On May 12, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that will share new research during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 3-7 and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress from June 9-12 (Press release, Astellas, MAY 12, 2022, View Source [SID1234614318]). A total of 13 abstracts from the company’s expanding portfolio of approved and investigational therapies will be presented across both meetings, underscoring the company’s commitment to advancing treatment options for advanced and rare cancers, including prostate, pancreatic and urothelial cancer, as well as acute myeloid leukemia (AML).

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"While a robust Phase 3 clinical trial program in gastric/gastroesophageal junction cancer for our investigational therapy zolbetuximab is well underway, the ASCO (Free ASCO Whitepaper) Annual Meeting will include the first trial-in-progress presentation from our expanded Phase 2 clinical trial in Claudin 18.2-positive pancreatic cancer," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "The progress of these clinical studies reflects our enthusiasm to continue investigating the potential to benefit patients by targeting the emerging Claudin 18.2 biomarker."

"At Astellas, our mission is to not only advance innovative science, but to create value for patients and the oncology community," said Erhan Berrak, M.D., Vice President of Global Medical Affairs, Oncology, Astellas. "Our advanced prostate cancer data at ASCO (Free ASCO Whitepaper), which range from new analyses of our ARCHES pivotal trial in metastatic hormone-sensitive prostate cancer to data on patient preferences and prescriber treatment decisions, will help inform discussions between patients and providers about novel hormone therapies."

Highlights at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting include:

An overview of the expanded Phase 2 open-label, randomized study of zolbetuximab in combination with nab-paclitaxel and gemcitabine as an investigational first-line treatment for patients with Claudin 18.2-positive metastatic pancreatic cancer
Long-term (24-month) data from the Phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor
Four post-hoc analyses from the Phase 3 ARCHES study, which compared enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC)
Highlights at the EHA (Free EHA Whitepaper) 2022 Hybrid Congress include:

Encore data from the COMMODORE Phase 3 confirmatory study of gilteritinib versus salvage chemotherapy in FLT3 mutation-positive relapsed or refractory AML in China and other countries
An overview of the CLEVO non-interventional investigational study of FLT3 mutation frequency in patients with AML in Europe and the U.S.
Astellas Presentations at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting

Enfortumab Vedotin

Presentation Title

Lead Author

Presentation Details

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

J. Rosenberg

Type: Poster Discussion

Abstract Number: 4516

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Poster Discussion Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 4:30 – 6 p.m. CDT

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

M. Galsky

Type: Poster Presentation

Abstract Number: 4575

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

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

G. Sonpavde

Type: Poster Presentation

Abstract Number: 4565

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

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

D. Petrylak

Type: Poster Presentation

Abstract Number: 4582

Date: Saturday, June 4, 2022

Poster Session: Genitourinary Cancer – Kidney and Bladder

Presentation: 1:15 – 4:15 p.m. CDT

Enzalutamide

Presentation Title

Lead Author

Presentation Details

Radiographic progression in the absence of prostate-specific antigen (PSA) progression in patients with metastatic hormone-sensitive prostate cancer (mHSPC): Post hoc analysis of ARCHES

A. Armstrong

Type: Poster Presentation

Abstract Number: 5072

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Prevalence of DNA damage repair (DDR) alterations in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving enzalutamide (ENZA) or placebo (PBO) plus androgen deprivation therapy (ADT): ARCHES post hoc analysis

A. Azad

Type: Poster Presentation

Abstract Number: 5074

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

The association of germline HSD3B1 genotype with outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without enzalutamide (ENZA) [ARCHES]

N. Sharifi

Type: Poster Presentation

Abstract Number: 5022

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Clinical outcomes and safety of enzalutamide (ENZA) plus androgen-deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) in patients aged <75 and ≥75 years: ARCHES post hoc analysis

R. Szmulewitz

Type: Poster Presentation

Abstract Number: 5069

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Reasons for oncologist and urologist treatment choice in metastatic castration-sensitive prostate cancer (mCSPC): A physician survey linked to patient chart reviews in the United States

S. Freedland

Type: Poster presentation

Abstract Number: 5065

Date: Monday, June 6, 2022

Poster Session: Genitourinary Cancer—Prostate, Testicular, and Penile

Presentation: 1:15 – 4:15 p.m. CDT

Patient preferences for treatment and outcomes in hormone-sensitive prostate cancer (HSPC)

D. George

Type: Abstract publication

Abstract Number: e18757

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

Zolbetuximab plus gemcitabine and nab-paclitaxel (GN) in first-line treatment of Claudin 18.2-positive metastatic pancreatic cancer (mPC): Phase 2, open-label, randomized study

W. Park

Type: Poster Presentation

Abstract Number: TPS4186

Date: Saturday, June 4, 2022

Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Presentation: 8 – 11 a.m. CDT

Astellas Presentations at EHA (Free EHA Whitepaper) 2022 Hybrid Congress

Gilteritinib

Presentation Title

Lead Author

Presentation Details

CLEVO: a non-interventional study to investigate clonal evolution of FMS-like tyrosine kinase 3 (FLT3) gene mutations during disease progression in patients with acute myeloid leukemia

P. Vyas

Type: Abstract publication

Abstract Number: PB1834

Gilteritinib versus salvage chemotherapy for relapsed/refractory FLT3-mutated acute myeloid leukemia: a Phase 3, randomized, multicenter, open-label trial in Asia

J. Wang

Type: Poster session

Abstract Number: P554

Enfortumab Vedotin and the Astellas and Seagen Collaboration
Astellas and Seagen 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.

