On February 15, 2022 ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd. (hereinafter referred to as "ImmuneOnco", the company) reported that the first bispecific antibody-receptor recombinant protein (project number: IMM2902) targeting human CD47 x HER2 has completed the first patient enrollment and dosing, and administration process was smooth and successful (Press release, ImmuneOnco Biopharma, FEB 15, 2022, View Source [SID1234655630]).

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IMM2902, a CD47xHER2 bispecific fusion protein designed for solid tumors, is at the forefront of global research. The project has previously been approved by the National Medical Products Administration (NMPA) and the US Food and Drug Administration (FDA) for clinical trials on June 29, 2021 and August 21, 2021. It is the third new drug project in the clinical research stage of the company based on targeting CD47/SIRPa. The completion of the first subject enrollment and dosing in the IMM2902 project is another major milestone for the company.

Dr. Wenzhi Tian, Founder and CEO of the company, is very confident in the clinical trial research of IMM2902.

"We are very pleased that our IMM2902 project has completed the first patient in. IMM2902 is a bispecific molecule developed on our mAb-Trap technique platform for CD47 and HER2. The molecule preferentially binds to tumor cells through the high affinity to HER2 and CD47, at the same time, it doesn’t bind to human red blood cells and other off-target cells, so as to avoid the "Antigen sink" effect, thereby greatly enhance the synergistic effect based on both targets against tumors. IMM2902 will have great potential in clinical development and commercial value."

On February 15, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial stage company engaged in the discovery, development and sale of drugs to treat severe metabolic, oncologic and neuropsychiatric disorders by modulating the effects of the hormone cortisol, reported its results for the quarter and year ended December 31, 2021 (Press release, Corcept Therapeutics, FEB 15, 2022, View Source [SID1234608128]).

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Financial Results
•Fourth quarter revenue of $98.8 million, compared to $85.7 million in fourth quarter 2020
•2021 revenue of $366.0 million, compared to $353.9 million in 2020
•2022 revenue guidance of $400 – $430 million
•Fourth quarter GAAP net income of $32.1 million, compared to $26.0 million in fourth quarter 2020
•2021 GAAP net income of $112.5 million, compared to $106.0 million in 2020
•Purchase of ten million shares of Corcept common stock for $207.5 million in fourth quarter 2021
•Cash and investments of $335.8 million
"Korlym is an excellent treatment for Cushing’s syndrome and there are many eligible patients who have yet to receive it. As pandemic restrictions and fears recede, as they already have in certain locations, we expect our growth to continue and are providing 2022 revenue guidance of $400 – $430 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.
Corcept’s fourth quarter 2021 revenue was $98.8 million, compared to $85.7 million in the fourth quarter of 2020. 2021 revenue was $366.0 million, compared to $353.9 million in 2020. The company expects 2022 revenue of $400 – $430 million.
GAAP net income was $32.1 million in the fourth quarter of 2021, compared to $26.0 million in the fourth quarter of 2020. For the full year, it was $112.5 million in 2021, compared to $106.0 million in 2020.
Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income in the fourth quarter was $42.6 million, compared to $34.7 million in the fourth quarter of 2020. For the full-year, non-GAAP net income was $149.5 million, compared to $145.6 million in 2020. A reconciliation of GAAP to non-GAAP net income is included below.
Cash and investments of $335.8 million at December 31, 2021 reflects the purchase of ten million shares of Corcept common stock for $207.5 million in the fourth quarter 2021.
Clinical Development
"In addition to successfully managing challenges posed by the pandemic for our commercial business, we significantly advanced our clinical development programs in 2021," said Dr. Belanoff. "Cortisol modulation has the potential to treat many serious diseases. Data generated by our ovarian cancer and non-alcoholic steatohepatitis (NASH) programs last year provided evidence of cortisol modulation’s broad application. In 2022, we will see important results from many of our ongoing clinical programs. We also continue to advance new cortisol modulators to the clinic. Of particular note, we plan to start a Phase 2 trial in patients with amyotrophic lateral sclerosis (ALS) in the second quarter."

