On December 12, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs, reported that it plans to release an update on clinical data from the ongoing Phase 2 trial of the combination of intratumoral tilsotolimod and ipilimumab for unresectable or metastatic melanoma following failure of anti-PD-1 inhibitor treatment prior to the opening of the U.S. financial markets on Friday, December 14, 2018 (Press release, Idera Pharmaceuticals, DEC 12, 2018, View Source [SID1234532053]).

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The company will host a conference call and live webcast, Friday, December 14 at 10:00 A.M. EST to review the data being presented along with a questions and answers session.

Investor Webcast Details
To participate in the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824 (international). The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com. The company will be posting a slide presentation to the Idera corporate website in the "Investors" section which will be referenced during the conference call.

Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

On December 12, 2018 Zai Lab Limited (NASDAQ: ZLAB), a Shanghai-based innovative commercial stage biopharmaceutical company, reported that the China National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for ZEJULA (niraparib, or ZL-2306) as a Category 1 drug for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete or partial response to platinum-based chemotherapy (Press release, Zai Laboratory, DEC 12, 2018, View Source [SID1234532051]). ZEJULA is a potent and highly selective PARP1/2 inhibitor that does not require BRCA mutation or other biomarker testing prior to administration.

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"The NMPA’s acceptance of our NDA submission for ZEJULA represents a major milestone for Zai Lab as this is our first ever NDA submission in Mainland China," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "ZEJULA will offer an important, new treatment option to more than 50,000 Chinese patients who suffer from ovarian cancer every year and we are grateful that NMPA recognizes this critical medical need and the promise of ZEJULA. Zai is a leader in the field of innovative oncology treatments in China and we have a deep and highly-differentiated pipeline, including three U.S. FDA-approved products and four other assets in late stage clinical development. As a result, we expect additional regulatory submissions in the coming years as we continue to advance our pipeline."

Dr. Yong-Jiang Hei, Chief Medical Officer for Oncology of Zai Lab said, "We believe ZEJULA is a best-in-class PARP inhibitor due to its compelling efficacy, once-daily dosing and superior pharmacokinetic properties including its ability to cross the blood brain barrier. The NDA submission based on the Category 1 designation of ZEJULA is a result of China-based clinical trials and manufacturing conducted by Zai Lab. We plan to expand our development efforts in collaboration with our partner Tesaro across several additional indications including, but not limited to, first-line maintenance treatment of ovarian cancer, lung cancer and gastric cancer."

William Liang, Chief Commercial Officer noted, "The Zai Lab commercial team is very excited about the attractive profile of ZEJULA and plans to leverage ZEJULA’s recent Hong Kong approval and commercial launch to prepare for the launch in China. If approved, we believe ZEJULA will provide a differentiated treatment option to benefit more ovarian cancer patients. We also intend to closely collaborate with local authorities and NGOs to develop patient assistant programs to increase access to more women who could benefit from this treatment. Zai Lab is committed to making a meaningful impact on the way cancer is treated in China and will continue to develop and bring new innovative oncology treatment options to patients in need."

About Ovarian Cancer

Ovarian cancer is one of the most common gynecologic cancers in China with approximately 51,000 newly diagnosed cases and 23,000 deaths in China in 2014. The 5-year overall survival rate of ovarian cancer patients is 46% across all stages, but only 29% in patients are diagnosed with distant metastatic disease. While platinum-based chemotherapy is effective at inducing an initial response in ovarian cancer, the disease will recur in the majority of women. Effective treatment options for patients with platinum-sensitive recurrent ovarian cancer remain limited. New agents that prolong the duration of response following platinum-based treatment and delay the inevitable relapse of ovarian cancer will benefit patients with ovarian cancer in China.

About ZEJULA

ZEJULA (niraparib, ZL-2306) is a highly potent and selective oral, once-daily small molecule poly (ADP-ribose) PARP 1/2inhibitor. It was approved in March 2017 by the FDA in the United States and in November 2017 by the EMA in the European Union under the trade name ZEJULA as a maintenance treatment for women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Based on the approval status in the United States and European Union by our partner, Tesaro, Zai Lab has obtained the approval for marketing ZEJULA in Hong Kong in October 2018.

On December 12, 2018 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that Aron Knickerbocker, Chief Executive Officer, will present at the 37th Annual J.P. Morgan Healthcare Conference, Wednesday, January 9, 2019 at 2:00 pm PT (Press release, Five Prime Therapeutics, DEC 12, 2018, View Source [SID1234532039]).

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The presentation will be webcast and may be accessed at the "Events & Presentations" section of the Company’s website at View Source Five Prime will maintain an archived replay of the webcast on its website for 30 days after the conference.

