On September 23, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from an integrated safety analysis of UKONIQ (umbralisib), the Company’s inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory lymphoid malignancies in Blood Advances, a journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, TG Therapeutics, SEP 23, 2021, View Source [SID1234590247]).

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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, "We are pleased that the integrated safety analysis of 371 patients treated with UKONIQ has been published in Blood Advances. We believe these data further support the differentiated safety profile of UKONIQ, the first and only PI3k-delta and CK1-epsilon inhibitor, which is now commercially available to patients with relapsed or refractory marginal zone lymphoma and follicular lymphoma. As we strive toward obtaining FDA approval of the investigational combination of UKONIQ and ublituximab, U2, in CLL by the PDUFA goal date of March 25, 2022, furthering our understanding of the safety and tolerability profile of UKONIQ remains paramount to us."

Matthew S. Davids, MD, MMSc, lead author of the integrated safety study and Director of Clinical Research in the Division of Lymphoma at Dana-Farber Cancer Institute stated, "Historically, the use of PI3K-delta inhibitors has been limited by high discontinuation rates. The integrated safety data analysis of umbralisib published [today/yesterday] is encouraging for patients, especially given the low rate of discontinuations due to adverse events observed. Our analysis further underscores the potential role of umbralisib in the treatment of relapsed or refractory marginal zone and follicular lymphoma and may support the future utilization of umbralisib in combination therapies for patients with lymphoid malignancies."

The manuscript includes integrated comprehensive toxicity data from 4 open-label phase 1 and 2 studies that included 371 adult patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients with follicular lymphoma (n=147), marginal zone lymphoma (n=81), diffuse large B-cell lymphoma/mantle cell lymphoma (n=74), chronic lymphocytic leukemia (n=43) and other (n=25). All patients were treated with umbralisib at 800mg or higher once daily. At data cutoff, median duration of umbralisib treatment was 5.9 months (range, 0.1-75.1), and 107 patients (28.8%) received umbralisib for ≥12 months.

Key highlights from this manuscript include:

The most common grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (11.3%), diarrhea (7.3%), and increase aminotransferases (5.7%).
AEs of special interest were limited and included pneumonia in 29 patients (7.8%), noninfectious colitis in 9 patients (2.4%), and pneumonitis in 4 patients (1.1%).
Treatment-emergent serious AEs occurred in 95/371 patients (25.6%).
AEs led to discontinuation of umbralisib in 51 patients (13.7%).
No cumulative toxicity over time was observed.

These data are described further in the manuscript entitled, "Integrated safety analysis of umbralisib, a dual PI3Kδ/CK1ε inhibitor, in relapsed/refractory lymphoid malignancies," which was published online in Blood Advances. The online version of the article can be accessed at View Source

On September 23, 2021 Pfizer Inc. (NYSE: PFE) reported that its board of directors declared a 39-cent fourth-quarter 2021 dividend on the company’s common stock, payable December 6, 2021, to holders of the Common Stock of record at the close of business on November 5, 2021 (Press release, Pfizer, SEP 23, 2021, View Source [SID1234590244]). The fourth-quarter 2021 cash dividend will be the 332nd consecutive quarterly dividend paid by Pfizer.

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On September 23, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that management will present at the 2021 Cantor Virtual Global Healthcare Conference on September 29, 2021 at 3:20 p.m. EDT (Press release, IGM Biosciences, SEP 23, 2021, View Source [SID1234590243]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.

On September 23, 2021 DURECT Corporation (Nasdaq: DRRX) reported that Dr. James E. Brown, President and CEO, Michael H. Arenberg, Chief Financial Officer, Dr. Norman Sussman, Chief Medical Officer, and Dr. WeiQi Lin, Executive Vice President of R&D, will be participating in a fireside chat hosted by Kristen Kluska, Director, Equity Research Analyst at Cantor Fitzgerald (Press release, DURECT, SEP 23, 2021, https://investors.durect.com/news-releases/news-release-details/durect-corporation-fireside-chat-cantor-fitzgerald-global [SID1234590240]).

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Presentation details are as follows:

Cantor Fitzgerald Global Healthcare Conference 2021

Date:

September 28, 2021

Time:

2:40 P.M. to 3:10 P.M. Eastern Standard Time

Format:

Fireside chat hosted by Kristen Kluska

Webcast:

View Source

The webcast link of the presentation will also be available by accessing DURECT’s homepage at www.durect.com and clicking on "Event Calendar" under the "Investors" section.

Management will also be available for virtual 1×1 meetings during the conference. If you would like to request a meeting, please contact Cantor Fitzgerald directly.

On September 23, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, reported that it has entered into a definitive agreement with Incyte Biosciences International Sàrl, the Swiss-based affiliate of Incyte (NASDAQ:INCY), for the exclusive rights to distribute tafasitamab (sold as Monjuvi in the United States and Minjuvi in Europe) and pemigatinib (Pemazyre) in Latin America (Press release, Knight Therapeutics, SEP 23, 2021, View Source [SID1234590239]). Under the terms of the agreement, Incyte will be responsible for the development, manufacture and supply to Knight of tafasitamab and pemigatinib, and Knight will be responsible for seeking the necessary regulatory approvals and distributing both medicines in Latin America.

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Tafasitamab in combination with lenalidomide is approved in the United States and Europe for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). DLBCL is the most common type of non-Hodgkin lymphoma, and there are approximately 12,000 – 16,000 new cases of DLBCL each year in Latin America1,2.

Pemigatinib is approved in the United States, Europe and Japan for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Cholangiocarcinoma is the most common cancer of the bile duct. FGFR2 fusions or rearrangements have been observed in 10-16%3 of patients with intrahepatic cholangiocarcinoma, whereas the incidence in patients with extrahepatic cholangiocarcinoma is rare. There are approximately 4,000 – 6,000 new cases of intrahepatic cholangiocarcinoma each year in Latin America1,4.

"We are delighted to partner with Incyte, a leading global biopharmaceutical company, to bring tafasitamab and pemigatinib to patients in Latin America upon approval," said Samira Sakhia, President and Chief Executive Officer of Knight. "Both products will strengthen and complement our oncology portfolio and will play a key role in the management of diseases with high unmet need."

"In Knight, we have found a partner with an extensive track record of successful partnerships and strong distribution capabilities," said Hervé Hoppenot, Chief Executive Officer of Incyte. "We are eager to work together to expand access to tafasitamab and pemigatinib so that eligible patients in Latin America have access to these innovative medicines."

About Tafasitamab

Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S., and marketed by Incyte under the brand name Minjuvi in the EU.

XmAb is a registered trademark of Xencor, Inc.

About Pemigatinib

Pemigatinib (Pemazyre) is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test5. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States, Europe and Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

Pemazyre is a trademark of Incyte.