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Thursday, August 4, 2022

Pieris Stops Work On Cancer Med, Tested In Combo With Eli Lilly Drugs

 

  • Pieris Pharmaceuticals Inc  decided to end work on Cinrebafusp alfa (PRS-343), a 4-1BB/HER2 anticalin-based bispecific, as part of a strategic pipeline prioritization to focus its resources.
  • The drug was slapped with an FDA clinical hold in July 2020
  • In August, Eli Lilly And Co  announced a trial collaboration to contribute its ramucirumab (Cyramza) and paclitaxel for the Phase 2 study in HER2-positive gastric cancer.
  • For the AstraZeneca plc -partnered program, Pieris says its Big Pharma did a “reforecast” of the study to account for “global challenges” in recruiting patients because of COVID-19’s impact.
  • The companies are loosening the enrollment criteria and focusing on the 3 mg cohort for the efficacy readout. Topline results are slated for Q3 of 2023 after initially expecting the data this year.
  • After the results come in, Pieris can exercise a co-development option and could co-commercialize the drug in the U.S.
  • Pieris held a cash balance of $117.8 million. With the wind-down of the cinrebafusp alfa phase 2 trials and the expectation of modest near-term development milestones, the company believes operations are sufficiently funded into Q2 of 2024.

Cognition Therapeutics Shares Biomarker Data From Alzheimer's Candidate

 Cognition Therapeutics Inc CGTX presented a proteomic analysis of clinical biomarker data from the SPARC study of CT1812 in mild-to-moderate Alzheimer's disease at the Alzheimer's Association International Conference. 

What Happened: The results support the proposed synaptoprotective mechanism of action of CT1812 and its role in normalizing cellular processes known to be adversely disrupted in Alzheimer's disease.

The analyses demonstrated the effect of CT1812 on multiple Alzheimer's biomarkers, including YKL-40, an inflammation biomarker.

Participants treated with CT1812 exhibited a downward shift in YKL-40 towards levels observed in healthy, non-demented individuals.

CT1812 has been well tolerated in clinical studies to date. 

Mild and transient elevations of liver enzymes without indication of liver injury have been recorded. 

Why It Matters: CT1812 is an oral small molecule designed to penetrate the blood-brain barrier and bind selectively to the sigma-2 (σ-2) receptor complex involved in regulating key cellular processes damaged by toxic interaction with Aβ oligomers, oxidative stress, and other stressors. 

This damage to sensitive synapses can progress to a loss of synaptic function, manifesting as cognitive impairment and Alzheimer's disease progression. 

https://www.benzinga.com/general/biotech/22/08/28360618/exclusive-cognition-therapeutics-shares-biomarker-data-from-alzheimers-candidate

Insmed Results, Business Update

 ARIKAYCE® (amikacin liposome inhalation suspension) Achieves 44% Year Over Year Growth for the Second Quarter of 2022 with Total Revenue of $65.2 Million, Marking the Strongest Quarter Since Launch--

--All Clinical Programs Progressing on Track--

--Company Reiterates Guidance of at Least 30% Revenue Growth in 2022 and Cash Runway into 2024 to Support Ongoing Programs--

https://finance.yahoo.com/news/insmed-reports-second-quarter-2022-113000262.html

PDS Trial Continuation without Modifications Urged

 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T cell activating technologies, today announced that its independent Data Monitoring Committee (DMC) met for its scheduled review of PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) for the potential treatment of recurrent or metastatic HPV16-positive head and neck cancer.

Data from the 43 patients included both Stage 1 and Stage 2 checkpoint inhibitor (CPI) naïve subjects and Stage 1 CPI refractory subjects in the safety analysis. Assessment of clinical efficacy was not a focus of the DMC meeting review. Based on their review of patients with available safety data, PDS0101 in combination with KEYTRUDA® continues to appear safe and well tolerated. Specifically, there were no drug discontinuations related to toxicity as of the DMC review. In addition, there were no Grade 3 or greater treatment-related adverse events attributed to the combination. The DMC recommended continuing the trial with no modifications.

