On September 13, 2021 Y-mAbs Therapeutics, Inc. ("Y-mAbs" or the "Company"), 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 its partner SciClone Pharmaceuticals (Holdings) Limited ("SciClone Pharmaceuticals") has been granted priority review of the Biologics License Application ("BLA") for DANYELZA (naxitamab-gqgk) for the treatment of patients with relapsed/refractory high-risk neuroblastoma by the Center for Drug Evaluation ("CDE") of China’s National Medical Products Administration ("NMPA") (Press release, Y-mAbs Therapeutics, SEP 13, 2021, View Source [SID1234587598]).

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"We are pleased to see SciClone Pharmaceuticals receive priority review of the DANYELZA BLA in China. Priority review in China is intended to expedite review and approval, which means that we could potentially be facing approval and launch of DANYELZA in China as soon as the first quarter of 2022," commented Thomas Gad, founder, Chairman and President at Y-mAbs.

Dr. Claus Moller, Chief Executive Officer, continued, "DANYELZA was recently prescribed for the first time in China, and we were excited to learn that the first patient had received treatment at the Lecheng Branch of Hainan Women and Children’s Medical Center in Hainan Boao Lecheng International Medical Tourism Pilot Zone."

Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the product.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) 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 and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

On September 13, 2021 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 (Press release, Eli Lilly, SEP 13, 2021, View Source [SID1234587597]). Patrik Jonsson, senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, will participate in a virtual fireside chat at 1:20 p.m., Eastern Time .

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On September 13, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that recapped the schedule of upcoming data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 – 20, 2021 (Press release, TG Therapeutics, SEP 13, 2021, View Source [SID1234587595]). Full text abstracts are now available through the iwCLL virtual platform, and details of the upcoming data presentations are below.

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The Company will also host a virtual investor and analyst event on Monday, September 20, 2021 at 8:30 AM ET, to review the updated Phase 1 data evaluating the investigational combination of UKONIQ (umbralisib) and ublituximab (U2) plus venetoclax presented at iwCLL, as well as provide an overview of the ULTRA-V Phase 2/3 trial.

Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, "We are pleased to see the iwCLL full text abstracts are now available, highlighting updated data from four combination trials including our proprietary U2 doublet regimen. Of particular note, is the updated U2 plus venetoclax Phase 1 data showing among 46 relapsed or refractory CLL patients, an overall response rate of 100% including 35% complete response rate. Additionally, at cycle 12, the data show 88% of evaluable patients achieved undetectable minimal residual disease (uMRD) in the peripheral blood, and 72% uMRD in the bone marrow. These data are encouraging, and we look forward to additional updates at the iwCLL conference as well as reviewing these data and an overview of the ULTRA-V program evaluating the U2 plus venetoclax combination during the virtual event we have planned for Monday, September 20, 2021."

IwCLL 2021 PRESENTATION INFORMATION

Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment-Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study

Abstract Number: 1083667
Presentation Date/Time: Saturday, September 18, 2021 at 1:30 PM EDT/ 19:30 CEST
Session: Session 6: Front-Line Therapy of CLL
Lead Author: Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland
Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Abstract Number: 1083987
Presentation Date/Time: Sunday, September 19, 2021 at 10:50 AM EDT/ 16:50 CEST
Session: Session 8: New Agents in CLL Clinical Trials
Lead Author: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY
Oral Poster Presentation Title: TG-1701, a Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia

Abstract Number: 1083634
Presentation Date/Time: Sunday, September 19, 2021 at 2:00 PM EDT/ 20:00 CEST
Session: Poster Session
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, and Medical School, University of Western Australia, Crawley, Western Australia
Poster Presentation Title: Phase I/II Study of Umbralisib (TGR-1202), Ublituximab (TG-1101), and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Transformation: 5-Year Follow-up

Abstract Number: 1083523
Presentation Date/Time: Available on demand
Session: Virtual Poster Gallery
Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
The above full text abstracts are now available via the iwCLL virtual platform at View Source

At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

INVESTOR & ANALYST VIRTUAL EVENT INFORMATION
The Company will host a virtual event on Monday, September 20, 2021 at 8:30 AM ET, to discuss the updated Phase 1 data evaluating UKONIQ (umbralisib) and ublituximab (U2) in combination with venetoclax in patients with CLL as well as provide an overview of the Phase 2/3 ULTRA-V program.

