On April 28, 2022 Seagen Inc. (Nasdaq:SGEN) reported upcoming presentations of new data from its expanding pipeline of marketed and investigational therapies at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 3-7, 2022 in Chicago (Press release, Seagen, APR 28, 2022, View Source [SID1234613152]). The accepted abstracts demonstrate the growth of Seagen’s portfolio and clinical progress across multiple cancer types, including cervical and urothelial cancers and pediatric and adult Hodgkin lymphoma. Groundbreaking overall survival data for Stage III/IV Hodgkin lymphoma patients who were treated with ADCETRIS (brentuximab vedotin) as part of a first-line therapy combination will be detailed in one of three oral presentations for the antibody-drug conjugate medicine.

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!

Other important data include interim results from the dose-expansion cohorts of the innovaTV 205 trial of TIVDAK (tisotumab vedotin-tftv) in combination with other anticancer agents in patients with recurrent metastatic cervical cancer, which will also be featured in an oral presentation. Long-term outcomes from the phase 3 EV-301 trial of PADCEV (enfortumab vedotin-ejfv) in patients with previously treated advanced urothelial carcinoma will be shared in a poster discussion.

"Significant improvements in overall and event-free survival are important new findings in adult and pediatric Hodgkin lymphoma patients, respectively," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "We look forward to the presentations and plan to submit supplemental applications to the Food and Drug Administration to update overall survival in the ADCETRIS prescribing information for Hodgkin lymphoma and expand its indication to include children."

Key data presentations for Seagen include:

Presentations of Company-Sponsored Trials

Abstract Title

Abstract #

Presentation

Lead Author

ADCETRIS (brentuximab vedotin)

First-line brentuximab vedotin plus chemotherapy to improve overall survival in patients with Stage III/IV classical Hodgkin lymphoma: An updated analysis of ECHELON-1

7503

Oral
Friday, June 3
2 p.m. CT

S. M. Ansell

Brentuximab vedotin in combination with lenalidomide and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma: Safety and efficacy results from the safety run-in period of the phase 3 ECHELON-3 study

7559

Poster
Saturday, June 4
8 a.m. CT

N. L. Bartlett

Updated safety and efficacy data from an open-label, phase 1/2 study of frontline brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) in pediatric patients with advanced-stage classical Hodgkin lymphoma (cHL)

10000

Oral
Monday, June 6
3 p.m. CT

A. R. Franklin

The impact of classic Hodgkin lymphoma (cHL) on informal caregivers: Results from the cHL: Real-world observations from physicians, patients, and caregivers on the disease and its treatment (CONNECT) study

E24004

Online Publication

D. R. Flora

PADCEV (enfortumab vedotin-ejfv)

Long-term outcomes in EV-301: 24-month findings from the phase 3 trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma

4516

Poster Discussion
Saturday, June 4
5:04 p.m. CT

J. E. Rosenberg

Study EV-103 Cohort H: Antitumor activity of neoadjuvant treatment with enfortumab vedotin monotherapy in patients with muscle-invasive bladder cancer who are cisplatin-ineligible

4582

Poster
Saturday, June 4
1:15 p.m. CT

D. P. Petrylak

Benchmarking maintenance therapy survival in first-line advanced urothelial carcinoma using disease modeling

4575

Poster
Saturday, June 4
1:15 p.m. CT

M. D. Galsky

Real world treatment patterns and clinical outcomes with first-line therapy in cisplatin-eligible and ineligible patients with advanced urothelial carcinoma

4565

Poster
Saturday, June 4
1:15 p.m. CT

G. P. Sonpavde

TIVDAK (tisotumab vedotin-tftv)

Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis

5532

Poster
Saturday, June 4
1:15 p.m. CT

K. Sonawane

Cervical cancer geographical burden analyzer: An interactive, open-access tool for understanding geographical disease burden in patients with recurrent or metastatic cervical cancer

5523

Poster Discussion
Saturday, June 4
4:30 p.m. CT

T. Castellano

Tisotumab vedotin (TV) + pembrolizumab (pembro) in first-line (1L) recurrent or metastatic cervical cancer (r/mCC): Interim results of ENGOT Cx8/GOG 3024/innovaTV 205

5507

Oral
Monday, June 6
10:12 a.m. CT

D. Lorusso

Productivity losses under various second-line recurrent or metastatic cervical cancer treatment scenarios in the United States

E17520

Online Publication

J. Ting

Patterns of care in Medicaid-enrollees with recurrent or metastatic cervical cancer

E17525

Online Publication

C. A. Leath

TIVDAK (tisotumab vedotin-tftv) Trials in Progress

Trial in progress update on ENGOT-cx8/GOG-3024/innovaTV 205: Addition of a new cohort with first-line (1L) tisotumab vedotin (TV) + pembrolizumab (pembro) + carboplatin (carbo) ± bevacizumab (bev) in recurrent/metastatic cervical cancer (r/mCC)

