On March 13, 2024 Enzo Biochem, Inc. (NYSE: ENZ) ("Enzo" or the "Company") reported financial results for the second quarter ended January 31, 2024 (Press release, Enzo Biochem, MAR 13, 2024, View Source [SID1234641111]).

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Second Quarter Highlights

● The Company’s Life Science division’s second-quarter revenue of $8.5 million improved year-over-year by 14%. During the 2024 period, we experienced a 25% revenue increase in the United States, driven by increased product demand in the drug development and cell and gene therapy market segments. Revenue for the six months ended January 31, 2024 of $16.4 million improved 12% compared to the same period in the prior year.

● The Life Science division’s second-quarter gross margin was 49%, which improved by 1,000 basis points year-over-year from 39%, and was also a sequential 500 basis point improvement from 44%. The six-month YTD margin was 47% which was also a 1,000 basis point improvement compared to the prior year. This favorable result was driven by the reported revenue increase, mix of products sold, and ongoing cost containment initiatives, including, but not limited to, a workforce reduction for continuing operations.

● The Life Science division reported second-quarter net income of $1.1 million, compared to net income of $0.2 million in the prior year period. The net loss in the Corporate & Other segment decreased year-over-year by $1.2 million.

● Enzo ended the second quarter with aggregate cash and cash equivalents of $60.2 million, a reduction of $23.1 million from July 31, 2023, primarily due to the significant paydown of accounts payable and accrued liabilities post the clinical lab asset sale. The Company’s current ratio was 3.2 as of January 31, 2024.

● Net loss from continuing operations for Q2 FY24 was $0.9 million or ($0.02) per common share, compared to a net loss in the prior year’s second quarter of $2.9 million or ($0.06) per common share.

● Net loss, representing the results of continuing and discontinued operations for Q2 FY24, was $3.1 million, or ($0.06) per common share, compared to a net loss in the prior year’s second quarter of $11.3 million, or ($0.23) per common share. The weighted average basic common shares outstanding as of January 31, 2024, was 50.5 million.

"Enzo’s strategy is to deliver sustainable, profitable revenue growth through market focus, technical strength, and operational conservatism. We are pleased to report a third consecutive quarter with double-digit revenue growth in the life science division, and I am proud of the team’s hard work resulting in higher gross margin and improved profitability in the second quarter within our Life Science division," said Kara Cannon, Enzo’s Chief Executive Officer. These achievements were driven by aligning our products in high-growth market segments made up of our drug development customers, while relying on our existing, stable global infrastructure to provide comprehensive, quality customer service. I am very encouraged by our financial and operational progress, and I am optimistic about our ability to maintain this positive momentum to deliver on longer-term goals."

On March 13, 2024 Plus Therapeutics presented its corporate presentation (Presentation, Plus Therapeutics, MAR 13, 2024, View Source [SID1234641109]).

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On March 13, 2024 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), reported financial results for its fiscal fourth quarter and full year ended December 31, 2023 and recent business highlights (Press release, Coherus Biosciences, MAR 13, 2024, View Source [SID1234641106]):

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RECENT BUSINESS HIGHLIGHTS

CORPORATE RESTRUCTURING SOLIDIFIES FOCUS ON ONCOLOGY

On March 1, 2024, Coherus closed the divestiture of the ophthalmology franchise to Sandoz for upfront, all-cash consideration of $170 million plus an additional $17.8 million for CIMERLI product inventory and prepaid manufacturing assets.
On or before April 1, 2024, Coherus plans to prepay $175 million of the $250 million principal balance of its term loan with Pharmakon Advisors LP ("Pharmakon"), leaving a residual balance of $75 million and reducing projected annualized Pharmakon related interest payments by about 70%.
The sharpened focus in oncology and a subsequent restructuring is expected to result in a reduction in workforce of 30% by the end of 2024, including 35 employees associated with the ophthalmology divestiture, for an estimated annualized cost savings of more than $25 million.
Expected SG&A and R&D expenses for 2024 reduced from $301.5 million in 2023 to $250-265 million representing at least a 12% decrease year over year.
The $25 million toripalimab NPC approval milestone due to be paid to Junshi Biosciences in Q1 2024 has been restructured such that $12.5 million will be paid in Q2 2024 and the remainder in Q1 2025, potentially adjusted downward for proceeds from Canadian rights.
UDENYCA RESULTS and ONBODY LAUNCH UPDATE

