On January 11, 2021 Alligator Bioscience AB (publ)’s ("Alligator" or the "Company") reported that rights issue of shares which was resolved upon by the Board of Directors on December 15, 2020 pursuant to the authorization from the Annual General Meeting on May 5, 2020 (the "Rights Issue") (Press release, Alligator Bioscience, JAN 11, 2021, View Source [SID1234573769]). The general public also has the opportunity to subscribe for shares in the Rights Issue.

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To ensure continued successful development in accordance with the Company’s business plan and strategy, the Board of Directors of Alligator has resolved to carry out the Rights Issue of approximately SEK 86 million before issue costs. The expected net proceeds from the Rights Issue will be used to initiate and conduct Phase II studies for mitazalimab and to complete phase I study and initiate preparatory work on Phase II study for ATOR-1017. The Rights Issue is secured to 100 per cent by subscription undertakings and guarantee commitments.

For complete information on the Rights Issue, please see the prospectus (the "Prospectus"), which has been prepared by the Board of Directors in connection with the Rights Issue.

Comment from Alligator’s CEO, Per Norlén
"With the capital injection from the rights issue, we secure the start of important efficacy studies for our focus projects mitazalimab and ATOR-1017. Just before year-end, we submitted a CTA for mitazalimab, an application to start Phase II in pancreatic cancer. For ATOR-1017, we plan to start Phase II studies in the second half of 2021, with gastric cancer as a prioritized indication. Based on strong data from preclinical models and clinical Phase I, we see great opportunities for both mitazalimab and ATOR-1017 to successfully treat patients with these cancers."– Per Norlén, CEO of Alligator

The Rights Issue
The Rights Issue comprises a maximum of 14,277,723 shares. The Rights Issue takes place with priority for those who were registered as shareholders in the Company on the record date, January 5, 2021. One (1) existing share in the Company entitles to one (1) subscription right. Five (5) subscription rights entitle to subscribe for one (1) new share.

Timeline for the Rights Issue

January 11 – January 21, 2021 – Trading in subscription rights
January 11 – January 25, 2021 – Subscription period
January 11, 2021 – Until the Rights Issue has been registered by the Swedish Companies Registration Office – Trading in paid-up subscribed shares (Sw. "BTA")
January 28, 2021 – Estimated publication of outcome of Rights Issue
Investor presentations
The Company will be presenting at Redeye Fight Cancer Seminar on January 21, 2021. Additional investor presentations may be arranged during the subscription period. Invitations will be presented on Alligator’s and Redeye AB’s respective websites.

Prospectus
The Prospectus, containing complete terms and conditions, is available on the Company’s, Aktieinvest FK AB’s and Redeye AB’s respective websites (www.alligatorbioscience.com, View Source and View Source). The Prospectus is also available on the Swedish Financial Supervisory Authority’s website (www.fi.se). Subscription forms are available on the Company’s and Redeye AB’s respective websites. Subscription forms can also be obtained by contacting Aktieinvest FK AB on telephone number 08-5065 1795.

Advisers
Redeye AB acts as financial adviser, Setterwalls Advokatbyrå AB acts as legal adviser and Aktieinvest FK AB acts as issuing agent in connection with the Rights Issue.

On January 11, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine the best treatment strategy for each patient (Press release, Hoffmann-La Roche, JAN 11, 2021, View Source [SID1234573768]). The image analysis algorithms use artificial intelligence to support pathologists in making faster, more accurate patient diagnoses in breast cancer.

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A mutation in the HER2 gene, which occurs in as many as 20 percent of the 2.1 million cases of breast cancer diagnosed globally each year, is responsible for aggressive growth in some patients. Identifying this mutation is important in determining which patients may benefit from targeted treatment.1,2

"About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive, which makes fast and accurate diagnosis critical," said Thomas Schinecker, CEO Roche Diagnostics. "Roche is continuing to innovate in HER2 diagnostics by providing precise information through image analysis algorithms for pathology decision support."

uPath HER2 (4B5) image analysis for breast cancer helps pathologists to quickly determine whether tumors are positive for the HER2 biomarker, highlighting positively stained tumor cell membranes with a clear visual overlay for easy reference. uPath HER2 Dual ISH image analysis for breast cancer assists the pathologist in the determination of HER2 gene amplification. A heatmap is provided to guide pathologists to areas of interest where the algorithm can identify cells to inform the determination of a treatment strategy.

