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InnoCare Announces First Subject Dosed in Clinical Trial of ICP-192 in the U.S.

On February 3, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported the first subject dosed in clinical trial of pan-FGFR inhibitor ICP-192 in the United States (Press release, InnoCare Pharma, FEB 3, 2021, View Source [SID1234574580]).

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ICP-192 is a highly selective small-molecule pan-FGFR inhibitor for the treatment of various solid tumors with FGFR aberrations. Currently it is in Phase I/II clinical studies in China and the United States.

The Phase II trial in China is a multi-center, open-label clinical trial designed to evaluate the safety and efficacy of ICP-192 in patients with advanced cholangiocarcinoma and urothelial cancer that have FGFR aberrations. The phase II clinical trials have enrolled nearly 20 patients, and cases of partial response and complete response have been observed in patients of FGFR gene alterations.

"We will continue to advance ICP-192 in clinical studies for the treatment of advanced solid tumors with FGFR aberrations in China and global," said Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare. "ICP-192 is an excellent drug candidate for the treatment of solid tumors with FGFR aberrations. We will work together with top clinical experts to rapidly advance the trials to explore the potential usage of ICP-192 in a variety of solid tumors. We hope to provide patients with better treatment options."

ICP-192 is the second innovative drug candidate discovered by InnoCare, which was approved for the initiation of clinical trials in the U.S.

Quanterix Announces Proposed Public Offering of $200.0 Million of its Common Stock

On February 3, 2021 Quanterix Corporation (Nasdaq: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that it has commenced an underwritten public offering of $200.0 million of its common stock (Press release, Quanterix, FEB 3, 2021, View Source [SID1234574579]). In connection with the offering, Quanterix intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock at the public offering price less the underwriting discounts and commissions. All of the shares in the offering will be sold by Quanterix. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Goldman Sachs & Co. LLC, SVB Leerink LLC and Cowen and Company, LLC are acting as joint bookrunning managers for the offering. Canaccord Genuity LLC is acting as lead manager for the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3ASR (File No. 333-249925) previously filed with the Securities and Exchange Commission ("SEC") on November 6, 2020, which automatically became effective upon filing. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Goldman Sachs & Co. LLC, 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526 or by e-mail at [email protected], from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at (800) 808-7525, ext. 6105 or by e-mail at [email protected], or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Indapta Therapeutics Announces Key Management Team Appointments to Advance into Clinical Trials in 2021

On February 3, 2021 Indapta Therapeutics Inc. ("Indapta"), a biotechnology company focused on developing and commercializing a proprietary, first-in-class, off-the-shelf, non-engineered, allogeneic FcRγ-deficient natural killer (G-NK) cell therapy to treat multiple cancers, reported the appointments of Lori Kunkel, M.D., as its Senior Clinical Advisor, Robert Sikorski, M.D., Ph.D., as its Founding Chief Medical Officer, and Jim Weiss as a member of its Board of Directors (Press release, Indapta Therapeutics, FEB 3, 2021, View Source [SID1234574578]).

"I’m delighted to welcome these industry veterans to our team at this exciting time in Indapta’s evolution into the clinic," said Guy DiPierro, Chief Executive Officer and Founder of Indapta. "Lori and Bob bring vast and relevant clinical experience and strategic expertise to help shepherd Indapta through our clinical trials in multiple indications and phases of development. Dr. Kunkel’s knowledge of oncology drug development and commercialization, along with Dr. Sikorski’s extensive cell therapy experience, will help accelerate our clinical programs in multiple cancer types. And Jim Weiss will bring data-driven digitally-based commercial strategy, marketing and communications savvy as product development and launches become increasingly virtual in the post pandemic landscape."

Dr. Kunkel has more than two decades of experience in oncology and immunology drug development and commercialization. Previously, she was the acting Chief Medical Officer at Loxo Oncology, which was acquired by Eli Lilly, and subsequently served on the Board of Directors. Earlier, she served as Chief Medical Officer at Pharmacyclics, which was acquired by AbbVie, and at Proteolix, Inc., which was acquired by Onyx Pharmaceuticals, which in turn was acquired by Amgen, where she contributed to the global approvals of cancer therapeutics IMBRUVICA and Kyprolis. Dr. Kunkel spent 10 years in academic medicine and served as a faculty member at the Bone Marrow Transplant Unit in the Division of Hematology/Oncology at the University of California, Los Angeles. She currently serves on the Boards of Directors of Curis, Inc., Nurix Therapeutics, OricPharma and Maverick Therapeutics.

"Indapta’s promising preclinical data combined with its proprietary manufacturing process and its innovative management team is what drew me to the company," said Dr. Kunkel. "I’m looking forward to working with Guy, the management team and Board members and applying my experience to position Indapta’s products in the current therapy regimen, design the clinical trials, work with the FDA, and help rapidly advance Indapta’s G-NK cell therapy through the clinic and too approval."

