On March 31, 2022 Onxeo S.A. (Euronext Growth Paris: ALONX, First North Copenhagen: ONXEO), ("Onxeo" or "the Company"), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage response (DDR), reported that it will present new preclinical data confirming AsiDNA’s abilities to protect from anticancer treatment toxicity and fight tumor resistance during poster and oral sessions at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR Annual Meeting 2022, April 8-13, 2022) (Press release, Onxeo, MAR 31, 2022, View Source [SID1234611270]).

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The oral presentation will describe how AsiDNA efficiently prevented the emergence of resistances to tyrosine kinase inhibitors in several models of targetable oncogenic addiction and will point to the therapeutic opportunity of combining AsiDNA and TKI (tyrosine kinase inhibitors) to overcome resistance in a clinical setting. These data were obtained within the framework of the collaboration with Pr. Gilles Favre (Cancer Research Center of Toulouse).

The poster presentation supports AsiDNA’s potential to protect healthy cells from toxicities of several anti-cancer treatments. When combined with different anti-cancer treatments (Carboplatin+/-Paclitaxel in long-term treatment, Radiotherapy, Doxorubicin, PARP inhibitors), AsiDNA induces its nuclear target engagement only in dividing cells, while preserving healthy non dividing cells. In addition, in certain proliferating healthy cells, AsiDNA induces a stop in their division or boosts their DNA repair activity, thus protecting them from the toxic effects of anti-cancer treatments. These data were obtained in in vivo and in vitro models within the framework of the collaboration with Pr. Marie Dutreix (Institut Curie).

Wael Jdey, Preclinical Lead of Onxeo, stated: "These new data accepted for presentation at the AACR (Free AACR Whitepaper) 2022 complement the pre-clinical and clinical package already obtained with AsiDNA. With its differentiated mechanism of action, AsiDNA has shown its ability to work in the new preclinical tumor models that are resistant to TKi’s especially Osimertinib in EGFR-mutated NSCLC models. We are excited to present these data to the scientific community and are looking forward to initiating the next steps of the AsiDNA development plan".

On March 31, 2022 Mereo BioPharma Group plc (NASDAQ: MREO) ("Mereo" or the "Company"), a clinical-stage biopharmaceutical company focused on oncology and rare diseases, reported financial results for the year ended December 31, 2021 and provided an update on recent corporate highlights (Press release, Mereo BioPharma, MAR 31, 2022, View Source [SID1234611291]).

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"During 2021, we continued to execute on all fronts and made substantial progress across our pipeline. We further advanced our etigilimab anti-TIGIT program, reporting highly promising interim data from the ongoing ACTIVATE Phase 1b/2 study and expanded our research to include clear-cell ovarian cancer through our partnership with Cancer Focus Fund and MD Anderson," said Dr. Denise Scots-Knight, Chief Executive Officer of Mereo. "In addition, we reported positive data from multiple studies of alvelestat, which also received orphan drug designation for the treatment of AATD. We ended the year well positioned for further success in 2022, with a strong balance sheet supported by the proceeds of our public offering early last year. Following our accomplishments in 2021, we look forward to our upcoming catalysts in 2022."

Highlights from 2021 and Recent Developments

Etigilimab (MPH-313)

Reported interim data in Q4 2021 from ACTIVATE Phase 1b/2 open label study of etigilimab anti-TIGIT antibody in combination with nivolumab in solid tumors
Based on analysis of 15 patients in the efficacy analysis set with a minimum of one scan to-date or clinical progression, those receiving the etigilimab / nivolumab combination have achieved one complete response in cervical cancer, one partial response in ovarian cancer and four instances of stable disease in ovarian cancer, cervical and uveal melanoma
Well tolerated with a favorable safety profile
Ongoing Phase 1b/2 basket combination study continues to enroll well
Update on additional patients and durability of initial responses expected in Q2 2022
Alvelestat (MPH-966)

