On February 15, 2022 Celularity Inc. (Nasdaq: CELU) (Celularity), a clinical-stage biotechnology company developing placental-derived off-the-shelf allogeneic cell therapies, reported the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for its investigational natural killer (NK) cell therapy, CYNK-101, for treatment of gastric/gastroesophageal junction cancer (Press release, Celularity, FEB 15, 2022, View Source [SID1234608167]). CYNK-101 is being developed as a first-line treatment in combination with standard chemotherapy, trastuzumab and pembrolizumab in patients with locally advanced unresectable or metastatic HER2/neu positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. CYNK-101 is an investigational genetically modified NK cell therapy designed to synergize with approved antibody therapeutics through enhanced antibody-dependent cellular cytotoxicity (ADCC).

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"This designation underscores the significant unmet need for these patients and CYNK-101’s potential in a new first-line treatment strategy," said Robert Hariri, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Celularity. "We are grateful for the FDA’s recognition of this potential treatment paradigm through Orphan Drug Designation and Fast Track designation, which we received earlier this year. At Celularity, we are committed to forging new treatment strategies that leverage the unique properties of placental-derived cellular therapies to improve the lives of patients with this difficult-to-treat cancer."

Andrew Pecora, M.D., President of Celularity, added, "The addition of cleavage-resistant CD16 significantly augments the antibody-dependent activity of our natural killer cell therapy. To date, we have seen promising clinical data from our unmodified NK cellular therapies and believe this genetically modified construct has significant potential in a range of indications. In our Phase 1/2a clinical trial of CYNK-101, we are excited to explore a multipronged strategy of our NK cells and activated T cells through check point inhibition to potentially enhance overall outcomes achieved with traditional chemotherapy and Traztuzumab in HER2/neu positive G/GEJ adenocarcinoma."

This is the fifth designation received by Celularity from the FDA in the past 12 months and follows fast track designations for CYNK-101, in development for the first-line treatment of advanced HER2/neu positive G/GEJ cancers, and CYNK-001, an unmodified investigational NK cell therapy in development for the treatment of acute myeloid leukemia and in development for the treatment of recurrent glioblastoma multiforme, as well as orphan drug designation for CYNK-001 for the treatment of malignant gliomas.

About Orphan Drug Designation

The Orphan Drug Act (ODA) provides incentives to encourage biotechnology and pharmaceutical companies to develop drugs for rare diseases and conditions. To qualify for orphan designation, both the drug and the condition must meet criteria specified in the ODA and FDA’s implementing regulations. Orphan designation qualifies the drug sponsor for development incentives including tax credits for qualified expenses, exemption from the FDA user fee, and the potential for seven years of exclusivity for a drug that obtains approval.

About Gastric Cancer

Gastric cancer is the fifth most common cancer worldwide. Despite recent improvements in treatment quality and options, advanced gastric cancer remains one of the hardest to cure cancers, with a median overall survival (OS) of 10–12 months and a five-year OS of approximately 5–20%.

About CYNK-101

Celularity’s lead therapeutic candidate based on its placental-derived genetically modified NK cell type is CYNK-101, an allogeneic, off-the-shelf human placental CD34+-derived NK cell product genetically modified to express high-affinity and cleavage-resistant CD16 (FCGRIIIA) variant to drive antibody-dependent cell-mediated cytotoxicity. Currently CYNK-101 is being developed as a treatment in combination with standard chemotherapy, trastuzumab and pembrolizumab for HER2 positive overexpressing gastric or gastroesophageal junction adenocarcinoma. The safety and efficacy of CYNK-101 have not been established, and CYNK-101 has not been approved for any use by the FDA or any other analogous regulatory authority.

On February 15, 2022 Bristol-Myers Squibb Company (NYSE:BMY) reported that it has priced a public offering (the "Offering") of senior unsecured notes in a combined aggregate principal amount of $6 billion (collectively, the "Notes") (Press release, Bristol-Myers Squibb, FEB 15, 2022, View Source [SID1234608163]). The Notes will be issued in four tranches: (i) $1,750,000,000 in aggregate principal amount of 2.950% notes due 2032, (ii) $1,250,000,000 in aggregate principal amount of 3.550% notes due 2042, (iii) $2,000,000,000 in aggregate principal amount of 3.700% notes due 2052, and (iv) $1,000,000,000 in aggregate principal amount of 3.900% notes due 2062. Bristol Myers Squibb expects that the closing of the Offering will occur on March 2, 2022, subject to the satisfaction of customary closing conditions.