UDENYCA net product sales increased 10% in the fourth quarter 2023 to $36.2 million compared to $33.0 million in the third quarter. Total unit demand grew 7% quarter over quarter. UDENYCA Autoinjector presentation unit demand grew 129% quarter over quarter. Since commercial launch in May 2023, more than 727 accounts have ordered the Autoinjector presentation.
UDENYCA ONBODY, a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv, was launched in February 2024. High customer demand coupled with confirmed payer coverage, drove robust uptake with 138 accounts ordering ONBODY within the first four weeks of launch.
Based on data from IQVIA, rolling 4-week UDENYCA market share as of March 1 was 26%.
LOQTORZI LAUNCH UPDATE

LOQTORZI is the first and only FDA-approved treatment for recurrent or metastatic NPC in all lines of therapy with commercial launch commencing on January 2, 2024.
NCCN Guidelines recommend LOQTORZI as the only immunotherapeutic agent with Preferred Category 1 status in first-line treatment for adults with metastatic or recurrent locally advanced NPC in combination with chemotherapy; LOQTORZI monotherapy is also recommended in NCCN guidelines as the only preferred regimen in subsequent lines of therapy.
Category 1 represents the highest level of evidence and uniformity among panel members in terms of agreement that translates into ease of reimbursement and the ability to establish a new standard of care for these patients.
Payer coverage for LOQTORZI has been confirmed across Medicare Fee for Service, as well as national and regional commercial health plans.
Early demand uptake tracking to expectations, with over 59 NPC targeted accounts ordering the product since launch.
NOVEL IMMUNO-ONCOLOGY PIPELINE ADVANCES

In January 2024, Coherus entered into a clinical collaboration with INOVIO to evaluate LOQTORZI (toripalimab-tpzi) in combination with INO-3112 in a Phase 3 clinical trial as a potential treatment for patients with locoregionally advanced, high-risk, HPV16/18 positive oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer commonly known as throat cancer.
Coherus presented new Phase 1b/2 clinical data for casdozokitug, a first-in-class IL-27 antagonist at the 2023 ESMO (Free ESMO Whitepaper) IO Congress in December and 2024 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January. Results show encouraging signs of antitumor activity and an acceptable safety profile for casdozokitug alone and in combination with PD-(L)1 inhibitors with or without bevacizumab in HCC and NSCLC respectively. Importantly, responses were associated with IL-27 related biomarkers and data support planned clinical trials with casdozokitug/ toripalimab-tpzi in NSCLC and HCC.
New preclinical data for CHS-1000 has been selected for a poster presentation at the upcoming 2024 AACR (Free AACR Whitepaper) Annual Meeting being held April 5-10, 2024, in San Diego.
Coherus plans to file an Investigational New Drug (IND) application in second quarter of 2024 for CHS-1000, a novel ILT4-targeted antibody.
"Throughout 2023, Coherus demonstrated significant progress in transforming the Company’s business model and product portfolio for long-term sustainable growth," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "We are clearly focused on driving our revenues, reducing our costs, and advancing our pipeline, with constant attention to long-term shareholder value. The divestiture of CIMERLI and debt paydown improves our capital structure and sharpens our focus on oncology. With a robust portfolio of FDA-approved products and a promising immuno-oncology pipeline, we are now better positioned than ever to execute on our mission of extending the lives of cancer patients."

FOURTH QUARTER and FULL YEAR 2023 FINANCIAL RESULTS

Net revenue was $91.5 million during the three months ended December 31, 2023 and included $36.2 million of net sales of UDENYCA, $52.4 million of net sales of CIMERLI, $2.2 million of net sales of YUSIMRY which was launched in July 2023 and $0.6 million of net sales of LOQTORZI which began shipping to distributors in December 2023 in preparation for launch. Net revenue was $45.4 million during the three months ended December 31, 2022. For the twelve months ended December 31, 2023 and 2022, net revenue was $257.2 million and $211.0 million, respectively. The increases in total net revenues were driven by the launches of CIMERLI and YUSIMRY and by the return to growth of UDENYCA throughout 2023.

