On April 4, 2022 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator drug, mocravimod, reported that it has entered a €1.5 million Loan Agreement with the regional Bpifrance in Strasbourg (Grand Est Bpifrance), via Priothera SAS, its French affiliate (Press release, Priothera, APR 4, 2022, View Source [SID1234611386]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This R&D innovation loan will be used to further support the clinical manufacture of mocravimod for a European, US and Asian registration-enabling clinical trial with mocravimod in Acute Myeloid Leukemia (AML) patients undergoing allogeneic hematopoietic stem cell transplant (HSCT).

Brice Suire, Co-Founder and Chief Financial Officer of Priothera, said: "This non-dilutive financing, alongside the funding from the European Investment Bank that we announced recently, will play an important role in financing the development of mocravimod. It will allow us to strengthen our local French team and accelerate delivery of the clinical supply of mocravimod needed for our upcoming registration-enabling global clinical trial. We are very pleased with the confidence shown by Grand Est Bpifrance in supporting the Company in its development program."

Alban Stamm, Innovation Manager at Bpifrance Alsace commented: "We believe that Priothera, with its drug candidate mocravimod, has the potential to enable a major breakthrough in preventing transplant rejection which would provide a tremendous benefit to AML patients undergoing a stem cell transplant. The Bpifrance loan will support Priothera’s key objective of establishing human proof of concept and generating registrational data, allowing the company to create significant socio-economic value in France and beyond that for patients globally."

Mocravimod, a sphingosine 1 phosphate (S1P) receptor modulator which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of HSCT in patients with AML. Moreover, it has shown clinically relevant benefits in an early clinical study in patients with hematologic malignancies undergoing HSCT.

On April 4, 2022 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Company’s Management will participate in a fireside chat and one-on-one investor meetings at the 21st Annual Needham Virtual Healthcare Conference, to be held virtually April 11-14, 2022 (Press release, Selecta Biosciences, APR 4, 2022, View Source [SID1234611385]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

21st Annual Needham Virtual Healthcare Conference
Format: Fireside chat and one-on-one investor meetings
Date: Thursday April 14, 2022
Time: 1:30 p.m. EST
Webcast: Click Here

An archived webcast will also be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

On April 4, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the Company’s TakeAim Leukemia Phase 1/2a study (NCT04278768) (Press release, Curis, APR 4, 2022, View Source [SID1234611384]). The TakeAim Leukemia study is a Phase 1/2a open-label, single arm dose escalation and expansion study of orally-administered emavusertib (CA-4948) as monotherapy and in combination with azacitidine or venetoclax in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

While the partial hold is in place, no new patients will be enrolled in the study, and current study participants benefitting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower.

With the partial hold, the FDA is requesting additional data from the study, including data related to the death of a R/R AML patient who experienced, among several conditions, rhabdomyolysis, which has previously been identified as a dose-limiting toxicity of emavusertib. Additionally, the FDA is requesting safety, efficacy, and other data, including data related to rhabdomyolysis and the Company’s determination of the Recommended Phase 2 Dose for emavusertib in this study.

"We are committed to ensuring the safety of patients in our studies and to working collaboratively with the FDA to develop therapies that meaningfully improve and extend patients’ lives," said James Dentzer, Chief Executive Officer of Curis. "Given the clinical profile of emavusertib observed to date, we are hopeful that the study can be resumed soon, after appropriate review. We continue to be confident in the potential of emavusertib to address the high unmet need of patients with AML or MDS."

Curis expects to provide updated guidance on the timing of discussing the potential for a rapid registrational path for emavusertib with the FDA after the partial clinical hold is resolved and the related impact on the trial can be determined.

While this partial hold does not affect the TakeAim Lymphoma study (NCT03328078), a Phase 1/2 open-label dose escalating clinical trial investigating emavusertib in patients with B-cell malignancies, the Company has decided to pause enrollment of new patients in that study as well, pending resolution of the partial clinical hold in the TakeAim Leukemia study.

On April 4, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported that members of IMV’s executive management team will be participating in the 21st Annual Needham Virtual Annual Healthcare Conference, which will be held April 11-14, and the Wells Fargo Biotech Forum, which will be held April 12-13 (Press release, IMV, APR 4, 2022, View Source [SID1234611383]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

21st Annual Needham Virtual Healthcare Conference
Format: Presentation and one-on-one investor meetings
Date: Thursday April 14, 2022
Time: 12:45 p.m. ET
Webcast: Click Here

Wells Fargo Biotech Forum
Format: One-on-one investor meetings
Date: April 12-13

A replay for the 21st Annual Needham Virtual Annual Healthcare Conference presentation will be available in the ‘Events, Webcasts & Presentations’ section of IMV’s website for 90 days.

