CELL AND GENE THERAPY
PacBio | July 26, 2021
Pacific Biosciences has had no trouble growing its business on its own in the year and a half since its acquisition by Illumina was blocked by the Federal Trade Commission due to concerns that the combination would establish a monopoly in DNA sequencing.
Earlier this year, the sequencer manufacturer received a staggering $900 million investment from SoftBank—a commitment almost as large as the $1.2 billion promised by Illumina for the planned acquisition.
PacBio is now making its acquisition, setting out a deal for up to $800 million to acquire Omniome, another provider of DNA sequencing technology.
The majority of the transaction is comprised of planned upfront payments totaling about $600 million. This will be paid out in $300 million in cash and 9.4 million shares of PacBio common stock. The additional $200 million will come from milestone payments made when Omniome meets certain specified objectives, which will also be paid in a mix of cash and shares.
PacBio has committed a small number of its current investors to a private issue of common stock to fund the acquisition. The total gross proceeds from this deal are expected to be about $300 million. Casdin Capital, SoftBank subsidiary SB Northstar LP, and T. Rowe Price Associates are among the investors who will buy approximately 11.2 million shares of PacBio stock for $26.75 per share, which is slightly less than the stock's closing price on the last full day of trading before the buyout was announced.
PacBio will be able to extend the capabilities of its single-molecule, real-time sequencing technology, or SMRT Sequencing, for use by its clients in biomedical and infectious disease research, as well as therapeutic and diagnostic development, after the transaction is completed.
PacBio's technology is based on long-read sequencing, which analyzes long strands of DNA at a time and can detect larger genomic variants and structural changes than short-read methods—though long-read sequencing has a higher potential error rate in those readings.
Meanwhile, Omniome has created its short-read technology that concentrates on the proteins that bind to DNA to generate what it claims are more accurate analyses than existing short-read sequencers.
Combining the two technologies is reminiscent of Illumina's planned acquisition of PacBio, which would have merged the latter's long-read technology with Illumina's short-read sequencing.
The merger is a significant boost for Omniome, which has attracted several life sciences, investors since its inception in 2013. Each of its most two funding rounds—a series B in mid-2018 and a series C in early 2020—raised $60 million, bringing the San Diego-based startup's total funding to over $130 million.
LBCL | April 04, 2022
Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta® (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P< 0.0001) over the current standard of care (SOC) that has been in place for decades. EFS was determined by blinded central review and defined as the time from randomization to the earliest date of disease progression, commencement of new lymphoma therapy, or death from any cause. Additionally, 2.5 times more patients receiving Yescarta (40.5%) were alive at two years without disease progression or need for additional cancer treatment, after their one-time infusion of Yescarta vs. SOC (16.3%), and the median EFS was four-fold greater (8.3 months vs. 2.0 months) with Yescarta vs. SOC. Yescarta is also being reviewed by global regulatory authorities for additional indications inclusive of the ZUMA-7 patient population. ZUMA-7 is considered a landmark trial for being the first and largest trial of its kind, with the longest follow-up.
Earlier this month, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for B-cell Lymphomas to include Yescarta for “Relapsed disease <12 mo or Primary Refractory disease” under Diffuse Large B-cell Lymphoma (DLBCL) as a Category 1 recommendation. Yescarta is the first CAR T-cell therapy to receive a NCCN Category 1 recommendation. NCCN defines Category 1 as recommendations based upon high-level evidence with uniform NCCN consensus that the intervention is appropriate.
Kite started with a very bold goal: creating the hope of survival through cell therapy. Today’s FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy.”
Christi Shaw, Chief Executive Officer of Kite.
CAR T-cell therapies are individually made starting from a patient’s own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite’s specialized manufacturing facilities where they are engineered to target the patient’s cancer, expanded, and then returned to the hospital for infusion back into the patient. Referring physicians and patients can immediately begin accessing Yescarta CAR T-cell therapy for this new FDA-approved indication through Kite’s 112 authorized treatment centers across the U.S.
Definitive clinical trial results such as these do not come along often and should drive a paradigm shift in how patients with relapsed or refractory LBCL are treated moving forward. Patients who do not respond to or relapse after initial treatment should quickly be referred to a CAR T-cell therapy authorized treatment center for evaluation.”
Jason Westin, MD, MS, FACP, ZUMA-7 Principal Investigator, Director, Lymphoma Clinical Research, and Associate Professor, Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center.
Kite CAR T-cell therapy products are widely covered by commercial and government insurance programs in the U.S. Kite has also invested in expansion of manufacturing capacity ahead of today’s FDA decision to support patient access.
LLS was an early supporter of CAR T-cell therapy research, and to be able to see this innovative advance become available as an earlier line of treatment is truly remarkable. Current standard of care is a difficult process for patients, and no one knows at the start who will make it to stem cell transplant. With today’s FDA decision, patients will have earlier access to this potentially curative treatment.”
Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS).
Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy. The ZUMA-1 trial has recently reported durable 5-year survival results, with Yescarta showing 42.6% of study patients alive at 5 years and that 92% of those patients alive at 5 years have needed no additional cancer treatment at this important milestone.
As the only company dedicated exclusively to the research, development, commercialization, and manufacturing of cell therapy on a global scale, Kite has all functions critical to cell therapy vertically integrated. This structure enables the continual refinement and support of the highly specialized and complex end-to-end processes needed to support and improve upon patient outcomes with CAR T-cell therapy.
About ZUMA-7 Study
The FDA approval of Yescarta CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy is based on results from the ZUMA-7 study. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous stem cell transplant (ASCT). Results were presented in a Plenary session at the American Society of Hematology’s (ASH) Annual Meeting & Exposition in December 2021 and simultaneously published in the New England Journal of Medicine (NEJM).
Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment.
BetterLife Pharma Inc. | September 17, 2020
BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAT) an emerging biotech company, today announced it has entered into an agreement with List Biological Laboratories, Inc. (“List Labs”) for the manufacture of its proprietary interferon alpha 2b for the treatment of COVID-19. "Following our recent merger, we are proud to be continuing the development of Altum Pharmaceutical’s proprietary interferon alpha 2b inhalation for treatment of COVID-19. We look forward to working with List Labs to bring this treatment to patients as quickly as possible as we prepare for our imminent trials in Australia" said BetterLife's Chief Executive Officer, Dr. Ahmad Doroudian. Under the terms of the agreement, List Labs will provide manufacturing services from its state-of-the-art biological development and cGMP manufacturing facility in Campbell, California.