On May 18, 2022 LabCorp reported that Finding treatment options for skin cancer may become easier with the launch of a new test by Labcorp (NYSE: LH), a leading global life sciences company (Press release, LabCorp, MAY 18, 2022, View Source [SID1234614803]). The new test measures Lymphocyte-activation gene 3 (LAG-3) expression levels by immunohistochemistry (IHC) in tumor tissue. LAG-3 is an immune-oncology target with demonstrable clinical benefit in patients with melanoma. The test is available for use in both clinical trials and for the care and treatment of patients.

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"Our goal is to provide diagnostic solutions that can help guide the clinical application of new cancer treatments, improving the lives of those living with cancer," Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp. "The LAG-3 IHC assay provides physicians with actionable information to evaluate the best treatment options, including newly approved treatments and clinical trials, for their patients."

The LAG-3 IHC assay was developed by Labcorp Drug Development for use in a clinical trial studying dual checkpoint inhibitors that included a LAG-3 immunotherapy. As is published in the Journal of Clinical Pathology, this assay will enable the analysis of LAG-3 status in the tumor and the correlation between expression status and response to LAG-3 immunotherapy. This assay is also being used in other ongoing clinical trials evaluating clinical response to LAG-3-directed cancer treatments.

According to the National Cancer Institute, skin cancer is the most common form of cancer in the United States. While melanoma is one of the rarer types, it poses a greater risk of spreading to other parts of the body. One of the first signs of melanoma is a change to the appearance of an existing mole. Anyone noticing a new mole or changes to existing moles should speak to health care provider. A tissue biopsy is the only way to diagnose melanoma and can be performed in most health care settings.

The development of the LAG-3 IHC assay coupled with its availability for clinical use, demonstrates Labcorp’s unique leading capabilities in diagnostic testing and comprehensive drug development services. By delivering targeted biomarker solutions to power better decisions by clinicians, Labcorp is helping to improve patient outcomes.

On May 18, 2022 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that it has received the first "Therapeutic Accelerator Award" from the Pancreatic Cancer Network (PanCAN) (Press release, Verastem, MAY 18, 2022, View Source [SID1234614819]). The Award will support a Phase 1b/2 clinical trial of the Company’s lead investigational candidates, RAF/MEK Clamp, VS-6766, with FAK inhibitor, defactinib, to evaluate whether a more complete blockade of KRAS signaling, which is mutated in more than 95% of pancreatic cancer tumors, will improve outcomes for patients with front-line metastatic pancreatic cancer.

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"The goal of the Therapeutic Accelerator Award is ultimately to develop new drugs for patients with metastatic pancreatic cancer faster and more efficiently than standard clinical trials," said Julie Fleshman, president and CEO of PanCAN. "We are delighted that Verastem, with rigorous scientific and clinical evidence for addressing this critical pathway, will be the inaugural awardee for this grant. We are looking forward to partnering with them to determine whether their investigational treatment combination will be beneficial to patients."

"We are honored to have been selected for this important award that will expand our development program for VS-6766 and defactinib to evaluate the combination in patients with metastatic pancreatic cancer," said Louis Denis, Chief Medical Officer at Verastem Oncology. "We look forward to a strong collaboration with PanCAN and applaud its commitment to bring patients, academia and industry together to advance the science and accelerate development of much needed novel treatment options for patients."

PanCAN created the Therapeutic Accelerator Award as part of its innovative approach to pancreatic cancer research. This includes grants for scientists across the country as well as large-scale research initiatives such as PanCAN’s Precision PromiseSM Clinical Trial, which seeks to accelerate the approval of new treatment options for pancreatic cancer patients and PanCAN’s Early Detection Initiative, with a goal of developing a strategy to diagnose pancreatic cancer early when surgery is still possible.

Verastem Oncology was selected to receive the 2022 PanCAN Therapeutic Accelerator Award of $3.8M through a rigorous, competitive process involving scientific, business and programmatic review from leading experts in the field.