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Concurrently with this offering, we commenced a tender offer (the "Tender Offer") to purchase, for cash, various series of our outstanding notes (the "Tender Offer Notes"). We intend to use the net proceeds of this offering (i) to fund the Tender Offer, (ii) to pay fees and expenses in connection therewith and this Offering, (iii) to fund the repayment of outstanding debt upon maturity or earlier redemption and (iv) to the extent of any remaining proceeds, for general corporate purposes. This offering is not contingent on the consummation of the Tender Offer or the purchase of any of the Tender Offer Notes in connection therewith.

BofA Securities, Inc., Deutsche Bank Securities Inc., Goldman Sachs & Co. LLC, and Wells Fargo Securities, LLC are acting as joint book-running managers for the Offering.

The Offering of the Notes is being made pursuant to an effective shelf registration statement (including a prospectus and preliminary prospectus supplement) (File No. 333-261623) filed with the U.S. Securities and Exchange Commission (the "SEC"). You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, Bristol Myers Squibb, any underwriter or any dealer participating in the Offering will arrange to send you the prospectus and the preliminary prospectus supplement (or, if available, the prospectus supplement) if you request it by contacting Bristol Myers Squibb Investor Relations or BofA Securities, Inc. at Attn: Prospectus Department, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, by email at [email protected] or by telephone at 1-800-294-1322, Deutsche Bank Securities Inc. at Attn: Prospectus Department, 60 Wall Street, New York, New York 10005, by email at [email protected] or by telephone at 1-800-503-4611, Goldman Sachs & Co. LLC at Attn: Prospectus Department, 200 West Street, New York, New York 10282-2198, by email at [email protected], or by telephone at 1-866-471-2526, or Wells Fargo Securities, LLC at Attn: WFS Customer Service, 608 2nd Avenue South, Suite 1000, Minneapolis, Minnesota 55402, by email at [email protected], or by telephone at 1-800-645-3751.

This press release shall not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, the Notes or any other security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful.

On February 15, 2022 ImpediMed Limited (ASX.IPD), a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximize patient health reported an abstract comparing concurrent measures using ImpediMed’s SOZO Digital Health Platform and dual x-ray absorptiometry (DXA) for assessing bone mineral content in cancer patients was accepted for poster presentation at the 39th Annual Miami Breast Cancer Conference on 3-6 March 2022 in Miami Beach, Florida, USA (Press release, ImpediMed, FEB 15, 2022, View Source [SID1234608159]).

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The abstract, titled, "The Routine Use of Bioimpedance Spectroscopy Measurements in the Clinic as a Surrogate for Bone Mineral Content in Oncology Patients: Practical Application of the SOZO Device," analyzes data collected using both SOZO and DXA in healthy participants and cancer patients.

The Miami Breast Cancer Conference draws the multidisciplinary cancer care team for in-depth discussion about current topics and technologies for breast cancer care. The poster will be presented to registered attendees in-person and online. Abstracts will be published online following the conference in the journal Oncology.

"The Miami Breast Cancer Conference is run by leaders in breast cancer care from every oncology specialty," commented Richard Carreon, Managing Director and CEO of ImpediMed. "This is the ideal venue to present the new data evaluating SOZO to assess changes in bone in cancer patients during and after treatment. We continue to stay focused on lymphedema in the near term while exploring new ways to use SOZO in caring for cancer patients as part of our long-term oncology growth strategy."

Expanding the use of SOZO to help care for cancer patients is central to ImpediMed’s growth strategy in the oncology marketplace. Lymphedema provides a strong entry point for adoption of SOZO into oncology practices. Developing new indications creates opportunity to expand SOZO utilization by placing additional SOZO devices and adding new licenses to existing devices. New indications also support the strategy for building large corporate accounts, many of which have interest in co-development and regulatory clearance for new ways to use SOZO to benefit their cancer patients and improve health economics.

There are 16.9 million cancer survivors in the US and approximately 32 million worldwide. The majority of survivors are women with early-stage breast cancers and men with nonmetastatic prostate cancers. These patients frequently receive hormonal manipulation therapies that can significantly impact their bone mineral content. These patients have a higher risk bone fractures potentially leading to hospitalization and death.

About SOZO Digital Health Platform

SOZO, the world’s most advanced, noninvasive bioimpedance spectroscopy (BIS) device, delivers a precise snapshot of fluid status and tissue composition in less than 30 seconds. Using ImpediMed’s BIS technology, SOZO measures 256 unique data points over a wide spectrum of frequencies from 3 kHz to 1000 kHz. Results are available immediately online for easy data access and sharing across an entire healthcare system. The FDA-cleared, CE-marked and ARTG-listed digital health platform aids in the early detection of secondary lymphedema, provides fluid status for patients living with heart failure, and can be used to monitor and maintain overall health – all on a single device.

