On December 10, 2020 Targovax ASA, reported that Øystein Soug, CEO of Targovax, will present the company at DNB’s 11th Annual Nordic Healthcare Conference, Tuesday 15 December (Press release, Targovax, DEC 10, 2020, View Source [SID1234572583]).

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DNB’s 11th Annual Nordic Healthcare Conference
Date: 15 December 2020
Presenter: Øystein Soug, CEO
Presentation time: 12:30 CET
The presentation will be available to download at www.targovax.com after the event.

On December 10, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported an exploratory analysis from the Phase III IMvigor010 study evaluating Tecentriq (atezolizumab), compared with observation, as an adjuvant (after surgery) monotherapy treatment for people with muscle-invasive urothelial cancer (MIUC) at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Virtual Congress, 9–12 December 2020 (Press release, Hoffmann-La Roche, DEC 10, 2020, View Source [SID1234572580]).

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Data from IMvigor010 show that in people with circulating tumour DNA (ctDNA), a benefit in disease-free survival (DFS) was seen in those receiving Tecentriq when compared with observation (median 5.9 months versus median 4.4 months, hazard ratio [HR]=0.58; 95% CI: 0.43–0.79). Overall survival (OS) at an interim analysis also favoured treatment with Tecentriq in the ctDNA-positive population, with a median of 25.8 months with Tecentriq, compared with 15.8 months for observation (HR=0.59; 95% CI: 0.41–0.86). Although these pre-specified analyses are exploratory and could not be formally tested per the statistical plan in the IMvigor010 study, the data further our understanding of the disease and will inform a new Phase III study in people with ctDNA-positive muscle-invasive bladder cancer.

"Bladder cancer is a complex and often difficult disease to treat, but as we continue to understand its biology, we are gaining greater clarity around new therapeutic avenues," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "By using ctDNA and other biomarkers, we hope to gain insights that enable a more personalised approach to treatment. We are applying these findings to our clinical development programme."

As presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 (ASCO20) Virtual Congress, IMvigor010 did not meet its primary endpoint of DFS compared with observation in people with high-risk MIUC in the intention-to-treat population (19.4 months with Tecentriq versus 16.6 months with observation [HR=0.89; 95% CI: 0.74–1.08; p=0.2446]). In an interim analysis of OS, the median was not reached in either treatment arm (HR=0.85). Safety data for Tecentriq were consistent with the known monotherapy safety profile, and no new safety concerns were identified.

The goal of current treatment in people with MIUC is to provide early intervention to reduce the risk of the disease recurring or spreading to other parts of the body. As tumours grow, dying cells are replaced by new ones, releasing tumour DNA into the bloodstream. This DNA, known as ctDNA, can be utilised in different ways, including identifying people with minimal residual disease who may benefit the most from adjuvant therapy as well as those for whom adjuvant therapy may not provide benefit. In MIUC, ctDNA is a strong prognostic marker of disease recurrence.1 More treatment options following surgery are needed because approximately half of people with MIUC will develop a recurrence of their disease within 2 years of surgery,2 and with no predictive or prognostic biomarkers used in current clinical practice for MIUC,1,3 there is a need for more personalised treatments for this disease.1

Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across several types of lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

These data were presented at the ESMO (Free ESMO Whitepaper) IO Virtual Congress in the Proffered paper oral session on 10 December 2020, 13:50-14:02 CET.

About the IMvigor010 study
IMvigor010 is a global Phase III, open-label, randomised, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared with observation in 809 people with MIUC, who are at high risk of recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomisation to invasive urothelial cancer recurrence or death.

Key efficacy results from the exploratory analysis are below:

ctDNA-positive population
(n=214, 37% of biomarker evaluable population, n=581)
Tecentriq (n=116) Observation (n=98)
Median DFS (months)
(95% CI) 5.9
(5.6–11.2) 4.4
(2.9–5.6)
DFS, HR
(95% CI) 0.58
(0.43–0.79)
p=0.0005
Median OS at interim analysis (months) 25.8
(20.5–NR) 15.8
(10.5–19.7)
OS, HR
(95% CI) 0.59
(0.41–0.86)
p=0.0059
ctDNA-negative population
(n=367, 63% of biomarker evaluable population, n=581)
DFS, HR
(95% CI) 1.14
(0.81–1.62)
p=0.45
OS at interim analysis, HR
(95% CI) 1.31
(0.77–2.23)
p=0.32
ctDNA-positive and PD-L1-positive population
(n=102)
DFS, HR
(95% CI) 0.52
(0.33–0.82)
ctDNA-positive and TMB-high population
(n=69)
DFS, HR
(95% CI) 0.34
(0.19–0.60)
Note: p-values from exploratory analyses are provided for descriptive purposes. NR=not reached. TMB=tumour-mutational burden.

