On November 18, 2021 Scandion Oncology reported its third quarter report for 2021 (Press release, Scandion Oncology, NOV 18, 2021, View Source,c3455924 [SID1234595765]). The following is taken from the report.

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Bo Rode Hansen, President and CEO comments

"During the third quarter, Scandion Oncology has continued the transformation towards the Cancer Drug Resistance company according to the company’s strategy. We completed the first Capital Markets Day where we conveyed the strategy for the registrational path to market of our clinical programs."

Highlights during Q3 2021

On August 25, Scandion Oncology announced that the US Patent and Trademark Office (USPTO) will grant the company’s patent US11,103,481 directed to the use of SCO-101. The granted patent covers combi­nation therapy with Scandion Oncology’s first-in-class lead candidate SCO-101. The patent claims the use of SCO-101 in combination with different anti-cancer agents across many cancer indications.
On August 27, Scandion Oncology announced that the company has obtained approval from the German regulatory authorities to initiate clinical trials in Germany with SCO-101 in the PANTAX Ib study.
On September 2, Scandion Oncology and Alligator Bioscience announced the conclusion of their collaboration with a very positive outcome.
On September 6, Scandion Oncology announced that the company has obtained approval from the Danish Medicines Agency and the Ethics Committee of the amendment of part 2 of the CORIST Phase II study. This means that the company can commence the inclusion of patients. To increase the recruitment rate, Scandion Oncology is expanding the number of sites in Denmark from 2 to 5 and plans to further add additio­nal sites in the EU.
On September 7, Scandion Oncology announced that the company has strengthened its Clinical Advisory Board with three international highly experienced Key Opinion Leaders in oncology.
On September 8, Scandion Oncology announced it will provide novel information on its lead candidate drug SCO-101 and a focused clinical strategy with a clear path to registration at its Capital Markets Day. The company will also communicate about its pipeline, future business opportunities and give an update from part 1 of the CORIST Phase II study.
Highlights after the end of the period

November 8, Scandion Oncology announ­ced that the timeline for read-out of the dose-finding clinical Phase Ib study PANTAX will be extended, and read-out is now expected in Q2-Q3 2022.
The third quarter report 2021 is available on the Company’s website: www.scandiononcology.com.

Audiocast today, November 18 at 10:00 am CET

Today at 10:00 Scandion Oncology’s executive management will host a webcast and conference call presenting the results and a company update.

At the end of the presentation there will be a Q&A session.
This information is information that Scandion Oncology A/S is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on November 18, 2021, at 8:30 CET

On November 18, 2021 Oasmia reported that Interim report for the period January 1, 2021 – September 30, 2021
(Press release, Oasmia, NOV 18, 2021, View Source [SID1234595764])

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SIGNIFICANT EVENTS DURING THE THIRD QUARTER
In August, Oasmia strengthened its internal capabilities with the appointments of Kia Bengtsson as Head of Clinical Development and Johanna Röstin as Head of Regulatory Affairs with effect from October 1, 2021.
In September, Oasmia signed a license agreement with the Swiss-based FarmaMondo Group for the commercialization of Paclical (Apealea) in Russia and the Commonwealth of Independent States.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
In October an Extraordinary General Meeting decided on adoption of a long-term incentive program based on employee stock options for senior executives in the company
In October Oasmia announced a global settlement of all disputes with MGC Capital, former Board Members of Oasmia and members of former management. The settlement will result in a negative cashflow effect of MSEK 24.5 but with a positive earnings effect of MSEK 32.5.
THIRD QUARTER: JULY 1, 2021 – SEPTEMBER 30, 2021
Consolidated net sales amounted to TSEK 11,920 (154)
Operating profit/loss var TSEK -29,572 (-35,194)
Net profit/loss after tax amounted to TSEK -30,987 (-36,784)
Earnings per share amounted to SEK -0.07 (-0.08)
THE PERIOD: JANUARY 1, 2021 – SEPTEMBER 30, 2021
Consolidated net sales amounted to TSEK 16,553 (201,628)
Operating profit/loss var TSEK -126,579 (15,117)
Net profit/loss after tax amounted to TSEK -129,873 (7,832)
Earnings per share amounted to SEK -0.29 (0.02)
CEO REVIEW
Transforming a business requires sustained effort and focus. Since I joined Oasmia in March 2020 we have set out a clear path to future growth as a sustainable global oncology business.

