Search This Blog

Friday, January 8, 2021

FDA puts early-stage trial of Neoleukin potential cancer treatment on hold

 Neoleukin Therapeutics Inc said on Friday the U.S. Food and Drug Administration has put on hold the drug developer’s application to start human trials of its protein-based candidate, NL-201, to treat cancer.

The company’s shares tumbled 20.6% to $12.5 before the bell after the agency asked the company to develop a new assay that more precisely measures the amount of protein being administered.

“We will be able to develop the requested assay and respond within the next several months,” said Jonathan Drachman, chief executive officer.

The company’s lead treatment is a cancer immunotherapy, designed to expand cancer-fighting CD8 T-cells and natural killer cells. 

https://www.reuters.com/article/neoleukin-therapeutics-fda/u-s-fda-puts-early-stage-trial-of-neoleukin-potential-cancer-treatment-on-hold-idUSL4N2JJ2U4

Oncology biotech Cullinan Management prices further upsized IPO at $21, above upward revised range

 Cullinan Management, a Phase 1/2a biotech developing and investing in oncology therapies, raised $250 million by offering 11.9 million shares at $21, above the upwardly revised range of $19 to $20. The company originally planned to offer 8.3 million shares at $17 to $19 before increasing the offering to 10 million shares at $19 to $20 on Wednesday.


Cullinan Management plans to list on the Nasdaq under the symbol CGEM. Morgan Stanley, SVB Leerink and Evercore ISI acted as lead managers on the deal.

Celularity, GX Acquisition to Merge, Create Public Cellular Therapy Company

 - Celularity has entered into a definitive merger agreement with GX Acquisition Corp. (Nasdaq: "GXGX"); upon closing, shares of the combined company will be listed on Nasdaq under the ticker symbol "CELU".

- Institutional investors and certain individuals have committed to invest approximately $80 million through concurrent equity investments (the "PIPE").

$372 million of total expected proceeds from the PIPE and cash held in GX Acquisition Corp.'s trust account (assuming no stockholder redemptions are effected) upon the closing of the business combination.

- Celularity stockholders (including Sorrento Therapeutics, affiliates of Bristol Myers Squibb, Starr Insurance Companies, and Dragasac Limited, a wholly owned subsidiary of Genting Berhad), GX Acquisition Corp. stockholders and PIPE stockholders will hold shares in the combined company that is expected to have an estimated initial post-transaction equity value of approximately $1.7 billion.

- The business combination is expected to be completed during the second quarter of 2021.

- Joint investor conference call to discuss the proposed transaction is being held today, January 8, 2021 at 8:00 a.m. EDT.

https://news.yahoo.com/celularity-gx-acquisition-corp-announce-120000185.html

Neurocrine Prelim Q4, 2020 Product Sales Results, 2021 Program Milestones

 INGREZZA® (valbenazine) Preliminary Fourth Quarter Net Product Sales and Inventory Adjusted Net Product Sales of Approximately $240 Million and $258 Million, Respectively

INGREZZA® (valbenazine) Preliminary Full-Year 2020 Net Product Sales and TRx Both Grew 32% to Approximately $993 Million and 175,700 TRx Respectively Versus the Prior Year

Company Plans to Provide Clinical Data for Key Programs and Expects to Initiate Seven Additional Mid-to-Late Stage Clinical Studies in 2021 for Neurological, Endocrine and Psychiatric Disorders


https://www.prnewswire.com/news-releases/neurocrine-biosciences-provides-preliminary-fourth-quarter-and-full-year-2020-net-product-sales-results-and-2021-program-milestones-301203297.html

Nanobiotix Announces Key Development Milestones for 2021

 

  • Nanobiotix will use a portion of the proceeds from the its IPO to launch its global phase III registration study in head and neck cancer in the United States in 2021
  • Following previously reported preliminary data regarding the ability of NBTXR3 to help transform anti-PD-1 non-responders into responders, the Company will provide the next update on its immuno-oncology phase I basket study evaluating NBTXR3 in combination with anti-PD-1 checkpoint inhibitors in the second quarter of 2021
  • The Company’s expansive global development plan for NBTXR3, both as a single agent activated by radiotherapy and in combination with other anti-cancer therapies, will continue as planned

Hologic 1Q F2021 Results Due Wednesday, January 27

  Hologic, Inc. (Nasdaq: HOLX) announced today that the Company plans to release its financial results for the first quarter of fiscal 2021 on Wednesday, January 27, after the market closes. In conjunction with the release, management will host a conference call that day at 4:30 p.m. Eastern Time.

Interested participants may listen to the call by dialing 888-204-4368 (in the United States and Canada) or +1 323-994-2093 (for international callers) and referencing access code 2632110. Participants may also click here to join. Participants should dial in 5-10 minutes before the call begins. A replay will be available approximately two hours after the call ends through Friday, February 26, 2021. The replay numbers are 888-203-1112 (U.S.) or +1 719-457-0820 (international), access code 2632110, PIN 7018.

Hologic will provide a live webcast of the call on the Company’s website at www.investors.hologic.com.