About bladder cancer and muscle-invasive urothelial cancer
In 2018, there were over half a million new cases of bladder cancer diagnosed globally, with approximately 200,000 deaths from the disease.4 Urothelial cancer is the most common type of bladder cancer, accounting for about 90–95% of all cases.5 MIUC is a type of urothelial cancer that has spread into the muscle of the bladder, ureter or renal pelvis.6 Approximately 25% of new cases of bladder cancer are diagnosed with muscle-invasive disease,7 which is associated with a poorer prognosis than non-MIUC.6

Roche will run a new Phase III study in people with ctDNA-positive muscle-invasive bladder cancer. More information is available here.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell lung cancer, small cell lung cancer, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies. To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link:
View Source

On December 10, 2020 AstraZeneca and Daiichi Sankyo Company reported that Updated results from the positive DESTINY-Breast01 Phase II trial showed (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) continued to demonstrate impressive efficacy and durable responses in patients with HER2-positive metastatic breast cancer following two or more prior HER2-based regimens (Press release, AstraZeneca, DEC 10, 2020, View Source [SID1234572577]).

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The updated data were presented in a Spotlight Poster Discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS).

With a median duration of follow-up of 20.5 months, patients treated with Enhertu (5.4 mg/kg) achieved an objective response rate (ORR) of 61.4% and a median duration of response (DoR) of 20.8 months. The median progression-free survival (PFS) was 19.4 months. In an exploratory landmark analysis of overall survival (OS), evaluated at 35% maturity, an estimated 74% of patients remained alive at 18 months.
In the previous analysis at 11.1 months of follow-up, an ORR of 60.9% was seen with a median DoR of 14.8 months and median PFS of 16.4 months. Additional trials are ongoing to confirm the results seen in DESTINY-Breast01.
Approximately one in five patients with breast cancer are considered HER2 positive, which is associated with aggressive disease, high recurrence rate, and increased mortality.1,2
Shanu Modi, MD, Breast Medical Oncologist, Memorial Sloan Kettering Cancer Center and principal investigator in the DESTINY-Breast01 trial, said: "These longer-term data from the DESTINY-Breast01 trial further highlight the role that this treatment option may have in changing clinical outcomes for patients with previously treated HER2-positive metastatic breast cancer. It is important that we are able to offer patients therapy like this which provides a meaningful clinical benefit, as historically there have been few therapies that were able to do that in this patient population."
José Baselga, Executive Vice President, Oncology R&D, said: "These results reinforce the transformational potential of Enhertu in patients with previously treated HER2-positive metastatic breast cancer. With a median duration of response of greater than twenty months, the updated results of DESTINY-Breast01 are unprecedented. We look forward to further confirming the DESTINY-Breast01 findings with results from our Phase III development programme for Enhertu."
Antoine Yver, Executive Vice President and Global Head, Oncology R&D, Daiichi Sankyo, said: "The updated findings illustrate the practice-changing potential for Enhertu to become a long-term treatment option for patients with previously treated HER2-positive metastatic breast cancer. The duration of response and long-term safety profile further validate that our proprietary DXd antibody drug conjugate technology delivers effective and durable treatment."

