EORTC and Walgreens Boots Alliance announce continued partnership in support of E²-RADIatE platform

On October 3, 2022 The European Organisation for Research and Treatment of Cancer (EORTC) and Walgreens Boots Alliance reported the next phase of their partnership in support of the organisation’s E²-RADIatE platform, the only radiation oncology platform in Europe (Press release, EORTC, OCT 3, 2022, View Source [SID1234621620]).

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The partnership
Over the past decade, WBA has supported EORTC in building and developing the SPECTA platform into the leading pan-European translational research infrastructure.

During the next three years, WBA aims to raise €1.8 million in support of the E²-RADIatE platform, aimed at defining optimal radiation oncology treatment strategies and interventions that can become the new standard of care for patients through the performance of clinical trials.

EORTC CEO, Dr. Denis Lacombe, commented, "Understanding the optimal use of new technologies for cancer patients is paramount to therapeutic progress. E²-RADIatE is the sole platform in Europe embracing the developing field of radiation oncology to deliver evidence for the best use of novel therapeutic options. We could not be prouder to count WBA as our partner."

Walgreens Boots Alliance Chief Operating Officer – International, Ornella Barra, commented: "Everyone at WBA is proud to continue to support the essential work of the EORTC, including this ground-breaking technology. E²-RADIatE is a platform that collects evidence to address health equity and could reduce health disparities in cancer care. This reflects WBA’s commitment to improving health equity as well as our mission to promote ‘More joyful lives through better health."

The programme
Radiotherapy is one of the mainstays of cancer treatment. Approximately 1 in 2 of all cancer patients need radiotherapy at least once in the course of their disease. Most of the time radiotherapy is given at an early stage of the disease, conveying the potential for cure. Improved technologies and their proper use are therefore critical factors in increasing the cure rate and decreasing the probability of radiation-induced toxicity.

The E²-RADIatE platform (a joint scientific collaboration between the EORTC and the European Society of Radiation Oncology, ESTRO) will streamline the efficient collection and linking of clinical information with diagnostic imaging data, radiation imaging, and treatment data as well as with health economic data. The platform will also collect patient-reported outcomes to address the increased emphasis on patient-centered care and the role of health-related quality of life (HRQoL) in evaluating new treatments.

The E²-RADIatE platform and downstream clinical research projects aim to make it easier to appropriately document new clinical indications treated with radiotherapy and to monitor the impact of new radiation treatments, techniques, and technologies, while new standards of care are developing in parallel.

E²-RADIatE will provide Europe with the means to maintain the capacity of excellence in high-level, science-driven knowledge development, in the best interest of patients. The platform combines the expertise of a knowledgeable network of specialists and the expertise of solid clinical research infrastructure, embedding the highest level of quality assurance in delivering radiation therapy.

Ligand Announces Record Date and Details for Distribution for OmniAb Spin-Off

On October 3, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its board of directors has set October 26, 2022 as the record date (Record Date) for the dividend of shares of common stock of OmniAb, Inc. to be distributed to Ligand shareholders in order to effect the separation of Ligand and OmniAb into two independent, publicly traded companies (Press release, Ligand, OCT 3, 2022, View Source [SID1234621619]). The dividend in OmniAb shares is expected to be distributed to Ligand shareholders on or about November 1, 2022, the expected closing date of the previously announced business combination (Business Combination) between OmniAb and Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA). Following the closing of the Business Combination, APAC will change its name to "OmniAb, Inc." (New OmniAb) and begin trading on the Nasdaq Global Market under the stock ticker symbol "OABI," and Ligand will continue to trade on the Nasdaq Global Market under the stock ticker symbol "LGND."

