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]).

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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.

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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]

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"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 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.

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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

On October 15, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that in conjunction with the two Proffered Papers Sessions (oral presentations) highlighting data from ongoing clinical trials of sitravatinib, the Company will conduct an investor conference call during the 2018 Annual Meeting of the European Society for Medical Oncology in Munich, Germany, on October 22nd at 2:00 p.m. CEST/8:00 a.m. EDT/5:00 a.m. PDT (Press release, Mirati, OCT 15, 2018, View Source [SID1234529931]).

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The Proffered Papers (Oral Presentations) Details:

Title: Sitravatinib demonstrates activity in patients with novel genetic alterations that inactivate CBL
Presentation Topic: Proffered paper session – Developmental therapeutics (ID 170)
Location: Hall B3 – Room 22, ICM München, Munich, Germany
Lecture Date and Time: October 21, 2018, at 11:00 a.m. – 11:12 a.m. CEST
Presentation Number: 408O
Presenter: Lyudmila Bazhenova, M.D.

The data being presented in this oral presentation will feature data from the ongoing Phase 1b trial of sitravatinib monotherapy in patients with certain genetic alterations.

Title: Stage 2 enrollment complete: Sitravatinib in Combination with Nivolumab in NSCLC Patients Progressing on Prior Checkpoint Inhibitor Therapy
Presentation Topic: Proffered paper session – Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (ID 159)
Location: Hall A2 – Room 18, ICM München, Munich, Germany
Lecture Date and Time: October 22, 2018, at 12:06 p.m. – 12:18 p.m. CEST
Presentation Number: 1129O
Presenter: Ticiana A. Leal, M.D.

The data being presented in this oral presentation comprise updated clinical data from the ongoing Phase 2 trial of sitravatinib in combination with OPDIVO (nivolumab) for the treatment of non-small cell lung cancer (NSCLC) patients who have progressed on prior immune checkpoint inhibitor therapy.

Investor Call and Webcast Information
In conjunction with the oral presentations, Mirati will host a live conference call and webcast, led by Dr. Charles Baum, on Monday, October 22, 2018, at 2:00 p.m. CEST/8:00 a.m. EDT/5:00 a.m. PDT. The live call can be accessed by dialing (866) 324-3683 (toll free) or (509) 844-0959 (international) and then using passcode 3890724. A telephone replay will be made available by dialing (855) 859-2056 (toll free) or (404) 537-3406 (international) using conference replay ID 3890724.

The call will also be webcast live through the "Investors" section of the Mirati corporate website at View Source A replay of the webcast will be available on the Mirati website shortly after the conclusion of the event.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial enrolling patients whose tumors harbor specific mutations in the CBL kinase. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations