On March 9, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Acorda Therapeutics, MAR 9, 2022, View Source [SID1234609772]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2021, we achieved our top corporate priorities: growing INBRIJA’s net revenue, achieving the top of our guidance for Ampyra net sales in the face of generic competition, executing two agreements to commercialize Inbrija outside the US, and maintaining fiscal discipline," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "INBRIJA net sales in 2021 were 22% greater than in 2020, despite the continuing impact of the pandemic on our business. As COVID-19 recedes, we believe we will gain significant opportunities to accelerate INBRIJA’s trajectory."

"We also made notable progress on our goal of strengthening Acorda’s financial position. We retired our short-term convertible debt and implemented budget cuts that are expected to result in a $60 million annualized reduction in operating expenses in 2022 as compared to 2020. We also expect new revenue streams to commence in 2022: Esteve projects that it will launch INBRIJA in Germany by mid-2022 and in Spain in early 2023. Acorda will receive a significant double-digit percent of the selling price in exchange for supply of the product, as well as sales-based milestones in Germany. We also expect that the double-digit royalties on Biogen’s ex-US sales of FAMPYRA will return to Acorda in mid-2022. Based on our projections, we are aiming to be cash flow neutral on a run rate basis by the end of 2022."

Fourth Quarter 2021 Financial Results

For the quarter ended December 31, 2021, the Company reported AMPYRA net revenue of $22.5 million compared to $25.3 million for the same quarter in 2020. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018, and the Company expects AMPYRA revenue to continue to decline.

The Company reported INBRIJA net revenue of $10.4 million, compared to $9.3 million for the same quarter in 2020.

Research and development (R&D) expenses were $1.4 million, including $0.1 million of share-based compensation compared to $4.3 million, including $0.3 million of share-based compensation for the same quarter in 2020.

Sales, general and administrative (SG&A) expenses were $28.4 million, including $0.4 million of share-based compensation, compared to $32.9 million, including $1.2 million of share-based compensation for the same quarter in 2020.

Change in fair value of derivative liability was ($0.3) million compared to $0.4 million for the same quarter in 2020.

Provision for income taxes was $1.7 million compared to a benefit from income taxes of $3.1 million for the same quarter in 2020.

The Company reported a GAAP net loss of $20.6 million, or $1.73 per diluted share, compared to a GAAP net loss in the same quarter of 2020 of $83.0 million, or $9.82 per diluted share.

Non-GAAP net loss was $7.9 million, or $0.67 per diluted share. Non-GAAP net loss in the same quarter of 2020 was $21.1 million, or $2.50 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, losses on assets held for sale, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

1 This guidance is a non-GAAP projection that excludes certain items as more fully described under "Non-GAAP Financial Measures."

Full Year Ended December 31, 2021 Financial Results

For the full year ended December 31, 2021, the Company reported AMPYRA net revenue of $84.6 million compared to $98.9 million for the full year 2020 and INBRIJA net revenue of $29.6 million compared to $24.2 million for the full year 2020.

Research and development (R&D) expenses were $10.4 million, including $0.7 million of share-based compensation, compared to $23.0 million, including $1.7 million of share-based compensation for the full year 2020.

Sales, general and administrative (SG&A) expenses were $124.4 million, including $2.3 million of share-based compensation, compared to $152.6 million, including $6.0 million of share-based compensation for the full year 2020.

Benefit from income taxes was $5.1 million, compared to a benefit from income taxes of $8.1 million for the full year 2020.

The Company reported GAAP net loss of $104.0 million, or $9.95 per diluted share, compared to a GAAP net loss for the full year 2020 of $99.6 million, or $12.32 per diluted share.

Non-GAAP net loss was $65.9 million, or $6.31 per diluted share. Non-GAAP net loss was $72.9 million, or $9.02 per diluted share for the full year 2020. This full year non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, changes in the fair value of acquired contingent consideration, asset impairment charges, losses on assets held for sale, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At December 31, 2021, the Company had cash, cash equivalents, and restricted cash of $65.2 million compared to $102.9 million at year end 2020. Cash at year end 2021 includes approximately $5.3 million associated with a December 2021 amendment to our Catalent manufacturing services agreement that modified our payment schedule. Under the terms of the amendment, the Company is required to pay Catalent only for actual product delivered during the period from July 1, 2021 through June 30, 2022, subject to a cap that corresponds to the original payment obligation. Restricted cash includes $18.6 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the convertible note exchange completed in December 2019. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.