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.

On May 12, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that the company management team, along with guest key opinion leaders (KOLs), will provide an update for the investment community on Thursday, June 2nd at 4:30 PM (Press release, Aptose Biosciences, MAY 12, 2022, View Source [SID1234614316]). The event will include an up-to-date review of clinical data available for Aptose’s two investigational products under development for hematologic malignancies: HM43239, an oral, myeloid kinome inhibitor in an international Phase 1/2 trial in patients with relapsed or refractory acute myeloid leukemia (AML); and luxeptinib, an oral, dual lymphoid and myeloid kinome inhibitor in a Phase 1 a/b trial in patients with relapsed or refractory B-cell malignancies, and in a separate Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS).

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The slides will be available on Aptose’s website here and a recording of the presentation will be archived shortly after the conclusion of the event.

Separately, preclinical data for HM43239 also will be presented in a poster at the EHA (Free EHA Whitepaper)2022 Hybrid Congress, to be held in Vienna, Austria June 9 – 17, 2022 and virtually. The accepted abstract is being published today, Thursday, May 12th at 16:00 CEST / 10:00 AM ET.

On May 12, 2022 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, reported that two abstracts highlighting data and information for zandelisib, an investigational phosphatidylinositol 3-kinase delta ("PI3Kδ") inhibitor in clinical development for the treatment of B-cell malignancies, will be presented at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress to be held June 9 – 17, 2022 (Press release, Kyowa Hakko Kirin, MAY 12, 2022, View Source [SID1234614315]).

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Oral Presentation Title: Efficacy and Safety of Zandelisib Administered by Intermittent Dosing (ID) in Patients with Relapsed or Refractory (r/r) Follicular Lymphoma: Primary Analysis of the Global Phase 2 Study TIDAL
Session Title: Indolent & mantle cell non-Hodgkin lymphoma – Clinical
Presenter: Andrew David Zelenetz, PhD, MD
Time: June 11, 11:30am-12:45pm CEST
Abstract Code: S208

Poster Title: Zandelisib on Intermittent Dosing as a Single Agent or in Combination with Rituximab or Zanubrutinib in Relapsed or Refractory (r/r) Follicular Lymphoma (FL): Results from a Multi-Arm Phase 1b Study
Session Title: Indolent & mantle cell non-Hodgkin lymphoma – Clinical
Time: June 10, 2:30pm-3:45pm CEST
Presenter: Jacob Drobnyk Soumerai, MD
Abstract Code: P1114

The abstracts are available on the EHA (Free EHA Whitepaper) Annual Congress website. All presentations will be made available on the EHA (Free EHA Whitepaper) website for on-demand viewing on June 10, 2022.

On May 12, 2022 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported first quarter 2022 financial results and summarized recent program developments (Press release, Monopar Therapeutics, MAY 12, 2022, View Source [SID1234614314]).

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Recent Program Developments

Validive – International Phase 2b/3 VOICE Clinical Trial, Actively Recruiting

The VOICE trial continues to enroll patients and add additional clinical sites, with the interim analysis anticipated to occur in 2H-2022.

Camsirubicin – Phase 1b Dose-Escalation Trial, Actively Recruiting

Monopar has cleared the third dose-level and is currently enrolling the fourth dose-level cohort. The fourth dose-level is approximately double the highest dose of camsirubicin ever tested in a prior trial.

Early signs of clinical benefit have been observed with camsirubicin in this Phase 1b trial.

MNPR-101 Radioimmunotherapeutic ("RIT")

Monopar is currently evaluating pathways to initiate a first-in-human study with the MNPR-101-PCTA radioimmunotherapeutic/radiodiagnostic candidate that Monopar generated with its partner NorthStar Medical Radioisotopes, LLC.

MNPR-202

Monopar’s collaborator, the Cancer Science Institute of Singapore at the National University of Singapore, is testing MNPR-202 in preclinical cancer models and the Company is awaiting initial results.

