On May 17, 2021 Asgard Therapeutics reported that it was shortlisted as a finalist of the 2021 Merck EU Advance Biotech Grants Program (Press release, Asgard Therapeutics, MAY 17, 2021, View Source [SID1234580109]). This program aims to support emerging biotech companies pushing innovative drugs to the market by allowing grant recipients to receive free products and services.

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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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On May 17, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that it will host a virtual investor update event on Wednesday, May 26, 2021 (Press release, Hutchison China MediTech, MAY 17, 2021, View Source [SID1234580125]). Members of the senior management team will provide updates on product launches in China, preparations for US commercialization, R&D, as well as a review of new data presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.

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Analysts and investors are invited to join a conference call and audio webcast presentation. The event will take place at 8:00 a.m. Eastern Daylight Time / 1:00 p.m. British Summer Time (BST) / 8:00 p.m. Hong Kong Time (HKT) on Wednesday, May 26. A first Q&A session will immediately follow the prepared remarks. For Asian investors, a recording of the webcast will be available for viewing the following morning and a second Q&A session will start at 12:00 noon HKT on Thursday, May 27.

The event will be webcast live and can be accessed at www.hutch-med.com/event. Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.

On May 17, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the three months ended March 31, 2021 and provided a business update (Press release, Onconova, MAY 17, 2021, View Source [SID1234580149]).

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Highlights for the first quarter of 2021 and subsequent weeks include:

The Phase 1 solid tumor study with ON 123300 in China is ongoing with no dose-limiting toxicities observed in the first two cohorts. Enrollment to the third cohort (120 mg) will now proceed.
The Phase 1 study with ON 123300 in the United States is open for enrollment, and actively screening patients.
The first patient has been dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC).
The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer has progressed nicely and has reached the maximum dose of oral rigosertib per the current protocol.
The Company strengthened its balance sheet with net proceeds of $35.2 million from two equity offerings; cash and cash equivalents as of March 31, 2021 were $48.0 million. The Company believes it has more than 18 months of cash runway.
Management Commentary

"We are off to a strong start in 2021 and remain focused on advancing our clinical programs, in particular with our lead product candidate ON 123300, a multi-kinase inhibitor that potently targets CDK 4 and 6, which are overexpressed in a number of cancers, including HR+ HER 2- metastatic breast cancer, a potential blockbuster commercial opportunity," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "We are delighted that our partner in China, HanX Biopharmaceuticals, is expected to begin the third cohort of their Phase 1 study at 120 mg per dose and that ON 123300 appears to be well tolerated with no dose-limiting toxicities observed to date. Notably, the HanX study is dosing patients on days 1 to 21 of 28-day cycles, while the U.S. Phase 1 study will be investigating a continuous daily dosing regimen. Collectively, we expect these complementary studies to generate important safety data that will inform the design of subsequent trials and potentially provide preliminary signals of efficacy in patients with advanced cancer."

Dr. Fruchtman continued, "Alongside the progress made with our lead product candidate, we have also seen advancements in several investigator-initiated trials evaluating rigosertib. The first patient was recently dosed in a Phase 2 trial evaluating rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, a disease with a critical unmet medical need. Additionally, the Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer continues to progress and has reached the highest dose per the current protocol. We expect to continue leveraging our relationships with leading cancer centers and industry collaborators to advance these trials and commence additional investigator initiated studies in RAS-driven cancers in combination with checkpoint inhibitors. We expect such an approach to facilitate our near- and long-term growth by allowing us to preserve our primary focus and resources on ON 123300 while simultaneously pursuing opportunities to develop rigosertib in high unmet need indications."

First Quarter Financial Results

Cash and cash equivalents as of March 31, 2021 were $48.0 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than 18 months.

Research and development expenses were $1.9 million for the first quarter of 2021, compared with $3.4 million for the first quarter of 2020. The decrease was primarily related to lower expenses for the oral rigosertib combination program and the completed Phase 3 INSPIRE study in the 2021 period.

General and administrative expenses were $2.2 million for the first quarter of 2021, compared with $1.8 million for the first quarter of 2020. The increase was primarily related to higher special stockholder meeting by proxy expenses and insurance costs in the 2021 period.

Net loss for the first quarter of 2021 was $4.7 million, or $0.02 per share on 219.2 million weighted average shares outstanding, compared with a net loss for the first quarter of 2020 of $5.1 million, or $0.03 per share on 160.3 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern time, during which management will discuss financial results for the first quarter of 2021, provide a business update and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 4895447.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

On May 17, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, will present at the UBS Virtual Global Healthcare Conference at 12:00 p.m. ET on Tuesday, May 25, 2021 (Press release, AngioDynamics, MAY 17, 2021, View Source [SID1234580165]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On May 17, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that it will share new data across its oncology portfolio during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, Astellas, MAY 17, 2021, View Source [SID1234580110]). Covering three approved treatments and one investigational therapy, the 12 Astellas-sponsored abstracts underscore the company’s commitment to advancing treatment options for difficult-to-treat cancers, including bladder, prostate and gastric/gastroesophageal junction (GEJ) cancers, as well as acute myeloid leukemia (AML).

