Adaptive Biotechnologies Announces Preliminary, Unaudited 2021 Revenue Results and CFO Transition

On January 10, 2022 Adaptive Biotechnologies Corporation (Nasdaq: ADPT) reported preliminary, unaudited revenue for the year ended December 31, 2021 (Press release, Adaptive Biotechnologies, JAN 10, 2022, View Source [SID1234598479]). Total revenue for the year ended December 31, 2021 is estimated to be in the range of $153 million to $154 million, representing an approximate increase of 56% at the mid-point of the range compared to $98.4 million for the year ended December 31, 2020.

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"The Adaptive team delivered strong results in 2021, setting the stage to accelerate our immune medicine and MRD business areas," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Our goal is to transform the genetics of the adaptive immune system into novel diagnostics and therapeutics. We are in a strong position and poised for sustainable future growth."

These preliminary, unaudited results are based on management’s initial analysis of operations for the year ended December 31, 2021 and are subject to change. Adaptive Biotechnologies expects to issue full financial results for the year ended December 31, 2021 on or around February 15, 2022.

Adaptive further announced that Chad Cohen, chief financial officer, will be resigning from his role, effective on or about February 15, 2022, following the filing of Adaptive Biotechnologies’ Annual Report on Form 10-K for the year ended December 31, 2021. Adaptive Biotechnologies’ principal accounting officer, Kyle Piskel, will serve as interim CFO after Mr. Cohen’s resignation. Adaptive Biotechnologies has initiated a search for a permanent CFO with the capabilities and qualifications to help accelerate the development and commercialization of products resulting from the insights provided by its proprietary immune medicine platform. Mr. Cohen will continue to work with Adaptive Biotechnologies and Mr. Piskel in a consulting capacity to ensure a smooth transition.

"I’d like to thank Chad Cohen for his excellent contributions to both the financial and operational success at Adaptive over the last seven years," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "We wish him all the best and we look forward to working with him through the transition."

21st Annual PepTalk

On January 10, 2022 ImmunoPrecise reported that it will be attending the 21st Annual PepTalk 2022, the Protein Science and Production Week, from January 17-19th, 2022 (Press release, ImmunoPrecise Antibodies, JAN 10, 2022, View Source [SID1234598478]). PepTalk is the largest annual gathering of protein science researchers in the world. The conference focuses on intensive learning to discover new opportunities, apply alternative solutions and develop promising partnerships through keynote speakers, seminars and short courses.

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Location:
San Diego Hilton Bayfront, San Diego, CA

Dates:
January 17-19, 2022

Booth #213

Rigel Pharmaceuticals Provides Business Update

On January 10, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported a business update including preliminary 2021 full-year total revenue, the status of the Phase 3 study in COVID-19, and upcoming catalysts in 2022 (Press release, Rigel, JAN 10, 2022, View Source [SID1234598477]).

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"Despite the challenges the global pandemic continued to present in 2021, our team responded with creative solutions to navigate the evolving landscape and now look forward to several catalysts that have the potential to be transformative for the company in 2022," said Raul Rodriguez, Rigel’s president and chief executive officer. "We’ve made strategic investments designed to accelerate TAVALISSE ITP sales in the U.S., prepare for pivotal readouts in two Phase 3 studies that have the potential to expand the market for fostamatinib into new indications such as wAIHA and COVID-19, and advance our clinical-stage IRAK1/4 and RIPK1 programs into Phase 2 development."

Commercial and Preliminary Financial Update
In the fourth quarter of 2021, a total of 1,814 bottles of TAVALISSE (fostamatinib disodium hexahydrate) were sold in the U.S., of which 1,785 were shipped directly to patients and clinics, representing the highest daily bottles shipped to patients and clinics in a quarter since launch. For the full year ended December 31, 2021, 6,787 bottles of TAVALISSE were shipped directly to patients and clinics, representing an increase of 8% compared to 2020. While Rigel is still in the process of determining final results for the fourth quarter of 2021, Rigel expects to report net product sales of $17.6 million compared to $17.7 million for the same period of 2020.