KRAS is mutated in more than 95% of pancreatic cancers and Verastem Oncology’s RAF/MEK clamp VS-6766 blocks tumorigenic signaling downstream of mutant KRAS. Verastem’s selective FAK inhibitor, defactinib, is included in the trial as FAK has been identified preclinically and clinically as a potential resistance mechanism to RAF and MEK inhibition. FAK inhibition has been shown to reduce stromal density in pancreatic cancer both preclinically and clinically which may enhance anti-tumor immunity and efficacy of the standard gemcitabine/nab-paclitaxel regimen.

About the Pancreatic Cancer Action Network

The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

In contrast to other MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.

On May 18, 2022 Laekna Therapeutics ("Laekna"), a clinical-stage global biotechnology company dedicated to developing next generation medicines to treat cancer and liver diseases, reported that it has raised $61 million in Series D financing led by CS Capital with support from Worldstar, and Infinity Capital (Press release, Laekna Therapeutics, MAY 18, 2022, View Source [SID1234614835]). Yanchuang Capital as the existing investor continued to support the company with additional funding.

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Laekna’s robust infrastructure has enabled the rapid development of 14 innovative drug candidates. The company has initiated six clinical programs, three of which are multi-regional clinical trials (including one pivotal trial) to address urgent, unmet medical needs in the standard of care-resistant cancers.

In the four rounds of financing to date, Laekna has been supported by leading healthcare-focused institutional investment firms. In addition to CS Capital, most recently, SCGC led the company’s $61 Series C financing in October 2020, after GP Healthcare Capital and OrbiMed Healthcare Fund Management led the Series B and Series A financing rounds, respectively.

Proceeds from the Series D financing will be used to accelerate the clinical development of Laekna’s two core product candidates, AKT kinase inhibitor afuresertib (LAE002) and the world’s first clinical-stage CYP17/CYP11B2 dual inhibitor (LAE001). Both product candidates cover three differentiated key mechanisms, namely targeted therapy, hormonal therapy, and immuno-oncology therapy. Laekna’s most advanced clinical trial is an open-label, randomized, multi-regional Phase 2 PROFECTA-II clinical trial of afuresertib, the world’s first registration-directed clinical trial of an AKT kinase inhibitor to treat platinum-resistant ovarian cancer.

"As Laekna celebrates its fifth anniversary in April, I would like to thank our new and existing investors. Over the past five years, it has been our honor to be recognized and supported by all of our partners. I believe that the time has come for Laekna as we work together with like-minded partners towards a better future," said Dr. Chris Lu, Chairman and CEO of Laekna. "We have arrived at a critical stage, and we understand that drug discovery and development is a long and often arduous journey. We remain committed to our vision to cure for a better future."

CS Capital life science investment team said, "The global biopharmaceutical industry is booming and has a myriad of thriving players. We decided to invest in Laekna as its R&D pipeline, innovation capabilities and management team deeply impressed us. We will work together with Laekna to help it become a partner and a leader in the industry to benefit patients worldwide."

On May 18, 2022 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will participate virtually in the H.C. Wainwright Global Investment Conference (Press release, iBioPharma, MAY 18, 2022, View Source [SID1234614787]). The hybrid conference will take place May 23-26, 2022.

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iBio’s pre-recorded presentation will be available on demand during the event for all registered attendees. Beginning on Tuesday, May 24, 2022, the presentation will also be available on the Company’s website at www.ibioinc.com under "News & Events" in the Investors section.

ON May 18, 2022 Pharma major Lupin Limited [BSE: 500257 | NSE: LUPIN] reported its financial performance for the quarter and fiscal year ending March 31, 2022 (Press release, Lupin, MAY 18, 2022, View Source [SID1234614804]). These audited results were taken on record by the Board of Directors at a meeting held today. Basis the long-term outlook, the Board has recommended a dividend of 200%.

