On October 30, 2019 Dendreon Pharmaceuticals, a commercial-stage biopharmaceutical company and pioneer in the development of immunotherapy, reported early completion of patient enrollment of its Phase 3 ProVent clinical trial. More than 450 subjects were randomized in the large-scale clinical trial, which is evaluating the effectiveness of sipuleucel-T (PROVENGE) in reducing disease progression in men with early-stage prostate cancer on active surveillance (AS) (Press release, Dendreon, OCT 30, 2019, View Source [SID1234550065]).

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 rapid pace of enrollment in the ProVent trial is a significant milestone for Dendreon, and underscores a strong interest by patients and physicians in the potential clinical benefit of sipuleucel-T in men on AS," said Bruce A. Brown, M.D., chief medical officer at Dendreon. "PROVENGE has been proven to extend life in men with mCRPC, and we intend to change the way prostate cancer is treated by showing that immunotherapy can reduce disease progression and the need for aggressive intervention in men with early-stage disease."

Nearly 175,000 men are diagnosed with prostate cancer every year.1 Of these, about 30 to 40% with a lower risk of prostate cancer will opt for AS, which includes regular monitoring to assess whether the cancer is progressing, instead of more aggressive treatment options such as surgery or radiation.2,3

"For men with low-risk, localized prostate cancer, the option of AS is regularly recommended; however, variation in PSA monitoring and the anxiety of having a ‘cancer’ diagnosis causes many men to leave surveillance management and undergo interventional treatment," said Neal D. Shore, M.D., FACS, ProVent principal investigator, medical director for the Carolina Urologic Research Center and a practicing urologist at Atlantic Urology Clinics in Myrtle Beach, S.C. "Both patients and physicians have desired a proactive therapy for appropriate AS patients in order to optimize their long-term outcomes. Given the numerous studies describing the effectiveness of sipuleucel-T immunotherapy for advanced prostate cancer, we are optimistic that data from ProVent may lead to the first-ever immunotherapy treatment option for men with early-stage prostate cancer."

About the ProVent Trial
The randomized, multicenter Phase 3 ProVent trial is assessing the efficacy of sipuleucel-T in reducing histopathologic disease progression in men on AS. Men age 18 or older who have histologically-proven adenocarcinoma of the prostate diagnosed within 12 months of randomization were eligible to enroll in the study, which is being conducted at approximately 60 sites across the United States. Study participants were randomized 2:1 to receive sipuleucel-T or remain on AS.

The primary endpoint is histological upgrade from ISUP Grade Group 1 to Grade Group 2 or higher, or Grade Group 2 upgraded to Grade Group 3 or higher at 33-39 months after randomization. Secondary endpoints include the number of study participants who receive subsequent prostate cancer treatment (e.g., surgery, radiation, hormone therapy), the percentage of participants with a negative biopsy, and safety. Exploratory objectives will evaluate quality of life and the association of immunologic responses with efficacy.

Enrollment in the ProVent study began in late 2018, and topline results are expected in 2023.

For more information, visit www.ProVentStudy.com or clinicaltrials.gov (NCT03686683).

About Active Surveillance (AS)
During AS, prostate tumors are not treated, but are regularly monitored via biopsies (every one to two years) and regular prostate-specific antigen (PSA) testing to determine disease progression. AS reduces the risk of overtreatment of clinically-insignificant prostate cancer while retaining the option of definitive therapy. AS is increasingly accepted as a treatment option for certain categories of prostate cancer.4 It is included in treatment guidelines from organizations including the American Urological Association, American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and National Comprehensive Cancer Network.

About PROVENGE (sipuleucel-T)
PROVENGE is the only FDA-approved immunotherapy made from a patient’s own immune cells for the treatment of prostate cancer. More than 30,000 men have been prescribed PROVENGE, and it has been clinically proven to extend life for certain men in advanced stages of the disease.

INDICATION
PROVENGE is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION
Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

On October 30, 2019 ImmunSYS, Inc., a clinical stage biotechnology company focused on the development of YourVaccx, a new intratumoral immunotherapy system for metastatic castrate resistant prostate cancer and other solid tumor cancers, reported that the company received the top award at the recent BioPitch 2019, a Shark Tank for life science companies that highlighted the 2019 BioFlorida annual conference (Press release, ImmunSYS, OCT 30, 2019, View Source [SID1234550064]).

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 company won $10,000 after besting 15 other seed-stage and early-stage life science firms that also pitched at the Oct. 22 conference in Tampa. More than 20 investor judges worked over the past several months to review a record-breaking number of applications for BioPitch, and they determined the 16 semi-finalists who presented at the conference, said Jane Teague, who organized the pitch competition and is executive director of the Institute for Commercialization of Florida Technology.

