On July 27, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) and BAKX Therapeutics Inc. reported that they have signed an exclusive worldwide-collaboration agreement to research, develop, manufacture and commercialize BKX-001 as a potential treatment for leukemia, lymphoma and solid tumors (Press release, Ipsen, JUL 27, 2021, View Source [SID1234585226]).

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Apoptosis is the naturally occurring process of programmed cell death. Deregulated apoptosis can lead to uncontrolled cell division and the development of a tumor.2 The apoptosis cell-signaling pathway has been proven to be a target for cancer therapy with the development and approval of BCL-2 inhibitors for the treatment of certain hematological malignancies.3 BAX is a novel target in this pathway that is downstream of all anti-apoptotic proteins like BCL-2, BCL-XL, MCL-1 etc.4 Direct activation of BAX has several possible outcomes as an investigational cancer therapy, potentially addressing multiple tumor types and the resistance encountered while targeting only the antiapoptotic BCL-2 family proteins. BAX activation by small-molecule agonists have been shown to promote apoptosis in leukemia-cell lines and human samples, while sparing healthy cells in vitro and suppress human acute myeloid leukemia xenografts and increased host survival without toxicity in vivo.5

Dr. Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen, said "As part of our strategy, we continue to strengthen our pipeline and deliver exciting external-innovation opportunities. We are, therefore, delighted to partner with the expert team at BAKX Therapeutics to move BKX-001 into further preclinical development, with the goal of achieving a development candidate that can be evaluated for the potential treatment of hematological malignancies and solid tumors. Importantly, this collaboration also reflects the shared values across our two organizations and, as a result, we will be building a strong cross-company team to advance this innovation for people living with these forms of cancer, and their healthcare teams."

Sree Kant, Founder and CEO of BAKX Therapeutics Inc. said "We are excited to partner with Ipsen on investigational BKX-001. This program is the result of pioneering work on the BAX protein driven by our scientific co-founders Loren D Walensky and Evripidis Gavathiotis. This partnership brings together Ipsen’s excellent clinical development and commercial capabilities with our industry-leading knowledge of the BAX protein and our unique computational platform. This is a collaboration of very distinct complementary capabilities that can together drive important treatment options in cancer therapy for patients, faster."

Under the agreement, Ipsen will pay BAKX Therapeutics Inc. $14.5m upon closing, comprising an equity investment and an upfront payment, followed by up to $837.5m in milestone payments. The companies would also share equally costs and profits.

On July 27, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the quarter ended June 30, 2021 (Press release, Dr Reddy’s, JUL 27, 2021, View Source [SID1234585225]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

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* Q4 FY21 financials have been adjusted with an additional charge of Rs. 191 Cr ($ 26.25 mn) arising out of the arbitration award in favor of Hatchtech towards the Xeglyze product as an adjusting subsequent event for filing IFRS financials with US SEC in Form 20F on June 30, 2021.

Commenting on the results, Co-Chairman & MD, G V Prasad said "The financial performance of the quarter has been driven by healthy sales growth. I am confident about improving our margins in the upcoming quarters which will be led by the scale up of recent launches, new product launches and productivity. While we continue to sharpen execution in our core business, we are also conducting pilots in areas such as Nutrition, Direct-to-Customer, and Digital Health & Wellness, which can be future growth drivers".

COVID portfolio

We continue to play our role in the fight against Covid-19 by acting proactively to bring multiple preventive and curative treatment options, including a vaccine. Some of our major Covid-19 products are:

Sputnik V vaccine: We launched the vaccine in India in May 2021 after receiving Emergency Use Authorization (EUA) in April 2021. We are working with RDIF for ramping up supplies. We are also working with six CMOs in India for manufacturing readiness. We have launched it across 80 cities and 2.5+ Lakh people have been vaccinated so far. We are also working on Sputnik Light, for which Russia phase 3 trials will be leveraged for India approval as per recommendation from SEC.

Remdesivir: We launched it in India and ramped up our supplies in this quarter to meet with the higher demand due to surge of the COVID cases during the second wave in India.

