Perrigo to Release Third Quarter 2022 Financial Results on November 8, 2022

On October 25, 2022 Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, reported that it will release its third quarter 2022 financial results on Tuesday, November 8, 2022 (Press release, Perrigo Company, OCT 25, 2022, View Source [SID1234622369]). The Company will also host a conference call beginning at 8:30 A.M. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 8518983. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EST) Tuesday, November 8, until midnight Tuesday, November 15, 2022. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 7261267.

Nektar to Announce Financial Results for the Third Quarter 2022 on Thursday, November 3, 2022, After Close of U.S.-Based Financial Markets

On October 25, 2022 Nektar Therapeutics (Nasdaq: NKTR) reported that it will announce its financial results for the third quarter 2022 on Thursday, November 3, 2022, after the close of U.S.-based financial markets (Press release, Nektar Therapeutics, OCT 25, 2022, View Source [SID1234622368]). Howard Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time.

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The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through December 3, 2022.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

Koneksa Announces Clinical Pipeline of Validated Digital Biomarkers to Accelerate Life Sciences Research

On October 25, 2022 Koneksa, a healthcare technology company developing evidence-based validated digital biomarkers, reported the launch of its clinical pipeline featuring biomarkers across neuroscience, oncology, respiratory, and other therapeutic areas (Press release, Koneksa, OCT 25, 2022, View Source [SID1234622367]). With 15 digital biomarker programs in development, the company will also be launching several upcoming clinical studies. Koneksa and collaborators have published more than 20 peer-reviewed papers.

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Koneksa’s digital biomarker platform uses algorithms to analyze and integrate real-time patient data into clinical trials, translating typically analog processes into digital. By developing a suite of validated, evidence-based digital biomarker solutions that can be seamlessly integrated into clinical studies, from at-home spirometry, actigraphy, gait and balance-monitoring tools, to vital-sign monitoring, Koneksa’s biomarker technology potentially increases precision and captures a richer dataset.

The launch of the clinical pipeline will enable Koneksa to expand biomarker evidence generation in the near-term and develop new digital biomarkers to support long-term industry and patient needs. The increasing adoption of clinically-validated digital biomarkers in studies which can be used in an at-home setting, significantly reduces patient burden and increases clinical trial efficiency. Digital biomarkers can also integrate data from multiple sources to help researchers better understand key drivers of disease progression to bring novel medicines to patients faster.

"Digital biomarkers need to be clinically validated. Without that validation, these tools are ultimately not useful in clinical trials," said Chris Benko, CEO & Founder of Koneksa. "Think of digital biomarkers versus a clinic-based assessment as the difference between a still photo and a video. A still photo is great, but a video can tell a much richer story. Over the last few years, our team has conducted over a dozen analytical studies, with the same level of clinical rigor to validate our digital biomarkers on par with traditional biomarkers for use in clinical trials."

"The more high quality measurements we capture, the higher precision and more power a clinical trial can have," said John Wagner, M.D., Ph.D., Chief Medical Officer, Koneksa. "Validation studies have shown that our digital biomarkers are equivalent to or better than the current standard – and we have done that work to the level of rigor required by regulators and the world’s leading biopharmaceutical companies. With the launch of our clinical pipeline, we’re extending our evidence generation and potential new digital biomarkers, further demonstrating that at-home digital biomarkers increase patient access outside of the clinic."

Koneksa has partnerships with life sciences companies, patient advocacy organizations and academic institutions on its digital biomarker pipeline. In respiratory disease, Koneksa partnered with Regeneron to implement and validate mobile spirometry. In oncology, Koneksa developed a step count measurement, in partnership with Montefiore Medical Center, to better characterize functional status. In neuroscience, the company partnered with Sanofi to develop biomarkers to measure gait in patients with neurological diseases such as multiple sclerosis. Koneksa recently announced a partnership with Aural Analytics to support clinical trials using speech measures to develop a variety of digital biomarkers for Parkinson’s Disease in collaboration with Northwestern University and the Michael J. Fox Foundation.