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Ligand shareholders as of the close of business on the Record Date will receive shares of OmniAb common stock on a pro rata basis representing 100% of Ligand’s interest in OmniAb. Immediately following the distribution of OmniAb shares, the Business Combination is expected to close. Upon the closing of the Business Combination, all shares of OmniAb common stock will be automatically exchanged for shares of New OmniAb on a pro rata basis according to a base exchange ratio (Base Exchange Ratio) calculated immediately prior to closing using a formula set forth in the merger agreement (Merger Agreement) among Ligand, OmniAb, APAC and a subsidiary of APAC. The Base Exchange Ratio is based on the number of shares of Ligand common stock outstanding and the relative trading values of the Ligand common stock in the "regular way" and "ex-distribution" markets during the five-trading-day period prior to the closing.

Based on an illustrative record date of June 30, 2022 and Ligand stock price as of such date and an estimated Base Exchange Ratio, Ligand shareholders would receive approximately 4.9 shares of New OmniAb common stock for each share of Ligand/OmniAb common stock.

In addition, as part of the exchange, Ligand shareholders as of the Record Date will receive earnout shares (Earnout Shares) of New OmniAb common stock on a pro rata basis according to an earnout exchange ratio (Earnout Exchange Ratio) calculated immediately prior to closing using a formula set forth in the Merger Agreement. Based on an illustrative record date of June 30, 2022 and Ligand stock price as of such date and an estimated Earnout Exchange Ratio, Ligand shareholders would receive approximately 0.75 shares of New OmniAb common stock for each share of Ligand/OmniAb common stock. The Earnout Shares will vest based upon the achievement of certain volume-weighted average trading prices for shares of New OmniAb during the five-year period following the closing of the Business Combination.

Based on the foregoing estimates, Ligand’s shareholders would receive aggregate shares of New OmniAb common stock representing approximately 76.3% (assuming no redemptions by APAC shareholders) to 85.0% (assuming maximum redemptions by APAC shareholders) of New OmniAb, APAC’s existing public shareholders would own approximately 18.0% (assuming no redemptions by APAC shareholders) to 0% (assuming maximum redemptions by APAC shareholders) of New OmniAb, and the sponsor and related parties of APAC (Sponsor) would own approximately 5.7% (assuming no redemptions by APAC shareholders) to 15.0% (assuming maximum redemptions by APAC shareholders) of New OmniAb, including the Earnout Shares in each case.

The actual number of shares of New OmniAb common stock and Earnout Shares that each Ligand shareholder will receive with respect to each share of OmniAb common stock will be calculated on the closing date and may differ from these estimates. No fractional shares of New OmniAb common stock will be issued in the merger, and instead Ligand shareholders will receive cash in lieu of any fractional share (other than with respect to Earnout Shares).

Ligand shareholders do not need to take any action. Their OmniAb shares received upon distribution of the dividend will automatically be exchanged for New OmniAb common stock and Earnout Shares in the merger on the closing date of the Business Combination. Following the closing of the Business Combination, Ligand shareholders will continue to hold, along with their new shares of New OmniAb common stock and Earnout Shares, the same number of shares of Ligand common stock that they held immediately prior to the closing. After the closing, investors should expect that Ligand’s share price will adjust to reflect the transfer of the OmniAb business to New OmniAb.

In connection with the Business Combination, OmniAb and APAC filed registration statements with the Securities and Exchange Commission (SEC), described below under "Important Information and Where to Find It." On September 30, 2022, the SEC declared both registration statements effective. The registration statements contain further information regarding the spin-off and Business Combination, including the conditions to completion of the Business Combination and additional details regarding the calculation of the applicable exchange ratios described above.

Factors that May Affect the Dividend and Spin-Off

The dividend is conditioned upon, and the spin-off and Business Combination are subject to, the satisfaction or waiver of closing conditions for the Business Combination. If certain closing conditions are not satisfied or waived in advance of the expected closing date, Ligand may elect to change the record date for the dividend to a later date or to not proceed with the dividend or the spin-off.

