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Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer


CAMBRIDGE, Mass., July 11, 2022 /PRNewswire/ — Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis (ISTH) Congress in London, UK.

The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby, addressing unmet medical needs. Drugs that are included in this program may be eligible for more frequent interactions with the FDA to discuss the development path, and if the program criteria are met, eligibility for a potential Rolling Review, Accelerated Approval, and Priority Review.

Venous Thromboembolism (VTE), including both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself.1 However, treatment of Cancer Associated Thrombosis (CAT) can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding.2,3

Click here to read the full article at Cision PR Newswire

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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Mersana Enters Busy Gastric Cancer Space with Orphan Drug Designation

On Thursday, Mersana Therapeutics announced that the U.S. Food and Drug Administration granted an orphan drug designation to one of its lead assets, XMT-2056, which is intended to treat gastric cancer.

Gastric cancer, also known as stomach cancer, accounts for approximately 1.5% of all new cancers diagnosed in the U.S. each year. Early signs of gastric cancer can include stomach discomfort, indigestion, nausea and being bloated, but the disease is typically not diagnosed until it is more advanced, causing symptoms such as blood in the stool, vomiting, weight loss, jaundice and fluid in the abdomen. Because it is often not diagnosed until advanced stages, treatment can be challenging. 

Mersana is coming to the treatment arena with XMT-2056. The therapeutic is a differentiated antibody that binds to a novel HER2 epitope, a growth-promoter protein found on some malignant cells. Mersana is investigating the therapeutic as both a monotherapy and a combinatorial therapy with other anti-HER2 treatments. A Phase I trial is anticipated to begin in mid-2022, and the therapeutic will be evaluated in gastric, breast and non-small-cell lung cancer. 

Click here to read the full article at BioSpace

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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Rare Disease Highlight: Gastric Cancer

Gastric Cancer (GC) is a disease in which malignant cells form into tumors in the lining of the stomach (NCI, 2021). About 90-95% of GC are adenocarcinomas, which develop from the gland cells in the mucosa (innermost lining of the stomach) (ACS, 2021a). With treatment, the 5-year survival rate of early GC can reach up to 95% (Song et al., 2017). However, 5-year survival rate of all stages combined (early to advanced disease) is 32% because there is no standard or routine screening test for GC in the US (ACS, 2021a; NCI, 2021; SEER, 2021). Most patients, ~73%, are diagnosed at an advanced stage with distant GC (AJCC stage IV). These patients have a 5-year survival rate of only 6%. GC is a rare disease that affects approximately 133,000 people in the US (SEER, 2021).

GC is a multifactorial disease because its occurrence and development are influenced by both environmental and genetic factors. Risk factors associated with GC include family history, diet, alcohol consumption, tobacco smoking, and Helicobacter pylori (H. pylori) and Epstein-Barr virus (EBV) infections. Although GC is largely sporadic, family history of GC remains one of the most crucial risk factors, with about 10% of cases displaying familial aggregation. Further, individuals with this family history have 3-fold higher risk of getting gastric carcinoma than individuals without such history (Machlowska et al., 2020). Salt-preserved foods may impact GC progression by inducing changes in the gastric mucosa towards precancerous conditions. Tobacco smoking also plays a role, as smoking is associated with up to 18% of GC cases (Marqués-Lespier et al., 2016). Additionally, there is a positive interaction between smoking and H. pylori infection (Piazuelo et al., 2013). H. pylori affects GC development by two mechanisms: an indirect inflammatory reaction to H. pylori infection on the gastric mucosa and a direct epigenetic outcome of H. pylori on gastric epithelial cells (Machlowska et al., 2020). Lastly, EBV is associated with GC development, although limited evidence exists of EBV-infected white blood cells entering the gastric epithelium (Figueiredo et al., 2017).

The symptoms of GC depend on the stage of the disease. In early stages, patients may experience indigestion, stomach discomfort, a bloated feeling after eating, mild nausea, loss of appetite, and/or heartburn. In advanced stages, patients may experience blood in the stool, vomiting, unexplained weight loss, stomach pain, yellowing of the skin (jaundice), build-up of fluid in the abdomen (ascites), and/or trouble swallowing (NCI, 2021). GC is staged based on the location and extent of the main tumor and classified as Stage 0, I, II, III, or IV, from early disease to advanced disease with metastasis (when the cancer spreads to other parts of the body) (ACS, 2021b; NCI, 2021).