Koneksa’s development and validation process for its digital biomarker solutions is based on the same FDA guidelines and level of rigor for traditional biomarkers such as the Biomarker Qualification Evidentiary Framework as well as the Digital Health Technologies Remote Data Acquisition In Clinical Investigations draft guidance.

Koneksa will also be hosting the grand opening of its new global headquarters on the 77th floor of One World Trade Center in New York City on Thursday, November 10th, 5:30-8:00 pm ET. Interested media can RSVP to [email protected] to tour our facility, learn more about our operations, and come meet the Koneksa team and our supporters.

Similis Bio Partners With Blau Farmaceutica to Co-Develop Four Biosimilar Programs

On October 25, 2022 JSR Life Sciences, LLC (JSR) and Blau Farmaceutica (Blau) (public company in Brazil B3 – BLAU3) reported that Similis Bio ("Similis"), its recently launched business unit focused on biosimilar development, has signed its first development and license agreement with Blau Farmacêutica ("Blau") (Press release, JLS, OCT 25, 2022, View Source [SID1234622366]). The agreement, Blau’s most recent move into the biosimilars market, is a multi-product and multi-year deal to develop products and licenses IP for four biosimilar assets targeting indications in oncology, inflammation, and blood disorders.

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"We launched Similis Bio as we saw the need to mitigate risk and accelerate timelines for biosimilar developers," said John Gabrielson, Senior Vice President at JSR Life Sciences and Head of Similis Bio. "We are thrilled to partner with Blau as they work to launch their biosimilar business initially in North and South America. We look forward to leveraging our expertise and experience to support programs that can provide additional treatment options for some of the most debilitating diseases patients face."

Similis Bio will provide full processes and associated IP for tech transfer to Blau, including cell lines, analytical data and methodologies, and upstream/downstream processes. Blau will utilize the licensed IP for GMP manufacturing and clinical development and seek regulatory approval.

Blau has exclusive worldwide rights and intent to sell in America by itself and partner with local organizations in other regions. The agreement is structured with upfront payments and long-term royalties upon commercial approval for sale. Blau and Similis expect the total value of the contract to exceed USD 100 million. The Companies are not disclosing additional financial terms.

These four biosimilars have an addressable market in the world of more than USD 42 billion and, in Brazil, of close to USD 1 billion, according to IQVIA, ensuring a robust pipeline for the Company in the long term.

The launch of these drugs will be a milestone in the history of Blau and Brazil, which will have a local producer developing and producing APIs (Active Pharmaceutical Ingredients) and biosimilar medicines in line with the national policy of independence in the production of APIs.

"This initiative will give the world population greater access to advanced medicines, raising the standard of care. Blau continues to invest at a strong pace in the development of new APIs and new highly complex drugs, in addition to expanding its production capacity, geographic presence, and relevance in the health industry," said Roberto Morais, Executive Director in Charge of M&A and Strategic Alliances. "We are developing products for the next decade, and we will further add new products to our partnership. This strategic and disruptive agreement reinforces Blau’s position in becoming a reference in the production of biosimilars in Latin America."

Normunity Announces $65 Million Series a Financing to Expand the Frontier of Precision Immuno-Oncology With Immune Normalizer Therapies

On October 25, 2022 Normunity, Inc., a biotechnology company creating novel precision anti-cancer immunotherapies, reported its launch and Series A financing of $65 million (Press release, Normunity, OCT 25, 2022, View Source [SID1234622365]). The Series A was led by Canaan Ventures and included participation by Sanofi Ventures, Taiho Ventures and Osage University Partners. Normunity’s new class of agents, called immune normalizers, target previously undiscovered mechanisms of immune disruption in cancer. The company’s pipeline is drawn from the ongoing and interactive academic-biotech research taking place at Yale School of Medicine, leveraging proprietary discovery platforms from the lab of Dr. Lieping Chen, an immuno-oncology luminary who identified PD-L1 (B7-H1) among other seminal contributions to the field.

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"Working together with Normunity, we are finding previously hidden mechanisms of tumor-dependent immune disruption and we aim to usher in a new era of drug discovery for precision immuno-oncology with medicines that normalize immune function."

