Longeveron Starts Phase 2a Trial of Lomecel-B for Alzheimer’s

 Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or the "Company"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced today the initiation of its Phase 2a clinical trial evaluating Lomecel-B as a treatment for Alzheimer’s disease (AD). The first patient has consented to participate in the trial and patient screening has begun.

This Phase 2a study is intended to build on encouraging preliminary Phase 1 data that were announced in 2021. Additionally, the Phase 2a trial is designed to measure brain anatomy using MRI, and include detailed assessments of the inflammatory and vascular systems thought to contribute to the worsening of AD. The study, which will be conducted at a minimum of 6 centers, is led by Mark L. Brody, MD, of Brain Matters Research, Delray Beach, Florida.

“This is an important next step in the progress of our Alzheimer’s disease clinical program,” said Geoff Green, CEO of Longeveron. “We are pleased to have initiated this Phase 2a trial, as this study is intended to build upon the Phase 1 results and marks an important milestone in our efforts to explore the therapeutic potential of Lomecel-B in AD,” Green added.

Dementia resulting from AD is associated with vascular function decline and involves a pro-inflammatory state. In Longeveron’s prior Phase 1 trial, Lomecel-B treatment met the primary safety endpoint, with no safety concerns – including no evidence of Alzheimer’s-related imaging abnormality, known as ARIA. In addition, the levels of certain pro-vascular and anti-inflammatory biomarkers increased in the Lomecel-B treated subjects compared to placebo.

The Phase 2a trial is a double-blind, randomized, placebo-controlled design investigating safety and tolerability, as well as secondary endpoints that include cognitive function and biomarkers, following single or multiple infusions of Lomecel-B compared to placebo, in individuals with mild AD. The study consists of 4 treatment arms of 12 patients each, for a total target enrollment of 48 patients.

https://finance.yahoo.com/news/longeveron-announces-initiation-phase-2a-130000184.html

Bicycle: Continued Clinical Progress and Updates to Management

 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced continued progress in its ongoing Phase I/II clinical trials of BT8009, BT5528 and BT7480.

"Last quarter, we reported interim clinical results from ongoing trials of two of our Bicycle toxin conjugates, BT8009 and BT5528, demonstrating preliminary anti-tumor activity in two tumor types, and announced the first patient dosed in the Phase I clinical trial of BT7480, our first tumor-targeted immune cell agonist to enter the clinic. In our trial of BT8009, we are pleased to confirm the preliminary activity and see that these patients remain on trial. We look forward to presenting interim BT8009 Phase I results at a medical meeting and initiating the BT5528 expansion cohorts this year," said Kevin Lee, Ph.D., Chief Executive Officer. "We are also pleased with our progress advancing BT7480 in the ongoing Phase I clinical trial and look forward to sharing additional details regarding the potential for Bicycles beyond our toxin conjugates as we strive to become a leader in the development of targeted oncology therapeutics."

Bicycle Toxin Conjugates® (BTCs) BT8009 and BT5528

In the ongoing Phase I portion of the Phase I/II clinical trial of BT8009, a second-generation BTC™ targeting Nectin-4, four out of 11 patients were previously reported to have a partial response under Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including one out of four (25%) in the 2.5mg/m2 dose and three out of seven (43%) at the 5.0 mg/m2 cohorts. All four patients previously reported as responders have since received at least one subsequent scan, and all have been confirmed as ongoing RECIST 1.1 responses. One patient in the 5.0 mg/m2 cohort, who previously was reported to have a partial response with an 89% tumor reduction, has now received two subsequent scans, which each showed that total tumor volume has been reduced by 100%, constituting a confirmed complete response. All four patients previously reported to have a RECIST 1.1 clinical response remain on therapy. The tolerability profile of the 2.5mg/m2 and 5.0 mg/m2 cohorts remains consistent with that previously reported.

Dose escalation in the BT8009 Phase I trial remains ongoing, with patients currently being dosed at 7.5mg/m2 weekly or every-other-week. Bicycle intends to present interim Phase I results from the ongoing clinical trial at a medical meeting this year.

The Phase I/II trial of BT5528, Bicycle’s second-generation BTC targeting EphA2, is also ongoing, with plans remaining on track to initiate the expansion cohorts this year, with an expected recommended Phase II dose of 6.5mg/m2 every-other-week.