Received orphan designation from the FDA for the treatment of AATD
Held an R&D Day update on the alvelestat programs in Q1 2022, including in the ongoing Phase 2 trial which enrolled 99 patients with AATD
Data expected in early Q2 2022
Reported positive bio-marker data from investigator-sponsored Phase 1b/2 study of alvelestat in patients with BOS following hematopoietic stem cell transplantation
Reported positive top-line results from Phase 1b/2 trial in hospitalized patients with COVID-19 respiratory disease; Alvelestat, on top of standard of care, resulted in a more rapid time to improvement in WHO Disease Severity score in the first 5-7 days compared to placebo plus standard of care.
Corporate Updates

Partnerships

Announced partnership with the Cancer Focus Fund supporting a Phase 1b/2 clinical study of etigilimab in combination with nivolumab in clear cell ovarian cancer to be conducted at The University of Texas MD Anderson Cancer Center
Ultragenyx expects to enroll the first patient in the Phase 2/3 study of setrusumab in 5–25 year-olds with osteogenesis imperfecta in 1H 2022
Public Offering of American Depositary Shares

Public offering gross proceeds of $115.1 million in Q1 2021
Strengthened Board of Directors

Pierre Jacquet, M.D., Ph.D. appointed to Board of Directors, September 2021
Anne Hyland appointed to Board of Directors, March 2022
Full Year 2021 Financial Results
Revenue was £36.5 million in 2021, representing the upfront payment under the licensing and collaboration agreement with Ultragenyx in January 2021 for the development and commercialization of setrusumab for OI.

Full year 2021 research and development expenses were £23.6 million, compared to £16.3 million in 2020, an increase of £7.2 million, or 44%. R&D expenses relating to etigilimab increased by £12.5 million. The increase was due to the costs associated with commencement of the open label Phase 1b/2 basket study in combination with nivolumab in a range of tumor types. R&D expenses relating to alvelestat increased £0.6 million, or 13%, primarily related to the ongoing Phase 2 proof-of-concept study. Partially offsetting the increases, R&D expenses relating to setrusumab and navicixizumab decreased by £4.1 million and £1.7 million, respectively. The decrease related to setrusumab was primarily driven by the licensing and collaboration agreement with Ultragenyx, under which Ultragenyx will fund global development of the program, and the decrease related to navicixizumab was driven by the global out-licensing agreement with OncXerna for the development and commercialization of navicixizumab.

Administrative expenses decreased by £5.3 million, or 25%, from £21.2 million in 2020 to £15.9 million in 2021. The decrease was primarily driven by a £4.0 million reduction in legal and professional fees in 2021, reflecting lower activity and related transaction costs in 2021 compared to 2020. Premises-related costs decreased by £1.3 million in 2021 primarily due to one-off transaction costs in 2020 associated with renegotiation of our office lease in Redwood City.

Net profit attributable to equity holders for the year 2021 was a net profit of £12.7 million, compared to a net loss of £163.6 million in 2020, reflecting an operating loss of £20.9 million and a gain of £40.0 million, due to changes in the fair value of financial instruments resulting from an unrealized gain on warrants.

Total ordinary shares outstanding at December 31, 2021 were approximately 585 million. Total ADSs outstanding at December 31, 2021 were approximately 116.5 million, with each ADS representing five ordinary shares of the Company.

Cash and short-term deposits totaled £94.3 million at December 31, 2021.

On March 31, 2022 Insud Pharma reported that it has entered into an agreement with Fresenius Kabi (Press release, mAbxience, MAR 31, 2022, View Source [SID1234611328]). Under the terms of the agreement Fresenius Kabi will acquire 55% of mAbxience, the global fully-fledged biotech company of the Spanish group.

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Founded in 2010, mAbxience has over a decade of experience in the development, manufacture, and commercialization of biopharmaceuticals. The company operates three state-of-the-art and R&D manufacturing facilities, located in Spain and Argentina, and has been developing a range of biopharmaceutical products focused on multiple therapeutic areas. mAbxience also offers contract development and manufacturing (CDMO) services to customers.

