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aTyr Pharma Announces Fourth Quarter and Full Year 2021 Results and Provides Corporate Update

On March 14, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported fourth quarter and full year 2021 results and provided a corporate update (Press release, aTyr Pharma, MAR 14, 2022, View Source [SID1234610121]).

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"2021 was a milestone year for aTyr, which culminated in clinical proof-of-concept for our lead therapeutic candidate, efzofitimod (ATYR1923), and validation for our tRNA synthetase biology platform," said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "The positive results reported from our Phase 1b/2a study of efzofitimod in pulmonary sarcoidosis, our initial interstitial lung disease (ILD) indication, suggest that this novel immunomodulator has the potential to be a transformative, disease modifying therapy for patients with this and other fibrotic lung diseases with high unmet need."

"We have carried this momentum into the start of 2022. The receipt of U.S. Food and Drug Administration (FDA) orphan drug designation for efzofitimod in sarcoidosis underscores the significant challenges faced by these patients. We have a path forward as a result of our positive End-of-Phase 2 meeting with the FDA and intend to initiate a planned registrational trial in pulmonary sarcoidosis in the third quarter of this year. We also remain on track with the IND-enabling work for ATYR2810, and we expect to initiate a Phase 1 study in cancer patients in the second half of this year. We ended 2021 with approximately $107.9 million in cash, and our strong balance sheet positions us well to advance our clinical programs and progress our pipeline in the year ahead."

Fourth Quarter 2021 and Subsequent Period Highlights

Held a Type B End-of-Phase 2 meeting with the FDA regarding the company’s lead therapeutic candidate, efzofitimod, for the treatment of pulmonary sarcoidosis. The meeting followed positive results that the company reported from a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in 37 patients with pulmonary sarcoidosis, which demonstrated safety, tolerability and consistent dose response for efzofitimod on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers. Following the FDA’s review of the data package, including data from the nonclinical program, early clinical trials and the recently completed Phase 1b/2a study, the company will proceed with the advancement of efzofitimod. The FDA discussed endpoints detailed by the company in its proposed registrational study and prioritization of outcome measurements that would best support the evaluation of efzofitimod’s efficacy. The FDA advised the continued evaluation of multiple doses of efzofitimod in a longer duration study to establish a controlled safety database that supports the determination of the optimal dose for chronic use. The company has a path forward to initiate a planned registrational study of efzofitimod that will incorporate feedback from the FDA, and the company is proceeding with its plans to initiate this study in the third quarter of 2022.
Received FDA orphan drug designation for efzofitimod for the treatment of sarcoidosis. Orphan drug designation is granted to support the development of medicines for patients with unmet needs for disorders affecting fewer than 200,000 people in the U.S. and provides certain benefits, including the potential for seven years of market exclusivity following regulatory approval, exemption from FDA application fees and tax credits for qualified clinical trials.
Announced that the United States Adopted Names Council and the World Health Organization’s International Nonproprietary Name Expert Committee selected "efzofitimod" as the nonproprietary (generic) name for ATYR1923. Going forward, aTyr will use the name efzofitimod in place of ATYR1923.
Announced an agreement with FUJIFILM Diosynth Biotechnologies, a leading contract development and manufacturing organization for biologics, viral vaccines and viral vectors, for the manufacture of efzofitimod. FUJIFILM Diosynth Biotechnologies will support process development and scale up of efzofitimod, including the manufacture of bulk drug substance for additional clinical trials in ILD.
Had a poster accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The poster, titled, "ATYR2810, a fully humanized monoclonal antibody targeting the VEGF-NRP2 pathway sensitizes highly aggressive and chemoresistant TNBC subtypes to chemotherapy," will present additional preclinical data generated for ATYR2810, the company’s lead anti-Neuropilin-2 (NRP2)/VEGF antibody and IND candidate. The company expects to initiate a phase 1 study of ATYR2810 in cancer patients in the second half of 2022.
Year Ended 2021 Financial Highlights and Cash Position

