On October 15, 2018 Dynavax Technologies Corporation (NASDAQ:DVAX) and Quantum Leap Healthcare Collaborative (QLHC) reported that the immunotherapy combination of Dynavax’s proprietary investigational compound SD-101 and KEYTRUDA (pembrolizumab) will be evaluated in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer (Press release, Dynavax Technologies, OCT 15, 2018, View Source [SID1234530123]).

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!

SD-101 is an intratumoral TLR9 agonist that modulates the tumor microenvironment and optimally primes T cells to generate a systemic anti-tumor response. SD-101 is expected to augment responses to anti-PD-1 therapy as has been reflected in early clinical studies of other tumor types. The combination will be added to standard of care in a new I-SPY 2 TRIAL treatment arm.

"The I-SPY TRIAL is designed to evaluate multiple emerging new agents simultaneously with the goal of getting effective and potentially less toxic treatments to patients much more quickly. We are excited to add SD-101 into I-SPY 2, and combine it with pembrolizumab with the goal of extending responses previously observed with pembrolizumab alone," stated Dr. Laura J. Esserman, MD, MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center.

"We are excited SD-101 has been chosen to be included in the I-SPY 2 trial and see this as an excellent opportunity to potentially expand its use into the emerging field of neoadjuvant immunotherapy," stated Eddie Gray, chief executive officer of Dynavax.

The I-SPY 2 TRIAL, sponsored by QLHC, is a standing phase 2 randomized, controlled, multicenter study with an innovative Bayesian adaptive design aimed to rapidly screen and identify promising new treatments in specific subgroups of women with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III). Dynavax will provide funding and SD-101; Merck will provide pembrolizumab. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.

About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative (QLHC) is a 501C(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY. For more information, visit www.quantumleaphealth.org.

About SD-101
SD-101, Dynavax’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in clinical studies to assess its safety and activity, including a Phase 2 study in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

On October 15, 2018 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer, reported the closing of its previously announced initial public offering of 20,700,000 shares of its common stock, which includes 2,700,000 shares sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, at a price to the public of $18.00 per share (Press release, Allogene, OCT 15, 2018, View Source [SID1234530319]). Including the option exercise, the gross proceeds to Allogene Therapeutics from the offering, before deducting the underwriting discounts and commissions and offering expenses, were $372.6 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!

Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies LLC acted as the joint book-running managers for the offering.

The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from:

Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or via telephone: 1-866-471-2526, or via email: [email protected]; or

J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or via telephone: 1-866-803-9204; or

Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or via email: [email protected]; or

Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or via telephone: 1-877-547-6340, or via email: [email protected].

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on October 10, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 15, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported the phase III KATHERINE study met its primary endpoint, showing Kadcyla (trastuzumab emtansine) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) compared to Herceptin (trastuzumab) as an adjuvant (after surgery) treatment in people with HER2-positive early breast cancer (eBC) who have residual disease (pathological invasive residual disease in the breast and/or axillary nodes) present following neoadjuvant (before surgery) treatment (Press release, Hoffmann-La Roche, OCT 15, 2018, View Source [SID1234529895]). The safety profile of Kadcyla in the KATHERINE study was consistent with previous clinical trials and no new safety signals were identified. [1,2]

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!

"We are highly encouraged by these positive results with adjuvant Kadcyla treatment in people with HER2-positive early breast cancer who have residual disease after neoadjuvant therapy," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We look forward to discussions with regulatory authorities with the goal of bringing this new treatment option to patients as soon as possible."

Full results will be submitted to health authorities around the world, and will be presented at the 2018 San Antonio Breast Cancer Symposium on Wednesday 5 December at 11.00 am CST.

The KATHERINE trial investigated a population of people with HER2-positive eBC who did not achieve a pathological complete response to neoadjuvant treatment. This state of residual disease is associated with a worse prognosis.[3,4]

The goal in treating early breast cancer is to provide people with the best chance for a cure. [5] While we come closer to this goal with each advance, many people still have a disease recurrence in the long-term. [6] Neoadjuvant treatment is given before surgery with the goal of shrinking tumours and helping to improve surgical outcomes. [7,8,9] Adjuvant treatment is given after surgery as part of a complete eBC treatment regimen and is aimed at eliminating any remaining cancer cells in the body, to help reduce the risk of the cancer returning. [7]

About the KATHERINE study[10]
KATHERINE is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive eBC who have pathological residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which, in this study, is defined as the time from randomisation to invasive breast cancer recurrence or death from any cause. Secondary endpoints include disease-free survival and overall survival.

About Kadcyla
Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells, potentially limiting damage to healthy tissues. [1,2] It combines two anti-cancer properties joined together by a stable linker: the HER2-targeting properties of trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. [11] Kadcyla is the only ADC approved as a single agent in 104 countries including the US and EU for the treatment of people with HER2-positive metastatic breast cancer who have previously received Herceptin and taxane chemotherapy, separately or in combination. Roche licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

About Roche’s medicines for HER2-positive breast cancer
Roche has been leading research into the HER2 pathway for over 30 years and is committed to improving the health, quality of life and survival of people with both early and advanced HER2-positive disease. HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 15-20% of patients. [12] Roche has developed three innovative medicines that have helped transform the treatment of HER2-positive breast cancer: Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine). Eligibility for treatment with Roche’s HER2-targeted medicines is determined via a diagnostic test, which identifies people who will likely benefit from these medicines at the onset of their disease.

