On July 15, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported the appointment of Dr. Joyson Karakunnel as Executive Vice President and Chief Medical Officer (CMO) (Press release, Innate Pharma, JUL 15, 2020, View Source [SID1234561930]). Dr. Pierre Dodion, CMO since 2014, is retiring from this position.

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Dr. Karakunnel comes to the Company with deep experience in immuno-oncology, and a proven track record in drug development. As CMO, he will be responsible for advancing Innate’s clinical pipeline and will lead a global team focused on clinical strategy, patient safety, regulatory and medical affairs.

Most recently, Dr. Karakunnel served as CMO and Senior Vice President at Tizona Therapeutics, where he led the development of the company’s biotherapeutics pipeline. Prior to Tizona, he held positions with Arcus Biosciences and AstraZeneca/MedImmune; his collective responsibilities included leading clinical development activities, drug safety and regulatory affairs. In addition, he serves as a medical advisor at the Parker Institute for Cancer Immunotherapy.

"We are pleased to welcome Dr. Joyson Karakunnel as our new Chief Medical Officer. As an experienced medical oncologist, Joyson brings in-depth immunology, oncology and hematology expertise, which will help further strengthen and accelerate the delivery of new medicines to patients," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "We are also grateful for Pierre’s invaluable contributions. During his six years at Innate, he drove the advancement of several key assets to late-stage clinical development, which will have a lasting impact on the Company."

Dr. Dodion joined Innate in 2014 and has been instrumental in the Company’s clinical strategy, successfully advancing key oncology programs to late-stage status. He has led the clinical development of several therapeutic programs, including monalizumab, a potentially first-in-class immune checkpoint inhibitor, and lacutamab, a first-in-class antibody designed for the treatment of advanced T-cell lymphomas. Dr. Dodion will transition to a consulting role with Innate following his retirement.

Dr. Joyson Karakunnel
Adding to his track record in oncology and hematology drug development, Dr. Karakunnel also served as a clinical trial investigator at the National Cancer Institute and a team leader for the hematologic group at Walter Reed National Military Medical Center. In addition, he was an associate professor at the Uniformed Services University of the Health Sciences and a medical reviewer at the U.S. Food and Drug Administration.

"I’m proud to join Innate at this exciting juncture with several molecules moving into late-stage development, new molecules moving into the clinic and novel indications being pursued in oncology as well as for COVID-19," said Joyson Karakunnel, Chief Medical Officer of Innate Pharma. "This is clearly a company with a robust pipeline and unique focus on the innate immune system, which complements the work I’ve done in both the academic and industry settings. I look forward to further advancing the innovative science with the talented scientists and clinicians at the Company."

Dr. Karakunnel completed fellowships in hematology and oncology at the National Cancer Institute and completed his internal medicine residency at the University of Medicine and Dentistry of New Jersey, where he was chief resident. He obtained his MD from Annamalai University in India, and also holds a MSc in pharmacology from the University of Maryland.

Dr. Karakunnel will be based in Innate’s Rockville, Maryland office.

On July 15, 2020 ESSA Pharma Inc. (Nasdaq: EPIX) (TSXV: EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported the first patient dosed in a Phase 1 clinical trial designed to demonstrate the safety and tolerability of EPI-7386 in metastatic castration-resistant prostate cancer ("mCRPC") patients who failed standard of care treatments, including second generation anti-androgens (Press release, ESSA, JUL 15, 2020, View Source [SID1234561892]). EPI-7386 is a small molecule inhibitor of the N-terminal domain of the androgen receptor (AR) which has shown preclinical activity in both anti-androgen sensitive and anti-androgen resistant prostate cancer models.

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"The initiation of this study represents a significant milestone for ESSA as it brings us a step closer to offering a potentially meaningful new therapeutic option to prostate cancer patients," said Dr. David Parkinson MD, Chief Executive Officer of ESSA. "The fact that EPI-7386 was first synthesized less than two years ago and yesterday began dosing in patients is a testament to the efficiency of our team and our collaborators". Dr. Parkinson continued, "The results from this trial will guide our future development plans and confirm the potential contribution of N-terminal domain AR inhibition to the treatment of prostate cancer".

The Phase 1 clinical trial (NCT04421222) expects to enroll approximately 18 mCRPC patients in the dose escalation part of the study at selected clinical sites in the United States and Canada, with an additional ten patients planned to be enrolled in a dose expansion cohort involving additional clinical sites. The study will evaluate the safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy.

On July 15, 2020 Terumo Corporation (TSE: 4543) reported it has completed the acquisition of Quirem Medical B.V., a Netherlands-based healthcare startup specializing in the development of next-generation microspheres for Selective Internal Radiation Therapy (SIRT), a treatment for liver tumors (Press release, Terumo, JUL 15, 2020, View Source [SID1234561890]). Under the terms of the agreement, Terumo acquired 80.1% of the shares of Quirem Medical. This is over and above its current share position of 19.9%, making Quirem Medical now a wholly owned subsidiary of Terumo.

