On September 20, 2021 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma (R/R HNSCC) (Press release, AVEO, SEP 20, 2021, View Source [SID1234587956]). Ficlatuzumab is AVEO’s investigational potent humanized immunoglobulin G1 monoclonal antibody that targets hepatocyte growth factor.

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"The FDA’s decision to grant FTD underscores the potential for ficlatuzumab to address a serious unmet need and serve as a meaningful therapeutic option for patients with metastatic HNSCC," said Michael Bailey, president and chief executive officer of AVEO. "We are committed to unlocking the full potential of ficlatuzumab in patients with HNSCC and look forward to working closely with the FDA to determine next steps for the program."

In June 2021, the Company announced positive results from a randomized confirmatory Phase 2 study of ficlatuzumab, AVEO’s hepatocyte growth factor (HGF) targeted antibody, alone or in combination with cetuximab, an EGFR-targeted antibody, in patients with metastatic HNSCC who relapsed or were refractory to prior immunotherapy, chemotherapy, and cetuximab (pan-refractory). Of note, patients with HPV negative disease, a subgroup normally associated with poorer outcomes, who received the ficlatuzumab and cetuximab combination demonstrated both a superior overall response rate and median progression free survival. A copy of the presentation is available at www.aveooncology.com.

As previously disclosed, a shortage of required key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing has delayed the delivery of the clinical supply of ficlatuzumab. The Company anticipates the potential start date for a registrational study in HPV negative HNSCC will be in 2023. The Company expects to continue to discuss potential ficlatuzumab pivotal study designs with the FDA and to continue ongoing partnership dialogues.

About Fast Track Designation

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is an investigational potent hepatocyte growth factor (HGF) immunoglobulin G1 (IgG1) inhibitory antibody that binds to the HGF ligand with high affinity and specificity. HGF is the natural ligand of c-Met and blocking HGF inhibits signaling through the HGF/c-Met signaling pathway. Ficlatuzumab is currently being evaluated in squamous cell carcinoma of the head and neck (HNSCC) and metastatic pancreatic ductal cancer (PDAC).

On September 20, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs, reported that it will present at four upcoming investor conferences (Press release, Actinium Pharmaceuticals, SEP 20, 2021, View Source [SID1234587955]).

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Sandesh Seth, Actinium’s Chairman and CEO, said, "Having recently completed enrollment of our pivotal Phase 3 trial for Iomab-B, we look forward to highlighting multiple upcoming milestones in the fourth quarter from our targeted radiotherapy pipeline including SIERRA data updates, updates from our novel Actimab-A combination trials and new programs arising from our AWE technology platform to a broad audience of investors. We are excited to finish 2021 with strong momentum as we look ahead to 2022 when we will present topline data from SIERRA."

Cantor Fitzgerald Global Healthcare Conference
September 27th – 30th

Benzinga Healthcare Conference
September 30th

BioFuture
October 5th – 6th

Alliance Global Partners Virtual Biotech & Specialty Pharma Conference
October 13th

Information about Actinium’s presentation at these conferences will be available on the investor relations page of Actinium’s website at www.actiniumpharma.com.

On September 20, 2021 Processa Pharmaceuticals, Inc. ("Processa Pharmaceuticals") Presented the Corporate Presentation (Press release, Processa Pharmaceuticals, SEP 20, 2021, View Source [SID1234587954]).

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On September 20, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported the appointment of David Meek as Chief Executive Officer (CEO), effective immediately (Press release, Mirati, SEP 20, 2021, View Source [SID1234587953]). Mr. Meek will also join the Company’s Board of Directors. Charles M. Baum, M.D., Ph.D. will continue to lead the research and development (R&D) organization as president, founder and head of R&D. Dr. Baum will remain on the Company’s Board of Directors.

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Mr. Meek has over thirty years of industry experience, where he held various global executive leadership positions in large pharmaceutical and commercial-stage biotechnology companies focused on oncology, including as CEO of Ipsen, a leading global biopharmaceutical company.

"I have had the privilege to lead Mirati over the last nine years as we develop a portfolio of breakthrough targeted oncology therapies, including adagrasib, our novel KRASG12C inhibitor, for which we are on track to submit a New Drug Application to the U.S. Food and Drug Administration in the fourth quarter of 2021," said Dr. Baum. "David brings broad global oncology experience and a proven track record in leading successful, high-performing commercial-stage companies. I am confident in David’s abilities to lead Mirati through its next chapter as we bring adagrasib, sitravatinib and other novel oncology therapeutics to patients."

"I am honored to lead Mirati and work alongside the incredibly talented people of this great company to build on what has been accomplished," said Mr. Meek. "Chuck has effectively led Mirati with an unrivaled passion for the science, people and most importantly, the patients. With his new appointment, we ensure the continuation of the scientific leadership and patient-centric culture that have made the company successful thus far."