On October 15, 2018 PellePharm, a late clinical-stage biopharmaceutical company committed to targeting rare skin conditions at their source, reported updated clinical data from two Phase 2 studies of patidegib topical gel in a poster session at NORD’s Rare Diseases and Orphan Products Breakthrough Summit 2018 in Washington, D.C. Results of the studies showed clinical clearance and prevention of basal cell carcinoma (BCC) tumors after 6 months of treatment with patidegib topical gel in patients with Gorlin Syndrome, a rare genetic disease; and both clinical and histologic clearance after 3 months of treatment in patients with sporadic, nodular BCCs (Press release, PellePharm, OCT 15, 2018, View Source [SID1234576274]).

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!

"We are pleased by these positive results showing the potential of patidegib topical gel in preventing new facial BCCs in patients with Gorlin Syndrome, potentially reducing the number of surgeries and resulting facial scarring that patients experience," said Sanuj Ravindran, M.D., president and chief executive officer of PellePharm. "Based on these Phase 2 findings, we intend to initiate a randomized, one-year registrational Phase 3 trial of patidegib topical gel at the end of 2018 in patients with Gorlin Syndrome, and we also plan to study patidegib topical gel in non-Gorlin patients with high-frequency BCCs."

Title: Hedgehog Inhibition by Topical Patidegib Reduces Facial BCC Burden in Patients with Gorlin Syndrome
Date and Time: Monday, October 15 – Tuesday, October 16, 2018
Poster Number: #71

The data presented at the NORD Summit are from two Phase 2 trials of topical patidegib gel – a randomized, double-blind, placebo-controlled, study in patients with Gorlin Syndrome in the UK and in a study in patients with sporadic, nodular BCCs in the US. In the Gorlin Phase 2 trial, 17 patients with a total of 85 surgically eligible BCCs (SEBs) applied patidegib topical gel (administered in strengths of 2% and 4%) or a topical vehicle control twice daily for 6 months to their face for prevention and to 5 SEBs for treatment.

The Phase 2 Gorlin trial showed that for prevention of surgically-eligible BCCs (SEBs), patients in the topical control group developed an average of 1.4 new SEBs in 6 months. In contrast, patients treated with patidegib topical gel 2% and 4% developed only 0.4 SEBs in Intent to Treat analysis (p=0.096) and only 0.3 SEBs in Per-Protocol analysis (p=0.008). Additionally, clinical clearance of tumors was observed in 27% (12 out of 45 SEBs) of the patidegib topical gel treated subjects compared to no tumors with clinical clearance in subjects in the vehicle group (N=16 SEBs, P=0.02).

In the U.S. trial, 36 non-Gorlin patients with sporadic, nodular BCCs applied patidegib topical gel 2%, 4%, or topical control to BCCs for 3 months. Use of patidegib topical gel 2% was significantly more effective in clinical and histologic clearance of BCCs after 3 months compared with the topical vehicle gel (p=0.045). This finding correlated with a decrease in hedgehog biomarker in BCC tumors after three months in patients using patidegib topical gel.

Across both studies, patients using topical patidegib gel did not experience any of the significant side effects characteristic of oral hedgehog inhibitors (e.g., hair loss, taste loss or frequent muscle cramps). Patients treated with patidegib topical gel 4% experienced mild skin irritation (e.g., redness, itching and swelling), but those using patidegib topical gel 2% did not.

About Patidegib

Patidegib topical gel has shown early promise in a Phase 2 clinical study for the mitigation of BCC tumors in Gorlin Syndrome by blocking the disease at its source within the hedgehog signaling pathway. Topical patidegib gel was developed to provide the efficacy previously demonstrated by oral patidegib in Phase 1 trials without the adverse systemic side effects. Patidegib’s gel formulation is stable at room temperature for at least two years, making it a viable potential therapy for ongoing, at-home management of Gorlin Syndrome. Patidegib has received both Orphan Drug Designation and Breakthrough Therapy Designation from the FDA.

About Gorlin Syndrome

Gorlin Syndrome is a rare, genetic, disease where patients are born with mutations in the tumor suppressor gene encoding PATCHED1 (PTCH1), which acts as the primary inhibitor of the hedgehog signaling pathway. This leads to the formation of multiple basal cell carcinomas, often on the face.

With no FDA-approved drugs available for Gorlin Syndrome BCCs, the standard of care is surgery. People with severe Gorlin Syndrome may have as many as 30 surgeries per year, which can be repetitive, scarring and disfiguring. Approximately 10,000 people in the United States, or one in 31,000, are believed to be affected by Gorlin Syndrome. Gorlin Syndrome is known by several names, including Gorlin-Goltz Syndrome, Basal Cell Nevus Syndrome (BCNS), and Nevoid Basal Cell Carcinoma Syndrome (NBCCS).

About High-Frequency Basal Cell Carcinoma (BCCs)

High-Frequency BCC, like Gorlin Syndrome, is a rare disease which is characterized by the development of an abnormally high number of BCCs. Unlike patients with Gorlin Syndrome, patients with high-frequency BCC are not born with a germline PTCH1 mutation and do not suffer from the other systemic manifestations of Gorlin Syndrome. The standard of care for patients with high-frequency BCC is surgery.

On October 15, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported its third quarter 2018 financial results on November 8, 2018 (Press release, Ligand, OCT 15, 2018, View Source [SID1234529913]). Ligand’s CEO John Higgins, President and COO Matt Foehr and Executive Vice President and CFO Matt Korenberg will host the conference call.

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!

Third Quarter 2018 Earnings Call

What: Ligand conference call to discuss financial results and provide general business updates

When: Thursday, November 8, 2018

Time: 9:00 a.m. Eastern time (6:00 a.m. Pacific time)

Conference Call: (833) 591-4752 within the U.S.
(720) 405-1612 outside the U.S.
Conference ID – 5777841

Webcast:
Live conference call webcast and replay accessible at www.ligand.com