Dr. Sikorski has extensive drug development experience, having most recently served as Chief Medical Officer at FivePrime Therapeutics, a public biotechnology company, where he led the development of a biologics pipeline that spanned preclinical discovery through proof of concept to pivotal trials. Previously, he led an early-stage clinical development group at Medimmune/AstraZeneca that advanced six novel molecules into clinical trials. He played a leading role in building Medimmune/AstraZeneca’s oncology portfolio through corporate partnering and acquisition efforts. Earlier in his career, he led late-stage clinical development and post marketing efforts for several commercial drugs and drug candidates at Amgen. He began his career as a Howard Hughes Research Fellow and Visiting Scientist at the National Cancer Institute and the National Human Genome Research Institute in the laboratory of Nobel Laureate Harold Varmus. Dr. Sikorski has served as an editor for Science and the Journal of the American Medical Association.

"The team at Indapta has developed a novel and powerful allogeneic NK cell product and manufacturing process that could serve as a platform for multiple next-generation anti-cancer therapies," said Dr. Sikorski. "I’m excited by the opportunity to bring this cutting-edge science to the treatment of cancer patients."

Mr. Weiss has 30 years of experience in strategic media and marketing communications in the healthcare and technology sectors and has been involved in nearly every aspect of corporate, product and organizational communications. He is the Founder and Chief Executive Officer of W2O, the leading independent provider of analytics-driven, digital-first marketing and communications to the healthcare sector. During his career, Mr. Weiss has been recognized as one of the most influential people in health communications, receiving many accolades, including Top 50 Health Influencer and Top 25 Innovator in Communications. He began his career at Genentech during its formative commercial years. Mr. Weiss currently serves on the Board of Trustees of the Cancer Research Institute and The Commons Project and is an Advisory Board member of both the Newhouse School and the Healthcare Businesswomen’s Association.

"Jim has advised me at numerous companies, from private to public, and from preclinical to commercial, driving value through key inflection points," said Dov Goldstein, M.D., Chief Financial and Business Officer of Indapta. "A founder and owner of a company that has grown to include more than 1,500 employees, Jim understands how to scale and evolve a company through various stages of success. We know our efforts at Indapta will benefit from his insights while serving on our Board."

Indapta’s G-NK Cell Therapy

Indapta Therapeutics is developing a universal, allogeneic G-NK cell therapy designed to substantially improve the cytotoxicity of monoclonal antibody therapy in multiple cancers. G-NK cells are a specific and potent subset of NK (natural killer) cells with specialized anti-tumor activity resulting from an epigenetic change, rather than engineering. Indapta has further enhanced G-NK cells via specific G-NK cell subset selection and its proprietary manufacturing process which, when combined, produce a G-NK cell therapy that demonstrates higher efficacy, persistence and enhanced cryopreservation than multiple monoclonal antibody therapies alone or monoclonal antibody therapies combined with conventional NK cells.

When a monoclonal antibody binds to the tumor target and to Indapta’s G-NK cell therapy product, it initiates the release of dramatically more cancer killing compounds than conventional NK cells, allowing for increased efficacy and potentially less frequent dosing. Indapta’s off-the-shelf G-NK cell therapy is further differentiated from other NK cell therapies in that it is a cell banked product with low variability. In vivo studies have demonstrated the safety of Indapta’s G-NK cell therapy.

HERTHENA-Lung01 Phase 2 Study of Daiichi Sankyo’s Patritumab Deruxtecan Initiated in Patients with EGFR-Mutated NSCLC

On February 3, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in HERTHENA-Lung01, a phase 2 study evaluating patritumab deruxtecan, a HER3 directed DXd antibody drug conjugate (ADC), in patients with epidermal growth factor receptor (EGFR)-mutated metastatic or locally advanced non-small cell lung cancer (NSCLC) previously treated with a tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy (Press release, Daiichi Sankyo, FEB 3, 2021, https://www.businesswire.com/news/home/20210203005120/en/HERTHENA-Lung01-Phase-2-Study-of-Daiichi-Sankyo%E2%80%99s-Patritumab-Deruxtecan-Initiated-in-Patients-with-EGFR-Mutated-NSCLC [SID1234574577]).

Lung cancer is the leading cause of cancer death among both men and women, and accounts for about one-fifth of all cancer deaths globally, with 80 to 85 percent classified as NSCLC.1,2 For patients with metastatic disease, prognosis is particularly poor, as only 6 to 10 percent live beyond five years after diagnosis.3

Approximately 25 to 30 percent of lung cancers worldwide have an EGFR-activating mutation, and it is estimated that about 83 percent of all NSCLC tumors express the HER3 protein, which can be associated with an increased incidence of metastases, reduced survival and resistance to standard of care treatment.4,5,6 There currently are no HER3 directed medicines approved for the treatment of NSCLC.

