On May 2, 2022 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported topline results from the six-week, Phase 2a, open-label, single-arm AESOP trial of avasopasem evaluating its ability to reduce the incidence of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy (Press release, Galera Therapeutics, MAY 2, 2022, View Source [SID1234613307]).

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The multicenter Phase 2a trial enrolled 39 patients (62 screened) with unresectable Stage 3A/3B or post-operative Stage 2B non-small cell (NSCLC) or limited-stage small cell (SCLC) lung cancers. Thirty-five patients completed treatment with 60 gray of intensity-modulated radiation therapy (IMRT) plus chemotherapy over six weeks. Of these 35 patients, 29 received at least five weeks of 90 mg of avasopasem on the days they underwent IMRT. These 29 patients were evaluated as the pre-specified per protocol population. Patients enrolled in this trial were considered at high risk for developing esophagitis due to the amount of radiation planned to be delivered to the esophagus.1 Patients were assessed and classified according to NCI-CTCAE criteria.2

Incidence of esophagitis by grade and timepoint in the AESOP trial (per protocol, n=29):

Grading Scale for Esophagitis per NCI Criteria
Grade 1 Asymptomatic; clinical or diagnostic observations only; intervention not indicated
Grade 2 Symptomatic; altered eating/swallowing; oral supplements indicated
Grade 3 Severely altered eating/swallowing; tube feeding, TPN, or hospitalization indicated
Grade 4 Life-threatening consequences; urgent operative intervention indicated
Grade 5 Death
Only two of the 29 patients (7%) experienced Grade 3 esophagitis at any time, with neither patient experiencing Grade 3 for more than one week. No patients experienced Grade 4 or 5 esophagitis at any point during the trial. These data compare favorably to the literature in which approximately 20-30 percent of these patients experienced Grade 3 or 4 esophagitis.3 Avasopasem was generally well tolerated. The adverse events experienced are comparable to those expected with chemoradiotherapy.

"These encouraging results demonstrate avasopasem’s potential to meaningfully reduce radiotherapy-induced Grade 3 or worse esophagitis," said Mel Sorensen, M.D., Galera’s President and CEO. "Patients with lung cancer undergoing chemoradiotherapy are at high risk of severe and potentially life-threatening esophagitis, including an inability to eat or swallow, severe pain, ulceration, infection, bleeding and weight loss, and there are no established drug therapies. Following the positive Phase 3 results of avasopasem in radiotherapy-induced severe oral mucositis (SOM), we believe these results in esophagitis support the safety and efficacy of avasopasem as a potential therapy to prevent the most severe forms of radiotherapy-induced toxicities."

Approximately 50,000 lung cancer patients undergo standard-of-care chemoradiotherapy every year in the U.S. and are at risk of developing esophagitis.

About Radiotherapy-Induced Esophagitis
Radiotherapy-induced esophagitis is a common and debilitating adverse effect that develops in patients receiving radiotherapy, most commonly for lung, esophageal, breast or head and neck cancers or for lymphoma. Radiotherapy-induced esophagitis is inflammation, edema, erythema, and erosion of the mucosal surface of the esophagus caused by radiotherapy. Esophagitis can be life-threatening, and symptoms include an inability to swallow, severe pain, ulceration, infection, bleeding and weight loss and may require hospitalization. There are currently no FDA-approved drugs and no established guidelines for the treatment of radiotherapy-induced esophagitis.

About Avasopasem
Avasopasem manganese (avasopasem, or GC4419) is a selective small molecule dismutase mimetic in development for the reduction of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) and for the reduction of radiation-induced esophagitis in patients with lung cancer. The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy, with or without systemic therapy.

About the Phase 2a AESOP Trial
The AESOP trial is an open-label, multicenter trial designed to evaluate the ability of avasopasem to reduce the incidence of radiotherapy-induced esophagitis in patients receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B non-small cell lung cancer, or small cell lung cancer treatable with chemoradiotherapy. For more information, please visit View Source

On May 2, 2022 Fresenius Kabi reported it has introduced Bortezomib for Injection, a new generic equivalent to Velcade in the U.S. and the newest addition to the most comprehensive injectable oncology portfolio in the industry (Press release, Fresenius Kabi Oncology, MAY 2, 2022, View Source [SID1234613323]).