TPS5603

Poster
Saturday, June 4
1:15 p.m. CT

I. Vergote

innovaTV 207: New combination dosing cohorts in the open label phase 2 study of tisotumab vedotin in solid tumors

TPS6100

Poster
Monday, June 6
1:15 p.m. CT

X. Le

TUKYSA (tucatinib) Trials in Progress

Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (HER2CLIMB-05, trial in progress)

TPS1108

Poster
Monday, June 6
8 a.m. CT

E. P. Hamilton

Phase 2 trial of tucatinib + trastuzumab deruxtecan in patients with HER2+ locally advanced or metastatic breast cancer with and without brain metastases (HER2CLIMB-04, trial in progress)

TPS1111

Poster
Monday, June 6
8 a.m. CT

I. E. Krop

Disitamab vedotin

Preliminary results of a phase Ib/II combination study of RC48-ADC, a novel humanized anti-HER2 antibody-drug conjugate (ADC) with toripalimab, a humanized IgG4 mAb against programmed death-1 (PD-1) in patients with locally advanced or metastatic urothelial carcinoma

4518

Poster Discussion
Saturday, June 4
5:26 p.m. CT

X. Sheng

A phase II study of RC48-ADC in HER2-negative patients with locally advanced or metastatic urothelial carcinoma

4519

Poster Discussion
Saturday, June 4
5:26 p.m. CT

H. Xu

RC48-ADC for metastatic urothelial carcinoma with HER2 -positive: Combined analysis of RC48-C005 and RC48-C009 trials

4520

Poster Discussion
Saturday, June 4
5:26 p.m. CT

X. Sheng

Pipeline Trials in Progress

Phase 1 study of SGN-B7H4V, a novel, investigational vedotin antibody–drug conjugate directed to B7-H4, in patients with advanced solid tumors (SGNB7H4V-001, trial in progress)

TPS3155

Poster
Sunday, June 5
8 a.m. CT

A. Patnaik

Phase 1 study of SGN-PDL1V, a novel, investigational vedotin antibody–drug conjugate directed to PD-L1, in patients with advanced solid tumors (SGNPDL1V-001, trial in progress)

TPS3154

Poster
Sunday, June 5
8 a.m. CT

A. Patnaik

Phase 1 study of SGN-ALPV, a novel, investigational vedotin antibody–drug conjugate directed to ALPP/ALPPL2 in advanced solid tumors (SGNALPV-001, trial in progress)

TPS3159

Poster
Sunday, June 5
8 a.m. CT

N. Lakhani

Phase 1b/2 study of ladiratuzumab vedotin (LV) in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (SGNLVA-002, trial in progress)

TPS1127

Poster
Monday, June 6
8 a.m. CT

J. L. Meisel

Presentations of Investigator-Sponsored or Cooperative Group Trials

Abstract Title

Abstract #

Presentation

Lead Author

Brentuximab vedotin and association with event-free survival (EFS) in children with newly diagnosed high-risk Hodgkin lymphoma (HL): A report from the Children’s Oncology Group phase 3 study AHOD1331 (NCT 02166463)

7504

Oral
Friday, June 3
2:12 p.m. CT

S. M. Castellino

Brentuximab vedotin and nivolumab alone and then combined with rituximab, cyclophosphamide, doxorubicin, and prednisone for frontline therapy of patients with primary mediastinal large B-cell lymphoma

TPS7589

Poster
Saturday, June 4
8 a.m. CT

R. E. Steiner

On April 28, 2022 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that its first quarter 2022 financial results will be released after the markets close on Wednesday, May 4th (Press release, DiaMedica, APR 28, 2022, View Source [SID1234613168]). DiaMedica will host a live conference call on Thursday, May 5th at 7:00 AM Central Time to provide a business update and discuss financial results.

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!

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until May 12, 2022, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 4814247.

On April 28, 2022 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that the abstracts of TST001 and MSB0254 have been accepted by the 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("2022 ASCO (Free ASCO Whitepaper) Annual Meeting") (Press release, Transcenta, APR 28, 2022, View Source [SID1234613184]). The abstracts are named "A Phase I Study of TST001, a High Affinity Humanized Anti-CLDN18.2 Monoclonal Antibody, in Combination with Capecitabine and Oxaliplatin (CAPOX) as a First Line Treatment of Advanced G/GEJ Cancer" and "A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MSB0254 in Chinese Solid Tumor Patients" respectively.

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 ASCO (Free ASCO Whitepaper) Annual Meeting showcases the most cutting-edge research in clinical oncology and state-of-the-art advanced cancer therapies and is the world’s most influential and prominent scientific gathering of the clinical oncology community. This year’s ASCO (Free ASCO Whitepaper) Annual Meeting will take place both online and in-person (McCormick Place; Chicago, IL) on June 3–7, 2022.

