OB-002 Significantly Reduces Bone Metastasis in a Murine Model of Breast Cancer

On October 31, 2019 Orion Biotechnology Canada, Ltd. reported that OB-002 was able to significantly reduce bone metastasis in a murine model of breast cancer (Press release, Orion Biotechnology, OCT 31, 2019, View Source [SID1234550114]). The study was conducted in collaboration with ProQinase (Heidelberg, Germany; View Source). Female BALB/c mice received orthotopic implantation of 4T1-M3_Luc cells into the mammary fat pad. The 4T1 breast cancer cells were transfected with firefly luciferase that allowed bioluminescent quantification of metastatic disease. Mice were randomized to receive placebo, OB-002, or a combination of OB-002 and an anti-PD-1. The OB-002 was administered via intraperitoneal (IP) injection daily (Monday through Friday) and the anti-PD-1 was administered IP every 3-4 days. The mice randomized to receive OB-002 at a dose of 20 mg/kg demonstrated a significant reduction in Day 20 primary tumor volume compared to placebo and the mice randomized to receive 80 mg/kg had a significant reduction in spinal bone metastasis.

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"These data demonstrating that OB-002 can induce a significant reduction in both primary and metastatic breast cancer are very exciting and add to the growing body of data suggesting that OB-002 has the potential to play an important role in cancer therapy," said Dr. Ian McGowan, Chief Medical Officer for Orion Biotechnology. "Unfortunately, bone is the most common site of metastatic breast cancer (Ording AG et al., Clin Exp Metastasis 2017) and approximately 70% of women dying from breast cancer have bone metastases (Awolaran O et al., Breast 2016). Clearly, any product that has the potential to reduce breast cancer-associated bone metastasis would be a major advance in the field."

Mark Groper, President and CEO of Orion Biotechnology, added, "Breast cancer is the most common cancer in women worldwide and remains a challenging disease to manage. Bone metastasis is a frequent and debilitating complication of breast cancer and so these preliminary pre-clinical data are very encouraging."

Agenus to Report Third Quarter 2019 Financial Results on November 4, 2019 and Host Conference Call and Webcast

On October 31, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, reported that it will release its third quarter 2019 financial results before the market opens on Monday, November 4, 2019 (Press release, Agenus, OCT 31, 2019, View Source [SID1234550113]). Agenus executives will host a conference call and webcast at 8:30 a.m. ET the same day to discuss the results and provide a business update.

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To access the live call, dial 1-844-492-3727 (U.S.) or 1-412-317-5118 (International) and ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company’s website at View Source or with this link View Source A replay will be available on the Company’s website approximately two hours after the call.

Entry into a Material Definitive Agreement.

On October 31, 2019, Myovant Sciences Ltd. ("Myovant") and Sumitomo Dainippon Pharma Co., Ltd. ("DSP") reported that it has entered into a letter agreement (the "Letter Agreement") pursuant to which Myovant and DSP agreed to take certain actions in connection with the transactions described in the publicly announced Memorandum of Understanding entered into by Roivant Sciences Ltd. ("Roivant") and DSP, which matters have been agreed to in a Transaction Agreement dated October 31, 2019 between DSP, Roivant and other parties (the "DSP-Roivant Agreement") (Filing, 8-K, Myovant Sciences, OCT 31, 2019, View Source [SID1234550112]). Upon the closing under the DSP-Roivant Agreement (the "Closing"), DSP, or an entity that will become a subsidiary of DSP (DSP or such entity, the "Acquiring Entity"), will acquire Roivant’s ownership interest in Myovant and become a significant shareholder of Myovant (the "Transactions"). Myovant understands that Roivant has committed in the DSP-Roivant Agreement that, at or prior to the closing, Roivant will ensure that the Acquiring Entity will obtain not less than a majority of the outstanding shares of Myovant by purchasing additional Myovant shares at prices not below market trading prices and delivering such shares, or voting rights with respect thereto, to the Acquiring Entity.

The terms of the Letter Agreement provide, among other things:

1.The Myovant Board of Directors has approved the Transactions and, subject to and at or prior to the Closing, the appointment of the Acquiring Entity’s director designees to the Myovant Board as described below.