Solid Tumors
•Updated overall survival data from Phase 2 trial in patients with recurrent platinum-resistant ovarian cancer expected in first quarter 2022; Phase 3 trial planned to start second quarter 2022
•Selection of the optimum dose of exicorilant or relacorilant plus enzalutamide in patients with castration-resistant prostate cancer (CRPC) expected in second quarter 2022
•Enrollment continues in 20-patient, open-label, Phase 1b trial of relacorilant plus PD-1 checkpoint inhibitor pembrolizumab in patients with adrenal cancer with cortisol excess
"Our 178-patient, randomized, controlled Phase 2 trial of relacorilant in patients with recurrent platinum-resistant ovarian cancer met its objective of improving progression free survival, without increased side effect burden," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "We and our investigators are excited to advance relacorilant for the potential treatment of ovarian cancer based on these statistically significant and clinically meaningful results. We expect the trial’s updated overall survival data later this quarter and plan to meet with the FDA in the coming months to define the best path forward."
Metabolic Diseases
•Enrollment completed in GRATITUDE II, a 150-patient, double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse long-standing antipsychotic-induced weight gain (AIWG); data expected in fourth quarter 2022
•Completion of enrollment in GRATITUDE, a double-blind, placebo-controlled Phase 2 trial of miricorilant to reverse recent AIWG, expected by mid-2022; data expected in fourth quarter 2022
•Enrollment continues in Phase 1b dose-finding trial of miricorilant in patients with presumed NASH
"We are pleased to have fully-enrolled GRATITUDE II and to be nearing completion of enrollment in GRATITUDE. AIWG is a serious metabolic disorder suffered by millions of patients in the United States, with few treatment options," said Dr. Guyer. "We initiated these double-blind, placebo-controlled, Phase 2 trials to build on the positive data from our studies of both miricorilant and mifepristone in healthy volunteers. We look forward to the data readout from both trials, which we expect in the fourth quarter."
"We and our investigators are very excited by the unprecedented rapidity and magnitude of liver fat reduction experienced by patients taking miricorilant in our previous NASH study," added Dr. Guyer. "The goal of our Phase 1b dose-finding study is to identify a dosing regimen that significantly reduces fat without causing excessive liver irritation."
Cushing’s Syndrome
•Enrollment continues in Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome; new drug application (NDA) submission expected in second quarter 2023
•Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
"Our Phase 3 GRACE and GRADIENT trials continue to accrue patients and generate data. We expect GRACE to serve as the basis for relacorilant’s NDA in Cushing’s syndrome, and we are on track to make this submission in the second quarter of 2023," said Dr. Guyer. "GRADIENT is on track to produce valuable data about an etiology of Cushing’s syndrome that affects many patients, but has not been subject to rigorous, controlled study."
Conference Call
We will hold a conference call on February 15, 2022, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, click this link (listen-only mode) or dial 1-833-693-0540 from the United States or 1-661-407-1581

internationally approximately 15 minutes before the start of the call. A replay will be available through February 22, 2022 at 1-855-859-2056 from the United States and 1-404-537-3406 internationally. The passcode will be 1861918. A replay will also be available on the Investors / Past Events tab of our website.
Hypercortisolism
Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

On February 15, 2022 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation for its circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOneTracker (Press release, Foundation Medicine, FEB 15, 2022, View Source [SID1234608146]). The assay uses optimized algorithms for identifying patient-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma. The Breakthrough Device designation was granted for the assay’s use in the detection of molecular residual disease, commonly known as MRD, in early-stage cancer after curative therapy. This molecular detection can help guide further therapy decisions depending on MRD status and an individual’s risk of relapse.

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Developed in partnership with Natera, FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in personalized ctDNA monitoring. The companies launched the research use only version of FoundationOne Tracker in June 2021, collaborating to support biopharma and academic partners with clinical trial and companion diagnostic planning.

In addition to the indications granted through the Breakthrough Device designation, FoundationOne Tracker’s personalized technology aims to address ctDNA detection and molecular monitoring in patients with both early- and advanced-stage cancers, including assessment of a patient’s response to therapy, as well as MRD detection, surveillance, and detection of molecular residual relapse following curative intent therapy.

"Foundation Medicine continues to shape the future of clinical care and research by helping oncologists and our industry partners find the answers they need to bring precision cancer care to patients," said Brian Alexander, M.D., M.P.H., chief executive officer at Foundation Medicine. "Personalized molecular disease monitoring enables early detection of ctDNA and can monitor for risk of relapse and track therapy response to help oncologists make personalized treatment plans for their patients. We are enthusiastic about our work to accelerate development of this assay so that it can more quickly impact care decisions in the clinic."

The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

On the heels of data presented at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium last month exploring the feasibility of MRD in metastatic colorectal patients who have undergone curative intent surgical resection, Foundation Medicine will also be presenting additional MRD data at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium on February 18 on the genomics of resected early-stage bladder cancer to validate CGP-informed MRD detection in ctDNA.

On February 15, 2022 Adaptive Biotechnologies Corporation ("Adaptive Biotechnologies") (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Adaptive Biotechnologies, FEB 15, 2022, View Source [SID1234608129]).

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"We finished the year strong with revenue increasing 57% year over year, driven by growth in both our sequencing and development revenue categories," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "As we move into 2022, I am encouraged by the momentum and the multiple shots on goal across our businesses, which could positively inflect the trajectory of the company."