To attend the live event, please visit the Events page, located within the Investors & Media section, of the Company’s website at View Source Following the live event, an archive file will be available for replay, for a period of 30 days after the call.

ABOUT U2 PLUS VENETOCLAX PHASE 1 TRIAL
The Phase 1/2 trial, (NCT03379051), is a multi-center, dose-escalation trial designed to assess the safety and efficacy of UKONIQ and ublituximab (U2) plus venetoclax in patients with relapsed or refractory CLL. The primary objective of the trial is to evaluate the safety of venetoclax after U2 induction. The secondary objectives are clinical efficacy as defined by overall response rate (ORR), including complete response (CR) rate, progression-free survival (PFS), and undetectable minimal residual disease (uMRD) rate after 12 cycles of therapy. The trial enrolled approximately 50 CLL patients and is being led by Dr. Paul Barr of the Wilmot Cancer Institute, University of Rochester Medical Center.

ABOUT ULTRA-V PHASE 2 TRIAL
The ULTRA-V Phase 2 trial, (NCT03801525), is an open-label, multicenter, trial designed to investigate the efficacy and safety of UKONIQ and ublituximab (U2) combined with venetoclax in subjects with CLL. The primary endpoint of the trial is overall response rate (ORR) and complete response (CR) rate. The trial enrolled approximately 165 patients with front-line and previously treated CLL at 26 sites throughout the United States.

ABOUT ULTRA-V PHASE 3 TRIAL
The ULTRA-V Phase 3 trial is an open-label, multicenter, randomized controlled clinical trial comparing the time-limited triple combination of UKONIQ and ublituximab (U2) plus venetoclax, to an active control arm of continuous U2. The Phase 3 trial includes two independent randomized cohorts of CLL subjects: a treatment-naïve cohort and a previously treated cohort, with each cohort being enrolled and evaluated independently of each other. The primary endpoint for the trial is progression-free survival (PFS). This trial is being led by Richard R. Furman, MD, Director of CLL Research Center at Weill Cornell Medicine and targeting over 60 U.S. trial sites.

On September 13, 2021 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), reported that Dr. Henry Ji, Chairman and CEO, will participate in the H.C. Wainwright 23rd Global Investment Conference (www.hcwevents.com/annualconference) (Press release, Sorrento Therapeutics, SEP 13, 2021, View Source [SID1234587594]). The conference is being held virtually on September 13-15, 2021.

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Dr. Henry Ji, Chairman and CEO of Sorrento, will provide corporate updates and highlights associated with Sorrento’s product pipeline in the strategic focus areas of the company: COVID-19, Cancer and Autoimmune Therapeutics, and Non-Opioid Pain Management.

COVID-19 Product Portfolio Highlights:

