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

On December 9, 2020 Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, reported the presentation of updated Phase 3 PFS and OS data demonstrating clinical benefits in efficacy and tolerability of oral paclitaxel versus IVP in patients with metastatic breast cancer (MBC) (Press release, Athenex, DEC 9, 2020, View Source [SID1234573868]). The findings further support the superiority of increased ORR observed with oral paclitaxel. These data were presented today during a spotlight poster presentation at the 2020 San Antonio Breast Cancer Symposium (SABCS).

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"Having previously presented superior efficacy on overall response rate and favorable tolerability versus IV paclitaxel at SABCS 2019, it is gratifying to report that our pivotal Phase 3 trial continues to show sustained efficacy and manageable adverse events with oral paclitaxel and encequidar," said Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex. "The updated Phase 3 PFS and OS data further support the clinical rationale for oral paclitaxel as an efficacious and tolerable treatment option for people living with metastatic breast cancer."

The spotlight poster presentation at SABCS featured an update on PFS and OS data from the Phase 3 trial. In the prespecified modified intent-to-treat (mITT) population (n = 360), the median PFS data showed a benefit for oral paclitaxel versus IVP (8.4 vs. 7.4 months, respectively; hazard ratio [HR] = 0.739; 95% confidence interval [CI]: 0.561, 0.974; p = 0.023). Median OS data also showed a benefit for oral paclitaxel versus IVP (23.3 months vs. 16.3 months, respectively; HR = 0.735; 95% CI: 0.556, 0.972; p = 0.026).

In the intent-to-treat (ITT) population, which included all 402 randomized patients, the median PFS showed a benefit for oral paclitaxel versus IVP (8.4 months vs. 7.4 months, respectively; HR = 0.768; 95% CI: 0.584, 1.01; p = 0.046). The median OS data demonstrated a trend favoring oral paclitaxel versus IVP (22.7 months vs. 16.5 months, respectively; HR = 0.794; 95% CI: 0.607, 1.037; p = 0.082).

Updated safety analyses of up to 112 weeks continue to demonstrate the reduction in incidence and severity of neuropathy favoring oral paclitaxel versus IVP: all grades of neuropathy were 22% vs. 64%, and grade 3 neuropathy was 2% vs. 15%.

Also presented were data on the effect of prophylactic treatments on the incidence and severity of gastrointestinal-related adverse events. After approximately 30% of patients were enrolled, the Phase 3 trial protocol was amended to allow patients randomized to the oral paclitaxel arm to receive prophylactic pre-medications for gastrointestinal side effects. Overall gastrointestinal (GI)-related adverse events (AEs) were less frequent in the IV paclitaxel arm. GI-related AEs improved in the oral paclitaxel arm following the amendment, as measured by lower incidences of grade 2 vomiting before and after amendment (24% vs. 7%) and grade 2 diarrhea before and after amendment (27% vs. 16%).

"The oral paclitaxel regimen appears to overcome some of the limitations of IV therapy, particularly in terms of reducing the risk of neuropathy," commented lead investigator Gerardo Antonio Umanzor Fúnez, M.D., a medical oncologist at Centro Oncologico Integral, working with DEMEDICA of San Pedro Sula, Honduras. "The lessened burden of neuropathy, the ability to manage GI side effects with prophylactic treatments, and the convenience of home-based administration, could be transformational in the treatment of metastatic breast cancer, especially in the current environment."

Oral paclitaxel has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic breast cancer with a PDUFA date of February 28, 2021.

About the Phase 3 Oral Paclitaxel and Encequidar Clinical Trial
The Phase 3 trial randomized 402 patients with any metastatic breast cancer subtypes in a 2:1 ratio to receive either the oral paclitaxel regimen (205 mg/m2 of oral paclitaxel plus 15 mg of encequidar) for three days a week or the approved IV paclitaxel regimen (175 mg/m2) as a three-hour infusion every three weeks. The primary efficacy endpoint was overall response rate (ORR) confirmed at two consecutive timepoints by a blinded, independent radiology review that used RECIST v1.1 criteria to evaluate patients’ tumors for response. The trial was designed to demonstrate superiority of oral paclitaxel over IVP on the primary end point of ORR. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). The trial was not powered to demonstrate superiority of oral paclitaxel versus IVP on the secondary survival endpoints of PFS and OS. These secondary endpoints were not controlled for multiplicity. P-values presented are nominal.

About Oral Paclitaxel
Athenex’s oral paclitaxel and encequidar ("oral paclitaxel") is the first oral formulation of paclitaxel in late-stage development for the treatment of metastatic breast cancer (MBC), and is also in earlier stages of development for other malignancies. Encequidar, the cornerstone of Athenex’s Orascovery technology platform, is a highly specific and potent inhibitor of the transport protein called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By localizing P-gp inhibitory activity in the GI tract, encequidar improves the absorption of chemotherapeutic agents while limiting the potential for unnecessary P-gp inhibition at other sites in the body. The potency, selectivity, and low absorption of encequidar enables the oral administration of IV chemotherapies, several of which are under development by Athenex.