Recent Highlights

Revenue of $37.9 million for the fourth quarter and $154.3 million for the full year of 2021, representing a 26% increase and 57% increase, respectively, over the corresponding periods in 2020.

clonoSEQ clinical sequencing volume increased 41% to 6,356 clinical tests delivered in the fourth quarter of 2021, compared to the fourth quarter of 2020 and ended the year with 22,516 clinical tests delivered, up 48% versus 2020.

Recognized $10.0 million in MRD regulatory milestones resulting from pharmaceutical partners who used data from our MRD assay to support their respective drug approvals.

Genentech selected TCR candidate targeting a shared cancer neoantigen to progress as a potential therapeutic product candidate.

Received Emergency Use Authorization (EUA) from FDA for T-Detect COVID to confirm recent or prior COVID-19 infection with over 30,000 tests ordered.

Confirmed T-Detect signals in Crohn’s disease and Multiple Sclerosis and identified signals in Ulcerative Colitis and Rheumatoid Arthritis.

Fourth Quarter 2021 Financial Results

Revenue was $37.9 million for the quarter ended December 31, 2021, representing a 26% increase from the fourth quarter in the prior year. Sequencing revenue was $23.1 million for the quarter, representing an 81% increase from the fourth quarter in the prior year. Development revenue was $14.9 million for the quarter, representing a 15% decrease from the fourth quarter in the prior year.

Operating expenses were $99.5 million for the fourth quarter of 2021, compared to $74.4 million in the fourth quarter of the prior year, representing an increase of 34%.

Net loss was $61.4 million for the fourth quarter of 2021, compared to $44.6 million for the same period in 2020.

Adjusted EBITDA (non-GAAP) was a loss of $44.9 million for the fourth quarter of 2021, compared to a loss of $34.6 million for the fourth quarter of the prior year.

Full Year 2021 Financial Results

Revenue was $154.3 million for the year ended December 31, 2021, representing a 57% increase from the prior year. Sequencing revenue was $78.9 million in 2021, representing a 90% increase from 2020. Development revenue was $75.4 million in 2021, representing a 32% increase from the prior year.

Operating expenses for 2021 were $363.3 million, compared to $251.2 million for 2020, representing an increase of 45%.

Net loss was $207.3 million in 2021, compared to $146.2 million in 2020.

Adjusted EBITDA (non-GAAP) was a loss of $151.7 million for 2021, compared to a loss of $119.6 million in the prior year.

Cash, cash equivalents and marketable securities was $570.2 million as of December 31, 2021.

2022 Financial Guidance

Management will provide the 2022 outlook during the conference call scheduled to discuss the 2021 financial results.

Webcast and Conference Call Information

Adaptive Biotechnologies will host a conference call to discuss its fourth quarter and full year 2021 financial results after market close on Tuesday, February 15, 2022 at 4:30 PM Eastern Time. The conference call can be accessed at View Source The webcast will be archived and available for replay at least 90 days after the event.

On February 15, 2022 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported a global, multi-year definitive licensing agreement whereby it granted Eli Lilly and Company (Lilly) exclusive rights to research, develop, and commercialize ADCs directed to targets selected by Lilly based on ImmunoGen’s novel camptothecin technology (Press release, ImmunoGen, FEB 15, 2022, View Source [SID1234608147]). ImmunoGen retains full rights to the camptothecin platform for all targets not covered by the Lilly license.

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As part of the agreement, Lilly will pay ImmunoGen an upfront payment of $13 million, reflecting initial targets selected by Lilly. Lilly may select a pre-specified number of additional targets, with ImmunoGen eligible to receive an additional $32.5 million in exercise fees if Lilly licenses the full number of targets. ImmunoGen is eligible to receive up to $1.7 billion in potential target program exercise fees and milestone payments based on the achievement of pre-specified development, regulatory, and commercial milestones. ImmunoGen is also eligible for tiered royalties as a percentage of worldwide commercial sales by Lilly. Lilly is responsible for all costs associated with research and development.

Camptothecins are an important class of anticancer drugs targeting Type I topoisomerase. ImmunoGen’s proprietary class of camptothecin linker-payloads are designed to optimize existing camptothecin technology to potentially deliver a wider therapeutic window with enhanced safety and efficacy.

"Lilly has a proven track record of bringing transformative oncology medicines to market, and we are pleased that they selected our novel camptothecin technology to integrate with their efforts to develop next-generation ADCs," said Stacy Coen, ImmunoGen’s Senior Vice President and Chief Business Officer. "This licensing agreement demonstrates ImmunoGen’s continued innovation in ADCs, creates value from our intellectual property around a proprietary platform, and further enhances our ability to re-invest in our business as we build out our pipeline and accelerate our transformation into a fully-integrated oncology company."