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2. At or promptly following the Closing, Myovant and DSP will enter into a secured low-interest Loan Agreement under which DSP will commit to provide Myovant a five-year term loan facility of US$350 million with a total interest rate in the single digits subject to further transfer pricing analysis and otherwise on mutually agreed terms (the "Loan Agreement").

3. The Myovant Board will (i) replace the three currently serving Roivant-selected directors with three DSP-selected directors who will be appointed to the Myovant Board, (ii) appoint two DSP-selected directors to the Nominating and Corporate Governance Committee to replace two currently serving members, and (iii) appoint one DSP-selected director to the Compensation Committee to replace one currently serving member.

4. At or prior to the Closing, the Myovant Bye-Laws will be amended to (i) remove the requirement that each of the Nominating and Corporate Governance Committee and the Compensation Committee be made up solely of Independent Directors (as defined below), provided that the Audit Committee shall continue to be made up solely of Independent Directors; and (ii) provide that the Board delegates to the Nominating and Corporate Governance Committee the right to fix the size of the Board and fill vacancies on the Board, other than three Independent Directors and their direct or indirect successors.

5. At the Closing, Myovant and the Acquiring Entity will enter into an Investor Rights Agreement that contains, among others, the following provisions:

(a) At all times that DSP and its affiliates (including the Acquiring Entity) hold 50% or more of the outstanding shares of Myovant (the "Ownership Threshold"):

(i) (A) the Myovant Board will include a minimum of three directors who each meet the definition of "independent director" as is required by New York Stock Exchange rules and who are independent of DSP and the Acquiring Entity ("Independent Directors") and at least one of whom is a financial expert, and (B) DSP has agreed that, provided that the existing Independent Directors serving on the Myovant Board continue to satisfy the requirements to serve as an independent director, the term of the current independent directors serving on the Myovant Board will continue;

(ii) the Audit Committee of the Myovant Board shall comprise the Independent Directors; the Nominating and Corporate Governance Committee shall comprise two DSP-selected directors and one Independent Director; and the Compensation Committee shall comprise two Independent Directors and one DSP-selected director;

(iii)the Bye-Law pursuant to which the Board delegates its right to the Nominating and Corporate Governance Committee will not be revised without prior written consent by DSP; and

(iv)DSP will vote its shares in connection with each election of Independent Directors in the same proportion as the shares held by shareholders other than DSP and its subsidiaries and will not, with respect to the election of Independent Directors, engage in any solicitation of proxies.

(b)Until such time as DSP or its subsidiaries hold less than 35% of the outstanding shares of Myovant and its subsidiaries, Myovant will not be permitted to take or commit to taking the following actions without prior approval of the Independent Directors:

(i)participation in specified "related-party transactions" between Myovant and DSP or any affiliate of DSP including use of DSPs commercial infrastructure (other than pursuant to the Loan Agreement in accordance with its terms);

(ii)any amendment of Myovant’s Certificate of Incorporation, Memorandum of Association, Committee Charters or Bye-Laws that would remove the Independent Directors, cause the appointment of any member of the Audit Committee who is not an Independent Director or change the right of the Independent Directors to approve the "related-party transactions"; or

(iii) making any modification of or causing Myovant to waive any rights under the Loan Agreement or the Investor Rights Agreement to expand DSP’s or the Acquiring Entity’s, as the case may be, rights thereunder.

6. A standstill provision, which provides that until such time as DSP or its subsidiaries hold less than 35% of the outstanding shares of Myovant, any transaction proposed by DSP or its controlled affiliates that would cause DSP or its subsidiaries to hold beneficial ownership of greater than 60% of the outstanding voting power of Myovant must be either:

(a)(i) made on a confidential basis to the Independent Directors; provided that after the three-year anniversary of the Closing, this requirement will only require a period of confidential discussions with the Independent Directors prior to making a public announcement thereof and shall except disclosures that are required by law;

(ii)until the three-year anniversary of the Closing, subject to approval by a majority of the Independent Directors; and

(iii)subject to a non-waivable condition requiring approval or acceptance by the holders of a majority of the Myovant shares voting and that are not beneficially owned by DSP or its affiliates;

or

(beffected under the circumstances set forth in a specified section of Myovant’s Bye-Laws having to do with third-party acquisition proposals.

