On August 10, 2021 Pharma major Lupin Limited [BSE: 500257 | NSE: LUPIN] reported its financial performance for the quarter ending June 30, 2021 (Press release, Lupin, AUG 10, 2021, View Source [SID1234586275]). These unaudited results were taken on record by the Board of Directors at a meeting held today.

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Financial Highlights (from Continuing Operations) – Consolidated IND-AS

Income Statement highlights – Q1 FY2022

Gross Profit was INR 27,094 mn compared to INR 24,417 mn in Q4 FY2021, with gross profit margin of 63.9%.
The Gross Profit was buoyed by the USD 50 mn received from Boehringer Ingelheim for achieving key milestones for its novel MEK inhibitor compound collaboration
Personnel cost was 18.5% of sales at INR 7,837 mn compared to INR 6,402 mn in Q4 FY2021
Manufacturing and other expenses were 24.3% of sales at INR 10,309 mn compared to INR 11,178 mn in Q4 FY2021
Investment in R&D for the quarter was INR 3,737 mn (8.8% of sales)
Balance Sheet highlights

Operating working capital was INR 59,615 mn as on June 30, 2021
Capital Expenditure for the quarter was INR 1,057 mn
Net Debt as on June 30, 2021 stands at INR (-)3,453 mn
Net Debt-Equity for the company as on June 30, 2021 stands at (-)0.02
Commenting on the results, Mr. Nilesh Gupta, Managing Director, Lupin Limited said, "While the quarter’s profits were bolstered by the Boehringer Ingelheim MEK program income, despite a tough operating environment, we see substantial room for growth. We remain committed to grow our US business both with our inline products as well as ramp up of Albuterol and Brovana, to continue above-market growth in India, and ensure growth in every part of the business. We see meaningful uplift in the second half and remain focused on our journey of expanding margins through driving strong double-digit revenue growth and optimizing costs, while ensuring the safety of our people and the highest standards of compliance."

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 and 62.7% of sales in Q1 FY2021. Manufacturing & Other Expenses adjusted for this change related to Royalty/Profit Share Expenses would be 28.0% of sales in Q4 FY2021 and 26.9% of sales in Q1 FY2021.
Operational Highlights

North America
Lupin’s North America sales for Q1 FY2022 were INR 13,330 mn, down 10.8% compared to INR 14,952 mn in Q4 FY2021, and up 9.6% as compared to INR 12,160 mn in Q1 FY2021; accounting for 35% of Lupin’s global sales.

Q1 FY2022 sales were USD 172 mn compared to USD 195 mn in Q4 FY2021 and USD 157 mn in Q1 FY2021

The Company filed 3 ANDAs in the quarter and received 3 ANDA approvals from the U.S. FDA, and launched 2 products in the quarter in the US market. The Company now has 167 products in the U.S. generics market.

Lupin continues to be the 3rd largest pharmaceutical player in both U.S. generic market and US total market by prescriptions (IQVIA MAT June 2021). Lupin is now the market leader in 55 products in the U.S. generics market and amongst the Top 3 in 120 of its marketed products (market share by extended units, IQVIA June 2021)

India
Lupin’s India formulation sales for Q1 FY2022 were INR 16,362 mn, up 27.2% as compared to INR 12,866 mn in Q4 FY2021 and up 27.3% as compared to INR 12,854 mn in Q1 FY2021; accounting for 42% of Lupin’s global sales.

India Region Formulations sales grew by 31.0% in the quarter as compared to Q1 FY2021.

Lupin is the 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT June 2021).

Growth Markets (LATAM and APAC)
Lupin’s Growth Markets registered sales of INR 3,328 mn for Q1 FY2022, up 9.7% compared to INR 3,033 mn in Q4 FY2021 and up 23.3% as compared to INR 2,699 mn in Q1 FY2021; accounting for 9% of Lupin’s global sales.

Lupin’s Brazil sales were BRL 63 mn for Q1 FY2022 compared to BRL 59 mn for Q4 FY2021 and BRL 55 mn for Q1 FY2021.

Lupin’s Mexico sales were MXN 163 mn for Q1 FY2022 compared to MXN 154 mn for Q4 FY2021 and MXN 123 mn for Q1 FY2021.

Lupin’s Philippines sales were PHP 362 mn for Q1 FY2022 compared to PHP 402 mn for Q4 FY2021 and PHP 278 mn for Q1 FY2021.

Lupin’s Australia sales were AUD 17.1 mn for Q1 FY2022 compared to AUD 14.2 mn for Q4 FY2021 and AUD 12.7 mn for Q1 FY2021.

Europe, Middle-East and Africa (EMEA)
Lupin’s EMEA sales for Q1 FY2022 were INR 2,613 mn, down 30.3% compared to INR 3,749 mn in Q4 FY2021, and up 4.5% compared to INR 2,500 mn in Q1 FY2021; accounting for 7% of Lupin’s global sales.