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Fresenius Kabi Bortezomib for Injection is available in a 3.5 mg per 10 mL single-dose vial presentation for subcutaneous (SQ) or intravenous (IV) use.

Fresenius Kabi Bortezomib for Injection is an affordable treatment option for adult patients with multiple myeloma and mantle cell lymphoma. Multiple myeloma represents nearly 2 percent of all new cancer cases in the U.S. and is expected to double in 20 years.1 Mantle cell lymphoma represents approximately 5 percent of all non-Hodgkin’s lymphoma diagnoses annually, and there are approximately 4,000 new cases each year.2,3

"Adding a generic equivalent Bortezomib for Injection to our expansive oncology portfolio reflects our continued plan of expanding access to affordable cancer therapies," said John Ducker, president and CEO of Fresenius Kabi USA. "We’re pleased to be able to provide an affordable option to patients and we are especially pleased that Fresenius Kabi Bortezomib for Injection is produced at one of our U.S. facilities."

Fresenius Kabi offers more than 30 different oncology drugs in the U.S., and nearly 90 percent are formulated, filled and finished in the U.S. Bortezomib for Injection is the newest example of the company’s commitment to investing "More in America." This effort is focused on providing more supply, more science, more support and more care to its customers and the patients they serve in the U.S. Fresenius Kabi has invested nearly $1 billion to modernize and expand advanced U.S. pharmaceutical production and distribution facilities.

Bortezomib for Injection, along with other oncology medicines, is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program that offers copay assistance to eligible U.S. patients. The program can lower out-of-pocket costs to as little as $0 per month for eligible patients. To determine eligibility, patients should speak to their physician. Enrollment is a simple online process. Details can be found on the KabiCare website at kabicare.us.

Important Safety Information
INDICATIONS AND USAGE

Bortezomib for Injection is a proteasome inhibitor indicated for:

treatment of adult patients with multiple myeloma
treatment of adult patients with mantle cell lymphoma
IMPORTANT SAFETY INFORMATION

Bortezomib for Injection is contraindicated in patients with hypersensitivity (not including local reactions) to bortezomib, boron, or mannitol, including anaphylactic reactions. Bortezomib for Injection is contraindicated for intrathecal administration.

For subcutaneous or intravenous use only. Each route of administration has a different reconstituted concentration. Exercise caution when calculating the volume to be administered.

Peripheral neuropathy: Manage with dose modification or discontinuation. Patients with pre-existing severe neuropathy should be treated with Bortezomib for Injection only after careful risk-benefit assessment.

Hypotension: Use caution when treating patients taking antihypertensives, with a history of syncope, or with dehydration.

Cardiac Toxicity: Worsening of and development of cardiac failure has occurred. Closely monitor patients with existing heart disease or risk factors for heart disease.

Pulmonary Toxicity: Acute respiratory syndromes have occurred. Monitor closely for new or worsening symptoms and consider interrupting Bortezomib for Injection therapy.

Posterior Reversible Encephalopathy Syndrome: Consider MRI imaging for onset of visual or neurological symptoms; discontinue Bortezomib for Injection if suspected.

Gastrointestinal Toxicity: Nausea, diarrhea, constipation, and vomiting may require use of antiemetic and antidiarrheal medications or fluid replacement.

Thrombocytopenia or Neutropenia: Monitor complete blood counts regularly throughout treatment.

Tumor Lysis Syndrome: Closely monitor patients with high tumor burden.

Hepatic Toxicity: Monitor hepatic enzymes during treatment. Interrupt Bortezomib for Injection therapy to assess reversibility.

Thrombotic Microangiopathy: Monitor for signs and symptoms. Discontinue Bortezomib for Injection if suspected.

Embryo-Fetal Toxicity: Bortezomib for Injection can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use effective contraception. Most commonly reported adverse reactions (incidence ≥ 20%) in clinical studies include nausea, diarrhea, thrombocytopenia, neutropenia, peripheral neuropathy, fatigue, neuralgia, anemia, leukopenia, constipation, vomiting, lymphopenia, rash, pyrexia, and anorexia.