Cost of goods sold (COGS) was $84.6 million and $14.2 million during the three months ended December 31, 2023 and 2022, respectively, and $159.0 million and $70.1 million during the full year ended December 31, 2023 and 2022, respectively. The increases in COGS for the three month and the annual periods each included a $47.0 million charge for the write-down of slow moving YUSIMRY inventory and the related partial recognition of certain firm purchase commitments. Increases in COGS also included $19.4 million and $47.5 million in royalty costs compared to the quarterly and annual periods in the prior year, respectively and increases in product costs of $11.5 million and $25.0 million, respectively, primarily driven by CIMERLI sales. The increase in the year over year COGS was partially offset by a $26.0 million write-down in the third quarter 2022 of inventory at risk of expiration and due to the sale in the second half 2023 of certain of those UDENYCA units having a total original cost of $9.9 million but no carrying value following the write-down. UDENYCA COGS includes a mid-single digit royalty on net sales payable through the first half of 2024, and CIMERLI COGS includes a low to mid 50% royalty on gross profits.

Research and development (R&D) expense for the three months ended December 31, 2023 and 2022 was $26.4 million and $29.0 million, respectively. For the full year ended December 31, 2023 and 2022, R&D expense was $109.4 million and $199.4 million, respectively. The decline compared to the prior year periods primarily resulted from the reduction in scope of the toripalimab collaboration and from the recognition in the first quarter of 2022 of the $35.0 million option exercise fee paid to Junshi Biosciences to license CHS-006. R&D expense for the full year of 2022 also included development costs for additional presentations of UDENYCA and certain manufacturing expenses for YUSIMRY which began to be capitalized in mid-2022.

Selling, general and administrative (SG&A) expense was $49.5 million and $53.6 million during the three months ended December 31, 2023 and 2022, respectively, and $192.0 million and $198.5 million during the full year ended December 31, 2023 and 2022, respectively. The decline in SG&A expense in both periods compared to the prior year periods primarily reflects lower headcount, partially offset by transaction costs associated with the Surface acquisition.

Net loss for the fourth quarter of 2023 was $79.7 million, or $(0.71) per share on a basic and diluted basis, compared to a net loss of $58.9 million, or $(0.76) per share on a basic and diluted basis for the same period in 2022. Net loss for the full year of 2023 was $237.9 million, or $(2.53) per share on a basic and diluted basis, compared to a net loss of $291.8 million, or $(3.76) per share on a basic and diluted basis for the full year of 2022.

Non-GAAP net loss for the fourth quarter of 2023 was $68.9 million, or $(0.62) per share on a basic and diluted basis, compared to non-GAAP net loss of $47.1 million, or $(0.60) per share on a basic and diluted basis for the same period in 2022. Non-GAAP net loss for the full year of 2023 was $186.2 million, or $(1.98) per share on a basic and diluted basis, compared to non-GAAP net loss of $234.8 million, or $(3.02) per share on a basic and diluted basis for the full year of 2022. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $117.7 million as of December 31, 2023, compared to $191.7 million at December 31, 2022.

2024 R&D and SG&A Expense Guidance
Coherus is introducing a guidance range of combined 2024 R&D and SG&A expenses from $250 to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes the effects of strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

Conference Call Information

When: Wednesday, March 13, 2024, starting at 5:00 p.m. Eastern Time

To access the conference call, please register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BI41e6b8f8ab024eefafe43493f6fd0cdf

Please dial-in 15 minutes early to ensure a timely connection to the call.

Webcast: View Source

An archived webcast will be available on the "Investors" section of the Coherus website at View Source

On March 13, 2024 ADC Therapeutics SA (NYSE: ADCT) reported financial results for the fourth quarter and full year ended December 31, 2023, and provided business updates (Press release, ADC Therapeutics, MAR 13, 2024, View Source [SID1234641104]).