Lupin’s South Africa sales for Q1 FY2022 were ZAR 273 mn, compared to ZAR 431 mn in Q4 FY2021 and ZAR 237 mn in Q1 FY2021.

Lupin is the 5th largest player in South Africa in the total generics market (IQVIA May 2021).

Lupin’s Germany sales for Q1 FY2022 were EUR 7.4 mn, compared to EUR 5.4 mn in Q4 FY2021 and EUR 7.6 mn in Q1 FY2021.

Global API
Lupin’s Global API sales for Q1 FY2022 were INR 2,459 mn, down 3.8% compared to INR 2,556 mn in Q4 FY2021, and down 39.9% as compared to INR 4,090 mn in Q1 FY2021; accounting for 6% of Lupin’s global sales.

Research and Development
Investment in R&D amounted to INR 3,737 mn (8.8% of sales) for Q1 FY2022 as compared to INR 3,427 mn (9.1% of sales) for Q4 FY2021.

Lupin received approval for 3 ANDAs from the U.S. FDA in the quarter. Cumulative ANDA filings with the U.S. FDA stand at 440 as of June 30, 2021, with the company having received 291 approvals to date.

The Company now has 50 First-to-Files (FTF) filings including 18 exclusive FTF opportunities. Cumulative US DMF filings stand at 202 as of June 30, 2021.

On August 10, 2021 Prescient Therapeutics (ASX: PTX) is a clinical stage oncology company reported that developing personalised medicine approaches to cancer, including targeted therapies, cell therapy enhancements and next generation CAR-T therapies (Press release, Prescient Therapeutics, AUG 10, 2021, View Source;utm_medium=rss&utm_campaign=90-seconds-with-steven-yatomi-clarke-from-prescient-therapeutics-asxptx [SID1234586274]).

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Encouraging progress through clinical trials of Prescient’s foundational assets PTX-100 and PTX-200 (with the PTX-100 trial progressing to expansion cohort last week following successful Phase 1b) and CAR-T safety and manufacturing milestone with OmniCAR.

On August 10, 2021 VERAXA Biotech GmbH, Heidelberg, and Indivumed GmbH, Hamburg, reported their agreement to jointly discover modulatory and functional antibodies against several targets that are relevant for colorectal cancer (Press release, Indivumed, AUG 10, 2021, View Source [SID1234586270]). The targets have been identified by Indivumed’s discovery solution platform nRavel, only two months after its launch. The antibody development and commercialization will be performed by Indivumed’s subsidiary, Ix Therapeutics.

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VERAXA Biotech GmbH is a pioneer in microfluidic technology for the screening of antibodies with modulatory function on complex signal proteins like GPCRs or ion channels. The high-throughput screening platform allows for the testing of millions of fully natural IgGs from humans and mice for therapeutic effects, rather than just for binding. Results are obtained in only a fraction of the time required by other technologies. The company offers customized screening services for users worldwide. Besides carrying out service projects, VERAXA is currently also establishing its own proprietary pipeline of therapeutic antibody candidates for further joint development with pharma partners.

Indivumed has set up a leading multi-omics database with extensive medical experience, bioinformatics expertise, and AI-integrated advanced analytics for a most effective medical diagnostics and predictive therapeutic use. Just recently, the company launched its AI-based platform nRavel, which together with Indivumed’s IndivuType multi-omics database will derive more precise insights into and much better predictors for certain pathologies and diseases with high medical needs.

"The high quality of data and the artificial intelligence tools that Indivumed utilizes means that we can be more confident in the validity of the targets," said Dr. Christoph Antz, CEO of Veraxa. "With our technology, we can move rapidly into the development of functional antibodies that have the potential to serve as new therapeutics."

"Having thousands of patient cases complete with comprehensive multi-omics and clinical data coupled with the advanced AI capabilities of nRavel gives us the ability to derive novel insights in just a short period of time," said Prof. Dr. Hartmut Juhl, Founder and CEO of Indivumed. "As we continue to uncover additional targets, having a partner like Veraxa who can develop functional antibodies in an accelerated manner is critical to our ability to discover new possibilities for cancer treatment in the shortest-possible time and fight this disease."

On August 10, 2021 Tesis Labs, a leader in targeted genetic sequencing, and Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported a new collaboration to maximize the power of genetic sequencing and bioinformatics (Press release, Personal Genome Diagnostics, AUG 10, 2021, View Source [SID1234586269]). Through this collaboration, the companies intend to combine resources and expertise to create new genomics solutions that could combat cancer and improve outcomes for patients, and advance market access initiatives to accelerate adoption in the market.

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The National Institutes of Health estimates that by 2040, there will be 29.5 million new cancer cases and nearly 16.4 million deaths worldwide per year. This new strategic collaboration brings together highly specialized clinical laboratory and biotechnology teams, enabling their expertise, creativity, and passion for delivering the latest genetic and bioinformatic insights to advance cancer predisposition, profiling, and treatment.