Validated on the VENTANA HER2 (4B5) assay and the VENTANA HER2 Dual ISH DNA Probe Cocktail, the algorithms are ready-to-use and integrated within the Roche uPath enterprise software. The uPath HER2 (4B5) image analysis and uPath HER2 Dual ISH image analysis algorithms for breast cancer expand Roche’s digital pathology portfolio to empower precision diagnosis. Roche is continuing to innovate in HER2 diagnostics through image analysis algorithms that provide an actionable assessment of scanned slide images that are objective and reproducible.

About uPath image analysis algorithm suite
The uPath image analysis algorithm suite for pathology decision support offers ready-to-use image analysis tools, providing fast, consistent and automated analysis so that pathologists can quickly, accurately and confidently assess immunohistochemistry and in situ hybridization. All algorithms in the suite for uPath software will provide image analysis of VENTANA DP 200 scanned slide images stained with a Roche Tissue Diagnostics assay. Together, Roche is delivering a new foundation of its digital pathology solution which will enable the development of artificial intelligence-based image analysis algorithms that can provide pathologists more tools to improve efficiency and precision.

Roche is delivering the end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated clinical image analysis algorithms. Roche minimizes the variables that can impact analysis, and it is this end-to-end development that produces the quality results customers can depend on for making clinical decisions. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented tools into routine clinical practice.

About breast cancer
Breast cancer is the second most common cancer in the world, with an estimated 1.7 million new cancer cases diagnosed in 2012 (25% of all cancers). It is the most common cancer in women globally. Incidence rates vary nearly four-fold across the world regions, with rates ranging from 27 per 100,000 in Africa and Asia to 92 per 100,000 in North America.1,2

On January 11, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company expects to report revenue between $464.5 million and $467.5 million for the fourth quarter ended Dec. 31, 2020 (Press release, Exact Sciences, JAN 11, 2021, View Source [SID1234573753]).

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"I’m incredibly proud of how the Exact Sciences team came together during 2020 to make progress towards our mission of eradicating cancer and the suffering it causes," said Kevin Conroy, chairman and CEO of Exact Sciences. "Following our combination with Thrive, we are confident in making blood-based, multi-cancer screening a reality and being a leading provider of earlier, smarter cancer tests for patients at every step of their journey. We’ve never been more excited about the impact Exact Sciences will have on patient lives with Cologuard, Oncotype, and our future tests."

Preliminary, Unaudited Fourth Quarter 2020 Financial Results

For the three-month period ended December 31, 2020, as compared to the same period of 2019 (where applicable):

Expected total revenue between $464.5 million and $467.5 million
Expected Screening revenue between $249 million and $250 million, an increase of 9 percent
Expected Precision Oncology revenue between $117 million and $118 million
Expected COVID-19 testing revenue between $98.5 million and $99.5 million
Preliminary, Unaudited 2020 Financial Results

For the twelve-month period ended December 31, 2020, as compared to the same period of 2019 (where applicable):

Expected total revenue between $1.490 billion and $1.493 billion
Expected Screening revenue between $814.5 million and $815.5 million, an increase of 1 percent
Expected Precision Oncology revenue between $440 million and $441 million
Expected COVID-19 testing revenue between $235 million and $236 million
For the fourth quarter and 2020, Screening includes laboratory service revenue from Cologuard and revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products.

Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2020. The revenue ranges presented in this news release for the fourth quarter of 2020 and for the year ended Dec. 31, 2020 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2020. Exact Sciences is in the process of completing its customary year-end close and review procedures as of and for the year ended Dec. 31, 2020, and there can be no assurance that final results for this period will not differ from these estimates. During the course of the preparation of Exact Sciences’ consolidated financial statements and related notes as of and for the year ended Dec. 31, 2020, the company’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Exact Sciences plans to report 2020 financial results during its February 2021 earnings call.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx only.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On October 1, 2021 Window Therapeutics, Inc. (Window), a Massachusetts-based therapeutics company, reported a foundational partnership and seed funding in collaboration with the National Foundation for Cancer Research (NFCR) through its AIM-HI Accelerator Fund (AIM-HI) biotechnology innovation award program (Press release, National Foundation for Cancer Research, JAN 10, 2021, View Source [SID1234609539]). Terms of the seed-funding round were not disclosed.

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Founded in 2020, Window is creating next-generation cancer therapeutics designed to overcome limited efficacy and prohibitive toxicity which often confound successful drug development and as well as favorable patient outcomes. The company’s revolutionary technology platform derives from research that began over ten years ago by Dr. Jeremiah Johnson at the Massachusetts Institute of Technology (MIT). Window’s Bottle-brush Analogue Macromolecule (BAM) platform modifies the therapeutic window of small molecule, immune-based, and combination drug treatments to maximize efficacy specifically within disease sites. AIM-HI identified Window, its technology, and lead drug programs as possessing significant potential for transforming cancer drug development and advancing promising targeted drugs and immunotherapeutic to the clinic in an accelerated manner. AIM-HI’s lead role in the seed-funding of Window is intended to catalyze the progression of its lead candidates to the clinic, based on BAM technology that alleviates the pharmacokinetics, bioavailability, and off-target effects that so often lead to drug candidate failure in clinical trials.