Contract revenues for the quarter ended December 31, 2021, are expected to be approximately $2.8 million, consisting of $1.8 million in revenue from collaborative partners and $1.0 million in government contract revenue from the U.S. Department of Defense (DOD).

For the fourth quarter of 2021, Rigel expects to report total revenue of approximately $20.4 million.

The company expects to report cash, cash equivalents, and short-term investments as of December 31, 2021, of approximately $124.9 million compared to $57.3 million as of December 31, 2020.

The above information is preliminary, has not been audited, and is subject to change upon the audit of the company’s financial statements for the year ended December 31, 2021.

Portfolio Update
Phase 3 Trial in wAIHA
Enrollment of Rigel’s FORWARD study, a Phase 3 pivotal trial of TAVALISSE in patients with wAIHA, is complete. Rigel expects to report topline data from the 24-week study in mid-2022 and proceed with regulatory filings if the data is positive. If approved, TAVALISSE has the potential to be the first-to-market therapy for patients with wAIHA in 2023.

COVID-19 Program
Rigel’s Phase 3 clinical trial evaluating fostamatinib in high-risk patients hospitalized with COVID-19 has enrolled 231 of the targeted 308 patients to date. In December, Rigel expanded the inclusion criteria to include patients with more severe disease (NIAID Ordinal Scale 6) to more accurately reflect the clinically predominant patient population hospitalized with COVID-19 and help speed enrollment. In collaboration with the United States Food and Drug Administration (FDA) and DOD, Rigel has also updated the primary endpoint for the study from progression to severe disease within 29 days, to the number of days on oxygen through day 29.

"As a study endpoint, reducing the number of days a patient spends on supplemental oxygen has proven to be clinically meaningful, is a good measure for recovery, and has been widely used in other large NIH sponsored trials in the recent past," said Wolfgang Dummer, M.D., Ph.D., Rigel’s chief medical officer. "The findings of the NIH/NHLBI phase 2 study provided evidence of broad, consistent and clinically meaningful improvement in mortality, time to sustained recovery, and the number of days on oxygen, for patients treated with fostamatinib in addition to standard of care. We look forward to confirming these findings in a larger patient population in our Phase 3 study."

This endpoint allows for closer comparison of the results with earlier results from the NIH/NHLBI Phase 2 trial with fostamatinib and various other NIH-sponsored trials, such as ACTIV-4, which uses a similar outcome measure as a primary endpoint. Rigel expects to complete enrollment and report topline data in mid-2022.

In addition to Rigel’s Phase 3 study, fostamatinib is also being evaluated as a treatment for COVID-19 in two ongoing studies, the NIH/NHLBI-funded Phase 3 ACTIV-4 Host Tissue trial and a Phase 2 open-label clinical trial conducted by Imperial College London.

IRAK1/4 Program
Rigel expects to advance R2899, a potent and selective IRAK1/4 inhibitor, into an open-label Phase 1b/2 clinical study in patients with low-risk myeloid dysplastic syndrome (MDS) in Q1 2022. R289 blocks inflammatory cytokine production in response to toll-like receptor (TLR) and interleukin-1 receptor family (IL-1R) signaling. TLRs and IL-1Rs play a critical role in the innate immune response, and dysregulation of these pathways can lead to various inflammatory conditions. Chronic stimulation of both these receptor systems is thought to cause the pro-inflammatory environment in the bone marrow responsible for persistent cytopenias in lower-risk MDS patients1.

RIPK1 Program Partnered with Eli Lilly
R5529, a potent and selective RIPK1 inhibitor, will advance into Phase 2 development in psoriasis in the 1H 2022 with partner Lilly. RIPK1 is implicated in a broad range of key inflammatory cellular processes and plays a key role in TNF signaling, especially in the induction of pro-inflammatory necroptosis. The program also includes RIPK1 compounds that cross the blood-brain barrier (CNS-penetrants) to address neurodegenerative diseases such as Alzheimer’s disease and ALS. Rigel is completing early discovery work on a potential candidate that Lilly may advance into clinical development.