“The safety profile of PDS0101 in combination with KEYTRUDA® was consistent with previously reported studies of KEYTRUDA® alone.” mentioned Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “The safety data in patients with recurrent or metastatic HPV16-positive head and neck cancer continues to appear to be well tolerated. We look forward to evaluating this further in the VERSATILE-002 trial.”

VERSATILE-002 enrollment has progressed to Stage 2 for the checkpoint inhibitor (CPI) naive cohort and is ongoing in Stage 1 for the CPI refractory cohort. The DMC is comprised of an independent group of clinical and scientific leaders in the field of immuno-oncology and is responsible for reviewing and evaluating patient safety and efficacy data in the Phase 2 VERSATILE-002 trial.

US to declare health emergency over monkeypox outbreak

 The U.S. will declare a public health emergency to bolster the federal response to the monkeypox outbreak that has infected more than 6,600 Americans, two people familiar with the matter said Thursday.

The announcement will free up federal money and other resources to fight the virus, which may cause fever, body aches, chills, fatigue and pimple-like bumps on many parts of the body. The people spoke on the condition of anonymity ahead of an official announcement.

The declaration comes as the the Biden administration has faced criticism over monkeypox vaccine availability. Clinics in major cities such as New York and San Francisco say they haven’t received enough of the two-shot vaccine to meet demand, and some have had to stop offering the second dose to ensure supply of first doses.

The White House said it has made more than 1.1 million doses available and has helped to boost domestic diagnostic capacity to 80,000 tests per week.

The monkeypox virus spreads through prolonged and close skin-to-skin contact, including hugging, cuddling and kissing, as well as sharing bedding, towels and clothing. The people who have gotten sick so far have been primarily men who have sex with men. But health officials emphasize that the virus can infect anyone.

The announcement comes three days after the Biden administration named top officials from the Federal Emergency Management Agency and the Centers for Disease Control and Prevention to serve as the White House coordinators to combat the monkeypox outbreak.

News of the expected declaration was first reported Thursday by Politico.

Such a declaration is an important — and overdue — step, said Lawrence Gostin, a public health law expert at Georgetown University.

“It signals the U.S. government’s seriousness and purpose, and sounds a global alarm,” he said.

Under a declaration by the Department of Health and Human Services, the agency can draw from emergency funds, hire or reassign staff to deal with the outbreak, and take other steps to control the virus.


CVS plans move into primary care by end of 2022

 CVS Health plans to make a move toward merging with or acquiring a primary care firm in the coming months in pursuit of expanding its services, CEO Karen Lynch said Wednesday.

Lynch was asked about the company's strategy for entering the primary care space during the company's earnings call, where she said CVS "can't be in the primary care without M&A," and that "we are very encouraged and confident that we'll take the next step on this journey by the end of this year."

CVS Health to expand

CVS Health says it will take action to enter the primary care space by the end of the year. (iStock / iStock)

TickerSecurityLastChangeChange %
CVSCVS HEALTH CORP.102.39+1.08+1.07%

CVS is one of the largest drugstore chains in the U.S. with nearly 10,000 locations, and has 1,100 MinuteClinic locations providing customers with services for minor injuries and illnesses. Lynch said MinuteClinics saw a 12% increase in patient visits last quarter.

The company also offers prescription drug plans for major companies through its Caremark arm, and provides health insurance to more than 24 million people after acquiring Aetna.

CVS

CVS Pharmacy logo above the entrance to one of their stores. (Alex Tai/SOPA Images/LightRocket via Getty Images / Getty Images)

In addition to expanding into offering primary care, Lynch said CVS is also pursuing expanding health services in provider enablement and home health categories.

CVS competitors Walgreens, Amazon and Walmart have already entered the primary care space. 

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Walgreens

An exterior view of a Walgreens in Mill Valley, California, Jan. 6, 2022. (Justin Sullivan/Getty Images / Getty Images)

TickerSecurityLastChangeChange %
WBAWALGREENS BOOTS ALLIANCE INC.38.96-0.23-0.58%
AMZNAMAZON.COM INC.142.97+3.46+2.48%
WMTWALMART INC.126.47-4.11-3.15%

Walgreens announced in 2020 that it would introduce in-store doctors' offices through a partnership with VillageMD, and Amazon inked a deal last month to acquire One Medical in order to begin offering primary care services.