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"While oncology has seen incredible advancements over the last decade, there are still many patients whose disease has few or no effective treatments. Astellas is determined to change that reality," said Andrew Krivoshik, M.D., Ph.D., Astellas Senior Vice President and Oncology Therapeutic Area Head. "Our data suggest that progress is possible, and we are committed to working with physicians, patients and others in the cancer community to change the course of hard-to-treat forms of cancer."

"The latest investigational research supported by Astellas reflects our commitment to understanding unmet needs in cancer care and our mission to turn innovative science into treatments that are truly valued by patients and healthcare professionals," said Erhan Berrak, M.D., Astellas Vice President of Medical Affairs, Oncology. "For example, research to be presented at ASCO (Free ASCO Whitepaper) includes a closer look at real-world treatment patterns in several clinical states of advanced prostate cancer, including the use of advanced treatments across racial groups – a topic closely aligned with the ASCO (Free ASCO Whitepaper) 2021 theme of equity."

Astellas will share data across its portfolio and investigational therapies, with highlights including:

Quality of life results from the Phase 3 EV-301 trial of enfortumab vedotin (EV) and an updated analysis of efficacy and safety data from EV-201 cohort 2 of EV; updated durability and long-term outcomes from the EV-103 clinical trial of EV and pembrolizumab – all in advanced types of urothelial cancer
Research on racial disparities in advanced prostate cancer treatment, as well as real-world treatment patterns for patients with advanced prostate cancer
Follow-up data from the Phase 3 ADMIRAL trial evaluating gilteritinib in patients with relapsed or refractory (resistant to treatment) AML with a FLT3 mutation
Data from the Phase 2 study of zolbetuximab plus mFOLFOX6 in claudin 18.2-positive (CLDN18.2+) locally advanced or metastatic gastric or GEJ adenocarcinoma
Astellas Presentations at ASCO (Free ASCO Whitepaper)21

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

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

B. McGregor

Type: Poster

Abstract Number: 4524

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)

T. Friedlander

Type: Poster

Abstract Number: 4528

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

R. Mamtani

Type: Poster

Abstract Number: 4539

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)

C. Hoimes

Type: Poster

Abstract Number: TPS4587

Opioid use in locally advanced or
metastatic urothelial carcinoma patients
and matched non-cancer controls

S. Grewal

Type: Publication Only

Abstract Number: e16517

Enzalutamide

Presentation Title

Lead Author

Presentation Details

The efficacy of enzalutamide (ENZA)
plus androgen deprivation therapy
(ADT) on bone oligometastatic
hormone-sensitive prostate cancer: A
post hoc analysis of ARCHES

A. Armstrong

Type: Poster

Abstract Number: 5071

Real world first-line (1L) treatment
patterns in patients (pts) with metastatic
castration-sensitive prostate cancer
(mCSPC) in a U.S. health insurance
database

U. Swami

Type: Poster

Abstract Number: 5072

Real-world utilization of advanced
therapies and racial disparity among
patients with metastatic castration-
sensitive prostate cancer (mCSPC): A
Medicare database analysis

S. Freedland

Type: Poster
Abstract Number: 5073

Real-world treatment patterns among
patients diagnosed with metastatic
castration-sensitive prostate cancer
(mCSPC) in community oncology
settings

D. George

Type: Poster
Abstract Number: 5074

Gilteritinib

Presentation Title

Lead Author

Presentation Details

Follow-up of patients with FLT3-mutated
R/R AML in the phase 3 ADMIRAL trial

A. Perl

Type: Poster

Abstract Number: 7013

Zolbetuximab

View News Release Full Screen
Presentation Title

Lead Author

Presentation Details

Phase 2 study of zolbetuximab plus
mFOLFOX6 in claudin 18.2-positive
locally advanced or metastatic gastric or
gastroesophageal junction adenocarcinoma (G/GEJ): ILUSTRO
cohort 2

K. Lee

Type: Publication Only

Abstract Number: e16078

The ASCO (Free ASCO Whitepaper) 2021 Annual Meeting abstracts are available at the ASCO (Free ASCO Whitepaper) Meeting Library.

Enfortumab Vedotin Collaborations
Astellas and Seagen Inc. are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. In the United States, Astellas and Seagen co-promote enfortumab vedotin. In the Americas outside the US, Seagen holds responsibility for commercialization activities and regulatory filings. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

Astellas and Seagen entered a clinical collaboration agreement with Merck to evaluate the combination of enfortumab vedotin and Merck’s KEYTRUDA (pembrolizumab), in patients with previously untreated metastatic urothelial cancer. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

Enzalutamide and the Pfizer/Astellas Collaboration
In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies jointly commercialize enzalutamide in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing enzalutamide outside the United States.