Results for the First Quarter Ended March 31, 2022, Compared to the First Quarter Ended March 31, 2021

Cash and Net Loss

Cash and cash equivalents as of March 31, 2022 were $17.8 million. Monopar anticipates that its current cash and cash equivalents will fund: the Phase 2b portion of the VOICE clinical trial; the commencement of the Phase 3 portion of the VOICE clinical trial; and the Phase 1b camsirubicin clinical trial through at least June 2023. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue camsirubicin clinical development through and beyond the ongoing open-label, dose escalation Phase 1b clinical trial.

Net loss for the first quarter of 2022 was $2.5 million or $0.19 per share compared to net loss of $1.9 million or $0.16 per share for the first quarter of 2021.

Research and Development (R&D) Expenses

R&D expenses for the three months ended March 31, 2022 were $1,678,000, compared to $1,207,000 for the three months ended March 31, 2021. The increase of $471,000 is attributed to (1) an increase of $244,000 in Validive clinical trial-related and clinical material manufacturing-related expenses, (2) an increase of $193,000 in R&D personnel expenses and (3) a $34,000 net increase of other R&D expenses.

General and Administrative (G&A) Expenses

G&A expenses for the three months ended March 31, 2022 were $779,000, compared to $688,000 for the three months ended March 31, 2021. The increase of $91,000 is primarily attributed to an increase in G&A personnel expenses.

On May 12, 2022 Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported first quarter financial results for 2022 and provided a corporate update (Press release, Pulmatrix, MAY 12, 2022, View Source [SID1234614313]).

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Ted Raad, Chief Executive Officer of Pulmatrix commented, "We have prioritized capital towards extending our cash runway through the Pulmazole Phase 2b top-line data anticipated in Q2 2024. We anticipate dosing for the Phase 2b study to begin in Q1 2023. Also in 2022, we will further analyze the PUR1800 Phase 1b data to finalize a potential Phase 2 study design while we execute to deliver PUR3100 Phase 1 top-line data in Q4 2022."

First Quarter 2022 and Recent Program Highlights

Pulmazole (PUR1900)

The Pulmazole Phase 2b efficacy study will include a 16-week dosing regimen with potential registration efficacy endpoints, is on track to begin dosing patients in Q1 2023. With a focus on capital conservation, we have extended our projected cash runway through the anticipated top-line data readout in Q2 2024.
PUR3100

On January 25, 2022, the Company conducted a Type C meeting with the FDA to add additional clarification around some of the written pre-IND responses in relation to the overall non-clinical and clinical program. Management concluded that conducting the Phase 1 study in Australia should allow the Company to generate the most comprehensive dataset for inclusion in an IND for Phase 2 in the United States, while also providing the most time efficient path to Phase 1 data in 2022.
PUR1800

On March 21, 2022, the Company announced top-line data from a Phase 1b clinical study of PUR1800 assessing the safety, tolerability and pharmacokinetics of PUR1800 in patients with stable COPD after dosing the first patient in February 2021. We are analyzing the Phase 1b clinical study data for future publication and to finalize design of a potential Phase 2 efficacy study in treatment of AECOPD.
First Quarter Corporate Highlights

On February 28, the Company completed a reverse stock-split at a ratio of 1-for-20 which reduced the number of outstanding shares of the Company’s common stock from approximately 65.9 million shares to 3.3 million shares.

On March 1, the Company announced the hiring of Dr. Margaret Wasilewski as the Company’s Chief Medical Officer. Dr. Wasilewski leverages over 25 years of experience in pharmaceutical drug development.

On March 17, the Company announced that it regained compliance for its listing on Nasdaq, allowing continued access to capital markets and liquidity for its investors.
First Quarter 2022 Financial Results

Revenue was $1.2 million for the first quarter ended March 31, 2022, compared to $1.4 million for the same period in 2021, a decrease of $0.2 million. Revenue for 2022 from the collaboration and license agreement with Cipla on the Company’s Pulmazole program increased, offset by no revenues from a previous JJEI License Agreement for the Company’s PUR1800 kinase inhibitor.

For the three months ended March 31, 2022, research and development expenses were $4.1 million compared to $3.9 million for the same period in 2021, an increase of $0.3 million. The increase was primarily due to increased spend of $0.7 million in employment costs and $0.1 million in rent costs, partially offset by decreased spend of $0.3 million on preclinical costs related to our PUR1800 program and $0.2 million on clinical and manufacturing costs related to the Pulmazole program.

General and administrative expenses were $2.0 million for the three months ended March 31, 2022, compared to $1.6 million for the three months ended March 31, 2021, an increase of $0.4 million. The increase was primarily due to increased spend of $0.1 million in employment costs, $0.3 million on consulting and legal, and $0.1 million on audit, tax and public company expense, partially offset by decreased patent expense of $0.1 million.

Our total cash and cash equivalents balance as of March 31, 2022 was $47.5 million. We expect that our existing cash and cash equivalents as of March 31, 2022 will enable us to fund our projected operating expenses and capital expenditures into Q2 2024.