Financial Guidance

AMPYRA net revenue for the full year 2022 is expected to be between $68 – 78 million.
Operating expenses for the full year 2022 are expected to be between $110 – 120 million. This guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."
2021 Highlights

In November, 2021, Acorda announced an agreement with Esteve to commercialize INBRIJA in Germany. As part of the agreement, Acorda received a $5.9 million up-front payment. The Company will also receive a significant double-digit percent of the selling price in exchange for supply of the product, and will receive additional sales-based milestones. Esteve expects to launch INBRIJA in Germany in mid-2022.
In September 2021, Acorda announced an agreement with Esteve to commercialize INBRIJA in Spain. Acorda will receive a significant double-digit percent of the selling price in exchange for supply of the product. Esteve expects to launch INBRIJA in Spain in early 2023.
Acorda retired its short-term convertible debt and implemented budget cuts that are expected to result in a $60 million annualized reduction in operating expenses in 2022 as compared to 2020.
Acorda announced several changes to its leadership. John Varian was appointed to Acorda’s board of directors in January 2022. In November, 2021, Michael Gesser joined Acorda as Chief Financial Officer and Neil Belloff joined as General Counsel. In addition, during 2021, Lauren Sabella was named Chief Operating Officer and Kerry Clem was named Chief Commercial Officer. Burkhard Blank, M.D., Acorda’s Chief Medical Officer, transitioned to a consulting role as of January 1, 2022.
Webcast

The Company will host a webcast in conjunction with its fourth quarter and year-end 2021 update and financial results today at 4:30 p.m. ET.

To register for the Webcast, use the link below:
View Source
If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast, you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on March 9, 2022 until 11:59 p.m. ET on April 8, 2022. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); reference code 309853. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP) and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income (loss), adjusted to exclude the items below, and has provided 2022 operating expense guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of non-GAAP net income (loss), when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) asset impairment charges that are not routine to the operation of the business, (v) expenses that pertain to corporate restructurings which are not routine to the operation of the business, (vi) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business, and (vii) losses on assets held for sale that pertain to a non-routine sale of manufacturing operations. The Company believes its non-GAAP net income (loss) measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income (loss), we have provided 2022 operating expense guidance on a non-GAAP basis, as the guidance excludes restructuring costs and share-based compensation charges. Due to the forward looking nature of this information, the amount of compensation charges needed to reconcile this measure to the most directly comparable GAAP financial measure is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of this non-GAAP financial measure, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because it excludes (i) expenses that pertain to corporate restructurings not routine to the operation of our business, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe this non-GAAP financial measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

On March 9, 2022 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, reported financial results for the full year ended December 31, 2021, and outlined key 2022 priorities (Press release, TScan Therapeutics, MAR 9, 2022, View Source [SID1234609788]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"As we had guided throughout 2021, in December we filed two INDs for our liquid tumor program. We also completed construction of our now fully functional 7,000 square-foot GMP manufacturing facility. Both of these steps are instrumental in our transformation to a clinical-stage company," said David Southwell, President and Chief Executive Officer. "We also advanced our growing pipeline of solid tumor candidates and look forward to sharing further details around these programs in the coming months."

Recent Corporate Highlights

In January 2022, the Company announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-100 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation. The target of TSC-100 is the minor histocompatibility antigen HA-1, which is a lineage-specific antigen found on blood cells. The Company has now submitted the clinical protocol to Institutional Review Boards (IRBs) for the initial study sites and expects to initiate clinical trials in the first half of 2022.

In December 2021, the Company presented two posters related to its lead liquid tumor candidates TSC-100 and TSC-101 at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. The posters highlighted the discovery of TSC-101, as well as the manufacturing process and clinical development plan for liquid tumor candidates TSC-100 and TSC-101.

During the fourth quarter of 2021, the Company completed the construction of a state-of-the-art good manufacturing practices (GMP) facility to manufacture Phase I/II TCR-T therapies. This facility will support the manufacturing of TSC-100 and TSC-101, as well as solid tumor candidates TSC-200, TSC-201, TSC-202, TSC-203, and TSC-204, designed to treat patients with solid tumors including head and neck, cervical, melanoma and non-small cell lung cancers.

