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Takeda Enters Collaboration and Licensing Agreement with Zedira and Dr. Falk Pharma to Develop First-in-Class Celiac Disease Therapy

On October 20, 2022 Takeda (TSE:4502/NYSE:TAK), Zedira and Dr. Falk Pharma GmbH reported a collaboration and licensing agreement to develop ZED1227/TAK-227, a Phase 2b investigational therapy for the treatment of celiac disease (Press release, Takeda, OCT 20, 2022, View Source [SID1234622237]). TAK-227 is a potential first-in-class therapy designed to prevent the immune response to gluten in celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage to the small intestine. There are currently no approved therapies for the treatment of celiac disease.

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"The continued development of TAK-227 in partnership with Zedira and Dr. Falk Pharma has the potential to offer a meaningful benefit to patients with celiac disease who suffer from symptoms and ongoing intestinal injury despite maintaining a gluten-free diet," said Chinwe Ukomadu, M.D., Ph.D., head, Gastroenterology Therapeutic Area Unit at Takeda. "With three novel programs now in the clinic, Takeda is at the forefront of developing transformative therapies for celiac disease and is advancing multiple therapies for patients living with this challenging lifelong autoimmune condition."

TAK-227 (ZED1227)1 is a selective, oral small molecule designed to inhibit tissue transglutaminase (TG2), an enzyme that generates immunogenic gluten peptide fragments upon the breakdown of gluten in the stomach and intestinal tissue. TAK-227 targets the dysregulated transglutaminase to prevent mucosal damage in the small intestine by preventing the body’s immune response to gluten, a disease process mediated by activation of gluten-specific T cells. A Phase 2a proof-of-concept study published in the New England Journal of Medicine previously demonstrated a protective effect of TAK-227 on the duodenal mucosa and symptoms during a six-week gluten challenge.2 The compound was also found to be safe and well tolerated.

"Patients with celiac disease urgently need appropriate therapeutic options to manage the significant negative impacts of the disease on health and daily quality of life," said Roland Greinwald, Ph.D., Managing Director Medicine & Pharmaceutics at Dr. Falk Pharma.

Martin Hils, Ph.D., CEO at Zedira, added "Takeda’s R&D expertise in gastroenterology, commercial footprint, and its strong commitment to develop therapies to treat celiac disease, make it an ideal partner to help us bring TAK-227 to patients."

Under the terms of the agreement, Takeda and Dr. Falk Pharma will conduct global clinical studies for TAK-227 in celiac disease. Takeda will receive an exclusive license to develop and commercialize TAK-227 in the United States and other territories outside of Europe, Canada, Australia and China. Zedira and Dr. Falk Pharma will receive an upfront payment and are eligible to receive potential development, regulatory and commercial milestones, as well as royalties on net sales. Originally discovered by Zedira, Dr. Falk Pharma licensed the European rights to ZED1227 from Zedira in 2011 and assumed responsibility for preclinical and clinical development of the program.

Takeda is advancing a portfolio of investigational therapies for the potential treatment of celiac disease. In addition to TAK-227, Takeda is developing two other investigational celiac disease therapies that recently entered Phase 2 clinical trials. TAK-062 is a potential best-in-class, highly potent glutenase – a protein that degrades ingested gluten – that was computationally engineered to treat celiac disease. TAK-101 is a potential first-in-class, immune-modifying nanoparticle containing gliadin proteins designed to promote immune tolerance to gluten in celiac disease by preventing gliadin-specific T-cell activation.

About Celiac Disease
Celiac disease is a systemic, immune-mediated disorder characterized by chronic enteropathic inflammation, and precipitated by exposure to dietary gluten in genetically predisposed individuals.3 Global prevalence of celiac disease is ~1%, with highest rates in women, in relatives of individuals with celiac disease, and in those with other immune-mediated disorders; prevalence of celiac disease is increasing worldwide, yet many cases remain undetected or not formally diagnosed.4,5,6 The amount of daily tolerable gluten varies widely among individuals with celiac disease. Although some can tolerate >50 mg/day, others develop mucosal abnormalities with gluten consumption of 10 mg/day, and mucosal damage has been associated with chronic exposures of as little as 1 mg/day.7,8,9 Celiac disease can cause symptoms, including abdominal pain, diarrhea, nausea, and vomiting. Long-term complications of celiac disease may include malnutrition, accelerated osteoporosis, nervous system problems and problems related to reproduction. There is no approved therapy for celiac disease. The only available management option for patients is maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten proteins from wheat, barley, and rye, which is not always effective.10

Biodesix to Report Third Quarter 2022 Financial Results on November 3, 2022

On October 20, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus on lung disease, reported that it will release financial results for the third quarter ended September 30, 2022 before the open of trading on Thursday, November 3 (Press release, Biodesix, OCT 20, 2022, View Source [SID1234622236]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. Eastern Time on the same day.

Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

PACIRA TO REPORT THIRD QUARTER 2022 FINANCIAL RESULTS ON THURSDAY NOVEMBER 3, 2022

On October 20, 2022 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its third quarter financial results before the open of the U.S. markets on Thursday, November 3, 2022 (Press release, Pacira Pharmaceuticals, OCT 20, 2022, View Source [SID1234622235]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

For listeners who wish to participate in the question and answer session via telephone, please pre-register here. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com. For those unable to participate in the live call, a replay of the webcast will be available on the Pacira website for approximately two weeks following the call.

Lantern Pharma Announces Issuance of New Patent that Strengthens Patent Portfolio for Cancer Drug Candidate LP-300

On October 20, 2022 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,471,431, for Lantern’s drug candidate LP-300, which is in a Phase 2 clinical trial, Harmonic, for never-smokers with relapsed non-small cell lung cancer (NSCLC) (Press release, Lantern Pharma, OCT 20, 2022, View Source [SID1234622234]).

The patent is directed to increasing the survival time of cancer patients receiving LP-300 for cancers that are marked by overexpression of the regulatory proteins thioredoxin (TRX) or glutaredoxin (GRX) and/or exhibition of TRX- or GRX-mediated resistance to one or more chemotherapeutic interventions. TRX and GRX are commonly overexpressed in adenocarcinomas, a cancer subtype of NSCLC, and can lead to increased tumor resistance to chemotherapy. LP-300 can inhibit activity of TRX and GRX, restoring the redox balance of cancer cells and improving their sensitivity to chemotherapy.

"Developing a strong and evolving patent estate around our drug candidates and technologies is an essential part of our business strategy. LP-300 has the potential to improve the lives of many cancer patient groups, including never-smokers with NSCLC," said Panna Sharma, Lantern President and CEO. "The issuance of this patent demonstrates our ability to create unique cancer insights that we can then translate into clinical practice. This has the potential to add significant value for patients and investors alike," continued Sharma.

U.S. Patent No. 11,471,431 is the latest U.S. patent added to LP-300’s patent portfolio. Lantern’s current patent estate for LP-300 includes 43 patents, covering 8 patent families. The strengthened patent estate relating to LP-300 will stimulate the opportunity for future partnering discussions with biopharma companies.

About LP-300:

LP-300 is a dithio-containing drug candidate that interferes with the activity of cancer promoting proteins by modifying cysteine residues and creating adducts. LP-300’s intended mechanism of action is to work together with chemotherapy to strongly interact with cancer-promoting proteins including TRX/GRX and tyrosine kinases. In a previous multi-center Phase 3 clinical trial, a subset of never smoker NSCLC patients who received LP-300 with chemotherapy showed increased overall and two-year survival of 91% and 125%, respectively, compared to patients who received chemotherapy alone. In addition, LP-300 has been administered in multiple clinical trials to more than 1,000 people and has been generally well tolerated.

Orion Group Interim Report 1–9/2022

On October 20, 2022 Orion reported that it’s Interim Report 1–9/2022 (Press release, Orion , OCT 20, 2022, View Source [SID1234622233]). The complete report is attached to this stock exchange release and is available at View Source

Net sales totalled EUR 1,046 million (EUR 765 million in 2021).
Operating profit was EUR 399 (203) million.
Profit before taxes was EUR 400 (202) million.
Equity ratio was 62% (71%).
Return on capital employed before taxes (ROCE) was 53% (32%).
Return on equity after taxes (ROE) was 49% (29%).
Basic earnings per share were EUR 2.26 (1.15).
Cash flow from operating activities per share was EUR 3.05 (0.99).
The outlook for 2022 remains unchanged. Orion estimates that net sales in 2022 will be clearly higher than in 2021 (net sales in 2021 were EUR 1,041 million). Operating profit is estimated to be clearly higher than in 2021 (operating profit in 2021 was EUR 243 million).

