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Cothera Receives Authorization from the FDA to Conduct a Phase 2 Clinical Trial to Test Its Targeted MYC Mutation Inhibitor PC-002 for the Treatment of Neuroendocrine Prostate Cancer (NEPC)

On September 27, 2021 Cothera Bioscience reported that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a global multi-center phase 2 clinical trial to test PC-002, an inhibitor that targets MYC mutations, in combination with carboplatin and etoposide (PE) in patients with castration resistant and neuroendocrine prostate cancer (NEPC) (Press release, Cothera Bioscience, SEP 27, 2021, View Source [SID1234618851]).

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NEPC most frequently develops in patients with castration-resistant prostate adenocarcinoma following standard treatment with androgen receptor antagonists, other hormonal therapy or taxane-based chemotherapy. Clinically, NEPC is highly aggressive and metastasizes to visceral organs, such as the liver, much more avidly than prostate adenocarcinoma. MYC is overexpressed in the majority of NEPC and appears to be critical to the development of NEPC. Recent data indicate that NEPC occurs in approximately one out of six patients who develop progressive hormone-resistant prostate cancer. The incidence of treatment-related NEPC is expected to rise due to the prevalent use of hormonal therapies in prostate cancer.

PC-002 is a first-in-class small molecule drug targeting MYC- mutated tumors. With more than 50% of human cancers showing increased expression, MYC is regarded as one of the most important yet "undruggable" cancer targets. With a unique mechanism of action, PC-002 selectively induces MYC protein degradation and cell apoptosis in MYC-dependent tumors. PC-002 may potentially target multiple indications in cancers involving MYC dysregulation.

Dr. Vernon Jiang, Co-founder and EVP of Cothera Bioscience, said: "The FDA’s approval of PC-002 to initiate human phase 2 clinical trials in NEPC is another important milestone for Cothera. The team worked efficiently to file the IND and obtained approval expeditiously. We will continue our effort to launch and execute late-stage clinical trials for other cancer indications, bringing breakthroughs and better treatment options to more cancer patients."

Chemomab Therapeutics Announces Collaboration with Leeds University to Further Elucidate the Role of CCL24 in Vascular Damage Associated with Systemic Sclerosis

On September 27, 2021 Chemomab Therapeutics Ltd. (Nasdaq: CMMB) ("Chemomab"), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported a research collaboration with Leeds University to further study the role of CCL24 in the vascular damage associated with systemic sclerosis (SSc), a rare rheumatic disease with high morbidity and mortality (Press release, Chemomab, SEP 27, 2021, View Source [SID1234594670]). The collaboration will be led by Francesco Del Galdo, MD, PhD, Professor of Experimental Medicine at the University of Leeds and Head of the Scleroderma Program at the Leeds Musculoskeletal Biomedical Research Centre. Prof. Del Galdo is a recognized expert in the study of SSc and other rheumatic conditions.

CCL24 is a soluble protein that has been shown to play a key role in mediating fibrotic and inflammatory processes that are the hallmark pathologies related to SSc. It is the novel target for Chemomab’s CM-101, a first-in-class, CCL24 neutralizing monoclonal antibody that Chemomab plans to assess in a Phase 2 trial in SSc patients beginning early next year. Chemomab has generated substantial mechanistic data related to CCL24-associated fibrosis and inflammation in SSc, as well as early data showing that CCL24 is potentially involved in the vascular damage associated with SSc. The partnership with Prof. Del Galdo will seek to provide additional insights into the mechanisms underlying CCL24-associated vascular damage and could also uncover additional application opportunities for CM-101.

"We are delighted to partner with Prof. Del Galdo and his team to further study how CCL24 contributes to the vascular damage in SSc," said Dr. Adi Mor, CEO of Chemomab. "They have developed state-of-the art models of vascular damage based on their large collection of SSc patient samples. At Chemomab, we have extensively studied how CCL24 causes fibrosis and inflammation in preclinical SSc models. This collaboration is expected to increase our understanding of the association between CCL24 and vascular damage using human samples, with the aim of helping guide future SSc registration trials and ultimately providing benefit to these patients who have no effective treatment options."