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"The normal immune system is a powerful anti-cancer force, and effective immune-stimulating strategies can result in long-lasting cancer remissions, even cures. Yet, today’s immunotherapies don’t capitalize on the full anti-cancer potential of the normal immune system, and most cancer patients do not respond to available treatment options. This leaves an untapped immune biology that we have begun to uncover," said Lieping Chen, MD, PhD, scientific founder of Normunity and UTC Professor in Cancer Research and Professor of Immunobiology, of Dermatology and of Medicine (Medical Oncology) at Yale School of Medicine. "Working together with Normunity, we are finding previously hidden mechanisms of tumor-dependent immune disruption and we aim to usher in a new era of drug discovery for precision immuno-oncology with medicines that normalize immune function."

The Series A financing will enable Normunity to advance its emerging pipeline of immune normalizers into the clinic. The company’s initial pipeline programs target mechanisms that drive the exclusion of T cells into immune-sensitive tumors and aim to deliver an active and effective immune system into ‘cold’ tumors. Proceeds from the financing will also be used to build on multiple discovery platforms in the Lieping Chen lab to pursue additional mechanisms that block normal anti-cancer immunity.

"It is so clear to everyone involved in launching Normunity that there is remarkable potential to translate the Lieping Chen lab’s leading-edge discoveries into breakthrough cancer immunotherapies. We have built the right team and the right seamless collaboration between Normunity and the Lieping Chen lab to rapidly cultivate scientific discovery, jointly share expertise, and advance a novel class of drugs that can potentially set a new standard in the immuno-oncology landscape," said Tim Shannon, MD, General Partner at Canaan Ventures and Chair of Normunity’s Board of Directors.

The company’s unique model is a collaborative and iterative workflow between the Lieping Chen lab and Normunity to identify novel immuno-oncology mechanisms through proprietary platforms, interrogate and validate the emerging targets together pre-clinically and clinically. This academic-biotech alliance leverages world-class scientists with deeply experienced drug designers and developers in a new way.

"Normunity is leading the way in establishing a new roadmap for I-O drug discovery with a simple and powerful premise: to free the immune system to work with maximal potential against cancer. With our scientific approach, we are pioneering novel mechanisms where there is unexplored potential for new medicines. With our R&D model, we have established a first-of-a-kind collaboration with the Lieping Chen lab that has already been prolific in identifying and validating novel targets," said Rachel Humphrey, MD, founding Chief Executive Officer. "We have strong momentum advancing our pipeline of immune normalizers as we translate groundbreaking biology into life-changing medicines for cancer patients."

Leadership in immuno-oncology

Leading the academic-biotech teams that are harnessing the potential of the Lieping Chen lab’s proprietary platforms and Normunity’s drug development are Rachel Humphrey, MD, Normunity’s Chief Executive Officer, and Lieping Chen, MD, PhD, whose lab is responsible for many important discoveries in immuno-oncology pathways.

Among his seminal contributions to the field of immuno-oncology, Dr. Chen played an integral role in the discovery of the PD‑1/PD-L1 pathway and its immune-suppressive functions. His lab performed foundational work that led to the invention of anti‑PD‑1/PD‑L1 antibody therapy. In addition, he was deeply involved in the first-in-human trial for Opdivo (nivolumab), and invented PD-L1 clinical measurement tools. Dr. Humphrey has 25 years of experience with a focus in oncology, including leading the development of the cancer immunotherapies Yervoy (ipilimumab) at BMS and Imfinzi (durvalumab) at AstraZeneca, as well as the tyrosine kinase inhibitor Nexavar (sorafenib) at Bayer. Her biotech leadership roles include CMO at Black Diamond Therapeutics, CytomX and Mirati, and independent Board of Director positions at CytomX, Xilio, Pyxis and Sporos.

The Normunity team brings together experienced drug development leaders with decades of experience in novel drug discovery and clinical advancement of novel cancer and immuno-oncology drugs who have played key roles in the development of more than 30 distinct approved drugs.