On June 10, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported the completion of target patient enrollment in the Clovis-sponsored Phase 3 ATHENA trial evaluating the combination of Clovis’ Rubraca(rucaparib), a poly (ADP ribose) polymerase inhibitor (PARP), and Bristol-Myers Squibb’s PD-1 inhibitor, OPDIVO (nivolumab), as front-line maintenance treatment of newly-diagnosed advanced ovarian cancer (Press release, Clovis Oncology, JUN 10, 2020, View Source [SID1234560970]). ATHENA is the first front-line switch maintenance study designed to show PARP monotherapy and PARP/PD-1 combination therapy in one study design.

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"The completion of target patient enrollment in the Phase 3 ATHENA trial is an important milestone for Clovis and a critical step toward developing additional therapeutic options for women with advanced ovarian cancer," said Patrick J. Mahaffy, President and Chief Executive Officer of Clovis Oncology. "This was a tremendous effort by trial investigators, our collaborators and our dedicated Clovis team to complete target enrollment in this 1,000-patient study in under two years. Most important, we are grateful to all of the patients who participated in this study."

ATHENA is a Phase 3, randomized, multinational, double-blind, placebo-controlled, four-arm trial evaluating Rubraca and Opdivoas maintenance treatment following response to front-line treatment in newly-diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples. The primary endpoint is investigator assessed progression-free survival (PFS); secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.

Target enrollment for the ATHENA trial was 1,000 ovarian cancer patients. Patients were enrolled at clinical trial centers in 24 countries including North America, Europe and Asia.

Topline data for the Rubraca monotherapy versus placebo arm in all study populations is expected in the second half of 2021 and, if supportive, would serve as the basis of an sNDA for the maintenance treatment of front-line, newly-diagnosed, advanced ovarian cancer patients. Topline data for the combination of Rubraca and Opdivo versus Rubraca monotherapy in all study populations are expected a year or more later and, if supportive, would serve as the basis of an sNDA for the combination therapy in front-line, newly-diagnosed ovarian cancer. In each of these, the primary efficacy analysis will evaluate two prospectively defined molecular sub-groups in a step-down manner: first, HRD-positive patients, including BRCA-mutant patients; and the intent-to-treat population, or all patients treated in ATHENA.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, and lung cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. Additionally, Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In Europe, Rubraca is approved for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. Rubraca is also approved in Europe for the treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy. Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

Rubraca is an unlicensed medical product outside of the U.S. and Europe.

On June 10, 2020 Checkmate Pharmaceuticals (Checkmate), a clinical stage biotechnology company focused on improving patients’ lives with its novel approach to cancer immunotherapy, reported that it has completed an $85 million Series C financing (Press release, Checkmate Pharmaceuticals, JUN 10, 2020, View Source [SID1234560968]). Checkmate plans to use the proceeds from the financing to support the continued clinical development of CMP-001 in anti-PD-1 refractory melanoma as well as to pursue studies in additional indications, such as front-line melanoma and head and neck squamous cell carcinoma.

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The Series C financing was led by Longitude Capital and Novo Holdings. They were joined by other new investors including Medixci, Omega Funds, Clough Capital Partners, Sectoral Asset Management and BrightEdge, the venture investment fund of the American Cancer Society. Checkmate’s existing investors Sofinnova Investments, venBio Partners, F-Prime Capital, and Decheng Capital also participated in the financing.

Oren Isacoff, M.D., of Longitude Capital, and Nilesh Kumar, Ph.D., of Novo Ventures, will join the company’s Board of Directors. "We are excited about the clinical data that we have generated to date, and we believe that CMP-001 has the potential to significantly advance the impact of cancer immunotherapy for the benefit of patients with melanoma and other types of cancer," said Barry Labinger, CEO of Checkmate.

"We greatly appreciate the continued strong support from our existing investors, and we are proud to welcome additional world-class investors to help us fully achieve the promise of the program."

Proceeds from the financing will be used to further advance clinical development of CMP-001, a differentiated Toll-like receptor 9 (TLR9) agonist delivered as a biologic virus-like particle utilizing a CpG-A oligonucleotide as a key component. To date, CMP-001 has been studied in more than 200 patients with melanoma in clinical trials. In these trials, CMP-001 in combination with anti-PD-1 antibodies improved the rate, duration, and depth of response when compared with independent data reported from third-party studies with single agent anti-PD-1 therapy. The additional funding will enable Checkmate to conduct advanced studies in anti-PD-1 refractory melanoma as well as to pursue studies in additional indications, such as front-line melanoma and head and neck squamous cell carcinoma, in which the company believes the approach may prove to be of clinical benefit.

