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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that John Houston, Ph.D., President and Chief Executive Officer and Ian Taylor, Ph.D., Chief Scientific Officer, will participate in a fireside chat at the Guggenheim Healthcare Talks: 2021 Oncology Day on Thursday, February 11 at 4:30 p.m. ET (Press release, Arvinas, FEB 8, 2021, View Source [SID1234574732]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live audio webcast of the presentation will be available here and on Arvinas’ website at www.arvinas.com. A replay of the webcast will be archived on Arvinas’ website for 30 days following the presentation.

On February 8, 2021 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by TG Therapeutics, Inc. to be the exclusive specialty pharmacy partner for UKONIQTM (umbralisib), a new oral treatment for adult patients with relapsed refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed refractory follicular lymphoma who have received at least three prior lines of systemic therapy (Press release, Onco360, FEB 8, 2021, View Source [SID1234574748]). These indications are approved under accelerated approval based on overall response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Onco360 is excited to be selected as the exclusive specialty pharmacy provider for UKONIQ patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "The recent approval of UKONIQ unlocks a new therapy option for patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). As a provider of this key treatment, Onco360 can support the highly specialized needs of MZL and FL patients and their physicians across the country."

ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) mature B-cell non-Hodgkin lymphomas (NHLs). MZL is generally considered a chronic and incurable disease. With an annual incidence of approximately 8,200 newly diagnosed patients in the United States, MZL is the third most common B-cell NHL, accounting for approximately ten percent of all NHL cases. MZL consists of three different subtypes: extranodal MZL of the mucosal-associated lymphoid tissue (MALT), nodal marginal zone lymphoma (NMZL), and splenic marginal zone lymphoma (SMZL).

ABOUT FOLLICULAR LYMPHOMA
Follicular lymphoma (FL) is typically an indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes. It is the second most common form of NHL. FL is generally not curable and is considered a chronic disease, as patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 13,200 newly diagnosed patients, FL is the most common indolent lymphoma accounting for approximately 17 percent of all NHL cases.

UKONIQ is marketed by TG Therapeutics, Inc., a commercial-stage biotechnology company focused on the acquisition, development and commercialization of novel treatments. The FDA’s approval of UKONIQ was based on overall response rate data from the Phase 2 UNITY-NHL trial which evaluated the efficacy of UKONIQ in 69 patients with MZL who received at least 1 prior therapy (including an anti-CD20 regimen) and in 117 patients with FL who received at least 2 prior systemic therapies, including an anti-CD20 monoclonal antibody and an alkylating agent. For full prescribing information, visit www.tgtherapeutics.com.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) ("CBMG" or the "Company") reported that, at the Company’s special meeting of stockholders held today, its stockholders approved the proposal to adopt the previously announced Agreement and Plan of Merger, dated as of August 11, 2020 (the "Merger Agreement"), by and among CBMG, CBMG Holdings ("Parent") and CBMG Merger Sub Inc., a wholly-owned subsidiary of Parent ("Merger Sub") (Press release, Cellular Biomedicine Group, FEB 8, 2021, View Source [SID1234574733]). The Merger Agreement provides for the merger of Merger Sub with and into CBMG (the "Merger"), with CBMG surviving the Merger as a wholly-owned subsidiary of Parent. Upon the closing of the Merger, CBMG’s stockholders will receive $19.75 per share in cash for each share of CBMG common stock they own.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the special meeting, more than 99% of votes cast were voted in favor of adopting the Merger Agreement. Shares voting in favor of adopting the Merger Agreement also included a majority of the outstanding shares of CBMG common stock entitled to vote at the special meeting and owned by CBMG’s stockholders other than members of the buyer consortium and their respective affiliates. CBMG’s stockholders also voted in favor of the proposal to approve, on an advisory (non-binding) basis, certain compensation that may be paid or become payable to CBMG’s named executive officers in connection with the Merger. The final voting results for all proposals will be filed with the Securities and Exchange Commission in a Current Report on Form 8-K.

The Merger is expected to be completed in February 2021, subject to satisfaction or waiver of the remaining closing conditions. Shares of CBMG common stock will be delisted from NASDAQ upon completion of the Merger.