We’ve done this by:

rightsizing the Company and terminating commercial drug production
putting our finances in order by eliminating unnecessary operating expenditure
building our in-house capabilities to make us an attractive partner for innovative assets and companies
reducing business risks, such as resolving inherited legal issues, eliminating these potential liabilities
Creating these solid foundations means we are now well placed to deliver on our string of pearls strategy, putting in place a diversified portfolio of innovative cancer therapies through in-licensing and M&A. Our ambition is to build a pipeline focused on hard-to-treat and late-stage cancers using different approaches and mechanisms of action which offer us multiple shots on goal, de-risking our portfolio significantly and therefore increasing our chances of success. During the third quarter we made steady progress towards achieving this vision.

Resolving outstanding legal disputes
Post period end, we announced the global settlement of all outstanding legal disputes with MGC Capital, former Board Members of Oasmia and members of former management. The settlement will result in a negative cashflow of MSEK 24.5 but will result in a positive earnings effect of MSEK 32.5. Reported debt in relation to the MGC litigation of MSEK 80, as well as a receivable of MSEK 40, is settled as a result of the agreement, strengthening our financial position and eliminating borrowings on the balance sheet. This is excellent news and enables us to look forward rather than back.

Progressing our in-licensed and wholly-owned development-stage oncology assets
Cantrixil is the first product of our string of pearls strategy, in-licensed from Kazia Therapeutics in March. It targets a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells thought to be responsible for disease relapse. Patients with chemotherapy-resistant ovarian cancer have a very poor prognosis, and Cantrixil could offer a much-needed new therapeutic option. Positive Phase 1 results were presented at AACR (Free AACR Whitepaper) earlier this year and Phase 2 study preparations in advanced ovarian cancer are well underway. In September, our Scientific Advisory Board, composed of key opinion leaders in oncology, met in Stockholm for the first time. The Board is offering invaluable guidance on the design of the Cantrixil Phase 2 trial and the longer-term clinical and regulatory path. Securing drug product for the Phase 2 trial through manufacturing agreements with multiple parties is a complex process and initiation of the trial will be later than originally envisaged. We will communicate further on the proposed timetable for the Phase 2 study when we have clarity on the supply situation.

A Phase 1b trial of our second clinical-stage program, docetaxel micellar, in development for advanced prostate cancer, continued to recruit patients in Switzerland under the leadership of the Swiss Group for Clinical Cancer Research (SAKK). SAKK has made excellent progress, with three centers open and enrolment is still expected to be completed by the end of 2022.

Exploring the full potential of our technologies
We recently provided an update on our collaboration with the Karolinska Institutet in Sweden to explore the full potential of our XR-17 drug solubilization technology platform. Work on our line extension for XR-17, which we have named XR-18, is progressing well and is intended to offer expanded utility. We are also preparing to evaluate formulations of XR-17/18 with our licensed product candidate, Cantrixil.

Our recent research into XR-19, our dual encapsulation technology designed to encapsulate two active pharmaceutical ingredients (APIs) in one micelle, has yielded encouraging proof-of-concept data. However, we have assessed the commercial utility of this approach to be limited and have therefore decided not to develop new product candidates with this technology, focusing our resources on other development opportunities.

Organizational update
Having the right scientific, regulatory, development and commercial skills to make Oasmia an attractive business partner for oncology drugs and companies around the world is critical to our success. Over the past 18 months, we’ve built a first-class team in all these areas, and in August I was pleased to announce the appointments of Kia Bengtsson as Head of Clinical Development and Johanna Röstin as Head of Regulatory Affairs. Kia and Johanna significantly strengthen Oasmia’s internal drug development expertise, supporting our ability to move products through to commercialization and to evaluate new opportunities. Peter Selin has decided to step down as Chief Business Officer and the search for a replacement has been initiated. Peter will remain in his current role during his notice period.