Summary of updated efficacy results from DESTINY-Breast01

Summary of updated efficacy results from DESTINY-Breast01
i Data from the 1 August 2019 cut-off were presented at the 2019 SABCS and published in The New England Journal of Medicine
ii As of data cut-off, 20.1% of patients remained on treatment with Enhertu
iii ICR, independent central review
iv CI, confidence interval
v NE, not estimable
vi 114 patients (62.0%) were censored at time of analysis
vii OS was estimated at 35% maturity, with 119 patients (64.7%) censored and only 17 patients at risk at 24 months; additional follow-up is required for more mature OS data
The overall safety and tolerability profiles of Enhertu were consistent with what has been previously reported, with few additional treatment discontinuations due to adverse events with longer treatment duration. In the updated analysis, 18.5% of patients discontinued treatment due to adverse events compared to 15.2% in the previous analysis. Most cases of interstitial lung disease (ILD) or pneumonitis occurred during the first 12 months of treatment and the results suggest the risk of developing ILD or pneumonitis toxicity is not related to cumulative treatment with Enhertu. There were three new cases of treatment-related ILD reported, as determined by an independent adjudication committee, including one Grade 1, one Grade 2 and one death (Grade 5). Two potential cases were pending adjudication at data cut-off. Continued attention to monitoring to identify pulmonary symptoms and ensure early intervention is warranted.
Enhertu was approved in the US and Japan for the treatment of HER2-positive, unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens in the metastatic setting based on the earlier results from the DESTINY-Breast01 trial. In the US, Enhertu was approved under FDA Accelerated Approval and confirmatory trials are underway.
Several ongoing randomised Phase III trials are further testing Enhertu in patients with HER2-expressing metastatic breast cancer. These include DESTINY-Breast02, which is evaluating Enhertu as a 3rd-line treatment for patients with HER2-positive metastatic breast cancer and DESTINY-Breast03, which is testing Enhertu as a 2nd-line treatment for these patients. DESTINY-Breast04 is investigating Enhertu in patients with metastatic breast cancer and low expression of HER2.
HER2-positive breast cancer
In women, breast cancer is the most common cancer and one of the most common causes of cancer mortality worldwide; there were an estimated 2.1 million new cases of female breast cancer diagnosed in 2018.3,4 Breast cancer occurs mainly in women, but in rare cases it occurs in men too.5

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including gastric, breast and lung cancers. HER2 overexpression is associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poorer prognosis.6 Approximately one in five patients with breast cancer are considered HER2 positive.2

DESTINY-Breast01
DESTINY-Breast01 is a pivotal Phase II, single-arm, open-label, global, multicentre, two-part trial evaluating the safety and efficacy of Enhertu in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine. The primary endpoint of the trial is ORR, as determined by ICR. Secondary objectives include DoR, disease control rate, clinical benefit rate, PFS and OS.

Enhertu

Enhertu is a HER2-directed antibody drug conjugate (ADC). Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform.

ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (‘payload’) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Enhertu is comprised of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker.
Enhertu (5.4mg/kg) is approved in the US and Japan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting based on the DESTINY-Breast01 trial. Enhertu (6.4mg/kg) is approved in Japan for patients with HER2-positive unresectable advanced or recurrent gastric cancer that progressed after chemotherapy.
Enhertu clinical development

A comprehensive development program is underway globally, with nine registrational trials evaluating the efficacy and safety of trastuzumab deruxtecan monotherapy across multiple HER2 cancers, including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

In October 2020, Enhertu was granted Priority Review from the US Food and Drug Administration for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. In May 2020, Enhertu received a Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) for gastric cancer, including GEJ adenocarcinoma.

In July 2020, The European Medicines Agency’s Committee for Medicinal Products for Human Use granted accelerated assessment for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens.
In May 2020, Enhertu also received a BTD for the treatment of patients with metastatic non-small cell lung cancer whose tumours have a HER2 mutation and with disease progression on or after platinum-based therapy.
Collaboration between AstraZeneca and Daiichi Sankyo
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise trastuzumab deruxtecan (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation SERD and potential new medicine AZD9833. PARP inhibitor, Lynparza (olaparib) is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease state. Building on the first approval of Enhertu, a HER2-directed antibody-drug conjugate, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy durvalumab in combination with other oncology medicines, including Lynparza and Enhertu, investigating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan (DS-1062).
AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of six scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response, Antibody Drug Conjugates, Epigenetics, and Cell Therapies – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

On December 9, 2020 Grand Pharmaceutical and Healthcare Holdings Limited reported that Group’s associate Sirtex Medical US Holding, Inc. ("Sirtex") has entered into several transactions and strategic cooperation with two U.S. based innovative companies Nanospectra Biosciences, Inc. and BlackSwan Vascular, Inc. respectively with an aim to enrich the Group’s highly innovative and high-barrier pipeline, and therefore will acquire certain shares of the two investees and carry out cooperation on related products, which helps to expand Sirtex’s and the Group’s strategic planning in the field of precision interventional diagnostics and treatment (Press release, Grand Pharmaceutical, DEC 9, 2020, View Source [SID1234653968]).