The main treatments for GC are surgery, chemotherapy, targeted drug therapy, immunotherapy, and radiation therapy. Generally, combinations of two or more drugs are used to treat GC, depending on cancer stage, patient’s overall health, and the ability to undergo radiotherapy. Surgery, such as gastrectomy (removal of all or part of the stomach), is a common treatment for all stages of GC. It is used as a curative treatment for stages I-III patients and as a palliative treatment for stage IV patients, as well as patients who relapse (NCI, 2021). Although surgical removal of the stomach offers the potential to cure GC and prolongs patient survival, it significantly affects patients’ quality of life. Following surgery, some patients still need chemotherapy and/or radiation therapy. These treatments can exacerbate nutritional deficiencies. To help with this problem, a jejunostomy tube (a soft, plastic tube placed through the skin of the abdomen into the midsection of the small intestine to deliver food and medicine) is placed into the intestine at the time of or after the surgery to provide liquid nutrition to patients (NCI 2021 b and NIC 2021) (ACS, 2021a). Targeted therapies such as monoclonal antibodies can be used to target specific cancer cells, so they only benefit a specific patient subgroup. An example is trastuzumab, which targets patients whose cancer cells overexpress the specific receptor known as human epidermal growth factor receptor 2 (HER2). However, up to 50% of patients who receive trastuzumab and standard chemotherapy show resistance (Pellino et al., 2019).

The high mortality rates despite available treatments, particularly in patients with advanced disease, demonstrate the significant unmet medical need GC patients experience. There is an urgent need to develop novel therapeutics that can increase patients’ quality of life and survival rates.

References

ACS. (2021a). What is Stomach Cancer? Retrieved from https://www.cancer.org/cancer/stomach-cancer/about/what-is-stomach-cancer.html

ACS. (2021b). Stomach Cancer Stages. Retrieved from https://www.cancer.org/cancer/stomach-cancer/detection-diagnosis-staging/staging.html

Figueiredo, C., Camargo, M. C., Leite, M., Fuentes-Pananá, E. M., Rabkin, C. S., & Machado, J. C. (2017). Pathogenesis of Gastric Cancer: Genetics and Molecular Classification. Curr Top Microbiol Immunol, 400, 277-304. doi:10.1007/978-3-319-50520-6_12

Machlowska, J., Baj, J., Sitarz, M., Maciejewski, R., & Sitarz, R. (2020). Gastric Cancer: Epidemiology, Risk Factors, Classification, Genomic Characteristics and Treatment Strategies. Int J Mol Sci, 21(11). doi:10.3390/ijms21114012

Marqués-Lespier, J. M., González-Pons, M., & Cruz-Correa, M. (2016). Current Perspectives on Gastric Cancer. Gastroenterol Clin North Am, 45(3), 413-428. doi:10.1016/j.gtc.2016.04.002

NCI, N. (2021). Gastric Cancer Treatment. Retrieved from https://www.cancer.gov/types/stomach/patient/stomach-treatment-pdq#_1

Pellino, A., Riello, E., Nappo, F., Brignola, S., Murgioni, S., Djaballah, S. A., Lonardi, S., Zagonel, V., Rugge, M., Loupakis, F., & Fassan, M. (2019). Targeted therapies in metastatic gastric cancer: Current knowledge and future perspectives. World J Gastroenterol, 25(38), 5773-5788. doi:10.3748/wjg.v25.i38.5773

Piazuelo, M. B., & Correa, P. (2013). Gastric cáncer: Overview. Colomb Med (Cali), 44(3), 192-201. Retrieved from https://colombiamedica.univalle.edu.co/index.php/comedica/article/download/1263/2301

SEER. (2021). Cancer Stat Facts: Stomach Cancer. Retrieved from https://seer.cancer.gov/statfacts/html/stomach.html

Song, Z., Wu, Y., Yang, J., Yang, D., & Fang, X. (2017). Progress in the treatment of advanced gastric cancer. Tumour Biol, 39(7), 1010428317714626. doi:10.1177/1010428317714626

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Breakthrough Therapy Designation in the US for patients with HER2-low metastatic breast cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki)has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Patients with hormone receptor (HR) positive breast cancer should additionally have received or be ineligible for endocrine therapy.

