On November 16, 2020 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported the presentation of new data in acute myeloid leukemia (AML) at the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 5-8, 2020 (Press release, Astellas, NOV 16, 2020, View Source [SID1234571060]).

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!

Nine Astellas-sponsored abstracts focused on patients with AML with a positive FLT3 mutation (FLT3mut+) are being presented, comprising five oral presentations, three posters and one online-only presentation. Oral presentations include new data on the use of gilteritinib, either as monotherapy or in combination, across the FLT3mut+ AML patient spectrum – from those newly diagnosed, to relapsed or refractory patients who have been pre-treated with other tyrosine kinase inhibitors (TKIs) – as well as a secondary analysis of the Phase 3 ADMIRAL trial.

"The research being presented at ASH (Free ASH Whitepaper) will shed light on critical unmet needs and continuing progress against AML, which remains a hard-to-treat cancer in spite of continuing medical advances," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. "Several presentations will describe the effects of gilteritinib in a wide range of AML patients with a positive FLT3 mutation. We also look forward to discussing our Phase 3 LACEWING trial in progress, as well as findings from the STREAMLINE study related to real-world FLT3 testing rates in AML patients, both upon diagnosis and after relapse."

Gilteritinib is approved as XOSPATA in the U.S. and selected other countries for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.

Oral Presentations

Title: A Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed AML: Final Results (Abstract 24)

Presenting author: Dr. Keith W. Pratz, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore
Session Date/Time: Saturday, Dec. 5, 7:30 a.m. PST
Title: Phase 3, Multicenter, Open-Label Study of Gilteritinib, Gilteritinib Plus Azacitidine, or Azacitidine Alone in Newly Diagnosed FLT3 Mutated (FLT3mut+) Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Induction Chemotherapy (Trial in progress) (Abstract 27)

Presenting author: Dr. Eunice S. Wang, Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, N.Y.
Session Date/Time: Saturday, Dec. 5, 8:15 a.m. PST
Title: Comparison of Gilteritinib and Salvage Chemotherapy in FLT3-Mutated Acute Myeloid Leukemia on the Number Needed to Treat for Various Clinical Outcomes: A Secondary Analysis of the ADMIRAL Trial (Abstract 213)

Presenting author: Amer M. Zeidan, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.
Session Date/Time: Saturday, Dec. 5, noon PST
Title: Efficacy and Safety of Venetoclax in Combination with Gilteritinib for Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia in the Expansion Cohort of a Phase 1b Study (Abstract 333) (Supported by AbbVie, Astellas and Genentech)

Presenting author: Dr. Naval G. Daver, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston
Session Date/Time: Sunday, Dec. 6, 10:15 a.m. PST
Title: Clinical Outcomes in Patients with Relapsed/Refractory Acute Myeloid Leukemia Treated with Gilteritinib Who Received Prior Midostaurin or Sorafenib (Abstract 334)

Presenting author: Dr. Alexander E. Perl, Abramson Cancer Center, University of Pennsylvania, Philadelphia
Session Date/Time: Sunday, Dec. 6, 10:30 a.m. PST
Poster Presentations
Poster presentations are available online from Saturday, Dec. 5, 7 a.m. PST to Monday, Dec. 7, 3:30 p.m. PST.

Title: STREAMLINE – Retrospective Cohort Study of Relapsed or Refractory (R/R) FLT3-Mutated Acute Myeloid Leukemia (AML): Real-World Treatment, Testing Patterns, and Outcomes (Abstract 2826)

Presenting author: Dr. Amer M. Zeidan, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.
Title: Clinical Outcomes Following Treatment with Gilteritinib or Quizartinib in Patients with Relapsed/Refractory FLT3-ITD+ Acute Myeloid Leukemia (Abstract 995)

Presenting author: Dr. Alexander E. Perl, Abramson Cancer Center, University of Pennsylvania, Philadelphia
Title: Pain and Opioid Use in Patients with FLT3 Mutation-Positive Relapsed/Refractory AML: A Subanalysis of Patient-Reported Outcomes from the ADMIRAL Trial (Abstract 2568)

Presenting author: Manasee V. Shah, Global Health Economics and Outcomes Research, Astellas
Online-Only Presentation

Title: Real-World Use of FLT3-TKIs in R/R FLT3-Mutated AML in the United States (Abstract 4413)

Astellas-Supported Satellite Symposium
Astellas will support the following pre-meeting Friday Satellite Symposia Live Webinar.