Cash & Investment Position: Cash, cash equivalents and investments as of December 31, 2021, were $107.9 million.
R&D Expenses: Research and development expenses were $23.3 million for the year ended 2021, which consisted primarily of product development costs for the efzofitimod and ATYR2810 programs. Program costs for efzofitimod included preparation for the upcoming planned registrational trial in pulmonary sarcoidosis, which included the manufacture of clinical trial material and initiation of technology transfer activities with FUJIFILM Diosynth Biotechnologies. Program costs for ATYR2810 included costs related to IND-enabling activities and the initiation of manufacturing activities with Lonza.
G&A Expenses: General and administrative expenses were $10.8 million for the year ended 2021. This included an increase in the number of employees as the company prepares for the efzofitimod planned registrational trial in pulmonary sarcoidosis and a phase 1 clinical trial of ATYR2810 in cancer.
Shares Outstanding: Common shares outstanding were 27,793,035 as of December 31, 2021.
Financial Guidance

The company expects its research and development expenses to increase in 2022 as it continues to develop efzofitimod and ATYR2810 as well as its discovery programs.
Conference Call and Webcast Details

aTyr will host a conference call and webcast today at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its financial results and provide a corporate update. Interested parties may access the call by dialing toll-free 844-358-9116 from the US, or 209-905-5951 internationally and using conference ID 3686825. Links to a live audio webcast and replay may be accessed on the aTyr website events page at: View Source An audio replay will be available for at least 90 days following the event.

About Efzofitimod

aTyr is developing efzofitimod as a potential therapeutic for patients with fibrotic lung disease. Efzofitimod, a fusion protein comprised of the immunomodulatory domain of histidyl-tRNA synthetase fused to the FC region of a human antibody, is a selective modulator of neuropilin-2 that downregulates innate and adaptive immune response in inflammatory disease states. aTyr’s lead indication for efzofitimod is pulmonary sarcoidosis, a major form of interstitial lung disease. Clinical proof-of-concept for efzofitimod was recently established in a Phase 1b/2a multiple-ascending dose, placebo-controlled study of efzofitimod in patients with pulmonary sarcoidosis, which demonstrated safety and a consistent dose response and trends of benefit of efzofitimod compared to placebo on key efficacy endpoints, including steroid reduction, lung function, clinical symptoms and inflammatory biomarkers. aTyr intends to initiate a planned registrational study of efzofitimod in pulmonary sarcoidosis in the third quarter of 2022.

Join EVERSANA at BIO-Europe Spring 2022

On March 14, 2022 EVERSANA reported that virtually at BIO-Europe Spring, March 28-31, 2022 (Press release, EVERSANA, MAR 14, 2022, View Source [SID1234610066]). With over 40 clients and a growing number of engagements in Europe, EVERSANA is leading the way as the only end-to-end provider of commercialisation services that span all stages of the product life cycle to deliver long-term value for patients, physicians and payers .

Join our team for virtual networking during BIO-Europe Spring or watch our experts speak during the following sessions.

Panel Discussion: How digital health technologies can support systemic change in healthcare
Monday, 28 March 2022 13:30 – 14:30Join EVERSANA’s Ed Cox. Executive Vice President, Strategic Alliances & Global Head of Digital Medicine and fellow panelists as they discuss how digital health technologies impact the patient’s healthcare experience, from how big data applications can help identify at-risk patients to feeding back RWE to inform the drug innovation process. The discussion will also touch on how these technologies can open new ways to provide access to therapeutics in underserved areas such as mental health and chronic diseases.

Panel Discussion: Early Trial Planning in Times of Pay-for-Performance Agreements & European HTA Harmonization
Wednesday, 30 March 2022 13:30 – 14:30
In this workshop, EVERSANA’s Mike Ryan, Executive Vice President, Europe and other industry experts will focus on innovative reimbursement for high-cost therapies in Europe. They will outline how mid-sized biotech companies can successfully bring their innovations into the European reimbursement systems through early study planning. Special emphasis is placed on the harmonization of the health technology assessment (HTA) procedures and the resulting study design requirements. Success factors for pay-for-performance models are also presented.