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"During 2023, we reset our business and capital allocation strategy, strengthened our team and established a clear roadmap to drive value creation for all our stakeholders," said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. "In the fourth quarter we saw results of our strategy in action across a number of key areas. The impact of our new commercial model resulted in a resumption of growth for ZYNLONTA sales volume compared to the third quarter, in both community and academic settings. Meanwhile, our prioritized pipeline delivered encouraging data, which we were pleased to share in a business update in January. We also disclosed for the first time our new, differentiated solid tumor platform, which can bring substantial opportunities for the Company through internal and external development. With an expected cash runway into the fourth quarter of 2025 and multiple potential value-generating catalysts ahead, I am excited about our prospects and look forward to updating you on our progress in 2024."

Recent Highlights and Developments

ZYNLONTA (loncastuximab tesirine-lpyl)
•ZYNLONTA generated product net sales of $16.6 million in the fourth quarter of 2023, representing a 17% increase over the third quarter of 2023 and a 16% decrease over the fourth quarter of 2022. A return to sequential quarter-over-quarter growth in the fourth quarter of 2023 followed the restructuring of the commercial model, with sales volume increasing in both community and academic settings. The year-over-year net sales decline reflected disruption during the year from the restructuring of the go-to-market model together with the impact of increased competition and higher gross-to-net sales deductions, partially offset by a slight price increase.

Hematology Pipeline
•LOTIS-5: The Phase 3 confirmatory trial for ZYNLONTA in combination with rituximab in patients with 2L+ diffuse large B-cell lymphoma (DLBCL) continues to see accelerated enrollment. As noted by the clinical team and confirmed with the Independent Data Monitoring Committee (IDMC), we have observed higher-than-expected censoring in this trial. As a result, we may need to enroll additional patients, beyond the originally planned 350 patients, to achieve the required number of pre-specified progression-free survival events. The Company continues to expect to complete enrollment of this trial in 2024. The IDMC noted no safety concerns and recommended the trial to proceed at its most recent meeting held on January 16, 2024.
•LOTIS-7: The Phase 1b trial of ZYNLONTA in combination with bispecific antibodies glofitamab or mosunetuzumab for the treatment of heavily pre-treated patients with DLBCL, follicular lymphoma (FL) and marginal zone lymphoma (MZL) is actively enrolling patients. The dose-limiting toxicity (DLT) period has been cleared for the first two dosing levels of ZYNLONTA (90 µg/kg, 120 µg/kg) in both arms and we are currently enrolling patients at 150 µg/kg. After the first Investigator assessment, we have seen evidence of anti-tumor activity among the majority of patients dosed at the first two levels, with mixed histologies including DLBCL, FL and MZL. The Company expects to share additional data once a larger and more mature dataset is available.
•Investigator-Initiated Trial: As announced by the Company on January 4, 2024, an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2023 Annual Meeting from the University of Miami investigator-initiated trial exploring ZYNLONTA in combination with rituximab in high-risk relapsed or refractory FL patients indicated a best overall response rate of 96.3% and a complete response rate of 85.2%. After a median follow-up of 9.7 months, the median progression-free survival (PFS) was not reached, and the 12-month PFS was 92.3%. The majority of AEs were grade 1. Grade 3 AEs included neutropenia (n=2; 6.2%), and one case each (3.1%) of hyperglycemia, increased ALT, fatigue, dyspnea and skin infection. Neutropenia was the only grade 4 AE (n=1; 3.1%).
•ADCT-602 (targeting CD22): Dose escalation and expansion in the Phase 1 study with relapsed or refractory acute lymphoblastic leukemia in collaboration with MD Anderson Cancer Center is progressing and additional clinical trial sites are being added to accelerate enrollment.

Solid Tumor Pipeline
•ADCT-601 (targeting AXL): In the Phase 1b trial, the maximum tolerated dose has been reached, and the study is currently in dose optimization. On January 4, 2024, the Company announced that early signs of anti-tumor activity had been seen in both monotherapy and in combination and that the safety profile indicated that ADCT-601 was well tolerated at the doses tested. Additional data from the trial are expected to be shared in a presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 (April 5–10, 2024). The abstract details are available online. The ongoing dose-optimization/expansion phase is comprised of a monotherapy arm including patients with sarcoma, pancreatic cancer and AXL-expressing non-small cell lung cancer (NSCLC) and a combination arm with gemcitabine in patients with sarcoma and pancreatic cancer. Screening was recently initiated for pancreatic cancer in the monotherapy arm.
•Early-stage pipeline: The Company is advancing a portfolio of investigational ADCs including those targeting Claudin-6, NaPi2b and PSMA. These candidates are based on an innovative proprietary approach which utilizes exatecan with a novel hydrophilic linker as a highly potent and differentiated payload. Data on the Claudin-6 and NaPi2b programs are expected to be shared in presentations at the AACR (Free AACR Whitepaper) Annual Meeting 2024. Abstracts details are currently available online. A research investor event is being planned for 2Q 2024 to share additional information.