Progress on Global Expansion in ITP
In December 2021, partner Kissei reported positive topline results for a Phase 3 study in ITP in Japan and is preparing a new drug application (NDA) for submission to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). In October 2018, Rigel entered into an exclusive license and supply agreement with Kissei to develop and commercialize fostamatinib in all current and potential indications in Japan, China, Taiwan and the Republic of Korea. Fostamatinib has Orphan Drug Designation in Japan and Korea.

About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO receptor agonists) and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
Autoimmune hemolytic anemia (AIHA) is a rare, serious blood disorder in which the immune system produces antibodies that destroy the body’s own red blood cells. AIHA affects approximately 45,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients. Warm antibody AIHA (wAIHA), the most common form of AIHA, is characterized by the presence of antibodies that react with the red blood cell surface at body temperature.

About COVID-19 & SYK Inhibition
COVID-19 is the infectious disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). SARS-CoV-2 primarily infects the upper and lower respiratory tract and can lead to acute respiratory distress syndrome (ARDS). Additionally, some patients develop other organ dysfunction including myocardial injury, acute kidney injury, shock resulting in endothelial dysfunction and subsequently micro and macrovascular thrombosis.2 Much of the underlying pathology of SARS-CoV-2 is thought to be secondary to a hyperinflammatory immune response associated with increased risk of thrombosis.3

SYK is involved in the intracellular signaling pathways of many different immune cells. Therefore, SYK inhibition may improve outcomes in patients with COVID-19 via inhibition of key Fc gamma receptor (FcγR) and c-type lectin receptor (CLR) mediated drivers of pathology such as pro-inflammatory cytokine release by monocytes and macrophages, production of neutrophil extracellular traps (NETs) by neutrophils, and platelet aggregation.4,5,6,7 Furthermore, SYK inhibition in neutrophils and platelets may lead to decreased thrombo-inflammation, alleviating organ dysfunction in critically ill patients with COVID-19.

About TAVALISSE
Indication
TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.
Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.
Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.
Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.
TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women about the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.
Drug Interactions

Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.
It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.
Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.
Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (eg, rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (eg, digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.
Adverse Reactions

Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).
Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.
Please see www.TAVALISSE.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE and TAVLESSE are registered trademarks of Rigel Pharmaceuticals, Inc.

Corporate Slide Presentation, dated January 10, 2022

On January 10, 2022 Atara Biotherapeutics, Inc. (the "Company") Presented the Corporate Presentation (Presentation, Atara Biotherapeutics, JAN 10, 2022, View Source [SID1234598476]).

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Biomea Fusion Announces 2022 Clinical Development Plan to Initiate Studies in up to Seven Different Tumor Types and in Diabetes for BMF-219

On January 10, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported that in 2022 it plans to initiate clinical studies to dose its irreversible covalent menin inhibitor, BMF-219, in up to seven different cancer indications as well as in diabetes (Press release, Biomea Fusion, JAN 10, 2022, View Source [SID1234598475]). Biomea is also confirming the preclinical development timeline of its second program, which the company is on track to announce in the first half of 2022 with an Investigational New Drug application (IND) planned within 12 months of candidate selection.

