On May 25, 2022 InnoCare Pharma (HKEX: 09969) reported that it has received approval to conduct a single-arm, open-label, multicenter phase II clinical trial evaluating the safety and efficacy of tafasitamab in combination with lenalidomide by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) (Press release, InnoCare Pharma, MAY 25, 2022, View Source [SID1234615046]).

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Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, which is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Tafasitimab is not approved by the NMPA for any indication.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "We will make every effort to accelerate the clinical development of tafasitamab in combination with lenalidomide to help address the unmet needs of DLBCL patients in China."

Tafasitamab (Monjuvi) is co-commercialized by Incyte and MorphoSys in the United States and by Incyte under the brand name Minjuvi in the EU. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globallyi. In China, DLBCL accounts for 45.8% of all NHLsi.

About Tafasitamab

Tafasitamab is a humanized monoclonal antibody targeting CD19.

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 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 ASCT. This indication is approved under accelerated approval based on overall response rate. Full approval for this indication may be contingent upon results 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.

Tafasitamab is not approved for use in China except for in the Boao Lecheng International Medical Tourism Pilot Zone through an early access program.

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. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

XmAb is a registered trademark of Xencor, Inc.

On May 25, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported that members of its executive team will participate in the following upcoming investor conferences (Press release, Aura Biosciences, MAY 25, 2022, View Source [SID1234615045]):

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Cowen’s Virtual 3rd Annual Oncology Innovation Summit on Thursday, June 2, 2022. Fireside chat at 9:00 a.m. ET.
Jefferies Global Healthcare Conference at the New York Marriot Marquis on Wednesday, June 8, 2022. Presentation at 1:30 p.m. ET.
A live webcast of the Cowen fireside chat and Jefferies presentation will be available on the "Investors & Media" page under the "Events & Presentations" section of the Company’s website at View Source, where a replay of the webcast will be archived for 90 days following the presentation date.

On May 25, 2022 Endeavor BioMedicines, a clinical-stage biotechnology company targeting the core drivers of terminal diseases including oncology and fibrosis, reported the first patient has been dosed in an open-label Phase 2 study evaluating ENV-101 (taladegib) in patients with advanced solid tumors harboring Patched-1 (PTCH1) loss of function mutations (Press release, Endeavor BioMedicines, MAY 25, 2022, View Source [SID1234615044]).

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"Dosing the first patient in the Phase 2 study of ENV-101 is a critical step for advancing medicines that treat cancer by attacking the genetic cause of disease," said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor BioMedicines. "The clinical effects of ENV-101, a small molecule inhibitor of the Hedgehog signaling pathway for the treatment of cancer have been evaluated in nearly 200 participants so far. ENV-101 has so far demonstrated exceptional ability to inhibit this oncogenic pathway and induce regression of tumors dependent on it. We hope this trajectory will continue as the drug advances through this next stage of clinical development."

The multi-center study employs a two-stage design to evaluate the efficacy and safety of ENV-101, a potent Hedgehog (Hh) pathway inhibitor, in patients with histologically or cytologically confirmed refractory advanced solid tumors characterized by loss of function (LOF) mutations in the PTCH1 gene. Endeavor expects to enroll 44 adults who are 18 and older in the first part of the study. Patients will receive 200 mg of ENV-101 once a day in one arm of the trial, and 300 mg of ENV-101 once a day in the other arm. The primary endpoint of the trial is Objective Response Rate (ORR) – comprised of Complete Response (CR) and Partial Response (PR), measured by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) – as determined by an independent review through study completion. Confirmed CR or PR will be defined as a repeat assessment performed no less than 28 days after the criteria for response is first met.

Dr. Christopher Vaughn, M.D., Oncologist at Hematology Oncology Associates of Fredericksburg (HOAF) in Virginia, stated, "It is wonderful and exciting to bring potentially landscape-changing new therapeutic advances to our patient community. I fully appreciate the collaboration and support between the Endeavor team and HOAF’s research department. The Endeavor trial embodies the model for individualized therapy and for potentially better response rates with limited side effects for our patients."

"ENV-101 is for patients with tumor mutations in the Hedgehog pathway, which affect approximately 2% of all cancers, amounting to roughly 30,000-40,000 patients annually in the U.S. alone," said Dr. Srikanth Pendyala, Chief Medical Officer, Endeavor Biomedicines. "Mutations in this pathway can aberrantly activate downstream signaling resulting in proliferation, survival and metastasis of cancer cells. ENV-101 is intended to inhibit the activity of the Hedgehog pathway which may significantly benefit the lives of cancer patients with these mutations."

ENV-101: Targeting the Hedgehog Signaling Pathway in Oncology and Fibrosis

ENV-101 (taladegib), an orally available small molecule inhibitor of the Hedgehog signaling pathway, has already demonstrated preliminary clinical efficacy and safety in nearly 200 subjects enrolled across six completed studies. Initially targeted for a broad group of patients with basal cell carcinoma (BCC), Endeavor is now investigating precision therapy approaches for ENV-101 in multiple types of cancers driven by oncogenic driver mutations in PTCH1, as well as in idiopathic pulmonary fibrosis (IPF).

