system diseases, heart disease and various genetic disorders."

Shortly after its 2019 launch, the company licensed technology from Harvard University that could potentially improve the success of cell therapy treatments. The technology provides a way of producing hypoimmunogenic stem cells that can be differentiated into any cell type. These cells can then be transplanted into a patient without causing immune rejection. The company’s plans are to take that technology platform and create hypoimmunogenic pluripotent stem cells that it can use to create novel cell therapies.

Sana’s ambitions and broad reach comes with a high burn rate. It currently has $459 million in cash and cash equivalents, but it spent $153 million on R&D in the first nine months of 2020, an increase from $80 million in the same period in 2019.

Of course, this is how biotech investments work. Early-stage companies are often years, often a decade or longer, from a marketable product. And once Phase II and Phase III clinical trials begin, the expenses add up fast and usually require either partnerships, IPOs or continued venture tranches.

The Wall Street Journal notes that Moderna, currently one of two companies to have an authorized COVID-19 vaccine in the U.S., had a trajectory similar to Sana—plenty of investor interest and a sky-high valuation, with no marketable products. When the company launched an IPO in late 2018, its valuation was $7 billion, which at the time was a record biotech IPO. Investors who bought then and held on have seen a sevenfold return on investment in two years.

Harr’s track record undoubtedly gave investors confidence as well. Juno Therapeutics was sold to Celgene in 2018 for $9 billion. Harr was also a director for Loxo Oncology. Loxo sold to Eli Lilly in 2019 for about $8 billion.

On October 30, 2020, Sana acquired Oscine Corp. Oscine focused on developing possibly curative or disease modifying cell therapies for brain and CNS diseases. The combination, they said at the time, would integrate Oscine’s glial progenitor cell program and technologies with Sana’s broader platform. Glial progenitor cells are a major support system of the brain. These cells differentiate into oligodendrocytes, which are the only source of myelin production the adult CNS, and astrocytes, which support neurons and are associated with many neurodegenerative and myelin diseases.

At this time, Sana’s in vivo cell engineering programs, all in the preclinical stage, are focused on non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), multiple myeloma, ornithine transcarbamylase deficiency (OTC), sickle cell disease and beta-thalassemia. Its ex vivo cell engineering programs, also all preclinical, are focused on NHL, ALL, CLL, multiple myeloma, and type 1 diabetes, Huntington’s disease, Pelizaeus-Merzbacher disease, secondary progressive multiple sclerosis, and heart failure.