On July 5, 2022 Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo platform to enable precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, reported that Richard Nieman, MD, has been appointed Chief Medical Officer, effective July 11, 2022 (Press release, Lyra Therapeutics, JUL 5, 2022, View Source [SID1234616488]). Dr. Nieman brings more than 25 years of experience in drug development and medical affairs, with a proven track record in developing medicines through commercialization and beyond.

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"We’re pleased to welcome Dr. Nieman as our Chief Medical Officer," said Maria Palasis, PhD, CEO of Lyra Therapeutics. "Dr. Nieman joins the Lyra team at a critical time with our lead candidate LYR-210 in pivotal Phase 3 trials. Having successfully developed and launched numerous innovative medicines for patients and their families during the course of his career, his experience building and leading medical organizations will be invaluable as we work to bring new treatments to patients with chronic rhinosinusitis (CRS)."

"I’m thrilled to be taking on this role during such an exciting time in Lyra’s growth and evolution with late-stage clinical programs," said Dr. Nieman. "There is a significant need for effective treatments for patients suffering with CRS, and I look forward to working with the Lyra team to build on the compelling data to date and contributing my abilities and experience as the company drives towards commercialization."

Dr. Nieman, a respiratory physician (pulmonologist) with deep pharmaceutical medicine experience, has had prior leadership roles as SVP & Worldwide Medical Head of Immunology at Bristol Myers Squibb (BMS), Head of R&D China at BMS, Global Medical Officer & Head of Medical at Teva, and Head of Asia Pacific Medical at Bayer. At Teva, he led the company’s medical and heath economic and outcome research (HEOR) function of 550 professionals and was a member of the Specialty Executive Team. In addition to his U.S. experience and credentials, Richard has also spent significant time working in China, throughout Asia and in Europe. He has been involved in bringing numerous important medicines to the market in the U.S. and Europe, including Cinquair in asthma, Copaxone 40 mg 3x/week in multiple sclerosis, Austedo in movement disorders, Ajovy in migraine and Xarelto in thrombosis and stroke prevention. Richard is a Fellow of the UK Royal College of Physicians, a Visiting Senior Lecturer at the School of Cancer and Pharmaceutical Sciences, Kings College, London, and was a Visiting Professor at Fudan University School of Public Health in Shanghai, China. He has published extensively and trained and practiced medicine in the UK. Dr. Nieman assumes the role of Chief Medical Officer previously held by Dr. Robert Kern, who will continue to work closely with the Company in the role of Chief Clinical Advisor.

Lyra has approved the issuance of an equity-based award pursuant to its 2022 Inducement Award Plan to Dr. Nieman upon the commencement of his employment. The inducement grant was approved by a majority of the Company’s independent directors and was made as a material inducement to Dr. Nieman’s acceptance of employment with Lyra in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation. The inducement grant consists of a non-qualified stock option to purchase an aggregate of 230,000 shares of the Company’s common stock. The inducement grant is subject to the terms and conditions of the award agreement covering the performance stock option grant and the Company’s 2022 Inducement Award Plan.

On July 5, 2022 Brand Institute reported its work with Solasia Pharma K.K. ("Solasia") in developing the brand name DARVIAS (Press release, Brand Institute, JUL 5, 2022, View Source [SID1234616487]).

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DARVIAS, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. DARVIAS provokes cell cycle arrest and apoptosis through disruption of mitochondrial functions and increased production of reactive oxygen species in tumor cells. DARVIAS is expected to exert an anticancer effect by inducing cell cycle arrest and apoptosis.

DARVIAS has been approved for relapsed or refractory Peripheral T-Cell Lymphoma by Japan’s Ministry of Health, Labour and Welfare (MHLW). Japan is the first country in the world where DARVIAS has been approved. DARVIAS has been granted orphan drug designation in the US and EU.

"The entire Brand Institute and Drug Safety Institute team congratulates Solasia on the MHLW approval of the DARVIAS injection," said Brand Institute’s Chairman and C.E.O., James L. Dettore.

On July 5, 2022 Skyhawk Therapeutics, Inc. reported the signing of an exclusive worldwide collaboration agreement with Sanofi to discover and develop novel small molecules that modulate RNA splicing for challenging oncology and immunology targets (Press release, Skyhawk Therapeutics, JUL 5, 2022, View Source [SID1234616486]).

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Frank Nestle
Global Head of Research and Chief Scientific Officer, Sanofi
"We look forward to this collaboration with Skyhawk, a pioneer in developing novel small molecules that modulate critical RNA splice sites. Skyhawk’s SkySTAR platform integrating proprietary computational biology tools, kinetic models, and conformational structural models of RNA, offers an exciting opportunity to build drugs that treat disease targets which today have limited or no therapeutic options."