Avigan (Favipiravir): We launched it in India and also in few other markets.

2-deoxy-D-glucose (2-DG): We developed it in collaboration with DRDO lab and received EUA as adjunct therapy for hospitalized moderate to severe Covid-19 patients. We have launched it in India in June 2021.

Molnupiravir: We are collaborating with 5 other pharmaceutical companies for the clinical trial of the investigational oral anti-viral drug for the treatment of mild Covid-19 in an outpatient setting in India.

Other Covid drugs: We are also working on Baricitinib and several other covid drugs for treatment ranging from mild to severe conditions.

Revenue Analysis

Global Generics (GG)

Revenues from GG segment at Rs. 41.1 billion:

ØYear-on-year growth of 17% was driven primarily by branded markets (India and emerging markets) and Europe. The overall growth was on account of new product launches and volume traction in the base business, partly offset by price erosion in some of our products and adverse forex rates.

ØSequential growth of 6% driven by higher sales in India. The overall growth was attributable to higher volumes and new product launches, offset partially due to price erosion in certain products.

North America

Revenues from North America at Rs. 17.4 billion:

ØYear-on-year growth of 1%, driven by launch of new products and increase in volumes of certain of our existing products, which was offset by price erosion in some molecules and adverse forex rates.

ØSequential decline of 1%, on account of price erosion in some of our products, partially offset by volume traction and new products launched.

ØDuring this quarter, we launched 6 new products. These were Sapropterin Dihydrochloride Powder, Albendazole Tablets, Ertapenem Injection and Icosapent Ethyl Capsules in the US and two products in Canada.

ØWe filed two new ANDAs during the quarter. As of 30th June 2021, cumulatively 93 generic filings are pending for approval with the USFDA (90 ANDAs and 3 NDAs under 505(b)(2) route). Out of these 93 pending filings, 47 are Para IVs and we believe 24 have ‘First to File’ status.

Europe

Revenues from Europe at Rs. 4.0 billion. Year-on-year growth of 12% and sequential growth of 1% was primarily on account of volume traction in base business and new product launches across our markets, which was partially offset by price erosion.

India

Revenues from India at Rs. 10.6 billion:

ØYear-on-year growth of 69% and sequential growth of 26% was primarily driven by increase in sales volumes of our existing products, led by increase in sale of covid drugs due to the severe second wave witnessed in India. The growth was also aided by contribution from new product launches and increase in sales prices of our existing products.

ØWe launched six new products during the quarter including Sputnik-V vaccine and 2-deoxy-D-glucose for covid. We also launched Curhealth, a nutritional health mix for building immunity.

Emerging Markets

Revenues from Emerging Markets at Rs. 9.1 billion. Year-on-year growth of 14% and sequential growth of 3%:

ØRevenues for Russia at Rs. 3.5 billion. Year-on-year growth of 8% was on account of increase in volumes and sales prices in our existing products and new products launches. Sequential decline of 13% was on account of lower volumes, offset partly by increase in sales price of certain products and new products launched.

ØRevenues from other CIS countries and Romania at Rs. 1.4 billion. Year-on-year growth of 4% driven by new product launches, offset partially by a reduction in sales volumes and prices of certain of our existing products. Sequential decline of 24% was on account of reduction in volumes and price of some of our existing products, offset partly by new products launched.

ØRevenues from Rest of World (RoW) territories at Rs. 4.2 billion. Year-on-year growth of 25% and sequential growth of 43% was largely attributable to new products launched and volume traction in our base business, partially offset by a reduction in sales prices of some of our products.

Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 7.5 billion. Year-on-year decline of 12% and sequential decline of 5%.

ØThe decline was on account of a decrease in sales volumes and prices of our existing products, partially offset by new products launched. Year-on-year was also impacted due to customer stocking up in last year.

ØDuring the quarter we filed DMFs for two products in the US.