COVISTIX: COVID-19 Rapid Antigen Detection Test in commercialization in Mexico with an EUA from COFEPRIS. Regulatory approval processes in progress in the US, Canada, Brazil, and WHO EUL (Emergency Use Listing), with active partnering discussions for global commercialization.
COVIDROPS (STI-2099): Intranasal neutralizing antibody (nAb) formulation in Phase 2 trials in UK, US and soon in Mexico for newly diagnosed COVID patients in an outpatient setting.
COVI-AMG (STI-2020): Potentially highly potent/low dose antibody in a 2 minute IV-push in Phase 2 trials for systemic treatment in an outpatient setting.
COVISHIELD antibody (STI-9167): Demonstrating potent in vitro virus neutralization across all currently known variants of concern (VoCs) and reducing replicating virus in the lungs of infected transgenic K18 mice (with human ACE2 receptor) to undetectable levels (following infection by SARS-CoV-2 WA-1 strain or VoCs including Alpha, Beta, Gamma, Delta, and Lambda).
MPI-8 and its SAR-Improved Analog (1121): Small molecule antiviral targeting SARS-CoV-2 main protease, demonstrating broad-spectrum, potent antiviral activities against SARS-CoV-2 and all currently known VoCs.
Multivalent mRNA COVID-19 Vaccine: Elicited a stronger humoral immune response against Delta VoC as compared to SARS-CoV-2 intramuscular mRNA vaccine in preclinical studies.
Recombinant RBD Subunit Vaccine: Demonstrated strong humoral immune response against WA-1 and Delta VoC in preclinical studies.
Abivertinib: Phase 2 studies for treatment of acute respiratory distress syndrome (ARDS) in hospitalized COVID patients in US (96 Pts) and Brazil (400 Pts) are completed.
COVI-MSC: Phase 2 for ARDS in ICU COVID patients are ongoing in US and Brazil.
Cancer and Autoimmune Product Portfolio Highlights:

Abivertinib: Phase 3 topline data in NSCLC available Q4 2021.
Abivertinib: IND for Phase 2 in Prostate Cancer to be filed Q4 2021.
PD-L1 antibody: In Phase 3 for SCLC and NDA submission in China for recurrent or metastatic cervical cancer.
CD38 ADC: In Phase 1 for Amyloidosis and Multiple Myeloma.
CD38 DAR-T: In Phase 1 for Relapsed and Refractory Multiple Myeloma.
CD47 antibody: In Phase 1 in solid tumors.
SOFUSA: Lymphatic delivery of Enbrel in Phase 1b in refractory rheumatoid arthritis patients.
Non-Opioid Pain Management Product Portfolio Highlights:

ZTlido: Commercial with strong sales growth and expanded coverage for up to 65% of lives nationally.
SP-102: Phase 3/pivotal trial (US) completed full enrollment.
Resiniferatoxin (RTX): In Phase 2 for Osteoarthritis pain management.
RTX: In Phase 2 trial for intractable cancer pain (pending FDA clearance).
An updated corporate presentation will also be available at www.sorrentotherapeutics.com

On September 13, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported that it has successfully completed the placement of the subordinated non-interest-bearing mandatory convertible bond, which the Company’s Executive Board had resolved to issue with the approval of the Supervisory Board (Press release, Epigenomics, SEP 13, 2021, View Source [SID1234587593]). The maximum volume of the mandatory convertible bond was placed in the aggregate principal amount of EUR 16,500,000.00. The mandatory convertible bond consists of 165,000 notes, which – subject to adjustments of the conversion price due to anti-dilution clauses – are convertible into 15,000,000 registered no-par value shares of the Company. Further details of the transaction were announced in the corporate news dated August 24, 2021. The gross proceeds from the issuance of the mandatory convertible bond amount to EUR 16,500,000.00.

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As announced in the ad-hoc announcements of June 11, 2021, and August 20, 2021, the issuance of the mandatory convertible bond was secured by a back-stop agreement with Deutsche Balaton Aktiengesellschaft. In connection with this back-stop agreement, Deutsche Balaton has subscribed for notes in the aggregate principal amount of EUR 2,717,800.00.

Epigenomics AG plans to use the proceeds from the issuance of the mandatory convertible bond to finance its operations, in particular the further development of the blood-based colorectal cancer screening test Epi proColon Next-Gen. For this purpose, the Company plans to conduct a clinical study in the U.S.A., which is required to obtain approval for the test by the U.S. Food and Drug Administration (FDA).

The full terms and conditions of the mandatory convertible bond are available on Epigenomics AG’s website at View Source