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Financial Highlights – Consolidated IND-AS

* Excluding one-time expenses of INR 1932 mn Q3 FY22 EBIDTA was INR 5971 mn and PBT was INR 3603 mn

**EBIDTA before Business Compensation expense

***Adjusted for Solosec Impairment & Business Compensation expense for Glumetza in Q2 FY 22

Income Statement highlights – Q4 FY2022

Gross Profit was INR 22,323 mn compared to INR 23,929 mn in Q3 FY2022, with margin of 57.8%
Personnel cost was 18.2% of sales at INR 7,032 mn compared to INR 7,438 mn in Q3 FY2022
Manufacturing and other expenses were 34.2% of sales at INR 13,212 mn compared to INR 13,518 mn in Q3 FY2022
Investment in R&D for the quarter was INR 3,442 mn (8.9% of sales)
Balance Sheet highlights

Operating working capital was INR 60,303 mn as on March 31, 2022
Capital Expenditure for the quarter was INR 1,577 mn and INR 6,872 mn for FY2022
Net Debt as on March 31, 2022 stands at INR 19,227 mn
Net Debt-Equity for the company as on March 31, 2022 stands at 0.16
Commenting on the results, Mr. Nilesh Gupta, Managing Director, Lupin Limited said, "The current quarter was challenging with headwinds in the U.S. on account of price erosion, and inflation in input materials and freight. Our other markets continue solid growth in revenues and profitability. We are focused on optimizing operating expenses and spend and ensuring the evolution of our complex generic platforms along with global portfolio maximization while doubling down on markets like India. We expect our efforts to yield meaningful uptick in profitability, especially in the second half of this fiscal and beyond"

Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 63.3% of sales in Q4 FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 28% of sales in Q4 FY2021.
In Q3 FY22, other expenses include the impact of one-time expenses of INR 1,932 mn related to residual Metformin returns from retail and consumers not identified previously, and a provision for aged stock returns of Oseltamivir given lack of an active flu season for the past two years.
Depreciation & Amortization & impairment expense of Q4 FY22 includes INR 1,267 mn on account of impairment of Gavis IPs.

1> Royalty/Profit Share Expenses on certain in-licensed/partnered products have been reclassified to Material Costs from Manufacturing and Other expenses starting Q1 FY2022. On a comparable basis, the Gross Margin adjusted for such change would be 63.1% of sales in FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 27.9% of sales in FY2021.

2. In Q3 FY22, other expenses include the impact of one-time expenses of INR 1932 mn related to residual Metformin returns from retail and consumers not identified previously, and a provision for aged stock returns of Oseltamivir given lack of an active flu season for the past two years.

3. In Q2 FY2022 we had created a provision of INR 18,795 mn [including INR 375 mn towards litigation and settlement related expenses] under Glumetza class actions. The amounts due to the two plantiffs group was settled in Q3. We had a small reversal on account of litigation expense in Q4 of INR 12 mn.

4. Q2 FY2022 includes impairment expense of INR 7,077 mn for Solosec IP.

Operational Highlights
North America

North America sales for FY2022 were INR 57,556 mn compared to INR 55,520 mn in FY 2021; accounting for 36% of Lupin’s global sales. Q4 FY2022 sales were INR 14,162 mn, down 10.2% compared to INR 15,775 mn in Q3 FY2022, down 5.3% as compared to INR 14,952 mn in Q4 FY2021; accounting for 37% of Lupin’s global sales.

U.S. FY2022 sales were USD 738 mn compared to USD 720 mn in FY2021.

Q4 FY2022 sales were USD 181 mn compared to USD 202 mn in Q3 FY2022 and USD 195 mn in Q4 FY2021.

The Company filed 10 ANDAs in the quarter, received 2 ANDA approvals from the U.S. FDA, and launched 2 products in the quarter in the U.S. The Company now has 166 generic products in the U.S.

Lupin continues to be the 3rd largest pharmaceutical player in both U.S. generic market and U.S. total market by prescriptions (IQVIA MAT March 2022). Lupin is the leader in 44 of its marketed generics in the U.S. and amongst the Top 3 in 113 of its marketed products (IQVIA MAT March 2022).

India

India formulation sales for FY2022 were INR 60,042 mn, up 13.9% as compared to INR 52,712 mn in FY2021; accounting for 38% of Lupin’s global sales. Q4 FY2022 sales were INR 13,511 mn, down 8.3% as compared to INR 14,733 mn in Q3 FY2022, up 5.0% as compared to INR 12,866 mn in Q4 FY2021; accounting for 35% of Lupin’s global sales.

