On January 26, 2022 Flatiron HealthⓇ reported a partnership with Japan’s National Cancer Center Hospital East (NCCHE) to build a real-world database of patients with gastro-intestinal cancers (Press release, Flatiron Health, JAN 26, 2022, View Source [SID1234607412]).

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"Insights from Flatiron’s U.S.-derived real-world data have brought important treatment alternatives to patients with cancer around the world," said Carolyn Starrett, Flatiron CEO. "Adding more patient experiences into the evidence that supports treatment, development and regulatory decisions is the best hope for truly transforming global cancer research and care. This agreement marks a major milestone in our commitment to bring Flatiron’s real-world data expertise into partnerships with hospitals and health networks in Asia and Europe."

Under the agreement signed with Flatiron Health K.K., real-world data (RWD) chronicling the aggregated and de-identified experiences of consented NCCHE patients will be curated into top-quality datasets for use by NCCHE to support its research and treatment decisions, and by other researchers and regulatory decision-makers to help answer previously unanswerable questions.

Founded in 2012, Flatiron brings together the boldest and most creative minds in medicine and technology to transform how cancer is understood and treated. The treatments and outcomes of only a small percentage of cancer patients are captured in the clinical trials that have traditionally formed the evidence base for most treatment, development and regulatory decisions. Flatiron helps to fill this gap with high-quality real-world evidence (RWE) derived from aggregated, de-identified patient information captured during routine care.

Flatiron’s U.S.-derived data have helped expand treatment alternatives for people around the world with gastric, colorectal, esophageal, breast, and head and neck cancer. Now, Flatiron International subsidiaries in Japan, Germany and the United Kingdom will partner with hospitals and health networks in RWD collaborations that produce more top-quality datasets for use by the partners who provide them, in research collaborations and under license, with specific terms and conditions, to biopharma companies, to accelerate cancer research.

"Each Flatiron International partnership is tailored to local legal, regulatory, data privacy and compliance standards and requirements, and designed to help local healthcare providers and partners generate and utilize high-quality RWD to advance oncology research and care," said Nathan Hubbard, Vice President, Head of Business Development and Flatiron International.

The datasets created in the Flatiron-NCCHE project will also be made available for analyses by SCRUM-Japan, an industry-academia collaborative whose members include NCCHE and other leading hospitals in Japan.

"We are honored to partner with NCCHE, one of Japan’s most influential cancer centers, and to collaborate with SCRUM-Japan, one of the most important cancer genomic screening national projects in the world," said Hiroshi Kojima, Head of Market Development, Flatiron Health K.K. "We look forward to expanding this partnership beyond gastro-intestinal cancers in due course."

On January 26, 2022 Aclys Bio Corp ("Aclys"), a company discovering and developing precision biologics for the treatment of cancer, earlier this month reported a new exclusive research and commercial license option agreement with Genmab A/S (Nasdaq: GMAB), an international biotech company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer (Press release, Celdara Medical, JAN 26, 2022, View Source [SID1234608166]).

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Under the terms of the agreement, Genmab secures exclusive rights to Aclys antibodies (specific to an undisclosed target) for further research in conjunction with Genmab’s proprietary platforms. Genmab is also granted the option to advance development and commercialization of resulting products.

Aclys has built a broad range of antibodies using its PILA platform to create targeted therapeutics for solid tumors. The agreement with Genmab recognizes the capability of the Aclys PILA platform to identify novel precision targets.

"We have differentiated, high value targets, unique antibody engineering capabilities, and a team that has delivered some of the most valuable monoclonal antibodies currently in development.", said Dr. Tony Cooper, Aclys Cofounder and CEO. "This agreement with Genmab is integral to advancing our goal of delivering life-saving therapies to patients." Aclys is a leader in the emerging field of precision immune medicine. Aclys utilizes a proprietary set of patient molecular data to select differentiated targets and create precision biologics with the safety profile and response rates only achievable with precision biologics.

On January 25, 2022 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2021 (Press release, Johnson & Johnson, JAN 25, 2022, View Source [SID1234606775]). "Our 2021 performance reflects continued strength across all segments of our business. Guided by Our Credo, I am honored to assume the role of CEO, leading our global teams in continuing our work to deliver life-changing solutions to consumers, patients, and health care providers" said Joaquin Duato, Chief Executive Officer . "Given our strong results, financial profile, and innovative pipeline we are well positioned for success in 2022 and beyond."

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FULL YEAR 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide adjusted operational sales increased 3.8%* primarily driven by over-the-counter (OTC) products including TYLENOL analgesics and digestive health, in addition to NEUTROGENA and AVEENO products in Skin Health / Beauty primarily due to COVID-19 market recovery. The growth was partially offset by external supply constraints mainly impacting Skin Health / Beauty.