The Company continues to strengthen its management team with the appointment of Ray Lockard as Vice President, Quality. Mr. Lockard brings over 25 years of experience in quality, validation, supply chain and manufacturing to TScan. Mr. Lockard most recently served as Executive Director, CMC QA and External Quality at Ultragenyx Pharmaceutical Inc. Prior to that, Mr. Lockard held positions of increasing responsibility for various biotechnology and life sciences companies including Biogen Inc., Alnylam Pharmaceuticals, Inc., Precision NanoSystems, Editas Medicine, Inc., and AveXis, Inc. (now Novartis Gene Therapies). Mr. Lockard holds a B.S. in Biology from Hampden-Sydney College and an M.B.A. from the University of North Carolina, Chapel Hill, Kenan-Flagler Business School.
Upcoming Expected Milestones and Key Priorities for 2022

Liquid Tumor Programs: TScan’s two lead liquid tumor TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, and treat patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation.

Initiate Phase 1 umbrella trial for TSC-100 following submission of clinical protocol to IRBs for the initial study sites, with plans to enroll patients in the first half of 2022.

As previously disclosed, the FDA placed a clinical hold on the IND for TSC-101 in January 2022. The Company has since received written communication from the FDA asking for additional assessment of the potential for off-tumor reactivity in certain tissues. TScan is working with the agency to resolve its questions as quickly as possible. The liquid tumor trial is based on an umbrella protocol, which will allow the Company to begin the TSC-100 and control arms in the near term and to open the TSC-101 arm of the ongoing trial upon clearance of the IND.

Present initial clinical data from the liquid tumor program at a medical meeting in the second half of 2022.
Solid Tumor Programs: TScan’s TSC-200 series of TCR-T therapy candidates include a combination of known targets, such as HPV16 for TSC-200, PRAME for TSC-203, and MAGE-A1 for TSC-204, as well as targets that are novel antigens for TCR-T therapy, such as those for TSC-201 and TSC-202.

Present initial preclinical data on the TSC-200 series at a medical meeting in the first half of 2022.

Progress IND-enabling studies for the TSC-200 series and submit two IND applications during the second half of 2022. These are expected to include TSC-200 for HPV and TSC-204 for MAGE-A1.

In 2023, the Company plans to release initial clinical data for the TSC-200 series TCRs, as well as file further INDs for additional programs in this series.
Infectious Disease Program

Research is continuing into potential T cell focused COVID-19 vaccine constructs utilizing TScan’s novel T cell target discoveries. The Company is currently conducting preclinical studies for this program.
Full Year 2021 Financial Results

As of December 31, 2021, TScan Therapeutics had cash and cash equivalents of $161.4 million excluding $5.0 million of restricted cash. Based on current operating plans, the Company believes that existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into 2024.

Revenue for the year ended December 31, 2021, was $10.1 million, compared to $1.1 million for the year ended December 31, 2020 (2020 Period). This increase is due to a full year of research activities related to TScan’s collaboration agreement with Novartis Institutes for Biomedical Research, on which work began in September 2020.

Research and development expenses for the year ended December 31, 2021, were $45.0 million, compared to $20.6 million for the 2020 Period. The increase of $24.4 million was primarily a result of increased personnel expenses and facility-related expenses, as well as expenses related to the progress of the Company’s liquid and solid tumor programs to IND filing.

General and administrative expenses for the year ended December 31, 2021, were $13.8 million, compared to $6.7 million for the 2020 Period. The increase of $7.1 million in general and administrative expenses was primarily a result of increased personnel expenses and other miscellaneous expenses, including expenses related to the IPO and status as a public company.

For the year ended December 31, 2021, TScan Therapeutics reported a net loss of $48.6 million, compared to a net loss of $26.1 million for the 2020 Period.

As of December 31, 2021, the company had issued and outstanding shares of 24,024,467 and 23,907,597, respectively.

On March 9, 2022 Orion’s collaboration Bayer reported the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) as well as the submission of a Variation Type II to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide. Bayer is seeking approval for the use of darolutamide in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) (Press release, Bayer, MAR 9, 2022, View Source [SID1234609804]). The compound is already approved in more than 60 markets around the world, including the U.S., the European Union (EU), Japan and China, under the brand name Nubeqa, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The submissions are supported by positive results from the Phase III ARASENS trial, showing a statistically significant improvement in overall survival (OS) for darolutamide plus ADT and docetaxel in men with mHSPC. These results were presented in February at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.