The company has successfully established alliances with key partners which have enabled multiple biosimilars to be launched across international markets allowing patients access to high quality biopharmaceutical products on a global basis.

As a result of this agreement, mAbxience will continue its ambitious growth plans and will keep its well-defined corporate identity, and team of around 600 professionals, ensuring continuity of its current business strategy. The boards of directors of both companies have unanimously approved the transaction, which is expected to close by midyear 2022, subject to regulatory and other conditions customary for a transaction of this type.

With this alliance, Insud Pharma plans to accelerate its biotech unit, bringing new and exciting opportunities to mAbxience customers and increasing its research activities – at the beginning of May, it is expected to open a new R&D facility in Spain-.

Furthermore, this transaction will be meaningful for the Spanish group Insud Pharma, which will continue to grow and invest worldwide, whilst entering into new activities.

"We’re delighted to announce our combination with Fresenius Kabi for the future development of mAbxience. This collaboration recognizes mAbxience’ s capabilities in biopharmaceuticals and our strong team of dedicated employees. This transaction is a tremendous opportunity to add further value to the industry, to make mAbxience bigger and stronger and to collaborate and work together with a company such as Fresenius Kabi", stated Lucas Sigman, CEO at Insud Pharma.

"mAbxience is the perfect example of how innovation, cutting-edge R&D and manufacturing platform technology is used to deliver high quality medicines to patients, provide cost-effective alternatives to healthcare systems and guarantee its sustainability. Today’s announcement is testament to the hard work of our people that have grown mAbxience from its inception to the leading business it is today", stated Sigman.

He continued "Furthermore, this is also great news for Insud Pharma. This transaction will give our company the chance to continue investing more and to open the door to faster expansion into new areas and opportunities. As joint partners with Fresenius Kabi, we fully expect to further accelerate our mission to deliver affordable medicines to patients worldwide", stated Sigman.

Emmanuelle Lepine, mAbxience CEO, said "We believe this new strategic partnership with Fresenius Kabi represents the best possible next step in line with mAbxience´s strategic growth plan. This partnership will allow the further progression of our development pipeline and will enable the acceleration of our capacity expansion, both of which will benefit patients, customers, and health systems. This new stage in the evolution of our company will bolster opportunities to grow our biopharmaceutical platform in key areas of high technological development and manufacturing, as well as accelerate access in strategic markets, adding a key collaboration to our already strong global partnership base".

She continued "Driven by a shared value in people and purpose, this partnership with Fresenius Kabi will enable mAbxience to advance towards its vision of bringing biopharma solutions that are Affordable, Accessible and Across the globe. We are convinced that this partnership will enhance our commitment to the long-term sustainable growth potential for the business and will be highly beneficial to the growth and development of the whole team".

Goldman Sachs acted as exclusive financial advisor to Insud Pharma, while Baker McKenzie acted as legal advisor.

On March 31, 2022 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to defeating cancer using RNA therapeutics, reported financial results for 2021 and recent business progress (Press release, TransCode Therapeutics, MAR 31, 2022, View Source [SID1234611344]).

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"2021 was a foundational year for TransCode, highlighted by our successful IPO on Nasdaq in July," said Michael Dudley, co-founder, president and CEO of TransCode. "With resources from the IPO, as well an important Small Business Innovation Research (SBIR) grant, we drove significant progress across the organization, including key additions to our team that bring valuable expertise, and continued advancement of our lead candidate and our preclinical development programs. We are now building on this foundation as we move toward clinical development which we expect will demonstrate the power and versatility of our TTX platform in solving the challenges of RNA delivery in oncology."

TransCode Therapeutics co-founder and Chief Technology Officer, Dr. Zdravka Medarova, added, "We are on track to submit an exploratory Investigational New Drug Application (eIND) this year to test our lead therapeutic candidate, TTX-MC138, in a Phase 0 study in metastatic solid tumors. We believe this study has the potential to establish proof-of-mechanism for our platform, upon which we hope to build a broad and diverse pipeline of therapeutics and diagnostics with the potential to reach previously undruggable genetic targets."

