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New St. Gallen International Breast Cancer Guidelines Recommend Oncotype DX Breast Recurrence Score® Test to Guide Chemotherapy for Node-negative and Node-positive Early-stage Breast Cancer

On August 21, 2019 Genomic Health reported that, based on results from the prospective TAILORx1 and PlanB2 studies, the 16thSt. Gallen International Breast Cancer Conference Expert Panel has recommended the Oncotype DX Breast Recurrence Score test to guide chemotherapy treatment use for patients with hormone-receptor positive, HER-2 negative early-stage breast cancer with and without lymph node involvement (up to three positive nodes) (Press release, Genomic Health, AUG 21, 2019, View Source [SID1234538908]).

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In particular, the panelists recognized the value of the landmark TAILORx study results and noted that women with node-negative cancers and Recurrence Score results ≤25 do not need chemotherapy.3 This group represents up to about 80% of patients who may be safely spared chemotherapy. The Breast Recurrence Score test also identifies those patients (with results of 26 to 100) who may receive a life-saving benefit from chemotherapy.

In the new guidelines, genomic testing with robust validation through prospective, randomized trials is preferred over clinical-pathological features "for basing the critical yes/no chemotherapy decision." 4 Results from a recently published subset analysis of the prospective, randomized TAILORx study5 showed that only the Breast Recurrence Score test is predictive of chemotherapy benefit; clinical and pathological features are only prognostic and do not provide predictive information.

"We are pleased that this expert panel once again recognized the unique value of the Oncotype DX test to guide chemotherapy treatment. An extensive body of clinical evidence supports the ability of the Recurrence Score to identify both patients who can be spared chemotherapy and, importantly, those who will clearly benefit from it," said Steven Shak, M.D., chief scientific officer, Genomic Health. "All major guidelines in the U.S. and Europe recommend Oncotype DX to help select patients for chemotherapy treatment, providing physicians with the highest level of evidence to support using the test as standard of care."

The new St. Gallen International Consensus guidelines, "Estimating the benefits of therapy for early stage breast cancer," were recently published online in the Advance Access section of Annals of Oncology and will appear in a future print issue.

The Oncotype DX Breast Recurrence Score test is incorporated in all major international guidelines.

Recently, it was elevated to highest 1A level of evidence in the updated ESMO (Free ESMO Whitepaper) guidelines for early-stage breast cancer. Similar to the St. Gallen guidelines, the ESMO (Free ESMO Whitepaper) guidelines refer to TAILORx and PlanB results, which identify groups of patients – both in the node-negative and node-positive setting – for whom chemotherapy can be safely spared, thus underscoring the clinical utility that the Breast Recurrence Score test provides to guide chemotherapy treatment decisions.

Over the last several months, results of the TAILORx study have influenced positive treatment guideline updates distinguishing the Oncotype DX Breast Recurrence Score test from prognostic-only tests based on clinical evidence and the critical importance of predicting chemotherapy benefit. This includes the recent update to ASCO (Free ASCO Whitepaper) guidelines, which increased the proportion of women who can be effectively treated without chemotherapy based on the Recurrence Score results, highlighting the importance of testing all medically eligible early-stage breast cancer patients with the Breast Recurrence Score test. The National Comprehensive Cancer Network (NCCN) updated its guidelines in 2018 to categorize the Breast Recurrence Score test as the only "preferred" test for chemotherapy treatment decision-making for patients with node-negative, early-stage breast cancer. NCCN also classified the Breast Recurrence Score test as the only test that is predictive of chemotherapy benefit.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic Health. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

Entry into a Material Definitive Agreement

On August 20, 2019, Vical Incorporated (the "Company") reported that it entered into an amendment (the "Amendment") with Brickell Biotech, Inc., a Delaware corporation and clinical-stage medical dermatology company ("Brickell"), and Victory Subsidiary, Inc., a Delaware corporation and wholly owned subsidiary of the Company ("Merger Sub"), to the Agreement and Plan of Merger and Reorganization dated as of June 2, 2019 by and among the Company, Brickell and Merger Sub (the "Merger Agreement") (Filing, 8-K, Vical, AUG 21, 2019, View Source [SID1234538907]). Pursuant to the Merger Agreement, as amended, and upon the terms and subject to the satisfaction of the conditions described in the Merger Agreement, as amended, Merger Sub will be merged with and into Brickell (the "Merger"), with Brickell surviving the Merger as a wholly owned subsidiary of the Company.

Pursuant to the Amendment, the parties revised the minimum Brickell net working capital closing condition from -$11.5 million to -$14.3 million, revised the Brickell valuation from $60.0 million to $50.2 million, and revised the range of Brickell closing net working capital, outside of which there will be a dollar-for-dollar adjustment to the Brickell valuation, to -$14.8 million to -$13.8 million and fixed the assumed share price for purposes of applying the treasury stock method to calculate the number of Brickell and Vical outstanding shares at $0.79 and $1.35, respectively. The amended Brickell valuation results in an ownership split between Brickell and Vical stockholders of approximately 56% and 44%, respectively (on a fully diluted basis using the treasury stock method in instances other than with respect to the NovaQuest Warrants (as defined in the Merger Agreement) and certain equity issuances by Brickell following the signing of the Merger Agreement and prior to the completion of the Merger), or 51% and 49%, respectively (on a fully diluted basis using the treasury stock method), subject to further adjustment pursuant to the terms of the Merger Agreement, as amended by the Amendment. Other than as set forth in the Amendment, the terms of the Merger Agreement are unchanged.