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Terumo will make a one-time, up-front payment of USD 20 million with up to USD 25 million additional payments based on the achievement of future milestones by 2030. It will be funded through cash on hand and will not significantly impact the company’s financial projections for the current fiscal year ending March 31, 2021.

Quirem Medical has developed and manufactures QuiremSpheres, the only commercially available microspheres containing the radioactive isotope Holmium-166. Recent trials have shown the safety and efficacy of holmium microspheres for the treatment of unresectable liver cancer. To improve patient selection, therapy planning and treatment verification, QuiremSpheres can be visualized and quantified even in low concentrations by means of Single-Photon Emission Computed Tomography (SPECT) and Magnetic Resonance Imaging (MRI). This is unique and cannot be done with currently available Yttrium-90 based microspheres.

Furthermore, Quirem Medical also produces QuiremScout, a low dose holmium microsphere that helps evaluate the biodistribution of microspheres prior to therapy, and a dosimetry software package, Q-Suite, which is used to plan QuiremSpheres treatments based on QuiremScout dose imaging. Q-Suite is also able to determine SIRT success immediately after the procedure by converting SPECT and MR imaging into absorbed dose distributions. Together, these three integrated products (QuiremSpheres, QuiremScout and Q-Suite) make up the full Holmium SIRT Platform. The Holmium Platform equips physicians with the necessary tools to optimize SIRT outcomes through more personalized treatment, addressing the individual needs of each patient.

QuiremSpheres, QuiremScout and Q-Suite are CE-Marked and currently available in Europe, the Middle East and Africa (EMEA). In the coming years, Terumo intends to launch the Holmium Platform globally as part of the ongoing expansion of its interventional oncology (IO) portfolio.

"The acquisition of Quirem Medical further strengthens our business, expands on our manufacturing and clinical development activities, and complements our comprehensive suite of offerings to support our customers," said Jim Rushworth, Chief Commercial Officer of the Interventional Systems Division of Terumo.

Using Quirem’s innovative Holmium-166 platform technology, physicians are further empowered to drive treatment outcomes after SIRT. "By adding the Holmium-166 platform to our existing IO portfolio, we will further contribute to giving liver cancer patients a better future," said Laurent Domas, Vice President, Global Interventional Oncology Strategy & Therapy Development, Terumo Europe. "This acquisition reflects Terumo’s commitment to build a broad platform of loco-regional treatment options for liver cancer and is another step forward as we aim to develop and provide treatment solutions for other organs as well."

"We are very excited with the acquisition of Quirem Medical by Terumo as it will further drive the adoption of our unique product offerings worldwide and accelerate our pace of innovation, reaching more patients that will benefit from our technology," said Jan Sigger, CEO of Quirem Medical.

The global interventional oncology market value is more than USD 1 billion, which is a rapidly growing field with a CAGR of 7%. Within this field, SIRT is one of the main treatments that is expected to help to drive this growth year on year.

Terumo has been building its presence in the interventional oncology field, with product offerings such as the micro catheter system (Progreat), compressible microspheres for embolization (HydroPearl), drug-eluting microspheres (LifePearl), and biodegradable drug eluting microspheres (BioPearl). In 2015, Terumo invested in Quirem Medical and became the exclusive global distributor of their technology.

On July 15, 2020 Sema4, a patient-centered health intelligence company, reported that it has secured approval from the New York State Department of Health (NYS DOH) to conduct its Sema4 Signal Whole Exome/Transcriptome Sequencing (WES/WTS) and PanCancer somatic tests (Press release, Sema4, JUL 15, 2020, View Source [SID1234561886]). Sema4 becomes the first company with a commercial laboratory to be approved by the NYS DOH for WES/WTS for solid and hematologic malignancies utilizing tumor-normal analysis. New York State’s approval comes shortly after Sema4’s launch of Sema4 Signal, a new family of products and services providing data-driven precision oncology solutions, including a market-leading hereditary cancer panel composed of a comprehensive 112 gene panel.

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Until now, Sema4 has been offering WES/WTS outside of New York. New York is the only state in the U.S. requiring an independent regulatory review for laboratory-developed tests, which represents one of the most rigorous levels of validation.

Sema4’s WES/WTS test provides clinically-actionable information across the whole exome about a broad range of genomic variants, gene fusion and alternative splicing, and tumor mutational burden and microsatellite instability for solid and hematologic cancers. Sema4 Signal PanCancer, with a ~2,200 gene panel that is the largest in the market, delivers a targeted approach to DNA and RNA sequencing for solid and hematologic cancers. These tests inform on both somatic and germline findings, supported by genetic counseling and digital tools, and can be combined with the Sema4 Signal Hereditary Cancer test and Informatics tools, including clinical trial recruiting.

