NEWPORT BEACH, Calif., Sept. 7, 2022 /PRNewswire/ -- Hoag Memorial Hospital Presbyterian has been named a Radiopharmaceutical Therapy Center of Excellence (RTCoE) by the Society of Nuclear Medicine and Molecular Imaging (SNMMI), a distinction held by only 17 centers in the U.S., including Stanford Health Care, Harvard Medical School and the University of California, San Francisco.

The designation is a recognition of Hoag's leading advancements in the burgeoning field of nuclear medicine research and treatment, according to the SNMMI.

"Radiopharmaceutical therapy represents an exciting new tool in the diagnosis, prevention and treatment of cancer, and we are honored to be recognized for our pioneering work in this emerging field," said Hoag CEO and President Robert T. Braithwaite. "This distinction is both an accomplishment and a promise to our patients and community that Hoag will continue to conquer cancer."

As a Radiopharmaceutical Therapy Center of Excellence, Hoag will continue to lead the nation in testing and offering evidence-based therapies to improve patient care at Hoag and throughout the world, said Gary A. Ulaner, M.D., Ph.D., F.A.C.N.M, James & Pamela Muzzy Endowed Chair in Molecular Imaging and Therapy and director of Molecular Imaging and Therapy for the Hoag Family Cancer Institute.

"Over time, there will likely be improvements in second- and third-generation agents, which will make it important to develop more therapies," Dr. Ulaner said. "Here at Hoag, we are offering the same therapies that are being offered at Memorial Sloan Kettering and other leading cancer institutions worldwide. Patients are often relieved to learn that they have access to these therapies right here in Orange County."

The elite SNMMI designation comes on the heels of the publication of two important peer-reviewed studies coming out of Hoag about the potential for nuclear medicine to change the course of cancer care.

Dr. Ulaner recently published two papers that analyzed molecular imaging in prostate cancer, as well as a separate study studying the effectiveness of imaging in a new targeted breast cancer therapy. His studies appeared in the journals Radiology and Nature Communications, respectively.

"With philanthropic support from the community, Hoag has continuously prioritized providing the best patient care available.With these innovative research programs, Hoag is developing and delivering the future of patient care," said Dr. Ulaner.

Molecular medicine advanced earlier this year when the FDA approved the first targeted radioligand therapy for prostate cancer patients whose tumor cells contain a protein called prostate-specific membrane antigen (PSMA). The therapy, known commercially as Pluvicto, is the first FDA-approved PSMA-targeted radiotherapy for metastatic prostate cancer.

Hoag's Molecular Imaging & Therapy program is the only program in Orange County to offer Pluvicto, as well as several similar radiotherapies that are currently in clinical trials for prostate and other cancers.

In addition to helping determine the effectiveness of Pluvicto, Dr. Ulaner explains that molecular medicine works like a lock and a key. Every cancer cell has a protein on its surface that can be thought of as a lock. Molecular agents designed to bind specifically to those locks are the key. Infused with radiation, those keys can either help detect or destroy the cancer cells wherever they are in the body, leaving neighboring healthy cells unharmed.

"This is a relatively new field," Ulaner said. "We are the only molecular imaging and therapy center in Orange County. We use molecular agents to help detect cancer and to treat cancer through radioactive molecules."

Hoag is offering ongoing clinical trials in molecular imaging and therapy for a number of cancer types. For more information, contact Hoag Family Cancer Institute at 949-7-CANCER.

ABOUT HOAG Hoag is a nonprofit, regional health care delivery system in Orange County, California.Deliveringworld-class, comprehensive, personalized care,Hoag consistsof 1,800 top physicians, 15 urgent care facilities,10health & wellness centers,andtwoaward-winning hospitals.Hoag offers a comprehensive blend of health care services that includessixinstitutes providing specialized services in the following areas:cancer,digestivehealth,heart and vascular,neurosciences, women's health, and orthopedics through Hoag's affiliate,Hoag Orthopedic Institute,which consists of an orthopedic hospital and four ambulatory surgical centers.Hoag is the highest ranked hospital in Orange County byU.S. News & World Reportandthe only OC hospital ranked in the Top 10 in California, as well asa designated Magnethospital by the American Nurses Credentialing Center (ANCC).For more information, visithoag.org.