Bill Haney
Chief Executive Officer, Skyhawk Therapeutics
"Sanofi is a global leader in the development and commercialization of innovative therapies, and we look forward to working with their talented team to build novel small molecule therapeutics that modify RNA splicing for the treatment of critical diseases of high unmet need. We are excited to develop drugs for challenging targets with Sanofi and look forward to working together on these potentially first- and best-in-class programs."

Terms of the Agreement
Under the collaboration agreement, Sanofi will pay Skyhawk $54 million upfront. Skyhawk will grant Sanofi exclusive licenses to worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following DC status, Sanofi will assume responsibility for further development and commercialization. Skyhawk is also eligible to receive over $2 billion in potential milestone payments, as well as potential royalties on future sales.

On July 5, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a pre-recorded fireside chat at the William Blair Biotech Focus Conference 2022, which will be available to view on-demand beginning Monday, July 11, 2022 (Press release, Exelixis, JUL 5, 2022, View Source [SID1234616484]).

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for at least 30 days.

On July 5, 2022 Boehringer Ingelheim, a leading research-driven biopharmaceutical company, the life science company Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and bioMérieux, a world leader in in vitro diagnostics, reported that they have formed a joint venture to create the next generation of antimicrobials along with actionable diagnostics to fight Antimicrobial Resistance (AMR) (Press release, Boehringer Ingelheim, JUL 5, 2022, View Source [SID1234616482]).

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The resulting company, Aurobac Therapeutics SAS, will combine the best capabilities of the three founding companies towards developing a new precision medicine approach, from diagnosis to cure. The aspiration is to succeed in the fight against AMR, which is a major public health threat. Having routine surgery such as caesarean sections or hip replacements may become life threatening, and complications from common diseases such as diabetes and injuries or cuts will become harder to manage because of growing resistance to antibiotics in patients.

"The rise of antibiotic-resistant infections – also called antimicrobial resistance, or AMR – is indeed a looming global crisis," said Michel Pairet, Head of Boehringer Ingelheim’s Innovation Unit and Member of the Board of Managing Directors. "Antibiotic resistance kills about 1.27 million people globally every year1 and it has been estimated that by 2050, as many as 10 million worldwide deaths could result from AMR2, making it potentially deadlier than cancer."

Werner Lanthaler, CEO of Evotec added: "The grim prospect of a post-antibiotic era has many causes but only one solution: The development of new, targeted, and effective antimicrobial therapies. We are excited to launch Aurobac together with our partners at Boehringer Ingelheim and bioMérieux, to combine our complementary strengths. By leveraging Evotec’s multimodality approach to infectious diseases, we are confident that Aurobac will be able to generate much-needed progress to tackle the global challenge of AMR."

"bioMérieux has a strong expertise in antimicrobial resistance. We supply the most comprehensive integrated diagnostic solutions to support an appropriate use of antibiotics (antimicrobial stewardship)," said Alexandre Mérieux, bioMérieux Chairman and CEO. "Our role within the joint venture is to develop and commercialize diagnostic tests, including Companion Diagnostics, which deliver rapid, reliable and actionable results. This participation in Aurobac is perfectly aligned with bioMérieux’ full commitment to sustain antibiotic efficacy for future generations."

Aurobac will work to shift the strategy related to antibiotic treatment regimens which at the moment leans heavily on empirical approaches using broad-spectrum and unfocused medicines. The goal is to turn this into a precision approach, using new highly effective and targeted modalities, combined with rapid and actionable diagnostics to quickly identify pathogens and their resistance patterns, and supported by new economic models.

Funded by Boehringer Ingelheim as lead investor with 30 million EUR and by Evotec and bioMérieux with 5 million EUR each, the 40 million EUR joint venture, which has its headquarters in Lyon (France), combines the world leading expertise of Evotec, one of the most active research companies in infectious diseases, with bioMérieux’s market-leading expertise in infectious disease diagnostics and with Boehringer Ingelheim’s broad drug discovery and significant clinical development capabilities.

Three partners committed to combat AMR

Boehringer Ingelheim’s participation in Aurobac is part of a wider so-called pandemic preparedness initiative, which includes a 50 million EUR investment in the AMR action fund by Boehringer Ingelheim. Boehringer Ingelheim Venture Fund has committed to invest up to 12 million EUR in AMR infection companies.

bioMérieux has over 55 years of diagnostics expertise with more than 75 percent of its research and development budget focused on antimicrobial resistance. Moreover, 80 percent of its turnover is related to the fight against AMR through a complete diagnostic solution facilitating antibiotic therapy decision-making, including antibiotic initiation, optimization, and discontinuation.

Evotec has built a world-leading platform to tackle infectious diseases. With a more than 200-strong anti-infective discovery team, the company has proven experience on multiple agent classes. On top of the company’s own pre-competitive pandemic preparedness and rapid response technology platform ("PRROTECT"), Evotec leverages its infectious disease capabilities with many industry, academic and non-profit partners and is active in a variety of networks such as the AMR Accelerator that is part of the EU’s Innovative Medicines Initiative ("IMI").