On February 15, 2022 Paige, the global leader in AI-based diagnostic software in pathology, and Mindpeak, the European leader for AI-based software for image analysis in pathology, reported a distribution partnership, which will enable pathologists to use Mindpeak’s BreastIHC* within the Paige Platform (Press release, Paige AI, FEB 15, 2022, View Source [SID1234608158]). Mindpeak’s BreastIHC is an AI software that reliably and accurately detects, classifies and quantifies breast cancer cells. This partnership enhances the utility of the Paige Platform by providing real-time results for routine breast cancer immunohistochemistry (IHC) biomarkers.

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The detection and quantification of IHC markers is an important step in treatment planning for breast cancer. Mindpeak’s BreastIHC is the first-ever plug-and-play AI solution for reliable HER2, Ki-67, estrogen (ER) and progesterone receptor (PR) quantification, without the need for complex set-up and calibration procedures. The product helps to differentiate between tumorous and non-tumorous structures on a single-cell basis, improving the specificity of the scoring.

"By combining MindPeak’s products for IHC with Paige’s AI products for H&E, our partnership will allow pathologists to drive efficient routine clinical cancer diagnostics in breast cancer," said Andy Moye, Ph.D., Chief Executive Officer at Paige. "We are excited to offer Mindpeak’s industry-leading BreastIHC directly within the Paige Platform to improve patient care. We believe integrating our products will drive the adoption of digital pathology technologies more broadly."

Paige Platform is a comprehensive digital pathology software platform that is inclusive of a viewer and storage capabilities and is compatible with existing digital pathology solutions, including most scanners, monitors, and laboratory information systems (LIS).

"This partnership brings us a big step closer to our shared goal of making pathological diagnosis of breast cancer quicker, more accurate and more reproducible," said Felix Faber, CEO at Mindpeak. "I am extremely excited that we will combine our respective strengths in analyzing H&E and IHC-stained tissue samples to make this vision of utilizing AI within pathology a reality."

* Mindpeak’s BreastIHC is available in the EU as a CE-IVD marked medical device. Outside the EU, BreastIHC is Research Use Only, not for use in diagnostic procedures.

On February 15, 2022 OncoBeta GmbH reported that the first patients have registered into the world-first International Registry that is capturing data-driven treatment results for NMSC treatments (Press release, OncoBeta, FEB 15, 2022, View Source [SID1234608156]).

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The first-of-its kind International Registry was launched by OncoBeta via specialist health solutions partner Avion Medical in November 2021 to collect real-world patient data for three mainstay treatments of NMSC. Its goal is to identify optimal methods of treating the disease that can be applied internationally.

The International Registry is an easy-to-use platform for physicians and will capture data observing how treatments and innovative approaches influence long-term patient outcomes. The Registry also has an important focus on patient-reported outcomes such as quality of life and comfort of treatment.

The first patients have been recorded into the online registry that follows the treatment journey, from the initial disease assessment to treatments and ongoing assessments. Not only that, but there is an opportunity for patients to contribute their feedback and record their experiences via a questionnaire that includes impact on quality of life as well as comfort score through the OncoBeta WeBe mobile app.

Dr Gerhard Dahlhoff, Medical Director at OncoBeta, says, "To date, no unified reportage on NMSC and its treatments is available to the international medical community. The Registry aims to rectify this shortfall in our understanding of the disease treatment. The WeBe app has been designed so it is easy to use for the patient and the physician, which is critical in ensuring participation and the delivery of robust data. The patient data collection will provide key insights from the patient’s perspective about their treatment and the disease."

An international committee made up of multi-disciplinary clinicians from South Africa, Australia, Italy and Germany is leading the data collection and outputs of the registry. Paolo Castellucci, Nuclear Medicine Physician at S. Orsola, Bologna, and chairman of the International Registry, says, "I’m excited to be involved in an International Registry that will be the first to capture robust, long-term data that will reveal patterns of care, identify which treatment provides the best long term outcomes for patients."

Shannon D Brown III, CEO at OncoBeta GmbH, says, "We are thrilled to see the first patients being registered in the International Registry. By working with clinicians around the world, the Registry will draw from a larger sample size to identify important insights and establish best practices in the treatment of NMSC."

Participation in the International Registry for Non-Melanoma Skin Cancer Treatment is by invitation only. Physicians that would like to become part of the Registry and offer Rhenium-SCT treatment at your centre, contact [email protected]

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans. The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments.1

The Rhenium-SCT is a painless*, single session†, non-invasive therapy providing for unparalleled aesthetic results, even in cases otherwise considered difficult to treat.2-4 The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The Rhenium-SCT is a precise, personalised therapy that is only applied to the area needed to treat without affecting the healthy tissue. The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patient’s skin and the application is safe and simple for the applying physician. Most cases of NMSCs (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT in one single session†4. Scar-free healing4 of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment4.