Maximizing the potential from out-licensed products
Maximizing the potential of our partnered ovarian cancer therapy Apealea has been another important focus. In September, we signed a license agreement with the Swiss-based FarmaMondo Group for the commercialization of Apealea in Russia and the Commonwealth of Independent States, where it is known under the brand name Paclical. This agreement marks the completion of the out-licensing of Apealea globally and we anticipate the first royalties from partnerships during 2022.

Elevar has informed Oasmia that it is reviewing the clinical and regulatory pathway for Apealea in the US in order to maximize the product’s commercial potential. This may impact the clinical development timelines for Apealea in the US and Oasmia will update investors when firm information has been provided by Elevar.

Building the business through in-licensing and M&A
As well as driving our existing portfolio in Q3, we’ve made further progress in making Oasmia a more attractive partner for innovative therapies and companies, positioning ourselves to add value in the sweet spot of early-to-mid-stage product development, demonstrated by the in-licensing of Cantrixil.

I’m pleased to report that our continuing transformation and new capabilities has attracted interest from a number of parties and that we are currently evaluating several promising opportunities. I look forward to updating you on progress in due course.

I’d like to thank you all for your continued support at this exciting time for the business as we look ahead to completing our transition to become a global oncology business.

On November 18, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has entered into a definitive agreement to acquire Toxikon, a contract research organization delivering best-in-class nonclinical testing services (Press release, LabCorp, NOV 18, 2021, View Source [SID1234595763]). Once completed, the transaction will create a strategic footprint for Labcorp to partner with pharmaceutical and biotechnology clients in the Boston, Mass., area and bolster its strong nonclinical development portfolio.

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"Adding Toxikon underscores our commitment to nonclinical development and advances our capabilities for both drug development and medical device testing," said Dr. Paul Kirchgraber, CEO of Labcorp Drug Development. "This acquisition extends Labcorp’s portfolio of full-service drug development and medical device solutions from discovery to market approval."

Toxikon’s strategic location allows Labcorp to further engage with large pharmaceutical companies and biotech firms in the region on nonclinical work, as well as facilitating entry into medical device investigational device exemption (IDE) submissions. As such, Toxikon will also complement Labcorp’s existing nonclinical medical device efficacy and safety testing and the associated clinical work performed by Labcorp’s medical device and diagnostics unit.

Headquartered in Bedford, Mass., and with annual revenues of around $40 million, Toxikon maintains specialized, state-of-the-art facilities and a robust roster of pharmaceutical, biotech and medical device clients. Its highly trained staff provides an extensive portfolio of in vivo and in vitro testing and related consulting services to support life sciences companies. The facility in Bedford also has capacity for growth and provides Labcorp Drug Development with an opportunity to expand its traditional toxicology business.

"As a part of the Labcorp family, we will have an opportunity to broaden our impact through access to extensive resources, knowledge and support," said Dr. Laxman S. Desai, Toxikon’s founder, president and CEO. "Together, we can provide better outcomes for our clients and, ultimately, the health care providers and patients who depend on our continued success and innovation."

The transaction is expected to close during the fourth quarter of 2021, subject to customary closing conditions and regulatory approvals, including under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. Specific terms of the transaction were not disclosed.

On November 18, 2021 Sanofi reported an equity investment of $180 million and a new strategic collaboration with Owkin comprised of discovery and development programmes in four exclusive types of cancer, with a total payment of $90 million for three years plus additional research milestone-based payments (Press release, Sanofi, NOV 18, 2021, View Source [SID1234595762]). Owkin, an artificial intelligence (AI) and precision medicine company, builds best-in-class predictive biomedical AI models and robust data sets. With the ambition to optimize clinical trial design and detect predictive biomarkers for diseases and treatment outcomes, this collaboration will support Sanofi’s growing oncology portfolio in core areas such as lung cancer, breast cancer and multiple myeloma.

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To accelerate medical research with AI in a privacy-preserving way, Owkin has assembled a global research network powered by federated learning, which allows data scientists to securely connect to decentralized, multi-party data sets and train AI models without having to pool data. This approach will complement Sanofi’s emerging strength in oncology, as the company’s scientists apply cutting-edge technology platforms to design potentially life-transforming medicines for cancer patients worldwide.

"Owkin’s unique methodology, which applies AI on patient data from partnerships with multiple academic medical centers, supports our ambition to leverage data in innovative ways in R&D," said Arnaud Robert, Executive Vice President, Chief Digital Officer, Sanofi. "We are striving to advance precision medicine to the next level and to discover innovative treatment methods with the greatest benefits for patients."

