Search This Blog

Thursday, June 3, 2021

Science chief wants next pandemic vaccine ready in 100 days

 The new White House science adviser wants to have a vaccine ready to fight the next pandemic in just about 100 days after recognizing a potential viral outbreak.

In his first interview after being sworn in Wednesday, Eric Lander painted a rosy near future where a renewed American emphasis on science not only better prepares the world for the next pandemic with plug-and-play vaccines, but also changes how medicine fights disease and treats patients, curbs climate change and further explores space. He even threw in a “Star Trek” reference.

“This is a moment in so many ways, not just health, that we can rethink fundamental assumptions about what’s possible and that’s true of climate and energy and many areas,” Lander told The Associated Press.

Lander took his oath of office on a 500-year-old fragment of the Mishnah, an ancient Jewish text documenting oral traditions and laws. He is the first director of the Office of Science and Technology Policy to be promoted to Cabinet level.

Lander said President Joe Biden’s elevation of the science post is a symbolic show “that science should have a seat at the table” but also allows him to have higher-level talks with different agency chiefs about making policy.

Lander is a mathematician and geneticist by training who was part of the human genome mapping project and directed the Broad Institute at MIT and Harvard. He said he is particularly focused not so much on this pandemic, but the lessons learned from this one to prepare for the next one.

“It was amazing at one level that we were able to produce highly effective vaccines in less than a year, but from another point of view you’d say, ‘Boy, a year’s a long time,’” even though in the past it would take three years or four years, Lander said. “To really make a difference we want to get this done in 100 days. And so a lot of us have been talking about a 100-day target from the recognition from a virus with pandemic potential.”

“It would mean that we would have had a vaccine in early April if that had happened this time, early April of 2020,” Lander said. “It makes you gulp for a second, but it’s totally feasible to do that.”

Scientists were working on so-called all-purpose ready-to-go platform technologies for vaccines long before the pandemic. They’re considered “plug-and-play.” Instead of using the germ itself to make a vaccine, they use messenger RNA and add the genetic code for the germ. That’s what happened with the Pfizer and Moderna COVID-19 shots.

Beyond being optimistic about confronting future pandemics, Lander wonders about the implications for preventing cancer.

“Maybe the same sort of experience about moving so much faster than we thought is applicable to cancer,” said Lander, who during the Obama administration was co-chair of the Presidential Council of Advisors on Science and Technology. A company already has been working on that.

For that matter, the pandemic and telehealth brought the doctor to patients in some ways. Lander said he is reimagining “a world where we rearrange a lot of things” to get more patient-centered health care, including community health workers checking up every few weeks on people about their blood pressure, blood sugar and other chronic problems.

Two of Lander’s predecessor praised him. Neal Lane, President Bill Clinton’s science adviser, said Lander is “perfect” for the pandemic because of the need for a strategy and international agreements. Obama’s science chief, John Holden, called him “a Renaissance man.”

Lander’s nomination had been delayed for months as senators sought more information about meetings he had with the late Jeffrey Epstein, a financier who was charged with sex trafficking before his apparent suicide. Lander said he only met with Epstein twice, in 2012, and never requested or received funds from Epstein or his foundation. At his confirmation hearing, Lander also apologized for a 2016 article he wrote that downplayed the work of two Nobel Prize-winning female scientists.

Lander, who has visited Greenland on a balmy 72-degree day, told the AP he sees climate change as “an incredibly serious threat to this planet in many, many ways.”

Still, Lander said he was more optimistic now than he and others were a decade ago because “I see a path to doing something about it.”

Lander pointed to a drop of about in 90% in solar and energy wind costs, making them now as cheap as fossil fuels that cause climate change. But he said what’s also needed is “an explosion of ideas” to improve battery life and provide carbon-free energy that is not weather-dependent. Those innovations need federal incentives that are part of Biden’s jobs package, he said.

Reducing methane is key to fighting climate change, Lander added, but first improvements are needed in technology to determine where methane is leaking from.

As for space, Lander said he was too new to comment on whether heading to the moon or Mars should be the goal. The Obama administration redirected NASA away from the Bush-era plan to send astronauts back to the moon and was more aimed for Mars or an asteroid. The Trump administration not only focused back on the moon but set a 2024 goal for a new moon landing.