MediLink Therapeutics closes US$70 million Series B financing

On March 14, 2022 MediLink Therapeutics (Suzhou) Co., Ltd (MediLink) reported that completion of a US$70 million Series B financing (Press release, Suzhou Medilink Therapeutics, MAR 14, 2022, View Source,Capital%20(HLC)%2C%20etc. [SID1234610065]). This round was led by LYFE Capital and Qiming Venture Partners, and co-invested by Legend Capital, Loyal Valley Capital and Highlight Capital (HLC), etc. The new funding will support clinical development of MediLink’s new generation Antibody-Drug Conjugate (ADC) pipeline, as well as early discovery and development of novel conjugated drugs.

A total of 14 ADC products have been approved globally after years of technology innovation in the ADC field. From the initial proof of concept in 2000 to the latest ADC products represented by Enhertu and Trodelvy, ADC technology has been advancing rapidly in recent years. In 2021, an article [1] published in Nature Reviews predicted that global sales for the marketed ADC products will exceed US$16.4 billion by 2026. A growing number of pharmaceutical companies have been shifting their R&D interests/focus to ADCs recently. According to Pharmcube database, the total BD transactions disclosed between 2019 and 2021 exceeded US$32.6 billion. As the competition is heating up, new and novel technologies in ADC biotech companies will play an important role to distinguish themselves in this area.

MediLink Therapeutics was established in 2020 by an experienced team with innovative ADC expertise and management skills. The company is committed to developing globally competitive conjugated drugs and building a differentiated proprietary ADC technology platform. MediLink focuses clinical drug development on unmet clinical needs, while establishing close collaborations with potential international partners. At present, the company has invented and patented several novel proprietary ADC linker-payload technologies. First program will start Phase I clinical trial in both China and the United States this year. In addition, the company has established collaboration with several partners using MediLink’s proprietary technology platform.

Dr. Tongtong Xue, Founder and CEO of MediLink said: "Over the past year, MediLink Therapeutics has focused on the development of the latest generation ADC technology platform. Thanks to the team’s innovation and execution capabilities, we have submitted the formal IND application of our first product to the FDA this month. 2022 will be a pivotal year for us as we move into the clinical phase. We are very fortunate to have brought new investors on board, while continuing to receive the unwavering support from existing investors. In the future, MediLink Therapeutics will focus on the development of internationally competitive conjugated drugs, as well as seeking to engage in collaboration with potential partners, accelerating global patients’ access to medicines that address unmet medical needs."

Mr. Gang Chen, managing partner at LYFE Capital, lead investor of this round, said: "LYFE Capital has always been dedicated to seeking out innovation in the medical field in global, while providing value creation for top-performing medical companies with differentiated technologies. ADC is one of the segments to which we continuously pay attention. The vision and the execution of MediLink’s team, combined with its past profound accumulation in ADC technologies, has helped the company to establish a differentiated ADC technology platform with independent intellectual property rights in just over one year following its inception. We are very pleased to have collaboration with MediLink and help MediLink build and expand its international platform through our international network and industry resources. We firmly believe that MediLink will become a world-leading ADC technology platform company under the leadership of the founding team and the support of new and existing shareholders."

Dr. Kan Chen, partner at Qiming Venture Partners, the joint lead investor of this round, said: "As an investor in the series A financing, we decided to also participate in this round as we believe that MediLink is uniquely positioned to excel in the international conjugated drug market. The MediLink’s team has a clear development strategy, solid technology accumulation and efficient execution ability. We witnessed the gradual transformation of MediLink into a biotech company with an internationally competitive ADC technology platform over the past year. We are honored to continue to support MediLink and hope the team will bring health and well-being to patients worldwide as soon as possible."

NeoVirTech SAS opens a new laboratory at the Cancerology Research Center of Toulouse (CRCT)

On March 14, 2022 NeoVirTech, a biotechnology company developing autofluorescent viruses for the discovery of antiviral molecules and the conception of oncolytic virotherapies, reported that joins one of the most advanced clinical research center in France to accelerate its development in the oncolytic field (Press release, Cancer Research Center of Toulouse, MAR 14, 2022, View Source [SID1234610064]). Oncolytic viruses are viruses that are specifically modified and armed to attack cancer cells and trigger a dual response by first inducing direct cancer cell killing and second by stimulating the patient immune system.