Two-Way Trading to Begin for Ligand on the Nasdaq Global Market (Nasdaq)

Beginning on or around the trading day prior to the Record Date and continuing through the close of trading on the closing date of the Business Combination, there will be two markets in Ligand common stock on Nasdaq: a "regular way" market and an "ex-distribution" market. During this period of two-way trading in Ligand common stock, there will also be a market on Nasdaq for New OmniAb common stock on a "when issued" basis.

The trading options that will be available during the two-way trading period are:

Ligand Regular Way Trading

If, during the period of two-way trading, a Ligand shareholder sells a share of Ligand common stock in the regular way market under Ligand’s Nasdaq symbol, "LGND," the shareholder will be selling both the share of Ligand common stock and the right to receive shares of New OmniAb common stock in the transaction.

Ligand Ex-distribution Trading

If, during the period of two-way trading, a Ligand shareholder sells a share of Ligand common stock in the ex-distribution market under the temporary Nasdaq symbol "LGNDV," the Ligand shareholder will be selling only a share of Ligand common stock and will retain the right to receive shares of New OmniAb common stock in the transaction.

New OmniAb When issued Trading

During the two-way trading period, a Ligand shareholder also has the option of selling the right to receive shares of New OmniAb common stock while retaining shares of Ligand common stock. This option will be available under the temporary Nasdaq symbol "OABIV."

Trades under the symbols "OABIV" and "LGNDV" will settle after the closing date of the Business Combination. If the transaction is not completed, all trades made under these temporary symbols will be cancelled.

In all cases, investors should consult with their financial and tax advisors regarding the specific implications of selling shares of their Ligand common stock or the right to receive shares of New OmniAb common stock on or before the closing date of the Business Combination.

About OmniAb

OmniAb’s discovery platform provides pharmaceutical industry partners access to the diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. We believe the OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through computational antigen design and immunization methods, paired with high-throughput single B cell phenotypic screening and mining of next-generation sequencing datasets with custom algorithms to identify fully human antibodies with superior performance and developability characteristics. An established core competency focused on ion channels and transporters further differentiates our technology and creates opportunities in emerging target classes. OmniAb antibodies have been leveraged across modalities, including bispecific antibodies, antibody-drug conjugates and others. The OmniAb suite of technologies span from BI-powered repertoire generation to cutting edge antibody discovery and optimization offering a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.

Boston Scientific Announces Conference Call Discussing Third Quarter 2022 Results

On October 3, 2022 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the third quarter ended September 30, 2022 on Wednesday, October 26, 2022 at 8:00 a.m. EDT (Press release, Boston Scientific, OCT 3, 2022, View Source [SID1234621618]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the third quarter on October 26 prior to the conference call.

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A live webcast and replay of the webcast will be accessible at investors.bostonscientific.com. The replay will be available approximately one hour following the completion of the event.

Viewpoint Molecular Targeting Announces VMT- -NET Granted U.S. FDA Fast Track Destination for the Treatment of Neuroendocrine Tumors

On October 3, 2022 Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, reported that the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of [212Pb]VMT-α-NET for treatment of patients with SSTR2-positive unresectable or metastatic neuroendocrine tumors (NETs) (including GEP-NETs or bronchial NETs and pheochromocytomas and paragangliomas) (Press release, Viewpoint Molecular Targeting, OCT 3, 2022, https://viewpointmt.com/viewpoint-molecular-targeting-announces-vmt-net-granted-u-s-fda-fast-track-destination-for-the-treatment-of-neuroendocrine-tumors/ [SID1234621617]).

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"Although several exciting new medicines have emerged in the past decade for patients with neuroendocrine tumors, there remains an unmet need for certain patient segments, where survival rates remain low" said Dr Frances Johnson, M.D., COO and co-founder of Viewpoint. Added Michael Schultz, Ph.D., CSO and co-founder of Viewpoint, "we applied for fast track designation based on the compelling results seen in head-to-head animal studies and are appreciative of the FDA being able to review the data expeditiously." The Company expects the results of those studies to be presented publicly at the upcoming European Association of Nuclear Medicine (EANM) conference to be held October 15-19, 2022 in Barcelona, Spain.

