On July 29, 2022 HanAll Biopharma (KRX: 009420.KS), a global biopharmaceutical company focusing on delivering breakthrough therapies for patients, reported financial results for the second quarter 2022 as well as an update to its R&D progress (Press release, HanAll Biopharma, JUL 29, 2022, View Source [SID1234617150]).

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"The second quarter delivered strong momentum for HanAll Biopharma. Our operating income has turned to profit while we continued our investment in R&D" said Sean Jeong, M.D., CEO of HanAll Biopharma.

"Moving forward over the next few quarters, we expect to see topline results for the Phase 3 study in dry eye disease in the US, while enhancing our portfolio through open collaborations. HanAll will continue to invest in R&D to bring innovative therapeutics to patients" he added.

SECOND QUARTER 2022 BUSINESS UPDATE
Pipeline Development Highlights

A comprehensive update on HanAll’s pipeline development includes an overview of HanAll’s research and a list of compounds in development with targeted indication and the phase of development.

Batoclimab (Project Code: HL161)

A novel, fully human, anti-FcRn antibody being developed as a subcutaneous injection for the treatment of rare autoimmune diseases mediated by pathogenic IgG antibodies.

In March 2022, Harbour BioMed, a licensed partner of HanAll updated full clinical development progress in batoclimab. The company is progressing towards Biologics License Application (BLA) submission in the calendar year of 2022, after obtaining topline results from Phase 3 clinical trial for myasthenia gravis (MG). Harbour is developing batoclimab in a wide range of autoimmune indications in addition to MG, including immune thrombocytopenic purpura (ITP), neuromyelitis optica spectrum disorder (NMOSD) and thyroid eye disease (TED).
In June 2022, Immunovant, a global licensed partner of HanAll initiated a Phase 3 study to further evaluate the efficacy of batoclimab in MG. Immunovant expects to reveal two new indication programs by August 2022.
HanAll Biopharma plans to initiate a Phase 3 clinical trial in MG in collaboration with Immunovant in Japan, during the 2H 2022.
Tanfanercept (Project Code: HL036)

A novel, topical anti-TNF alpha biologic therapy for dry eye disease (DED) which aims to treat inflammatory eye diseases by inhibiting TNF alpha, which is critical in ocular inflammation.

HanAll Biopharma and Daewoong Pharmaceutical are continuing to conduct their second Phase 3 clinical study (Study name: VELOS-3) in DED to examine the safety and efficacy of the medication, at nine clinical sites located in the U.S. The study design was recently expanded to include a pharmacogenomics component that could deliver more value for patients and prescribers from this study.
Harbour BioMed is conducting its pivotal Phase 3 trial on tanfanercept in patients with DED.
HL187/ HL186

HanAll is advancing its development in immuno-oncology therapeutics, that respectively target TIM-3 and TIGIT with Daewoong Pharmaceutical.

HL187 is in pre-clinical development and antibody screening is ongoing to select the lead molecule in HL186.
Major Development Highlights

HanAll further advanced its partnerships with companies with promising technologies.

HanAll supported Neudive, a company developing digital therapeutic solutions to help neurodiverse children. Neudive’s platform is expected to deliver individually tailored therapy programs to children with neurodevelopmental disorders by using VR technology.
FINANCIAL HIGHLIGHTS (PROVISIONAL)
Key Highlights

Sales were 26.2 billion won in the second quarter, a 12% increase compared to the same period last year. Sales growth was mainly driven by continued strong performance from pharmaceuticals sold under the names of Normix, Eligard, Biotop and other major products.
R&D expenses showed 45.1 % increase compared to the same period last year, recording around 3.6 billion won.
Operating income was 682 million won, a 56.6% decrease, compared to the same period last year, mainly due to increased investment in R&D.

On July 29, 2022 Fresenius Kabi reported that Thiotepa Injection, a cancer therapeutic, is now available in the United States (Press release, Fresenius, JUL 29, 2022, View Source [SID1234617133]). It has multiple indications, including for the treatment of patients with adenocarcinoma of the breast or ovary. This is the newest addition to the company’s portfolio of generic IV oncology products – the largest such portfolio in the U.S.