Proprietary Products (PP) & Others

Revenues from PP & Others at Rs. 541 million. Year-on-year growth of 1% and sequential decline of 14%.

Income Statement Highlights:

ØGross profit margin for the year at 52.2%:

-Decreased by ~380 bps over previous year and by ~150 bps sequentially, majorly on account of price erosion and increase in inventory provisions related to few products. Q1 FY 21 was higher due to higher export incentives and favourable product mix.

-Gross profit margin for GG and PSAI business segments are at 57.7% and 21.6% respectively.

ØSelling, general & administrative (SG&A) expenses at Rs. 15.0 billion, increased by 18% on a year-on-year basis and by 5% sequentially. This increase was primarily attributable to investments being done towards marketing of some of our key brands, investments in digitalization and annual increments. The year-on-year increase is also due to additional expenses incurred with the integration of Wockhardt acquired portfolio.

ØResearch & development (R&D) expenses at Rs. 4.5 billion. As % to revenues – Q1 FY22: 9.2% | Q4 FY21: 8.7% | Q1 FY21: 9.0%. We continue our focus on investing in R&D to build a healthy pipeline of new products across our markets including development of biosimilars and products pertaining to COVID-19 treatment.

ØOther operating income at Rs. 487 million compared to Rs. 118 million in Q1 FY21. The increase was on account of certain settlements and other income during the quarter.

ØNet Finance income at Rs. 652 million compared to Rs. 605 million in Q1 FY21.

ØProfit before Tax at Rs. 7.4 billion, declined by 16% year-on-year and increased by 21% sequentially.

ØProfit after Tax at Rs. 5.7 billion. The effective tax rate is 23.1% for the quarter.

ØDiluted earnings per share is at Rs. 34.34.

Other Highlights:

ØEBITDA is at Rs. 10.2 billion and the EBITDA margin is 20.7%.

ØCapital expenditure is at Rs. 3.2 billion.

ØFree cash-outflow is at Rs. 6.8 billion.

ØNet cash surplus for the company is at Rs. 451 million as on June 30, 2021. Consequently, net debt to equity ratio is (0.003).

Earnings Call Details (05:30 pm IST, 08:00 am EDT, July 27, 2021)

The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

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Transcript: Transcript of the Earnings call will be available on the Company’s website: www.drreddys.com

On July 27, 2021 Novartis reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for NIS793 in combination with standard of care chemotherapy for the treatment of pancreatic cancer (Press release, Novartis, JUL 27, 2021, View Source [SID1234585224]). NIS793 is a potential first in class novel antibody specific for Transforming Growth Factor Beta (TGFβ), which is known to have an important role in metastatic pancreatic ductal carcinoma (mPDAC) and other solid tumors.

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Pancreatic cancer has one of the lowest survival rates of any cancer, with typically late detection and poor outcomes with standard of care treatment. The 5-year overall survival rate is approximately 11% in the US1, with few novel approaches advancing in the clinic and targeted and immunotherapy agents having shown limited activity.

NIS793 is a fully human anti-TGF-β IgG2 monoclonal antibody designed to inhibit the TGF-β pathway in tumor cells and to modulate the tumor microenvironment. In preclinical models, inhibiting TGFβ can reduce fibrosis characteristic of pancreatic and other solid tumor types, as well as enhance the response to chemotherapy and immunotherapy.
NIS793 has shown proof of mechanism and acceptable safety profile in a first in-human trial in patients with advanced solid tumors2 and is in development for pancreatic cancer and other solid tumor types. A Phase II study is ongoing, and a Phase III trial in 1L mPDAC is planned to start enrolling patients later this year.

An ODD grants special status to a drug being developed to treat a rare disease or condition, and provides companies certain benefits to encourage the continued development of medicines that bring novel solutions to patients with these diseases.3

On July 27, 2021 ImmunityBio, Inc., a publicly traded immunotherapy company, reported that it has been granted a patent by the U.S. Patent and Trademark Office for its proprietary NANT Cancer Vaccine (U.S. Patent 11,071,774) (Press release, ImmunityBio, JUL 27, 2021, View Source [SID1234585222]). This novel investigational treatment for cancer is designed to bolster a patient’s own immune response to cancerous cells, augment that response with additional natural killer and T-cell therapies to overcome the cancer’s resistance, and induce long-term T-cell memory to induce remission across multiple tumor types.

