On December 15, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that clinical experience for naxitamab and data from the Company’s SADA technology programs will be presented at the Company’s R&D event, which will take place virtually today at 12 p.m. Eastern Time (Press release, Y-mAbs Therapeutics, DEC 15, 2021, View Source [SID1234597223]).

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!

Investors, analysts, members of the media and public may access the event via a live webcast.

The Y-mAbs research and development day will feature presentations from oncology key opinion leaders ("KOLs") Javier E. Oesterheld, M.D. (Atrium Health) and Jaume Mora, M.D., Ph.D. (SJD Barcelona Children’s Hospital). An update on Y-mAbs’ broad and advanced product pipeline, including the Company’s SADA Technology, will follow from Vignesh Rajah, MBBS, DCH, MRCP(UK), MBA, (SVP, Chief Medical Officer at Y-mAbs) and Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at Y-mAbs).

SADA Technology

Dr. Lisby will present new details on the proposed mechanism of action for the SADA Technology. The Company plans to file an Investigational New Drug Application ("IND") with the US Food & Drug Administration ("FDA") for GD2-SADA by the end of this year.

Naxitamab

Dr. Mora, who has experience treating neuroblastoma patients with both naxitamab and a competing anti-GD2 antibody, will present compassionate use data regarding an investigational infusion protocol for naxitamab, systematically increasing the infusion rate during the treatment. Using the revised infusion rate, for which a provisional patent application has been filed by Y-mAbs and the co-inventors Jaume Mora from SJD Barcelona Children’s Hospital and Dr. Nai-Kong Cheung, MD, PhD, and Shakeel Modak, MD, both from Memorial Sloan Kettering Cancer Center ("MSK") in New York, it was observed that the protocol may help with managing Grade 3 and Grade 4 adverse events.

DANYELZA (naxitamab-gqgk)

Dr. Oesterheld will present his personal experience from Levine Children’s Hospital after several patient treatment experiences with DANYELZA (naxitamab-gqgk).

"I am delighted to see that the efforts led by Dr. Mora and supported by Y-mAbs as well as Dr. Cheung and Dr. Modak from MSK has led to what we believe may be a significant discovery. After years of experience in the clinic, we believe that Dr. Mora’s method of managing the infusion rate of naxitamab now potentially may open up the use of naxitamab for a wide range of GD2 positive indications, such as breast cancer, melanoma, sarcomas, small-cell lung cancer and other cancers, for which we can now consider planning Phase 2 studies," said Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer further notes, "We are excited to share these new updates on both our naxitamab program and the SADA Technology. We believe that the prospects for the SADA Technology which combines antibodies and radioactive payloads are highly encouraging and could potentially revolutionize many cancer treatments known today."

Researchers at MSK developed naxitamab and the SADA Technology, which are exclusively licensed by MSK to Y-mAbs. As a result of these licensing arrangements, MSK has institutional financial interest related to the compound and technology and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest, anaphylaxis, hypotension, bronchospasm and stridor and neurotoxicity, such as severe neuropathic pain, transverse myelitis and reversible posterior leukoencephalopathy syndrome. See full Prescribing Information for complete Boxed Warning and other important safety information.

On December 15, 2021 Targovax ASA’s (the "Company") stock exchange reported that published on 14 December 2021 regarding the preliminary results in the rights issue of 101,744,186 new shares in the Company (the "Offer Shares") at a subscription price of NOK 1.72 per share (the "Rights Issue") (Press release, Targovax, DEC 15, 2021, View Source [SID1234597218]). The subscription period for the Rights Issue in the Company expired at 16:30 hours (CET) on 14 December 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!

At the expiry of the subscription period in the Rights Issue, the Company had received subscriptions for a total of 109,748,125 Offer Shares.

The final allocation of the Offer Shares in the Rights Issue has now been completed based on the allocation criteria set out in the Company’s prospectus dated 29 November 2021, comprising a registration document and a securities note (jointly, the "Prospectus").