Title: Consensus or Controversy? Investigators Discuss Clinical Practice Patterns and Available Research Data Guiding the Management of Acute Myeloid Leukemia (Part 3 of a 4-part Series)

Session Date/Time: Friday, Dec. 4, 3-6 p.m. PST

On November 16, 2020 Genome & Company, a leading global microbiome anti-cancer drug, immuno-anti-cancer microbiome treatment (GEN-001), reported that followed by the US FDA for a company-led phase 1/1b clinical trial (NCT04601402) The Clinical Trial Plan (IND) was approved by the Korea Food and Drug Administration (MFDS) (Press release, Genome & Company, NOV 16, 2020, View Source [SID1234571049]). As a result, Genome & Company is planning to accelerate the development of GEN-001 by obtaining approval for both research-led clinical trials (GEN001 alone therapy) and company-led clinical trials (GEN001 combination therapy) in Korea.

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!

With the approval of this clinical trial, a domestic clinical trial site will be added in addition to the US clinical trial site, and it is expected that the clinical trial period will be shortened through rapid patient recruitment, and opportunities for treatment through participation in clinical trials will be expanded to domestic terminal cancer patients. In particular, amidst global clinical trials being delayed in the aftermath of COVID-19 this year, Genome & Company and its partners are expected to successfully digest the scheduled clinical trial schedule through rapid crisis response capabilities.

‘GEN-001’ is an immuno-anticancer microbiome treatment based on a single strain of microbiome ( Lactococcus lactis , hereinafter L. lactis ), and is preclinical through co-administration with an immuno-anticancer drug, PD-L1 inhibitor. Based on the safety and efficacy results of the phase, a phase 1/1b clinical trial is currently in progress. In particular, at the end of October, OHSU (Oregon Health & Science University) among the US clinical trial sites successfully administered the first patient.

Bae Bae-soo, CEO of Genome & Company said, "The approval of GEN-001 for this domestic clinical trial is one step closer to the development of a microbiome immune chemotherapy drug for the first time in the world." I will not spare any effort for it."

Meanwhile, Genome & Company signed a’clinical trial cooperation and supply contract’ with Merck and Pfizer in December last year to conduct clinical trials of anticancer drugs. Genome & Company will oversee the entire clinical trial process, and Merck and Pfizer will cooperate in overall clinical trials, including providing advice on clinical trial operation, and will seek joint commercialization after successful clinical trials are over.

On November 13, 2020 BridgeBio Pharma, Inc. (Nasdaq: BBIO) and affiliate Navire Pharma, Inc. reported that the first patient has been dosed in a Phase 1 clinical trial of its SHP2 inhibitor (BBP-398) in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes (Press release, BridgeBio, NOV 13, 2020, View Source [SID1234576221]). BBP-398 was developed through a collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division.

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!

In this two-part Phase 1 study, safety and preliminary anti-tumor activity will be examined. Part 1 is a dose escalation to establish the recommended Phase 2 dose (RP2D) of BBP-398. Part 2 will examine preliminary anti-tumor activity in four cohorts of patients with certain molecular alterations. Those cohorts include advanced KRAS G12C mutant non-small cell lung carcinoma (NSCLC), advanced KRAS G12C mutant non-NSCLC, advanced solid tumors with other MAPK pathway mutations and advanced EGFR-mutant NSCLC. David S. Hong, professor of Investigational Cancer Therapeutics at MD Anderson, will serve as the lead principal investigator for the study.

The primary objective of the study is to evaluate the safety of BBP-398 in advanced cancer patients, with secondary objectives assessing preliminary anti-tumor activity, including objective response rates and duration of response. Patients enrolling in the study must have a diagnosis of advanced (primary or recurrent) or metastatic solid tumor with potentially susceptible genomic alterations in the MAPK pathway (excluding BRAF V600X).