"Checkmate is a compelling story of a team driven to find a viable solution for patients in the cancer immunotherapy space. We are proud to support this team and look forward to the advancement of CMP-001," said Oren Isacoff, M.D., of Longitude Capital.

"We are pleased to join a great investor syndicate in supporting Checkmate," said Nilesh Kumar. "CMP-001 has demonstrated impressive clinical data and we look forward to seeing the program advance in melanoma and additional indications."

About CMP-001
CMP-001 comprises a virus-like particle containing a CpG-A oligonucleotide. It is designed to activate the body’s innate immune system via TLR9 and mediate the tumor microenvironment by the subsequent induction of both innate and adaptive anti-tumor immune responses. We believe CMP-001 is the only CpG-A oligonucleotide in clinical development.

On June 10, 2020 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that the Company will participate in an upcoming virtual investor conference. Jigar Raythatha, CEO, will present at the Goldman Sachs 41st Annual Global Healthcare Conference at 8:00 AM EDT on June 11 (Press release, Constellation Pharmaceuticals, JUN 10, 2020, View Source [SID1234560967]). A live audio webcast of Mr. Raythatha’s presentation and archives for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replay will be available for 30 days following the live presentation.

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On June 10, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that Jounce management will participate in a fireside chat at the Raymond James Human Health Innovation Conference on Wednesday, June 17, 2020 at 3:00 p.m. ET (Press release, Jounce Therapeutics, JUN 10, 2020, View Source [SID1234560964]).

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A live webcast of the presentation will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcast will be archived for 30 days following the presentation.

On June 10, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar") and Adgero Biopharmaceuticals Holdings, Inc. ("Adgero") reported the companies have entered into a definitive merger agreement pursuant to which DelMar, a biopharmaceutical company focused on the development of new solid tumor cancer therapies, will acquire Adgero, a privately held biopharmaceutical company focused on the development of its late stage photodynamic therapy platform for the treatment of serious cutaneous oncology indications (Press release, DelMar Pharmaceuticals, JUN 10, 2020, View Source [SID1234560963]). In an all-equity transaction, Adgero stockholders will receive shares of DelMar common stock for shares of Adgero common stock.

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Upon completion of the merger, current DelMar and Adgero stockholders will own 50.5% and 49.5% of the total voting power of the combined company, respectively, exclusive of securities to be issued in a financing to occur prior to the merger closing, as well as compensation payable in connection with the merger and the financing. Subject to stockholder approval of both companies and other closing conditions, the transaction is expected to close in the third quarter of 2020, at which time DelMar is expected to change its name to Kintara Therapeutics, Inc. and trade on Nasdaq under the new ticker symbol "KTRA."

This combination brings together DelMar’s first-in-class, DNA-targeting chemotherapeutic with proven anti-cancer activities with Adgero’s photodynamic therapy platform. The combined company expects to benefit from complementary capabilities along with greater financial resources and flexibility to engage in a wide range of research and development activities that the companies believe will ultimately result in the creation of sustainable long-term growth.

"The acquisition of Adgero by DelMar positions the combined company for long-term corporate growth and increased shareholder value by bringing together DelMar’s oncology therapeutic candidate, VAL-083, and Adgero’s REM-001 photodynamic therapy with a lead indication in CMBC," commented Saiid Zarrabian, President and Chief Executive Officer of DelMar. "This acquisition is the result of an extensive search for a suitable oncology therapy and provides the combined company with a diversified, late-stage oncology pipeline. During the next 12-18 months, we expect to achieve significant clinical milestones, driven by a seasoned leadership team that will bolster our oncology drug development expertise."

Mr. Zarrabian continued, "The clinical data from Adgero’s REM-001 has demonstrated significant anti-tumor efficacy to date, with 80% complete responses reported across four studies in CMBC, and we believe it will be a valuable late-stage pipeline complement to DelMar’s VAL-083 as we prepare for the GBM AGILE registration study."