SOURCE Hoag Memorial Hospital Presbyterian

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Hoag Named Radiopharmaceutical Therapy Center of Excellence, Publishes Results of Breast and Prostate Cancer Trials - PR Newswire

State-of-the-Art Platform Comprised of Established and Emerging Technologies Across a Wide Spectrum of RNA Discovery, Development and Delivery, Excluding RNAi Therapeutics

Strategic Partnership with Beam Therapeutics Provides Access to Beams RNA and Delivery Technologies for Multiple Therapeutics Applications

Founding and Leadership Teams Comprised of Recognized Scientific Pioneers, Successful Drug Developers and Accomplished Biopharma Executives

Initial Funding Led by ARCH Venture Partners with Participation from a16z Bio + Health and Newpath Partners

CAMBRIDGE, Mass., September 07, 2022--(BUSINESS WIRE)--Orbital Therapeutics launched today with a vision of enhancing global health by unleashing the full potential of RNA medicines to treat human disease in ways that were not previously possible.

"The breakthroughs in RNA therapeutics over the last decade have been remarkable achievements by the biopharmaceutical industry, with several approved products for a range of diseases and many more in development. This frontier of science represents the future of medicine, and we are just beginning to realize the full breadth of its applications in treating a wide range of serious diseases," said John Maraganore, Ph.D., Orbital co-founder and chairman of the board of directors. "Orbital Therapeutics has a unique opportunity to integrate and apply a spectrum of innovative RNA technologies to advance a portfolio that could dramatically expand the potential of todays RNA therapeutic approaches."

Game-Changing RNA VisionRNA-based medicines represent a fast-growing and disruptive class of therapeutics for a breadth of disease areas. First-generation RNA treatments successfully overcame multiple hurdles, such as the rapid degradation of exogenous RNA, delivery of RNA and complications associated with immunogenicity.

To further broaden the application of this important class of treatments, Orbital is building a first-in-kind RNA platform that integrates both established and emerging technologies and delivery mechanisms, excluding RNAi. This platform is designed to extend the durability and half-life of Orbitals novel RNA therapeutics, while also expanding their delivery to a larger number of cell types and tissues. As the company grows, Orbital intends to continue investing in the growth of its platform capabilities and technologies.

Story continues

With a platform that provides access to state-of-the-art RNA and novel delivery technologies, Orbital plans to build an expansive portfolio across a range of human diseases, including in the areas of vaccines, immunomodulation, protein replacement and regenerative medicine.

Collaboration with Beam TherapeuticsAs part of its launch, Orbital and Beam Therapeutics have entered into a license and research collaboration under which Orbital and Beam have each granted the other access to respective RNA technology and non-viral delivery technology. Orbitals exclusive field of use consists of vaccines and certain therapeutic proteins, while Beams exclusive field of use consists of gene editing and conditioning for use in cell transplantation.

"The field of RNA medicines is advancing rapidly, and we are excited to participate in the launch of Orbital. Its also an exciting opportunity for Beam, as we continue our strategy of pursuing creative partnerships that can generate value from the full breadth of our platform and accelerate the development of novel and diverse medicines for patients," said John Evans, chief executive officer of Beam Therapeutics. "The collaboration with Orbital also enables us to leverage cutting-edge advancements in RNA science for the development of our pipeline of potential transformative medicines focused on gene editing."

World-Class FoundersOrbital is founded by a collective group of scientific pioneers and proven biopharma company builders, including:

Howard Chang, M.D., Ph.D., professor of cancer research and professor of genetics, Stanford University

Ravi Majeti, M.D., Ph.D., professor of medicine, chief of division of hematology, Stanford University

Drew Weissman, M.D., Ph.D., professor in vaccine research, Perelman School of Medicine, University of Pennsylvania

Gene Yeo, Ph.D., MBA, professor of cellular and molecular medicine, UC San Diego

Giuseppe Ciaramella, Ph.D., president and chief scientific officer, Beam Therapeutics

John Maraganore, Ph.D., former founding chief executive officer of Alnylam Pharmaceuticals

Kristina Burow, managing director, ARCH Venture Partners

Carol Suh, partner, ARCH Venture Partners

In addition, Orbital is initially funded by ARCH Venture Partners, a16z Bio + Health and Newpath Partners.