TST001 (Claudin18.2)
Abstract Number: 4062
Session Date and Time: June 4, 2022, 8:00 AM-11:00 AM CDT
Title: A Phase I Study of TST001, a High Affinity Humanized Anti-CLDN18.2 Monoclonal Antibody, in Combination with Capecitabine and Oxaliplatin (CAPOX) as a First Line Treatment of Advanced G/GEJ Cancer
First author: Professor Jifang Gong, Peking University Cancer Hospital and Research Institute
Presentation Format: Poster

MSB0254 (VEGFR2)
Abstract Number: 3023
Session Date and Time: June 5, 2022, 8:00 AM-11:00 AM CDT
Title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MSB0254 in Chinese Solid Tumor Patients
First author: Professor Tianshu Liu, Zhongshan Hospital, Fudan University
Presentation Format: Poster

About TST001

TST001 is a high affinity humanized anti-Claudin18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) activities and potent anti-tumor activities in tumor xenograft models. TST001 is the second Claudin18.2 targeting antibody therapeutic candidate being developed globally. TST001 is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. TST001 kills Claudin18.2 expressing tumor cells by mechanisms of antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). Leveraging advanced bioprocessing technology, the fucose content of TST001 was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of TST001. Clinical trials for TST001 are ongoing in China and US (NCT04396821, NCT04495296/CTR20201281). TST001 was granted Orphan Drug Designation in the US by FDA for the treatment of patients with gastric cancer or gastroesophageal junction (GC/GEJ).

About MSB0254

MSB0254 is a high affinity humanized anti-VEGFR-2 mAb, with an anti-tumor mechanism of action by inhibiting tumor angiogenesis. MSB0254 has been generated using Transcenta’s in-house antibody discovery platform. VEGFR-2 is overexpressed in neovascular tumor endothelial cells in many tumors in comparison to normal endothelial cells. Vascular permeability, survival and migration of the vascular endothelial cells are controlled by the VEGFR-2 pathway. VEGFR-2 inhibitors has been shown to be able to inhibit tumor-induced angiogenesis and effectively block tumor growth, and thus may have a potential therapeutic role in multiple tumor types.

On April 28, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer cell therapies to treat cancer, reported the closing of its previously announced underwritten public offering of 13,333,334 shares of its common stock at a price to the public of $15.00 per share, and the exercise in full by the underwriters of their option to purchase an additional 2,000,000 shares of common stock (Press release, Nkarta, APR 28, 2022, View Source [SID1234613136]). The exercise of the underwriters’ option brought the total number of shares of common stock sold by Nkarta to 15,333,334 shares and increased the gross proceeds raised in the offering, before deducting underwriting discounts and commissions and offering expenses, to $230 million.

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!

Nkarta intends to use the net proceeds from the offering to fund the continued clinical development of NKX101 and NKX019, preclinical studies for research stage programs and the continued buildout of internal manufacturing capabilities, and for working capital and for general corporate purposes.

Cowen, SVB Securities, Evercore ISI and Stifel acted as joint book-running managers for the offering.

The offering was conducted pursuant to a shelf registration statement (File No. 333-258766), which was filed with the Securities and Exchange Commission ("SEC") on August 12, 2021 and declared effective by the SEC on September 2, 2021. The offering was made only by means of a prospectus supplement and accompanying prospectus describing the terms of the offering. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting the following: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; and Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104 or by telephone at (415) 364-2720 or by email at [email protected]. These documents may also be obtained for free on the SEC’s website located at View Source

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any offer, solicitation or sale of these securities in any state or 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 jurisdiction.

On April 28, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that tumor response and overall survival data from the ongoing Phase 2a study of VBI-1901, the Company’s cancer vaccine immunotherapeutic candidate in recurrent glioblastoma (GBM), was accepted for presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, VBI Vaccines, APR 28, 2022, View Source [SID1234613153]).

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!

VBI’s data was selected for presentation and discussion in both a poster session and a poster discussion session. The poster discussion will highlight selected abstracts from the poster session, placing the abstracts in context, with a focus on how the findings apply to clinical practice and future research.

Presentation Details

Title: Evaluation of tumor responses and overall survival in patients with recurrent glioblastoma (GBM) from a Phase IIa trial of a CMV vaccine immunotherapeutic candidate (VBI-1901)
Date: Sunday, June 5, 2022
Poster Session/Poster Discussion Session: Central Nervous System Tumors
Poster Session Time: 8:00 AM – 11:00 AM CDT
Poster Discussion Session Time: 11:30 AM – 1:00 PM CDT
About VBI-1901 and GBM

VBI-1901 is a novel cancer vaccine immunotherapeutic candidate developed using VBI’s enveloped virus-like particle (eVLP) technology to target two highly immunogenic cytomegalovirus (CMV) antigens, gB and pp65. Scientific literature suggests CMV infection is prevalent in multiple solid tumors, including glioblastoma (GBM). GBM is among the most common and aggressive malignant primary brain tumors in humans. In the U.S. alone, 12,000 new cases are diagnosed each year. The current standard of care for treating GBM is surgical resection, followed by radiation and chemotherapy. Even with aggressive treatment, GBM progresses rapidly and has a high mortality.