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Phase 1 Drug Candidate GLR2007 Developed by Gan & Lee has been Granted Fast Track Designation by the U.S. FDA

On January 29, 2021 Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee) (Shanghai: 603087.SH), a global biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for GLR2007, for the treatment of patients with glioblastoma (Press release, Gan and Lee Pharmaceuticals, JAN 29, 2021, View Source;lee-has-been-granted-fast-track-designation-by-the-us-fda-301218146.html [SID1234574430]). GLR2007 is a cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor that Gan & Lee is developing for the treatment of advanced solid tumors including glioblastoma, an aggressive form of brain cancer with a low survival rate. Although considered a rare disease, glioblastoma is the most common brain and central nervous system (CNS) malignancy, accounting for 45.2% of malignant primary brain and CNS tumors[1].

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The one-year survival rate for glioblastoma is 39.3%. By year two and year five post-diagnosis, the survival rate drops to 16.9% and 5.5%, respectively. The average survival time for untreated patients is only three months[2]. Current available treatments improve prognosis only by a matter of months. According to Julius Huang, Director of Global Clinical Sciences, Gan & Lee, "The poor prognosis and low survival rates for glioblastomas, demonstrate an unmet need for new treatment options." The FDA’s Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Receiving Fast Track Designation potentiates frequent meetings and written communication with the FDA. The GLR2007 application is also eligible for Rolling Review and may be eligible for Accelerated Approval, and Priority Review[3].

Scopus BioPharma Announces Closing of $9 Million Follow-On Public Offering

On January 29, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported the closing of a $9 million follow-on public offering (Press release, Scopus BioPharma, JAN 29, 2021, View Source [SID1234574429]). The offering consisted of 1,000,000 shares of common stock at a public offering price of $9.00 per share. The company has granted the underwriters a 45-day option to purchase up to an additional 150,000 shares of common stock at the public offering price.

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company’s lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. This drug candidate is highly distinctive, encompassing both gene therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment.

Scopus intends to use the proceeds of the offering principally for further development of the company’s lead drug candidate, including in combination with checkpoint inhibitors.

The Benchmark Company, LLC acted as Sole Bookrunning Manager and Joseph Gunnar & Co., LLC acted as Co-Manager for the offering.

Greenberg Traurig, LLP is acting as counsel to the company. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is acting as counsel to the underwriters.

An offering statement relating to the shares of common stock was filed with the U.S. Securities and Exchange Commission and became qualified on January 26, 2021. The offering is being made only by means of an offering circular, copies of which may be obtained, when available, by contacting: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th Floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected]; or Joseph Gunnar & Co., LLC, Attention: Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, by calling (212) 440-9600 or by email at [email protected]. The offering circular is also available on the U.S. Securities and Exchange Commission website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

ImmunoGen Announces Conference Call to Discuss Its 2020 Operating Results

On January 29, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, February 12, 2021 to discuss its 2020 operating results (Press release, ImmunoGen, JAN 29, 2021, View Source [SID1234574428]). Management will also provide a brief update on the business.

Conference Call Information

To access the live call by phone, dial (877) 621-5803; the conference ID is 1666147. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location.

Takeda Completes Sale of Select OTC and Non-Core Assets to Hypera Pharma

On January 29, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported the completion of its previously-announced sale of a portfolio of select products sold in Latin America to Hypera S.A. ("Hypera Pharma") for a total value of $825 million USD (Press release, Takeda, JAN 29, 2021, View Source [SID1234574427]). This divestment agreement was first announced in March 2020.

The divested portfolio includes select over-the-counter and prescription pharmaceutical products sold in Brazil, Mexico, and other South American, Central American and Caribbean countries, which are part of Takeda’s Growth & Emerging Markets Business Unit (GEM BU). The products, while addressing key patient needs in these countries, are outside of the business areas Takeda has designated as core to its global long-term growth.