Bicycle tumor-targeted immune cell agonist™ (Bicycle TICA™) BT7480

Bicycle also initiated a Phase I clinical trial of BT7480, a novel, fully synthetic Bicycle TICA targeting Nectin-4 and agonizing CD137, in the fourth quarter of 2021, and dose escalation in that trial remains ongoing. BT7480 and other Bicycle TICAs, including a novel NK-cell-engaging molecule, were the subjects of four posters at SITC in November 2021.

Management Team Updates

Bicycle is also announcing the expansion of and transition in its management team. Michael Skynner, Ph.D., the company’s Chief Operating Officer (COO), has been appointed to the newly created position of Chief Technology Officer, effective January 3, 2022, to focus on leading and overseeing the growth of Bicycle’s proprietary phage display discovery platform in oncology, as well as on creating innovative opportunities for the platform outside of oncology. Dr. Skynner joined the company in January 2016 as Vice President, Operations and Discovery and had served as COO since March 2018. Alistair Milnes, who has served as the company’s Vice President, Human Resources and Communications since January 2021, has assumed the COO role. Mr. Milnes previously led human resources and communications at multinational energy and mineral companies. Both Dr. Skynner and Mr. Milnes are based in the United Kingdom.

"We are delighted to announce our recent management team appointments, with Mike Skynner becoming our new CTO and Alistair Milnes moving to the COO role. Mike has been an invaluable contributor to Bicycle’s success to date and has led our platform discovery efforts since joining in early 2016. Following recent promising clinical progress, we believe it is time to focus on accelerating the growth of our proprietary oncology pipeline and on identifying innovative ways to potentially capitalize on our unique technology beyond our current therapeutic focus. I am confident that Mike can help us achieve these objectives." 

https://finance.yahoo.com/news/bicycle-therapeutics-announces-continued-clinical-120000547.html

Pfizer upped to Buy from Neutral by B of A

 Target to $70 from $59

https://finviz.com/quote.ashx?t=pfe&ty=c&ta=1&p=d

Spectrum Pharmaceuticals Announces Strategic Restructuring

 Workforce reduction of approximately 30%

Cash runway extended into 2023

Resources to be focused on late-stage assets, poziotinib and ROLONTIS®

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a strategic restructuring. The company will prioritize its late-stage product opportunities, poziotinib and ROLONTIS® (eflapegrastim), and will deprioritize development activities of its early-stage clinical development and research programs. The company has made these decisions following a detailed review of its operations, portfolio and growth opportunities, and will focus its resources accordingly.

"The decision to restructure the organization is necessary to focus on our advanced clinical programs that will drive our future growth. I would like to express my appreciation to our colleagues who are affected by this decision and are leaving Spectrum. We are grateful for their dedication and their contributions to advancing our mission," said Tom Riga, President and Chief Executive Officer, Spectrum Pharmaceuticals. "The changes we are implementing are expected to result in a reduction in operating expenses and the extension of the company’s cash runway into 2023."

Spectrum intends to implement the following strategic restructuring initiatives to reduce its expenses and extend its existing cash runway:

• Spectrum is prioritizing the development activities for its late-stage assets, poziotinib and ROLONTIS, and will deprioritize work on its early-stage pipeline, FIT Program (IGN 002) and IL-12.

• The company restructuring will result in a workforce reduction of approximately 30%.

• Operating cash burn is expected to be reduced by 20-25%, which should extend the cash runway into 2023.

• The physical footprint of selected facilities will be significantly reduced in 2022.

https://finance.yahoo.com/news/spectrum-pharmaceuticals-announces-strategic-restructuring-130000360.html

OraSure Technologies Announces Actions to Enhance Stockholder Value

 Provides Preliminary 4Q21 Financial Outlook

Commences Review of Strategic Alternatives

Announces Transition of CEO and Organizational Changes

 OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, today announced preliminary Q4 2021 results, organizational changes, and a Board-level review of strategic alternatives to enhance stockholder value.

InteliSwab™ Update and 4Q21 Financial Outlook

OraSure expects to deliver total revenue in the fiscal fourth quarter at the low end of the Company’s guidance range of approximately $60 million, driven by lower than anticipated InteliSwab™ sales coupled with outperformance in the Company’s Molecular Solutions business unit.

The Company anticipates total InteliSwab™ revenue of approximately $12 million for the quarter and $20 million for the full year. During the fiscal fourth quarter OraSure made material progress in resolving the technology transfer issues and is now in the process of normal scale-up. Given the time involved to resolve those issues and the impact of additional hiring, training, and global supply chain challenges experienced by OraSure in the fourth quarter, the Company did not achieve its InteliSwab™ guidance for the fiscal year. The Company anticipates continued scaling of its InteliSwab™ production from 4Q21 levels and will provide an additional update on its 4Q21 earnings call. The Company is also in the process of hiring staff for additional shifts and installing additional automated equipment to further increase production.