Propanc Biopharma Receives Granted US Patent Covering Additional Composition Claims for PRP

On August 21, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that it has received a granted US patent from the United States Patent and Trademark Office (USPTO) covering composition of matter claims involving trypsinogen and chymotrypsinogen (Press release, Propanc, AUG 21, 2019, https://ir.propanc.com/news/detail/92/propanc-biopharma-receives-granted-us-patent-covering-additional-composition-claims-for-prp [SID1234538906]). The additional composition claims are a continuation from the original foundation patent in the U.S., and as a result, both method of treatment and composition claims now protects the Company’s lead product candidate, PRP, a pharmaceutical composition consisting of two proenzymes, trypinsogen and chymotrypsinogen, for treating cancer.

The granted patent issued by the USPTO now confers exclusive rights to the Company’s lead product, PRP, by demonstrating that compositions comprising trypsinogen and chymotrypsinogen exhibit a synergistic ability to inhibit the growth of various cancer cell lines.

"We continue to grow and strengthen our intellectual property portfolio and it is pleasing to receive additional patent claims for PRP in one of our most important global jurisdictions," said James Nathanielsz, Propanc’s Chief Executive Officer. "Presently, we have 65 patents either in force, or pending, in major global regions around the world, and this is very significant as we advance PRP towards human trials."

"We continue to fund research programs with our university partners, and plan to file additional patent applications in the future," said Dr Julian Kenyon, Propanc’s Chief Scientific Officer. "Intellectual property lies at the heart of any early stage Biotech company and we look forward to expanding our portfolio covering further aspects of our invention related to PRP, especially as we advance further down the clinical development pathway."

Mersana Therapeutics Announces Initiation of Expansion Study of XMT-1536 in Patients with Platinum-Resistant Ovarian Cancer and Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma

On August 21, 2019 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported the dosing of the first patient in the expansion portion of the Phase 1 study of XMT-1536, its first-in-class, wholly-owned Dolaflexin ADC targeting NaPi2b (Press release, Mersana Therapeutics, AUG 21, 2019, View Source [SID1234538905]). The expansion cohorts will assess the efficacy, safety and tolerability of XMT-1536 at 36 mg/m2 every four weeks in patients with platinum-resistant ovarian cancer and NSCLC adenocarcinoma. The Company also announced that it has not determined a maximum tolerated dose and that it plans to continue the dose escalation portion of the study in parallel.

"The initiation of the expansion cohorts is an important milestone for Mersana. We have chosen a dose that continues to show a promising efficacy and tolerability profile in heavily pretreated patients without selecting for NaPi2b expression," said Anna Protopapas, President and CEO of Mersana Therapeutics. "The advancement of XMT-1536 brings us one step closer to proof of concept and our goal of significantly improving outcomes for people living with cancer."

"We are excited to move our study into this important next phase of clinical development. With additional sites participating in the expansion cohorts we look forward to establishing the benefits of XMT-1536 in larger, more defined patient populations with high unmet medical need," said Dirk Huebner, M.D., Chief Medical Officer of Mersana Therapeutics. "In addition, because we have not determined a maximum tolerated dose and have not observed the severe toxicities seen with other ADC platforms (e.g., neutropenia, peripheral neuropathy or ocular toxicity), we plan to continue dose escalation and will begin dosing patients at 43 mg/m2. Taken together, these data will provide critical information to guide our path to registration for XMT-1536."

The expansion study includes two patient cohorts. One is enrolling platinum-resistant ovarian cancer patients who have failed standard therapy and have had no more than three lines of prior therapy. The other cohort is enrolling NSCLC adenocarcinoma patients who have failed front line platinum-based chemotherapy, either in combination or sequentially treated with an anti-PD-1 or anti-PD-L1 therapy. Patients in the expansion portion of the XMT-1536 Phase 1 study will be treated with the 36 mg/m2 once-every-four-week dosing regimen. Patients will not be pre-selected for NaPi2b expression, but eligibility criteria require archived tumor samples and fresh tumor biopsies when medically feasible. The study aims to enroll approximately 45 patients in each cohort.

Additional information can be found at: View Source;rank=1

About XMT-1536

XMT-1536 is a first-in-class ADC targeting the sodium-dependent phosphate transport protein (NaPi2b) and utilizing the Dolaflexin platform to deliver an average of 10-15 DolaLock payload molecules per antibody. The NaPi2b antigen is broadly expressed in non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer. XMT-1536 is in Phase 1 clinical trials in patients with tumors expressing NaPi2b, including ovarian cancer and NSCLC adenocarcinoma. More information on the ongoing Phase 1 clinical trial can be found at clinicaltrials.gov (NCT03319628).

MEI Pharma to Release 2019 Fiscal Year End Financial Results and Provide Corporate Update on August 28, 2019

On August 21, 2019 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that the Company will release its 2019 fiscal year end financial results after the close of the U.S. financial markets on August 28, 2019 (Press release, MEI Pharma, AUG 21, 2019, View Source [SID1234538904]). The Company will host a conference call and live webcast with the investment community to provide a corporate update the same day at 5:00 p.m. ET.

Conference Call & Webcast Information
When: August 28, 2019, 5:00 p.m. ET
Dial-in: (866) 939-3921 (United States) or (678) 302-3550 (International)
Conference ID: 48926540

Please join the conference call at least 10 minutes early to register. You can access the live webcast under the investor relations section of MEI’s website at: www.meipharma.com. A replay of the conference call will be archived under events and webcasts for at least 30 days after the call.