Key 2021 Highlights

·Completed an over-subscribed initial public offering on Nasdaq in July, raising gross proceeds of $28.8 million; the Company’s outstanding convertible promissory notes were converted into common stock upon completion of the IPO.

·Expanded the leadership team with the appointment of TransCode’s scientific co-founder, Zdravka Medarova, Ph.D., as Chief Technology Officer effective October 1. Dr. Medarova is a leader in the field of non-coding RNA delivery to cancer and has authored multiple high-impact publications on the topic of RNA delivery, nanotechnology, and the biology of cancer metastasis. Leadership team further strengthened in 2021 with additional key appointments, including:

Susan Duggan as VP of Clinical Operations, Dustan Bonnin as VP of Corporate Strategy and Subrata Ghosh, Ph.D, as Principal Scientist; and
Dejan Juric, M.D., appointed to the Scientific Advisory Board. Dr. Juric, a renowned expert in personalized cancer medicine and a breast cancer specialist, serves as director of the Henri and Belinda Termeer Center for Targeted Therapies and Investigational Cancer Therapeutics Program at Massachusetts General Hospital.

·Awarded a Fast-Track Small Business Innovation Research (SBIR) grant from National Institutes of Health (NIH), totaling $2.3 million. The award is a fast track award based on milestones achievement, to support the clinical evaluation of TTX-MC138, including translational experiments to identify and optimize a method for measuring miR-10b expression in breast cancer clinical samples, as well as IND-enabling activities and measurement of delivery of TTX-MC138.

Expected Upcoming Milestones

TransCode’s goals to continue to advance its portfolio include:

·TTX-MC138

Submission to FDA of an eIND application for First-in-Human (FIH) clinical trial.
Initiation of a FIH Phase 0 clinical study evaluating delivery of TTX-MC138 to metastatic lesions in 10 Stage IV patients with solid tumors
Concurrent completion of IND-enabling studies to support filing of an IND application for a Phase I clinical trial of TTX-MC138.

·Publication of preclinical results supporting the lead therapeutic candidate TTX-MC138 in pancreatic cancer and glioblastoma multiforme.

·Continuation of preclinical studies for therapeutic candidates TTX-RIGA, TTX-siPDL1, and TTX-siLin28b.

2021 Financial Highlights (in millions)

•Cash: $ 20.8
•R&D Expenses: $ 2.8
•G&A Expenses: $ 3.4
•Operating Loss: $ 6.8

Financial Guidance

TransCode expects that its cash of $20.8 million as of December 31, 2021, together with additional funding expected from an April 2021 SBIR award, are sufficient to fund planned operations into the first quarter 2023 but not for a full 12 months from the date of our financial statements.

Conference Call

The Company will host an investor conference call at 4:30 p.m. ET on April 7, 2022. A question-and-answer session will follow management’s presentation.

If you are unable to participate during the live call, the call will be recorded and later made available on the Company’s website.

On March 31, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that William G. Rice, Ph.D., Chairman, President and Chief Executive Officer, will participate in a panel to discuss new approaches of treating acute myeloid leukemias (AML) at Canaccord Genuity’s 2022 Horizons in Oncology Virtual Conference (Press release, Aptose Biosciences, MAR 31, 2022, View Source [SID1234611237]):

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Canaccord Genuity’s 2021 Horizons in Oncology Virtual Conference

•Panel: Attacking AML: New Approaches

Date: Thursday, April 14, 2022
Time: 1:30 – 2:30 PM ET
Format: Panel Moderated by John Newman, Ph.D., Managing Director, Biotechnology Analyst
Webcast: Link
The audio webcast also will be accessible through the Aptose website at www.aptose.com and will be archived shortly after the live events.

The Aptose management team will be hosting 1×1 investor meetings during the event.