ENHERTUis a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

Up to half of all patients with breast cancer have tumors with a HER2 immunohistochemistry (IHC) score of 1+, or 2+ in combination with a negative in-situ hybridization (ISH) test, a level of HER2 expression not currently eligible for HER2-targeted therapy.1-4 Low HER2 expression occurs in both HR-positive and HR-negative disease.5

Click here to read the full article at BusinessWire

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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Rare Disease Highlight: Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the most common form of liver cancer, accounting for 90% of cancer cases starting in the liver. [1, 2] Further, it is the fifth most common cancer worldwide but is rare in the United States with a prevalence of just over 100,000. [2, 3] HCC is also highly metastatic, meaning as the cancer progresses it may spread to other locations in the body, like the lungs, bone, or lymph nodes in the abdomen, and a lethal cancer. [1, 4] Specifically, it is the third major leading cause of cancer-related deaths worldwide, with only 20.8% of patients expected to survive more than 5 years in the US. [3, 5] Other complications of HCC may include, but are not limited to, bleeding in the esophagus due to enlarged veins, which are called varices, blood clots in veins involved with the liver system, and formation of pus-filled pockets of fluid within the liver. [2] While most liver cancers are preventable, the incidence of HCC has increased in the US, possibly due to the prevalence of common risk factors such as chronic liver disease, viral liver infections such as hepatitis, and severe scarring of the liver. [2, 3] HCC can be treated with liver transplant, surgery, and chemotherapy, but it has a high risk of developing resistance to chemotherapy techniques, such as sorafenib. [4, 6] Additionally, 60-80% of HCC patients who receive liver transplantation or surgery are expected to survive more than 5 years. However, after 5 years following the surgical procedure, the risk of HCC recurrence remains high at 70%, while less than 15% of patients are expected to have disease recurrence post-transplantation. [2] Based on the overall dismal prognosis and inadequate available treatment interventions, there is a clear need for new treatment options for this serious condition.

References

1.           ACS. What Is Liver Cancer? 2019  4/27/2022]; Available from: https://www.cancer.org/cancer/liver-cancer/about/what-is-liver-cancer.html.

2.           Asafo-Agyei, K.O. and H. Samant. Hepatocellular Carcinoma. 2021  4/27/2022]; Available from: https://www.ncbi.nlm.nih.gov/books/NBK559177/.

3.           SEER. Cancer Stat Facts: Liver and Intrahepatic Bile Duct Cancer. 2019  4/27/2022]; Available from: https://seer.cancer.gov/statfacts/html/livibd.html.

4.           NCCN. Liver Cancer – Hepatobiliary Cancers. 2021  4/27/2022]; Available from: https://www.nccn.org/patients/guidelines/content/PDF/liver-hp-patient.pdf.

5.           Globocon, WHO: Liver Fact Sheet. 2020.

6.           Pan, S.T., et al., Molecular mechanisms for tumour resistance to chemotherapy. Clin Exp Pharmacol Physiol, 2016. 43(8): p. 723-37.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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After 18 years in development, AstraZeneca’s CTLA-4 antibody gets the red carpet treatment at the FDA

After a decade, a second CTLA-4 antibody may finally be on its way to approval.

AstraZeneca announced Monday that the FDA had given priority review to tremelimumab, its long-gestating CTLA-4 antibody, in combination with the PD-L1 inhibitor Imfinzi for patients with liver cancer that can’t be treated with surgery.

The Big Pharma’s application is based on a multi-year, 1,324-patient study that showed 30.7% of patients who received a “priming dose” of tremelimumab followed by Imfinzi were alive after three years, compared to 20.2% of patients who received Bayer’s sorafenib, the standard of care.

Susan Galbraith, AstraZeneca’s cancer R&D chief, called that data “unprecedented.” Others raised questions about how the data held up compared to an alternative treatment regimen being developed by Roche, and how much benefit the CTLA-4 antibody offered, given that patients who received Imfinzi alone showed nearly identical survival at the two-year mark. The difference only emerged after three years.

Click here to read the full article at Endpoints News

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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Rare Disease Highlight: Small Cell Lung Cancer

Small cell lung cancer (SCLC) is an aggressive form of lung cancer primarily associated with a history of cigarette smoking (Rudin et al., 2021). SCLC is a highly metastatic cancer, meaning it spreads from site of origin (the lungs) to other parts of the body. Approximately 70% of patients present with advance disease showing macro metastases in either the brain, liver, bones, or lymph nodes at initial diagnosis (Ko et al., 2021). The highly aggressive nature of SCLC leads to significant morbidities and 1-year survival rates of only 32.9%. Survival continues to drop, with only 10.7% of patients surviving 3 years after diagnosis (SEER, 2022). SCLC is a rare disease that affects approximately 30,000 people in the US (SEER, 2018, 2022).

