On April 6, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) (Press release, HUYA Bioscience, APR 6, 2021, View Source [SID1234577612]).

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!

"R/R PTCL carries a poor prognosis. The benefit of chemotherapy diminishes with each subsequent relapse. Data from the Phase 2 study of HBI-8000 has demonstrated meaningful tumor response and progression-free duration despite the advanced stage of disease, to address an important unmet medical need in this patient population ", said Dr. Kensei Tobinai, visiting scientist of the National Cancer Center Hospital in Japan and medical expert of HBI-8000 Phase 2 study.

The new drug application is based on data from a Phase 2b study of 55 patients with aggressive PTCL in Japan. These patients all had advanced disease, refractory or relapsed relative to prior therapies. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This is an important Public Health contribution as R/R PTCL patients will have an effective treatment alternative. It is our second regulatory submission for drug approval in Japan in 6 months and we continue to work hard to benefit patients with difficult to treat diseases."

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) enzymes to induce cell cycle arrest, suppress the expression of a number of oncogenes and modulate the of acetylation of PD-L1 to enhance the activity of immune checkpoint inhibitors. The drug also has immunomodulatory impact by increasing the efficacy of checkpoint inhibitors in preclinical animal models.

On April 6, 2021 Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported the publication in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), of peer-reviewed data in support of the scientific rationale for the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion (Press release, Elevation Oncology, APR 6, 2021, View Source [SID1234577611]). The CRESTONE study is currently enrolling at sites across the United States.

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 manuscript titled "The anti-HER3 monoclonal antibody seribantumab effectively inhibits growth of patient-derived and isogenic cell line and xenograft models with oncogenic NRG1 fusions," can be accessed online here: Odintsov et al., Clinical Cancer Research 2021

"With this work, we aimed to expand the biological understanding of NRG1 fusions as an oncogenic driver and the importance of broad inhibition of downstream signaling activated through ERBB family complexes involving HER3 (ERBB3) in tumors driven by NRG1 rearrangements," said Igor Odintsov, MD, Research Fellow, Memorial Sloan Kettering Cancer Center (MSK), lead author, who performed these studies with Romel Somwar, PhD, Senior Research Scientist in the Ladanyi Lab at MSK. "Given that HER3 is required for NRG1 fusion-driven tumor growth but does not have an active kinase domain to directly target with small molecule antagonists, targeting HER3 with an antibody is an attractive therapeutic strategy."

The study results reported in the manuscript suggest that targeted inhibition of HER3 with the anti-HER3 mAb seribantumab is not only able to inhibit ligand-dependent activation by the NRG1 fusion protein but also to de-stabilize the entire subsequent ERBB and downstream signaling pathways that drive tumor growth and proliferation, leading to significant tumor regression of 50 – 100% in NRG1 fusion models. Notably, the entire biologically effective dose range observed in these models of 1 mg BIW – 10 mg BIW seribantumab falls below the equivalent human dosage of seribantumab currently being used in clinical trials. In contrast, similar tumor regression in response to afatinib, a pan-ERBB inhibitor, was only observed at 15 mg/kg QD, above the recommended dose of afatinib for patients based upon allometric scaling.

Seribantumab is currently being clinically evaluated in the tumor-agnostic Phase 2 CRESTONE trial for patients with solid tumors harboring an NRG1 fusion. CRESTONE is currently open and enrolling patients across the United States. The primary objective of the study is to describe the Objective Response Rate (ORR) of seribantumab by independent central radiographic review, and key secondary endpoints are Duration of Response (DoR) and safety.

"We thank our collaborators at MSK for their rigorous evaluation of therapeutic approaches for this rare, genomically defined patient population, and their commitment to developing the novel NRG1 fusion models that enable targeted preclinical investigation of seribantumab," said Shawn Leland, PharmD, RPh, Founder and CEO of Elevation Oncology. "This publication represents the first peer-reviewed data in support of the specific development of seribantumab for patients whose solid tumors are driven by an NRG1 fusion, showing that across these preclinical models of aggressive disease in various tumor types and fusion partners, direct inhibition of HER3 by seribantumab shows potential to generate significant and durable anti-cancer effects at clinically achievable doses."

On April 6, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company developing PVSRIPO, a novel viral immunotherapy that activates innate and adaptive immunity to facilitate a functional antitumor CD8+ T cell response, reported two upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The AACR (Free AACR Whitepaper) Annual Meeting will be held virtually April 10-15 and May 17-21, 2021 (Press release, Istari Oncology, APR 6, 2021, View Source [SID1234577606]).

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 full text of the following abstracts will be posted to the AACR (Free AACR Whitepaper) Online Planner at 12:01 a.m. ET on Friday, April 9 at aacr.org and the associated presentations will be made on Saturday, April 10 at the times indicated below. E-posters will be available at on the AACR (Free AACR Whitepaper) website at that time and on istarioncology.com.

Title: LUMINOS-101: Phase 2 study of PVSRIPO with pembrolizumab in recurrent glioblastoma
Abstract #: CT240
Presenter: Andrea True Kelly, Ph.D.
Session Title/Category: PO.CT08.02 – Phase II Clinical Trials in Progress
Date/time: April 10, 2021, 8:30 a.m. – 11:59 p.m. EDT
ClinicalTrials.gov Identifier: NCT04479241

Title: LUMINOS-103: A basket trial evaluating the safety and efficacy of PVSRIPO in patients with advanced solid tumors
Abstract #: CT242
Presenter: Shannon R. Morris, M.D.
Session Title/Category: PO.CT08.02 – Phase II Clinical Trials in Progress
Date/time: April 10, 2021, 8:30 a.m. – 11:59 p.m. EDT
ClinicalTrials.gov Identifier: NCT04690699

For more information about Istari Oncology and their ongoing clinical trials and research in PVSRIPO, visit istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct target (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

On April 6, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, has scheduled a conference call for Tuesday, May 4, 2021, at 8 a.m. (ET) reported its first quarter financial results for the period ending April 2, 2021 (Press release, Leidos, APR 6, 2021, View Source [SID1234577605]). The company plans to issue its quarterly earnings press release before the conference call on May 4, 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!

The details for the earnings conference call follow:

Replay:

A telephone playback of the first quarter earnings conference call is scheduled to be available beginning at 11:30 a.m. (ET) on May 4, 2021, through 11:59 p.m. (ET) on May 11, 2021. The replay will be accessible by calling 877-660-6853 (International callers: +1-201-612-7415), and entering conference ID 13718327.

An archived version of the webcast will be available on the Leidos Investor Relations website at View Source

On April 6, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Thursday, May 6, 2021, at 8:00 a.m. CDT to review third quarter 2021 financial results (Press release, Bio-Techne, APR 6, 2021, https://investors.bio-techne.com/news/detail/243/bio-techne-to-host-conference-call-on-may-6-2021-to-announce-third-quarter-2021-financial-results [SID1234577604]).

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!

Access to the discussion may be obtained as follows:

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13718437.

The replay will be available from 11:00 a.m. CDT on Thursday, May 6, 2021 until 11:00 p.m. CDT on Sunday, June 6, 2021.