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.

On September 23, 2021 Immunocore Holdings Plc (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, reported that data from a phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator’s choice in first-line metastatic uveal melanoma (mUM) has been published in The New England Journal of Medicine (NEJM) (Press release, Immunocore, SEP 23, 2021, View Source [SID1234590238]).

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The paper concluded that tebentafusp is the first systemic treatment to show a survival benefit in mUM and should become a new treatment option for this poor prognosis disease.

"The publication of these phase 3 data in a leading peer-reviewed scientific publication like NEJM demonstrates the significance of Immunocore’s work in the field of TCR therapy," said Bahija Jallal, Chief Executive Officer of Immunocore. "This further validates the potential of tebentafusp to provide a much needed treatment option for patients with metastatic uveal melanoma, making a meaningful difference to patients’ lives. In addition, we believe these data show the broader potential of Immunocore’s TCR technology for the treatment of other solid tumors."

Results from the randomized, open-label, phase 3 trial of tebentafusp vs. investigator’s choice in previously untreated HLA-A*02:01-positive patients with mUM demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Treatment-related adverse events were manageable and consistent with the proposed mechanism.

Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore’s biologics license application for approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma was recently accepted by the FDA. In addition, the European Medicine Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) accepted Immunocore’s Marketing Authorisation Application (MAA).

On September 23, 2021 Allarity Therapeutics A/S, a clinical-stage precision medicine company actively advancing a pipeline of in-licensed oncology therapeutics for patients with difficult-to-treat cancers, and Lonza, a CDMO partner to the biopharma industry, reported an agreement to develop and manufacture dovitinib (Press release, Allarity Therapeutics, SEP 23, 2021, View Source [SID1234590237]). The agreement aims to commence manufacturing of dovitinib in 2022 to meet Allarity’s projected needs for bringing dovitinib to market following anticipated regulatory approvals.

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Dovitinib represents Allarity’s most advanced clinical asset, targeting metastatic renal cell carcinoma (RCC) with possible use in other indications, such as liver cancer, breast cancer and various solid tumors. This pan-tyrosine kinase inhibitor targets fibroblast growth factor receptor, vascular endothelial growth factor receptor and other receptor tyrosine kinases.

Steve Carchedi, CEO, Allarity commented: "Entering this agreement with Lonza is an important step in our long-term preparations to take dovitinib towards commercialization. Allarity now has a robust agreement covering the production and ongoing supply of dovitinib that we will need in the years to come."

Under the terms of the agreement, Lonza will leverage its capabilities for commercial manufacturing of small-molecules and oral solid dosage forms to provide Allarity with cGMP compliant drug product supply and regulatory support towards commercialization. Allarity will leverage Lonza’s global network, technical capabilities, and integrated solution covering both drug substance and drug product. The drug substance manufacturing and particle size reduction by micronization will be performed at Lonza’s facility in Visp (CH). The drug product manufacturing will take place at the Tampa, FL (US) facility.

Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules, Lonza, added: "Our collaboration with Allarity Therapeutics demonstrates our commitment to supporting companies with their development pipeline. Our unique and comprehensive set of capabilities supporting drug substance through to drug product development and manufacturing enable Allarity to focus on dovitinib commercialization."

On September 23, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported that Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm, will present at the Cantor Fitzgerald Virtual Global Healthcare Conference taking place September 27-30, 2021 (Press release, KemPharm, SEP 23, 2021, View Source [SID1234590236]). The live presentation will be available via webcast from the conference’s virtual platform.

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Details of the presentation are as follows:

Event: Cantor Fitzgerald Virtual Global Healthcare Conference
Date: September 28, 2021
Time: 1:20 p.m., ET
Webcast: View Source
Dr. Mickle and members of the KemPharm management team will host virtual one-on-one meetings with registered investors and pharmaceutical company executives. Investors may register for the event by using the webcast link provided above, or by contacting their Cantor Fitzgerald sales representative.

Following the conclusion of the event, a recording of Dr. Mickle’s presentation will be available under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source

On September 23, 2021 VaxEquity, developing transformative RNA vaccines and therapeutics based on its next generation self-amplifying RNA (saRNA) platform originating from Imperial College London, reported a collaboration with AstraZeneca to progress the company’s platform technology through proof of concept to enable the development of multiple products (Press release, AstraZeneca, SEP 23, 2021, View Source [SID1234590235]). VaxEquity could receive development, approval and sales-based milestones totalling up to $195 million and royalties in the mid-single digits per drug target. VaxEquity also received an upfront equity investment from AstraZeneca and global life sciences investor Morningside Ventures.

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The strategic, long-term research collaboration with AstraZeneca aims to optimise and validate VaxEquity’s saRNA platform and apply it to advance novel therapeutic programmes. AstraZeneca will support VaxEquity with research and development funding and has the option to collaborate with VaxEquity on up to 26 drug targets. VaxEquity’s modified saRNA platform uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level.

Michael Watson, Executive Chairman of VaxEquity, said, "We are delighted to collaborate with AstraZeneca given its strong track record in innovation and welcome them as a new investor. We are also grateful for the ongoing support of our existing investor, Morningside Group. With our self-amplifying RNA platform, we aim to underpin the next generation of RNA-delivered medicines enabling not only vaccines but also broad range of therapeutic applications."

Professor Robin Shattock, Head of Immunology of Infection within the Department of Infectious Diseases at Imperial College London, and co-founder of VaxEquity, said, "We have all seen how technologies based around RNA have been fundamental to preventing ongoing severe disease and death in major global pandemics. The prospect of further therapeutic applications adds to this technology’s great potential."

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca, said "This collaboration with VaxEquity adds a promising new platform to our drug discovery toolbox. We believe self-amplifying RNA, once optimised, will allow us to target novel pathways not amenable to traditional drug discovery across our therapy areas of interest."

Professor Alice Gast, President of Imperial College London, said: "I am deeply proud of my colleagues’ work in pioneering self-amplifying RNA technology. This collaboration will help realise our ambition of building a lasting legacy from the great scientific advances Imperial made in this pandemic."

The proprietary, flexible platform enables the simultaneous expression of a broad range of targets and immunomodulatory proteins that can be rapidly produced and delivered at scale. Using saRNA, rather than mRNA, means that a lower (1/3 to 1/10th) dose of RNA is required to provide greatly enhanced protein expression as the RNA replicates for longer post-administration. VaxEquity modifies the RNA to include elements (called ‘Innate Inhibitory Proteins’ or IIPs) that finely tune the innate immune response (based on interferons) preventing suppression of RNA replication and thereby maximizing protein expression by saRNA.

As part of this investment and collaboration, Tyrell Rivers and Anders Holmén from AstraZeneca will join VaxEquity’s Board as Investor Directors. Will West and Jason Dinges will represent Morningside. Charles Mallo will represent Imperial. Robin Shattock will remain on the Board, while Michael Watson will assume the role of Executive Chair.