PTCH1 oncogenic driver mutations in the Hedgehog signaling pathway are found in approximately 2% of all cancers. Because of its prevalence across multiple types of cancer, Endeavor plans to enroll patients in a tumor agnostic study that includes any patient with oncogenic hedgehog mutations irrespective of tissue of origin. Endeavor is currently enrolling patients in an open label Phase 2 clinical trial in oncology (www.clinicaltrials.gov identifier NCT05199584).

For more information about our clinical trial please contact us at: [email protected] or call us at 858-727-3199.

On May 25, 2022 SunRock Biopharma S.L. ("SunRock"), a biopharmaceutical company that is developing a portfolio of innovative bispecific antibodies to treat incurable cancer, and Ellipses Pharma Limited ("Ellipses"), a global drug development company focused on accelerating the development of new oncology treatments, reported that they have entered into an exclusive licensing agreement for SRB22, a fully human bifunctional HER3:TRAIL fusion protein, which going forward will be known as EP0017 (Press release, Ellipses Pharma, MAY 25, 2022, View Source [SID1234615043]).

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Under the agreement, Ellipses has been granted global rights to develop and commercialise EP0017 and will assume the full cost and responsibility for the remaining pre-clinical and clinical development of the compound. In line with its strategy, Ellipses intends to out licence EP0017 for commercialisation if it proves safe and effective in clinical trials. SunRock will continue to be involved in the development of EP0017 to ensure efficient translational activities through a service agreement with Ellipses. If Ellipses out-licences EP0017, SunRock will also receive milestone payments and royalties.

EP0017 is a first-in-class bifunctional fusion protein with a dual mechanism of action. It selectively targets HER3, which is overexpressed in several different tumour types, and additionally, binds to the tumour death receptors DR4 and DR5, inducing tumour cell death. Promising data has been generated in a range of preclinical models that demonstrate the potential of EP0017.

Laureano Simón, Ph.D., CEO of SunRock Biopharma, said
"The agreement with Ellipses will speed up the development of EP0017, moving this potentially life-changing asset towards the clinic and then hopefully towards cancer patients who desperately need novel approaches to fight invasive tumours."

Rajan Jethwa, MD, CEO of Ellipses Pharma commented:
"Our mission is to rapidly develop innovative cancer therapies, to get these therapies into the clinic as quickly as possible and potentially save more lives. We are excited about the opportunity to progress the development of this promising asset and look forward to working with SunRock to expedite the preclinical work."

On May 25, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and the Vall d’Hebron Institute of Oncology (VHIO), one of Europe’s leading cancer research organizations, reported that the first blood-based cancer testing services in Europe based on Guardant Health’s industry-leading digital sequencing platform are now available at the VHIO liquid biopsy testing facility in Barcelona (Press release, Guardant Health, MAY 25, 2022, View Source [SID1234615042]).

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Guardant Health and VHIO established the partnership in January 2021 to give more patients access to Guardant Health’s industry leading liquid biopsy technology. This testing service will provide essential genomic information through comprehensive genomic profiling (CGP) for patients with any solid cancerous tumor. From a simple blood draw, the test identifies patients with actionable biomarkers more quickly than starting with tissue biopsy. The VHIO testing services will be available for clinical research and clinical care.

"The opening of this service will give more patients with advanced cancer access to blood-based biomarker testing and help their healthcare professionals make more informed treatment decisions," said Helmy Eltoukhy, Guardant Health co-CEO. "We look forward to continuing to build our partnership with VHIO, working together to ensure cancer patients across Spain and beyond have access to the latest innovations in precision oncology and striving to achieve better patient outcomes."

"The incorporation of this technology in VHIO will enable us to continue advancing towards precision medicine, improving the use of liquid biopsy to detect genomic alterations in tumors and come out with more effective treatments for patients," said Dr Josep Tabernero, Director of VHIO and Head of the Medical Oncology Department of Vall d’Hebron University Hospital. "Our goal is to ensure that the use of liquid biopsy becomes a common diagnostic option, so that oncologists can use it to determine the best treatment for their patients. Thanks to this agreement, we can move towards this scenario."

"Implementing this technology in our lab is a leap forward in the liquid field for us. We have performed an in-house extensive analytical validation of the assay and we attain very high levels of sensitivity and specificity with the test," said Dr Ana Vivancos, Group Leader of the VHIO Cancer Genomics Group, where this testing will take place. "Guardant Health’s next generation broad panel sequencing technology gives us the capabilities to screen for a large number of gene mutations and provides complete genomic results without the need for a tissue sample."

In 2020, there were over 282,000 new cancer cases in Spain and approximately 113,000 cancer deaths, with lung cancer and colon cancer being the leading causes of cancer-related death.1 Guardant Health’s tests are used by oncologists around the world to guide treatment decisions across solid tumor cancers, and by pharmaceutical companies and academic researchers in clinical trials to accelerate precision medicine drug development.