Kiniksa Q3 Report, Portfolio Update

 - Q3 2021 ARCALYST® (rilonacept) net revenue of $12.1 million -

- ARCALYST prescribed by more than 200 physicians for recurrent pericarditis since approval -
- Data from Phase 3 trial of mavrilimumab in COVID-19-related ARDS expected in Q1 2022 -
- Data from Phase 2b trial of vixarelimab in prurigo nodularis expected in 2H 2022 -
- Conference call and webcast scheduled for 8:30 am ET today -

Financial Guidance

• Kiniksa expects ARCALYST net revenue for the fourth quarter of 2021 to be between $16.0 million and $17.0 million.

• Kiniksa continues to expect that its cash, cash equivalents and short-term investments will fund its current operating plan into 2023.

Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 am ET on Monday, November 1, 2021 to discuss third quarter 2021 financial results and to provide a corporate update.

Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1699563. To access the webcast, please visit the Investors and Media section of Kiniksa’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

https://finance.yahoo.com/news/kiniksa-pharmaceuticals-reports-third-quarter-120000891.html

Justice Dept. Agrees with Rite Aid to Make Online COVID Vax Portal Accessible to DIsabled

 The Justice Department and the U.S. Attorney’s Office for the Middle District of Pennsylvania today announced a settlement agreement with Rite Aid Corporation that will help people with disabilities get information about COVID-19 vaccinations and book their vaccination appointments online. 

Rite Aid’s COVID-19 Vaccine Registration Portal, currently located at https://www.riteaid.com/covid-19, was not accessible to some people with disabilities, including those who use screen reader software and those who have a hard time using a mouse. For instance, the calendar on Rite Aid’s website used for scheduling vaccine appointments did not show screen reader users any available appointment times, and people who use the tab key instead of a mouse could not make a choice on a consent form that they needed to fill out before scheduling their appointment.       

“Equal access to healthcare is one of the most important rights guaranteed by the Americans with Disabilities Act,” said Assistant Attorney General Kristen Clarke of the Justice Department’s Civil Rights Division. “As the nation continues its response to the COVID-19 pandemic — through booster shots, vaccinations for children under 12, and ongoing outreach to those still in need of initial doses — people with disabilities must be able to schedule potentially lifesaving vaccine appointments as easily as people without disabilities can.”    

Under today’s settlement, Rite Aid has agreed to make content about the COVID-19 vaccine, including the forms for scheduling an appointment to get the vaccine, conform to the Web Content Accessibility Guidelines (WCAG), Version 2.1, Level AA. WCAG is a set of voluntary industry guidelines for making information on a website accessible to users with disabilities.  Rite Aid also must regularly test the pages of its website about vaccine scheduling and information and quickly fix any problems that keep people with disabilities from being able to use these pages.

This matter was handled jointly by the Disability Rights Section of the department’s Civil Rights Division and Civil Rights Coordinator Michael Butler of the U.S. Attorney’s Office for the Middle District of Pennsylvania. Title III of the Americans with Disabilities Act (ADA) requires public accommodations like drugstores and grocery stores to provide individuals with disabilities with full and equal enjoyment of goods and services, such as vaccines. The ADA also requires public accommodations to ensure effective communication with people with disabilities, including by using auxiliary aids and services like accessible technology.

https://www.justice.gov/opa/pr/justice-department-secures-agreement-rite-aid-corporation-make-its-online-covid-19-vaccine

Inovio victim to AstraZeneca's 'usual pipeline pruning' as HPV cancer vax deal axed

 AstraZeneca is wielding the ax to a bloated pipeline and Inovio has found itself the latest victim. MedImmune, an AstraZeneca unit, has terminated a collaboration agreement with Inovio for the cancer immunotherapy MEDI0457, which was being developed to target cancers caused by certain types of the human papillomavirus.

The deal, originally signed in 2015, was worth $27.5 million upfront with $700 million in biobucks down the line. Inovio has managed to pick up a couple million dollars through the partnership, but the remaining funds are now off the table.

MedImmune will continue to fund a handful of phase 2 trials still underway as they wrap up. One trial in head and neck cancer recently completed a final data cutoff with a readout expected by year-end 2022, Inovio said. A second externally sponsored trial with MD Andersen will also continue until completion.

Inovio will regain the rights to MEDI0457, which was known as INO-3112 back at the Pennsylvania biotech’s headquarters. But the therapy’s future is still unclear. Inovio will cease any development activities that would have required reimbursement from MedImmune while they consider the next steps.

