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TESARO Expands Our Way Forward Program for the Ovarian Cancer Community and Partners With Olympic Gymnast Shannon Miller

On September 28, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the availability of a number of new support resources and services that address unmet educational needs for women living with ovarian cancer (Press release, TESARO, SEP 28, 2017, View Source [SID1234520693]). The new resources are part of the expansion of the Our Way Forward platform — a program launched earlier this year, which features the results of a national survey that uncovered gaps in communication amongst patients and physicians. The expanded website includes numerous resources and tools for ovarian cancer patients and their loved ones, as well as a series of local ovarian cancer educational programs, including a special storytelling event with "The Moth" this fall. World-champion gymnast and gold medalist, Shannon Miller, will join TESARO to complement the Our Way Forward program and educate and empower the ovarian cancer community, sharing her experience as an ovarian cancer survivor.

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"As the Our Way Forward survey indicated, we as a community still have a long way to go to meet the needs of women with ovarian cancer. As a company, we measure our success by the number of patients and their loved ones that we impact in a positive manner," Mary Lynne Hedley, Ph.D., President and Chief Operating Officer. "By offering expanded educational content that emerged from perspectives and experiences of patients, survivors and caregivers like Shannon, we are committed to addressing the physical and emotional challenges that ovarian cancer brings to women."

The Our Way Forward website expansion used the findings uncovered in the Our Way Forward survey to develop informed resources and provide a call-to-action for patients, their loved ones and physicians to rethink how they talk about advanced, recurrent ovarian cancer. The Our Way Forward survey was conducted online in the U.S. by Harris Poll on behalf of TESARO, Inc. between April 2017 and May 2017, among 254 women living with ovarian cancer and 232 physicians who treat ovarian cancer patients. The updated website includes tailored content that addresses the emotional support needs of the caregiver, self-care and empowerment tips for women at any point during their personal ovarian cancer experience, first-person perspectives from women living with ovarian cancer and video content from "The Moth" storytelling event.

"As an ovarian cancer survivor, I am well aware of the anxiety and fear that goes along with an initial diagnosis, as well as the fear of recurrence even after treatment. It’s something that is always there. That’s why I am thrilled to join TESARO to be a part of a program that directly addresses the unique challenges of women after an ovarian cancer diagnosis and those currently living with ovarian cancer," said Mrs. Miller. "With Our Way Forward, TESARO has demonstrated their commitment to women like me — and their families and caregivers — who are faced with the possibility of cancer returning. As new medicines become available to treat women living with recurrent ovarian cancer, programs to support women from an emotional and psycho-social standpoint remain equally critical."

Upcoming resources will include new content created by Mrs. Miller, as she shares her personal ovarian cancer story, including the risks one still faces with an ovarian cancer diagnosis and treatment.

The Our Way Forward survey revealed that around half (53 percent) of patients polled felt that ovarian cancer had a severe or very severe impact on their lives. For patients who are currently in treatment or who have been treated, about half (49 percent) admitted that they find not being sure of the path forward after diagnosis to be very or extremely challenging. According to the survey, more than two in five patients who are either currently in treatment, or who have been treated, find not knowing what to expect during treatment (46 percent) or after treatment (47 percent) to be very or extremely challenging.

Approximately 85 percent of women with advanced ovarian cancer will experience recurrent disease after treatment. Despite high response rates to chemotherapy, its effectiveness diminishes over time. Many women have been told to "watch and wait" — along with the healthcare professionals, monitoring the cancer for recurrence. Until recently, before maintenance treatments were available, after a response to platinum-based chemotherapy, women had limited treatment options that would delay progression of the disease. These treatments have been shown to extend patients’ time in remission and increase progression-free survival rates.

About the Our Way Forward Survey
The Our Way Forward survey was conducted online in the U.S. by Harris Poll on behalf of TESARO, Inc. between April 13 and May 2, 2017, among 254 women 18+ years of age living in the U.S. who have been diagnosed with ovarian cancer. Survey respondents were selected from individuals who had agreed to participate in surveys through the Harris Poll and their partners, or were recruited to participate by patient advocacy organizations, NOCC and OCRFA. Results are representative of only those surveyed. A parallel survey was conducted between April 17 and May 5, 2017, among 232 physicians who treat ovarian cancer patients in the U.S., consisting of 201 medical oncologists and 31 gynecologic oncologists. Survey respondents were selected from physicians who had agreed to participate in surveys through the Harris Poll and their partners. More information about the campaign, full survey methods and survey findings, including important resources to enhance conversations about ovarian cancer, are available on the Our Way Forward website at www.ourwayforward-oc.com and via NOCC at ovarian.org and OCRFA at ocrfa.org.