SCLC has been directly linked to carcinogens associated with tobacco products (Saltos et al., 2020). Smoking is believed to be the cause of 98% of SCLC cases, whether it be in active smokers, or people with a prior history of smoking. The remaining 2% of cases, known as never-smokers, may be linked to air pollution but data is still limited. Regardless of a patient’s smoking status, SCLC is initiated by the concomitant inactivation of the genes TP53 and RB1. These genes encode the tumor suppressor proteins p53 and retinoblastoma (RB), both of which have important effects in the life cycle of human cells and control of tumor progression. RB inhibits entry to the S phase of the cell cycle, the period of the cell cycle during which DNA is replicated, and thus blocks cell division. The p53 protein is an important regulator of cell cycle arrest and cellular death (known as apoptosis) as a response to genetic aberrations (Rudin et al., 2021). The inactivation of these proteins leads to unregulated proliferation of aberrant and cancerous pulmonary neuroendocrine cells (specialized airway epithelial cells), ultimately causing SCLC (George et al., 2015, Noguchi et al., 2020).

The current standard of care (SoC) for SCLC patients is either chemoradiation therapy or combination chemotherapy. SCLC is typically very responsive to either option initially, with response rates as high as 70% (Rudin et al., 2021; Wang et al., 2019). Unfortunately, this initial response is short-lived and SCLC inevitably becomes resistant to chemotherapeutic agents (Wang et al., 2019). The only available second line therapy is the chemotherapeutic agent, topotecan (Hycamtin), with low response rates between 6-17% and median survival time of only 26 weeks after treatment initiation (Hiddinga et al., 2021). Although it has not become SoC, surgical resection is an option for patients with stage I disease. However, only 4% of patients present with solitary tumor and the currently available studies on resection have not provided clear evidence of any long-term benefit (Hiddinga et al., 2021; Wang et al., 2019). The high mortality rates along with the general lack of response durability and alternative treatment options for patients with SCLC highlights a significant unmet medical need in this patient population.

References

  • George, J., Lim, J. S., Jang, S. J., Cun, Y., Ozretić, L., Kong, G., . . . Thomas, R. K. (2015). Comprehensive genomic profiles of small cell lung cancer. Nature, 524(7563), 47-53. doi:10.1038/nature14664
  • Hiddinga, B. I., Raskin, J., Janssens, A., Pauwels, P., & Van Meerbeeck, J. P. (2021). Recent developments in the treatment of small cell lung cancer. European Respiratory Review, 30(161), 210079. doi:10.1183/16000617.0079-2021
  • Ko, J., Winslow, M. M., & Sage, J. (2021). Mechanisms of small cell lung cancer metastasis. EMBO Mol Med, 13(1), e13122. doi:10.15252/emmm.202013122
  • Noguchi, M., Furukawa, K. T., & Morimoto, M. (2020). Pulmonary neuroendocrine cells: physiology, tissue homeostasis and disease. Dis Model Mech, 13(12). doi:10.1242/dmm.046920
  • Rudin, C. M., Brambilla, E., Faivre-Finn, C., & Sage, J. (2021). Small-cell lung cancer. Nat Rev Dis Primers, 7(1), 3. doi:10.1038/s41572-020-00235-0
  • Saltos, A., Shafique, M., & Chiappori, A. (2020). Update on the Biology, Management, and Treatment of Small Cell Lung Cancer (SCLC). Front Oncol, 10, 1074. doi:10.3389/fonc.2020.01074
  • SEER. (2018). Small cell carcinoma of the Lung and Bronchus
  • People Alive with Cancer (U.S. Prevalence) on January 1, 2018. Retrieved from https://seer.cancer.gov/explorer/application.html?site=611&data_type=5&graph_type=12&compareBy=sex&chk_sex_1=1&series=9&race=1&age_range=1&prev_duration=1&advopt_limprev_y_axis_var=0#tableWrap
  • SEER. (2022). Small cell carcinoma of the Lung and Bronchus. Surveillance Epidemiology and End Results Retrieved from https://seer.cancer.gov/explorer/application.html?site=611&data_type=1&graph_type=2&compareBy=sex&chk_sex_1=1&hdn_rate_type=1&race=1&age_range=1&stage=101&advopt_precision=1&advopt_show_ci=on&advopt_display=2#tableWrap
  • Wang, S., Zimmermann, S., Parikh, K., Mansfield, A. S., & Adjei, A. A. (2019). Current Diagnosis and Management of Small-Cell Lung Cancer. Mayo Clinic Proceedings, 94(8), 1599-1622. doi:https://doi.org/10.1016/j.mayocp.2019.01.034