"The formation of Orbital by a group of visionary leaders and scientific pioneers establishes a single organization that integrates a wide expanse of RNA technologies with a goal of delivering new medicines with a far-reaching impact on human health worldwide," said Ms. Burow. "The ability to combine the highest caliber science with potentially revolutionary technologies and a dynamic organizational structure led by proven experts in RNA, provides a special opportunity to create a therapeutically transformational company, and we at ARCH are thrilled to be a part of such a bold and impactful mission with Orbital."

Expert Leadership and BoardOrbital will be led by Giuseppe Ciaramella, Ph.D., who will serve as interim chief executive officer and a member of the board of directors, in addition to his ongoing role as president and chief scientific officer at Beam Therapeutics. Dr. Ciaramella has more than 25 years of drug discovery expertise and is a leader in the field of RNA research and drug development. Prior to Beam, Dr. Ciaramella served as chief scientific officer of the infectious diseases division at Moderna Therapeutics, where he led the establishment of its initial mRNA vaccine pipeline and the execution of its first investigational new drug application submission.

"In the history of medicine, certain therapeutic classes have revolutionized the treatment of both prevalent and rare diseases, and RNA-based therapeutics is undoubtedly one of them," said Dr. Ciaramella. "The creation of Orbital brings together a critical mass of the latest innovations in RNA technology under one roof to enable near-term clinical readiness, while advancing the durability, tissue-specific programmability and breadth of clinical applications. We stand at the forefront of science with an opportunity to treat human diseases in ways that have not yet been done, and I am excited to be leading the company in this endeavor."

Orbital has also appointed Gilles Besin, Ph.D., as chief scientific officer, bringing more than 15 years expertise in immunology and vaccines for infectious diseases, oncology and metabolic disorders. Dr. Besin joins Orbital from Affinivax Inc., where he served as vice president, head of discovery, leading all research efforts. Previously, Dr. Besin had increasingly senior roles at Moderna Therapeutics, where he led the platform immunology group and the efforts to modulate T cell responses in cancer and autoimmune diseases using mRNA lipid nanoparticles. Earlier in his career, Dr. Besin led research and discovery groups at In-Cell-Art, a biopharmaceutical company specializing in the development of DNA/RNA based vaccines and therapeutics. Dr. Besin earned an Engineering degree in biotechnology (Masters-equivalent) from cole Suprieure de Biotechnologie de Strasbourg (Strasbourg Graduate School of Biotechnology), as well as a Ph.D. in immunology from the Max Planck Institute of Immunobiology and Epigenetics. Dr. Besin is a member of the Scientific Advisory Board of Ovensa Inc.

In addition to Dr. Ciaramella, Orbitals highly experienced board of directors includes:

Vineeta Agarwala, M.D., Ph.D., general partner, a16z Bio + Health

Kristina Burow, managing director, ARCH Venture Partners

John Evans, chief executive officer, Beam Therapeutics

John Maraganore, Ph.D., former founding chief executive officer of Alnylam Pharmaceuticals, and chairman of the Orbital board of directors

Carol Suh, partner, ARCH Venture Partners

To support the near-term growth of the company, Orbital will leverage the resources and talent of the Beam team in addition to Dr. Ciaramella, for leadership capabilities, operational support, and research and development.

About Orbital TherapeuticsOrbital Therapeutics aims to enhance global health by unleashing the full potential of RNA-based medicines (excluding RNAi therapeutics) to treat human disease in ways that were not previously possible. The company is building a first-in-kind platform designed to sit at the intersection of RNA technology delivery methods, data science and automation to develop an expansive portfolio of medicines, initially focused in the areas of vaccines, immunomodulation, protein replacement and regenerative medicine. Founded by experts in the fields of genetic medicine and RNA development and delivery, Orbital has a dynamic operational structure designed to harness the ingenuity of a deep and diverse team of scientists, drug developers and business leaders. For more information, please visit http://www.OrbitalTx.com.

