On October 20, 2016 Inspyr Therapeutics, Inc. (OTCQB:NSPX), a biotech company developing a novel prodrug therapeutic for the treatment of cancer, announced that the United States Patent and Trademark Office (USPTO) recently issued patent 9,446,141 B2 "Methods of Producing Cancer Compounds (Press release, Inspyr Therapeutics, OCT 20, 2016, View Source [SID1234515934])." Inspyr’s patent portfolio includes the commercial form and the proprietary methods for manufacturing the Company’s lead therapy Mipsagargin, a novel prodrug for the treatment of cancer. This new patent covers the methods for producing Mipsagargin (G-202) and is a key component to protecting the Company’s exclusive right to manufacture Mipsagargin. This patent expands Mipsagargin’s coverage through 2034.

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"Our proprietary production methods included under this new patent add another layer of strength to our intellectual property portfolio," commented Chris Lowe, Inspyr’s President and Chief Executive Officer. "Our team is focused on building a development program which meets the needs of patients."

Founded upon patents exclusively licensed from Johns Hopkins University, Inspyr has strategically expanded its portfolio to include 15 issued U.S. patents and more than 40 pending applications worldwide, focused on the U.S., Europe, and Asia Pacific.

On October 20, 2016 Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, reported that Dr. Doreen Jackson delivered a podium presentation on Galena’s GALE-301 and GALE-302 clinical program at the American College of Surgeons Clinical Congress 2016 in Washington, D.C (Press release, Galena Biopharma, OCT 20, 2016, View Source [SID1234515933]). GALE-301 (E39) and GALE-302 (E39’ – variant of E39) are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. The Phase 1b is a single-center, randomized, single-blinded, three-arm study in patients with breast or ovarian cancer diagnosis who were treated with standard of care and were without evidence of disease. This trial augments the Phase 1/2a trial with single-agent GALE-301 in ovarian and endometrial cancers.

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The presentation is entitled, "A Phase Ib Trial Comparing Different Doses/Schedules of a Folate Binding Protein (FBP)-derived Peptide Vaccine, E39, and its Attenuated Version, E39’, to Induce Long-term FBP-specific Immunity in Disease-free Cancer Patients." In this trial, which enrolled mostly breast cancer patients, who have lower FBP exposure than ovarian patients, the 500mcg dose appears to provide a more optimal immunological response. This differs from the results in ovarian cancer patients, who have much higher FBP expression, with potential secondary immune tolerance, where 1000mcg was the optimal dose. However, E39’ (GALE-302) given after E39 (GALE-301) was able to induce long-term immunity in both dosing cohorts, underscoring the potential importance of attenuated peptides in relatively antigen-naïve patients.

In the patients who received 500mcg of peptide (n=14), delayed-type hypersensitivity (DTH), but not E39-specific cytotoxic T-lymphocytes (CTLs), increased at 1- and 6-months post-primary vaccine series (PVS)(p=0.03 for both). No differences were seen in the patients (n=16) who received 1000mcg of peptide. Comparing the 3 arms in patients who received 500 mcg dosing, only the patients who received E39 followed by E39’ showed increased DTH at 1-month (p=0.013) and 6-months (p<0.0001). In the patients with this same schedule who received 1000mcg of peptide, at 6-months they saw increased DTH (p=0.02) and CTLs (p=0.046). There were no clinicopathologic differences or toxicities greater than grade 2 seen in any of the doses or schedules.

"Similar to the FBP expression levels presented earlier this month from the GALE-301 clinical trial, this GALE-301/GALE-302 data on dosing and treatment schedules is extremely valuable as it highlights the potential utility of the vaccine in different cancer indications as we plan the next path forward for our clinical program targeting FBP," said Bijan Nejadnik, M.D., Executive Vice President and Chief Medical Officer. "This data adds to the body of science for the vaccine and is instrumental in understanding the interaction of our peptides in the treatment landscape. Importantly, the immunologically active doses of the vaccine targeting FBP seem to vary between the breast and ovarian patient populations, and may reflect the implication of the level of FBP expression on the cells. We may consider the use of an attenuated version of this peptide in patient populations with lower FBP expression, since the potency of the FBP vaccine could lead to T-cell burn-out in patients over time."

Dr. Nejadnik continued, "We would like to congratulate Dr. Jackson who was given an award for ‘Excellence in Research’ by the American College of Surgeons for her work on this program. And, we look forward to her poster presentation in December at the San Antonio Breast Cancer Symposium where she will be providing additional data from this trial in breast cancer patients."