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BMF-219 is designed to be a highly selective, orally bioavailable small-molecule irreversible inhibitor of menin. Menin, a protein involved in transcriptional regulation, impacting cell cycle control, apoptosis, and DNA damage repair, plays a direct role in oncogenic signaling in multiple cancers. The menin complex plays a critical role in MYC-dependent oncogenic signaling, whereby menin enhances MYC-mediated transcription to promote cancer progression. Inhibition of menin is a novel approach to cancer treatment. Nonclinical studies of BMF-219 have shown sustained potent abrogation of menin-dependent oncogenic signaling and pathway control in vitro and in vivo. BMF-219 demonstrated consistent on-target inhibition with a strong anti-proliferative effect on various menin-dependent acute myeloid leukemia (AML) cell lines; diffuse large B-cell lymphoma (DLBCL) cell lines representing categories of Double/Triple Hit Lymphoma (DHL/THL) and Double Expressor Lymphoma (DEL); and multiple myeloma (MM) cell lines harboring diverse mutational backgrounds, including MYC dysregulation. BMF-219 also exhibited high potency in in vitro KRAS-driven cancer cell models. MYC, which exerts much of its oncogenic activity through interaction with menin, is a major downstream effector of the KRAS pathway. As previously announced, BMF-219 was also able to normalize glucose levels in both diabetic preclinical models studied with the glucose tolerance and homeostasis effect maintained despite complete washout of BMF-219.

In 2021, Biomea transformed into a clinical stage company with the initiation of BF-MNN-101, its first Phase I clinical trial of BMF-219. The trial is designed to assess BMF-219’s control of menin’s negative impact on patients with relapsed/refractory acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL). Biomea is confirming its clinical development plans to initiate additional clinical studies of BMF-219 in the following liquid tumors —MM and DLBCL— in the first half of 2022, and the following solid tumors —non-small cell lung cancer (NSCLC), pancreatic cancer, and colorectal cancer (CRC)— in the fourth quarter of 2022. In addition, subject to submission and clearance of an IND, Biomea plans to initiate a Phase I/II clinical trial of BMF-219 in diabetes during the second half of 2022.

"The preclinical profile of BMF-219 is highly compelling due both to its strong control of the menin pathway and very favorable safety profile. I am excited for Biomea to explore the clinical potential of this first-in-class and first-in-human irreversible menin inhibitor in multiple tumor types. We now know that the menin pathway is central to multiple cancer types. Targeting menin with a covalent binder is a very innovative approach and oncologists are eager to utilize BMF-219 for these patients who have limited therapeutic options," said Steve Morris, MD, Independent Medical Oncologist and Leukemia/Lymphoma Expert, Retired Faculty Member, Yale University School of Medicine and St. Jude Children’s Research Hospital; who performed basic and translational research regarding menin-driven leukemias and cared for patients with these malignancies during his 30-year career in academic medicine.

"From the very beginning, we recognized menin as a key node in the oncogenic pathways of a broad array of tumors. We are very excited about what we have learned over the past years in preclinical studies with our irreversible menin inhibitor, BMF-219. Having observed essentially complete pathway control with consistent on-target effect across multiple tumor types, these studies demonstrated that BMF-219 has the potential to irreversibly inhibit the function of menin while maintaining a wide safety margin. These results have validated our plans to pursue BMF-219 for the treatment of 7 select liquid and solid tumors which we are planning to initiate during this year," said Thomas Butler, CEO and Chairman of the Board. "We have also completed the preclinical validation of BMF-219 for the treatment of diabetes with two important animal models and are now preparing the IND to support the initiation of a Phase I/II clinical trial to begin in the second half of this year."

About Irreversible Menin Inhibitor BMF-219 Target Indications

Acute Myeloid Leukemia (AML) and Acute Lymphocytic Leukemia (ALL)
AML is the most common form of acute leukemia in adults and represents the largest number of annual leukemia deaths in the U.S. and Europe. AML originates within the white blood cells in the bone marrow and can rapidly move to the blood and other parts of the body, including the lymph nodes, spleen, and central nervous system. Approximately 20,000 people in the U.S are diagnosed with AML each year, and the five-year overall survival rate in adults is roughly 29% (Source: NCI SEER Data). Among patients with relapsed/refractory disease, the need is greatest, as the overall survival is approximately 3 to 9 months. It is estimated that upwards of 45% of AML patients have menin dependent genetic drivers (MLL-r or NPM1). ALL is a less common leukemia, with approximately 6,000 new cases in the U.S. each year and a higher five-year survival rate of nearly 70% (Source: NCI SEER Data). Between 10-15% of adult ALL patients and 60-70% of pediatric ALL patients have MLL-r translocations.

