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]).

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"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.

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.

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"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.

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]).

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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.

On September 27, 2021 Sihuan Pharmaceutical Holdings Group Ltd., together with its subsidiaries and SignalChem Lifesciences Corporation reported that Sihuan Pharmaceutical Holdings Group Ltd subsidiary company Xuanzhu Biopharmaceutical Co., Ltd. ("Xuanzhu") and SignalChem Lifesciences Corporation ("SignalChem") have entered into an exclusive collaboration and licensing agreement for the clinical development and commercialization of SLC-391, a potent and selective AXL targeting inhibitor, in the Greater China region (Press release, Lifescience Newswire, SEP 27, 2021, View Source [SID1234590366]).

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Under the terms of the agreement, Xuanzhu will pay to SignalChem an upfront fee of thirteen million US dollars (US$13,000,000). Additional development milestones and royalties have also been committed. The exclusive rights for SLC-391 for the field of oncology is for the Greater China region (Mainland China, Hong Kong, Macau and Taiwan).

AXL is a member of TAM (Tyro3, AXL, Mer) family of receptor tyrosine kinases. AXL along with its ligand GAS6 (growth arrest-specific gene 6) is highly expressed and activated in many malignant tumors, such as acute myeloid leukemia, kidney, pancreatic, breast, lung and ovarian cancer, etc. As one of the crucial signaling pathways promoting tumor growth and metastasis, immune escape and drug resistance, GAS6-AXL pathway is considered to be an attractive target for cancer treatment and has attracted widespread attention.

"The agreement with SignalChem will further advance Xuanzhu’s pipeline in the solid tumor and hematoma space. The results from preclinical and phase 1 clinical development demonstrated SLC-391 superiority not only as SLC-391 has prominent single-agent activities in multiple solid and hematological tumors but also can potentially be administered with a variety of drugs under development at Xuanzhu. Both parties will use their respective resources to accelerate the clinical approval of SLC-391 in China," said Ms. Xu Yanjun, Chairman of Xuanzhu. "Xuanzhu will continue to expand its efforts to develop and commercialize innovative drugs in the oncology field."

"Xuanzhu Biopharmaceutical, a subsidiary of Sihuan Pharmaceutical, is a highly innovative and progressive company," commented by Mr. Jun Yan, the Chairman and President of SignalChem, "We are very pleased to establish a partnership with Xuanzhu. This licensing agreement is of great significance for SignalChem to further validate and expand SLC-391’s clinical superiority. This agreement will accelerate SLC-391’s development timeline to reach the market and provide more effective treatment alternatives for patients with cancer." Mr. Jun Yan added, "the size of the agreement, including upfront, milestone and royalties, with Xuanzhu may be one of the largest agreements signed in Canada with a Chinese bio-pharma company for the Chinese territory rights, and we are looking forward to reaching all anticipated objectives. Furthermore, SignalChem will continue its efforts to expand and accelerate clinical development with SLC-391 for wider indications in even more geographic territories."

About SLC-391

SLC-391 is a potent, highly selective and orally bioavailable small molecule AXL inhibitor. Preclinical investigational data shows SLC-391 is a superior AXL inhibitor and has the potential to become a first-in-class inhibitor. Phase I clinical study is currently underway in Canada. SignalChem has established a collaboration with Merck (MSD) to evaluate the efficacy of SLC-391 in combination with Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC). In pre-clinical studies, SLC-391 demonstrated strong efficacy as a single agent or in combination with other approved drugs in multiple animal models for cancer. SLC-391 will be developed to undisclosed cancer indications as a single agent or in combination with other therapies.

On September 27, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and UNION therapeutics A/S (UNION), a privately-held, multi-asset, clinical stage, pharmaceutical company focused on immunology and infectious diseases, reported that they have entered into a strategic collaboration and license agreement for the development and commercialization of orismilast in China (Press release, Innovent Biologics, SEP 27, 2021, View Source [SID1234590356]).

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Under the terms of the agreement, UNION grants Innovent an exclusive license to research, develop and commercialize orismilast in China, including participating in and recruiting Chinese patients for potential future global studies of orismilast. UNION will receive an upfront payment of USD 20 million and is further entitled to receive up to USD 247 million in milestone payments as well as tiered royalties on sales of orismilast in China. UNION will retain global rights for orismilast outside of China.

In China there are approximately fifty million patients suffering from atopic dermatitis and six million patients suffering from psoriasis, and their prevalence is rising with changing lifestyles. Current standard of care treatments are topical steroids, oral immunosuppressants and injectable biologics, all of which have certain limitations in efficacy, safety or route of administration, presenting significant unmet clinical needs. In Phase 2a clinical studies, orismilast has demonstrated potential best-in-class profiles in these conditions, with a combination of improved efficacy and tolerability, and could be well positioned to address the unmet needs of these patient populations.

Dr. Yongjun Liu, President of Innovent, said: "We are very pleased to enter a collaboration with UNION. We have been impressed with our partner’s capability to advance the global development of orismilast and we are excited to help bring orismilast to patients in China. This collaboration further strengthens our position in autoimmune by adding a mid-stage potential best-in-class therapy into our portfolio. Innovent is proud to be an ideal partner for worldwide biotech and pharmaceutical companies in terms of accelerating the development and commercialization progress of novel assets to benefit a broader patient population."

Kim Kjøller, Chief Executive Officer of UNION therapeutics, said, "We are excited to enter into this strategic collaboration with Innovent, whose deep insights and presence in China make them an ideal partner to bring orismilast to Chinese patients. We are impressed by Innovent’s track record of international partnering, advancing assets through clinical development and commercial execution. This agreement provides independent validation of our belief in the best-in-class potential of orismilast, and expands our global footprint in an underserved market with significant potential. Partnering with pharmaceutical companies is core to our strategy of maximizing the value of our product candidates, and we are therefore excited to enter this collaboration with an internationally recognized partner."

About orismilast

Orismilast is a potent and selective, next-generation PDE4 inhibitor with broad anti-inflammatory properties, which was originally developed by LEO Pharma and acquired by UNION in 2020. Orismilast has generated positive proof of concept data orally in psoriasis and topically in atopic dermatitis and is being developed as a potential best- or first-in-class treatment option in both diseases. The selectivity of orismilast for PDE4 subtypes B and D and the novel modified release delivery is expected to result in an attractive therapeutic window, i.e., the combination of improved efficacy and tolerability, compared to other PDE4 inhibitors. UNION has two product candidates with orismilast in Phase 2 clinical development: UNI50001, an oral PDE4 inhibitor investigated for the treatment of psoriasis, atopic dermatitis and hidradenitis suppurativa; and UNI50002, the topical formulation of orismilast investigated for the treatment of atopic dermatitis. The safety and tolerability of PDE4 inhibitors is well understood, with two oral treatments and one topical currently approved and marketed.