Upcoming Expected Milestones

ZYNLONTA
•Achieve commercial brand profitability in 2024
•LOTIS-5: Complete enrollment in 2024
•LOTIS-7: Additional data from the Phase 1b dose-escalation in 3L+ in mixed histologies (Part 1) in 2Q 2024 and from the dose-expansion in 2L+ DLBCL (Part 2) in 2H 2024

•Investigator-initiated trial in FL: The study is being expanded to 100 patients in a multicenter clinical trial. Updates are expected at medical meetings.
•Investigator-initiated trial in MZL: The study is designed to enroll 50 patients in a multicenter clinical trial. A futility analysis is expected to be conducted in 2Q 2024. Updates are expected at medical meetings.

Pipeline

ADCT-601 (targeting AXL)
•Additional data updates from the Phase 1 study in patients with sarcoma, pancreatic cancer and NSCLC in 2024

ADCT-602 (targeting CD22)
•Additional data from the Phase 1 study in 2024

Preclinical
•Advancing a broad portfolio of investigational ADCs for solid tumor indications

Fourth Quarter and FY 2023 Financial Results

Cash and Cash Equivalents

Cash and cash equivalents were $278.6 million as of December 31, 2023, compared to $326.4 million as of December 31, 2022. The Company currently expects its cash runway to extend into the fourth quarter of 2025.

Product Revenues

Net product revenues were $16.6 million for the fourth quarter and $69.1 million for full year 2023, compared to $19.8 million and $74.9 million, respectively, for the fourth quarter and full year 2022. Net product revenues are for U.S. sales of ZYNLONTA. The fourth quarter and full year decrease was primarily due to higher gross-to-net deductions and lower sales volume which was impacted by disruption following restructuring of the commercial organization and increased competition, partially offset by a slightly higher price.

License Revenues and Royalties

License revenues and royalties were $0.1 million for the fourth quarter and $0.5 million for full year 2023, compared to $50.0 million and $135.0 million, respectively, for the fourth quarter and full year 2022. The fourth quarter and full year decrease was primarily due to upfront and milestone payments under our exclusive license agreements with Sobi and MTPC that were recognized in 2022.

Research and Development (R&D) Expenses

R&D expenses were $30.3 million for the fourth quarter and $127.1 million for full year 2023, compared to $48.1 million and $186.5 million, respectively, for the fourth quarter and full year 2022. R&D expenses decreased due to less investment in camidanlumab tesirine (Cami), as well as productivity initiatives and focused investment toward prioritized development programs. The decrease in R&D expenses related to Cami was primarily due to completion of the Phase 2 study in 2022 and the Company’s decision to pause the program while it evaluated FDA feedback.

R&D expenses in the fourth quarter and full year 2023 also decreased due to lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations.

Selling and Marketing (S&M) Expenses

S&M expenses were $13.9 million for the fourth quarter and $57.5 million for full year 2023, as compared to $16.2 million and $69.1 million, respectively, for the fourth quarter and full year 2022. The decrease in S&M expenses for the fourth quarter and full year was primarily due to lower spend on marketing and analytics, lower wages and benefits, as well as lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations.

General & Administrative (G&A) Expenses

G&A expenses were $11.3 million for the fourth quarter and $48.4 million for full year 2023, compared to $15.7 million and $74.4 million, respectively, for the fourth quarter and full year 2022. G&A expenses decreased for the fourth quarter and full year primarily due to lower share-based compensation expense resulting from fluctuations in the share price and award forfeitures in connection with terminations, as well as lower wages and benefits and insurance costs.

