On November 30, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), reported the closing of its previously announced private placement of equity (Press release, Regulus, NOV 30, 2021, View Source [SID1234596294]). The Company received gross proceeds of approximately $34.6 million from the sale of 58,923,352 shares of the Company’s common stock ("Common Stock") at a purchase price of $0.36 per share. In addition, the Company sold 3,725,720 shares of non-voting Class A-4 convertible preferred stock, in lieu of shares of Common Stock, at a price of $3.60 per share. Each share of non-voting Class A-4 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The Company expects to use the net proceeds from the transaction for non-clinical and clinical development activities for its product candidates and general corporate purposes. SVB Leerink acted as the lead placement agent for the financing. H.C. Wainwright and Co. acted as co-placement agent for the financing.

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The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

Additional details regarding the private placement are included in the current reports on Form 8-K filed with the Securities and Exchange Commission on November 24, 2021 and November 30, 2021.

On November 30, 2021 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, and Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the novel drug olverembatinib has been approved by the China National Medical Products Administration (NMPA) for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test (Press release, Innovent Biologics, NOV 30, 2021, View Source [SID1234596293]). Olverembatinib is the sixth approved product and the second approved small-molecule drug of Innovent.

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Olverembatinib is a potentially best-in-class drug that developed by Ascentage Pharma and supported by the major new drug project of the Ministry of Science and Technology. Innovent and Ascentage will be mutually committed to the commercialization of olverembatinib in China market. As China’s first third-generation BCL-ABL TKI developed for the treatment of TKI-resistant CML, this approval addresses an important unmet treatment need in T315I-mutant CML, bringing benefits for more patients and their families.

This approval for olverembatinib is based on the results from two pivotal Phase II studies – the HQP1351CC201 study and the HQP1351CC202 study. These results showed that olverembatinib is efficacious and well-tolerated in patients with CML-CP and CML-AP, and the probability and deepness of clinical response is expected to increase with prolonged treatment period.

CML is a hematologic malignancy of the white blood cells. The introduction of BCR-ABL TKIs have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, hence presenting an urgent unmet medical need for an effective treatment.

The leading principal investigator of olverembatinib in China, Prof. Xiaojun Huang, MD, Director of the Institute of Hematology, Peking University, Director of the Hematology Department at Peking University People’s Hospital, commented: "Efficacy and safety data from studies to date have consistently showed that olverembatinib has enormous potential in effectively addressing the unmet medical need in the treatment of chronic myeloid leukemia, and is a drug with best-in-class potential. The clinical progress with this novel therapeutic has also received widespread interest from the global hematology community over the years. I am excited that olverembatinib is now approved in China, as it finally brings about a breakthrough to the clinical conundrum caused by drug-resistance and a milestone in the treatment of CML. In a broad sense, this approval also signifies that China is rapidly emerging as an important player in hematology clinical development in the global landscape."

The principal investigator of olverembatinib in China, Prof. Qian Jiang, MD, Deputy Director of the Hematology Department at Peking University People’s Hospital, noted: "First- and second-generation TKIs are ineffective in patients with T315I-mutant CML-CP and CML-AP, and drug-resistant CML has been long presented as an urgent unmet clinical need. This approval for olverembatinib bears great significance for doctors and patients, offering a breakthrough to the CML treatment landscape. I am convinced that the approval of olverembatinib will bring new hope to adult patients with CML."

Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics, stated: "We are pleased about the NDA approval of olverembatinib in China, which further strengthens Innovent’s franchise in oncology and hematology area by adding a new generation anti-cancer therapy to our commercial portfolio. In oncology area, Innovent has a robust pipeline of up to 20 assets, an industry-leading product development team, and a broad channel coverage with a commercial team of nearly 3000 people. We look forward to collaborating with Ascentage Pharma for the co-commercialization of olverembatinib, in order to bring forth this novel drug to solve the unmet medical needs from Chinese TKI-resistant T315I-mutated CML patients as early as possible."

Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma, said: "This approval for olverembatinib, Ascentage Pharma’s first product entering commercialization, marks a very encouraging milestone in our transition from a R&D-driven biotech into a full-fledged biopharmaceutical company with a commercialized product. At present, we are collaborating with Innovent to go full steam ahead to the buildout of the commercial infrastructure for olverembatinib, Meanwhile, we are partnering with key stakeholders such as genetic testing companies, commercial insurance companies, and online pharmacies, in order to bring this global-leading China-developed novel therapy to patients as soon as possible. We are honored about our commitment to global innovation and our mission of addressing unmet clinical needs in China and around the world. Moving forward, we will continue to explore additional indications of this drug, advance its clinical development overseas, and accelerate the global development of other drug candidates in our pipeline to further solidify our global presence. "

About Chronic Myeloid Leukemia

Chronic myeloid leukemia (CML) is a malignancy caused by the clonal proliferation of hematopoietic stem cell in the bone marrow. Also referred to as chronic myelocytic leukemia, CML is one of the most common subtypes of chronic leukemia, accounting for 15% of all leukemia cases in adults. According to epidemiology data, the onset of CML in Chinese patients happens at a younger age than that in the West; the median age of onset of CML in China is around 45 – 50 years old, while it is 67 years old in the West.