"The Window Therapeutics’ approach embodies our passion to urgently address the limitations of current cancer therapies," said Sujuan Ba, Ph.D., co-Founder of AIM-HI and Chief Executive Officer of NFCR. "Our support for translating promising research from academia to the clinic by selectively identifying and nurturing early-stage companies accelerates treatment breakthroughs for cancer patients worldwide."

"AIM-HI’s support in creating a path forward to the clinic for our novel, bottle-brush macromolecule-based drug programs to benefit cancer patients is truly transformational," remarked Jeremiah Johnson, Ph.D., Window Therapeutics co-Founder, and Scientific Advisor. "Following a decade of progressive development to reconfigure drug therapeutic windows, we aspire to help clinicians and patients achieve and sustain successful outcomes."

On January 10, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for PVSRIPO for the treatment of advanced melanoma (stage IIB-IV) (Press release, Istari Oncology, JAN 10, 2021, View Source [SID1234577675]). PVSRIPO is a novel viral immunotherapy, based on the Sabin type 1 polio vaccine, that activates a patient’s innate and adaptive immune system to facilitate an anti-tumor response and establish long-term immunologic memory to help prevent the cancer’s return.

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"We are happy to kick off the new year with the announcement that our request for an orphan drug designation has been granted to PVSRIPO for the treatment of advanced melanoma," said Matt Stober, President and Chief Executive Officer at Istari Oncology. "This is just one of many milestones to come in 2021 as we continue to drive the clinical development of PVSRIPO across multiple indications."

Currently, Istari is recruiting for LUMINOS-102, a Phase 2 open-label, randomized trial (clinicaltrials.gov NCT04577807) in patients with advanced, unresectable melanoma who previously failed anti-PD1 therapy. This study will characterize the safety, tolerability, and initial efficacy of PVSRIPO intratumoral injection alone and in combination with a PD-1 inhibitor. The first patient is expected to be dosed this quarter.

LUMINOS-102 follows a successful Phase 1 monotherapy study of PVSRIPO in anti-PD1 refractory advanced melanoma in which patients who received 3 injections (6/12) had an overall response rate of 67% (4/6).

"We are encouraged by the data from our Phase 1 trial presented at last year’s Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2020 annual meeting" said Garrett Nichols, MD, MS, Chief Medical Officer at Istari Oncology. "We plan to build upon that success with LUMINOS-102. As those data and the data from our other solid tumor trials emerge, we will continue to work closely with the FDA toward the goal of bringing PVSRIPO to market."

Melanoma is the deadliest type of skin cancer today with approximately 7,000 deaths in the U.S. each year. Treatment-resistant, advanced melanoma patients have very poor survival rates, with less than 28% of metastatic melanoma patients surviving 5 years1. PVSRIPO aims to address the significant unmet need in advanced melanoma, since most patients are treated with checkpoint inhibitors, and many do not respond or later become resistant and require other options, which are limited.

Orphan drug designation is granted by the FDA Office of Orphan Products Development (OOPD) to drugs or biological products intended for the treatment of rare diseases or conditions that impact fewer than 200,000 people in the U.S. This designation acts as a stimulus for the development of drugs for rare diseases through several incentives, including eligibility for federal grants, research and development tax credits, waiver of filing fees, and the potential for a seven-year marketing exclusivity period after FDA approval.

The granting of an orphan drug designation does not alter the standard regulatory requirements and process for obtaining marketing approval. More information about orphan drug designation can be found on the OOPD website.

For more information about Istari Oncology and their ongoing clinical trials, visit istarioncology.com.

About PVSRIPO
PVSRIPO is a virus based on the live attenuated Sabin type 1 polio vaccine that has been genetically modified for safety. Unlike other viral immunotherapies, PVSRIPO has a distinct target (the poliovirus receptor CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via sublethal infection of antigen presenting cells in the tumor, which unleashes an inflammatory cascade resulting in sustained systemic antitumor immunity. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

About Melanoma
There are estimated to be over 12,000 new and recurrent cases of advanced, unresectable melanoma diagnosed in the U.S. each year, and around 7,000 deaths. While immune checkpoint inhibitors have dramatically improved the outlook for advanced melanoma patients today, most patients treated with these immunotherapies are either primary non-responders or eventually develop immune-refractory progressive disease and require additional therapy.