Being located at the CRCT will allow NeoVirTech to combine its expertise in the tagging and visualization of DNA related mechanisms to advanced pilot preclinical research programs of the CRCT. NeoVirTech will share its expertise in high throughput phenotypic screening with CRCT researchers to validate candidate drugs or therapeutic targets. NeoVirTech will also develop new collaborative projects based on its ANCHORTM technology for real-time imaging of single genes in live cells.

The first iconic research program will be to develop novel oncolytic viruses with the Team 10 from CRCT led by Dr Pierre Cordelier. The goal is to provide a collection of ANCHORTM tagged oncolytic viruses to investigate their infection and replication capacities, in vitro and in vivo, and soon directly on patient derived samples. This will allow the measurement of oncolytic potential and help decision-making in terms of individualized cancer treatment by providing quantitative data on treatment efficiency and reduce time-to-decision.

Speeding oncolytic virotherapies development, from bench to bed
NeoVirTech SAS is a French biotechnology company focusing its activity on the development of autofluorescent viruses for the discovery of antiviral molecules, the development of oncolytic virotherapies and the measurement of virus disinfection processes. The company provides services to investigate the behavior of oncolytic viruses according to cell type, dose or the combination with pre-existing treatment. Combined with its ANCHORTM technology, that allows the visualization of the infection and replication of viruses in living cells using high content microscopy approaches, NeoVirTech oncolytic platform provides ultra-fast quantitative and qualitative results on the infection capacity of an oncolytic vector. The company already collaborates with major actors in the oncolytic field such as Transgene SA (Gallardo F et al. Fluorescent Tagged Vaccinia Virus Genome Allows Rapid and Efficient Measurement of Oncolytic Potential and Discovery of Oncolytic Modulators, Biomedicines. 2020 doi:10.3390/biomedicines8120543). The company also develops bespoke programs aiming at the visualization of other class of oncolytic viruses such as parvoviruses.

The Cancer Research Center of Toulouse is a center of excellence developing innovation for the understanding of cancer and the development of anticancer therapies. By combining more than 400 people in a multidisciplinary environment, the CRCT is one of the most advanced cancerology research center in France. Eighteen research teams are located in this center. Among them, Dr Pierre Cordelier’s team ImPact (therapeutic innovation for pancreatic cancer) investigates innovative strategies for patient diagnosed with pancreatic cancer. The team uses NeoVirTech’s proprietary technology to visualize new generation of oncolytic treatment, especially looking at the intrinsic resistance of pancreatic cancer cells to oncolytic viruses. The team also looks for means to sensitize resistant cells to oncolytic virotherapies. This long term collaboration already led to the publication of a scientific article (Quillien, L. et al. A Novel Imaging Approach for Single-Cell Real-Time Analysis of Oncolytic Virus Replication and Efficacy in Cancer Cells. Hum Gene Ther 32, 166–177 (2021). By combining their expertise, NeoVirTech and the Impact team within CRCT aim to develop a theragnostic platform for not only to interrogate the antitumoral efficacy of oncolytic virus in preclinical models, but also to identify combination to increase virotherapy therapeutic index.

NeoVirTech brings to the alliance its know-how in high throughput imaging techniques and innovative models of virus visualization in living cells. NeoVirTech is equipped with high content screening microscope combined with pipetting robots in BSL2, BSL2+ environment. CRCT gives access to its technology platforms and to its scientific expertise in cancer biology and therapy, in close collaboration with clinicians from the University Institute of Cancer of Toulouse, Oncopole.

they testify

"By joining the CRCT, we are structuring our anticancer activities in a place at the forefront of cancer innovation. By being close to teams dedicated to cancer therapies, we will make our best effort to develop innovative virotherapies and optimized screening platform to ensure efficacy of oncolytics and other drugs in development. Our technology combined with state-of the art imaging platform gives a unique, robust and rapid way to measure how a specific tumor cell line, patient derived cell line or in the future patient biopsies respond to specific treatment. We aim at speeding up time-to-decision, maximizing the chance of patients to receive the correct and therefore efficient oncolytic vector, the sooner the better. "
Franck Gallardo, CEO NeoVirTech SAS