BCR-ABL tyrosine kinase inhibitors (TKIs) have significantly improved the clinical management of CML. However, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, therefore the mutation had long been a clinical obstacle undermining patients’ long-term survival.

About Olverembatinib

Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing program, the orally active, third-generation BCR-ABL inhibitor olverembatinib is the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant chronic myeloid leukemia (CML). Olverembatinib can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation.

In October 2020, olverembatinib was granted the Priority Review status by the Center for Drug Evaluation (CDE) in China for the treatment of adult patients resistant to TKIs and with T315I-mutant chronic phase CML (CML-CP) and accelerated phase CML (CML-AP). In March 2021, it was granted the Breakthrough Therapy designation by the CDE. In overseas, olverembatinib was cleared by the US FDA in July 2019 to directly enter a Phase Ib study. In May 2020, olverembatinib was sequentially granted an Orphan Drug designation and Fast Track designation by the US FDA. In November 2021, olverembatinib was granted an Orphan Designation by the European Union. Furthermore, since 2018, the clinical results of olverembatinib have been selected for oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meetings for four consecutive years, and was nominated for "Best of ASH (Free ASH Whitepaper)" in 2019.

In July 2021, Ascentage Pharma (6855.HK) and Innovent Biologics (1801.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

*Olverembatinib has not been approved for any indication in the U.S.

Results from the two pivotal Phase II studies

1) The HQP1351CC201 study in patients with CML-CP

HQP1351CC201 is an open-label, multicenter, single-arm Phase II designed to evaluate the safety and efficacy of patients with T315I-mutant CML-CP who have received prior treatment with BCR-ABL1 TKIs. The primary endpoint of the study is major cytogenetic response (MCyR).

As of data cut-off date of August 25, 2020, the median duration of follow-up in patients with CML-CP was 13.0 months (range: 7.2-16.3). Of the 31 patients evaluable for hematologic responses, all 31 (100%) patients achieved a complete hematologic response (CHR); In the 41 patients evaluable for cytogenetic responses, 31 (75.6%) patients achieved a MCyR, including 28 (68.3%) with complete cytogenetic response (CCyR), and 3 (7.3%) with partial cytogenetic response (PCyR); Among the 41 patients evaluable for molecular responses, 23 (56.1%) achieved a major molecular response (MMR). The 12-month progression-free survival (PFS) was 85.7% (95% CI: [63.6%-94.9%]) and the overall survival (OS) was 100% (95% CI: [100.0% -100.0%].

2) The HQP1351CC202 study in patients with CML-AP

HQP1351CC202 is an open-label, multicenter, single-arm Phase II designed to evaluate the safety and efficacy of patients with T315I-mutant CML-AP and resistance to TKIs developed on prior treatment with BCR-ABL1 TKIs. The primary endpoint of the study is major hematologic response (MaHR).

As of data cut-off date of July 27, 2020, the median duration of follow-up in patients with CML-AP was 14.3 months (range: 6.6-15.2). Of the 17 patients evaluable for hematologic responses, 12 (70.6%) patients achieved a major hematologic response (MaHR), including 11 (64.7%) with CHR and 1 (5.9%) with no evidence of leukemia (NEL); Among the 17 evaluable patients, 8 (47.1%) achieved a MCyR, all of whom achieved (47.1%) a CCyR, and another 7 (41.2%) achieved MMR. The 12-month PFS was 73.3% (95% CI: [43.3%-89.1%]), and the 12-month OS was 88.2% (95% CI: [60.6%-96.9%].

On November 30 2021 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it plans to offer 17,500,000 shares of its common stock in an underwritten public offering (Press release, MEI Pharma, NOV 30, 2021, View Source [SID1234596292]). In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, prepare for and support the commercial launch of zandelisib, subject to receiving FDA marketing approval, and for other general corporate purposes.

Jefferies, Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering. LifeSci Capital is acting as co-manager.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. When available, copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by email at [email protected]; Stifel, Nicolaus & Company Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001 at 833-690-2713 or email a request to [email protected]. An electronic copy of the preliminary prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

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

On November 30, 2021 GE Healthcare reported collaborations with SOPHiA GENETICS, The University of Cambridge and Optellum as part of its vision to advance care, make precision health more accessible, and ultimately improve outcomes for cancer patients (Press release, GE Healthcare, NOV 30, 2021, View Source [SID1234596290]).

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These alliances are intended to help GE Healthcare support integrated health systems at the local level by providing the technology to deploy software across imaging networks and helping to make the newest innovations accessible across the broader population. It is hoped this will enable local oncologists and medical experts to deliver earlier diagnoses and more accurate treatments — a crucial component in achieving positive health outcomes with cancer patients.