HLA-A2-positive breast or ovarian cancer patients were enrolled after completion of standard of care and without evidence of disease, regardless of FBP expression level. The PVS includes six inoculations, one every 3-4 weeks containing 250mcg GM-CSF plus 500mcg peptide in the first five patients per arm (n=14) and 250mcg GM-CSF + 1000mcg of peptide in the second five patients (n=16). Delayed-type hypersensitivity (DTH) and E39-specific CTLs were assessed at one and six months post-PVS. Thirty-nine patients were randomized into three arms with 30 breast (n=27) or ovarian (n=3) cancer patients completing the PVS and assessed for this presentation:

E39 (GALE-301) x 6 inoculations (n=10)
E39 (GALE-301) x 3 inoculations followed by E39’ (GALE-302) x 3 inoculations (n=10)
E39’ (GALE-302) x 3 inoculations followed by E39 (GALE-301) x 3 inoculations (n=10)
About GALE-301 and GALE-302

GALE-301 and GALE-302 are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. GALE-301 is the E39 peptide, while GALE-302 is an attenuated version of this peptide, known as E39’. FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers, and is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells. Two trials are ongoing with FBP peptides: the GALE-301 Phase 2a portion of the Phase 1/2a clinical trial is ongoing in ovarian and endometrial adenocarcinomas (ClinicalTrials.gov Identifier: NCT01580696); the GALE-301 plus GALE-302 Phase 1b clinical trial is ongoing in breast and ovarian cancers (ClinicalTrials.gov Identifier: NCT02019524).

About Breast Cancer1

New cases of breast cancer occur at an annual rate of 125 per 100,000 women in the U.S., with an estimated 246,660 new cases and 40,450 deaths in 2016. Approximately 89.7% of breast cancer patients are expected to survive five years after diagnosis. Approximately 12.4% of women will be diagnosed with breast cancer at some point during their lifetime (2011 – 2013 data). The prevalence data from 2013 showed an estimated 3,053,450 women living with breast cancer in the United States.

About Ovarian Cancer1

New cases of ovarian cancer occur at an annual rate of 11.9 per 100,000 women in the U.S., with an estimated 22,280 new cases and 14,240 deaths in 2016. Approximately 46.2% of ovarian cancer patients are expected to survive five years after diagnosis. Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2011 – 2013 data). The prevalence data from 2013 showed an estimated 195,767 women living with ovarian cancer in the United States.

Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease, with an estimated 75% of women presenting with advanced-stage (III or IV) disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While many patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse. Depending upon their level of residual disease, the risk for recurrence after completion of primary therapy ranges from 60% to 85%. Unfortunately for these women, once the disease recurs, treatment options are limited and the disease remains incurable.

On October 20, 2016 Seattle Genetics, Inc. (Nasdaq: SGEN) today highlighted multiple data presentations at the 10th International Symposium on Hodgkin Lymphoma (ISHL) taking place in Cologne, Germany, October 22-25, 2016, evaluating ADCETRIS (brentuximab vedotin) across a broad range of Hodgkin lymphoma (HL) disease settings (Press release, Seattle Genetics, OCT 20, 2016, View Source;p=RssLanding&cat=news&id=2213330 [SID1234515932]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL that plays a role in tumor pathogenesis. ADCETRIS is being evaluated globally as the foundation of therapy for HL in more than 45 ongoing corporate- and investigator-sponsored clinical trials.

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"For more than a decade, we have been committed to improving treatment outcomes for classical HL patients. We have made tremendous progress with ADCETRIS, which is now FDA-approved for two HL indications in the U.S. and Europe and is being evaluated broadly across all lines of therapy and in many novel regimens," said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. "The data presented at ISHL continue to advance our goal of establishing ADCETRIS as the foundation of care for HL. With 21 abstracts accepted for presentation, we, along with our partner Takeda, are pleased to share new and updated data with the scientific community at ISHL to help move the field forward."

Data presented at ISHL include an update of the progression-free survival and safety from the phase 3 AETHERA trial approximately four years since the last patient was enrolled, demonstrating sustained progression-free survival benefit after extended observation. In addition, updates will be presented from trials evaluating ADCETRIS as both mono- and combination therapy in frontline HL patients age 60 and older, and as second-line therapy for relapsed or refractory HL. Lastly, preclinical data will be presented indicating additional potential mechanisms of action for ADCETRIS, including immunogenic cell death, supporting evaluation of combination therapy with immuno-oncology agents.