About Ovarian Cancer

Approximately 22,000 women in the United States are diagnosed with ovarian cancer each year, many of whom will be diagnosed with advanced disease; while more than 65,000 women are diagnosed annually in Europe. In 2017 alone, 14,000 women will die of ovarian cancer, as it is the fifth leading cause of cancer death among women. Despite high-response rates to platinum-based chemotherapy in the second-line advanced treatment setting, approximately 85 percent of patients will experience recurrence within two years.

MabVax Announces Adjournment of Special Meeting of Stockholders
Special Meeting to Resume on Monday, October 2, 2017

On September 28, 2017 — MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX) a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that its Special Meeting of Stockholders scheduled for and convened on September 28, 2017 (the "Special Meeting"), was adjourned to achieve a quorum on the proposals to be approved (Press release, MabVax, SEP 28, 2017, View Source [SID1234520692]).

The Special Meeting has been adjourned to 3:00 p.m. Pacific Daylight Time/6:00 p.m. Eastern Daylight Time on Monday, October 2, 2017, at the offices of the Company at 11535 Sorrento Valley Road, Suite 400, San Diego, CA 92121, to allow additional time for MabVax stockholders to vote on proposals to approve the following:

1. A reverse stock split of the Company’s issued and outstanding common stock by a ratio of not less than one-for-two and not more than one-for-twenty at any time prior to September 28, 2018, with the exact ratio to be set at a whole number within this range as determined by the Board of Directors;

2. The potential issuance of up to an aggregate of 3,400,000 shares of common stock, in excess of 19.99% of the number of shares of common stock that were issued and outstanding on August 11, 2017, consisting of (i) 2,386,360 shares of common stock issuable upon conversion of Series J Preferred Stock, issued to investors in a financing consummated in August 2017 and (ii) 1,013,640 shares of common stock available for issuance under designated but unissued shares of Series J Preferred Stock;

3. If the Proposal 2 is approved, to approve the potential issuance of up to 6,500,000 shares of common stock upon conversion of Series K Preferred Stock issuable in connection with a financing consummated in August 2017, in excess of 19.99% of the number of shares of common stock that were issued and outstanding on August 11, 2017;

4. The issuance of securities in one or more non-public offerings where the maximum discount at which securities will be offered will be equivalent to a discount of 30% below the market price of the common stock, as required by and in accordance with Nasdaq Marketplace Rule 5635(d);

5. The issuance of securities in one or more non-public offerings where the maximum discount at which securities will be offered will be equivalent to a discount of 20% below the market price of the common stock, as required by and in accordance with Nasdaq Marketplace Rule 5635(d); and

6. The Fifth Amended and Restated MabVax Therapeutics Holdings, Inc. 2014 Employee, Director and Consultant Equity Incentive Plan, including the reservation of 6,128,406 shares of common stock for issuance, each as set forth in the MabVax’s proxy statement filed with the Securities and Exchange Commission ("SEC").

The affirmative vote of over 50% of the issued and outstanding voting power of MabVax’s outstanding voting shares is required for the approval of the reverse stock split; a majority of the votes cast is required for the approval of Proposal 2, provided however, that no shares of common stock underlying the Series J Preferred Stock may be counted towards approval of this proposal; a majority of the votes cast is required for the approval of Proposal 3, provided however, that no shares of common stock underlying the Series K Preferred Stock may be counted towards approval of this proposal; and a majority of the votes cast is required for the approval of each of the remaining proposals.

During the period of the adjournment, MabVax will continue to solicit proxies from its stockholders with respect to the proposals set forth in the proxy statement. Only stockholders of record on the record date of August 28, 2017, are entitled to and are being requested to vote. If a stockholder has previously submitted its proxy card and does not wish to change its vote, no further action is required by such stockholder.

No changes have been made in the proposals to be voted on by stockholders at the Special Meeting. The Company’s proxy statement and any other materials filed by the Company with the SEC remain unchanged and can be obtained free of charge at the SEC’s website at www.sec.gov.

