On April 6, 2021 Sapience Therapeutics, Inc., a clinical stage biotechnology company focused on the discovery and development of peptide therapeutics to address difficult to treat oncology indications, reported multiple poster presentations, including a late-breaker, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which is being held in a virtual format (Press release, Sapience Therapeutics, APR 6, 2021, View Source [SID1234577642]). The posters will be available on April 10, 2021.

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Details of the poster presentations are as follows:

Title: Tumor uptake and predictable PK of ST101 – a peptide antagonist of C/EBPβ – in patients with advanced unresectable and metastatic solid tumors
Abstract Control Number: 5106
Presentation Time: The e-poster will be available on the AACR (Free AACR Whitepaper) website on Saturday, April 10, 2021
Session Type: E-Poster Session (late-breaker)
Session Category: Experimental and Molecular Therapeutics
Session Title: New Targets
Permanent Abstract Number: LB114

Title: C/EBPβ antagonist peptide, ST101, as a therapeutic approach in breast cancer
Abstract Control Number: 3578
Presentation Time: The e-poster will be available on the AACR (Free AACR Whitepaper) website on Saturday, April 10, 2021
Session Type: E-Poster Session
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents
Permanent Abstract Number: 959

Title: β-catenin antagonist peptide attenuates Wnt-dependent oncogenic activity
Abstract Control Number: 3677
Presentation Time: The e-poster will be available on the AACR (Free AACR Whitepaper) website on Saturday, April 10, 2021
Session Type: E-Poster Session
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents
Permanent Abstract Number: 964

More details can be found at View Source

About ST101

ST101 is a peptide inhibitor of C/EBPβ, which is a transcription factor overexpressed in many cancers that regulate cellular differentiation and promote tumor survival and proliferation. ST101 significantly decreases the expression of C/EBPβ target genes/proteins involved in cell survival, proliferation and differentiation including BCL-2, MCL-1, BIRC5/survivin, cyclins and ID family of proteins. ST101 has been demonstrated to induce selective cancer cell cytotoxicity across a variety of tumor types, including but not limited to breast cancer, melanoma, prostate cancer, GBM, lung cancer, and AML. C/EBPβ is expressed and active in cancer cells but not active in normal cells (post-differentiation), providing a therapeutic opportunity.

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.

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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 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its first quarter 2021 financial and operating results on Thursday, May 6, 2021, before the U.S. financial markets open (Press release, Regeneron, APR 6, 2021, https://www.prnewswire.com/news-releases/regeneron-to-report-first-quarter-2021-financial-and-operating-results-and-host-conference-call-and-webcast-on-may-6-2021-301263387.html [SID1234577643]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 7794757. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

On April 6, 2021 PCI Biotech (OSE: PCIB), a clinical-stage biopharma company developing innovative therapeutics that address significant unmet medical needs in cancer reported that it will present at the European Biotech Investor Days 2021, a US based online event taking place April 7-8, 2021 and hosted by Goodwin, Solebury Trout, Deutsche Bank and Nasdaq (Press release, PCI Biotech, APR 6, 2021, View Source [SID1234585154]).

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On Thursday, April 8, 2021 at 15:00 (CEST), Dr. Per Walday, CEO, will present an overview of PCI Biotech’s proprietary platform technology via a general company presentation.

The presentation can be accessed live through this link View Source

The presentation slides will be made available on PCI Biotech’s website (www.pcibiotech.com) under "Other presentations" after the event.

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]).

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"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.