Sanofi will leverage the comprehensive Owkin Platform, in order to find new biomarkers and therapeutic targets, building prognostic models, and predicting response to treatment from multimodal patient data. Sanofi’s investment will support Owkin’s development and goal to grow the world’s leading histology and genomic cancer database from top oncology centers.

"Owkin’s mission is to improve patient’s lives by using our platform to discover and develop the right treatment for every patient," said Thomas Clozel, M.D., Co-Founder and CEO at Owkin. "We believe that the future of precision medicine lies in technologies that can unlock insights from the vast amount of patient data in hospitals and research centers in a privacy-preserving and secure way. This landmark partnership with Sanofi will see federated learning used to create research collaborations at a truly unprecedented scale. The future of AI to transform how we develop treatments is incredibly bright, and we are proud to partner with Sanofi on this mission."

This collaboration agreement will allow Sanofi to work closely with Owkin in identifying new oncology treatments across four cancers.

"We look forward to working with our colleagues at Owkin to analyze data from hundreds of thousands of patients," said John Reed, M.D., Ph.D., Global Head of Research and Development, Sanofi. "Sanofi’s investment in the company includes a three-year agreement that will help discover and develop new treatments for non-small cell lung cancer, triple negative breast cancer, mesothelioma and multiple myeloma. This partnership will help accelerate our ambitious oncology program as we advance a rich pipeline of medicines to address unmet patient needs."

On November 17, 2021 Orange Grove Bio, a preclinical drug investment and development firm, and the University of Pittsburgh reported the establishment of a collaboration designed to advance the development and commercialization of novel therapeutics by supporting the translation of scientific discoveries made by researchers at the University of Pittsburgh (Press release, Orange Grove Bio, NOV 17, 2021, View Source [SID1234633191]). The newly established partnership will aim to cultivate the Pittsburgh biotech landscape by increasing entrepreneurship, education, and scientific translation of promising technologies. These efforts will be focused in the areas of oncology and autoimmune and inflammatory diseases.

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"University of Pittsburgh innovators have a strong track record of achieving impact for their research through commercial translation," said Joe Havrilla, Associate Vice Chancellor for Innovation and Entrepreneurship. "This new collaboration with Orange Grove Bio will allow us to further our commercialization efforts and we look forward to the positive impact it will have for our faculty and students and ultimately for patients."

Under terms of the partnership, Orange Grove Bio will provide commercialization guidance and support to the University of Pittsburgh Innovation Institute, an internship program for the university’s Ph.D. students, and educational seminars for primary investigators and researchers at the university. Additionally, as part of these activities, Orange Grove Bio’s head of chemistry, William H. Miller, Ph.D., has joined the University of Pittsburgh’s external advisory board for novel technologies.

"Researchers at the University of Pittsburgh are engaged in a wide range of cutting-edge research that has the potential to meaningfully impact human health," said Dr. Miller. "At Orange Grove, we want to do our part to support these ongoing research efforts and further develop the local biotech environment to enable the development and commercialization of these discoveries."

In addition to working closely with the technology transfer office and supporting educational initiatives, Orange Grove Bio will increase its on-the-ground presence by onboarding new team members from the Pittsburgh area, who will perform critical scientific and business functions.

Orange Grove Bio’s mission is to develop new therapeutic options for patients by harnessing the significant research potential found in universities across the United States. Orange Grove Bio fosters strong relationships with technology transfer offices outside of the traditional medical technology hubs of Boston and San Francisco. Collectively, Orange Grove Bio’s team possesses more than one hundred years of drug development and company creation experience, allowing it to build and finance innovative programs from the research and development stage to clinical trials.

"We believe that the University of Pittsburgh and its talented researchers are well positioned to serve as a hotbed for the incubation of innovative drug development companies capable of delivering the ground-breaking therapies of tomorrow," said Marc Appel, Orange Grove Bio’s chief executive officer. "We are committed to fostering and supporting this rich scientific ecosystem through collaboration with the University of Pittsburgh, academic researchers, and investors to drive the commercialization of novel therapies for patients."