Moleculin has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Moleculin, 2017, NOV 13, 2017, View Source [SID1234521988]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 13, 2017 BioTime, Inc. (NYSE American: BTX), a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases, reported that its management will participate in the following conferences (Press release, BioTime, NOV 13, 2017, View Source;p=RssLanding&cat=news&id=2316395 [SID1234521958]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Torrey Hills Capital Emerging Growth Conference on Tuesday, November 14, 2017. This conference is being held at the Morgan Run Club and Resort in Rancho Santa Fe, CA.
LD Micro 10th Annual Main Event Conference on Wednesday, December 6, 2017. This conference is being held at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.
At each conference mentioned above the Company will be hosting one-on-one and group meetings throughout the day. Analysts and portfolio managers that wish to attend the conference or would like to request a meeting should contact Torrey Hills Capital or LD Micro.

On November 13, 2017 Adaptimmune Therapeutics plc (Nasdaq: ADAP), a leader in T-cell therapy to treat cancer, reported that it is presenting two trials in progress posters summarizing study designs for ongoing clinical trials with MAGE-A4 and NY-ESO SPEAR T-cells at the 2017 SITC (Free SITC Whitepaper) annual meeting at the Gaylord National Hotel & Convention Center in National Harbor, Maryland, United States (Press release, Adaptimmune, NOV 13, 2017, View Source [SID1234521993]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Overview of Study Designs:

· MAGE-A4 SPEAR T-cells targeting multiple solid tumors(1):

· Open-label, non-randomized pilot study evaluating the safety, tolerability, and antitumor activity of MAGE-A4 SPEAR T-cells in patients with HLA-A*02 and MAGE-A4 positive inoperable locally advanced or metastatic tumor(s)

· This dose escalation study utilizes a modified 3+3 design:

· Group 1: to enroll 3-6 patients; dose of 100 million transduced SPEAR T-cells, 21-day interval for safety review

· Group 2: to enroll 3-6 patients; dose of 1 billion transduced SPEAR T-cells, 7-day interval for safety review(2)

· Group 3: to enroll 3-6 patients; dose of 1-5 billion transduced SPEAR T-cells, 7-day interval for safety review(2)

· Study allows for expansion at optimal dose range up to 20 patients across tumors

· Patients must be: > 18 yrs old; HLA-A*02 positive; have MAGE-A4 positive inoperable locally advanced or metastatic tumor(s) at >1+ intensity in > 10% of tumor cells MAGE-A4 expression by immunohistochemistry (IHC); have ECOG status 0 or 1; and adequate organ function

· Lymphodepletion regimen: fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days

· Efficacy assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months until confirmation of disease progression

· The study is open and enrolling

· NY-ESO SPEAR T-cells with or without KEYTRUDA(pembrolizumab) in multiple myeloma:

· Open-label, randomized pilot study evaluating the safety, tolerability, and antitumor activity of NY-ESO SPEAR T-cells with or without KEYTRUDA in patients with multiple myeloma

· Eligible patients will be randomly assigned to a treatment arm: NY-ESO SPEAR T-cells alone (Arm 1) or NY-ESO-1 SPEAR T-cells in combination with KEYTRUDA (Arm 2)

(1) Urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC (squamous, adenosquamous, or large cell), esophageal (squamous and adenocarcinoma) or gastric cancer

(2) If, in Group 1 or Group 2, 1 out of 3 patients experiences a dose limiting toxicity (DLT) requiring expansion of an additional 3 patients (n=6), the subsequent observation periods in Group 2 or Group 3 will be increased from 7 days to 14 days for the respective groups.

· Target enrollment is 20 patients with 10 in each arm; eligible patients who do not receive the T-cell infusion may be replaced.

· Patients must be: > 18 yrs old; HLA-A*02:01, *02:05, or *02:06 positive; have histologically confirmed diagnosis of multiple myeloma with either primary refractory or relapsed/refractory disease expressing NY-ESO-1 and/or LAGE-1a; have received prior therapies including IMiD and a proteasome inhibitor as separate lines or a combined line of therapy; have ECOG status 0 or 1; and adequate organ function

· Lymphodepletion regimen: fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days, followed by granulocyte-colony stimulating factor

· For patients in Arm 2, KEYTRUDA will be administered every 3 weeks, starting at week 3 following T-cell infusion until week 108

· Target dose of 1 – 8 × 109 transduced SPEAR T-cells

· Efficacy will be assessed by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Overall response rate, time to response, duration of response, progression-free survival, and overall survival will be determined.

