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PRESS RELEASE – START OF NP137 PHASE I CLINICAL TRIAL

On March 14, 2022 NETRIS Pharma, a pioneer in the development of dependence receptor targeted cancer medicines, reported the start of enrollment of patients with advanced/metastatic solid tumors in its Phase I clinical study of NP137, a humanized monoclonal antibody targeting Netrin-1 (NCT02977195) (Press release, Netris Pharma, MAR 14, 2022, View Source [SID1234611179]). The study represents the first time a drug candidate targeting dependence receptors has been evaluated in humans. Dependence receptors are tumor suppressors that trigger cell death unless engaged by a ligand, in this case Netrin-1. Blocking Netrin-1 could re-introduce the natural tumor cell death pathway.

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"The launch of this first of its kind clinical trial represents a key milestone in the dependence receptor field as well as for NETRIS Pharma in our commitment to find new therapeutic solutions for cancer patients," said Patrick Mehlen, CEO and co-founder of NETRIS Pharma. "We see in this study the confirmation of the ability to translate the potential of our innovative approach on dependence receptors to a first application of a drug candidate in patients."

This open-label study includes a first phase of dose escalation, followed by an extension phase. The main objective of the dose escalation phase is to determine the maximum tolerated dose (MTD) of NP137 and the recommended Phase II (RP2D) dose. The main objective of the extension phase is to confirm the safety and tolerance of NP137 and collect preliminary clinical activity data.

The study will recruit a maximum of 44 patients in three French centers, the Centre Léon Bérard in Lyon (Prof. Philippe Cassier – principal investigator of the study), the Institut Claudius Régaud in Toulouse and the Institut Gustave Roussy in Villejuif.

"The new therapeutic approach developed by NETRIS Pharma explores a so far non-druggable pathway in oncology. It offers another avenue of research to help us achieve the precision medicine needed in treating cancer. If the Phase I safety profile, which is expected in 2017, is positive, NP137 may represent a major therapeutic advance in the management of cancer patients," said Prof. Jean-Yves Blay, Director General of the Centre Léon Bérard, Lyon.

About Dependence Receptors Concept
Cells depend on external signals for their survival. These signals are mediated by various transmembrane receptors and sensors, such as soluble trophic factors, cytokines, hormones. For any given required stimulus, withdrawal leads to programmed cell death (apoptosis). Data obtained over the past 15 years, pioneered by Prof Patrick Mehlen and his research team at the Cancer Research Center of Lyon – Centre Léon Bérard, argue for a novel form of signal transduction that actively induces cell death following stimulus withdrawal.

This "negative signal transduction" leading to cell death is mediated by specific dependence receptors that induce apoptosis in the absence of the required stimulus, but block apoptosis in its presence. The expression of various dependence receptors at the surface of the cells seems to create a state of dependence (or addiction) to their respective ligands. To date, more than twenty of such receptors have been identified.

About NP137
Most types of tumors have been shown to produce an abnormal amount of dependence receptors’ ligands, thus preventing cells from dying. For instance, the Netrin-1 ligand has been shown to be overexpressed in 60% of metastatic breast cancers, in more than 70% of ovarian cancers, 50% of lung cancers or 80% of melanoma. Its expression often correlates with disease severity and no therapy has ever been tested on this new pathway.

NP137, a humanized monoclonal antibody of isotype IgG1 directed against the ligand Netrin-1, is the first drug candidate developed by NETRIS Pharma. NP137 prevents the binding of Netrin-1 on its dependence receptors, thus re-inducing cell death and leading to tumor growth regression.

Pre-clinical studies show an anti-cancer effect of NP137 in mice, in monotherapy but also in combination with demethylating agents and chemotherapy agents. In addition, remarkable effects are observed on tumor relapse. A synergistic effect of NP137 with immune-checkpoint inhibitors has also been observed, opening novel strategies for clinical investigation.

INmune Bio, Inc. to Participate in the 32nd Annual Oppenheimer Healthcare
Conference and the 2022 Maxim Group Virtual Growth Conference

On March 14, 2022 INmune Bio (NASDAQ: INMB), a clinical stage immunology company focused on developing treatments that harness the patient’s immune system to fight disease, reported that RJ Tesi, MD., President and CEO has been invited to participate in the 32nd Annual Oppenheimer Healthcare Conference and the 2022 Maxim Group Virtual Growth Conference (Press release, INmune Bio, MAR 14, 2022, View Source [SID1234610171]).

Dr Tesi will present a corporate overview at the 32nd Annual Oppenheimer Healthcare Conference, which is being held virtually on March 15 – 17, 2022.

Event Details

Date: Wednesday, March 16, 2022

Time: 11:20am ET

To set up 1X1 meetings with management, please contact your Oppenheimer representative.

Dr. Tesi will participate in a fireside chat with Jason McCarthy, Ph.D., Senior Managing Director, Head of Biotechnology Research at Maxim Group during the 2022 Maxim Group Virtual Growth Conference, which is being held virtually on March 28– 30, 2022.

Event Details

Date: Wednesday, March 30, 2022

Time: 11:00am ET

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]).

"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."