On June 14, 2021 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has released two video presentations related to the ONCOS-102 mesothelioma 24-month data (Press release, Targovax, JUN 14, 2021, View Source [SID1234583942]).

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!

The 24-month follow-up data from the randomized phase 1/2 trial of ONCOS-102 in combination with Standard of Care (SoC) chemotherapy in patients with malignant pleural mesothelioma (MPM) was announced 10 June 2021 (see press release here). It showed that the median overall survival will be in the range of 21.9 to 25.0 months for first-line ONCOS-102-treated patients in the randomized group (n=8). This is a clear improvement over the median overall survival of 13.5 months observed in the first-line standard of care-only control group (n=6). Previous malignant pleural mesothelioma clinical trials have reported median overall survival in the range of 12–16 months for patients receiving the same SoC chemotherapy treatment1.

In addition, a broad and powerful immune activation pattern was observed in patients treated with ONCOS-102, clearly associated with both tumor responses and survival outcomes.

For the presentations of the data, please see link below:

Video presentations related to the ONCOS-102 mesothelioma 24-month data

1 Vogelzang 2003, Ceresoli 2006, Zalcman 2015, Tsao 2019, Scagliotti 2019, Baas 2020

On June 14, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Richard Murray, Ph.D., chief executive officer and president will participate in a fireside chat at the Raymond James Human Health Innovation Conference, taking place virtually on Monday, June 21, 2021 at 12:40 p.m. ET (Press release, Jounce Therapeutics, JUN 14, 2021, View Source [SID1234583960]).

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 webcast of the fireside chat will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcast will be archived for 30 days following the presentation.

On June 14, 2021 Protagonist Therapeutics, Inc. (Nasdaq:PTGX), a clinical stage biopharmaceutical company, reported that it has commenced an underwritten public offering of $100,000,000 of shares of its common stock (Press release, Protagonist, JUN 14, 2021, View Source [SID1234583976]). All of the shares of common stock are being offered by Protagonist. In connection with this offering, Protagonist expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

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!

J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler are acting as joint book-running managers for the offering. JMP Securities LLC and H.C. Wainwright & Co., LLC are acting as co-lead managers for the offering. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Prospective investors should read the preliminary prospectus supplement, when available, and the accompanying prospectus and other documents Protagonist has filed with the SEC for more complete information about Protagonist and the offering. Copies of the prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email at [email protected].

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

On June 14, 2021 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported new data presentations from two clinical studies at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, NeoImmuneTech, JUN 14, 2021, View Source [SID1234583670]). The company presented data from clinical studies evaluating NT-I7, a novel long-acting human IL-7, 1. in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) as a treatment for advanced solid tumors, and 2. given concurrently with adjuvant chemotherapy in patients with high-grade gliomas.

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!

Data from a Phase 1b/2a study evaluating NT-I7 in combination with KEYTRUDA in patients with solid tumors were presented by Aung Naing, M.D., FACP, Professor of the Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center. These data showed that this combination was well tolerated and support continued evaluation in the phase 2a portion of the study. Encouraging efficacy signals were also noted with this therapeutic regimen, including significant increase in T cell counts in both the tumor microenvironment and peripheral blood, indicating strong pharmacodynamic effects. Additionally, one patient with metastatic mucosal melanoma who had not responded to prior combination therapy of 2 checkpoint inhibitors, nivolumab (a PD-1 inhibitor) and ipilimumab (a CTLA-4 inhibitor), had a rapid, confirmed partial response with the combination of NT-I7 + KEYTRUDA.

Data from a Phase 1/2 study evaluating NT-I7 with standard-of-care adjuvant chemotherapy in patients with newly diagnosed high-grade gliomas, after concurrent chemoradiotherapy, were presented by neuro-oncologist Jian Campian, M.D., Ph.D., Associate Professor of Medicine at Washington University School of Medicine in St. Louis, who is leading the trial. These data also showed that NT-I7 was well tolerated and supports continued evaluation in the phase 2 portion of the study. Notably, ALC increased in a dose-dependent manner with a range of 1.3 – 4.1 fold at week 4 after NT-I7 injection and lasted up to 12 weeks. Immune profiling and cytokine analysis are ongoing and will be updated.

"We are pleased to have shared the latest data from two of NIT’s ongoing studies evaluating the therapeutic potential of our lead asset, NT-I7," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. "These data, together with the previously presented data for NT-I7 + KEYTRUDA in triple-negative breast cancer, demonstrate that combining NT-I7 with other anti-cancer agents thus far is safe and tolerable in the clinic, and shows encouraging early efficacy signals. We look forward to continuing clinical evaluation and advancing these trials further."

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

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On June 14, 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, JUN 14, 2021, View Source [SID1234583961]). 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.

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 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 7 June 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 13,705,192 B shares of DKK 0.20 as treasury shares, corresponding to 0.6% 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 11 June 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 14,866,694 B shares at an average share price of DKK 457.93 per B share equal to a transaction value of DKK 6,807,945,570.