Syros Receives FDA Orphan Drug Designation for Tamibarotene for the Treatment of MDS

On February 2, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to tamibarotene for the treatment of myelodysplastic syndrome (MDS) (Press release, Syros Pharmaceuticals, FEB 2, 2022, View Source [SID1234607621]). Tamibarotene, an oral first-in-class selective retinoic acid receptor alpha (RARα) agonist, is currently being evaluated in combination with azacitidine in the SELECT-MDS-1 Phase 3 trial for RARA-positive patients with newly diagnosed higher-risk MDS (HR-MDS).

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"The FDA’s orphan drug designation is an important milestone in the development of tamibarotene as a treatment for MDS," said David A. Roth, M.D., Syros’ Chief Medical Officer. "We believe tamibarotene’s novel mechanism of action, promising clinical activity data, oral delivery, and favorable tolerability profile supports a potential new option for the approximately 30% of HR-MDS patients who are RARA-positive. We are focused on developing the first potential therapy for a targeted population in HR-MDS as we continue to advance our ongoing SELECT-MDS-1 pivotal trial."

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

The ongoing SELECT-MDS-1 Phase 3 clinical trial is evaluating the safety and efficacy of tamibarotene in combination with azacitidine for RARA-positive patients with newly diagnosed HR-MDS. Data from the pivotal trial are expected in the fourth quarter of 2023 or the first quarter of 2024, with a potential new drug application filing expected in 2024.

Syros is also evaluating tamibarotene in combination with azacitidine and venetoclax for RARA-positive patients with newly diagnosed unfit acute myeloid leukemia (AML), for which tamibarotene had previously received orphan drug designation. Safety lead-in data from the ongoing SELECT-AML-1 Phase 2 trial is expected in the second half of this year.

Turning Point Therapeutics to Participate in Upcoming Investor Conferences

On February 2, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported that President and CEO Athena Countouriotis, M.D., will participate in the Guggenheim Healthcare Talks 2022 Oncology Day on February 9 and the 11th Annual SVB Leerink Global Healthcare Conference on February 16 (Press release, Turning Point Therapeutics, FEB 2, 2022, View Source [SID1234607638]).

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Dr. Countouriotis is scheduled to participate in fireside chats at 2 p.m. ET p.m. on February 9 and at noon ET on February 16. Both sessions will be accessible via webcast through the Investors page of www.tptherapeutics.com.

Singlomics Completes CNY 300 Million Series B to Develop COVID-19 Antibodies and Other New Pipelines using High-throughput Single-cell Technology

On February 2, 2022 Singlomics Biopharmaceuticals, an innovative biopharmaceutical company committed to the discovery and development of antibody drugs using single-cell sequencing technology platform, reported the completion of close to CNY 300 million series B financing lead by LEGEND CAPITAL and MSA CAPITAL, and multiple co-investors including JIANYI CAPITAL, CASH CAPITAL, FOUNDER H FUND, RUIHUA CAPITAL and WITRUTH CAPITA (Press release, Singlomics Biopharmaceuticals, FEB 2, 2022, View Source [SID1234643982]). Existing shareholders – HUAGAI CAPITAL, GL VENTURES, BOHE ANGEL FUND, and the company’s management team have also invested further. This funding round will be used to develop COVID-19 neutralizing antibodies, while enhancing new pipelines.
Singlomics Biopharmaceuticals is an innovative drug company dedicated to research and development of antibody drugs using single-cell sequencing technology platform, focusing on infectious diseases, autoimmune diseases and cancers. DXP-593 and DXP-604, our two most advanced products, are neutralizing monoclonal antibodies screened from convalescent COVID-19 patients, using the state of the art high-throughput single-cell sequencing technology platform. They are currently in the clinical development phase, for treatment and prevention of COVID-19.
Quan Zhou, Managing Director of LEGEND CAPITAL, said: "We are very pleased to establish this collaboration with Singlomics Biopharmaceuticals. We have been bullish in pursing the application of single-cell sequencing technology in the research, clinical and pharmaceutical fields. Academician Xiaoliang Xie, a heavyweight in the single-cell genome field in China, quickly organized a team to develop broad-spectrum therapeutic antibodies during the COVID-19 outbreak, and has pioneered their deployment on a compassionate basis, making a significant contribution to the country’s anti-epidemic efforts. The company is also constantly expanding new pipelines for the future."
"We are very optimistic about the development of Singlomics Biopharmaceuticals, a classic joint venture between scientists and entrepreneurs," said Ms. Yu Zeng, Founder Partner of MSA CAPITAL, "Academician Xiaoliang Xie is one of the world’s founders of single-cell sequencing technology accumulated many outstanding achievements in this field. Dr. Qian Shi is an enterprise leader, with a long professional & technical background and rich experience in enterprise management. The team led by Dr. Xie and Dr. Shi is a golden league, and we have great hopes for our collaboration with them. Meanwhile, Singlomics Biopharmaceuticals has been focusing on the discovery of novel therapeutic antibodies derived from patient samples, using the single-cell sequencing technology, a radical departure from traditional antibody drug discovery processes. Their current DXP-604 COVID-19 neutralizing antibody is one of the best neutralizing antibody products in the world. We will spare no effort to support the development of Singlomics Biopharmaceuticals by leveraging MSA CAPITAL’s own advantages in our resources as well as our professional post-investment service capability."