"New York State’s approval of our somatic profiling solutions is testament to the outstanding accuracy of the tests and reinforces that we have a market-leading solution for clinical care, research, and clinical trials," said Eric Schadt, PhD, Founder and Chief Executive Officer of Sema4. "Following our announcement about Sema4 Signal, this development further highlights our commitment to using data science to improve cancer treatment. The data we generate from Sema4 Signal WES/WTS and PanCancer will be critical to delivering actionable insights that providers can use to administer care to their current patients while building better predictive models for future treatments."

Sema4 is now starting to engage with the U.S. Food and Drug Administration (FDA) on securing federal government approval for the tests. As part of its mission to improve the diagnosis, treatment, and prevention of disease, Sema4 is also already collaborating with several clinician researchers and investigators, and pharmaceutical companies on initiatives related to its WES/WTS tests.

On July 15, 2020 LintonPharm Co. Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T-cell engaging bispecific antibodies for cancer immunotherapy, reported the China National Medical Products Administration (NMPA) authorized the company to proceed with a Phase III trial (clinicaltrials.gov: NCT04222114) for catumaxomab in patients with peritoneal carcinomatosis, a form of advanced gastric cancer that has spread to the tissue that lines the abdominal cavity (Press release, Lintonpharm, JUL 15, 2020, View Source [SID1234561885]).

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"Gastric cancer is the sixth most common cancer globally. Approximately 70 percent of patients are located in China and the majority of these patients are diagnosed with late stage disease. Given this high unmet need, we are hopeful that catumaxomab will offer a new treatment option to gastric patients"

The two-stage, multi-center, open-label, randomized, controlled registrational clinical trial will evaluate the safety and efficacy of an intraperitoneal infusion of the bi-specific antibody catumaxomab into the abdominal cavity in patients with peritoneal carcinomatosis. LintonPharm also recently received Clinical Trial Application (CTA) authorization for the same indication from the Taiwan Ministry of Health and Welfare (MOHW) and the Korea Ministry of Food and Drug Safety (MFDS).

"We are excited to re-initiate clinical development of catumaxomab which we believe may have benefit in a broad range of cancers," said Robert Li, co-founder and CEO of LintonPharm. "Our initial development strategy is based on a robust foundation of clinical data that support the therapeutic potential of catumaxomab in advanced gastric cancer."

Catumaxomab was the first T-cell engaging bispecific antibody approved by the European Medicines Agency (EMA) in 2009 for the treatment of malignant ascites, a fluid buildup in the peritoneal cavity that indicates the presence of malignant cells. It was later voluntarily withdrawn from the market for commercial reasons.

"Gastric cancer is the sixth most common cancer globally. Approximately 70 percent of patients are located in China and the majority of these patients are diagnosed with late stage disease. Given this high unmet need, we are hopeful that catumaxomab will offer a new treatment option to gastric patients," said Dr. Horst Lindhofer, co-founder and Chief Scientific Officer of LintonPharm.

About Advanced Gastric Cancer with Peritoneal Carcinomatosis

Gastric cancer is the sixth most common cancer globally with an estimated incidence of 1,033,701 cases and 782,685 deaths in 2018.1 About 70 percent of gastric cancer patients are located in China, with 679,100 new cases and 489,000 deaths2 in 2015. More than 70 percent of Chinese patients are diagnosed with late stage (stage III or IV) gastric cancer. Peritoneal carcinomatosis (PC) is one of the primary causes of death in late stage gastric cancer. Approximately 20 percent of patients are diagnosed with PC before or during surgery, and more than 50 percent of patients are diagnosed with PC after cancer reduction surgery. The prognosis for gastric cancer with PC is extremely poor, with an expected survival of less than one year3. Current therapies for gastric cancer include trastuzumab for Her2 positive patients and systemic chemotherapies (1st line and 2nd line). There are limited options for patients who fail frontline therapies, especially for those who developed PC.

About Catumaxomab

Catumaxomab is a trifunctional bispecific antibody which originated from Lindis Biotech’s Triomab platform. The antibody binds to a transmembrane glycoprotein on the tumor cell–the epithelial cell adhesion molecule (EpCAM)–and CD3 on the T-cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab kills tumor cells by engaging T-cell and accessory cell mediated cytotoxicity and has potential to induce long-term vaccinal effects against tumor cells due to the unique FcγR binding and activation profile.

Catumaxomab was first approved by the EMA in 2009 for the treatment of malignant ascites (MA). MA is manifested as the abnormal accumulation of fluid in the peritoneal cavity, which develops from the proliferation of peritoneal carcinomatosis tumor cells in the cavity. There are various cancers that generate MA, for example ovarian, gastric, pancreatic and colorectal cancers. Patients with MA are usually diagnosed in the advanced stages of disease and their quality of life is greatly impaired. Currently, these patients face an extremely poor prognosis with a median overall survival of one to six months.