Beam Therapeutics Inc.s Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Investors are cautioned not to place undue reliance on these forward-looking statements, including, but not limited to, statements related to Beams license and collaboration agreement with Orbital and any potential benefits that may be achieved thereunder. Each forward-looking statement is subject to important risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement, including, without limitation, the risks and uncertainties identified under the headings "Risk Factors Summary" and "Risk Factors" in Beams Annual Report on Form 10-K for the year ended December 31, 2021, Beams Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, and in any subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release. Factors or events that could cause Beams actual results to differ may emerge from time to time. Beam undertakes no obligation to update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220907005434/en/

Contacts

Media Dan Budwick, 1ABdan@1abmedia.com

Investor Monique Allaire, THRUSTmonique@thrustsc.com

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Orbital Therapeutics Launches to Advance New Frontiers of Science with the Next Generation of Innovative RNA Medicines - Yahoo Finance

The U.S. developed the worlds most widely used COVID-19 vaccines with brand-new technology in record time, but China just shot ahead in the huffing and sniffing phase of COVID-19 vaccine development.

On Sunday, Chinas government approved CanSino Biologics inhaled COVID-19 vaccine for use as a booster dose. CanSino is a private, Tianjin-based vaccine maker that has partnered with the Chinese military-run Academy of Military Medical Sciences to produce COVID-19 vaccines. The inhaled vaccine uses the same technology as the firms World Health Organizationapproved viral vector COVID-19 vaccine. The new version is breathed in through the mouth, and clinical trial data showed that it was more effective as a booster at preventing infections from Omicron and other variants than the injectable, inactivated vaccine from Chinese firm Sinovac. CanSinos new vaccine is not just the first inhaled vaccine for COVID, it is the first inhaled vaccine for any disease.

The vaccine is a game changer, Pierre Morgon, an executive vice president at CanSino Biologics, told Fortune. This is the first-ever inhaled vaccine to be commercialized. Im so proud to be part of it.

For now, the vaccine will only be available in China. But Morgon said he hopes that CanSinos inhaled vaccine will be approved in more countries by the end of the year.

Some scientists in the U.S., meanwhile, have been calling on the Biden administration and vaccine manufacturers to step up efforts to produce an inhaled or nasal spray vaccine because of the technologys potential to reduce transmission more effectively than injectable immunizations.

Eric Topol, professor of molecular medicine at Scripps Research in San Diego, and Akiko Iwasaki, immunobiology professor at Yale University, urged the U.S. government to create an Operation Nasal Vaccine similar to Operation Warp Speed, which funded initial COVID-19 vaccine development, in a July piece for Science Immunology.

With [Omicron] there has been a marked falloff in the capacity for vaccinations and booster shots to block infections and transmission, Topol and Iwasaki wrote. They explained that blocking transmission and preventing breakthrough infections have become a major unmet clinical need that nasal vaccines may be able to fix.

Intramuscular shots alonedo not provide tissue-level mucosal immunity, they wrote. The only path to achieve this will be via nasal or orally administered vaccines.

Topol and Iwasaki said there were 12 nasal spray vaccines in clinical development globally, but it appeared unlikely that one would hit the U.S. market soon. The U.S. Food and Drug Administration has approved only one nasal spray vaccinefor the fluand has never approved an inhaled vaccine.

U.S. President Joe Bidens administration has signaled that its open to new vaccine delivery methods.

[We are supporting] innovations like nasal sprays and skin patches, instead of needles, to administer vaccines in a more comfortable and accessible way so that everyone in America and around the world can readily benefit from them, Alondra Nelson, the White Houses deputy director for science and society, said in July at a summit on the future of COVID-19 vaccines.

But even at the summit, it was unclear how the U.S. government would fund the development of new COVID-19 vaccine technology. Last spring, Biden failed to strike a deal with Congress for more funding for the governments pandemic response, and the two sides have been in a stalemate over the matter ever since.

Morgon said a relatively simple process turned CanSinos injectable vaccine into a huffable one.

CanSinos inhaled vaccine uses the same technology as its successful viral vector COVID-19 vaccine. Essentially, CanSino takes the liquid used in its injectable vaccines and turns the solution into a mist with a device called a nebulizer. Patients inhale the mist and hold it in their lungs for 15 seconds or so before breathing out.

Its the exact same thing: same composition, same ingredients, Morgon said of the two vaccines. The only difference is the dose.

There is nothing stopping other vaccine makers from developing their own inhaled vaccines, CanSino said.