“Are we going to go to the moon and are we going to go to Mars and are we going to moons of Jupiter? Sure. The exact order I think is great to think about or great to talk about,” Lander said.

He quoted “Star Trek IV: The Voyage Home,” when Captain James T. Kirk’s love interest asked if he was from outer space. He responded: “I’m from Iowa, I only work in outer space.”

Adds Lander: “That was a fun line in ‘Star Trek IV,’ but folks in Iowa are really going to say that.”

https://apnews.com/article/us-news-only-on-ap-technology-climate-change-pandemics-efa1b5a9107d7fc5a3580a96a9abbf31

Teva to Present Latest Data on AJOVY® Injection at American Headache Society

 11 presentations examine clinical and real-world AJOVY data in the reduction of migraine days

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that 11 presentations examining clinical and real-world data for AJOVY® (fremanezumab-vfrm) injection will be presented at the 2021 American Headache Society (AHS) Annual Meeting, taking place virtually June 3-6.

"Our goal is to continue supporting the migraine community through our rigorous and innovative scientific research programs so we can ultimately uncover the full potential of AJOVY for patients," said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. "The data being presented at this year’s AHS meeting underscore the impact AJOVY can have on the healthcare community as seen in clinical analyses and real-world experiences."

Data being presented include results from clinical and real-world analyses and post-hoc Phase 3 data examining the long-term response of AJOVY over the course of 15 months, an analysis of the real-world impact of treatment among patients with comorbid depression, anxiety or hypertension, as well as a Phase 3b analysis examining the consistency in migraine days over the course of a dosing regimen for patients with inadequate responses to 2-4 prior treatments.

This year’s annual AHS meeting is fully virtual. Data presentations can be accessed by registering for the meeting.

https://finance.yahoo.com/news/teva-present-latest-data-ajovy-120000360.html

Seagen: Long-Term Results from TUKYSA® Trial in HER2-Positive Breast Cancer at ASCO

 Updated Analysis Shows Median Overall Survival for TUKYSA Arm Extended to Two Years, with Benefit Maintained Across All Prespecified Patient Subgroups in HER2CLIMB Trial -

- Results Further Support TUKYSA as Well-Tolerated Treatment Option That Improves Survival in Patients with Previously Treated Metastatic HER2-Positive Breast Cancer With and Without Brain Metastases -

https://www.businesswire.com/news/home/20210603005326/en/Seagen-Announces-Long-Term-Results-from-TUKYSA%C2%AE-tucatinib-Pivotal-Trial-in-Patients-with-HER2-Positive-Breast-Cancer-During-the-Virtual-Scientific-Program-of-the-2021-ASCO-Annual-Meeting

Medtronic to Stop Distribution and Sale of HVAD™ System

 Company Developing Support Program for Current HVAD Patients

- Medtronic Coordinating with Global Regulators to Assure Patient Access to Left Ventricular Assist Devices

DUBLINJune 3, 2021 /PRNewswire/ -- Medtronic (NYSE:MDT), the global leader in medical technology, is stopping the distribution and sale of the Medtronic HVAD™ System. This morning, the company notified physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support.

Medtronic also announced that it is developing a support program for patients who have had an HVAD implanted and for caregivers and health care professionals who participate in their care. This program is being developed with an independent panel of clinician advisors to ensure the ongoing care and safety of patients who are currently supported by the HVAD system. Though the company will stop distribution and sale of the HVAD System, Medtronic is committed to serving the needs of the approximately 4,000 HVAD patients currently implanted with the device.

Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.

In addition, Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient's heart condition, lead to a heart attack, require hospitalization, and result in death.

Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD System, consistent with its commitment to prioritize patient safety.

https://www.biospace.com/article/releases/medtronic-to-stop-distribution-and-sale-of-hvad-system/

Bayer Acquires Noria and PSMA Therapeutics to Expand Pipeline in Prostate Cancer

 

  • Broadens company’s oncology platform of Targeted Alpha Therapies (TATs)
  • Acquisition includes actinium-225 labeled differentiated prostate-specific membrane antigen (PSMA) small molecule being studied as an investigational compound in prostate cancer
 

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. (Noria) and PSMA Therapeutics Inc. Through this acquisition, Bayer will obtain exclusive rights to a differentiated alpha radionuclide investigational compound based on actinium-225 and a small molecule directed towards prostate-specific membrane antigen (PSMA). The acquisition broadens Bayer’s existing oncology portfolio of targeted alpha therapies (TATs), which currently includes Xofigo® (radium Ra 223 dichloride), which is approved for metastatic castration resistant prostate cancer (mCRPC) with symptomatic bone metastases and no known visceral metastases, and the proprietary platform of investigational TATs based on thorium-227.