On May 2, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows (Press release, Regeneron, MAY 2, 2022, View Source [SID1234613339]):

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BofA Securities Healthcare Conference at 1:20 p.m. PT (4:20 p.m. ET) on Tuesday, May 10, 2022
Goldman Sachs 43rd Annual Global Healthcare Conference at 8:40 a.m. PT (11:40 a.m. ET) on Tuesday, June 14, 2022
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

On April 30, 2022 Genome Insight, a global leader in Whole Genome Sequence analysis and interpretation, reported $23 million in Series B funding (Press release, Genome Insight, APR 30, 2022, View Source [SID1234613261]).

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Dunamu & Partners led the financing with participation from InterVest, Signite Partners, KC, and VNTG Corporation, as well as existing investors DSC Investment, Paratus Investment, and Schmidt. The funding will be allocated towards advancing Genome Insight’s data production and curation pipelines that enable scalable investigation of whole-genome sequences (WGS), the most comprehensive technique for understanding the molecular origin of human diseases. These efforts will bring WGS in real-world clinics for clinicians and patients for next-generation medical practice, in particular, for cancer and rare diseases.

Genome Insight is a start-up company with expertise in the biomedical curation of WGS data. WGS examines the entire genomic sequence of diseased tissues, providing the most comprehensive characterization of tens of thousands of genomic mutations carried on it as a whole. While historically confined as a research tool, due to its massive data size and high cost for data curation, WGS is a leading driver for opening up an ultimate era of personalized medicine with entire genomic information. Making biomedical sense of the vast amount of WGS data at an affordable cost, predictable timeline, and standardized procedure has been the main barrier to the widespread use of WGS.

"With the falling cost of genome data production, we are at the tipping point of a whole-genome based transformation in treating genetically driven illnesses such as cancer and rare diseases. We plan to bring the analysis and interpretation technologies to make whole-genome sequences meaningful," said Young Seok Ju, founder of Genome Insight. "We are excited to have as our new investors, not only those in bio-tech but also those in digital-tech. This investment is a clear signal that the field is at the forefront of bio-tech and digital-tech convergence."

Genome Insight was founded in 2020 in South Korea by co-founders Young Seok Ju and Jeong Seok Lee, who are both physician-scientists and professors at KAIST (Korea Advanced Institute of Science and Technology). Earlier this year, the Company announced its incorporation as a US company and is now headquartered in San Diego, at the heart of the genomics hotbed of the west coast.

On April 30, 2022 Yiling Pharmaceutical reported its 2021 Annual Report Friday and disclosed the main development statistics (Press release, Yiling Pharmaceutical, APR 30, 2022, View Source;301536781.html [SID1234613262]). According to the report, its annual revenue reached USD 1.53 billion, an increase of 15.19% from last year, besides, net profit attributable to equity holders reached USD 203.75 million, achieving a 10.27% growth YoY.

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The annual revenue of Tongxinluo Capsules, Shensong Yangxin Capsules, and Qili Qiangxin Capsules, Yiling’s 3 main products for cardio-cerebrovascular diseases, reached USD 687.4 million, accounting for 44.82% of the overall revenue, achieving a 31.56% YoY growth despite the Covid-19 hit. Notably, in 2021, the annual revenue of Lianhua Qingwen Capsules reached USD 622.8 billion. It also ranked No.1 in the sales of patented traditional Chinese medicine for cold in China’s public medical market in 2021H1, according to statistics.

Public information indicates that Lianhua Qingwen Capsules was developed in the SARS period, it is the only herbal medicine for cold and flu that has won the Second Prize of China’s National Progress Award in Science and Technology.

In 2020, a clinical study Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial published in Phytomedicine, shows that along with routine treatment, oral administration of Lianhua Qingwen Capsules for 14 days, COVID-19’s clinical symptoms such as fever, fatigue, and cough can be alleviated significantly, and the pulmonary imaging lesions can be improved dramatically, the duration of symptoms was obviously shortened and the clinical cure rate was obviously elevated.

Lianhua Qingwen has been granted for sale in nearly 30 countries and regions. Furthermore, it has been approved for COVID-19 indications in Kuwait and Mongolia, and selected to be listed on the whitelist of anti-epidemic drugs issued by the Ministry of Health of Uzbekistan. In July 2021, it has been adopted as a treatment in the COVID-19 patients’ self-care protocol at home by the Cambodian Ministry of Health.