On December 12, 2018 Generex Biotechnology Corporation (OTCQB:GNBT) reported that the FDA had reviewed the company’s investigational new drug (IND) application and given notification that the study can proceed (Press release, Generex, DEC 12, 2018, View Source [SID1234532037]). The study: A Phase II Clinical Trial of Pembrolizumab (Keytruda) in Combination with the AE37 Peptide Vaccine in Patients with Metastatic Triple Negative Breast Cancer, is sponsored by Generex and conducted under a collaboration agreement with Merck and a clinical trial agreement with the NSABP Foundation, Inc. (NSABP).

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The combination study builds on previous clinical studies of both AE37 and Keytruda. AE37, a cancer vaccine, was the subject of a 300 patient prospective, randomized and single-blinded Phase II study in patients with breast cancer. That study showed a strong trend toward reduced relapses,particularly in patients with triple negative breast cancer. Keytruda also has shown encouraging results in patients with triple negative breast cancer when used as monotherapy. The complementary mechanisms of action of the two drugs suggest the combination may have the potential to be better than either alone.

AE37 is unique among therapeutic cancer vaccines in that it ensures specific activation of CD4+ T helper cells, which are critical in generating an effective immune response. Its improved immunological potency, along with an excellent safety profile, offers particular advantages for combination studies. In addition to the Phase II study in breast cancer patients, AE37 also has been tested in a Phase I study in prostate cancer patients. AE37 treated patients have consistently displayed a robust, long-lasting and specific response to the vaccine.

Liesha Emens, M.D., Ph.D., Principal Investigator for the study and Professor of Medicine at the University of Pittsburgh Medical Center commented: "So far, metastatic triple negative breast cancer patients treated upfront with immunotherapy benefit clinically from immune checkpoint immunotherapy only if their tumors contain PDL1+ cells. Increasing the number of patients with immune-activated tumors should bring the benefit of immunotherapy to even more patients. This Phase II trial will test whether the AE37 vaccine may trigger immunity in triple negative breast cancer patients, priming them for clinical benefit from immune checkpoint blockade."

Eric von Hofe, President of NuGenerex-ImmunoOncology commented: "We are gratified to see this important trial moving forward. While we have tested AE37 in breast and prostate cancer patients, there is good rationale for inclusion of AE37 in the treatment regimen of a variety of additional cancer types of high unmet need. Gastric, colon, ovarian and bladder cancers all express the same tumor target expressed in breast and prostate cancer that AE37 activates the immune system to recognize."

About AE37

AE37 is an investigational therapeutic cancer vaccine being developed to treat certain types of breast cancer. It is a combination of portions of two proteins that together stimulate the immune system to fight cancer cells.

Up to 80 percent of breast cancers express some level of a protein called HER2. While treatments exist to target HER2 in breast cancer patients with the highest level of HER2 expression (roughly 25%), the majority of patients who have lower levels of expression have more limited treatment options. AE37 consists of a protein derived from the HER2 protein combined with a portion of the MHC class II associated invariant chain which has been termed Ii-Key.

AE37 does not directly target HER2, but rather acts as a vaccine to activate the immune system to recognize the HER2 protein, which is expressed on cancer cells as foreign. AE37 ensures activation of CD4-positive lymphocytes, immune cells that are important in stimulating both the antibody response (antibodies against HER2) and cellular responses directed against the HER2 protein in breast cancer cells. The Ii-Key peptide is coupled with the HER2 protein to ensure a more robust and long-lasting response.

On December 12, 2018 Apexian Pharmaceuticals reported is shedding light on the question of how pre-leukemic cells transform into full-blown leukemia (Press release, Apexian Pharmaceuticals, DEC 12, 2018, View Source [SID1234532036]).

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Genetic mutations by themselves are rarely enough to flip the switch. Inflammation also plays a role. But, until now, the question of "how" remained unanswered.

Apexian Chief Science Officer Mark Kelley, PhD, and his colleagues presented their findings at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s December 1, 2018 meeting in San Diego, California. When a putative tumor-suppressor gene called TET2 does not function well, acute inflammation or infection can enhance the production of myeloid stem and progenitor cells in the bone marrow that are precursors to circulating mature myeloid cells. The TET2 loss of function amplifies; inflammatory proteins increase, and myeloid cells rapidly mature, increasing in sheer numbers as well as developing resistance to programmed cell death.

Myeloid cells, which contribute to immunity, are normally very short-lived. However, when those cells live too long or become too numerous, dangerous levels of inflammation can result. Using a mouse model, Kelley and his colleagues demonstrated that Apexian’s flagship compound APX3330 can prevent precancerous cells from proliferating and block cells from making inflammatory proteins.

Such anti-inflammatory therapy could be of clinical value in people carrying TET2 mutations.

"Apexian continues to develop a robust portfolio of APE1/Ref-1 compounds that have broad utility in oncology, hematology and other diseases," says Steve Carchedi, President and CEO. "We are excited by the recent scientific findings and continue to expand our research and development beyond solid tumors."

APX3330 also has clinical utility with solid tumors. A Phase 1 trial for patients with advanced solid tumors is concluding