"Cross-functional partnerships between organizations are key to the creation of new approaches and intelligent tools that enable cancer to be detected as early as possible and with the greatest degree of accuracy," said Dr. Ben Newton, Global Head of Oncology Solutions at GE Healthcare. "By partnering with SOPHiA GENETICS, Optellum, and the University of Cambridge, we’re looking to create a more powerful oncology care pathway that promotes high-quality, personalized, and effective medical care."

GE Healthcare’s comprehensive diagnostic imaging and monitoring portfolio can be deployed throughout the patient’s cancer journey, from initial screening and diagnosis, through therapy guidance facilitating minimally invasive treatment, to monitoring patient progress.

As cases of cancer continue to rise and are predicted to reach 29.5 million new cases per year by 20401 there is a growing demand for data-driven medicine, both for clinical practice and clinical trials. GE Healthcare is utilizing its Edison platform to integrate data from diverse sources, such as electronic health records (EHR) and radiology information systems (RIS), imaging and other medical device data. This integrated data can be used to develop and deploy AI enabled solutions to help simplify oncology patient workflows, better understand increasingly complicated clinical patient data, and compare data from patient to patient.

SOPHiA GENETICS and GE Healthcare will be collaborating on opportunities in the healthcare market, including various initiatives and projects in the fields of digital oncology and radiogenomic analysis. The companies will initially work together on the creation of infrastructure to integrate data between GE’s Edison platform and the SOPHiA DDM platform, as well as co-marketing and pilot site recruitment across oncology and radiogenomics.

The companies will be deploying GE Healthcare’s extensive medical imaging and monitoring capabilities and Edison platform-enabled data aggregation with the SOPHiA DDM cloud-based software-as-a-service analytics genomic insights platform and related solutions, which are available in more than 750 hospitals, laboratories and biopharma companies.

The University of Cambridge, Cambridge University Hospitals and GE Healthcare have agreed to collaborate on developing an application aiming to improve cancer care, with Cambridge providing clinical expertise and data to support GE Healthcare’s development and evaluation of an AI-enhanced application that integrates cancer patient data from multiple sources into a single interface.

Building on research supported by The Mark Foundation for Cancer Research and Cancer Research UK, the collaboration aims to address the problems of fragmented or siloed data and disconnected patient information, which is challenging for clinicians to manage effectively and can prevent cancer patients receiving optimal treatment.

UK-based company Optellum is a leader in AI- decision support for the early diagnosis and optimal treatment of lung cancer. Together, the companies are seeking to address one of the largest challenges in the diagnosis of lung cancer, helping providers to determine the malignancy of a lung nodule: a suspicious lesion that may be benign or cancerous. The majority of incidentally detected pulmonary nodules present an indeterminate cancer risk, which are incredibly challenging for clinicians to diagnose and manage, leading to delayed treatment for cancer patients and invasive procedures on healthy people.

Optellum’s Virtual Nodule Clinic identifies and scores the probability of malignancy in a lung nodule, which is key to determining whether biopsy is necessary, and accelerating diagnosis. It is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer2, and has been shown to improve the sensitivity and specificity of malignancy assessments of indeterminate nodules 3 ­— enabling pulmonologists and radiologists to make optimal clinical decisions4.

On November 30, 2021 Iterative Scopes, a pioneer in the development of precision-based gastrointestinal disease technologies, reported that it has CE marked its SKOUT medical device under the MDD (Directive 93/42/EEC) after successfully completing the assessment of the conformity of the device with the applicable MDD requirements in April 2021 (Press release, Iterative Scopes, NOV 30, 2021, View Source [SID1234596289]).1 This milestone marked the product’s first regulatory certification and will enable its distribution and marketing in Europe, a key step in Iterative Scopes’ global expansion plans.

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SKOUT is an artificial intelligence (AI) driven medical device intended to detect potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance.2

Using AI-enabled advanced computer vision technology, SKOUT recognizes suspicious tissue and provides real-time feedback to gastroenterologists, that draws their attention to areas of interest. According to clinical studies performed by Iterative Scopes, SKOUT has been demonstrated to confer an increase in Adenomas Per Colonoscopy when compared to historical controls,3 which can potentially have a significant impact to a patient’s risk for colorectal cancer.4

"The CE Mark is the first step of many in Iterative Scopes’ go to market plans to apply AI in gastroenterology," said Dan Wang, VP of Operations at Iterative Scopes. "SKOUT is our first product and targets colorectal cancer prevention. In addition, Iterative Scopes has developed a deep bench of other AI products which we have the internal strength and rigor in the regulatory domain to bring to market."

The ability to offer SKOUT to European gastroenterologists continues Iterative Scopes’ rapid growth this year as the company pursues its vision of applying proprietary, cutting-edge AI and computer-vision technologies to improving endoscopy.

A $30 million Series A financing that closed in August 2021 included a roster of top-tier investors and is supporting the company’s near-term goals of building its talent base and attracting major drug developers and other stakeholders that are key to its holistic approach to transforming the GI space.

Iterative Scopes was founded in 2017 as a spin out of the Massachusetts Institute of Technology (MIT) by Jonathan Ng, MBBS a physician entrepreneur, who developed the company’s foundational concepts while he was at MIT and Harvard.