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The NCV has been in clinical testing since 2017 and has its foundation in earlier work that led to the development of Abraxane, an albumin nanoparticle that enables the delivery of paclitaxel to the tumor microenvironment. The basis of the orchestrated, multi-modal NCV approach is delivery of chemotherapy agents in a ‘metronomic’ fashion—low doses spread over time—to expose the tumor to immune system recognition by release of tumor-specific antigens. The tumor antigens are then targeted by antigen-specific T-cells activated via ImmunityBio’s adenoviral- and yeast-based vaccine vectors. T cell activation can then be enhanced further by infusion of the company’s proprietary, off-the-shelf, natural killer cell platform and its IL-15 superagonist N-803 (Anktiva).

To study the safety and early efficacy signals across multiple tumor types, the company has launched a series of Quantitative Lifelong Trials (QUILT). To date, the NANT Cancer Vaccine has been studied in more than 100 patients across multiple tumor types, including pancreatic, breast, colorectal, and head and neck cancers. Among these studies is QUILT 88, a Phase 2 trial studying the NCV in metastatic pancreatic cancer patients. Enrollment of Cohort C, patients who have previously failed two lines of standard-of-care therapy, is expected to be completed in the third quarter of 2021 and an early readout of survival data is expected in the first quarter of 2022.

"We are excited to be developing this orchestrated approach to activate as many elements of the immune system that we can and overcome cancer’s ability to evade the immune system. Our hypothesis is that by revealing tumor antigens to the immune system, we activate tumor-specific T cells and targeted natural killer cells to eradicate tumors by what is known as immunogenic cell death," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "The issuance of the NANT Cancer Vaccine patent is recognition of this innovative approach to therapy that not only potentially provides long-term immune system protection from cancer, it does so with a reduced risk of the toxicity risk that comes with using high-dose chemotherapy and radiation. This closely aligns with the FDA’s recent ‘Project Optimist’ guidelines for exploring lower doses of therapeutic agents."

ImmunityBio’s intellectual property portfolio includes more than 1,100 issued and pending patents worldwide across multiple categories including biologics, vaccine vectors, natural killer cells, and GMP devices. Patents for key areas such as N-803 (Anktiva), adenovirus vaccine vectors, yeast vaccine vectors, NK-92 cells and therapies extend to 2035 and beyond.

On July 27, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the manufacturing, preclinical and clinical development plan for KVA12.1 (Press release, Kineta, JUL 27, 2021, View Source;utm_medium=rss&utm_campaign=kineta-announces-pre-ind-meeting-for-kva12-1 [SID1234585217]). Kineta has gained alignment with FDA on the initial Phase 1/2 clinical trial of the safety and efficacy of Kineta’s KVA12.1 as a single agent and in combination with pembrolizumab in patients with unresectable or metastatic solid tumors.

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"We greatly appreciate the FDA’s guidance as we prepare to advance our novel anti-VISTA immunotherapy into the clinic next year", said Shawn Iadonato, PhD, Chief Executive Officer of Kineta. "The successful completion of this engagement with the FDA is an important milestone that provides regulatory clarity for KVA12.1 and confidence with the planned development program for this novel anti-cancer immunotherapy.

A pre-IND meeting provides an opportunity for an open communication between a drug development company and the FDA to discuss the IND development plan and to obtain the agency’s guidance for clinical studies of the company’s new drug candidate. The FDA reviewed the IND enabling preclinical data, manufacturing plan and phase 1/2 clinical study protocol synopsis for KVA12.1, provided guidance and addressed Kineta’s questions on the development plan. Kineta plans to initiate the Phase 1/2 first-in-human clinical studies in mid-2022.