Prof. Del Galdo said, "Systemic sclerosis is a connective tissue disease caused by an unfortunate combination of fibrosis, inflammation and vascular damage. Because of the nature of the tissue damage caused by SSc, it remains one of the most severe autoimmune diseases, with a poor prognosis and very limited treatment options. Extensive preclinical studies indicate that CCL24 is an important mediator of fibrosis and inflammation. We welcome the opportunity to partner with Chemomab to better understand the role of CCL24 in causing the vascular damage that contributes significantly to the overall morbidity and mortality of SSc patients."

About Systemic Sclerosis

SSc, also known as scleroderma, is a rare autoimmune rheumatic disease characterized by fibrosis and inflammation of the skin, joints and internal organs, as well as vascular abnormalities. It predominantly affects women and is typically diagnosed when patients are between 30 and 50 years old. It is the most lethal of the systemic rheumatic diseases with a median survival of only 10 years. There is no approved disease modifying drug for SSc. There currently are an estimated 100,000 SSc patients in the US.

Fierce Biotech names Tvardi Therapeutics as one of its “Fierce 15” Biotech Companies of 2021

On September 27, 2021 Tvardi Therapeutics ("Tvardi") reported that Fierce Biotech has named it as one of 2021’s Fierce 15 biotechnology companies, designating it as one of the most promising early-stage biotechnology companies in the industry (Press release, Tvardi Therapeutics, SEP 27, 2021, View Source [SID1234590681]).

"In 2020, we got to celebrate the best and brightest biotechs trying to dig the world out of the pandemic. Speaking with this year’s class of Fierce 15 winners showed us that not even a global pandemic can stop incredible innovations in medicine, and we’re on the cusp of some new breakthrough treatments that have continued apace despite unprecedented disruption last year," said Annalee Armstrong, Senior Editor of Fierce Biotech. "Slowing down was not an option for our 2021 Fierce 15 winners. From a biotech exploring a new type of viral vector for gene therapies to one trying to crack fibroblasts as a way to target resistant tumors, the Fierce Biotech team heard one thing in common: strong teams of scientists and professionals united in a goal to advance life-changing medicines. We’re proud to showcase this esteemed group of emerging biotechs to the world."

Tvardi (www.tvardi.com) is a clinical-stage biopharmaceutical company developing small molecule inhibitors of STAT3, a key regulatory molecule positioned at the intersection of signaling pathways critical to cancer, chronic inflammation, and fibrosis. The company’s lead product, TTI-101, is currently being studied in a Phase 1 trial of patients with advanced solid tumors who have failed all lines of therapy. To date, TTI-101 has been well-tolerated and demonstrated multiple durable radiographic objective responses in cancer patients treated with TTI-101 monotherapy.

Imran Alibhai, Ph.D., chief executive officer at Tvardi, added, "We are thrilled that Fierce has selected us for this honor. It not only validates the compelling clinical data we have generated but also our small and growing team of industry veterans, drug developers, and preeminent researchers that are bringing our transformative therapies to patients in need. I would also like to congratulate all awardees of this year’s Fierce 15 competition, as we are proud to join them in this accolade."

The Fierce 15 celebrates the spirit of being "fierce" – championing innovation and creativity, even in the face of intense competition. This is Fierce Biotech’s 19th annual Fierce 15 selection.

An internationally recognized daily report reaching a network of over 300,000 biotech and pharma industry professionals, Fierce Biotech provides subscribers with an authoritative analysis of the day’s top stories. Every year Fierce Biotech evaluates hundreds of early-stage companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position.

Sarah Cannon Announces Opening of Oncology Drug Development Unit in Collaboration with Florida Cancer Specialists & Research Institute and The University of Central Florida in Lake Nona

On September 27, 2021 Sarah Cannon reported that recently opened its newest drug development unit (DDU) in collaboration with Florida Cancer Specialists & Research Institute (FCS) and The University of Central Florida College of Medicine (UCF) in Lake Nona, Fla (Press release, Sarah Cannon Research Institute, SEP 27, 2021, View Source [SID1234590434]). The unit, located in the Sarah Cannon | UCF Lake Nona Cancer Center, is led by Cesar Augusto Perez, MD, a recognized expert in Phase 1 oncology research. The first of its kind in Lake Nona, the DDU focuses exclusively on oncology clinical trials at the earliest phases of research and was designed to meet the specialized needs of patients seeking advanced cancer treatment options. The first patient was treated on a clinical trial at the new unit earlier this month.