Multiple Myeloma (MM)
MM is a cancer of plasma cells, which make antibodies (immunoglobulins) and are mainly located in the bone marrow. As cancerous cells migrate from the bone marrow, organ damage due to excess immunoglobulins in bones and blood and weakening of bones are common features. Approximately 35,000 people in the U.S. are diagnosed with MM each year and the 5-year relative survival rate is ~56% (Source: NCI SEER Data). Among patients with relapsed or refractory disease, the need is greatest, with overall survival as low as 6 months in some patients. Additionally, it is estimated that more than 60% of MM patients have menin dependent genetic drivers (MYC addicted or driven) and that these drivers are more common in the relapsed or refractory setting.

Diffuse Large B-Cell Lymphoma (DLBCL)
DLBCL is the most common subtype of Non-Hodgkin Lymphoma. DLBCL starts in white blood cells called lymphocytes and it usually grows in lymph nodes. Every year, approximately ~18,000 people in the U.S. are diagnosed with DLBCL (Source: NCI SEER Data). Following initial treatment with standard chemotherapy, approximately 70% of patients have a complete response and approximately 50% of patients are cured. For patients with relapsed or refractory DLBCL, median overall survival is between 6-7 months. Double Hit Lymphomas (DHL), Triple Hit Lymphomas (THL), and Double Expressor Lymphomas (DEL) are high grade B-cell lymphomas (HGBLs) that have high MYC and BCL2 dependency. Based on their aggressive nature, DHL, THL, and DEL represent a large portion of the relapsed or refractory DLBCL population.

Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer is the most common form of lung cancer, representing ~84% of all lung cancer cases or approximately 200,000 cases in the U.S. each year (Source: NCI SEER Data). Additionally, the five-year survival rate of NSCLC is ~25%. While lung cancer is the 3rd most common form of cancer in the U.S. based on incidence, lung cancer contributes to the highest number of annual cancer deaths in the U.S.. KRAS is the most frequent oncogene in NSCLC, occurring in ~30% of patients with NSCLC.

Pancreatic Cancer
Pancreatic cancer is a relatively rare form of cancer in the U.S., representing approximately 60,000 cases in the U.S. each year (Source: NCI SEER Data). Pancreatic cancer is an aggressive cancer with a very low five-year survival rate of ~11%, indicating that there is a large unmet need. It is rarely diagnosed early, contributing to the low survival rate. Among patients with pancreatic cancer, RAS mutations (including KRAS) occur in up to approximately 98% of patients.

Colorectal Cancer (CRC)
Colorectal cancer is the fourth most common form of cancer in the U.S., representing approximately 150,000 cases in the U.S. each year (Source: NCI SEER Data). These cancers start in the rectum or the colon and can be diagnosed/identified early, even potentially as noncancerous polyps. The five-year survival rate of CRC is approximately 65%. Among other mutations, KRAS mutations occur in approximately 50% of patients with CRC.

Diabetes
Diabetes mellitus is characterized by a reduced ability to produce insulin and/or by a dysregulated response to insulin and affects nearly 34 million people in the U.S. (Source: CDC). Diabetes is grouped into a few clinical categories based on etiology or timing of diagnosis according to the latest guidance from the American Diabetes Association. Accounting for 1.6 million diagnosed patients in the U.S., Type 1 diabetes is due to autoimmune beta-cell destruction, usually leading to absolute insulin deficiency, including latent autoimmune diabetes of adulthood. Type 2 diabetes has been diagnosed in approximately 25.3 million people in the U.S. and is due to a progressive loss of adequate beta-cell insulin secretion frequently on the background of insulin resistance. The primary treatment goal is to achieve glycemic control by reducing HbA1c (A1c), a marker for the amount of sugar in the bloodstream, to 6.5% or lower. Glycemic control is a validated approach to delaying disease progression, which leads to significant and potentially fatal renal, cardiac, neurological, and ophthalmic comorbidities.