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.

On December 9, 2020 Qu Biologics Inc., a private clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, reported an oversubscribed $8 million financing (Press release, Qu Biologics, DEC 9, 2020, View Source [SID1234574979]). With the proceeds, Qu Biologics will complete stage 1 of the RESTORE Phase 2 clinical trial for patients with moderate to severe Crohn’s disease and its Phase 2 Study to assess activation of anti-cancer immune response in colon cancer.

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"We are pleased to have oversubscribed our bridge round based on the promising interim data from our RESTORE trial and we are looking forward to the important full data from our two studies, which will both complete in the first half of 2021", said Hal Gunn, MD, CEO of Qu. "Our first-in-paradigm platform is designed to safely achieve immune balance and healing by restoring multiple important immune functions simultaneously – we are excited about our unique and novel treatment’s transformational potential in preventing and treating cancer and chronic disease."

Qu Biologics will use the funds raised to expand its team and capacity and progress its proprietary immunotherapy platform.

On December 9, 2020 BriaCell Therapeutics Corp. ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported the presentation results of the clinical studies with its lead product candidate, Bria-IMT, summarized in a poster session held on December 9 – 11 during the 2020 San Antonio Breast Cancer Symposium (SABCS) (Press release, BriaCell Therapeutics, DEC 9, 2020, View Source [SID1234574780]).

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The poster summarizes the clinical and pathological data of the Bria-IMT monotherapy (i.e. the Bria-IMT regimen alone) study and Phase I/IIa clinical study of Bria-IMT in combination with immune checkpoint inhibitors including pembrolizumab (KEYTRUDA; manufactured by Merck & Co., Inc.), and more recently, Incyte’s INCMGA00012 (by Incyte Corporation), in advanced breast cancer.

Details and results on the poster presentation are summarized below:

Abstract Number: 1313
Presentation Title: Response to a modified whole tumor cell targeted immunotherapy in patients with advanced breast cancer correlates with tumor grade
Session Date: December 9-11, 2020
Program Number: PS17-20
Session Title: Poster Session 17
Summarized Data: 30 patients were treated with the Bria-IMT regimen (19 with the Bria-IMT regimen alone, 4 who began on the Bria-IMT regimen and transitioned to combination with a combination with Incyte’s INCMGA00012, and 7 with combination therapy with of Bria-IMT with KEYTRUDA).

11 of those patients had moderately-well differentiated tumors:

• 70% of these patients who were able to develop an immune response showed disease control suggesting that the Bria-IMT, with a molecular signature most closely related to moderately-well differentiated tumors, may result in disease control especially in patients with moderately-well differentiated tumors. These patients were very heavily pre-treated with a median of 7 prior systemic therapy regimens (including chemotherapy, biological and "targeted" therapy). The median Progression-free survival (PFS) of this cohort was 5.7 months in the monotherapy study, and 6.9 months in combination therapy. Of the group, there were 9 patients with evaluable lesions including 6 with stable disease and 2 with partial responses according to RECIST criteria. One patient with stable disease had a marked reduction in numerous non-target lesions. The data suggests clinical and survival benefit for patients with moderately-well differentiated tumors who were treated with the Bria-IMT regimen with or without check point inhibitors. Notably, the survival benefit was higher in the group that received the Bria-IMT regimen with check point inhibitors suggesting an additive or synergistic effect.

• The median overall survival (OS) for the combined monotherapy and combination therapy was 12.5 months (data on 6 patients with moderately-well differentiated tumors). An OS of 7.2-9.8 months in similar patients with metastatic breast cancer in the third line setting has recently been published (Kazmi S, et al. "Overall survival analysis in patients with metastatic breast cancer and liver or lung metastases treated with eribulin, gemcitabine, or capecitabine." Breast Cancer Res Treat. 2020). This suggests a potentially significant survival benefit for the patients treated with the Bria-IMT regimen alone or in combination with check point inhibitors.

In summary, BriaCell observed tumor reduction and clinical benefit in heavily pre-treated advanced breast cancer patients, especially in those with moderately-well differentiated tumors, treated with the Bria-IMT regimen with or without immune checkpoint inhibitors. The addition of immune checkpoint inhibitors to the Bria-IMT regimen appeared to provide an additional clinical benefit suggesting an additive or synergistic effect.

A copy of the poster will be posted at the following: View Source