“The Board and executive leadership team are taking action to ensure that we are in the best position to drive long-term value for our stockholders,” said OraSure President and Chief Executive Officer Stephen Tang, Ph.D. “Despite the slower scale-up in InteliSwab™ revenue in 2021, we are encouraged by our potential in 2022 for a significant step up in InteliSwab™ revenue given the strong demand environment and our United States government procurement contract. In addition, we are very pleased with the continued strong performance in our Molecular Solutions business unit, which has grown at over a 30% CAGR the last two calendar years including double-digit growth in our core molecular kits and services businesses.”

OraSure can also confirm that InteliSwab™ detects the Omicron variant when tested by an outside third-party laboratory with live viral samples. In addition, as previously confirmed, InteliSwab™ also detects the Delta variant and other variants of concern so consumers and caregivers can be confident in the results.

The estimated preliminary revenue results presented above are based on the information available to OraSure as of the date of this press release. OraSure has not yet completed its quarter-end closing. Actual results for the fourth quarter and year ended December 31, 2021 may vary from these estimated preliminary results and will not be finalized until after the date of this press release.

Evaluation of Strategic Alternatives

The COVID-19 pandemic has provided OraSure an opportunity to fundamentally transform into a higher growth, more innovative and efficient organization with broader customer reach, both within and outside the United States. The Company believes it is well positioned to address current public health challenges and capitalize on diagnostic trends in the market and enhance its operational and competitive profile. Against this backdrop, the OraSure Board of Directors intends to explore and evaluate a broad range of strategic alternatives with the goal of maximizing value for stockholders.

There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. OraSure does not intend to make any further public comment regarding the review until it has been completed or the Company determines that disclosure is required or appropriate. Evercore is serving as OraSure’s financial advisor and Troutman Pepper is serving as the Company’s legal advisor in this evaluation.

Leadership Changes

OraSure also announced that Stephen Tang Ph.D., President and CEO, will be the leaving the Company as of March 31, 2022. In the interim, Dr. Tang will focus primarily on assisting the Board in its strategic review process and helping to ensure an orderly transition of the CEO role. Under Dr. Tang’s four years as CEO, OraSure acquired four companies and launched several COVID-19 products, including InteliSwab™. As a member of the Board, he will have served for 11 years, including Chairman.

The Board has initiated a search for his successor as CEO. During this transition, while the CEO search is in process, the Board of Directors will be taking a more active role. For this purpose, the Board has appointed Director Eamonn Hobbs to serve as point person for the Board. Mr. Hobbs will not be a candidate for the permanent CEO position.

Organizational Changes

The Company is also making certain organizational changes to focus priorities, resources, expertise, and drive improved operational performance. Under the new vertically integrated business unit structure, operations, R&D and manufacturing will now report to each of the respective business unit leaders. Key to these changes, Lisa Nibauer will become President of Diagnostics and Kathleen Weber will become President of Molecular Solutions.

Ms. Nibauer joined OraSure as Executive Vice President, Business Unit Leader, Diagnostics, in May 2020. She previously spent eight years at Becton Dickinson, Inc. (“BD”), most recently as Vice President & General Manager, Global Medication Delivery Solutions, where she had complete operational and strategic responsibility for $1.6 billion in annual revenue globally and was also accountable for the largest business within BD. Prior to joining BD, she held general management, sales and marketing positions at several large healthcare companies.

Ms. Weber has served as the Executive Vice President, Business Unit Leader for Molecular Solutions, since January 2019 and previously held various senior executive leadership roles at OraSure since joining the Company in 2012. She is responsible for establishing the strong foundation of both our HIV self-testing and emerging disease programs. Prior to joining OraSure, Ms. Weber held several executive leadership positions at Pfizer, Johnson and Johnson and Schering–Plough leading and accountable for multi-billion dollar business units.

“The focus of the Board of Directors continues to be on ensuring OraSure can execute at a high level. We believe the organizational changes and other actions we are undertaking will best position the Company as it scales up with InteliSwab™ and delivers on its significant potential in key, high growth areas of healthcare. We appreciate Steve Tang’s years of service to OraSure and look forward to his continued leadership as we evaluate available strategic alternatives to maximize stockholder value,” said OraSure Chairman of the Board, Michael Celano.