India Region Formulations sales grew by 13.3% in the quarter as compared to Q4 FY2021. The company launched 1 brand in the Anti-Diabetic therapy, 1 brand in the Anti-Viral therapy and 1 brand in the VMS therapy in the quarter.

Lupin is the 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT March 2022).

Growth Markets (LATAM and APAC)

Growth Markets sales for FY2022 were INR 14,019 mn, up 17.2% as compared to INR 11,964 mn in FY2021; accounting for 9% of Lupin’s global sales. Q4 FY2022 sales were INR 3,810 mn, up 12.4% compared to INR 3,390 mn in Q3 FY2022, up 25.6% as compared to INR 3,033 mn in Q4 FY2021; accounting for 10% of Lupin’s global sales.

Brazil sales were BRL 224 mn for FY2022, compared to a sales of BRL 239 mn for FY2021. Q4 FY2022 sales were BRL 64 mn, compared to BRL 49 mn for Q3 FY2022 and BRL 59 mn for Q4 FY2021.

Mexico sales were MXN 713 mn for FY2022, compared to a sales of MXN 621 mn for FY2021. Q4 FY2022 sales were MXN 183 mn, compared to MXN 195 mn for Q3 FY2022 and MXN 154 mn for Q4 FY2021.

Philippines sales were PHP 1,881 mn for FY2022, compared to a sales of PHP 1,388 mn for FY2021. Q4 FY2022 sales were PHP 475 mn, compared to PHP 401 mn for Q3 FY2022 and PHP 402 mn for Q4 FY2021.

Australia sales were AUD 74 mn for FY2022, compared to a sales of AUD 57 mn for FY2021. Q4 FY2022 sales were AUD 20.8 mn, compared to AUD 17.8 mn for Q3 FY2022 and AUD 14.2 mn for Q4 FY2021.

Europe, Middle-East and Africa (EMEA)

EMEA sales for FY2022 were INR 13,592 mn, up 6.3% as compared to INR 12,781 mn in FY 2021; accounting for 9% of Lupin’s global sales. Q4 FY2022 sales were INR 4,072 mn, up 19.0% compared to INR 3,422 mn in Q3 FY2022, up 8.6% compared to INR 3,749 mn in Q4 FY2021; accounting for 10% of Lupin’s global sales.

South Africa sales were ZAR 1,375 mn for FY2022, compared to a sales of ZAR 1,295 mn for FY2021. Q4 FY2022 sales were ZAR 426 mn, compared to ZAR 319 mn in Q3 FY2022 and ZAR 431 mn in Q4 FY2021. Lupin is the 6th largest player in South Africa in the total generics market (IQVIA February 2022).

Germany sales were EUR 32.4 mn for FY2022, compared to a sales of EUR 29.2 mn for FY2021. Q4 FY2022 sales were EUR 8.4 mn, compared to EUR 8.8 mn in Q3 FY2022 and EUR 5.4 mn in Q4 FY2021.

Global API

Global API sales for FY2022 were INR 9,904 mn, down 28.4% as compared to INR 13,823 mn in FY2021; accounting for 6% of Lupin’s global sales. Q4 FY2022 sales were INR 2,203 mn, down 14.1% as compared to INR 2,564 mn in Q3 FY2022, down 13.8% as compared to INR 2,556 mn in Q4 FY2021; accounting for 6% of Lupin’s global sales.

Research and Development

Investment in R&D was INR 14,024 mn (8.7% of sales) for FY2022 and INR 3,442 mn (8.9% of sales) in Q4 FY2022.

Lupin received approval for 2 ANDAs from the U.S. FDA in the quarter. Cumulative ANDA filings with the U.S. FDA stand at 457 as of March 31, 2022, with the company having received 297 approvals to date.

The Company now has 53 First-to-File (FTF) filings including 21 exclusive FTF opportunities. Cumulative U.S. DMF filings stand at 196 as of March 31, 2022.