"We are excited to partner with PGDx and leverage our aligned vision and collective expertise to enable new and creative clinical opportunities," stated Ron King, Tesis Labs CEO. "Genetic sequencing and genetic biomarkers are revealing new opportunities for medicine. Our clinical expertise and approaches to unlocking the power of genetic sequencing are bringing new insights to cancer research, profiling and treatment."

"We are thrilled to partner with Tesis Labs, a company that shares our passion for expanding the reach of genetic sequencing through decentralized testing," said Megan Bailey, Chief Executive Officer of PGDx. "We look forward to working with Tesis Labs to further progress advancements in genomic insights and patient-centered oncology care."

Tesis uses a genetically integrated medical platform for targeted genetic sequencing and comprehensive genetic data collection to support many medical specialties. The company’s existing labs are in Denver, Lafayette, Colo., and Houston.

PGDx currently offers three pan-cancer NGS kitted solutions – elio tissue complete, an FDA cleared kit, elio plasma complete, a comprehensive liquid biopsy solution, and elio plasma resolve, which has received FDA breakthrough device designation – that provide researchers and clinicians with the ability to identify biomarkers and profile tumors through advanced genomic sequencing within their own hospital systems and laboratories.

On August 10, 2021 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized cancer neoantigen vaccines, reported the online publication of new research describing its novel and proprietary algorithm for the identification and prioritization of patient-specific tumor neoantigens, VENUS (Press release, NousCom, AUG 10, 2021, View Source [SID1234586268]).

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The VENUS algorithm predicts tumor specific mutated peptides that have the highest likelihood of inducing an immune response and act as neoantigens. Each neopeptide is assigned a score that combines its abundance and expression across tumor cells, with the likelihood of being presented on the tumor cell surface.

The paper entitled: "VENUS, a Novel Selection Approach to Improve the Accuracy of Neoantigens’ Prediction" (G. Leoni, A.M. D’Alise et al, reference below) has been published in the special issue of the peer-reviewed journal Vaccines focused on cancer neo-antigen vaccines.

The publication describes the predictive power of VENUS both in silico and in vivo when incorporated into Nouscom’s heterologous prime boost viral vector platform. In silico, the authors demonstrated VENUS’ ability to select 19 out of 20 neo-antigens inducing spontaneous CD8 or CD4 T cell mediated immune responses, from the top 60 ranked mutated peptides from 9 cancer patients.

In addition, an adenoviral vector vaccine encoding the top 60 ranked mutations, demonstrated efficacy and a potent T cell response, when used in combination with an anti-PD1 checkpoint inhibitor, in a murine cancer model.

The VENUS algorithm, in combination with Nouscom’s heterologous prime/boost viral vector platform, comprising a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Ankara vector (MVA), has been used to develop NOUS-PEV, a novel personalized cancer immunotherapy. NOUS-PEV is being evaluated in a Phase 1b clinical trial in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1. The trial (NCT04990479) is currently enrolling patients across multiple sites in Europe.

Dr. Elisa Scarselli, Chief Scientific Officer and Co-Founder of Nouscom, said: "The data published in Vaccines highlights the significance of using VENUS to enhance the accuracy of neoantigen prediction for cancer vaccine development. Combining VENUS with Nouscom’s viral vector platform allows the targeting of up to 60 tumor mutations in each patient that can generate broad and deep immune responses, potentially overcoming issues of tumor heterogeneity and escape through immunoediting. This could be an important advantage for Nouscom’s approach to personalized cancer immunotherapy."

"We look forward to announcing the first patient being dosed with Nouscom’s personalized immunotherapy, NOUS-PEV.”

References

G. Leoni, A.M. D’Alise et al. VENUS, a Novel Selection Approach to Improve the Accuracy of Neoantigens’ Prediction Vaccines (MDPI).

Online publication: View Source

About NOUS-PEV

NOUS-PEV is a personalized cancer immunotherapy designed for each patient based on selection and prioritization of mutations unique to that patient’s tumor. The strategy is based on Nouscom’s heterologous prime boost platform already clinically validated by its lead off-the-shelf clinical development program NOUS-209, composed of a proprietary non-human adenoviral vector (GAd) and Modified Vaccinia Ankara vector (MVA). Each of the two viral vector systems encodes multiple personalized neoantigens selected with a proprietary algorithm (VENUS), which prioritizes up to 60 mutations that represent the most immunogenic neoantigens.

NOUS-PEV is being evaluated in a Phase 1b clinical trial in combination with the anti-PD-1 checkpoint inhibitor pembrolizumab in patients with either locally advanced 1L melanoma or 1L non-small cell lung cancer (NSCLC) expressing more than 50% PD-L1. The trial (NCT04990479) commenced in 2021 and is currently enrolling patients across multiple clinical sites in Europe.