On February 8, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported that on February 1, 2021, the first patient was dosed in a Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) (Press release, Cue Biopharma, FEB 8, 2021, View Source [SID1234608286]). CUE-101 is being evaluated in combination with KEYTRUDA as first-line treatment for human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC).

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"We are very pleased to have initiated our combination trial of CUE-101 with KEYTRUDA," said Ken Pienta, M.D, acting chief medical officer of Cue Biopharma. "In our ongoing dose escalation monotherapy Phase 1 trial, CUE-101 has been well tolerated at doses where we’ve observed preliminary evidence of clinical activity, and in preclinical studies we’ve demonstrated that the combination of CUE-101 and checkpoint blockade appear synergistic by significantly extending survival in mouse models of HPV positive cancers. These data taken together support our belief that the combination of CUE-101 with KEYTRUDA has the potential to enhance anti-tumor activity and prolong patient survival."

This Phase 1 dose escalation combination trial (NCT03978689) is being conducted in parallel at the same clinics that are conducting the ongoing Phase 1 monotherapy study of CUE-101. Due to the tolerability profile demonstrated to date in the CUE-101 monotherapy dose escalation trial, the first dose in the combination arm is 1 mg/kg every three weeks (Q3W), which is also the recommended dosing interval for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in highly targeted T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused.

On February 8, 2021 Pan Cancer T B.V., a biotech spin-off from the Erasmus MC founded by Prof. Dr. Reno Debets (CSO) and Dr. Dora Hammerl (VP R&D), reported the closing of a seed investment and start of operations (Press release, Pan Cancer T, FEB 8, 2021, https://pancancer-t.com/2021/02/07/life-saving-tcr-t-cell-therapies-for-hard-to-treat-solid-tumors/ [SID1234577957]). Together with Katrien Reynders-Frederix (CEO), the team is committed to the discovery and development of novel TCR therapies against solid tumors such as triple negative breast cancer, bladder cancer, lung cancer, and glioma. Seed investors are Swanbridge Capital and Van Herk Ventures, and the young company is further awarded a Health~Holland grant for a public-private-partnership with Erasmus MC.

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Over the past decades, innovations in cancer treatments have improved the survival of cancer patients. Despite successes of therapies like Chimeric Antigen Receptor (CAR) T-cell therapies, the vast majority of solid cancers remain refractory to such treatments. Pan Cancer T introduces new treatment options for hard-to-treat solid cancers through adoptive therapy with T-cells that are genetically engineered with TCRs. TCR therapy exploits the ability of the immune cells, in this case T-cells, to specifically and efficiently recognize and kill malignant cells according to the expression of intracellular target antigens. The company develops safe and first-in-class TCR T-cell therapies against unique and proprietary targets that are exclusively expressed in multiple tumor types, but absent in healthy tissues. In addition, the company delivers smart treatments that act against tumor micro-environmental hurdles and maximizes the efficacy of TCR T-cells towards solid tumors.

Katrien Reynders-Frederix, CEO of Pan Cancer T, said: "Immunotherapy currently holds a large potential for cancer treatment. Adoptive T-cell therapy is one of the most promising approaches that has already proven its feasibility and clinical benefit in tumors in several clinical trials. The team is committed to develop safe and potent therapies, and the first data underscore the potential of our lead program where T-cells are directed against the PCT-1 target. Thanks to the support of our investors and Health~Holland, we are able to advance our pre-clinical programs. I am honored to be part of a company that has the potential to positively impact millions of lives. We are looking forward to further expanding our investor base and raising a Series A financing round to accelerate our programs."

Reno Debets, CSO of Pan Cancer T, Professor at Erasmus MC and specialist in T-cell immunity and adoptive therapy of tumors, stated: "The fact that tumors grow and metastasize is often a consequence of immune evasion, pointing to the inherent ability of T-cells to selectively recognize and potently destruct tumors. To translate this ability towards patient care, we exploit fundamental platforms established over the last decade in our laboratory. Our platforms cover tumor-selective targets for T-cells; technologies to identify safe and effective TCRs; as well as strategies to overcome T-cell suppressive effects of the tumor micro-environment. It is exactly this research fundament that goes head-on against the current challenges of immunotherapies. I am really proud and confident that with our enthusiastic team we will make important steps towards improved patient care".

Thijs Spigt, Director of Technology Transfer Office at Erasmus MC Rotterdam: "Erasmus MC’s mission is to provide excellence in patient care, education and research. A key strategic element supporting this mission is the valorization of research findings. The establishment of Pan Cancer T, together with Swanbridge and Van Herk, fits a series of perfect examples how Erasmus MC is able to translate excellent research into development of new therapies for difficult to treat cancer types. We continue to support the team, and look forward to a prosperous future for the company".

Cillian King, Investment Manager at Swanbrigde Capital, commented: "Recent advances in our understanding of the immune system and its role in cancer have resulted in the uptake of many new immunotherapies into clinical practice. However, despite remarkable results for some patients, many patients still lack effective treatment options, particularly those with solid tumors with immune suppressive microenvironments. We believe the science, expertise, and vision behind Pan Cancer T has the potential to profoundly impact patient outcomes and we look forward to supporting the company along this exciting journey".

On February 8, 2021 Herantis Pharma Plc ("Herantis"), an innovative clinical stage biotech company pioneering new disease modifying and regenerative biologic and gene therapies, reported that Craig Cook, Chief Executive Officer, will hold a company presentation in the upcoming Swiss Nordic Bio Conference investor conference, this year taking place virtually (Press release, Herantis Pharma, FEB 8, 2021, View Source,c3282325 [SID1234577479]).

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Event Details:

Swiss Nordic Bio Conference

10 – 11 February 2021

On 11 February 2021 all presentations will be available via a digital library, which is accessible to event participants only. Please contact the organizers at the Swiss Nordic Bio Conference if you wish to attend.

On February 8, 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, FEB 8, 2021, View Source [SID1234577314]). 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 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021.

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 950,648 B shares in the period from 3 February 2021 to 5 February 2021. The shares in these transactions were not part of the Safe Harbour repurchase programme.

With the transactions stated above, Novo Nordisk owns a total of 39,231,660 B shares of DKK 0.20 as treasury shares, corresponding to 1.7% 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 3 February 2021. As of 5 February 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 290,000 B shares at an average share price of DKK 447.44 per B share equal to a transaction value of DKK 129,758,188.

On February 8, 2021 Revolution Medicines, Inc. (Nasdaq:RVMD) reported the closing of an underwritten public offering of 6,666,666 shares of common stock at a public offering price of $45.00 per share, before underwriting discounts and commissions (Press release, Revolution Medicines, FEB 8, 2021, View Source [SID1234575015]). The shares of common stock issued and sold in the offering include 869,565 shares issued upon exercise in full by the underwriters of their option to purchase additional shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Revolution Medicines, were $300 million. All shares in the offering were offered by Revolution Medicines.

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J.P. Morgan, Cowen, SVB Leerink and Guggenheim Securities acted as the joint book-running managers for the offering.

A registration statement relating to the shares sold in this offering was declared effective by the Securities and Exchange Commission on February 3, 2021. The offering was made only by means of a prospectus, copies of which may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.