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with a unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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Nkarta’s NK Cell Therapies for Blood Cancer Tout Full Recoveries

Nkarta, a biopharmaceutical company that engineers natural killer cell therapies to treat cancer, announced that two of its therapies have shown complete remission in patients with blood cancer. The exciting results from the Phase I studies are some of the latest hopeful developments in the biopharma space for difficult-to-treat blood cancers.

San Francisco-based Nkarta develops therapies in the oncology space, including for blood cancers. The company has two leading candidates, drugs NKX101 and NKX019.

In a Phase I clinical trial, Nkarta tested NKX101 on patients with relapsed or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Because of the difficulty of treating AML, there is currently no standard of care. Nkarta received Orphan Drug Designation from the U.S. Food and Drug Administration for NKX101 in December 2021.

“Relapsed/refractory acute myeloid leukemia (AML) is a historically hard-to-treat disease, and given the lack of effective treatments, people with cancer and those who treat them are faced with few options,” Marcello Rotta, M.D., who works at the Colorado Blood Cancer Institute and was an investigator in the NKX101 clinical trial, said in a statement.

Click here to read the full article at BioSpace

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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Adicet Bio Receives FDA Fast Track Designation for Lead Candidate ADI-001

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead program ADI-001, an investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL).

ADI-001 is currently being evaluated in an ongoing dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001 for the potential treatment of NHL. The Fast Track Designation was granted based on ADI-001’s potential to address an unmet need within the adult NHL patient population.

“Fast Track Designation represents an important milestone in the clinical development of ADI-001,” said Chen Schor, President and Chief Executive Officer of Adicet Bio. “We believe ADI-001 is unique in that it is designed to target malignant B cells by leveraging the innate and adaptive receptors found naturally on gamma delta T cells with the added benefit of an engineered anti CD20 CAR. We remain optimistic about the potential of our program and look forward to reporting additional data from the Phase 1 trial of ADI-001 in the first half of 2022.”

Click here to read the full article at Business Wire

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.

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GSK Acquires Sierra in $1.9B Complimentary Deal Aimed at Rare Cancers

GlaxoSmithKline is acquiring California biopharmaceutical firm Sierra Oncology for $1.9 billion in a deal expected to help both companies take a major step in developing a treatment for rare types of cancer.

The deal values Sierra’s shares at $55 each. The takeover will happen via a one-step merger that will cancel all outstanding shares in Sierra and convert these into the right to receive the per-share price in cash. The merger needs to be approved by at least a majority of the issued and outstanding shares to push through, plus regulatory and other customary conditions. The transaction is expected to close on or before the third quarter of 2022.

Central to the takeover is Sierra’s momelotinib, which with GSK’s expertise in hematology, may be developed to create therapies that address many critical unmet needs of patients diagnosed with myelofibrosis with anemia. Myelofibrosis is a fatal type of cancer of the bone marrow.

Click here to read the full article at BioSpace

Disclaimer: BioPharma Global is not responsible for, and expressly disclaims all liability for, damages of any kind arising out of use, reference to, or reliance on any information contained within the article. Content available through the site may contain links and information to other websites. Links from BioPharma Global to third-party sites do not constitute an endorsement by BioPharma Global of the mentioned parties.

BioPharma Global is a mission-driven corporation dedicated to using our FDA and EMA regulatory expertise and knowledge of various therapeutic areas to help drug developers advance treatments for the disease communities with unmet medical needs. If you are a drug developer seeking regulatory support for Orphan Drug designation, Fast Track designation, Breakthrough Therapy designation, other FDA/EMA expedited programs, type A, B (pre-IND, EOPs), or C meeting assistance, or IND filings, the BioPharma Global team can help. Contact us today to arrange a 30-minute introductory call.