Walmart has already opened dozens of standalone Walmart Health centers in several states.

https://www.foxbusiness.com/markets/cvs-plans-move-primary-care-end-2022

In Adult ADHD, Home-Based Brain Stimulation Improved Attention

 Home-based transcranial direct current stimulation (tDCS) improved attention in adults with attention deficit-hyperactivity disorder (ADHD) who were not taking stimulant medications, a randomized trial showed.

Among 64 adults, the mean inattention score measured by the clinician-administered version of the Adult ADHD Self-report Scale (CASRS-I) was 18.88 in those who received 4 weeks of daily treatment with the home-based tDCS device compared with 23.63 in those who received sham treatment, reported Luis Augusto Rohde, MD, PhD, of Universidade Federal do Rio Grande do Sul, in Porto Alegre, Brazil, and colleagues.

Linear mixed-effects models showed a statistically significant treatment by time interaction for CASRS-I (β interaction -3.18, 95% CI -4.60 to -1.75, P<0.001), they noted in JAMA Psychiatry.

"Our findings support the use of tDCS as a safe and effective treatment for adults with ADHD with no concomitant treatment with stimulants," the group wrote. "Investigating effective nonpharmacological treatments for ADHD is a pressing concern," given the low rates of long-term adherence and persistence with stimulant medication, the recommended first-line treatment for most ADHD patients.

tDCS sessions shorter than 40 minutes using less than 4 mA have not been linked with any serious or irreversible side effects. Skin redness, scalp burn, tingling, and headache are the most common adverse effects.

The recent availability of reliable home-based tDCS devices has reduced the need for daily office visits and the associated potential for reduced adherence, Rohde and team noted. The dropout rate for this study was 14%, mainly due to COVID-19 restrictions.

Another noninvasive approach to neuromodulation, trigeminal nerve stimulation (TNS), was the first device-based therapy approved by the FDA for children with ADHD.

So far, most studies of tDCS in ADHD have looked at the cognitive effects of targeting the dorsolateral prefrontal cortex (DLPFC), and results have varied, the authors said, citing a meta-analysis that showed some "small trendwise significant effects for inhibition and processing speed, but not attention functions"; pilot studies in adults and kids showing that tDCS had an effect on inattention but not hyperactivity-impulsivity; and a large randomized trial in teenage boys that showed no symptom improvement after 15 sessions of tDCS over the right inferior frontal cortex. However, these studies varied in design, and many had "small sample sizes and short treatment periods," they added.

Like these studies, the current study found "no statistically significant differences in secondary outcomes of hyperactivity-impulsivity, depression, or anxiety," Rohde and team wrote. This may reflect exclusion of people with pre-existing depression or anxiety, or involvement of different areas of the brain in ADHD patients presenting with inattention versus hyperactivity-impulsivity, which has been linked with "a hypoactivation in the right inferior frontal cortex rather than right DLPFC."

In the absence of a consensus regarding the optimal montage for ADHD, the group used the right rather than left DLPFC based on reports of decreased activation in this region "in adult patients with ADHD during tasks that require attention," the group noted.

"In a conservative appraisal of our findings, the lowest limit of the 95% CI of the estimated effect size indicates at least a moderate effect, similar to the one reported with TNS, as well as to the second-line treatment for ADHD, atomoxetine, highlighting the potential use of neuromodulation as an effective alternative treatment for this population," Rohde and team wrote.

For this double-blind, parallel study, which was conducted from July 2019 to July 2021 at a single center, the authors enrolled 64 adults with ADHD and moderate or severe symptoms of inattention; 48% of participants had inattentive subtype and 52% had combined subtype. Mean age was 38 years, and 47% were women.

Study limitations included that patients' electrode placement and exposure were not supervised, in contrast to other studies of tDCS, as well as the use of a relatively homogeneous population of ADHD patients with no significant comorbid depression or anxiety. In addition, patients receiving pharmacological treatment for ADHD were excluded, which may limit generalizability.

Disclosures

Rohde reported relationships with Aché, Bial, Medice, Novartis/Sandoz, Pfizer/Upjohn, Shire/Takeda, Oxford Press, ArtMed, and the National Council for Scientific and Technological Development.

Co-authors reported multiple relationships with industry and other organizations.