On April 4, 2022 Novartis reported the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade (Press release, Novartis, APR 4, 2022, View Source [SID1234611382]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The simpler organizational model we are unveiling today is central to our growth strategy as it will make us more agile and competitive, enhance patient and customer orientation, unlock significant potential in our R&D pipeline and drive value-creation through operational efficiencies," said Vas Narasimhan, CEO Novartis. "With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term."

Integrating Pharmaceuticals and Oncology business units
Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus—Innovative Medicines US and Innovative Medicines International. The two units will have full P&L responsibility across all therapeutic areas and ownership of customer experience, marketing and sales, and market access for their respective markets. The elevation and establishment of an independent US commercial organization strengthens Novartis’s ability to achieve its goal of becoming a top-five company in the US in terms of sales while maintaining and growing its leadership position internationally. The new model will also help Novartis bring increased focus and commitment to its core therapeutic areas of Cardiovascular, Hematology, Solid Tumors, Immunology and Neuroscience.

Marie-France Tschudin, currently President, Novartis Pharmaceuticals, will become President, Innovative Medicines International and Chief Commercial Officer. In her capacity as Chief Commercial Officer, Marie-France Tschudin will oversee global marketing, medical affairs and value and access across all therapeutic areas. Victor Bulto, currently Head of US Pharmaceuticals, will become President, Innovative Medicines US. They will both report to Vas Narasimhan effective immediately.

New Strategy & Growth Function
Novartis will create a new Strategy & Growth function combining corporate strategy, R&D portfolio strategy and business development. This function will help drive the company’s growth strategy end-to-end and will look across internal and external opportunities to strengthen Novartis’s pipeline with medicines that are both transformational and can make significant contributions to growth. This new function will be led by a Chief Strategy & Growth Officer who will become a member of the ECN and report to the CEO. The search is currently underway for this new leader, and in the interim the function will be led by Lutz Hegemann, M.D., Ph.D., President, Global Health.

Integrated Operations and Global Functions
Novartis will also combine its Technical Operations and Customer & Technology Solutions units to create a new Operations unit. This new unit will provide a stronger and simpler operational backbone that can accelerate multiple technology transformation initiatives more efficiently, create novel digital solutions at scale and increase productivity, while maintaining industry-leading quality and service levels. Effective immediately, Steffen Lang, currently Global Head of Novartis Technical Operations, will become President, Operations reporting to Vas Narasimhan. In addition, all G&A functions—Finance, People & Organization, Ethics, Risk & Compliance, Legal, and Communications & Engagement—will be integrated on global and country levels.

Change in Global Drug Development (GDD) Leadership
Novartis has appointed Shreeram Aradhye, M.D., as President, Global Drug Development and Chief Medical Officer effective May 16th, 2022. Dr. Aradhye, who is returning to Novartis, was most recently Executive Vice President and Chief Medical Officer at Dicerna Pharmaceuticals where he led the development of multiple clinical stage RNAi assets. Previously, he was Chief Development Officer at Axcella Health. Dr. Aradhye has dedicated his entire professional career to improving patient lives, first as an academic clinician and then as a drug developer and business leader. He brings significant experience in global clinical development of innovative medicines across several therapeutic areas and has played a key leadership role in the development of multiple innovative therapeutics. During his 20-year tenure at Novartis, he held several global leadership roles including as development head for the company’s Neuroscience franchise and Global Head of Medical Affairs for the Pharmaceuticals business unit. Dr. Aradhye will report to Vas Narasimhan and join the ECN. With the changes in organizational structure and operating model, John Tsai, M.D., has decided to pursue opportunities outside Novartis effective May 15th, 2022.

"I would like to extend my deep gratitude to Susanne, Robert and John for their invaluable contributions to the company. Susanne has been an inspiring and dedicated leader at the company for 25 years, and she has played a pivotal role in strengthening our global Oncology business. Over the last four years, Robert has led a successful transformation of our business services and technology operations and helped create a strong Customer & Technology Solutions unit. Since taking over as Head of GDD in May 2018, John has played a key leadership role in advancing our mid-stage pipeline and delivering 18 major drug approvals to patients around the world. I wish them the very best in their future endeavors," added Vas Narasimhan, CEO Novartis. "I would like to congratulate Marie-France, Shreeram, Steffen and Victor on their new roles, and extend a warm welcome back to Shreeram. I look forward to working closely with them as we embark on this new phase of our journey to reimagine medicine together."