On January 19, 2021 Lion TCR reported that Health Sciences Authority (HSA) has granted approval for our local open label, single-arm, single center Phase 1 Investigational New Drug (IND) clinical trial application to further analyze liver cancer tumor microenvironment (TME) (Press release, Lion TCR, JAN 19, 2021, View Source [SID1234574089]).

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Study name: Phase 1 Safety and Tolerability Study of Redirected HBV-Specific T-Cells in Patients with Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)
Protocol No.: LTCR-HCC-3-3
Certificate number: CTC2100001
Approval date: 04 January 2021
Product: LioCyx-M (Autologous T-cells transfected with mRNA encoding HBV antigen-specific TCR)

Lion TCR has pioneered the use of mRNA to engineer T cells as an anti-tumor therapy. Our lead product LioCyx-M consists of a preparation of autologous T-cells transfected with mRNA encoding HBV antigen-specific TCR. These HBV-TCR engineered T cells are able to transiently recognize and lyse HBV-expressing hepatocellular carcinoma cells. We have previously studied the safety and preliminary efficacy of LioCyx-M both in patients with recurrent HBV-related hepatocellular carcinoma (HCC) post liver transplant [1] and in patients with advanced primary HBV-related HCC [2].

In this new study, we aim to determine, in unresectable patients with HBV-related primary HCC, the capability of LioCyx-M to not only directly lyse HCC cells expressing HBV antigens but also to alter HBV-related HCC microenvironment. Safety, HCC tumor volume reduction and alteration of tumor microenvironment will be sequentially monitor in treated patients. Preliminary results have suggested that LioCyx-M therapeutic efficacy might be linked to its ability to alter the tumor microenvironment (convert "cold tumours" to "hot tumours"). Hot tumours are characterized by the proinflammatory cytokines production and T-cell infiltration and are linked to longer survival. With a better understanding of the mechanism of action of LioCyx-M, we might be able to exploit LioCyx-M treatment to favor a more durable therapeutic efficacy in combination with other immunotherapy strategies such as immune checkpoint inhibitors.

This trial will be conducted at Singapore General Hospital (SGH) in collaboration with SGH Senior Consultant, Dr Thinesh Lee Krishnamoorthy and Professor Antonio Bertoletti from Duke-NUS Medicine School.

References
1. Chen W, Cheng J, Zheng X, et al 273 Phase I study of LioCyx-M, autologous hepatitis B virus (HBV)-specific T cell receptor (TCR) T-cells, in recurrent HBV-related hepatocellular carcinoma (HCC) post-liver transplantation. Journal for ImmunoTherapy of Cancer 2020;8:doi: 10.1136/jitc-2020-SITC2020.0273
2. Wang F, Meng F, Jin J, et al 272 Use of LioCyx-M, autologous hepatitis B virus (HBV)-Specific T cell receptor (TCR) T-cells, in advanced HBV-related hepatocellular carcinoma (HCC). Journal for ImmunoTherapy of Cancer 2020;8:doi: 10.1136/jitc-2020-SITC2020.0272

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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