Mr. Meek added, "Mirati has an unprecedented opportunity as we transition from developing targeted treatments that transform the way cancer is treated, to also delivering them to meaningfully impact the lives of patients living with cancer. Our end-to-end innovative oncology portfolio includes two late-stage clinical assets, adagrasib and sitravatinib, and a promising discovery pipeline, which includes Mirati’s synthetic lethal PRMT5 inhibitor, MRTX1719, with an IND submission in the fourth quarter of this year."

David Meek most recently served as president, CEO and board member of FerGene focused on developing an innovative gene therapy for bladder cancer. During his tenure as CEO at Ipsen, Mr. Meek led the transformation of the company into a high-growth and leading global biopharmaceutical organization through the expansion of the oncology portfolio in the U.S. and Europe, and growing the R&D portfolio through internal and external innovation.

Mr. Meek’s prior leadership roles include serving as executive vice president and president of oncology at Baxalta from 2014 to 2016, until its acquisition by Shire plc. He was also chief commercial officer of Endocyte from 2012 to 2014. Prior to that, Mr. Meek served in various executive leadership roles at Novartis Pharma and Novartis Oncology after beginning his career at Johnson & Johnson and Janssen from 1989 to 2004. He holds a Bachelor of Arts from the University of Cincinnati.

Mr. Meek has also served on the boards of Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), and currently serves on the boards of uniQure N.V., Entasis Therapeutics Holdings Inc. and Stargazer Pharmaceuticals.

On September 20, 2021 Boston Scientific Corporation (NYSE: BSX) reported the EPOCH clinical trial of the TheraSphere Y-90 Glass Microspheres (TheraSphere treatment) successfully met both primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) of patients with metastatic colorectal cancer (mCRC) of the liver. In the trial, TheraSphere treatment – a selective internal radiation therapy (SIRT) comprised of microscopic glass beads containing radioactive yttrium (Y-90) that are specifically delivered to target tumors – was used as a second-line treatment in combination with standard of care systemic chemotherapy (SOC) for patients who had disease progression during or after first-line chemotherapy. The clinical findings were presented today as late-breaking data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 and will be published in the Journal of Clinical Oncology.

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"The EPOCH trial not only demonstrated positive safety and efficacy data for the patients treated in this study, but underscores the success of integrating a device-based therapy like TheraSphere treatment in the continuum of care with systemic chemotherapy and biologic regimens, thereby providing the rationale and setting the stage for future investigation in other cancer types," said Riad Salem, M.D., M.B.A, interventional radiologist at Northwestern Memorial Hospital and co-principal investigator of the EPOCH trial.i

TheraSphere Vial and Sphere ID

TheraSphere Vial and Sphere ID
An estimated 1.9 million global cases of colorectal cancer (CRC) are diagnosed each year, making it the third most common cancer worldwide.ii Approximately one third of all patients with CRC present with, or subsequently develop, metastases in the liver (liver dominant mCRC).iii Patients with mCRC are most commonly treated with surgery and systemic chemotherapy, a therapy that targets the entire body. TheraSphere treatment, indicated for use in patients with hepatic neoplasia/malignancies including liver dominant mCRC in Canada, Europe and regions of Asia, delivers Y-90 directly to liver tumors via catheter, which minimizes radiation exposure to surrounding healthy tissue.

"EPOCH is the first positive phase 3 SIRT trial in any disease setting and the data is expected to support our regulatory submission to the U.S. FDA, with the hope that more patients with liver dominant mCRC will gain access to TheraSphere as a treatment option in the future," said Peter Pattison, president, Interventional Oncology, Peripheral Interventions, Boston Scientific.

The global, prospective EPOCH pivotal clinical trial is a phase 3 study, designed to assess therapeutic benefit compared to SOC, which randomized 428 patients with mCRC to second line chemotherapy, with or without the addition of TheraSphere treatment. Both primary endpoints were met and included progression-free survival and hepatic progression-free survival, which reflect how long patients live without the disease progressing further, both systemically and within the liver. The addition of TheraSphere treatment significantly increased both PFS (p=0.0013) and hPFS (p<0.0001). Patients receiving TheraSphere treatment with second-line chemotherapy were 31% less likely to show disease progression or death (HR = 0.69) and 41% less likely to show hepatic disease progression or death versus with chemotherapy alone (HR = 0.59).

"In the second line of therapy for metastatic colorectal cancer, with disease isolated to the liver, the addition of TheraSphere with chemotherapy resulted in a significant delay in overall tumor progression," said Mary F. Mulcahy, M.D., medical oncologist at Northwestern Memorial Hospital and co-principal investigator of the EPOCH trial.i "Additionally, chemotherapy-related adverse events were comparable between the trial arms."

Earlier this year, the U.S. FDA approved TheraSphere for the treatment of unresectable hepatocellular carcinoma (HCC) and granted Breakthrough Device Designation for expedited review as a treatment of patients with glioblastoma, an aggressive type of cancer that can occur in the brain or spinal cord. It is the only radioembolization technology in the U.S. indicated for unresectable HCC.

CAUTION: In the U.S., the use of TheraSphere for mCRC is for investigational use only as the safety and effectiveness have not been established.

For more information on TheraSphere treatment, visit www.therasphere.com.