In addition to the pitch competition, the conference featured biotech leaders presenting research updates, and panels discussing the state of the industry in Florida.

To learn more about ImmunSYS and BioPitch 2019, you can read the recap here: https://stpetecatalyst.com/meet-the-company-that-won-10000-at-biopitch

On October 30, 2019 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported the pricing of its initial public offering of 3,000,000 shares of common stock at a public offering price of $12.00 per share (Press release, RAPT Therapeutics, OCT 30, 2019, View Source [SID1234550062]).

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!

In addition, the underwriters have been granted a 30-day option to purchase up to an additional 450,000 shares of common stock at the initial public offering price, less the underwriting discount. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by RAPT, are expected to be $36.0 million, excluding any exercise of the underwriters’ option to purchase additional shares. The shares are expected to begin trading on the Nasdaq Global Market on October 31, 2019, under the ticker symbol "RAPT." The offering is expected to close on November 4, 2019, subject to the satisfaction of customary closing conditions.

BMO Capital Markets, Wells Fargo Securities and UBS Investment Bank are acting as joint book-running managers for the offering.

The offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from: BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036, by telephone at (800) 414-3627 or by e-mail at [email protected]; Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York, New York 10152, or by email at [email protected], or by telephone at (800) 326-5897; or UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, by telephone at (888) 827-7275 or by email at [email protected]. Copies of the preliminary prospectus and, when available, the final prospectus related to the Offering are also available, or will be available, at www.sec.gov.

A registration statement relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on October 30, 2019. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 30, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its third quarter 2019 financial results after the market closes on Wednesday, November 13, 2019 (Press release, Personalis, OCT 30, 2019, View Source [SID1234550061]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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!

Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 8749318. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On October 30, 2019 The Mary Kay FoundationSM, a decades-long leader in the mission to eliminate cancers affecting women, reported that donated $100,000 to Baylor Scott & White Dallas Foundation to help fund research conducted by Dr. Joyce O’Shaughnessy, breast oncologist with TEXAS Oncology and the Celebrating Women Chair in breast cancer research at Baylor University Medical Center (Press release, The Mary Kay Foundation, OCT 30, 2019, View Source [SID1234550060]). Dr. O’Shaughnessy’s deep portfolio of research includes the study of triggers that may cause heightened sensitivity of triple negative breast cancer (TNBC) cells and the effectiveness of therapies based on this sensitivity.

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!

TNBC is a high-risk breast cancer with few effective options for patients. It usually affects younger women, African American women, and women with a BRCA1 genetic mutation. Compared with other breast cancer subtypes, TNBC is associated with a worse prognosis, including shorter time to recurrence in early-stage diseases (within 3 years) and a shorter time between recurrence and death in the metastatic setting (between 9-12 months).

"At The Mary Kay Foundation, our mission is to eradicate cancers that affect women around the world, and each year we invest millions in groundbreaking research and support for organizations like Baylor Scott & White," said Dr. Lucy Gildea, Chief Scientific Officer of Mary Kay Inc. "We’re honored to help fund Dr. O’Shaughnessy’s potentially lifesaving research, and we look forward to following along and learning how these results might impact the prognosis of metastatic TNBC patients in the future."

Dr. O’Shaughnessy has focused her research on the metastatic TNBC population due to the very high, unmet medical need. Dr. O’Shaughnessy has worked with Baylor Scott & White Research Institute, which oversees research efforts and provides staffing and other clinical support for the healthcare system, to also design and develop Investigator Initiated Studies examining TNBC.

"The goal of this work is to understand more about the pathways that might allow patients to achieve highly durable complete responses to their treatment and to determine the molecular characteristics of TNBCs that predict the benefit from different treatment strategies," said Dr. O’Shaughnessy. "This type of work could expand the options available to patients with metastatic diseases and bring greater hope to those in need."

"As the largest not-for-profit healthcare system in Texas, Baylor Scott & White relies upon generous donations from organizations like The Mary Kay FoundationSM to continue our innovative research on behalf of patients," said Rowland K. Robinson, president of Baylor Scott & White Dallas Foundation. "We’ve seen promising results from Dr. O’Shaughnessy’s trials so far. And, with The Mary Kay Foundation’s support, we’re hopeful her important work will continue to help us gain additional insight to better serve those with metastatic triple negative breast cancer."

Over the course of more than two decades, The Mary Kay FoundationSM has awarded more than $80 million to women’s shelters and domestic violence service providers, as well as cancer research programs and related causes throughout the United States.