The board of directors of the Company has allocated a total of 101,744,186 Offer Shares in the Rights Issue, of which 69,352,805 Offer Shares were allocated based on validly exercised subscription rights and the remaining Offer Shares were allocated to the subscribers who had exercised their subscription rights and over-subscribed Offer Shares on a pro rata basis based on the number of subscription rights exercised by each such subscriber, which includes the two underwriters who subscribed for Offer Shares in the subscription period.

Notifications of allocated Offer Shares and the corresponding subscription amount to be paid by each subscriber are expected to be distributed later today, on 15 December 2020. Payment for the allocated Offer Shares falls due on 17 December 2021 in accordance with the payment procedures described in the Prospectus.

The Offer Shares may not be transferred or traded before they have been fully paid and the share capital increase pertaining to the Rights Issue has been registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret). It is expected that the share capital increase will be registered in the Norwegian Register of Business Enterprises on or about 21 December 2021 and that the Offer Shares will be delivered to the VPS accounts of the subscribers to whom they are allocated on or about the next day. The Offer Shares are expected to be tradable on the Oslo Stock Exchange from and including 22 December 2021.

On December 15, 2021 Targovax ASA (OSE: TRVX) a clinical stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that the Research Council of Norway has awarded Targovax a NOK 9.8m research grant towards product and clinical development for the TG mutant KRAS cancer vaccine program (Press release, Targovax, DEC 15, 2021, View Source [SID1234597216]).

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 Research Council of Norway has awarded the grant within the category "Innovation Project for the Industrial Sector".

Project title: "Development of targeted therapies for mutant RAS cancers"
Awarded by: The Research Council of Norway
Granted amount: 9.8 MNOK
Time frame: 2022-2025

Dr. Erik Digman Wiklund, CEO of Targovax, commented: "We are very grateful to be awarded this substantial and prestigious grant by the Research Council of Norway, which is a strong endorsement of the underlying science and broad potential of our mutant RAS program. These funds will enable continued clinical development of our TG vaccine candidates, as well as support important immunological characterization and product development".

On December 15, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it plans to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. Syndax may, in lieu of common stock, offer and sell to certain investors pre-funded warrants to purchase shares of its common stock in the underwritten public offering (Press release, Syndax, DEC 15, 2021, View Source [SID1234597214]). Syndax also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold in the public offering. All of the shares in the proposed offering are to be sold by Syndax.

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!

Goldman Sachs & Co. LLC is acting as book-running manager for the offering.

The shares are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs and Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 866-471-2526, facsimile: 212-902-9316 or by emailing [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. Any offer, if at all, will be made only by means of a prospectus supplement and accompanying prospectus, which are a part of the effective registration statement.

On December 15, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, reported that the European Patent Office has issued an Intention to Grant notice for a patent in respect of an invention associated with Sareum’s proprietary SDC-1802 TYK2/JAK1 Kinase Inhibitor Programme (Press release, Sareum, DEC 15, 2021, View Source [SID1234597211]).

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 patent (EPO Patent Application no. 17787186.0) will protect the SDC-1802 molecule and pharmaceutical preparations thereof as a therapeutic to treat TYK2-dependent T-cell acute lymphoblastic leukaemia (T-ALL – a cancer of a particular type of white blood cell called a T lymphocyte) by inhibiting TYK2 kinase. This programme is in preclinical development.

The Company expects that the patent will be formally granted within four months, subject to certain formalities being completed.

Sareum’s CSO, Dr John Reader, commented:

"Our aim is to build broad robust patent protection for our proprietary TYK2/JAK1 inhibitor candidates as they advance through their respective development programmes, to ensure that Sareum retains full value in these programmes as part of its business development discussions. We are pleased therefore to receive this ‘Intention to Grant’ notice from EPO around our patent application for SDC-1802 as a potential treatment for T-ALL. We expect to complete the formalities that would lead to a full grant of this patent in due course."