On February 10, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported that, following shareholder approval, the proposed strategic investment by and partnership (the "CGP/Sirtex Transaction") with Grand Decade Developments Limited, a wholly owned subsidiary of China Grand Pharmaceutical and Healthcare Holdings Limited ("CGP"), and its U.S. affiliate, Sirtex Medical US Holdings, Inc. ("Sirtex") has closed (Press release, OncoSec Medical, FEB 10, 2020, View Source [SID1234554102]).

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The CGP/Sirtex Transaction brings significant benefits to OncoSec, including:

Immediate Capital
An immediate $30 million cash infusion at $2.50 per share, an approximate 25% premium to the average share price over the 20 days prior to the signing of the deal on October 9, 2019. The capital received today will significantly help fund OncoSec’s ongoing KEYNOTE clinical trials of its lead product candidate, TAVO (plasmid-based interleukin-12), in combination with Merck’s KEYTRUDA to completion.
CGP Partnership Provides Access to Chinese Market
China is the second largest market in the world after the U.S., but historically has been challenging for U.S. biopharma companies to enter due to regulatory barriers.
As a public company listed on the Hong Kong stock exchange (with a market capitalization of approximately $1.8 billion), CGP is an active and established pharmaceutical leader in China. CGP currently develops, manufactures and distributes its products in China to approximately 6,000 hospitals and 30,000 pharmacies and has a sales team of more than 2,000 employees. It also has significant experience dealing with regulatory bodies, research and development and product commercialization in China.
OncoSec plans to leverage its strategic alliance with CGP to develop and introduce TAVO to the important Chinese market. Under the license agreement with CGP, OncoSec has granted an exclusive license to develop, manufacture and commercialize OncoSec’s current and future products in greater China and other Asian markets. CGP will pay for all development costs and will also pay OncoSec up to 20% royalties on the net sales of such products in the region, less development costs.
Sirtex Partnership Provides Access to Top-Notch Commercial Talent and Resources
Sirtex will support and assist OncoSec with pre-marketing activities for TAVO and its visceral lesion applicator (VLA) in exchange for low single-digit royalties on those products.
Sirtex is a global life-sciences company that has an approved medical device product for targeted radiation therapy for liver cancer. They have a highly experienced and dedicated oncology sales force and have supplied product to more than 1,300 medical centers in more than 45 countries.
"At a time when our peer companies are engaging in highly dilutive financings that often include discounts and the issuance of warrants, we are grateful that OncoSec’s progress to date enabled us to secure a premium investment by two first-rate healthcare companies," said Daniel J. O’Connor, President and Chief Executive Officer of OncoSec. "The license granted to CGP in greater China has significant value to OncoSec shareholders because it enables us to access the greater China market decades earlier than we ever would have been able to and with CGP bearing the development and commercialization costs. We will also now have the ability to access China for clinical data. Likewise, the services agreement with Sirtex is also very valuable for OncoSec as Sirtex, a company with significant sales and marketing capabilities, will conduct the requisite sales and marketing preparatory activities, which needs to begin now in order to be prepared to launch TAVO, should it gain regulatory approval. Both of these agreements bring significant economic value to our shareholders and we are excited to begin our partnership with CGP and Sirtex."

About CGP

CGP is a public company listed on the Hong Kong stock exchange with a market capitalization of approximately $2.1 billion USD. CGP develops, manufactures and distributes pharmaceutical products and medical devices to retailers and medical organizations. CGP currently distributes its products to approximately 6,000 hospitals and approximately 30,000 pharmacies and has a sales team of more than 2,000 employees. CGP also has significant experience in R&D and product commercialization in China. Such experience dealing with the relevant Chinese regulatory bodies makes CGP an ideal strategic partner for OncoSec as it looks to gain regulatory approval to introduce TAVO to the Chinese market. For more information, visit www.chinagrandpharm.com.

About Sirtex

Sirtex is a global healthcare business company with offices in the U.S., Australia, Europe and Asia, working to improve outcomes in people with cancer. Sirtex’s current lead product is a targeted radiation therapy for liver cancer called SIR-Spheres Y-90 resin microspheres. More than 100,000 doses have been supplied to treat patients with liver cancer at more than 1,300 medical centers in over 45 countries. Sirtex’s global focus on drug development makes it a natural partner for the Company as it looks to develop and introduce TAVO into markets around the world. For more information, visit www.sirtex.com. SIR-Spheres is a registered trademark of Sirtex SIR-Spheres Pty Ltd.

On February 10, 2020 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2019 (Press release, Cel-Sci, FEB 10, 2020, View Source [SID1234554101]).