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On July 29, 2022 Novasenta Inc., a startup biotechnology company focused on the discovery and validation of novel targets to develop cancer therapies, reported the completion of $40 million in Series A financing led by UPMC Enterprises, the innovation, venture capital and commercialization arm of leading health system UPMC (Press release, Novasenta, JUL 29, 2022, View Source [SID1234617151]). The funding will allow Novasenta to advance its pipeline of antibody-based therapeutics and expand its proprietary computational platforms for target discovery, while continuing to recruit top talent.

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Novasenta comprehensively maps the tumor microenvironment — the network of cells and structures that surround and interact with tumor cells inside the body — to develop immunotherapies that enable the body’s own immune system to fight cancer. Co-founded in late 2018 by Robert Ferris, M.D., Ph.D., Dario Vignali, Ph.D., and Greg Delgoffe, Ph.D., all of the UPMC Hillman Cancer Center and the University of Pittsburgh, Novasenta is building on decades of research in the fields of tumor biology, immunology, computational biology and drug discovery.

Through its relationship with UPMC, the company has access to high-quality human tumor samples representing more than a dozen solid tumor types across various stages of disease and treatment for single-cell level analysis of gene expression profiles. This differentiated approach enables Novasenta’s discovery of novel druggable targets and development of therapeutics.

"With our significant Series A funding, Novasenta expects to move at least one of our three nominated programs into the clinic by 2024, with the potential to transform care for patients with solid tumors," said Mani Mohindru, Ph.D., Novasenta’s chief executive officer and a veteran biotechnology leader.

"Our partnership with UPMC and UPMC Enterprises, especially in these challenging times, is just one of many advantages driving the growth of Novasenta," said Mohindru. "Our unique target discovery and validation platform, access to patient tumor samples and the expertise of our founders are critical advantages as we strive to bring life-saving therapies to market." She noted that the company has expanded its senior management team in the past 12 months, attracting leaders with proven industry expertise and drug development success.

"Immunotherapies like checkpoint inhibitors and CAR T-cell therapies have revolutionized cancer care and improved patient outcomes," said co-founder Ferris, who is also director of the UPMC Hillman Cancer Center and Hillman Professor of Oncology at the University of Pittsburgh. "Unfortunately, these leading-edge treatments work for only a small subset of patients, leaving a vast, unmet need for effective therapies. With our team’s unusual ability to understand the complex interactions between specific tumor types and the immune system, Novasenta aims to fill that need, bringing hope to patients who currently have no good treatment options or for whom existing immunotherapies have stopped working."

Jeanne Cunicelli, president of UPMC Enterprises, added: "We’re excited to continue our significant support for Novasenta, whose programs promise to produce the next generation of novel immuno-oncology drug candidates that can potentially transform the lives of patients with cancer."

Part of $24 billion health care provider and insurer UPMC, based in Pittsburgh, UPMC Enterprises is focused on two key areas: translational sciences and digital solutions. It provides its portfolio companies and partners with capital, connections and resources to develop solutions to health care’s most complex problems.

Working in close collaboration with innovators from UPMC and the University of Pittsburgh Schools of the Health Sciences, as well as others worldwide, UPMC Enterprises strives to accelerate science from the bench to the bedside and has committed to investing $1 billion in novel drugs, diagnostics and devices by 2024.

On July 29, 2022 Leidos Holdings, Inc. (NYSE:LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.36 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, JUL 29, 2022, View Source [SID1234617135]). The cash dividend is payable on September 30, 2022, to stockholders of record as of the close of business on September 15, 2022.

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On July 29, 2022 Otsuka reported its consolidated Financial Results for the second quarter of the Fiscal Year Ending December 31, 2022 (Press release, Otsuka, JUL 29, 2022, View Source [SID1234618760]).

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