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Scientists urged the Biden administration to launch an Operation Warp Speed to develop inhaled COVID vaccines. China beat the U.S. to the punch -...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced that the company and its collaborators will present 14 abstracts at the 2022 European Society for Medical Oncology Congress being held virtually and in person in Paris from September 9-13, 2022.

Highlights from the presentations include:

This data demonstrates the power of our tissue- and liquid-based comprehensive genomic profiling tests for enabling critical research on complex genomic signatures and emerging biomarkers, said Priti Hegde, PhD, Chief Scientific Officer at Foundation Medicine. Were proud to be working across the cancer research community to deepen our collective understanding of cancer biology and ultimately support better care for patients in the future.

The following is a list of abstracts that will be presented at the meeting. To access all abstracts being presented at ESMO, please visit: https://oncologypro.esmo.org/meeting-resources/esmo-congress

Follow Foundation Medicine on Twitter and LinkedIn for more updates from #ESMO22 and visit us in person at booth #306.

Abstract #

Title

Product*

Collaborators

Proffered Paper Session

Sunday, September 11, 2022,

4:40 - 4:50 PM CET

#1696O

Genomic profiling and molecular targeting of lung cancer brain metastases

FoundationOne CDx

Montefiore Einstein Cancer Center

Mini Oral Sessions

Saturday, September 10, 2022,

11:15 - 11:20 AM CET

#660MO

Molecular targets in salivary gland cancers: A comprehensive genomic analysis of 1,666 cases

FoundationOne CDx

Upstate Medical University

Monday, September 12, 2022,

3:35 - 3:40 PM CET

#1487MO

A pan-sarcoma investigation of genetic alterations associated with high telomeric content

FoundationOne Heme

Omico (Australian genomic Cancer Medicine), Garvan Institute of Medical Research; St Vincents Clinical School, University of New South Wales, Australia

Posters

Saturday, September 10, 2022

#97P

Pan-cancer landscape of clonal tumor mutational burden (cTMB)

FoundationOne CDx

Massachusetts General Cancer Center, MA, USA; Harvard Medical School, MA, USA; Georgia Institute of Technology, GA, USA; Massachusetts General Hospital, MA, US

Saturday, September 10, 2022

#100P

Co-mutational landscape of key fibroblast growth factor receptor (FGFR) alterations in intra-hepatic cholangiocarcinoma (iCCA), bladder cancer (BC) and glioma

FoundationOne CDx

Ospedale San Raffaele,

Vita-Salute San Raffaele University, Milan, Italy; Tyra Biosciences, Carlsbad, CA, USA; F. Hoffmann-La Roche Ltd, Basel, Switzerland; Jefferson Health, Philadelphia, PA, USA; Ohio State University, Columbus, OH, USA; Repare Therapeutics, Cambridge, MA, USA; Hannover Medical School, Hannover, Germany

Sunday, September 11, 2022

#1373P

SPOP mutations (mtSPOP) are a treatment-selection biomarker in patients (pts) with de novo metastatic castration-sensitive prostate cancer (dn-mCSPC).

Clinico-Genomic Database (CGDB)

Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah; University of Minnesota Masonic Cancer Center, Minneapolis, MN

Sunday, September 11, 2022

#1393P

Comparison of genomic alterations (GA) landscape in SPOP mutated (SPOPmut) and SPOP wild type (SPOPwt) clinically advanced prostate cancer (CAPC)

FoundationOne CDx

Ospedale San Raffaele,

Vita-Salute San Raffaele University, Milan, Italy/Moffitt Cancer Center/SUNY Upstate Medical University

Sunday, September 11, 2022

#1368P

TALAPRO-1: Talazoparib monotherapy in metastatic castration-resistant prostate cancer (mCRPC) with DNA damage response alterations (DDRm)Exploration of tumor genetics associated with prolonged benefit

FoundationOne CDx

The Institute of Cancer Research and The Royal Marsden Hospital, London, UK; various other institutions; Pfizer

Sunday, September 11, 2022

#1521P

Comprehensive genomic profiling (CGP) of epithelioid hemangioendothelioma (EHE) and liver angiosarcomas (LAS)

FoundationOne CDx

Medical College of Wisconsin

Excerpt from:
Foundation Medicine to Share 14 Abstracts at the 2022 European Society for Medical Oncology (ESMO) Congress Demonstrating the Power of Genomic...