· The study is open and enrolling

On November 13, 2017 Arcus Biosciences, a clinical-stage biotechnology company focused on the discovery and development of innovative cancer immunotherapies, reported the completion of a $107 million Series C financing (Press release, Arcus Biosciences, NOV 13, 2017, View Source [SID1234521995]). This financing brings the total equity capital that the company has raised since its inception in 2015 to $227 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The proceeds from this financing will be used for the advancement of Arcus’s clinical programs for AB928, a first-in-class dual adenosine receptor antagonist, and AB122, a PD-1 antibody. Earlier this month, Arcus initiated a phase 1 trial of AB928 in healthy volunteers and Arcus plans to initiate a phase 1/2 trial of AB928 in combination with AB122 in cancer patients during the first half of 2018. Also in November, Arcus initiated a phase 1 trial of AB122 in cancer patients in Australia. Data from the AB122 trial will be available in 2018 and Arcus plans to evaluate AB122 in combination with its other product candidates, in addition to AB928, in the future. The proceeds raised will also allow Arcus to advance at least two additional product candidates into clinical development, including AB680, a first-in-class small molecule CD73 inhibitor, and AB154, a TIGIT antibody.

The financing was led by GV (formerly Google Ventures), with participation from new investors, including Wellington Management Company LLP, EcoR1 Capital, BVF Partners L.P., Decheng Capital, Hillhouse, Aisling Capital and entities affiliated with Leerink Partners. Arcus’s existing investors, including The Column Group, Foresite Capital, Invus Opportunities, DROIA, Celgene Corporation and Taiho Ventures, also participated in the financing.

"We are extremely pleased to add several outstanding investors with significant expertise in biotechnology to our investor group," said Terry Rosen, Ph.D., CEO of Arcus Biosciences. "We have been assembling a team of staff, investors, leadership and advisors with a highly aligned long-term vision to create, develop and commercialize innovative cancer immunotherapies that may offer a meaningful benefit to patients over existing treatments. These new investors share this vision, and we are thrilled to add their expertise, leadership and commitment to our team."

On November 13, 2017 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a revenue-stage biopharmaceutical company engaged in the development of a proprietary cancer vaccine technology, targeted cancer therapies and commercialization of a portfolio of products internationally, reported the latest data updating the progression results at 19 weeks for all 20 patients, who have completed 6 vaccines in their Phase 1 clinical trial of ProscaVax for recurrent prostate cancer patients with increasing prostate specific antigen (PSA) (Press release, OncBioMune Pharmaceuticals, NOV 13, 2017, View Source [SID1234522143]). ProscaVax is OncBioMune’s novel immunotherapeutic cancer vaccine consisting of a combination of prostate cancer associated PSA with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

All 20 patients enrolled in the trial completed ProscaVax therapy per protocol and have now completed the first follow-up at 19 weeks. 16 of 20 patients (80%) demonstrated stable disease/no prostate cancer progression. Only four patients progressed during ProscaVax therapy (3 PSA progression, 1 radiological progression in the brain).

The safety review confirmed there were no drug-related serious adverse events or dose-limiting toxicities resulting from the vaccine therapy.

OncBioMune is awaiting additional follow-up data related to our previously disclosed study data. This includes additional results on patients beyond the previously reported 12 of 15 patients that received ProscaVax vaccine, who exhibited an increased immune response to PSA as determined with a Lymphocyte Blastogenesis Assay. Also, additional results on the 6 patients vaccinated after OncBioMune previously reported that 9 of 14 patients who received six ProscaVax vaccinations demonstrated increased PSA doubling times. Additional follow-up will provide longer follow-up intervals for the last six patients who completed the vaccine therapy.

"All the data to date is consistent with previous study data showing ProscaVax elicits immune responses to fight tumor growth in prostate cancer," said Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We are impressed that 80 percent of the patients treated with ProscaVax demonstrated stable disease. We look forward to continuing to follow the patients in this study to collect additional data and also to conducting a larger study to further validate the therapeutic benefit of our vaccine platform technology."