On April 29, 2021Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), will release its first quarter 2021 financial results on Thursday, May 6, 2021 after the markets close (Press release, Lexicon Pharmaceuticals, APR 29, 2021, View Source [SID1234578785]). Management will conduct a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) that day to discuss the financial results and to provide a business update.

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 dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

On April 29, 2021 Seagen Inc. (Nasdaq:SGEN) reported the presentation of new data from its growing pipeline of marketed and investigational therapies at the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4-8 (Press release, Seagen, APR 29, 2021, View Source [SID1234578807]).

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!

"Emerging data and the breadth of our clinical development programs continue to illustrate progress across our oncology portfolio, highlighting the company’s research efforts in multiple cancers with a high unmet need," said Roger Dansey, M.D., Chief Medical Officer at Seagen. "Notably, we are looking forward to sharing updated results of the EV-103 and EV-201 clinical trials for PADCEV (enfortumab vedotin-ejfv) in locally advanced or metastatic urothelial cancer and additional data from the HER2CLIMB trial of TUKYSA (tucatinib) in previously treated HER2+ metastatic breast cancer patients."

Key data to be presented include:

Abstract Title

Abstract #

Presentation type

Lead Author

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: Update on durability results and long-term outcome of enfortumab vedotin + pembrolizumab in first line locally advanced or metastatic urothelial carcinoma (la/mUC)

4528

Poster Presentation

T. Friedlander

Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors: An updated analysis of EV-201 Cohort 2

4524

Poster Presentation

B. McGregor

Quality of life, functioning, and symptoms in patients with previously treated locally advanced or metastatic urothelial carcinoma from EV-301: A randomized Phase 3 trial of enfortumab vedotin vs chemotherapy

4539

Poster Presentation

R. Mamtani

KEYNOTE-B15/EV-304: Randomized Phase 3 study of perioperative enfortumab vedotin plus pembrolizumab versus chemotherapy in cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC)

TPS4587

Poster Presentation

C. Hoimes

TUKYSA (tucatinib)

Updated results of tucatinib vs placebo added to trastuzumab and capecitabine for patients with pretreated HER2+ metastatic breast cancer with and without brain metastases (HER2CLIMB)

1043

Poster Presentation

G. Curigliano

Pharmacokinetic (PK) analyses in CSF and plasma from TBCRC049, an ongoing trial to assess the safety and efficacy of the combination of tucatinib, trastuzumab and capecitabine for the treatment of leptomeningeal metastasis (LM) in HER2 positive breast cancer

1044

Poster Presentation

E. Stringer-Reasor

SGNTUC-019: Phase 2 basket study of tucatinib and trastuzumab in previously treated solid tumors with HER2 alterations (trial in progress)

TPS3151

Poster Presentation

T. Stinchcombe

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

TPS1097

Poster Presentation

I. Krop

A011801 (CompassHER2 RD): Postneoadjuvant T-DM1 + tucatinib/placebo in patients with residual HER2-positive invasive breast cancer

TPS595

Poster Presentation

C. O’Sullivan

ADCETRIS (brentuximab vedotin)

Brentuximab vedotin with chemotherapy in adolescents and young adults (AYAs) with stage III or IV Hodgkin lymphoma: A subgroup analysis from the Phase 3 Echelon-1 study

7528

Poster Presentation

H. Crosswell

Brentuximab vedotin in combination with lenalidomide and rituximab in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (trial in progress)

TPS7571

Poster Presentation

N. Bartlett

Tisotumab vedotin

Tisotumab vedotin vs investigator’s choice chemotherapy in second- or third-Line recurrent or metastatic cervical cancer (innovaTV 301/ENGOT-cx12/GOG 3057, trial in progress)

TPS5596

Poster Presentation

I. Vergote

Early Pipeline

SGNTGT-001: A Phase 1 study of SEA-TGT, an effector-function enhanced monoclonal antibody (mAb), in advanced malignancies (trial in progress)

TPS2657

Poster Presentation

E. Garralda

A Phase 1 study of SGN-B6A, an antibody-drug conjugate targeting Integrin beta-6, in patients with advanced solid tumors (SGNB6A-001, trial in progress)

TPS3144

Poster Presentation

A. Patnaik

On April 29, 2021 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, reported a business update for the first quarter ended March 31, 2021 (Press release, Genocea Biosciences, APR 29, 2021, View Source [SID1234578800]).