The news was revealed in an 8-K (PDF) from Inovio issued after-market on Friday, a key biotech method of tying to partly bury bad news. Inovio said the collaboration has so far garnered about $2 million and change from MedImmune. RBC Capital Markets had expected Inovio to collect about $210 million in milestones and double-digit royalties on $300 million in peak sales, according to a Monday note.

Inovio’s therapy has fallen victim to AstraZeneca’s “usual pipeline pruning,” according to RBC—but the cut is “still a disappointment.” This is not the first time the U.K. pharma has axed a collaboration with Inovio. The companies previously cut ties over two preclinical DNA-based oncology vaccine programs in 2019.

The 2015 partnership was also trimmed back in 2019 down to the one vaccine, MEDI0457.

RBC noted “a pattern of pressure” on Inovio’s pipeline, and the end of the MedImmune deal is another stressor. But the biotech’s COVID-19 vaccine INO-4800 is slowly making headway, even as it's fallen behind the first-to-market winners. The vaccine was recently selected to be part of a large phase 3 clinical trial conducted by the World Health Organization.

The goal of the trial is to develop the next generation of shots that can be needle-free. Inovio’s vaccine is given through a device called Cellectra that administers an electrical pulse to the skin to open up the pores for delivery of the medicine.

Inovio's shares were mostly holding steady as the markets opened Monday, down just over 1% to $7.05. 

https://www.fiercebiotech.com/biotech/inovio-falls-victim-to-astrazeneca-s-usual-pipeline-pruning-as-human-papillomavirus-cancer

Digital health firm Better Therapeutics makes Nasdaq debut

 Better Therapeutics has joined the ranks of publicly-listed digital health companies after completing a merger with blank cheque company Mountain Crest Acquisition Corp II.

The company, which specialises in prescription digital therapeutics (DTx) for cardiometabolic diseases, listed on the Nasdaq under the BTTX ticker late on Friday.

Shares initially fell back slightly from an opening price of $10.04 after the merger closed with the special purchase acquisition company (SPAC), but then rocketed to $16.76 in pre-market trading.

The SPAC route to a public listing is increasingly being used by digital health companies as an alternative to an initial public offering (IPO), with other recent examples including DTx specialist Pear Therapeutics and telehealth company Babylon Health.

It can be quicker, simpler and cheaper than an IPO, which can see investment banks taking a sizeable slice of gross proceeds in fees, but also involves less scrutiny of a company’s finances, liabilities and operational processes.

The proceeds of around $70 million will keep the company funded through 2023, and will be used to bring forward Better Therapeutics’ lead prescription DTx for type 2 diabetes – BT-001 – through clinical trials and submission for FDA approval, according to the digital health company.

BT-001 is a tool designed to change behaviours that are the root cause of type 2 diabetes, and is being investigated in a pivotal study as a treatment used under physician supervision for people with uncontrolled diabetes.

The DTx works by blending clinical, behavioural and psychological inputs into a series of therapy lessons and skill-building modules.

Better Therapeutics recently recruited the first patient in a real-world study of BT-001 partnered with US primary care organisation Catalyst Health Network to gauge the long-term impact of the tool.

The cash injection will also be used to advance the digital health firm’s prescription DTx pipeline for other cardiometabolic conditions, which includes BT-002 for hypertension and BT-003 for high blood cholesterol as well as a candidate for non-alcoholic fatty liver disease (NAFLD).

Better Therapeutics meanwhile also gets access to an additional $40 million credit facility, subject to certain milestones being achieved.

“We envision a future where digital therapeutics are often the first prescription written in order to address the root causes of disease caused by patient behaviours,” said Kevin Appelbaum, Better Therapeutics’ co-founder and chief executive

“The completion of this transaction and the capital raised will be instrumental in helping our team lead the way in this transformation, beginning with cardiometabolic diseases,” he added.

https://pharmaphorum.com/news/digital-health-firm-better-therapeutics-makes-nasdaq-debut/

U.S. vaccines for children plan fully operational next week: White House

  The United States is rolling out Pfizer/BioNTech COVID-19 vaccines for children aged 5 to 11 this week, but most of the 15 million shots being shipped initially are unlikely to be available before next week, the White House said on Monday.

Millions of doses specifically formulated for children of that age group will start arriving at distribution centers over the next few days, White House coronavirus response coordinator Jeff Zients said, and the federal government has purchased enough supply for all eligible 28 million children.