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Precision interventional diagnostics and treatment is one of the Group’s focus areas in strategic planning, which can be further divided into three sub-fields: precision anti-tumor intervention, precision vascular intervention and precision neurointervention. In the field of precision anti-tumor intervention, Sirtex, plus OncoSec Medical Incorporated (NASDAQ: ONCS), another associate of the Group in the US specializing in anti-tumor intervention and DNA immunotherapy, are both important associates and international research and development ("R&D") and production platforms of the Group. The Group together with Sirtex owns or has access to six world-class innovative products for treatment of five solid tumors including colorectal cancer, prostate cancer, melanoma, triple negative breast cancer and squamous cell carcinoma in this field.

1) Subscribe Shares of Nanospectra and Entered into Cooperation Agreement

Sirtex entered into a strategic investment arrangement (the "Nanospectra Agreement") with Nanospectra, pursuant to which Sirtex has made US$1.5 million equity investment for approximately 6% of first round series B-1 preferred shares in Nanospectra. In addition, Sirtex can appoint a member in the board of director of Nanospectra, and has a limited duration exclusive right to negotiate for access to Nanospectra’s world-class innovative product AuroLase in regions outside the U.S. Sirtex also has the exclusive right of first negotiation should Nanospectra seek to transfer a controlling interest in the future. In the event of declaration of dividend (subject to the conditions stated in the articles of Nanospectra) or liquidation, Sirtex, along with holders of other Preferred series B-1 shares will carry a dividend or entitle to the assets respectively in preference to the holders of other classes of shares. The preferred series B-1 shares also carry the same voting rights as other classes of shares of Nanospectra.

Based in Houston, Texas, Nanospectra is an innovative medical device company, of which the lead product AuroLase was initially developed by a team composed of scientists led by Professor Naomi Halas, a member of the National Academy of Sciences and the National Academy of Engineering and Jennifer West, also a member of the National Academy of Engineering. Nanospectra launched a pivotal trial in prostate tissue ablation in the first quarter of this year. Professor Naomi Halas is the founding director of the Laboratory for Nanophotonics at Rice University and Director of the Smalley-Curl Institute. As one of the pioneering researchers in the field of plasmonics, Professor Naomi Halas created the concept of the "tunable plasmon" and invented a family of nanoparticles with the applications in biomedicine, optoelectronics, chemical sensing, photocatalysis, and most recently in solar energy. In conjunction with Professor West, they co-founded Nanospectra to advance the clinical development of targeted photothermal treatment of soft tissue using nanoparticles.

AuroLase, Nanospectra’s innovative medical device, for the ablation of solid tumors, utilizes the unique "optical tunability" of a new class of nanoparticles. AuroLase for prostate tissue ablation is expected to the world’s first and only ultra-focal tissue ablation therapy. Compared with surgery, radiotherapy or alternative focal therapy approaches, AuroLase therapy can maximize treatment effectiveness while minimize side effects typically associated with surgery, radiation, and alternative focal therapies. The AuroLase project for the treatment of prostate cancer tissue ablation is conducting a multi-site pivotal clinical trial in the US, with clinical safety and effectiveness among patients being demonstrated preliminarily. It is expected to become the first marketed innovative product in the field of ultra-focal thermal ablation to treat prostate cancer tissue ablation. AuroLase technology is highly scalable and is expected to be applied to various solid tumors such as thyroid cancer and breast cancer.

2) Purchase Certain Shares of BlackSwan and Obtain the Rights of Full Acquisition

Sirtex and BlackSwan have entered into a shares purchase agreement. Under the agreement, Sirtex will invest US$5 million in exchange for approximately 12.5% preferred shares in BlackSwan and Sirtex will appoint an observer member to the board of directors. In addition, Sirtex has an option to purchase the remaining shares of BlackSwan at a consideration of no more than US$41.5 million in aggregate, within a certain period of time upon the submission of pre-market approval ("PMA") application of BlackSwan’s products.