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!

"Genocea continues to accumulate evidence that our ATLAS platform may enable immunotherapies that preferentially attack the surface-presented antigens driving anti-tumor responses or as we say, ‘Targets Matter’," said Chip Clark, Genocea’s President and Chief Executive Officer. "Whether through our ongoing clinical trials with GEN-011, our neoantigen-targeted peripheral T cell ("NPT") therapy and GEN-009, our neoantigen vaccine, or through our research efforts with Inhibigens and SARS-CoV-2 antigen discovery, we look forward to providing updates consistent with this thesis throughout the year."
Clinical updates
GEN-011 Phase 1/2a clinical trial (the "TITAN study")
•GEN-011 is in development to treat checkpoint inhibitor-refractory patients. Genocea believes using patient T cells taken from easily accessible peripheral blood and expanding the T cells only on tumor neoantigens prioritized by our ATLAS platform may give GEN-011 efficacy, accessibility and cost advantages over other T cell therapies. The TITAN study is designed to explore safety, biomarkers of activity and anti-tumor efficacy. During the first quarter, Genocea continued to add clinical sites and accrue patients. The company expects to have initial efficacy data from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022.
GEN-009 Phase 1/2a clinical trial
•The Company will provide long-term follow-up clinical and immunogenicity data from the ongoing Phase 1/2a clinical study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") 2021 Annual Meeting from June 4 – June 8.
Research updates
Inhibigens
•At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2021 in April, the Company presented novel preclinical Inhibigen data highlighting that the presence of a single Inhibigen in an otherwise protective immunotherapy can completely reverse the therapy’s intended anti-tumor responses and the Inhibigen effect can be seen as early as 4 days post-dosing.

SARS-CoV-2
•The Company continues its SARS-CoV-2 research efforts to identify conserved antigens of protective T cell responses that may enable a next-generation vaccine protecting against a wide range of strains.
Other business updates
Strengthened executive leadership team
•Genocea appointed Jacquelyn Sumer as Chief Legal and Compliance Officer. Jackie brings over fifteen years of legal experience, including roles at several biopharmaceutical companies with a focus in oncology and cell therapy experience development and commercialization.
Financial and other updates
First quarter 2021 financial results
•Cash position: As of March 31, 2021, cash and cash equivalents were $66.0 million compared to $79.8 million as of December 31, 2020.
•Research and Development (R&D) expenses: R&D expenses were $8.8 million for the quarter ended March 31, 2021, compared to $10.0 million for the same period in 2020.
•General and Administrative (G&A) expenses: G&A expenses were $3.7 million for the quarter ended March 31, 2021, compared to $3.4 million for the same period in 2020.
•Net loss: Net loss was $12.0 million for the quarter ended March 31, 2021, compared to $12.9 million for the same period in 2020.
Debt Refinancing
•In February 2021, the Company entered into an agreement with Silicon Valley Bank for a $10 million term loan. The proceeds from the loan were used to repay the Company’s outstanding loan from Hercules Capital, Inc., and for general corporate purposes.
Guidance
•Genocea’s operating plan extends its cash runway to the end of 2022.

Conference Call
Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 2191366. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On April 29, 2021 The Board of Directors of McKesson Corporation (NYSE: MCK) reported a regular dividend of 42 cents per share of common stock (Press release, McKesson, APR 29, 2021, View Source [SID1234578842]). The dividend will be payable on July 1, 2021, to stockholders of record on June 1, 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!

On April 29, 2021 Vedanta Biosciences, a leading clinical-stage microbiome company developing a new category of oral therapies using rationally defined bacterial consortia manufactured from clonal cell banks, reported that members of its management team will participate in the SVB Leerink Biopharma Private Company Connect Event being held virtually Thursday, May 6 – Friday, May 7, 2021 (Press release, Vedanta Biosciences, APR 29, 2021, View Source [SID1234578747]).

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!

Event: SVB Leerink Biopharma Private Company Connect Event
Date: Thursday, May 6 – Friday, May 7, 2021