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In October 2019, the Independent Data Monitoring Committee (IDMC) for the Company’s pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) performed an official review of the study data and recommended that the trial continue until the appropriate number of events has occurred. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. The IDMC reviewed "progression free and overall survival and limited demographic and safety data available for the aforementioned protocol."
The Company is now awaiting final study results for the Phase 3 trial, which is the largest study in the world in head and neck cancer. All that remains to be done is to continue to track patient survival until the required number of events have occurred and all of the data have been reviewed and recorded in the study database to allow a determination to be made if the primary endpoint has been met. The primary endpoint of the study is a 10% improvement in overall survival of the Multikine treatment regimen plus standard of care (SOC) vs. SOC alone, the two main comparator arms of the study.
"Our study has now been running for 9 years with the last patients being enrolled in September 2016. We believe that the delay in reaching 298 events is a good sign for the study because patients appear to be living longer than was expected when the study was planned. However, we would be surprised if the study did not end soon. Since the study is well controlled and the SEER data base shows no improvement in the survival of patients treated with standard of care since the study began, it seems illogical that the patients living longer than expected would be patients receiving the standard of care therapies only. We are therefore preparing for commercial scale production of Multikine at our manufacturing facility," stated CEL-SCI CEO, Geert Kersten.

In December 2019, the Company raised gross proceeds of approximately $5.5 million through an underwritten public offering of 606,395 shares of its common stock at a price of $9.07 per share. In January 2020, the underwriters fully exercised the over-allotment option of an additional 90,959 shares of common stock at a price of $9.07 per share bringing the total gross proceeds to approximately $6.325 million.

CEL-SCI reported a net loss of approximately $5.5 million for the quarter ended December 31, 2019 versus net income of approximately $1.2 million for the quarter ended December 31, 2018. The net income decrease was mainly due to the non-cash derivative gain of approximately $0.8 million for the three months ended December 31, 2019 versus a gain on derivative instruments of approximately $5.6 million for the three months ended December 31, 2018. Net interest expense also decreased by approximately $0.2 million for the three months ended December 31, 2019 compared to the three months ended December 31, 2018.

CEL-SCI’s total operating expense increased by approximately $1.6 million for the quarter ended December 31, 2019 versus the quarter ended December 31, 2018. General and administrative expenses increased by approximately $0.9 million compared to the three months ended December 31, 2018. Approximately $0.7 million of the change relates to an increase in the non-cash employee stock compensation expense. Research and development expenses increased by approximately $0.7 million compared to the three months ended December 31, 2018. Major components of this increase include approximately $0.7 million of cost incurred preparing the manufacturing facility for the potential commercial manufacture of Multikine, $0.5 million increase in non-cash employee stock option expense and $0.2 million increase in depreciation expense on the manufacturing facility as a result of adopting the new leasing standard. These increases were offset by a decrease of approximately $0.7 million in expenses related to the Company’s on-going Phase 3 clinical trial.

On February 10, 2020 Gibson Oncology, LLC ("Gibson"), a privately held clinical stage company, obtained world-wide,reported an exclusive commercial rights to a novel series of 56 rationally designed compounds called Azaindenoisoquinolines ("Aza Compounds"), from Purdue University and the National Cancer Institute (Press release, Gibson Oncology, FEB 10, 2020, View Source [SID1234554100]). These Aza Compounds have proven to be dual inhibitors of cMyc and topoisomerase I (TOP1).

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Previous attempts over decades to target cMyc, a major oncogene involved in driving 80% of all tumors, have failed because of the peculiar characteristics of the shallow binding pockets on the cMyc protein, which created the reputation of being an "undruggable" target. Gibson’s novel Aza Compounds were rationally designed to avoid this issue through a novel mechanism of action (MOA) involving the stabilization of the G-quadruplex in the cMyc promoter, resulting in inhibition of transcription of the cMyc gene and thus inhibition of production of the Myc protein. In addition, these Aza Compounds are also potent TOP1 inhibitors, which synergizes with their G-quadruplex stabilizing activity and further enhances their anti-cancer abilities.

Gibson has already signed contracts to produce clinical candidates suitable for an IND.

Dual targeting of cMyc and TOP1 may serve as a novel and highly effective anticancer strategy across a spectrum of cancers. New intellectual property on composition of matter and method of use claims cover such novel compounds to at least 2037.

Randall Riggs, the CEO of Gibson Oncology, LLC, said that "We are excited about the Aza Compounds because scientific literature reports that 80% of all tumors are driven by cMyc. Developing a cMyc inhibitor has been long sought and offers a potential breakthrough therapeutic for many cancers."