The pre-IND program focuses on the treatment of prostate cancer, the second most commonly diagnosed cancer in men.1

“Bayer is focused on addressing the various medical needs of cancer patients, providing treatments that have the potential to improve patient outcomes throughout the different stages of the disease,” said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. “This acquisition is another important milestone in enhancing Bayer’s oncology portfolio through both in-house expertise and strategic collaborations and agreements.”

The companies acquired by Bayer, Noria and PSMA Therapeutics, have exclusive world-wide rights to technology licensed from Weill Cornell Medicine (New York, NY, USA) and Johns Hopkins University (Baltimore, MD, USA). Noria was founded by Dr. John Babich, Chief, Radiopharmaceutical Sciences in Radiology at Weill Cornell Medicine.

“Weill Cornell Medicine is committed to bringing our faculty’s innovations to market so that patients can benefit from the latest therapeutics,” said Dr. Lisa Placanica, Senior Managing Director Center for Technology Licensing at Weill Cornell Medicine. “Bayer’s acquisition of Noria and PSMA Therapeutics which have nurtured Dr. Babich’s radiopharmaceutical and diagnostic technology, is an important milestone in drug development, and we look forward to the advances this collaboration can make to enhance prostate cancer therapies.”

With the first and only approved targeted alpha therapy Xofigo, Bayer has successfully established Xofigo as a TAT for men with mCRPC, symptomatic bone metastases and no known visceral metastases. Adding actinium-225-labeled small molecule to the company’s platform of investigational targeted thorium conjugates, supports our commitment to researching differentiated treatment options for cancer patients.

“Despite increased cancer survivorship overall, there continues to be a significant unmet need in oncology,” said Marianne De Backer, MBA, PhD, Member of the Executive Committee of the Pharmaceuticals Division and Head Strategy and Business Development & Licensing at Bayer. “We remain committed to exploring collaborations for innovative and pioneering scientific research for patients with unmet needs.”

Financial terms of the agreement were not disclosed.

https://www.biospace.com/article/releases/bayer-acquires-noria-and-psma-therapeutics-to-expand-pipeline-in-prostate-cancer/

VBL Adds Progression Free Survival as Second Primary Endpoint in Ovarian Cancer Study

 

  • Second primary endpoint added following discussion with the U.S. Food and Drug Administration
  • Successfully meeting either PFS or OS primary endpoints expected to be sufficient for submitting a BLA for potential full FDA approval
  • PFS endpoint readout expected in 2022; BLA submission could be possible one year earlier than previously projected with OS endpoint alone
  • Clinical trial amendment reported in an OVAL Clinical Trial in Progress poster presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

Replimune Updates on RP1, RP2 Programs, to Expand RP2/3 Beyond Phase 1

 High rate of complete responses in RP1 skin cancer cohorts underscore the potential for profound patient benefit and supports the ongoing registration directed development programs

RP2 data confirms the signal with RP1 in anti-PD1 failed melanoma, uveal melanoma and in treating patients whose cancer has metastasized to the liver

Announces plans to initiate broad Phase 2 development of RP2 and/or RP3 in tumor types that commonly metastasize to the liver

Virtual investor event to be held at 8:00 am ET

Investor event and webcast information

Replimune will host a virtual investor event today, Thursday, June 3, 2021 at 8:00 a.m. ET. The webcast and slides will be accessible live under “Events & Presentations” on the Investors page of the Company’s website at www.replimune.com or by clicking here. A replay of the event will be available on Replimune’s website.

https://www.globenewswire.com/news-release/2021/06/03/2241138/0/en/Replimune-Provides-Data-Update-from-its-RP1-vusolimogene-oderparepvec-and-RP2-Programs-and-Announces-Plans-to-Expand-the-Development-of-RP2-3-Beyond-Phase-1.html