"We are thrilled to receive FDA Fast Track Designation for our leading program," said Thijs Spoor, CEO of Viewpoint. "This designation will allow us to actively explore the fastest ways to bring our personalized alpha-particle theranostics to patients."

The FDA Fast Track Designation is one of several approaches utilized by the FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over available therapies, act via a different mechanism of action than available therapies, or have a benefit in patients who are unresponsive to or intolerant of available therapies. Programs that receive Fast Track Designation are entitled to more frequent interactions with the FDA on drug development plan, as well as eligibility for accelerated approval, priority review, and rolling review.

About Neuroendocrine Tumors (NET)

Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are approximately 175,000 people living with this diagnosis.

Sysmex and JCR Pharmaceuticals Establish a Joint Venture in the Field of Regenerative Medicine and Cell Therapy

On October 3, 2022 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) and JCR Pharmaceuticals Co., Ltd. (HQ: Ashiya, Hyogo Prefecture; Chairman and President: Shin Ashida) reported that they have established a joint venture (hereafter "the joint venture") for carrying out research and development, manufacture and sales of cell-based regenerative medicine products including hematopoietic stem cells and other stem cells (Press release, Sysmex, OCT 3, 2022, View Source [SID1234621616]).

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In recent years, the significant potential of regenerative medicine and cell therapy have been established in particular in areas that have traditionally been difficult to address with conventional chemically synthesized low molecular weight drugs1 or biopharmaceuticals,2 such as the restoration of tissues and functions lost as a result of aging, illness, autoimmune diseases, or cancer. In particular, research and development on the therapeutic application of stem cells including hematopoietic stem cells, mesenchymal stem cells, and iPS cells have generated significant attention.

Since its foundation, Sysmex has provided network solutions using IoT (Internet of Things) and automated testing flows to improve the safety of healthcare professionals and for the optimization of operational efficiency in clinical laboratories. In addition, while providing quality control testing for companies which develop regenerative medicine products, Sysmex has conducted research and development related to new pre-transplant compatibility testing examining the patient’s immune response against the organ or tissue to be transplanted.

Since its inception, JCR has been engaged in the research, development, manufacturing and sales of pharmaceutical products using regenerative medicine, genetic engineering, and gene therapy technologies to advance therapies in the rare disease field. This is exemplified in the field of regenerative medicine, by the approval of TEMCELL HS Inj.,3 the first allogeneic regenerative medicine in Japan (Non-proprietary name: Human (allogeneic) bone marrow-derived mesenchymal stem cells) in February 2016 for the treatment of acute graft-versus-host disease (acute GVHD),4 a serious complication that develops after hematopoietic stem cell transplantation. In recent years, JCR has further streamlined and integrated its expertise around the establishment of groundbreaking medicines for the advancement of highly innovative medicines that could not be developed without such groundbreaking technologies.

In the joint venture, the two companies aim to realize the social implementation of regenerative medicine and cell therapy by integrating Sysmex’s expertise in quality control testing technology and knowledge of workflows efficiency using robotics technology, including IoT, with JCR’s expertise in developing, manufacturing and marketing regenerative medicine products. AlliedCel Corporation, which is the corporate name of the joint venture following prior discussions regarding the alliance both companies, was established on October 3, 2022. The joint venture will advance programs of the potential for technology development and commercialization, including the project currently being promoted by both companies using hematopoietic stem cell proliferation technology.

The name AlliedCel stands for the joint venture’s aspiration to integrate knowledge and expertise from a broad set of collaborators and stakeholders including business partners, patients and their families, with the united goal of unleashing the power of cells in supporting patients in their need for life-changing therapies. Through the research and development of regenerative medicine products using diverse cells such as stem cells, AlliedCel aims to provide appropriate treatment options to patients and improve their prognosis.