Darolutamide is developed jointly by Orion and Bayer. Additional filings in mHSPC are planned by Bayer globally. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801).

About the ARASENS Trial

The ARASENS trial is a randomized, Phase III, multi-center, double-blind, placebo-controlled trial which was prospectively designed to investigate the efficacy and safety of oral darolutamide, an androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.1

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 5% of men will already suffer from prostate cancer with distant metastases when first diagnosed. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited survival.

About darolutamide

Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. A low blood-brain barrier penetration would explain the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.

The product is approved under the brand name Nubeqa in more than 60 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. The compound is also being investigated in further studies across various stages of prostate cancer, including another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). Information about these trials can be found at www.clinicaltrials.gov.

On March 9, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present new data from its broad portfolio of blood tests at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 8-13, 2022 (Press release, Guardant Health, MAR 9, 2022, View Source [SID1234609819]). Included in the presentation will be data from its multi-cancer screening assay, next-generation Guardant SHIELD.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to share the feasibility data for our innovative multi-cancer screening assay. This data will demonstrate that our assay provides sensitive detection of early-stage cancers with accurate tissue of origin identification," said AmirAli Talasaz, Guardant Health co-CEO. "The data to be presented at this year’s AACR (Free AACR Whitepaper) meeting demonstrates our deep commitment to providing physicians with the resources to help patients at all stages of cancer live longer and healthier lives."

Full List of Guardant Health Presentations

Development of a highly-sensitive targeted cell-free DNA epigenomic assay for early-stage multi-cancer screening (Abstract 2141). Session MS.CL11.02 – Biomarkers 2, oral presentation.
CDK4/6 inhibitors (CDK4/6i) is effective in the real-world setting for hormone receptor-positive metastatic breast cancer (HR+ MBC) with ESR1 mutations and fusions (Abstract 5248)
Multiomic, plasma-only circulating tumor DNA (ctDNA) assay identifies breast cancer patients with minimal residual disease (MRD) and predicts distant recurrence (Abstract 3403/9)
Genomic landscape of circulating tumor DNA alterations in patients with paraganglioma and pheochromocytoma (Abstract 5790)
Predictive ability of circulating tumor DNA by Guardant360 in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations (Abstract 3400/6)
Longitudinal evaluation of ctDNA molecular response for monitoring clinical benefit and investigating treatment related impacts in metastatic colorectal cancer patients treated with different drug regimens (Abstract 5748)
Occurrence of BRAF class II and III alterations is common across solid tumors and is associated with inferior clinical outcomes in NSCLC and melanoma (Abstract 4122/6)
Characterization of sub-clonal RAS/BRAF alterations in an anti-EGFR treated advanced CRC cohort using a liquid biopsy-based real world clinical genomics database (Abstract 5245)

On March 9, 2022 Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (NK) cell and macrophage platforms, reported that two of its abstracts have been accepted for presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting taking place April 8-13, 2022 in New Orleans, LA (Press release, Shoreline Biosciences, MAR 9, 2022, View Source [SID1234609834]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We’re thrilled to present data on Shoreline’s innovative screening platform and methodology to discover iPSC-derived cell therapies at AACR (Free AACR Whitepaper) 2022," said Kleanthis G. Xanthopoulos, Ph.D., Chairman and CEO. "This is the first time we are showcasing our science at such an important scientific meeting, and we look forward to contributing to the advancement of the cell therapy space through our differentiated approach."

Details of the poster presentations are below:

Title: "A novel method to produce clinical scale induced pluripotent stem cell-derived natural killer (iPSC-NK) cells with improved anti-tumor activity for next-generation allogenic cell therapies"
Abstract Number: 4319
Session Title: Stem Cells and Regulatory Pathways in Cancer
Session Date and Time: Tuesday April 12, 2022 1:30 PM – 5:00 PM
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 12

Title: "Development of an iPSC-derived NK cell screening platform for discovery of NK cell optimized Chimeric Antigen Receptors (CARs) for next-generation CAR-NK cell immunotherapies"
Session Title: Adoptive Cell Therapy 1
Session Date and Time: Sunday April 10, 2022 1:30 PM – 5:00 PM
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 36

Abstracts and full session details can be accessed through the AACR (Free AACR Whitepaper) meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2022 | April 8-13, 2022 | New Orleans