BOSTON, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (NASDAQ: GLUE), a biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the companys investigational new drug application (IND) for MRT-2359, a potent and selective GSPT1-directed MGD. The company is on track with initiating a Phase 1/2 clinical trial of MRT-2359 in patients with MYC-driven solid tumors, including lung cancer, and expects to dose the first patient in the fourth quarter of 2022.

The FDAs clearance of our first IND serves as a critical milestone for Monte Rosa and continues to validate our differentiated approach to protein degradation, said Markus Warmuth, M.D., CEO of Monte Rosa. Molecular glue degraders hold tremendous promise in tackling the universe of previously undruggable proteins and fostering a new generation of precision medicine therapeutics. After reporting compelling preclinical data, we are excited to advance MRT-2359 into a Phase 1/2 study for patients with MYC-driven solid tumors who otherwise have limited treatment options.

About MRT-2359MRT-2359 is a potent, selective and orally bioavailable molecular glue degrader (MGD) that induces the interaction between the E3 ubiquitin ligase component cereblon (CRBN) and the translation termination factor GSPT1, leading to the targeted degradation of GSPT1 protein. The MYC transcription factors (cMYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Our preclinical studies have shown that this addiction to MYC-induced protein translation creates a dependency on GSPT1. MRT-2359 exploits this vulnerability by inducing degradation of GSPT1, disrupting protein synthesis preferentially in MYC-driven cell lines and leading to anti-tumor activity in MYC-driven tumor models. A Phase 1/2 clinical study aims to evaluate the safety, tolerability and anti-tumor activity of MRT-2359.

About Monte RosaMonte Rosa Therapeutics is a biotechnology company developing a portfolio of novel molecular glue degrader (MGD) medicines. These medicines are designed to employ the bodys natural mechanisms to selectively eliminate therapeutically relevant proteins. The company has developed a proprietary protein degradation platform, called QuEEN(Quantitative andEngineeredElimination ofNeosubstrates), that enables it to rapidly identify protein targets and MGD product candidates that are designed to eliminate therapeutically relevant proteins in a highly selective manner. The companys drug discovery platform combines diverse and proprietary chemical libraries of small molecule protein degraders with in-house proteomics, structural biology, AI/machine learning-based target selection, and computational chemistry capabilities to predict and obtain protein degradation profiles. For more information, visitwww.monterosatx.com.

Forward-Looking StatementsThis communication includes express and implied forward-looking statements, including forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward looking statements include all statements that are not historical facts, and in some cases, can be identified by terms such as may, might, will, could, would, should, expect, intend, plan, objective, anticipate, believe, estimate, predict, potential, continue, ongoing, or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward-looking statements contained in herein include, but are not limited to, statements about our product development activities, including our expectations around MRT-2359, the ongoing development of our QuEEN platform and the advancement of our pipeline and the various products therein, our expectations of timing, including for initiation and patient dosing, of our clinical trial for MRT-2359, our ability to initiate and the timing of initiation of additional lead optimization programs, and our expectations regarding our ability to nominate and the timing of our nominations of additional development candidates. By their nature, these statements are subject to numerous risks and uncertainties, including the impact that the current COVID-19 pandemic will have on our development activities and operations, as well as those risks and uncertainties set forth in our most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K for the year ended December 31, 2021 filed with the US Securities and Exchange Commission, and any subsequent filings, that could cause actual results, performance or achievement to differ materially and adversely from those anticipated or implied in the statements. You should not rely upon forward looking statements as predictions of future events. Although our management believes that the expectations reflected in our statements are reasonable, we cannot guarantee that the future results, performance or events and circumstances described in the forward-looking statements will be achieved or occur. Recipients are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date such statements are made and should not be construed as statements of fact. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, any future presentations or otherwise, except as required by applicable law. Certain information contained in these materials and any statements made orally during any presentation of these materials that relate to the materials or are based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimates and research. While we believe these third-party studies, publications, surveys and other data to be reliable as of the date of these materials, we have not independently verified, and make no representations as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of our internal estimates or research and no reliance should be made on any information or statements made in these materials relating to or based on such internal estimates and research.

