On January 31, 2022 Patrys reported its Quarterly Activities Report and 4C Quarterly Cash Flow Report (Press release, Patrys, JAN 31, 2022, View Source [SID1234607498]).

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Standout achievements for this Quarter have included:

PAT-DX3 manufacturing development program significantly ahead of schedule;
Non-clinical studies further define biological and pharmaceutical profile of PAT-DX3 deoxymab and potential use for expanded clinical applications;
Business development momentum;
Rodent, non-GLP toxicology studies confirm an acceptable safety and tolerability profile for PAT-DX1; and,
Balance sheet capacity with closing cash balance of $10.76M at 31 Dec 2021, with an additional $2M in short-term investments.

On January 31, 2022 The Janssen Pharmaceutical Companies of Johnson & Johnson reported the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of teclistamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) (Press release, Johnson & Johnson, JAN 31, 2022, View Source [SID1234607527]). Teclistamab is an investigational, off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3.1

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"Despite the significant progress that has been made in the treatment of multiple myeloma, it remains an incurable cancer, with approximately half of newly diagnosed patients not reaching five-year survival and almost a third dying within one year of diagnosis," said Edmond Chan MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. "Today’s submission is an important step forward in our mission to improve outcomes for people living with multiple myeloma, where the need for new treatment strategies remains high."

In December 2021, the EMA granted accelerated assessment for teclistamab. Accelerated assessment reduces the timeframe for the Committee for Medicinal Products for Human Use (CHMP) to review a MAA and is granted when a medicinal product is of major interest for public health and therapeutic innovation.2

The submission to the EMA is supported by data from MajesTEC-1 (NCT03145181, NCT04557098), an open-label, multicentre clinical trial evaluating the safety and efficacy of teclistamab in adults with RRMM.1 Efficacy outcomes assessed included overall response rate, very good partial response and complete response, using the International Myeloma Working Group (IMWG) criteria.3 Safety outcomes evaluated included dose limiting toxicity and the number of participants with adverse events as a measure of safety and tolerability.4 Updated MajesTEC-1 data were recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2021 annual meeting.1

"We are pleased to announce the submission of teclistamab to the European Medicines Agency. Once again, this shows our commitment to continue to provide innovative, transformative therapies for patients with relapsed or refractory multiple myeloma," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.

The application to the EMA follows a Biologics License Application (BLA) submitted to the U.S. Food and Drug Administration (FDA) seeking approval of teclistamab for the treatment of RRMM. Additionally, a MAA for teclistamab was recently submitted to the Swiss Agency for Therapeutic Products (Swissmedic) through a Type A Project Orbis submission. Project Orbis is an initiative of the FDA Oncology Center of Excellence, and provides a framework for concurrent submission and review of oncology products among international partners, with the aim of facilitating faster patient access to high-impact, innovative cancer therapies across multiple countries.5 A Type A application is submitted concurrently (within 30 days) to the FDA and the Project Orbis Partners (POPs), allowing for maximal collaboration during the review phase and the possibility of concurrent approval decisions.5

About Teclistamab
Teclistamab is an investigational, off-the-shelf, T-cell redirecting bispecific antibody targeting both BCMA and CD3. BCMA is expressed at high levels on multiple myeloma cells.6,7,8,9,10 Teclistamab redirects CD3-positive T-cells to BCMA-expressing myeloma cells to induce killing of tumour cells.11

Teclistamab is currently being evaluated in several monotherapy and combination studies.3,12,13,14,15 In 2020, the European Commission (EC) and the U.S. FDA each granted teclistamab Orphan Drug Designation for the treatment of multiple myeloma. In January 2021 and June 2021, teclistamab received a PRIority MEdicines (PRIME) designation by the EMA and Breakthrough Therapy Designation (BTD) by the FDA, respectively. PRIME offers enhanced interaction and early dialogue to optimise drug development plans and speed up evaluation of cutting-edge, scientific advances that target a high unmet medical need.16 The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.17

About Multiple Myeloma
Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.18,19 When damaged, these plasma cells change and grow out of control. Abnormal plasma cells can crowd out or suppress the growth of other healthy cells in the bone marrow.19 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,500 patients died.20 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, or kidney failure.21

On January 31, 2022 Ember Technologies, Inc. (Ember) and Cardinal Health (NYSE: CAH) reported a partnership to offer the world’s first self-refrigerated, cloud-based shipping box–the Ember Cube (Press release, Cardinal Health, JAN 31, 2022, View Source [SID1234607546]). Ember and Cardinal Health will collaborate to deliver a cold chain solution that ensures product integrity and security throughout the supply chain, while significantly reducing shipping waste in the transport of temperature-sensitive medicines.