BlackSwan’s core product LavaTM is a global leading innovative medical device in the field of precision vascular intervention, and is indicated for peripheral vascular applications. LavaTM has radiopacity with low imaging artifact. Its rapid mixing leads to a short 3 minutes preparation time, increasing its ease of use and enabling emergent procedures to improve patients’ chances of survival.

In the future, it also has the potential to expand into other indications in anti-tumor field in combination with SIR-Spheres Y-90. The potential of radiolabeling LavaTM with radioisotopes creates synergies for additional brachytherapy and interventional therapies for Y-90 and other radioisotopes. LavaTM received an investigational device exemption ("IDE") approval from the United States Food and Drug Administration ("FDA") in September this year, and it has the potential to become the first liquid embolic approved for commercialization in the US for peripheral vascular applications.

KonaTM, BlackSwan’s second liquid embolic product candidate, has a target indication for neurovascular applications. It has potential to become drug loadable with chemotherapeutics or radioisotopes for controlled drug delivery in multiple treatment, providing the ability to compete with particle-based transcatheter arterial chemoembolization ("TACE"), ablation and brachytherapy combined with surgery. In addition, KonaTM also has the potential to be used in combination with SIR-Spheres Y-90 and chemical drugs.

The Board of China Grand Pharmaceutical and Healthcare Holdings Limited, commented: "Sirtex’s cooperation with Nanospectra and BlackSwan and acquiring multiple world-class high-tech innovative products have expanded its product portfolio in oncology and precise intervention and enhanced its connection to research and development capabilities in tumor treatment and precision interventional diagnostics and treatment, strengthened its core competitiveness and propelled the Group’s technological innovation and global planning process."

"Sticking to patients-centered and innovation-driven, the Group has increased its investment in the world-class innovative products and advanced technologies to meet unmet clinical needs in recent year. After years of development, the Group has built its global ‘precision diagnostics + treatment’ strategic platform integrating ‘oncological, vascular, and neurological’. It also becomes a rare innovative global pharmaceutical company that exhibits rapid development with interventional products covering ‘oncological, vascular, and neurological’ in China. The Group will continue to develop world-class innovative products and advanced technologies in the field of precision interventional diagnostics and treatment, striving to build a leading ‘paninterventional diagnostic and therapeutic platform’ in China as well as the world."

"With the continuous expansion of global innovative product portfolio, the Group’s technological advancements have shown their effects. Multiple progresses have demonstrated the Group’s hardcore advantages, which is, in the first step stable operations laying a solid foundation of capital and resource for global expansion. Then in turn the innovative products with high barriers and high added value which are developed by the Group’s multiple global R&D centers generate momentum for future business growth once these products are launched to the market. Meanwhile, through adopting the strategy of ‘global expansion and dual-cycle operation’, the Group has gradually formed a new pattern of domestic and international cycles that synergize with each other. With synergistic effects from multiple global R&D centers, the Group will provide patients with more advanced and diverse treatment options in the world.

On December 9, 2020 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 16,666,667 shares of common stock of the Company, at a price to the public of $4.50 per share, less underwriting discounts and commissions (Press release, Oncternal Therapeutics, DEC 9, 2020, View Source [SID1234576290]). The closing of the offering is expected to occur on or about December 14, 2020, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to an additional 2,495,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds to Oncternal, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional common stock, are expected to be approximately $75.0 million. The Company intends to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical and preclinical development of cirmtuzumab and TK216, preclinical development of its ROR1 CAR-T program, and for working capital.

The shares of common stock are being offered by Oncternal pursuant to a "shelf" registration statement on Form S-3 (File No. 333-222268) previously filed with the Securities and Exchange Commission (the "SEC") on December 22, 2017 and declared effective by the SEC on January 5, 2018. The offering of the shares of common stock is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the shares of common stock being offered has been filed with the SEC and is available on the SEC’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A final prospectus supplement and the accompanying prospectus relating to the shares of common stock being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities 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.