"While oncolytic viruses are quickly moving toward the forefront of modern medicines, much remains to be elucidated for creating highly effective treatments based on these biologics. This alliance represents a unique occasion to rationalize the use of oncolytic virus for cancer therapy. With NeoVirTech technology, we will not only have the opportunity to better understand the dialog between oncolytic virus and tumor cells, but also to accelerate personalized therapeutic profiling programs based on oncolytic virotherapy, especially for the management of patient with diseases with no cure such as pancreatic cancer"."
Pierre Cordelier PI, ImPact, CRCT

"One of the CRCT priorities is to foster public-private collaborations with highly dynamic start-ups such as NVT. This gives members of the center privileged access to innovation and supports very promising therapeutic strategies such as the use of oncolytic viruses for cancer therapy"

Biodesix Announces Fourth Quarter and Year End 2021 Results and Highlights

On March 14, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the fourth quarter and year ended December 31, 2021 (fiscal 2021) and provided a corporate update (Press release, Biodesix, MAR 14, 2022, View Source [SID1234610063]).

"Despite the ongoing challenges caused by the global pandemic, the fourth quarter and fiscal 2021 were very productive." said Scott Hutton, CEO of Biodesix. "Most notably, we successfully executed on our revenue growth strategy by doubling our direct, dedicated sales force, which significantly contributed to our core lung diagnostic revenue growth of 48% and 49% for fourth quarter and fiscal 2021, respectively. We further executed on our third quarter 2021 commitment to a commercial launch of our GeneStrat NGS test in January 2022. From the clinical data standpoint, we presented new data during the fourth quarter of 2021 on our NodifyXL2 test from the prospective ORACLE study, and on our VeriStrat test from the prospective INSIGHT study. This new data truly underscores the value of both products in the real-world setting and adds to the body of evidence. We continue to be excited about the trajectory of the business, despite the challenges from the ongoing pandemic, which gives us confidence heading into 2022."

Fourth Quarter and Full Year 2021 Financial Results

•Total revenue of $7.2 million and $54.5 million for the fourth quarter and fiscal 2021, respectively,
▪Continued lung diagnostic year over year growth despite COVID-19 variant surges;
•Core lung diagnostic revenue of $5.4 million and $18.7 million for the fourth quarter and fiscal 2021, respectively, an increase of 48% and 49% over the respective prior year comparable periods;
▪Nodify nodule management tests and sales force expansion continue to drive lung diagnostic growth;
•BioPharma Services revenue of $1.4 million and $5.6 million for the fourth quarter and fiscal 2021, respectively, a decrease of 29% and increase 20% over the respective prior year comparable periods;
•COVID-19 testing revenue of $0.4 million and $30.2 million for the fourth quarter and fiscal 2021, respectively, a decrease of 98% and increase 7% over the respective comparable periods in 2020;
▪Decline over the fourth quarter of 2020 commensurate with the shift away from lab-based testing and towards point-of-care and at-home rapid antigen testing during much of the back half of 2021;

•Fourth quarter 2021 gross margin of $4.7 million or 65% as a percentage of revenue as compared to 46% in the compaable prior year period primarily driven by the mix shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing;
•Operating expenses (excluding direct costs and expenses) of $16.4 million and $64.9 million for the fourth quarter and fiscal 2021, an increase of 9% and 40% over the comparable prior year periods;
▪Doubled the size of lung focused direct and dedicated sales force in 2021;
▪Includes non-cash stock compensation expense of $1.3 million and $4.9 million during fourth quarter and fiscal 2021, respectively;
•Net loss of $13.3 million and $43.2 million for the fourth quarter and fiscal 2021, respectively, an increase of 193% and 38% over the respective comparable periods in 2020;
•Cash and cash equivalents of $32.7 million, inclusive of a fourth quarter 2021 equity capital issuance of $15.7 million in net proceeds and the prepayment of $20 million of the 2021 Term Loan;
▪Announced a Common Stock Purchase Agreement for up to $50 million.
2022 Financial Outlook

The Company anticipates generating between $37.5 million to $39.5 million in total revenue in 2022.

Conference call and webcast information

Management will host an investor conference call and webcast today, March 14, 2022 at 8:30 a.m. Eastern Time.

An archived replay of the webcast will be available on the Company’s website for a period of 90 days.

For a full list of Biodesix’s press releases and webinars, please visit Biodesix.com.