On February 10, 2020 Aptorum Group Limited (Nasdaq: APM) ("Aptorum Group"), a biopharmaceutical company focused on the development of novel therapeutics to address global unmet medical needs, reported positive data and development in relation to its repurposed drug candidate, SACT-1, for the treatment of neuroblastoma, a rare type of childhood cancer that develops in infants and young children (Press release, Aptorum, FEB 10, 2020, View Source [SID1234554099]). Subject to completion of current validation studies, Aptorum Group plans to leverage the 505(b)(2) pathway and submit an IND submission with the FDA for SACT-1 in H2 2020.1

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SACT-1 is the first repurposed drug candidate to be developed under the Smart-ACTTM drug discovery platform, which employs a systematic approach to identify, repurpose and develop existing approved drugs against a currently identified universe of 7000+ (and increasing) orphan diseases.2

Through this platform, Aptorum Group intends to accelerate and fast track repurposed drug candidates, which usually have well established human safety and toxicity profiles and data, through the development and clinical phases in order to address the rapidly growing market of orphan diseases. Aptorum Group aims to screen a number of orphan disease areas including, but not limited to, oncology, autoimmune, metabolic and genetic diseases.

Through the Smart-ACTTM platform, Aptorum has successfully identified potential efficacy for and develops SACT-1 for the treatment of neuroblastoma, being an entirely new therapeutic area from its approved indication. In our recent studies, SACT-1 has been shown to be effective against numerous neuroblastoma cell lines, of which 2 are MYCN-amplified cells, which represent the high-risk neuroblastoma patient group. In addition, by using a combination index as a quantitative measure of the extent of drug interaction, Aptorum Group has seen a high and robust synergism between SACT-1 and traditional chemotherapy in vitro, indicating a potential efficacy enhancement/dose reduction of the chemotherapy. In addition, in our recent study, the maximum tolerable dose of SACT-1 in a rodent model was determined to be higher than 400mg/kg. Compared with the MTD of standard chemotherapy such as paclitaxel (20-30mg/kg)3 and cisplatin (6mg/kg) 4, the safety profile of SACT-1 appears to be very impressive.

The reformulation of SACT-1 is a pediatric formulation to better address the needs of neuroblastoma patients who are exclusively children younger than 5. Based on our internal observations of pre-existing information from approved products,5 SACT-1 also exhibits a well-established safety profile: at 150mg/day, the death rate was 0% in prior clinical studies) with no dosage related adverse events.

About neuroblastoma

Neuroblastoma is a rare form of cancer, and classified as an orphan disease, that forms in certain types of nerve tissue and most frequently in the adrenal glands as well as spine, chest, abdomen or neck, predominantly in children, especially for those aged 5 years and below. For the high-risk group, which is close to 20%6 of total new patient population per year, the 5-year survival rate of this condition is around 40-50% as observed by the American Cancer Society7. The current high drug treatment cost for high risk patients can average USD200,000 per regimen (all 6 cycles)8. In addition, most pediatric patients often do not tolerate or survive the relevant chemotherapy stage which, subject to further clinical studies, may be positively addressed by the SACT-1 candidate due to the potential synergistic effects when applied with standard chemotherapy as described above.

On February 10, 2020 TriSalus Life Sciences, a company committed to developing comprehensive solid tumor solutions, reported that Mary Szela, President and CEO, will speak on the panel, "Expanding the Toolkit for Fighting Solid Tumors" at the 2020 BIO CEO & Investor Conference in New York City (Press release, TriSalus Life Sciences, FEB 10, 2020, View Source [SID1234554098]).

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This panel will explore the breadth of the solid tumor-fighting pipelines and those clinical benefits likely to be realized soonest. Experience has shown that to date there has been limited success with the currently approved or experimental therapeutics in impacting solid tumors and that these often have undesirable side effects. While we have witnessed a surge of systemic therapies in recent years (For example, the check point inhibitors), the need for safer and truly effective treatment remains.

However, exciting approaches in other mechanisms of action are also expanding our understanding of solid tumors, the tumor microenvironments, and the opportunities to disrupt tumor growth and help cancer patients. "I am honored to participate in such an important panel discussion of how we can improve outcomes in solid tumors through new approaches such as TriSalus’ tri-pronged approach which combines CAR-T with an immuno-modulation agent and proprietary, intravascular delivery to treat liver metastases and pancreatic cancer," said Mary Szela, President and CEO of TriSalus.

Now in its 22nd year, the BIO CEO & Investor Conference is one of the largest independent investor conferences focused on established and emerging publicly traded and select private biotech companies including two days of productive partnering meetings with institutional and early-stage investors, industry analysts, and senior biotechnology executives, in one location.

Mary has limited availability during the conference. If you are interested in setting up a meeting with Mary, please contact Lisa DeScenza from LaVoieHealthScience at [email protected].