Pharmaceutical
Pharmaceutical worldwide adjusted operational sales grew 13.6%* driven by DARZALEX (daratumumab), a biologic for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, and INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. Also contributing to growth were sales of the Janssen COVID-19 Vaccine (Ad26.COV2.S) for the treatment of the SARS-CoV-2 virus. This growth was partially offset by declines in U.S. sales of REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases.

Medical Devices
Medical Devices worldwide adjusted operational sales grew 16.8%*, driven primarily by the market recovery from COVID-19 impacts and the associated deferral of medical procedures in the prior year across all of our businesses including Surgery, Interventional Solutions, Vision and Orthopaedics.

NOTABLE NEW ANNOUCEMENTS IN THE QUARTER:
The information contained in this section should be read in conjunction with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investors section of the company’s website at news releases, as well as www.factsabouttalc.com,www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

FULL-YEAR 2022 GUIDANCE:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

Other modeling considerations will be provided on the webcast.

WEBCAST INFORMATION:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson Website. A replay and podcast will be available approximately two hours after the live webcast in the Investors section of the company’s website at events-and-presentations.

On January 25, 2022 Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, reported that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for Pidnarulex, a first-in-class G-quadruplex stabilizer, for the treatment of patients with breast and ovarian cancers BRCA1/2, PALB2, or other HRD mutations (Press release, Senhwa Biosciences, JAN 25, 2022, View Source [SID1234606791]).

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"We are excited to receive Fast Track Designation and look forward to working closely with the US FDA to accelerate the development of Pidnarulex, aiming to bring a meaningful treatment to patients with breast and ovarian cancer whose tumors have BRCA1/2. PALB2, or other HRD mutations," said Mei-Hui Kuo, Acting Chief Executive Officer of Senhwa Biosciences. FTD expedites the review of new drugs for serious conditions to fill an unmet medical need. Through Fast Track, Senhwa is eligible to apply for Accelerated Approval and Priority Review upon reaching relevant criteria with the US FDA.

Currently, Pidnarulex is tested in a Phase 1b Open-label, Multi-center Expansion Study (in both US and Canada) to determine a tolerable dose in patients with selected solid tumors (such as Breast Cancer, Ovarian Cancer, Pancreatic Cancer and Prostate Cancer) with BRCA2 and PALB2, and Ovarian Cancer with BRCA1 and other HR gene mutations. This dose will be used in future Phase II trials.

In a previous Phase 1 trial, Pidnarulex demonstrated clinically significant and lasting benefits in patients with BRCA1/2, and PALB2 mutations and that were also resistant to platinum and other chemotherapeutics. Due to a DNA repair defect, BRCA1/2 deficient tumor cells are more sensitive to PARPi through the mechanism of synthetic lethality. However, PARPi resistance is not uncommon in clinical use. According to an article published on Molecular Cancer in 2020, more than 40% of BRCA1/2 deficient patients fail to respond to PARPi alone.

Addressing treatment resistant tumors continues to be an unmet medical need in cancer treatment. Pidnarulex has proven human efficacy across certain tumor types by accelerating dsDNA breaks. By targeting the G-quadruplex DNA structure instead, Senhwa’s Pidnarulex has great potential as an alternative treatment for patients who have developed resistance to PAPRi or other chemotherapies.

About Pidnarulex (CX-5461)

Specific mutations within the Homologous Recombination (HR) pathway may be exploited by Pidnarulex through a "synthetic lethality" approach by targeting the DNA repair defects in HR Deficient tumors. Specifically, Pidnarulex is designed to stabilize DNA G-quadruplexes of cancer cells, which leads to disruption of the cell’s replication fork. While acting in concert with HR pathway deficiencies, such as BRCA1/2 mutations, replication forks stall and cause DNA breaks, ultimately resulting in cancer cell death.

On January 25, 2022 Evotec reported that the Company has entered a target and drug discovery partnership with Boehringer Ingelheim, focusing on induced pluripotent stem cell ("iPSC")-based disease modelling for ophthalmologic disorders (Press release, Evotec, JAN 25, 2022, View Source [SID1234606760]). Millions of people are affected by vision-related diseases worldwide, and there is a high unmet need for novel therapeutic solutions.

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Through phenotypic screening of human iPSC-derived cells, supported by Evotec’s PanOmics platform, Evotec will identify small molecules able to modulate disease phenotypes, and then validate the underlying promising targets for potential therapeutic interventions. Boehringer Ingelheim will then continue with the discovery and development of potential therapeutic candidates. Besides an undisclosed upfront and FTE-based research payment, Evotec will continue to benefit from the successful further development of the candidates in the form of milestones and layered royalties.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "We are excited to utilise our unique iPSC- and PanOmics-based approaches to ophthalmologic diseases in this new partnership with Boehringer Ingelheim. Phenotypic screening approaches have a long history of delivering highly effective drugs based on novel molecular mechanisms. Phenotypic screens based on human iPSC-derived disease models combined with our unbiased PanOmics readouts are more likely to deliver disease relevant drugs than any other cell-based screening approach."