"Our focus is to rapidly and strategically advance the clinical development program of patritumab deruxtecan in cancers where HER3 is frequently overexpressed and is associated with poor prognosis," said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. "This study will further inform whether targeting HER3 with an antibody drug conjugate may become a potential treatment strategy to overcome diverse mechanisms of EGFR TKI and chemotherapy resistance seen in patients with metastatic EGFR-mutated non-small cell lung cancer."

Exploratory biomarker analyses from the ongoing phase 1 study of patritumab deruxtecan in patients with previously treated metastatic or locally advanced EGFR-mutated NSCLC were recently presented at the IASLC 2020 World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer. Encore clinical results from this phase 1 study also were presented at WCLC.

About HERTHENA-Lung01

HERTHENA-Lung01 is a global, multicenter, open-label, phase 2 study evaluating the safety and efficacy of patritumab deruxtecan in patients with locally advanced or metastatic NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) who have progressed after receiving at least one EGFR TKI and at least one platinum-based chemotherapy regimen.

The study will randomize patients into one of two patritumab deruxtecan treatment arms in a 1:1 ratio. Patients in the first arm of the study will receive a 5.6 mg/kg fixed dose regimen of patritumab deruxtecan intravenously every three weeks. Patients in the second arm will receive an up-titration dose regimen of patritumab deruxtecan in three week cycles, with a 3.2 mg/kg dose given in the first cycle, a 4.8 mg/kg dose in the second, and 6.4 mg/kg in the third and subsequent cycles.

The primary endpoint of HERTHENA-Lung01 is objective response rate (ORR), as assessed by blinded independent central review (BICR). Secondary endpoints include duration of response, progression-free survival, disease control rate, and time to response – all assessed by both BICR and investigator assessment – as well as investigator-assessed ORR, overall survival, safety and tolerability. The level of HER3 protein expression in tumor tissue and its relationship with efficacy will be analyzed. Pharmacokinetics and immunogenicity also will be assessed.

HERTHENA-Lung01 is expected to enroll up to approximately 420 patients in the U.S., Europe and Asia, including Japan. For more information about the study, visit ClinicalTrials.gov.

About Non-Small Cell Lung Cancer

Lung cancer is the most common cancer and the leading cause of cancer mortality worldwide; there were an estimated 2.2 million new cases of lung cancer and 1.8 million deaths in 2020.1 Most lung cancers are diagnosed at an advanced or metastatic stage.2 Non-small cell lung cancer (NSCLC) accounts for 80 to 85 percent of all lung cancers.7

The introduction of targeted therapies and checkpoint inhibitors in the past decade has improved the treatment landscape for patients with advanced or metastatic NSCLC; however, the prognosis is particularly poor among patients who have progressed after treatment with standard therapies. For those who are not eligible for current treatments, or whose cancer continues to progress, new therapeutic approaches are needed.8

The mutationally-activated EGFR tyrosine kinase is a well-established oncogenic driver and molecular target for management of advanced stage NSCLC.9 For patients with advanced EGFR-mutated NSCLC, targeted therapy with EGFR TKIs offer higher response rates and progression-free survival compared to chemotherapy.8 However, most patients eventually develop resistance to these therapies, and standard treatment options are limited.10 Clinical resistance to EGFR TKIs has been linked to multiple molecular mechanisms, and in many cases, the underlying mechanism of resistance remains unknown.11,12,13

About HER3

HER3 is a member of the EGFR family of receptor tyrosine kinases, which are associated with aberrant cell proliferation and survival.14 Approximately 25 to 30 percent of lung cancers worldwide have an EGFR-activating mutation, and it is estimated that about 83 percent of all NSCLC tumors express the HER3 protein, which can be associated with an increased incidence of metastases, reduced survival and resistance to standard of care treatment.4,5,6 Currently, no HER3 directed medicines are approved for the treatment of cancer.

About Patritumab Deruxtecan

Patritumab deruxtecan (HER3-DXd, U3-1402) is one of three lead DXd antibody drug conjugates (ADC) in the oncology pipeline of Daiichi Sankyo. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, patritumab deruxtecan is comprised of a human anti-HER3 antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Patritumab deruxtecan is currently being evaluated in a comprehensive development program across multiple cancers as both a monotherapy and in combination with other anticancer treatments. The development program includes HERTHENA-Lung01, a phase 2 study in patients with EGFR-mutated metastatic or locally advanced NSCLC previously treated with a TKI and platinum-based chemotherapy; a phase 2 study in patients with advanced/metastatic colorectal cancer with progression following at least two prior lines of systemic therapy; a phase 1/2 study in HER3 expressing metastatic breast cancer; a phase 1 study in combination with osimertinib in locally advanced/metastatic EGFR-mutated NSCLC; and, a phase 1 study in previously treated patients with metastatic or unresectable NSCLC.