7.Myovant has agreed, until the Closing, to reasonably assist and reasonably cooperate with Roivant in complying with the interim operating covenants contained in the DSP-Roivant Agreement that relate to Myovant, in which Roivant has agreed, among other things, to cause Myovant to (a) afford to DSP reasonable access to its offices, properties, employees and business and financial records, (b) furnish to DSP such additional information concerning its assets, properties, operations and businesses as DSP may reasonably request, and (c) conduct its business in the ordinary course, including refraining from taking a list of actions without DSP’s consent, including (subject to certain limitations) but not limited to incurrence of additional indebtedness, issuance of equity securities, granting of liens, and sales of assets.

Oncolytics Biotech(R) Provides Update on Partner Adlai Nortye’s Clinical Progress

On October 31, 2019 Oncolytics Biotech Inc. (NASDAQ:ONCY)(TSX:ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reorted an update on its partner, Adlai Nortye’s, clinical progress and approval by the National Medical Products Administration (NMPA) of China for initiating a phase 3 clinical trial for pelareorep (Press release, Oncolytics Biotech, OCT 31, 2019, View Source [SID1234550111]).

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"We congratulate Adlai on this significant regulatory and business achievement that paves the way for pelareorep’s development in the world’s second largest pharmaceutical market," said Andrew de Guttadauro, President of Oncolytics Biotech U.S. and Global Head of Business Development. "Since the consummation of this partnership almost two years ago, we’ve been very happy with how Adlai is progressing the development of pelareorep in China, the second largest and rapidly growing pharmaceutical market in the world."

The phase 3 study, initially based on positive results from the randomized phase 2 metastatic breast cancer study IND-213, will be finalized based on data from Oncolytics’ AWARE-1 breast cancer study in combination with Roche’s Tecentriq and BRACELET-1 metastatic breast cancer study in combination with Pfizer’s and Merck KGaA’s Bavencio. These studies provide valuable biomarker data that will help define enrollment criteria to include patients most likely to respond to treatment with pelareorep and increase the likelihood of a positive clinical outcome in this important phase 3 registrational study.

Oncolytics and Adlai Nortye entered into an $86.6 million regional licensing agreement in November 2017, providing Adlai with exclusive development and commercialization rights to pelareorep in China, Hong Kong, Macau, Singapore, South Korea and Taiwan. To date Oncolytics has received $5 million in up front payments and is eligible for $81.6 million in milestone payments.

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

U.S. FDA Agreed with Can-Fite’s Proposed Pivotal Phase III Trial Design to Support
a New Drug Application Submission and Approval of Namodenoson in the Treatment of Liver Cancer

On October 31, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported it has concluded an End-of-Phase II Meeting with the U.S. Food and Drug Administration (FDA) regarding its recently completed Phase II study of Namodenoson in the treatment of hepatocellular cancer (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, OCT 31, 2019, View Source [SID1234550100]). The purpose of the meeting was to review the Phase II study data with the FDA and to present Can-Fite’s proposed Phase III study design to the regulatory agency.

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The FDA agreed with Can-Fite’s proposed pivotal Phase III trial design to support a New Drug Application (NDA) submission and approval. The Phase III study will enroll patients with advanced HCC, with underlying Child Pugh B7 (CPB7) cirrhosis, whose cancer has progressed on first line therapy. This design leverages the previously announced Phase II trial data, which showed promising efficacy signals in this population. The FDA’s guidance will be incorporated into the Phase III study’s final protocol.

"Namodenoson is a novel approach to treating advanced liver cancer with an orally bioavailable drug specifically targeting the tumor cells, a unique mechanism that contributes to the favorable safety profile. We are very pleased with this outcome from our meeting with the FDA. With the FDA’s guidance, we plan to now finalize our Phase III study protocol for this unmet advanced liver cancer indication," stated Dr. Michael Silverman, Can-Fite’s Medical Director.

Can-Fite’s completed Phase II liver cancer study found that Namodenoson increased overall survival in HCC patients with CPB7 cirrhosis, the largest subpopulation of the study, even though the Phase II study did not achieve its primary endpoint of overall survival in the whole population.

DelveInsight estimates the HCC drug market will reach $3.8 billion in 2027 in the G8 countries. According to the American Cancer Society, in the U.S. liver cancer incidence has tripled since 1980, with an estimated 42,000 cases diagnosed and 32,000 deaths annually. Incidence of liver cancer is much higher in other countries, with more than 800,000 diagnoses and 700,000 deaths estimated globally each year.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being developed as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.