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.

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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 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that it plans to host a conference call on Thursday, May 5, 2022, at 8:30 a.m. ET to discuss its financial results for the quarter ended March 31, 2022 and provide a business update (Press release, Selecta Biosciences, APR 28, 2022, https://selectabio.gcs-web.com/news-releases/news-release-details/selecta-biosciences-host-conference-call-and-webcast-discuss-8 [SID1234613151]).

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Individuals may participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10157872. Investors and the public can access the live and archived webcast of this call and a copy of the presentation via the Investors & Media section of the company’s website, www.selectabio.com.

On April 28, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results and highlights for the first quarter ended March 31, 2022. Cash and cash equivalents at March 31, 2022 were $76.5 million (Press release, GlycoMimetics, APR 28, 2022, View Source [SID1234613150]).

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"During the first quarter, we advanced our transformation from a research company to a commercially-focused organization. Our clinical team continues to collect and confirm data and track events in real time from our Phase 3 trial in the relapsed/refractory patient population. Based on current projections, we now anticipate reaching our overall survival events trigger in mid-2023, with top line data disclosure shortly thereafter. Beyond uproleselan, we reiterate our plan to submit an IND for GMI-1687 in sickle cell disease in the first half of 2022," commented Harout Semerjian, Chief Executive Officer.

Operational Highlights

Uproleselan

GlycoMimetics continued a focused effort to collect and confirm data received from the 70 sites in the U.S., Europe, Canada, and Australia that enrolled a total of 388 patients in the Company’s pivotal Phase 3 trial in relapsed/refractory AML. Based on current projections, GlycoMimetics now anticipates mid-year 2023 for the overall survival events trigger, with top line data disclosure shortly thereafter.
In parallel, the National Cancer Institute (NCI), in its Phase 2/3 clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, is preparing for its planned interim analysis of event free survival from its Phase 2 enrollment of 267 patients. The Company intends to share the outcome of the NCI’s analysis of the Phase 2 data.
Investigator-sponsored clinical trials to evaluate expanded indications for uproleselan enrolled patients at the University of California-Davis, Washington University at St. Louis, MD Anderson Cancer Center, and the University of Michigan.
GMI-1687

The Company completed IND-enabling activities for GMI-1687 and placed finished GMP clinical product on stability to support use in a first-in-human clinical study.
GMI-1687 demonstrated no safety concerns from GLP 28-day toxicity studies in two different species as well as from a standard battery of IND-enabling studies.
The Food and Drug Administration, in response to its pre-IND meeting with GlycoMimetics, provided guidance that will be incorporated into the IND submission.
The Company is on track to submit an IND in the first half of 2022 to evaluate the compound in sickle cell disease patients with acute VOC as the lead indication.
Organizational Updates

The Company expanded its executive management in the first quarter of the year. Bruce Johnson joined the Company as Senior Vice President and Chief Commercial Officer, and Deepak Tiwari joined GlycoMimetics as Vice President, Technical Operations.
As GlycoMimetics pivots to a focus on commercialization activities, the Company implemented a workforce reduction of 20% in April, primarily in early-stage research and chemistry. GlycoMimetics’ core expertise in research and institutional knowledge remains intact.
First Quarter 2022 Financial Results:

Cash position: As of March 31, 2022, GlycoMimetics had cash and cash equivalents of $76.5 million as compared to $90.3 million as of December 31, 2021.
Revenue: There was no revenue recognized during the three months ended March 31, 2022. During the three months ended March 31, 2021, the Company recognized $1.1 million in revenue from the sale of clinical supplies to Apollomics under a clinical supply agreement.
R&D Expenses: The Company’s research and development expenses decreased to $9.6 million for the quarter ended March 31, 2022, as compared to $11.1 million for the same period in 2021. The decreased expenses were primarily due to lower clinical trial and development costs related to our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML as patient enrollment ended in November 2021. The decrease was partially offset by higher manufacturing expenses for uproleselan validation batches.
G&A Expenses: The Company’s general and administrative expenses increased to $5.1 million for the quarter ended March 31, 2022, as compared to $4.2 million for the first quarter of 2021 primarily due to commercial start-up expenses for uproleselan and higher patent fees.
Shares Outstanding: Shares of common stock outstanding as of March 31, 2022, were 52,392,444.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 1068226. Participants are encouraged to connect 15 minutes in advance of the call to ensure they can connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, with participant code 1068226.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. FDA and from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a highly-potent E-selectin antagonist that represents a potential life-cycle extension to uproleselan. GMI-1687 has been shown in animal models to be fully bioavailable following subcutaneous administration. As such, GMI-1687 is being positioned as a potentially self-administered drug to be used in the outpatient setting for the treatment of inflammatory diseases such as acute vaso-occlusive crisis of sickle cell disease, as well as hematologic indications such as AML and MDS.

On April 28, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will report its financial results for the first quarter of 2022, on Thursday, May 5, 2022, before the U.S. financial markets open(Press release, Concert Pharmaceuticals, APR 28, 2022, View Source [SID1234613149]). The Company will host a conference call and webcast at 8:30 a.m. ET to discuss its first quarter 2022 financial results and provide a business update. Individuals interested in participating in the call should dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International).

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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

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A live webcast of the conference call may be accessed in the Investors section of the Company’s website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert’s website for three months.

On April 28, 2022 MannKind Corporation (Nasdaq: MNKD) reported that it will release its 2022 first quarter financial results and its management will host a conference call to discuss the financial results and corporate updates at 5:00 PM (Eastern Time) on Thursday, May 5, 2022 (Press release, Mannkind, APR 28, 2022, View Source [SID1234613146]).

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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

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under Events.