John Liatos, interim Chief Executive Officer and Chief Financial Officer of Adgero, added, "This combination provides us with the opportunity to not only deepen our pipeline but also strengthen our oncology drug development expertise and capabilities. Furthermore, our enthusiasm to merge with DelMar was reinforced by the Global Coalition for Adaptive Research’s (GCAR) invitation to include VAL-083 in its GBM AGILE pivotal study for the treatment of newly-diagnosed and recurrent GBM. This is an important milestone with the potential to greatly reduce VAL-083’s development timeline and speaks to the potential of VAL-083 given that only a limited number of drug candidates will be invited to participate in the study. On our end, we are tremendously proud of the progress we have accomplished to date, and through this combination we look forward to creating a highly focused oncology company that can develop new therapies to help physicians and patients combat cancers where current treatment options are limited."

Strategic Rationale for the Merger:

Creates a diversified, late-stage oncology company with two Phase 3-ready products that target rare, unmet medical needs in oncology;
Combined robust development efforts to date with an estimated $300 million invested in the development of DelMar’s VAL-083 and Adgero’s REM-001, both of which have demonstrated anti-tumor activity in clinical trials and possess a large patient safety database;
Potential future pipeline expansion opportunities with an existing Orphan designation and an approved IND in ovarian cancer, and existing Orphan designations in basal cell carcinoma nevus syndrome and hemodialysis grafts; and
Bolstered oncology drug development expertise by the combination of DelMar and Adgero leadership is instrumental for the further clinical development of VAL-083 and REM-001.
Anticipated Late-stage Clinical Milestones Over the Next 12-18 Months*:

Report at various oncology meetings, including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II being held June 22-24, 2020;
Top-line results from VAL-083’s Phase 2 study in newly-diagnosed GBM;
Top-line results from VAL-083’s Phase 2 study conducted at the MD Andersen Cancer Center in recurrent GBM;
Top-line results from VAL-083’s Phase 2 study conducted at the MD Andersen Cancer Center in adjuvant GBM;
Initiation of patient enrollment into the VAL-083 arm of the Global Coalition for Adaptive Research’s GBM AGILE registrational study in newly-diagnosed and recurrent GBM patients; and
REM-001 confirmatory trial results in CMBC
*(subject to financing proceeds available to the combined company)

Organizational Structure

Following the close of the transaction, Saiid Zarrabian, DelMar’s President and Chief Executive Officer, will continue to serve as President and Chief Executive Officer, John Liatos, Adgero’s interim Chief Executive Officer and Chief Financial Officer, will serve as Senior Vice President, Business Development, Scott Praill, DelMar’s Chief Financial Officer, and Dennis Brown, DelMar’s Chief Scientific Officer, will each continue to serve in their respective capacities, and Steve Rychnovsky, Adgero’s Vice President, Operations and Product Development will serve as Vice President, Research and Development.

The combined Company’s Board of Directors will consist of seven directors, four of which will be designated by DelMar, two of which will be nominated by Adgero and approved by DelMar, and the remaining Director will be mutually agreed upon by DelMar and Adgero.

Merger Process Overview and Financial Rationale

Each outstanding share of Adgero common stock will be converted into shares of DelMar common stock at an exchange ratio such that current DelMar and Adgero stockholders will own 50.5% and 49.5% of the total voting power of the combined company, respectively (the "Exchange Ratio"), upon completion of the merger and exclusive of (i) securities to be issued in a financing to occur prior to the merger closing and (ii) compensation payable in connection with the merger and the financing. Each of the 1,470,092 outstanding warrants to purchase Adgero’s common stock will be exchanged for a warrant to purchase DelMar common stock as calculated based on the Exchange Ratio, resulting in a total of 2,299,036 additional DelMar warrants outstanding. Each outstanding Adgero stock option, whether vested or unvested, that has not been exercised will be cancelled for no consideration as it is anticipated that none of the options will be in-the money at the time of the merger.

The transaction has been unanimously approved by the Boards of Directors of DelMar and Adgero. The transaction is subject to customary closing conditions, including, among others, approval by the stockholders of each company, the closing on a minimum $10 million financing, and DelMar’s continued listing on the Nasdaq Capital Market, and is expected to close in third quarter of 2020. Additionally, the transaction has the support from each of the directors and executive officers of DelMar and Adgero.

Lowenstein Sandler LLP acted as external legal counsel to DelMar and Ladenburg Thalmann & Co. Inc. provided a fairness opinion to DelMar. Gracin & Marlow, LLP acted as external legal counsel to Adgero.