About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services, and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Multiple government agencies, including the DOD and HHS are working to address COVID-19 testing needs. Development of the InteliSwab™ COVID-19 Rapid Test has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research, Innovation and Ventures under contract number 75A50120C00061, utilizing Health Care Enhancement Act (HCEA) funding. The DoD's Defense Assisted Acquisition (DA2) Cell led the manufacturing expansion effort for the InteliSwab™ COVID-19 rapid test in coordination with the Department of the Air Force’s Acquisition COVID-19 Task Force (DAF ACT). This effort was funded through the American Rescue Plan Act (ARPA) to enable and support domestic industrial base expansion for critical medical resources.

OraSure has received Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for its InteliSwab™ COVID-19 rapid tests. The FDA has authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and InteliSwab™ COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. InteliSwab™’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result. With less than one minute of “hands-on time,” it is as simple as Swab, Swirl, and See.

This product has not been FDA cleared or approved; but authorized by the FDA under an EUA; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

https://finance.yahoo.com/news/orasure-technologies-announces-actions-enhance-120500859.html

CytoDyn Leronlimab 14-Week, NASH Trial Met Primary, Secondary Endpoints

 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.

The primary endpoint, PDFF (proton density fat fraction), is an MRI-derived biomarker for fatty deposition, while the secondary endpoint, cT1, is an iron-corrected T1 mapping representative of liver inflammation and fibrosis. These two values are used to evaluate the risk of NASH. CytoDyn’s Phase 2 clinical trial compared the changes from baselines in these endpoints. The leronlimab 350 mg dose versus placebo comparison for the primary endpoint PDFF was statistically significant. Leronlimab compared to placebo also reached near significance for the secondary endpoint cT1. There were no significant differences in treatment emergent adverse events between leronlimab and placebo groups.

https://www.bakersfield.com/ap/news/leronlimab-14-week-nash-clinical-trial-met-primary-endpoint-pdff-and-secondary-endpoint-ct1-for/article_7da5a918-05ed-5164-a502-68264fb805e7.html

Omicron 'acts as natural vaccine':Dangerous idea rooted in ‘pandemic fatigue’

 

• The Omicron causing milder infections and less hospitalisation and deaths have led to the notion that the new variant of concern may act as a natural vaccine.
• 
  
• Experts have dismissed the claim of the Omicron variant of coronavirus being a natural vaccine as a “dangerous idea” by irresponsible people who don’t take long Covid into account. The Omicron causing milder infections and less hospitalisation and deaths have led to the notion that the new variant of concern may act as a natural vaccine. A Maharashtra health official recently said that the new variant spread faster than Delta, but there have been few hospitalisations.

"We hope this trend continues. If this happens, Omicron will act as a natural vaccination and may help in its (COVID-19) progression towards the endemic stage," state surveillance officer Dr Pradeep Awate told PTI.

Noted virologist Shahid Jameel said it is a dangerous idea spread by irresponsible people.

"It breeds complacency and is rooted more in pandemic fatigue and the inability to do more, than in evidence available at this time," PTI quoted Jameel as saying.

Jameel said that those propagating the natural vaccine theory don’t take into account the effects of “long Covid”.

"Especially in India, where malnutrition, air pollution and diabetes are rampant, to willingly let people be exposed to a virus about which you understand little is not good science and public health," he added.

Giridhara R Babu, the head of Lifecourse Epidemiology at the Public Health Foundation of India, urged people to stay away from this misinformation, saying there have been deaths and hospitalisations due to the Omicron variant.

“Compared to vaccination, natural infection cannot protect the population (against death or hospitalisation) against any variant (Alpha, Beta, Gamma or Delta). Proponents of herd immunity are saying it again that Omicron would provide herd immunity. Evidence matters, not opinions," he said.

Shuchin Bajaj, founder-director, Ujala Cygnus Group of Hospitals, cautioned about the long term effects of the disease.

"It has been shown that it can be seen persisting for more than six months in various other organs in addition to lungs, like heart and brain and kidneys etc, even after very mild infections. So we don't really know what long term effects it can cause. We are already seeing a lot of long COVID patients with brain fogging, inappropriate sinus tachycardia," he said.

"So we should not really think of this as a vaccine. It's not really a vaccine, we have had deaths due to Omicron. We have had ICU admissions due to Omicron. So it is a much milder version compared to Delta but still, it is a virus and we need to be careful," he added.

https://www.hindustantimes.com/india-news/omicron-acts-as-natural-vaccine-experts-say-notion-rooted-in-pandemic-fatigue-101641107770257.html