"The bottom line is there's plenty of supply of the Pfizer vaccine and we look forward to parents having the opportunity to vaccinate their kids," Zients told reporters at a briefing.

The U.S. Food and Drug Administration on Friday authorized the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years, making it the first COVID-19 shot for young children in the United States.

The U.S. Centers for Disease Control and Prevention still needs to advise on how the shot should be administered, which will be decided after a group of outside advisers discuss the plan on Tuesday.

Following the CDC's decision, parents will be able to visit vaccines.gov and filter locations offering the vaccine for the children, Zients said.

"The whole plan is based on Pfizer vaccines," he said.

Moderna Inc said on Sunday it would delay filing its request for an emergency use authorization for a half-strength 50-microgram dose of the vaccine for children ages 6 to 11.

At the end of last week, the seven-day average number of coronavirus cases dropped 3% to around 69,000 daily cases and the daily deaths average fell 10% to around 1,100, though the average hospitalization rate climbed 10% to around 5,100 cases, CDC Director Dr. Rochelle Walensky said at the same briefing.

U.S. Chief Medical Advisor Dr. Anthony Fauci said it was "very likely" everyone would be able to get a vaccine booster shot "within a reasonable amount of time."

Currently the CDC recommendations for boosters cover specific categories of people. 

https://finance.yahoo.com/news/1-u-vaccines-children-plan-165921512.html

BioSig Increases Case Volume Estimates

 The Company reports increased adoption and commercial activity of its signal processing technology for arrhythmia care

BioSig Technologies, Inc. (Nasdaq: BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it exceeded its procedural target of 1500 patient cases in 2021.

As of October 21, 2021, the PURE EP(tm) System had been used in over 1560 patient cases by 71 physicians, up from 1000 cases in June 2021, when the procedural guidance was raised amid increased technology usage in elective procedures. As the adoption of the technology increases and the COVID-19 hospitalization rates continue to decline, the Company intends to complete between 1700-1800 procedures by the end of 2021.

“We are seeing increased utilization of PURE EP(tm) in the 13 hospitals we are currently working in. Physicians recognize value both clinically and economically or they would not be increasing their usage. Hospitals are rapidly scaling their elective procedures and thus we are now seeing increased case volumes and commercial activity,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

Clinical data acquired by the PURE EP(tm) System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP(tm) signals over conventional sources.

https://finance.yahoo.com/news/biosig-increases-case-volume-estimates-163000960.html

Weeks into CEO shakeup, Mirati bids adieu to 2 C-suiters with KRAS drug filing around corner

 Mirati is on the cusp of emerging as the sole challenger against Amgen in the suddenly hot KRAS inhibitor market and thinks it has the man to take it across the finish line. But new leadership often means shakeups, and now two Mirati execs are being shown the door.

Mirati CMO Joseph Leveque and Daniel Faga, the biotech’s chief operating officer and principal financial officer, have both departed the company as it enters the homestretch for filing its KRAS drug adagrasib with the FDA, Mirati revealed in an SEC filing Monday.

Details on the departures are slim, with Mirati noting the decisions on both positions were made Oct. 28. In Faga’s place, Mirati accounting lead Vickie Reed will step into the principal financial officer role without an increase in pay, the biotech said.

The shakeup comes a little over a month after Mirati appointed David Meek, a former CEO at FerGene and Ipsen, to the head role, replacing founding CEO Charles Baum.

Meek, who was mostly recently ousted from FerGene after the biotech imploded in spectacular fashion earlier this year, came on board right as Mirati races to an expected filing for adagrasib this quarter, looking to keep the heat on Amgen and its own KRAS inhibitor Lumakras. The company rolled out Phase II data for adagrasib in non-small cell lung cancer in September it says will serve as the basis for that filing, as well as winning mid-stage colon cancer data at ESMO21.

Leveque had served as CMO at Mirati since May 2020, jumping over from Synthorx, where he served as CMO for a little under two years. Prior to that, Leveque jumped around between a spate of biotechs and Big Pharmas, including EMD Serono, Bristol Myers Squibb, Onyx and Amgen.

Faga had been with Mirati since January 2020, previously holding the chief business officer role at Spark Therapeutics for more than three years. He was previously a managing director at Centerview Partners and an associate at Merrill Lynch.

https://endpts.com/weeks-into-ceo-shakeup-mirati-bids-adieu-to-a-pair-of-c-suiters-with-kras-drug-filing-around-the-corner/