MabVax encourages all stockholders that have not yet voted to vote their shares by 11:59 p.m. on Sunday, October 1, 2017, Eastern daylight time. If you have not voted, or have mislaid your proxy materials or are uncertain if you have voted all the shares you are entitled to vote please see "How You Can Vote," below. Every single vote counts.

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Baxter to Host Third Quarter 2017 Financial Results Conference Call for Investors

On September 28, 2017 Baxter International Inc.(NYSE:BAX), reported that it will host a conference call to discuss its third quarter 2017 financial results on Wednesday, October 25, 2017, at 7:30 a.m. Central Standard Time (Press release, Baxter International, SEP 28, 2017, View Source [SID1234520893]).

To access the call, dial 844.886-1929 (domestic) or 225.239.4663 (international). Please dial into the call at least 10 minutes prior to the start to connect. The Conference ID is 68201200.

This call is also being webcast by Nasdaq OMX and can be accessed at Baxter’s website at www.baxter.com. The conference call will be recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter’s permission.

Galena Biopharma Announces Completion of Enrollment in Two NeuVax (nelipepimut-S) Clinical Trials in Combination with Trastuzumab

On September 28, 2017 Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company developing hematology and oncology therapeutics that address unmet medical needs, reported that two clinical trials evaluating NeuVax (nelipepimut-S) in combination with trastuzumab (Herceptin; Genentech/Roche) for the prevention of recurrence in breast cancer patients have enrolled the protocol-defined number of patients to complete enrollment (Press release, Galena Biopharma, SEP 28, 2017, View Source [SID1234520707]). The milestones were reported by the clinical research organization conducting both trials – a Phase 2b clinical trial in HER2 1+/2+ patients and a Phase 2 clinical trial in HER2 3+ patients.

“Completing enrollment in both of these trials represents a major milestone for NeuVax development,” said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer of Galena. “The combination of trastuzumab and NeuVax has been shown to be synergistic in preclinical investigation, and we believe could be an effective treatment to prevent breast cancer recurrence in patients with no other treatment options. We would like to thank our investigators and patients who are participating in these trials as we look forward to the interim results next year for the Phase 2b trial and the primary endpoints for both trials in 2019.”

Phase 2b Clinical Trial in HER2 1+/2+ Patients

The Phase 2b clinical trial has enrolled the necessary 300 patients to complete enrollment. The clinical trial is a randomized, multicenter, investigator-sponsored, study enrolling HER2 1+ and 2+, HLA A2+, A3+, A24 and/or A26, node positive, and high-risk node negative breast cancer patients. Eligible patients are randomized to receive NeuVax + GM-CSF + trastuzumab or trastuzumab + GM-CSF alone. Once enrolled, all patients receive the standard trastuzumab dosing for 12 months. One cohort also receives six doses of NeuVax given as a primary vaccine series starting with the third dose of trastuzumab and then goes on to receive a NeuVax booster inoculation once every six months for up to 36 months. The next milestone for the trial will be the interim efficacy analysis that is scheduled to be performed by the Data Safety Monitoring Board (DSMB) in the first quarter of 2018. The primary endpoint of the study is disease-free survival after 24 months, with results expected from that milestone in the fourth quarter of 2019. Genentech/Roche is providing the trastuzumab and partial funding for this trial.

Data presented in October 2016 demonstrated that this novel combination of trastuzumab and NeuVax with HER2 low-expressing patients is well tolerated and the cardiac effects of trastuzumab are not impacted by the addition of NeuVax. In February 2017, the DSMB reported that there were no safety concerns with the trial and the trial is not futile. The recommendation from the DSMB was to continue the trial with one revision to the statistical analysis plan regarding the timing of the pre-specified interim analysis. Given the lengthy duration of enrollment for the trial, the DSMB determined that the pre-specified interim efficacy analysis be moved up from 12 months to 6 months after the last patient is enrolled. Therefore, the DSMB expects to perform the interim efficacy analysis in the first quarter of 2018.