The call will be archived there for 30 days.

https://www.biospace.com/article/releases/hologic-to-announce-financial-results-for-the-first-quarter-of-fiscal-2021-on-wednesday-january-27-2021/

Thursday, January 7, 2021

How One Health System Balances COVID Surge, Vaccination Drive

 As COVID-19 infections, hospitalizations, and deaths reach new highs nationally, one healthcare system in Texas is managing the surge thus far, and is well on its way to vaccinating its entire staff.

Houston Methodist, which includes an academic medical center and six community hospitals in the greater Houston area, has vaccinated (or is about to vaccinate) 60% of its employees, Marc Boom, MD, the organization's president and CEO, told Medscape Medical News.

The healthcare system recently offered its employees a $500 bonus (to be paid in March) on the proviso that they get vaccinated by then. Eventually, Boom said, COVID-19 vaccination will be mandatory for employees, as flu shots have been at Houston Methodist for the past 15 years.

The healthcare system is currently challenged by the biggest surge in COVID-19 cases since July. Houston Methodist is now caring for about 740 COVID-19 patients, up from 140 in September, Boom said.

However, its hospitals are nowhere near running out of ICU capacity. While they have more patients in med-surg beds than ever before, Boom said, there are 130 patients in their ICUs, compared with 190 at the peak of last summer's surge.

"So we have some room to go," he said. "The latest surge has forced us to curtail some elective procedures that might need ICU time and that can be safely delayed."

Houston Methodist has also avoided staff shortages, partly by not laying off any staffers in 2020. Moreover, the staff is not feeling overwhelmed, Boom said. "Our people are seasoned veterans, they've been through this twice, particularly the big surge in the summer. Morale is good, they're working hard, and people have gotten a little bit of hope from the vaccine."

The only cause for concern about staffing, he added, is the current shortage of traveling nurses, whom Houston Methodist used quite a bit last summer. To make up for that shortfall, the system is adjusting schedules so that nurses can be moved around. For example, a nurse who normally cares for people after surgery can now help in the ICU.

Ramping Up Vaccinations

As of today, Houston Methodist had administered about 30,000 first doses of vaccine and close to 4000 second doses, Boom said. Of the 30,000 first doses, about half were given to the hospitals' employees. So 15,000 of the system's 26,000 staff members had been vaccinated.

In addition, he noted, another 2000 to 3000 affiliated physicians had gotten their shots at Houston Methodist. While thousands of other physicians provide services at Houston Methodist, many of them admit patients to other systems, and they might be getting vaccinated there, he said.

The remainder of Houston Methodist's vaccine supplies are being administered to people outside the hospital system, according to Texas' vaccination schedule. The first group includes firefighters, home healthcare workers, hospice workers, and physician office staff, Boom said. The healthcare system has also begun to vaccinate patients who are 75 or older.

Some hospitals in New York and California have used only a fraction of the vaccine supplies they've received. But Boom says Houston Methodist has administered the majority of its vaccine doses.

"We're getting vaccines into arms within days. Our supply is expected to come in today. If it does, we'll have more unused doses until we catch up with them," he said. "To schedule effectively, we try to have a few days' supply on hand. It's a weekly shipment, so the best way to schedule is to space it out evenly over the week."

Yesterday, he added, "we vaccinated the most patients we've ever done — about 4500 — and we continue to ramp that up." He said the system has hired additional clinicians to carry out the vaccination program.

Outpatient physicians have offered to help, he said. At some point, Houston Methodist will launch a mass vaccination program on weekends, when doctors can vaccinate people outside of office hours.

Supplies are Rate-Limiting Factor

No provider in the state is getting as much vaccine supply as they'd like, and that's the "rate-limiting factor, much more than the ability to vaccinate," Boom said. One reason for the shortfall is that nursing homes are being prioritized — a decision he strongly supports. In a few weeks, he said, most patients and staff at nursing facilities will be vaccinated, and the supply to hospitals should improve.

In the meantime, he said, about half of the Houston Methodist staff have rushed to get vaccinated. Another 30%-40% of employees have taken a wait-and-see attitude, but they're increasingly getting on board after seeing that 15,000 of their colleagues have been safely inoculated. 

One factor in the increasing acceptance of the vaccine has been the system's 800 employed physicians, 80% of whom have already gotten shots. "Those are the people who are the most educated and science-based, so they set the example," he said.

He estimated that around 10%-15% of the staff are still reluctant to be vaccinated. "We'll continue to work them with multiple strategies," including the $500 bonuses, he said.

Overall, Boom is fairly optimistic about the future, though he said the next 4-6 weeks will be tough. "I don't see an end to the curve we're on, but I'm hoping people have gotten the holidays out of their system and are ready to hunker down for a while," he said. "In theory, when we get this surge under control, and the vaccines start kicking in — barring some horrible mutation — this should be our last peak, and that gives us all some optimism. When we get over this peak, because of the vaccine rollout, we're going to continue to see this [infection rate] come down, and it should be our last surge."

https://www.medscape.com/viewarticle/943766