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BD Announces Live Webcast Of First Fiscal Quarter Earnings Conference Call

On January 9, 2020 BD (Becton, Dickinson and Company) (NYSE:BDX) reported that it will conduct a live webcast of its first fiscal quarter 2020 earnings conference call on Thursday, February 6, 2020, at 8:00 a.m. (ET) (Press release, BD Pharmaceutical Systems, JAN 9, 2020, View Source [SID1234552945]). BD will issue a press release detailing the quarter’s earnings earlier that morning.

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The webcast of the conference call, along with related slides, will be accessible through BD’s website at www.bd.com/investors and will be available for replay through Thursday, February 13, 2020.

Mirati Therapeutics Announces Pricing Of Public Offering Of Common Stock

On January 9, 2020 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported the pricing of an underwritten public offering of 3,076,924 shares of its common stock at a price to the public of $97.50 per share (Press release, Mirati, JAN 9, 2020, View Source [SID1234552944]). The aggregate gross proceeds from this offering are expected to be approximately $300.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Mirati. The offering is expected to close on or about January 14, 2020, subject to customary closing conditions. Mirati has also granted the underwriters a 30-day option to purchase up to an additional 461,538 shares of common stock in connection with the public offering. All of the shares are being sold by Mirati.

Mirati expects to use the net proceeds from this offering for general corporate purposes, including expenses related to the clinical development of MRTX849 and sitravatinib, manufacturing scale-up, the preclinical development of a KRAS G12D inhibitor and the development of other preclinical programs, for the expansion of its organizational capabilities, including establishing commercial operations, and for working capital.

Goldman Sachs & Co. LLC, SVB Leerink and Cowen and Company, LLC are acting as joint book-running managers in the offering. Credit Suisse is acting as lead manager in the offering. JonesTrading Institutional Services LLC is acting as a co-manager in the offering.

The securities described above are being offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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.

Jasper Therapeutics Announces Expansion of Series A Financing, Bringing Total Corporate Fundraising to More than $50 Million

On January 9, 2020 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported the expansion of its Series A financing with an additional investment of $14.1 million led by Roche Venture Fund and with participation from other investors, bringing the total company financing to more than $50 million to date (Press release, Jasper Therapeutics, JAN 9, 2020, View Source [SID1234552943]). The initial Series A round was led by Abingworth LLP and Qiming Venture Partners USA, with further investment from Surveyor Capital (a Citadel company) and participation from Alexandria Venture Investments, LLC.

Jasper plans to use the proceeds to advance and expand the study of its lead clinical asset, JSP191. A humanized antibody targeting CD117 on hematopoietic stem cells, JSP191 is designed to replace toxic chemotherapy and radiation therapy as conditioning regimens to prepare patients for curative stem cell and gene therapy. JSP191 is the only antibody of its kind in clinical development as a single conditioning agent for people undergoing curative hematopoietic cell transplantation.

This investigational agent is currently being evaluated in a Phase 1/2 dose-escalation and expansion study as a conditioning agent to enable stem cell engraftment in patients with severe combined immunodeficiency (SCID) who received a prior stem cell transplant that resulted in poor outcome. Initial positive results from this ongoing clinical trial were presented in an oral session at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2019. Jasper plans to expand the Phase 1/2 clinical study to include patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) receiving hematopoietic cell transplant. The development of JSP191 is supported by a collaboration with the California Institute for Regenerative Medicine (CIRM).

About Hematopoietic Cell Transplantation
Blood-forming, or hematopoietic, stem cells are rare cells that reside in the bone marrow and are responsible for the generation and maintenance of all blood and immune cells. These stem cells can harbor inherited or acquired abnormalities that lead to a variety of disease states, including immune deficiencies, blood disorders or hematologic cancers. Replacement of the defective or malignant hematopoietic stem cells in the patient’s bone marrow by transplantation and engraftment of healthy stem cells is the only cure for most of these life-threatening conditions. Successful transplantation is currently achieved by subjecting patients to toxic treatment with radiation and/or chemotherapy followed by transplantation of a donor or gene-corrected hematopoietic cell graft. These toxic regimens cause DNA damage and lead to short- and long-term toxicities, including unwanted damage to organs and prolonged hospitalization. As a result, many patients who could benefit from a hematopoietic cell transplant are not eligible. New approaches that are effective but have minimal to no toxicity are urgently needed so more patients who could benefit from a curative stem cell transplant could receive the procedure.

Safer and more effective hematopoietic cell transplantation regimens could overcome these limitations and enable the broader application of hematopoietic cell transplants in the cure of many disorders. These disorders include hematologic cancers (e.g., myelodysplastic syndrome [MDS] and acute myeloid leukemia [AML]), autoimmune diseases (e.g., lupus, rheumatoid arthritis, multiple sclerosis and Type 1 diabetes), and genetic diseases that could be cured with genetically-corrected autologous stem cells (e.g., severe combined immunodeficiency syndrome [SCID], sickle cell disease, beta thalassemia, Fanconi anemia and other monogenic diseases).

