On June 25, 2021 Alphageneron Pharmaceuticals, Inc. ("Alphageneron" or the "Company"), a privately-held clinical-stage biopharmaceutical company developing autologous and allogeneic Natural Killer (NK) cellular and antibody therapeutics reported that Robert Brooks, JD, founder and Chief Executive Officer of Alphageneron, will participate in the ROTH Healthcare Private Company Forum to be hosted virtually on Monday, June 28, 2021 (Press release, Alphageneron Pharmaceuticals, JUN 25, 2021, View Source [SID1234584647]).

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Alphageneron’s CEO, Robert Brooks will speak on the Cancer Panel 2, entitled "Natural Killer Cell Approaches To Eradicate Tumors," as one of the presenting companies on the panel with "proof of concept" data utilizing NK cells against solid tumors. Mr. Brooks, will discuss a prior completed Phase IIa Clinical Trial with Advanced non-small lung cancer (NSCLC) patients, receiving autologous Hsp70 targeted NK Cell therapy (ENKASTIM), after radio-chemotherapy, in Germany. The Company is planning a Phase IIa Clinical Combination Trial with Advanced NSCLC patients receiving ENKASTIM and PD (L)-1 checkpoint inhibitors, after Standard of Care, in the United States. Alphageneron is also planning a Phase I clinical Combination trial with Metastatic Colorectal cancer with allogeneic donor genetically edited NK cell therapy, (ANKASTIM) in the United States.

Date: Monday January 28, 2021
Time: 12pm-1pm EDT

On June 25, 2021 Cambridge start-up Lucida Medical has reported that it has joined the Edison Accelerator, a programme designed by GE Healthcare in partnership with innovation organisation Wayra UK, to support early-stage and technologically advanced businesses developing AI applications for healthcare (Press release, GE Healthcare, JUN 25, 2021, View Source [SID1234584375]).

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Participation in the Edison Accelerator programme is a major advance towards Lucida Medical’s goal to disrupt the cancer diagnostic pathway with technology that finds prostate cancer more accurately by analysing MRI, enabling radiologists to save time and patients to receive the best possible diagnosis and treatment.

Prostate cancer is the most common cancer in men in Europe, Africa and North and South America, with 1.4 million diagnosed worldwide each year and 375,000 deaths. Earlier and better detection saves lives.

The Edison Accelerator creates a collaborative environment for start-ups, research centres, hospitals, clinicians and large corporations across the EMEA region. It aims to foster open innovation and digital transformation of healthcare.

Lucida Medical was invited to join the Edison Accelerator programme for its pioneering work in helping identify prostate cancer and its exceptional development team led by Prof Evis Sala and Dr Antony Rix, both highly experienced in artificial intelligence, or AI, medical technology.

In joining the Edison Accelerator programme, Lucida Medical will:

Receive mentoring on problem validation, business, regulatory and clinical validation, and deployment.
Participate in joint pilots between start-up and healthcare partners.
Access support in customer discovery and product validation.
Access support in adapting, integrating and launching solutions on the Edison marketplace.
Access GE Healthcare global commercial force and customers in various markets.
Receive support for clinical studies and regulatory preparation in target geographies.
Catherine Estrampes, President and CEO, Europe, Middle East & Africa, GE Healthcare, said: "The future of innovation will be about working across silos and collaborating across the healthcare ecosystem, including start-ups, research centres, hospitals and clinicians. The Edison Accelerator brings together leading technology providers, developers and academic institutions under a single, connected ecosystem to create real impact from the bottom line to better patient outcomes."

Dr Antony Rix, CEO and Co-founder, said: "That Lucida Medical has been chosen to join the prestigious Edison Accelerator programme is both a demonstration of confidence in the technology and our team. This development comes soon after our Prostate Intelligence technology received a CE mark. The support of GE Healthcare and Wayra will help us develop further our technology and access new partners and markets."

Co-founder and Chief Medical Officer Prof Evis Sala, Professor of Oncological Imaging at the University of Cambridge, said: "We are tremendously excited by our ability to support radiologists to detect cancer accurately and early. The Edison Accelerator programme will now help us bring our technology into clinical use."

XTX Ventures, the venture capital arm of XTX Markets, provided Lucida Medical with early-stage investment capital from a group of investors in March 2021.

On June 25, 2021 InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported that China’s National Medical Products Administration (NMPA) has approved the initiation of a Phase I clinical trial of ICP-033, the Company’s novel RTK (Receptor Tyrosine Kinase) inhibitor and its sixth innovative drug to enter clinical development (Press release, InnoCare Pharma, JUN 25, 2021, View Source [SID1234584376]).

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As a novel multi-target RTK inhibitor, ICP-033 is designed to selectively inhibit discoid domain receptor 1/2 (DDR1/2), vascular endothelial growth factor receptor 2/3 (VEGFR 2 /3) and platelet-derived growth factor receptor (PDGFR α/β). Through multiple synergistic mechanisms targeting endothelial cells, pericytes and stroma, ICP-033 can potentially inhibit angiogenesis and tumor cell invasion, normalize abnormal blood vessels, and reverse the immunosuppressive state of the tumor microenvironment for improved anti-tumor effects.

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnnoCare, said, "ICP-033 is our second drug approved for clinical trial this year, and it will further enrich our product pipeline in the field of solid tumors and potentially provide another treatment option for cancer patients worldwide."

ICP-033 will be used potentially as monotherapy and/or in combination with immunotherapy and other targeted therapy drugs to treat liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors.

On June 25, 2021 InxMed (Shanghai) Co., Ltd. ("InxMed" or "Company"), a clinical stage biotech company dedicated to developing innovative, individualized medicines with international impact, reported one study in collaboration with Ruijin Hospital, Shanghai Jiaotong University School of Medicine made an online publication on Advanced Science titled "Focal Adhesion Kinase (FAK) Inhibition Synergizes with KRAS G12C Inhibitors in Treating Cancer through the Regulation of the FAK–YAP Signaling" (Press release, InxMed, JUN 25, 2021, View Source [SID1234584377]). This study demonstrated that cancer cells under the effect of KRAS G12C inhibition induce sustained activation of focal adhesive kinase (FAK) leading to its drug resistance and showed that a combination therapy comprising KRAS G12C inhibition and a FAK inhibitor (IN10018) achieves synergistic anticancer effects with multiple in vitro and in vivo models. It can simultaneously reduce the extent of drug resistance to improve treatment outcomes of KRAS G12C inhibitors.

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FAK is one of the downstream targets of KRAS. Its inhibition is effective against KRAS mutant cancers preclinically. FAK activation is closely related to drug resistance of chemotherapies and targeted therapies. This study elucidated that the sustained hyperactivity of FAK signaling induces the drug resistance KRAS G12C inhibition. Diverse CDX and PDX models of KRAS G12C mutant cancers were tested and synergistic benefits from the combination therapy of KRAS G12C inhibitors (AMG510 or MRTX849) and FAK inhibitor (IN10018) were consistently observed. Mechanistically, it is found that aberrant FAK–YAP signaling leading to the development of KRAS G12C inhibitor resistance. This study provides an innovative combination therapy strategy to improve treatment outcomes for KRAS G12C mutant cancers.

Dr. Zaiqi Wang, InxMed’s Chairman and CEO, said "This study showed that FAK inhibitor (IN10018) overcomes drug resistance of KRAS G12C inhibitors and provides a potential innovative combination therapy to improve treatment outcomes for KRAS G12C mutant cancers. FAK inhibitor (IN10018) has performed three clinical trials in United States, Australia and China which showed IN10018 with good safety tolerance and antitumor effects. InxMed will fully develop on translational medicine research and global clinical trial organization capabilities to resolve the problem of unmet needs from clinics and eventually benefit patients by providing efficient treatment options."

About IN10018

IN10018, formerly known as BI853520, is a potent and selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor under clinical development stage in United States, Australia, and China. InxMed owns the exclusive global rights for development and commercialization. Early clinical data of IN10018 has demonstrated a favorable safety profile and promising efficacy signals against a number of tumor types. Emerging science also showed that FAK inhibitors, like IN10018, potentially overcomes fibrotic barrier and immune tolerance, boosting multi-modalities including targeted therapy, chemotherapy, immune-therapy and radiation therapy.

On June 25, 2021 MorphoSys AG (FSE: MOR; NASDAQ: MOR) and Incyte (NASDAQ: INCY) reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab 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 transplantation (ASCT) (Press release, MorphoSys, JUN 25, 2021, View Source [SID1234584363]).

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"The CHMP’s positive opinion of tafasitamab is a pivotal step towards addressing an urgent unmet medical need for the 30-40% of patients with relapsed or refractory DLBCL who do not respond to initial therapy or relapse thereafter," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Following the U.S. FDA’s approval of tafasitamab in July 2020, we eagerly await the European Commission’s decision as we look forward to bringing this new therapy to eligible patients in Europe as soon as possible."

"Tafasitamab in combination with lenalidomide represents an important new targeted treatment option for patients with relapsed or refractory DLBCL," said Dr. Malte Peters, Chief Research & Development Officer, MorphoSys. "Patients with relapsed or refractory DLBCL have limited treatment options and often face a poor prognosis. There is an urgent need for effective therapies and if approved, this combination could provide patients in Europe with an important new therapeutic option."

The CHMP opinion to recommend the use of tafasitamab is now being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union (EU). If approved, tafasitamab would be commercialized in the EU under the brand name Minjuvi.

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide comprising 40% of all cases1 and characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs.2 It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.3 In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL.4,5,6

MorphoSys and Incyte share global development rights to tafasitamab and Incyte has exclusive commercialization rights to tafasitamab outside the United States. MorphoSys and Incyte co-commercialize tafasitamab under the brand name Monjuvi in the United States.

About L-MIND

The L-MIND trial is a single arm, open-label Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g., rituximab), who are not eligible for high-dose chemotherapy (HCD) or autologous stem cell transplant (ASCT). The study’s primary endpoint is overall response rate (ORR). Secondary outcome measures include duration of response (DoR), progression-free survival (PFS) and overall survival (OS). The study reached its primary completion in May 2019.

For more information about L-MIND, visit View Source

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).

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).

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 marketed under the brand name Monjuvi in the US. If approved in the EU, tafasitamab will be marketed under the brand name Minjuvi.

XmAb is a registered trademark of Xencor, Inc.