Net Loss and Adjusted Net Loss

Net loss was $85.0 million, or a net loss of $1.03 per basic and diluted share, for the fourth quarter of 2023 and $240.1 million, or a net loss of $2.94 per basic and diluted share for full year 2023. This compares to a net loss of $23.3 million, or a net loss of $0.29 per basic and diluted share, for the fourth quarter of 2022 and $157.1 million, or a net loss of $2.01 per basic and diluted share, for full year 2022. The increase in net loss in both periods primarily reflects the reduction in license revenues and royalties, together with higher income tax expense and lower product revenues, partially offset by lower operating expense.

Adjusted net loss, which is a non-GAAP financial measure, was $79.5 million, or an adjusted net loss of $0.97 per basic and diluted share for the fourth quarter of 2023 and $185.7 million, or an adjusted net loss of $2.27 per basic and diluted share for the full year 2023. This compares to an adjusted net loss of $6.7 million, or an adjusted net loss of $0.08 per basic and diluted share, for the fourth quarter of 2022 and $80.3 million, or an adjusted net loss of $1.03 per basic and diluted share, for full year 2022. The increase in adjusted net loss for the fourth quarter and full year 2023 primarily reflects the reduction in License revenues and royalties, together with higher income tax expense and lower product revenues, partially offset by lower operating expense.

Conference Call Details

ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under "Events & Presentations" in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.

On March 12, 2024 Lamassu Bio Inc., a cutting-edge biotech company dedicated to innovative cancer therapies, reported the company has been awarded a grant from the National Institutes of Health (NIH) and National Cancer Institute ( NCI) for the development of their groundbreaking treatment for p53 wild-type sarcomas (Press release, Lamassu Pharma, MAR 12, 2024, View Source [SID1234646265]). The $2.05 million grant will help fund the clinical trial integral to this new cancer treatment. The trial will be conducted in collaboration with Cleveland Clinic Taussig Cancer Center and Cleveland Clinic Children’s Pediatric Hematology and Oncology Department.

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P53 is a crucial tumor suppressor gene commonly mutated in human cancers. Its role in preventing tumor formation by inducing programmed cell death in response to cellular stress makes it a key target for cancer therapy. The project focuses on advancing SA53, a novel therapeutic that targets p53 wild-type sarcomas, malignant tumors of connective or non-epithelial tissue.

SA53 has demonstrated remarkable potency, efficacy and safety in preclinical models, positioning it for an Investigational New Drug (IND) submission. This innovative approach offers promising prospects for addressing chemo-resistant cancer and presents a significant pathway for advancing cancer care.

"We are looking forward to investigating how this drug could work to possibly teach cancer cells how to die in a variety of cancers. We are pleased to be a part of research focused on a disease that impacts so many," said Dr. Peter Anderson, pediatric oncologist at Cleveland Clinic Children’s and Principal Investigator of the study.

Sarcomas represent approximately 13,000 cancer cases each year in the United States and pose significant challenges in terms of treatment due to their complexity and propensity for metastasis. Current therapies involve invasive surgery, toxic chemotherapy, and radiation, but many patients do not respond to these treatments.

The proposed therapy aims to trigger the body’s natural defense mechanism, p53 by blocking MDM2, a protein that deactivates p53 and contributes to treatment resistance. The clinical trial will focus on achieving objectives such as determining a safe dosage for future trials, understanding pharmacokinetic profiles, and assessing early signs of effectiveness in treating soft tissue sarcomas with wild-type p53. The main goal is to advance SA53 through trials to offer a potential new and effective treatment option for patients.

"We believe that this genetically targeted therapy is potentially game-changing and can bring new hope for thousands of patients dealing with these cancers," said Gabi Hanna, Lamassu CEO and Founder. "The NIH grant will play a pivotal role in facilitating the transition of our research from the laboratory to the bedside. Collaborating with the exceptional team at Cleveland Clinic and NCI will also help accelerate the advancement of this therapy to the next phase of development. Together, we’re poised to make meaningful strides in bringing innovative treatments to those in need who has no good option."

The collaboration between Lamassu and Cleveland Clinic represents a significant step forward in cancer research, offering hope for improved outcomes for patients with sarcomas and potentially other cancers that may respond to p53 deactivation.