Multiple corporate and investigator presentations will be featured at ISHL. Abstracts can be found at www.hodgkinsymposium.org and include the following:

Immune Systems Engagement Results in Non-Classical Antibody-Drug Conjugate Antitumor Activity of Brentuximab Vedotin (Abstract #P099, poster presentation)
Evaluation of Serum TARC Levels in Patients at Risk of Progression Following Autologous Stem Cell Transplant for Hodgkin Lymphoma: Results from the AETHERA Trial (Abstract #P060, poster presentation)
Brentuximab Vedotin After Autologous Stem Cell Transplant Yields the Strongest Benefit in Hodgkin lymphoma Patients with ≥ 2 Risk Factors: Results of a Multivariate Analysis (Abstract #P089 , poster presentation)
Brentuximab Vedotin Alone and in Combination With Dacarbazine or Bendamustine in Patients Aged ≥60 Years With Newly Diagnosed Hodgkin Lymphoma: Interim Results of a Phase 2 Study (Abstract #P023, poster presentation)
Brentuximab Vedotin Plus Bendamustine as a Salvage Treatment Regimen for Patients with Relapsed or Refractory Hodgkin Lymphoma (Abstract #P082, poster presentation)
PET Adapted Dose Escalation of Brentuximab Vedotin as First Line Salvage Therapy in Relapse/Refractory HL (Abstract #P083, poster presentation)
Post Transplant Outcomes in a Multicenter Phase II Study of Brentuximab Vedotin as First Line Salvage Therapy in Relapsed/Refractory HL Prior to ASCT (Abstract #P086, poster presentation)
Pharmacokinetics, Immunogenicity and Safety of Weekly Dosing of Brentuximab Vedotin in Pediatric Patients with Hodgkin Lymphoma (Abstract #P067, oral presentation)
A Phase I Study with an Expansion Cohort of the Combination of Ipilimumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma: A trial of the ECOG-ACRIN Cancer Research Group (Abstract #P080, poster presentation)
The Pharmacokinetic and Pharmacodynamic Properties of Brentuximab Vedotin in a Patient Undergoing Hemodialysis (Abstract #P098, poster presentation)
Single-Arm Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin lymphoma who are Ineligible for Stem Cell Transplantation or Multiagent Chemotherapy (Abstract #P104, poster presentation)
Combining Brentuximab Vedotin with DHAP as Salvage Treatment in Relapsed/Refractory Hodgkin lymphoma: a Phase 1 Dose-Escalation study (Abstract #T024, oral presentation)
Preliminary Results of a Phase II Study of Brentuximab Vedotin Using a Response Adapted Design in the First Line Treatment of Patients with Hodgkin lymphoma Unsuitable for Chemotherapy Due to Age, Frailty or Co-morbidity (BREVITY) (Abstract #P002, poster presentation)
Real-World Effectiveness of Brentuximab Vedotin vs. Other Treatments in Patients with Relapsed/Refractory Hodgkin Lymphoma post Autologous Stem-Cell Transplantation (Abstract #P094, poster presentation)
Brentuximab Vedotin in Patients who are Ineligible for Autologous Stem Cell Transplant with Relapsed or Refractory Hodgkin Lymphoma: A UK and Germany Retrospective Study (Abstract #P093, poster presentation)
Risk Factors for Relapse in Patients with Relapsed or Refractory Hodgkin Lymphoma after Autologous Stem Cell Transplant: A Real-World Analysis in Germany and the United Kingdom (Abstract #P095, poster presentation)
Superiority of Modified Progression Free Survival to Evaluate Chemotherapy Effectiveness for Advanced Stage Hodgkin Lymphoma (Abstract #P007, poster presentation)
Sequential Brentuximab Vedotin and Adriamycin, Vinblastine and Darabazine (AVD) for Older Patients with Untreated Hodgkin Lymphoma: Findings from a Phase II Window study (Abstracts #P001, poster presentation)
PET-adapted Therapy with Brentuximab Vedotin and Augmented ICE for Relapsed/Refractory Hodgkin Lymphoma – Lack of Improvement with 3 versus 2 Cycles of Weekly BV (Abstract #P088, poster presentation)
An International Multicenter Phase I/II Study of Brentuximab Vedotin and Bendamustine in Patients with Heavily Treated Relapsed or Refractory Hodgkin Lymphoma and Anaplastic Large T-Cell Lymphoma (Abstract #P085, poster presentation)
HALO Study: a Phase 1/2 Clinical Trial of Brentuximab Vedotin and Bendamustine in Elderly Patients with Previously Untreated Advanced Hodgkin Lymphoma (Abstract #P011, poster presentation)
ADCETRIS is currently not approved for the treatment of frontline or salvage HL in patients eligible for autologous transplant, graft-versus-host disease (GVHD) or as a combination therapy for HL.

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system and is the most common type of blood cancer. There are two major categories of lymphoma: HL and non-Hodgkin lymphoma. Classical HL is distinguished from other lymphomas by the characteristic presence of CD30-positive Reed-Sternberg cells.

According to the American Cancer Society, approximately 8,500 cases of HL will be diagnosed in the United States during 2016 and more than 1,100 will die from the disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with HL each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 ongoing clinical trials, including two phase 3 studies, ECHELON-1 in frontline classical HL and ECHELON-2 in frontline mature T-cell lymphomas, as well as trials in many additional types of CD30-expressing malignancies, including B-cell lymphomas.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. ADCETRIS has received marketing authorization by regulatory authorities in 65 countries.

