On October 15, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292, a selective RET inhibitor, for the treatment of patients with advanced RET fusion-positive thyroid cancer who require systemic therapy, have progressed following prior treatment and have no acceptable alternative treatment options (Press release, Loxo Oncology, OCT 15, 2018, View Source [SID1234529908]). This designation supplements the two LOXO-292 Breakthrough Therapy Designations granted in September 2018. The Breakthrough Therapy Designation announced today was also based on data from the ongoing global Phase 1/2 LIBRETTO-001 clinical trial.

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The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

About LOXO-292
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 has been granted Breakthrough Therapy Designation by the U.S. FDA.

LOXO-292 is currently being studied in the global LIBRETTO-001 Phase 1/2 trial. For additional information about the LOXO-292 clinical trial, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].

About RET-Altered Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of medullary thyroid cancer (MTC). Both RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

On October 15, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will report third quarter financial results after the Nasdaq market closes on Monday, Nov. 5, 2018 (Press release, Neurocrine Biosciences, OCT 15, 2018, View Source;p=RssLanding&cat=news&id=2371705 [SID1234530025]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a Company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-876-9176 (US) or 785-424-1667 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for one month.

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.