"SHP2 inhibitors have the potential to be effective additions to the therapeutic arsenal for difficult-to-treat cancers by overcoming multiple mechanisms that tumors use to evade treatments," said Eli Wallace, Ph.D., chief scientific officer of oncology at BridgeBio, Navire’s parent company. "This study is a critical step in understanding the potential that BBP-398 has for patients with tumors driven by RAS or other MAPK-pathway activating mutations and informing our future clinical development activities."

SHP2, a conserved protein tyrosine phosphatase, plays a critical role in cell signaling and growth, which are important in the progression of cancer. As SHP2 regulates receptor tyrosine kinase signaling pathways commonly overly activated in cancer, targeting SHP2 may offer a potential new approach to treat this disease.

BBP-398 was initially discovered and developed by a team of scientists in MD Anderson’s Institute for Applied Cancer Science (IACS) and Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platforms, both engines within the Therapeutics Discovery division. The ongoing research is supported by Navire through a global licensing and development agreement with MD Anderson.

On November 13, 2020 Affibody Medical AB (publ) ("Affibody" or "the Company"), a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod, reported its Third Quarter Report for 2020 (Press release, Affibody, NOV 13, 2020, View Source [SID1234575696]).

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!

Financial Highlights

Revenue for the 3rd Quarter 2020 amounted to SEK 0.1 (47.6) m, and to 119.4 (294.6) m for the full nine-month period
Operating result for the quarter amounted to SEK -78.8 (-17.5) m, and to -127.4 (110.8) m for the full nine-month period
Net result for the quarter amounted to SEK -80.0 (-6.0) m, and to -130.9 (116.9) m for the full nine-month period
Cash flow for the quarter amounted to SEK -99.3 (-27.9) m, and to -196.6 (298.2) m for the full nine-month period
Cash and cash equivalents at the end of the period amounted to SEK 178.2 (389.2) m
Significant Events during the rest of the Year

An EGM on February 17, 2020 elected José Suarez as Board member.
On April 30, 2020 we announced that Daewoong, a South Korea-based pharmaceutical company, had exercised an option under the collaboration related to a half-life extended biotherapeutics product
On May 15, 2020, we and Inmagene Biopharmaceuticals announced a strategic partnership to develop and commercialize ABY-035, a bispecific molecule targeting Interleukin-17A (IL-17), for multiple auto-immune diseases. Inmagene will be responsible for commercialization in mainland China, Hong Kong, Taiwan, and Macau (Greater China), and South Korea, as well as development activities in the Asia Pacific region, excluding Japan. Affibody will retain global commercial rights outside of Greater China and South Korea. The partners will work together to enroll patients into global registrational trials to support Biologics License Applications (BLAs) in multiple indications worldwide. Under the terms of the agreement, Affibody will receive a $10 million upfront payment and is eligible to receive up to $215.5 million in additional regulatory and sales milestones, plus royalties on sales in Inmagene’s commercialization territory.
On June 15, 2020 we announced positive top-line data from our Phase 2, 52-week trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with moderate-to-severe psoriasis ("AFFIRM-35").
On June 15, 2020 we announced the completion of the ABY-039 Phase 1 trial and the termination of the ABY-039 program, our FcRn inhibitor, due to tolerability observations that would limit the target product profile of subcutaneous high dose once monthly maintentance injections. Based on these observations Alexion has terminated the co-development agreement with Affibody.
Significant Events after the close of the Reporting Period

On November 10, 2020, we announced the initiation of a 52-week trial investigating the novel bispecific IL-17A inhibitor ABY-035 in patients with psoriatic arthritis (PsA).
Affibody is a clinical stage biopharmaceutical company with a broad product pipeline focused on developing innovative bi- and multi-specific next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody molecules and Albumod.

The company operates a focused experimental medicine model and currently has two clinical stage programs. The first is a therapeutic program that targets psoriasis. The second program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.

Affibody AB is a holding of Patricia Industries.

On November 13, 2020 OncXerna Therapeutics, Inc., a precision medicine company using an innovative RNA-based biomarker platform to predict patient responses for potentially first-in-class targeted oncology therapies, reported that Laura Benjamin, Ph.D., Founder and CEO of OncXerna, will participate at the Piper Sandler Virtual Healthcare Conference taking place November 30-December 3, 2020 (Press release, OncXerna Therapeutics, NOV 13, 2020, View Source [SID1234574521]).

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!