About JSP191
JSP191 (formerly AMG 191) is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow. JSP191 binds to human CD117, a receptor for stem cell factor (SCF) that is expressed on the surface of hematopoietic stem and progenitor cells. The interaction of SCF and CD117 is required for stem cells to survive. JSP191 blocks SCF from binding to CD117 and disrupts critical survival signals, causing the stem cells to undergo cell death and creating an empty space in the bone marrow for donor or gene-corrected transplanted stem cells to engraft.

Preclinical studies have shown that JSP191 as a single agent safely depletes normal and diseased hematopoietic stem cells, including in an animal model of MDS. This creates the space needed for transplanted normal donor or gene-corrected hematopoietic stem cells to successfully engraft in the host bone marrow. To date, JSP191 has been evaluated in more than 80 healthy volunteers and patients. It is currently being evaluated as a sole conditioning agent in a Phase 1/2 dose-escalation and expansion trial to achieve donor stem cell engraftment in patients undergoing hematopoietic cell transplant for SCID, which is curable only by this type of treatment. For more information about the design of the clinical trial, visit www.clinicaltrials.gov (NCT02963064). Clinical development of JSP191 will be expanded to also study patients with AML or MDS who are receiving hematopoietic cell transplant. IND-enabling studies are planned to advance JSP191 as a conditioning agent for patients with other rare and ultra-rare monogenic disorders and autoimmune diseases.

Physicians’ Education Resource® Presents the 2nd Annual Precision Medicine Symposium in New York City

On January 9, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education, reported that it will host the 2nd Annual Precision Medicine Symposium: An Illustrated Tumor Board (Press release, Physicians’ Education Resource, JAN 9, 2020, View Source [SID1234552942]). The dynamic symposium will take place April 17-18 at InterContinental New York Barclay in New York City and will be chaired by Andre H. Goy, M.D., chairman, executive director, and lymphoma division chief at John Theurer Cancer Center at Hackensack University Medical Center; and chief science officer and director of research and innovation at Regional Cancer Care Associates in Hackensack.

"We look forward to hosting our precision medicine conference for the second year in a row," said Phil Talamo, president of PER. "This meeting is designed to take a targeted approach to treatment, focusing on how biomarkers and testing strategies can personalize care to patients, often times in a tumor agnostic setting."

Across a two-day, pan-tumor symposium, expert faculty will cover the latest topics in solid and liquid tumors, including lung, breast, gastrointestinal, genitourinary, skin cancers and hematologic malignancies. The educational meeting will feature high-impact sessions and keynote lectures that will focus on practical takeaways regarding the latest updates in next-generation sequencing, liquid biopsy and cytogenetic testing. The program will review updates in targeted treatment, including tumor-agnostic indications based solely on genomic markers and other biomarkers. The tumor board overall will emphasize the role of advanced genetic panel testing and the use of targeted therapies, with a focus on data that is most relevant to patient care.

MiraDx Enrolling First-Ever Non-Tumor Based microRNA Clinical Trial at UCLA

On January 9, 2020 Molecular genetics company MiraDx reported it is opening patient enrollment in collaboration with UCLA for a first-ever non-tumor based microRNA biomarker-driven clinical trial for KRAS-variant positive HPV-positive head and neck cancer patients (HNSCC) (Press release, MiraDx, JAN 9, 2020, View Source [SID1234552941]). The trial will randomize 70 patients to current standard of care (radiation plus cisplatin) or radiation, cisplatin and ERBITUX (cetuximab), an epidermal growth factor receptor (EGFR) antagonist, to compare differences in overall survival.

The trial is intended to further confirm findings from a previous Phase 3 randomized study for HNSCC patients, RTOG 0522 (NCT00265941), which MiraDx previously analyzed and showed that the subgroup of patients with the KRAS-variant who received ERBITUX in combination with radiation and cisplatin had significantly improved overall survival.

"This trial is groundbreaking in that it will further validate that there are powerful biomarkers in regions of DNA, previously considered ‘junk’ DNA, which can predict improved survival when certain targeted agents, such as cetuximab, are added to radiation," said Dr. Joanne Weidhaas, Chair of MiraDx and Head of Translational Research, Department of Radiation Oncology, David Geffen School of Medicine. "Our goal is to continue to prove that these types of microRNA mutations can enable clinicians to more accurately identify individuals who will benefit from specific therapeutic combinations, to truly individualize cancer therapies in meaningful ways to improve patient survival."

The trial is expected to begin enrolling patients with locally advanced HNSCC this month. It is expected to last approximately two years with an interim analysis after year one. Patients will be recruited from across the U.S. Enrollment will begin at UCLA and potentially expand to other sites. The primary investigator is Robert K. Chin, MD, PhD, a radiation oncologist affiliated with the Ronald Reagan UCLA Medical Center and UCLA Medical Center, Los Angeles. Dr. Weidhaas is a co-investigator.

The KRAS-variant is an inherited genetic marker that predicts cancer risk as well as unique response to cancer therapies. Numerous studies have already shown the KRAS-variant to be predictive across cancer types (rather than tumor-specific), functional (its presence or lack thereof has direct implications for how a patient will respond to specific therapies, stressors to the immune system, etc.), and actionable (a direct link between the presence of the KRAS-variant and the course of action for cancer treatment).