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.

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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.

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.

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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.

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.

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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.

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.

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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."

On January 29, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that interim results from the ongoing SUMMIT trial of neratinib in the cohort of metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor (EGFR) exon 18 mutations who have been previously treated with an EGFR targeted tyrosine kinase inhibitor (TKI) (Press release, Puma Biotechnology, JAN 29, 2021, View Source [SID1234574425]). The data were presented in an oral discussion at the 2020 World Conference on Lung Cancer (WCLC 2020) presented by the International Association for the Study of Lung Cancer (IASLC) that is currently taking place in Singapore. The presentation, entitled, "Neratinib in Pretreated EGFR Exon 18-Mutated Non-Small Cell Lung Cancer (NSCLC): Initial Findings from the SUMMIT Basket Trial," is being presented at an Oral Session by Valentina Boni, MD, PhD, START Madrid-CIOCC, Centro Oncologico Clara Campal, HM Sanchinarro.

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The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR exon 18 or HER2 mutations. In the EGFR exon 18 mutation cohort, patients with lung cancer with single or complex EGFR exon 18 mutations, who were EGFR TKI naïve or were previously exposed to EGFR TKI, were enrolled into this study and received 240 mg of neratinib daily as a single agent.

In this cohort of 11, patients had received a median of 2 prior lines of therapy in the metastatic setting (range 1-3 prior regimens) before entering the trial. 10 patients had been previously treated with an EGFR targeted tyrosine kinase inhibitor (gefitinib, erlotinib, osimertinib and/or afatinib).

The interim efficacy results from the trial showed that for the 10 evaluable patients who had previously been treated with an EGFR tyrosine kinase inhibitor, 6 patients (60%) experienced a partial response, which included 4 patients (40%) with a confirmed partial response. 8 patients (80%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 16 weeks). The median duration of response was 7.5 months and the median progression-free survival was 9.1 months. The success criteria for both the 1st stage and the 2nd stage of the Simon’s 2-stage design were met and enrollment in the 2nd stage of this cohort continues.

The safety profile observed in the subgroup of patients with EGFR exon 18-mutated NSCLC showed that for the 11 patients who received neratinib in the trial, there were no reports of grade 3 or higher diarrhea. 4 patients (36%) reported grade 1 and 1 patient (9%) reported grade 2 diarrhea. No patients required a dose hold, dose reduction, hospitalization or permanently discontinued neratinib due to diarrhea.

Dr. Boni, an investigator of the trial, said, "We are very excited about these early study results in EGFR exon 18 mutant lung cancer, for whom very few effective treatment options are available once they fail first-line FDA approved EGFR TKI therapy."

Jonathan Goldman, MD, Associate Professor of Hematology & Oncology, Associate Director of Drug Development, and Director of Clinical Trials in Thoracic Oncology at UCLA, said, "These early study results open up a potentially effective option for EGFR exon 18 mutation-positive NSCLC patients once they fail first-line FDA approved TKI therapy."

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are pleased to present this data at the World Conference on Lung Cancer and increase the awareness of neratinib’s activity in this patient population within the lung cancer community. We are continuing to enroll this cohort of patients in the SUMMIT trial and we continue to believe that there is a need for new treatments for patients with EGFR exon 18-mutated NSCLC who have previously been treated with EGFR targeted tyrosine kinase inhibitors."