Patritumab deruxtecan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.

4D Pharma Presents Update on Oncology Program

On February 3, 2021 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) – a novel class of drug derived from the microbiome, reported progress on activities in its development program for lead immuno-oncology single strain Live Biotherapeutic candidate MRx0518 (Press release, 4d Pharma, FEB 3, 2021, View Source [SID1234574576]).

"4D pharma has continued to make excellent progress with the MRx0518 development program on multiple fronts. We have generated additional safety and efficacy data, building on the positive data from both the monotherapy and KEYTRUDA combination studies last year. This clinical and development progress has been achieved in spite of the headwinds of COVID-19," said Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. "As 4D pharma extends its leading position in this exciting and rapidly maturing field, we see the next 12 months as being instrumental for the space. We look forward to generating more clinical data from our ongoing studies of MRx0518 in multiple different tumor types and treatment settings. This will support 4D pharma’s continued productive engagement with regulatory authorities to develop the clinical strategy to bring this novel therapeutic to patients suffering from a range of cancers."

MRx0518 in Combination with KEYTRUDA

MRx0518 is in an ongoing Phase I/II clinical trial in combination with immune checkpoint inhibitor (ICI) Keytruda (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with advanced malignancies who have previously progressed on ICI therapy. This study is comprised of two parts – Part A, an initial safety phase assessing dose-limiting toxicities of the combination, and the Part B cohort expansion phase to assess clinical benefit in addition to safety. In May 2020 the successful completion of Part A and initiation of Part B was announced.

24 additional patients across five active US sites have now been treated in Part B of this ongoing study. The safety review following the first Part B cohort of 10 renal cell carcinoma (RCC) patients has been completed indicating no dose limiting toxicities. A total of 12 patients with RCC, nine patients with non-small cell lung cancer (NSCLC) and three bladder cancer patients have been enrolled in Part B to date. Recruitment will continue up to a total of 30 patients in each of these indications.

Target tumor reductions in Part B patients have been observed as patients reach the first scheduled restaging timepoint (nine weeks). These include the first signals of anti-tumor activity for the combination in bladder cancer, adding to the previously reported activity in RCC and NSCLC in patients in Part A.

Three Part A patients with RCC and NSCLC that were previously reported to have experienced clinical benefit continue on the study. Two of these patients have now been treated for over 18 months and have had further target tumor reductions or extended disease control since the last update. Efficacy of the combination continues to be evaluated on an ongoing basis.

Following the positive results of Part A in RCC and NSCLC, the new tumor cohorts added to Part B of the study are now open to recruitment. Patients with advanced malignancies resistant to ICI therapy, including triple-negative breast cancer, head and neck squamous cell carcinoma and microsatellite instability-high/mismatch repair deficient cancers, are now eligible for inclusion. Enrolment for the trial is expected to complete in Q4 2021.

MRx0518 with Radiation in Pancreatic Cancer

Five patients are now enrolled in this Phase I trial. The study is designed to evaluate safety and efficacy in 15 patients receiving treatment with MRx0518 and hypofractionated radiation prior to surgery for pancreatic cancer. This study will generate valuable data to assess the relationship between systemic and tumor biomarkers, as well as clinical outcomes. Study treatment is well tolerated to date. Enrolment continues and we anticipate receiving initial data from this clinical trial in 2021.

MRx0518 in Neoadjuvant Setting Monotherapy

The previously reported 17 patients in the completed Part A of this Phase I study continue in the follow up phase for survival outcomes. Biomarker and safety data from the study were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2020, demonstrating systemic immune and tumor microenvironment modulation following two to four weeks of treatment with MRx0518. Additional biomarker analyses are underway to further investigate the immune response induced by MRx0518. These additional results may inform an optimization of Part B of this study.

About MRx0518

MRx0518 is single strain Live Biotherapeutic product in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumors. It is currently being evaluated in three clinical trials in cancer patients. MRx0518-I-001 (NCT03934827) is a neoadjuvant monotherapy study in a variety of solid tumors and is being conducted at Imperial College (London, UK). MRx0518-I-002 (NCT03637803) is in combination with KEYTRUDA (pembrolizumab) in patients who have previously progressed on anti PD-1 therapies. The Coordinating Investigator of the study is at The University of Texas MD Anderson Cancer Center, Houston, USA, with multiple additional sites in the US. The study is being conducted in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. MRx0518-I-003 (NCT04193904) is in combination with preoperative radiotherapy in resectable pancreatic cancer.