"Lake Nona is known for building a community of collaborators, and by working together with our colleagues at FCS and UCF – we are proud to open a drug development program that is offering greater access to novel therapies that are essential to advancing science and transforming cancer care for patients," said Howard A. "Skip" Burris, III, MD, President of Clinical Operations and Chief Medical Officer, Sarah Cannon. "Dr. Perez has dedicated his career to translational oncology research and we are looking forward to his leadership over this new program."

Cesar Perez, MD most recently served as an Associate Professor of Medicine at the University of Miami where he also was one of the leaders for Phase 1 oncology clinical research. He was previously an Assistant Professor of Medicine at the University of Louisville, where he received the Best Faculty Teacher Award in 2015 and 2017. After completing a hematology and oncology fellowship at the University of Miami, Dr. Perez received the Peter A. Cassileth, MD Award as an outstanding fellow, and served as Chief Fellow.

"It is an honor to join Florida Cancer Specialists and lead Sarah Cannon’s newest drug development program in Lake Nona so that we can advance therapies for patients who vitally need them," said Dr. Perez. "By having our unit aligned to FCS’s medical oncology practice and located in UCF’s center focused on delivering cutting-edge offerings, we are offering a more comprehensive care experience."

As Director of Drug Development for Sarah Cannon Research Institute at FCS – Lake Nona, Dr. Perez works with a team that includes Sarah Canon and FCS research nurses, pharmacists, and patient support members that provide patients with access to the latest research and compassionate care without needing to travel far from home.

"Over the last two decades, FCS has partnered with Sarah Cannon to bring new treatment options to patients facing cancer throughout the state," said Lucio Gordan, MD, President & Managing Physician, Florida Cancer Specialists & Research Institute. "The DDU, which is co-located with one of our newest medical oncology practices, ensures patients can access specialized oncology care in a purposefully-designed space that brings together essential oncology services under one roof."

Located on the Sarah Cannon | UCF Lake Nona Cancer Center campus, the new 10,000 square-foot Sarah Cannon Research Institute at FCS drug development unit is a part of a new treatment facility, which combines medical oncology services and Phase 1 clinical trial options for cancer patients in one convenient location, 6400 Sanger Road, Suite A-2400, Orlando, Florida 32827. Radiation oncology will also be offered at this location later this year in collaboration with Sarah Cannon and HCA Healthcare’s UCF Lake Nona Medical Center. Additionally, departments for the UCF College of Medicine and HCA Healthcare Center for Clinical Advancement are located within the center.

"The UCF College of Medicine welcomes partnership with Sarah Cannon and FCS as new members of Lake Nona’s growing health and life sciences cluster," said Deborah German, MD, Founding Dean and VP for Health Affairs at the UCF College of Medicine. "By partnering with Sarah Cannon and FCS, we are able to make greater strides for people facing cancer from the bench to the bedside."

Currently, Sarah Cannon and FCS offer clinical trials through more than 36 locations in the state, including existing drug development programs in Sarasota and Lake Mary. All three units will work closely to increase early phase trial options for patients.

NexImmune to Present at the 2021 Cantor Virtual Global Healthcare Conference

On September 27, 2021 NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, reported that Scott Carmer, Chief Executive Officer, will present at the 2021 Cantor Virtual Global Healthcare Conference Wednesday, September 29, 2021 at 2:00 PM Eastern time (Press release, NexImmune, SEP 27, 2021, View Source [SID1234590402]).

The webcast will be accessible on the Investor Relations page of NexImmune’s website at Events and Presentations | NexImmune, Inc. A replay of the presentation will be available at the same location for 90 days following the conference.