Contacts:

InvestorsMichael Morabito, Solebury Troutir@monterosatx.com

MediaDan Budwick, 1ABdan@1abmedia.com

See the article here:
Monte Rosa Therapeutics Announces FDA Clearance of Investigational New Drug Application for MRT-2359, a GSPT1-directed Molecular Glue Degrader Phase...

Dr. Anthony Fauci, Bidens chief medical adviser, said in a White House briefing earlier Tuesday: It is becoming increasingly clear that, looking forward with the COVID-19 pandemic, in the absence of a dramatically different variant, we likely are moving towards a path with a vaccination cadence similar to that of the annual influenza vaccine, with annual, updated COVID-19 shots matched to the currently circulating strains for most of the population.

We expect that the updated vaccines will offer better protection against the SARS-CoV-2 subvariants that are currently circulating, Fauci added.

Dr. Ashish Jha, the White House COVID-19 response coordinator, said that barring any new variant curveballs ... for a large majority of Americans, we are moving to a point where a single annual COVID shot should provide a high degree of protection against serious illness all year. Thats an important milestone.

Jha noted that people at highest risk may need more than annual protection, and we will ensure in this administration that they get whatever protection they need.

He also acknowledged the possibility that a new variant could emerge, saying, We plan for what we think is the median, the most likely scenario. But were always watching for that unusual event, and if that happens, we will address it and we will adjust to it and well account for it.

Fauci said there was always the possibility of a wildcard of a way-out, out-of-left-field variant coming in. If that happens, all bets are off, and we change.

Jha said in a stream of tweets Tuesday that the formula to control COVID-19 included the updated vaccines, as well as antiviral medicines, rapid tests, and improved indoor ventilation.

Some experts tweeted that there are still unanswered questions, including how well the updated boosters will work and whether people will get them.

Annual Covid booster? Possibly, but a few stars need to align first I think, tweeted Dr. Peter Hotez, codirector of the Center for Vaccine Development at Texas Childrens Hospital and dean of the National School of Tropical Medicine at Baylor College of Medicine.

Eric Topol, a professor of molecular medicine at Scripps Research, questioned whether the shots would last a whole year, tweeting, I dont see any evidence for how an annual Covid shot will provide durable protection (current ones wane after 4-6 months) without better vaccines. He noted efforts to create a vaccine that will protect against all variants, to improve the lipid nanoparticle delivery system of vaccines, and to develop a nasal vaccine.

Katelyn Jetelina, an epidemiologist in Texas and author of the newsletter Your Local Epidemiologist, said in a post that the administration was gambling because its not clear if an annual vaccination like the flu vaccination will work. The fall bivalent vaccine is ... our first attempt to apply the flu model to SARS-CoV-2. This is our pilot. And we really need to see how the pilot works in the real world before making sweeping declarations, like an annual shot. We need the data, the time, and the humility to tell. Lets first get through winter, she said.

Dr. Robert Wachter, who chairs the Department of Medicine at the University of California at San Francisco, told CNN, The biggest problem with the vaccines today is that people arent getting them.

Wachter said officials were hoping to get more people boosted by taking away uncertainty about when to get shots. The overall goal, he told CNN, was to cast boosters as more manageable, something you do every year, like getting a flu shot.

I think its a really smart way of rebranding and rethinking it, Wachter said.

The Globe reported Sunday it wasnt clear if people were going to get the shots, but doctors said interest might pick up after the holiday weekend and people return to school and work.

Experts say the updated boosters are crucial to blunting the impact of an expected surge of infections this fall and winter.

Staying up to date on vaccines, including boosters, is the most effective way to prevent serious illness, hospitalization, and death from COVID-19. While vaccine protection decreases over time, boosters re-stimulate the immune system and increase vaccine efficacy again. Boosters are an important defense, even if youve already had COVID, the state Department of Public Health said in a statement.

The department said people can check for updates at http://www.mass.gov/covidbooster, and that locations with the updated booster are in the process of being added to vaxfinder.mass.gov.

Winter is not that far away. The past two years, we have seen COVID-19 cases and deaths soar. It does not have to be that way this year. If you are 12 and older, go get your new COVID-19 shot this fall, Biden said in his statement.

Martin Finucane can be reached at martin.finucane@globe.com.

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Biden administration says the once-a-year shot phase of the COVID-19 pandemic has arrived - The Boston Globe