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The Ember Cube is a digital shipping box that features cloud-based temperature reporting, GPS location tracking, and return-to-sender technology, versus the current industry standard for transporting temperature-sensitive medicine which includes single-use ice packs, Styrofoam, and cardboard. The Ember Cube uses an onboard cellular radio to report real-time temperature and humidity tracking and GPS location information that can be viewed via Ember’s proprietary cloud-based dashboard. This patented technology allows for precision control, so medicines and vaccines arrive at the required temperature range, ready for use.

"Since Ember’s inception, it has been our goal to leverage our temperature control technology to serve the healthcare industry, with the ultimate mission of helping to improve and save lives," said Clay Alexander, Founder and Group CEO of Ember. "We have formed a powerful new partnership with Cardinal Health to codevelop and commercialize many of our patented healthcare industry inventions to bring this vision to life."

Cardinal Health plays a leading and critical role in delivering logistics solutions for specialty pharmaceutical products, which often have unique temperature requirements. As global spending on cold-chain pharmaceutical products grows to more than $21 billion by 20241, it will be increasingly critical to support the market with secure and sustainable cold storage solutions. Through its partnership with Ember, Cardinal Health will leverage its technology infrastructure and national presence as a leading distributor of pharmaceutical and medical products to hospitals, pharmacies, and physician clinics to deploy Ember’s cold chain technology, ensuring patients can access life-saving therapies.

"Cardinal Health is investing in digital solutions and technology to help our healthcare customers solve problems in innovative ways," said Heidi Hunter, President of Cardinal Health Specialty Solutions. "Our partnership with Ember utilizes technology solutions to set a new industry standard for real-time visibility and product integrity, while also providing transformative waste reduction."

"The Ember Cube will be a particularly relevant solution for the many cell and gene therapies that are in the drug development pipeline, due to their temperature sensitivity, high value and need for real-time integrated tracking," added Hunter.

Ember’s return-to-sender technology allows each Ember Cube to be reused hundreds of times, reducing waste, and eliminating single-use packaging. Once a healthcare provider has received its shipment of medicine, the Ember Cube uses its built-in cellular radio to communicate with the shipping service to schedule a pick-up, automatically providing its current GPS location. Once the Ember Cube notifies the shipping service that it is ready to be picked up, it generates a new shipping label on its e-ink screen and is returned to Cardinal Health’s distribution center.

Cardinal Health plans to launch a customer pilot for the Ember Cube in 2022.

On January 31, 2022 NEC reported that Consolidated Financial Results for the Nine-month Period Ended
December 31, 2021 (April 1, 2021 – December 31, 2021) (Press release, NEC, JAN 31, 2022, View Source [SID1234607499])

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1. Consolidated Financial Results for the Nine-month Period Ended December 31, 2021

(1) Consolidated Operating Results
(2) Consolidated Financial Position

2. Dividends

3. Consolidated Financial Results Forecast for the Year Ending March 31, 2022 (April 1, 2021 – March 31, 2022)

This consolidated financial results falls outside the scope of quarterly review procedures to be performed by certified public accountants or an audit firm.

*Explanation concerning the appropriate use of the financial results forecast and other special matters
(Adjusted profit (loss))
"Adjusted operating profit (loss)" is an indicator for measuring underlying profitability in order to clarify the contribution of acquired companies to the NEC Group’s overall earnings. It is measured by deducting amortization of intangible assets recognized as a result of M&A and expenses for acquisition of companies (financial advisory fees and other fees) from operating profit (loss). Also, "Adjusted net profit (loss) attributable to owners of the parent" is an indicator for measuring underlying profitability attributable to owners of the parent. It is measured by deducting adjustment items of operating profit (loss) and corresponding amounts of tax and non-controlling interests from net profit (loss) attributable to owners of the parent.

On January 31, 2022 Sierra Oncology, Inc. (Nasdaq: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported the closing of its previously announced underwritten public offering of 4,074,075 shares of its common stock at a price to the public of $27.00 per share and, in lieu of shares of common stock, to a certain investor, pre-funded warrants to purchase up to 925,925 shares of common stock at a price to the public of $26.999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each pre-funded warrant (Press release, Sierra Oncology, JAN 31, 2022, View Source [SID1234607528]). The gross proceeds to Sierra Oncology from the offering were approximately $135.0 million, before deducting underwriting discounts and commissions and other offering expenses. Net proceeds to Sierra Oncology from the offering were approximately $126.6 million after deducting underwriting discounts and commissions and other offering expenses. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes.

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Jefferies and Cantor are acting as the joint book-running managers and representatives of the underwriters for the offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the offering.

A shelf registration statement on Form S-3 relating to the securities offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on November 5, 2021 and declared effective by the SEC on November 12, 2021. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.