President and CEO Timo Lappalainen:
Sales developed well – milestone having material impact on net sales and operating profit

"Orion’s net sales and operating profit for January-September 2022 increased clearly compared to the comparative period. Both figures were boosted by the global development and commercialisation agreement for the ODM-208 molecule announced in July and the related upfront payment of USD 290 million, of which we recognised EUR 228 million in net sales and operating profit in the third quarter. Even without this milestone payment, net sales were slightly higher than in the comparative period due to positive development of sales and because the acquired animal health company VMD’s (Inovet) net sales is now included in Orion’s net sales.

Operating profit without the ODM-208 agreement related milestone payment and costs was slightly lower than in the comparative period, mainly due to clearly higher operating costs. The ODM-208 agreement related costs were approximately EUR 20 million. These expenses include, among others, non-recurring advisory fees and provisions for certain variable incentive systems. But even without the ODM-208 related costs, the operating costs were clearly higher than in the comparative period. Sales and marketing costs increased because of a clear increase in promotional activities since COVID-19. Research & development costs increased clearly mainly due to the timing of research and clinical development projects and their costs. However, excluding the ODM-208 agreement related milestone and costs, the year 2022 is proceeding as we anticipated in the beginning of the year.

Sales of the Proprietary Products unit excluding the ODM-208 milestone payment increased slightly, mainly due to strong growth of Nubeqa and the Easyhaler product family. Sales of Parkinson’s medicines also developed well. Nubeqa sales recorded by Orion show expected fluctuations between quarters due to the way Orion records Nubeqa sales and does not reflect the development of market sales of the product. Sales of Dexdor and Simdax continued to decline as expected due to generic competition and price erosion. The Specialty Products unit saw an increase in sales, driven by self-care products, but prescription sales also performed well. Various respiratory tract infections have occurred more abundantly than in previous years, which partly explains the increase. The acquisition of VMD’s animal health business in June is reflected in the net sales of the Animal Health unit. Fermion’s net sales decreased slightly from the comparative period. The decrease is mainly due to a higher share of Fermion’s capacity being used for the production of Orion’s proprietary active pharmaceutical ingredients.

We have started a Phase I clinical trial with the NaV 1.8 blocker that is intended for the treatment of acute and chronic pain (ODM-111), for which we acquired the rights earlier this year. The study will investigate the safety and tolerability of the drug candidate in healthy volunteers. We have completed a Phase I clinical trial with tasipimidine (ODM-105) and, based on the accumulated data, we are preparing to initiate a Phase II clinical trial to evaluate the efficacy and safety of the drug candidate in the treatment of psychiatric disorders. In addition, we have decided to discontinue the development of Easyhaler tiotropium for COPD. This decision is based on a reassessment of the product’s commercial potential. The decision will have no impact on the existing Easyhaler portfolio, which will continue to be an important and growing product group for Orion.

The operating environment remains challenging due to the impact of the COVID-19 pandemic, the war in Ukraine and cost inflation. Orion is continuously working hard to ensure continuity of production, product availability, patient safety and to manage risks in global supply chains. The impact of cost inflation has already started to show up in the income statement and is expected to intensify in 2023. Energy availability and price risks are also increasing across the supply chain.

I have worked for Orion since 1999 and as CEO since the beginning of 2008. I would like to express my sincere thanks to all Orion employees, customers and partners for these years. I also thank Orion’s shareholders and Board of Directors for their support and trust. From the beginning of November, I will take on the role of advisor and shareholder of Orion. Building of well-being continues and I have strong confidence in Orion’s future."

A note from the Board of Directors of Orion

The time under Timo Lappalainen’s leadership will remain as one of the most successful periods in Orion’s long history. Timo’s contribution for this has been significant. This period now ends at Orion history’s highest operating profit quarter. Ahead of Timo’s retirement as the CEO, the Board of Orion wants to use this opportunity to thank Timo for his great leadership and for the very supportive and collaborative way he has worked with the Board. Timo is very much respected and liked by the Board, as he is by the whole Orion family and partners alike. We wish him all the best for the future!

Outlook for 2022 (provided on 13 July 2022)

Orion estimates that net sales in 2022 will be clearly higher than in 2021
(net sales in 2021 were EUR 1,041 million).

Operating profit is estimated to be clearly higher than in 2021
(operating profit in 2021 was EUR 243 million).

News conference and conference call

A webcast and a conference call for analysts, investors and media will be held today on Thursday, 20 October 2022 at 13.30 EEST. The event will be held only online and by conference call.

A link to the live webcast will be available on Orion’s website at www.orion.fi/en/investors. A recording of the event will be available on the website later the same day.