Close to 300 Takeda commercial employees will transition with the divested portfolio at close. As part of a manufacturing and supply agreement, Takeda will continue to exclusively manufacture the divested products.

Takeda intends to use the proceeds from the sale to reduce its debt and accelerate deleveraging towards its target of 2x net debt/adjusted EBITDA within Fiscal Years 2021–2023.

Takeda exceeded its $10 billion non-core asset divestiture target in 2020, announcing 11 deals since January 2019 to date for a total aggregate value of up to approximately $11.6 billion.

BostonGene Announces Publications in Two Scientific Journals in Collaboration with Leading Cancer Institute

On January 29, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported the publication of two manuscripts furthering our understanding of heterogeneity in diffuse large B-cell lymphoma (DLBCL) (Press release, BostonGene, JAN 29, 2021, View Source [SID1234574426]). "A Probabilistic Classification Tool for Genetic Subtypes of Diffuse Large B Cell Lymphoma with Therapeutic Implications" was published in Cancer Cell while the Journal of Experimental Medicine published "Compromised Counterselection by FAS Creates an Aggressive Subtype of Germinal Center Lymphoma". The studies were completed in collaboration with researchers from the National Cancer Institute, part of the National Institutes of Health.

A Probabilistic Classification Tool for Genetic Subtypes of Diffuse Large B Cell Lymphoma with Therapeutic Implications – Cancer Cell

In this research study, the NCI team developed a probabilistic algorithm that classifies individual patient DLBCL into one of seven genetic subtypes. The novel DLBCL classification tool, termed LymphGen, promises significant clinical utility and applicability to precision oncology. BostonGene supported the NCI in this endeavor by conducting B-cell receptor (BCR) repertoire analysis in the different genetic subtypes of DLBCL to further uncover the underlying BCR-mediated signaling mechanisms distinct to each genetic subtype. Overall, analysis of the genetic subtypes highlight distinct vulnerabilities to targeted therapy, supporting the use of this classification in precision medicine trials.

"The classification of DLBCL into seven genetic subtypes that differ with respect to oncogenic pathway engagement, gene expression phenotype, immune microenvironment, survival rates, and potential therapeutic targets will ultimately aid in the development of targeted therapy for patients with DLBCL," said Louis M. Staudt, MD, PhD, National Cancer Institute.

"We are honored to support NCI in their work on understanding genetic features of DLBCL," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Ultimately, if a DLBCL genetic subtype is enriched for therapeutic responses, it could be used as a selection criterion for an expansion cohort in a subsequent clinical trial."

Compromised Counterselection by FAS Creates an Aggressive Subtype of Germinal Center Lymphoma – Journal of Experimental Medicine

The research study, led by NCI in collaboration with BostonGene, investigated the role of fas on germinal center (GC) B cells and fas mutations in DLBCL, identifying a unique DLBCL subgroup. Results showed that the absence of fas produced a strong cell-intrinsic survival advantage of GC B cells caused by decreased cell death in the light zone of the GC. Fas alterations occurred more commonly in GC-derived DLBCL and were associated with inferior survival of DLBCL patients and an altered tumor microenvironment (TME) enriched with T follicular helper (Tfh) cells. BostonGene provided insights into how fas-deficient DLBCL cells interact with the Tfh-enriched microenvironment, particularly through a co-deficiency with Herpes virus entry mediator (HVEM), a member of the tumor necrosis factor receptor superfamily. This work reveals that fas is a critical component involved in GC homeostasis, which may act as a molecular basis of differential responses to therapy observed in DLBCL patients.

"The results underscore the critical role of Fas in germinal center homeostasis and the importance of determining cell intrinsic and extrinsic factors to positively impact patient clinical outcomes," said Jagan R. Muppidi, MD, PhD at National Cancer Institute.

"The data published in the Journal of Experimental Medicine supports the need to fully understand the immune cell composition and spatial distribution of an altered TME," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "An integrated analysis into the architecture of the TME will improve treatment outcomes for individual DLBCL patients."