In June 2016, the European Commission extended the current conditional approval of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On October 20, 2016 Pain Therapeutics, Inc. (Nasdaq:PTIE) reported financial results for the third quarter of 2016 (Press release, Pain Therapeutics, OCT 20, 2016, View Source [SID1234515931]). Net loss in Q3 2016 was $3.5 million, or $0.08 per share, compared to a net loss in Q3 2015 of $3.7 million, or $0.08 per share.

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At September 30, 2016, cash and investments were $21.8 million, compared to $24.6 million at June 30, 2016. The Company has no debt.

"We continue to evaluate the comments recently raised by the FDA with regards to REMOXY," said Remi Barbier, President and Chief Executive Officer. "We are encouraged by the preliminary feedback we have received from external experts in the field and look forward to announcing a new strategy after further consultation with external advisors."

Financial Highlights for Q3 2016

Research and development expenses increased to $2.7 million in Q3 2016 from $2.4 million in Q3 2015, primarily due to increased activities related to REMOXY ER (oxycodone capsules CII). Research and development expenses included non-cash stock-related compensation costs of $0.3 million in both Q3 2016 and Q3 2015.
General and administrative expenses decreased to $0.9 million in Q3 2016 from $1.3 million in Q3 2015, primarily due to lower compensation costs. General and administrative expenses included non-cash stock-related compensation costs of $0.5 million in both Q3 2016 and Q3 2015.
Net cash used in Q3 2016 was $2.8 million.

On October 20, 2016 Debiopharm International (Debiopharm – www.debiopharm.com) reported that it has entered into a collaboration agreement with Merck and Pfizer (NYSE:PFE) to evaluate Debio 1143, an oral, small molecule inhibitor of IAPs (Inhibitor of Apoptosis Proteins), in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Press release, Debiopharm, OCT 20, 2016, View Source [SID1234525193]). Debio 1143 is currently in Phase II development for Head & Neck and Ovarian Cancer. Avelumab is under clinical investigation across a broad range of tumor types by the Merck-Pfizer Alliance. Under the terms of the agreement, Debiopharm will be responsible for conducting the Phase I/Ib clinical trial in NSCLC.

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"We are delighted to initiate this collaboration in immuno-oncology with the Merck-Pfizer Alliance. It is a great opportunity to explore in the clinic the immunomodulatory properties of Debio 1143 observed in preclinical studies," said Dr Chris Freitag, Vice President, Clinical Research & Development, Debiopharm International SA. "We are hopeful that the immunosensitizing effect of our compound in combination with avelumab may translate into a potentially better treatment outcome for patients suffering from this major debilitating disease."

Globally, lung cancer is the leading cause of cancer death among both men and women, responsible for more deaths than colon, breast and prostate cancer combined.1 NSCLC is the most common type of lung cancer, accounting for 80-85% of all lung cancers.2 The 5-year survival rate for people diagnosed with late-stage lung cancer that has spread (metastasized) to other areas of the body is 4%.3

"Inhibition of the PD-1/PD-L1 pathway has shown promising activity in patients with advanced NSCLC," said Alise Reicin, M.D., Head of Global Clinical Development in the biopharma business of Merck. "We hope that our exploration of avelumab as a combination therapy with Debio 1143 will generate results that could potentially one day make a real difference to patients fighting this deadly cancer."

"Investigating the potential of combination therapy is an important strategic focus for the Merck-Pfizer Alliance," said Chris Boshoff, M.D., Ph.D., Head of Immuno-Oncology, Early Development, and Translational Oncology at Pfizer. "This collaboration with Debiopharm provides a significant opportunity to explore the potential synergistic effects of these two agents in combination."

About Debio 1143
Debio 1143 is an oral, small molecule inhibitor of IAPs (Inhibitor of Apoptosis Proteins) that promotes apoptosis of cancer cells by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC). Evasion of apoptosis is a hallmark of cancer and a common mechanism of resistance to current treatments and Debio 1143 is being investigated as chemo- and radio-sensitizer in Ovarian Cancer and Head & Neck Cancer. In addition, like other members of the class, Debio 1143 displays strong immunomodulatory properties that make it a natural candidate for combination with Immune Checkpoint Inhibitors.

About Avelumab
Avelumab (also known as MSB0010718C) is an investigational, fully human antibody specific for a protein found on tumor cells called PD-L1, or programmed death ligand-1. Avelumab is thought to have a dual mechanism of action which may enable the immune system to find and attack cancer cells. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells such as T-cells, exposing them to anti-tumor responses. Avelumab is also thought to help white blood cells such as natural killer (NK) cells find and attack tumors in a process known as ADCC, or antibody-dependent cell-mediated cytotoxicity. In November 2014, Merck, the science and technology company, and Pfizer announced a strategic alliance to
co-develop and co-commercialize avelumab.