Phase 2 Clinical Trial in HER2 3+ Patients

The Phase 2 clinical trial has enrolled the necessary 100 patients to complete enrollment. This multi-center, prospective, randomized, single-blinded trial enrolled patients with a diagnosis of HER2 3+ breast cancer who are HLA A2+ or HLA A3+ and are determined to be at high-risk for recurrence. High-risk is defined as having received neoadjuvant therapy with an approved regimen that includes trastuzumab but not obtaining a pathological complete response at surgery, or underwent surgery as a first intervention and was found to be pathologically node-positive (³4 positive lymph nodes, or having 1-3 positive lymph nodes (pN1) if hormone receptor negative). These high-risk patients are known to have higher recurrence rates than other HER2 3+ breast cancer patients. Eligible patients are randomized to receive NeuVax + GM-CSF + trastuzumab or trastuzumab + GM-CSF alone. Once enrolled, all patients receive the standard trastuzumab dosing for 12 months. One cohort also receives six doses of NeuVax given as a primary vaccine series starting with the third dose of trastuzumab and then goes on to receive a NeuVax booster inoculation once every six months for up to 36 months. The primary endpoint of the study is disease-free survival after 24 months, with results expected from that milestone in the fourth quarter of 2019. Partial funding for this trial was awarded through the Congressionally Directed Medical Research Program funded through the Department of Defense, via a Breast Cancer Research Program Breakthrough Award.

In February 2017, the DSMB reported that there were no safety concerns with the trial and the trial is not futile. The pre-specified interim safety analysis was completed on n=50 patients and demonstrated that the agent is well tolerated with no increased cardiotoxicity associated with giving NeuVax in combination with trastuzumab. The recommendation from the DSMB was to continue the HER2 3+ trial unmodified.

About NeuVax (nelipepimut-S)

NeuVax (nelipepimut-S) is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. It is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. In clinical studies, NeuVax is combined with recombinant granulocyte macrophage-colony stimulating factor (GM-CSF).

NeuVax is currently in two breast cancer studies in combination with trastuzumab (Herceptin; Genentech/Roche): a Phase 2b trial in node positive and triple negative HER2 IHC 1+/2+ (clinicaltrials.gov identifier: NCT01570036); and, a Phase 2 trial in high risk, node positive or negative HER2 IHC 3+ patients (clinicaltrials.gov identifier: NCT02297698). A Phase 2 clinical trial is also ongoing with NeuVax in patients with ductal carcinoma in situ (DCIS) (clinicaltrials.gov identifier: NCT02636582), and a Phase 2 trial is planned in patients with gastric cancer.

FDA approves new treatment for certain advanced or metastatic breast cancers

On September 28, 2017 The U.S. Food and Drug Administration reported that they approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzenio is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread (metastasized) (Press release, US FDA, SEP 28, 2017, View Source [SID1234520694]).

“Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Verzenio works by blocking certain molecules (known as cyclin-dependent kinases 4 and 6), involved in promoting the growth of cancer cells. There are two other drugs in this class that are approved for certain patients with breast cancer, palbociclib approved in February 2015 and ribociclib approved in March 2017.

Breast cancer is the most common form of cancer in the United States. The National Cancer Institute at the National Institutes of Health estimates approximately 252,710 women will be diagnosed with breast cancer this year, and 40,610 will die of the disease. Approximately 72 percent of patients with breast cancer have tumors that are HR-positive and HER2-negative.

The safety and efficacy of Verzenio in combination with fulvestrant were studied in a randomized trial of 669 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and who had not received chemotherapy once the cancer had metastasized. The study measured the length of time tumors did not grow after treatment (progression-free survival). The median progression-free survival for patients taking Verzenio with fulvestrant was 16.4 months compared to 9.3 months for patients taking a placebo with fulvestrant.

The safety and efficacy of Verzenio as a stand-alone treatment were studied in a single-arm trial of 132 patients with HR-positive, HER2-negative breast cancer that had progressed after treatment with endocrine therapy and chemotherapy after the cancer metastasized. The study measured the percent of patients whose tumors completely or partially shrank after treatment (objective response rate). In the study, 19.7 percent of patients taking Verzenio experienced complete or partial shrinkage of their tumors for a median 8.6 months.

Common side effects of Verzenio include diarrhea, low levels of certain white blood cells (neutropenia and leukopenia), nausea, abdominal pain, infections, fatigue, low levels of red blood cells (anemia), decreased appetite, vomiting and headache.

Serious side effects of Verzenio include diarrhea, neutropenia, elevated liver blood tests and blood clots (deep venous thrombosis/pulmonary embolism). Women who are pregnant should not take Verzenio because it may cause harm to a developing fetus.

The FDA granted this application Priority Review and Breakthrough Therapy designations.

The FDA granted the approval of Verzenio to Eli Lilly and Company.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.