Tackling the COVID-19 Pandemic with Science
Singlomics Biopharmaceuticals was founded in June 2020. Co-founder Professor Xiaoliang Xie is an internationally renowned biophysical chemist, a member of the National Academy of Sciences and National Academy of Medicine, a fellow of the American Academy of Arts and Sciences, and a foreign academician of the Chinese Academy of Sciences. He was a former Mallinckrodt Professor of Chemistry and Chemical Biology at Harvard University. Returning to China full-time in 2018 to contribute to research and education, he is now Lee Shau-kee Chair Professor of Peking University. Academician Xie has pioneered the development and medical application of single-cell genome sequencing technology over the past decade. Immediately after the outbreak of COVID-19, he organized an outstanding multidisciplinary team with members from universities and industries to tackle this critical challenge. His team successfully applied single-cell genomics to the screening of neutralizing antibodies from humans for the first time, and rapidly obtained highly active neutralizing antibodies which are expected to provide a distinctly efficacious treatment for COVID-19.
Dr. Yunlong Cao, Co-founder, graduated from Harvard University in 2019. He then joined the Biomedical Pioneering Innovation Center of PEKING UNIVERSITY. His research work has been published in several papers in Cell and Nature. He is the scientific leader of the multidisciplinary team organized by Dr. Xiaoliang Xie for the research and development of highly active neutralizing antibodies against COVID-19, directing from experimental design to implementation. In 2021, he was selected as one of the "35 Innovators under 35" in China by MIT Technology Review.
Dr. Qian Shi, CEO of Singlomics Biopharmaceuticals, said: "In terms of the team created by Academician Xiaoliang XIE, it has its own aura. The team is jointly composed of academicians and entrepreneurs, and it is favored by investors with such a make-up. In terms of technology, the single-cell sequencing technology accelerates new drug development. The company’s COVID-19 antibody drugs are entering clinical Phase II, and Sinopharm Wuhan Institute of Biological Products has signed an agreement with us to conduct Phase III clinical trials. From a market perspective, DXP-604 has already been deployed on a compassionate basis in multiple regions during the epidemic in China, showing promising results. Therefore, from the points of view of team, technology, product and market, Singlomics Biopharmaceuticals has built a stable foundation with excellent and broad-ranging development prospects, likely to attain recognition by investment institutions."
Dr. Qian Shi joined Singlomics Biopharmaceuticals as CEO in August 2021. He has twenty years of research experience in oncology, with a deep understanding of the current situation and needs of scientific research, pharmaceutical industry and clinical practice. He also brings rich leadership experience in managing cross-regional and cross-cultural teams. Prior to joining Singlomics Biopharmaceuticals, he was the General Manager and Head of Scientific Research of the Chinese arm of Apollomics Inc. Under his leadership, his team accomplished the submission of two INDs for the treatment of acute myeloid leukemia (a Phase III study) and solid tumors (a Phase I study), respectively, enabling the company to enter clinical stage. Before his appointment at Apollomics, he worked for more than seven years at Crown Bioscience Inc., as the General Manager of Taicang branch and Vice President of Oncology, directing the Department of In vitro & In vivo Tumor Pharmacology.
At present, there are 26 team members at Singlomics Biopharmaceuticals. The core scientists in the research team are all graduates of prestigious universities including Harvard, PEKING UNIVERSITY and Fudan University, and have accumulated decades of experience in single-cell genomics, transcriptomics, methylomics, immunology and oncology.
Singlomics Biopharmaceuticals has independently built a single-cell high-throughput drug screening and development platform with unique features. The advantages of this technology include taking immune cells with well-defined biological functions as research & development objects and adopting a reverse discovery process with the capacity of higher-volume information gathering and higher-throughput measurements than conventional antibody discovery technologies, leading to superb precision. This technology can greatly shorten the time dedicated for antibody discovery and also reduce the failure rate of ensuing development.
At present, there are three categories in Singlomics Biopharmaceuticals’ R&D pipelines. The first category includes several neutralizing antibodies against COVID-19, with DXP-593 and DXP-604 being the two main products. Both were discovered by screening and characterizing viral antigen-specific B cells collected from 60+ convalescent COVID-19 patients, using high-throughput single-cell transcriptome and VDJ sequencing technologies. The company will focus on developing DXP-604, since we found the latest COVID variants, including the Delta strain emerging from India and the recent Omicron strain, can escape DXP-593’s neutralizing activities; on the contrary, DXP-604 has strong anti-Delta and anti-Omicron efficacy. In vitro studies also showed that such a single monoclonal antibody is effective of neutralizing COVID-19 variants with a very broad range of mutations. Hence, we will now focus on developing DXP-604. The DXP-604 product is currently in clinical Phase II in China, in conjunction with Sinopharm Wuhan Institute of Biological Products. Phase III clinical development will be conducted overseas in cooperation with Sinopharm Wuhan. "Because there are more outbreaks overseas where much higher number of patients allow fast enrollment into clinical trials than in China. Phase III trials will be conducted overseas in order to bring the product into clinical use much more quickly." Dr. Qian Shi said.
"Domestically, deployment for compassionate use and clinical development are being conducted simultaneously. In addition to clinical Phase II, we have deployed for compassionate use to over 300 patients in cities like Beijing, Tianjin, Xi’an and Shaoxing. When there is an outbreak, we surmount all hurdles to allow the drug to enter local hospitals as soon as possible and to help patients as well as doctors. This is our greatest honor as a drug developer," said Dr. Qian Shi.
In addition to its COVID-19 products, Singlomics Biopharmaceuticals has other product pipelines in early development, including drugs to treat chronic hepatitis B infections and cancers.

Affordable Drugs for China Via a Two-pronged Approach of Independent Research & Development and Licensing-in
The main advantage of single-cell sequencing technology in drug development is its high speed in discovering the lead drug molecules, which can be accelerated into the clinical stages, greatly reducing costs, time and manpower. On the other hand, single-cell sequencing can be used not only in obtaining and screening antibody molecules, but also in a wide range of application scenarios. In the pharmaceutical industry, single-cell technology enables drug target screening, pharmacokinetic analysis, pharmacodynamic evaluation, efficacy measurement etc. in high-throughput fashions. It can greatly shorten the drug discovery durations, reduce the development costs and optimize the management of drug development pipelines. Hence, the application of single-cell sequencing technology to the entire biopharmaceutical industry has great future potential. However, it is still in the early experimental stage at the current time, with application being relatively narrow.
Dr. Qian Shi said: "This is mainly due to the high cost of single-cell sequencing technology and the pressing need for technical expertise and subsequent data analysis, which limit broader application of this technology. Currently, only a few companies and research institutions have mastered single-cell sequencing technology. We hope to see more application scenarios and greater use of this technology in future. In the current situation, Singlomics Biopharmaceuticals aims to work closely with Sinopharm Wuhan Institute of Biological Products, and smoothly complete the Phase III clinical validation of DXP-604, so achieving true commercialization. Looking into the future, Singlomics Biopharmaceuticals will continue to reinforce its product pipelines to treat infectious diseases and cancer, through strengthening in-house R&D capabilities for novel antibody drugs and licensing-in innovative products from partners globally. Via such a two-pronged approach side by side, we are aiming to achieve our vision of "Using the single-cell sequencing technology platform to continuously promote innovative drug research for various indications, including infectious diseases and cancer, and Developing good drugs that are affordable for the people of China".

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Xencor to Present at Upcoming Investor Conferences

On February 2, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that company management will participate at two upcoming virtual investor conferences (Press release, Xencor, FEB 2, 2022, View Source [SID1234607622]):

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Guggenheim Healthcare Talks | 2022 Oncology Conference
Presentation Date: Wednesday, February 9, 2022
Presentation Time: 2:00 p.m. EST / 11:00 a.m. PST
11th Annual SVB Leerink Global Healthcare Conference
Presentation Date: Wednesday, February 16, 2022
Presentation Time: 3:40 p.m. EST / 12:40 p.m. PST
Live webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Replays will be posted on the Xencor website approximately one hour after the live event and will be available for at least 30 days.

City of Hope Completes Strategic Acquisition of Cancer Treatment Centers of America, Building a National, Integrated Cancer Research and Treatment System With a Singular Focus on Eradicating Cancer

On February 2, 2022 City of Hope, a world-renowned, National Cancer Institute-designated comprehensive cancer center, reported that it has completed its acquisition of Cancer Treatment Centers of America (CTCA), a network of oncology hospitals and outpatient care centers across the United States, expanding access to world-class research and cancer care to patients nationally (Press release, City of Hope, FEB 2, 2022, View Source [SID1234607639]). City of Hope now has one of the largest geographic footprints in cancer research and treatment, providing cancer patients with timely access to exceptional care, clinical trials and leading-edge innovation.

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"With the completion of this acquisition, City of Hope and Cancer Treatment Centers of America are combining complementary strengths, with a shared commitment to providing the best, most compassionate care possible," said Robert Stone, president and CEO of City of Hope and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "Together, we are creating a new model for how cancer care is delivered, leveraging real-world cancer care experience to inform scientific innovation and making tomorrow’s new discoveries available to the people who need them today."

With CTCA, the combined organization will serve approximately 115,000 patients each year, with more than 11,000 team members and 575 physicians across a network of locations in California, Arizona, Illinois and Georgia, expanding the portfolio, reach and impact of City of Hope’s world-class cancer services and capabilities, including research and development, to more patients, families and communities nationwide.

J.P. Morgan acted as exclusive financial advisor and Jones Day acted as legal counsel to City of Hope in the transaction. Goldman Sachs & Co. acted as exclusive financial advisor and McDermott Will & Emery and Katten Muchin Rosenman LLP acted as legal counsel to CTCA.

With the completion of this acquisition, City of Hope intends to begin the process of converting CTCA to a nonprofit organization. CTCA President and CEO Pat Basu, M.D., will report directly to Stone.