BuzzFeed (BZFD) to use ChatGPT creator OpenAI into content

 BuzzFeed said it would rely on ChatGPT creator OpenAI to enhance its quizzes and personalize some content for its audiences, becoming the latest digital publisher to embrace artificial intelligence.

In a memo to staff sent Thursday morning, Chief Executive Jonah Peretti said he intends for AI to play a larger role in the company’s editorial and business operations this year. 

-=Adamis Pharma (ADMP) : opioid overdose treatment gets FDA approval

 

Adamis Pharma announces that the U.S. Food and Drug Administration has approved Adamis' ZIMHI 5 mg/0.5 mL product

ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose.

-=Tyme Technologies (TYME) : metabolomic technology platform patent win

The patent, U.S. Patent No. 11,058,638, involves a targeted delivery of therapeutics to cancer cells.

The company was founded in 2014 and became publicly traded in 2015 when it executed a reverse merger into Global Group Enterprises and executed a private placement at $2.50 a share. 

Tyme Technologies: US Patent and Trademark Office granted additional patent claims related to the Company's metabolomic technology platform

• The patent, U.S. Patent No. 11,058,638, involves a targeted delivery of therapeutics to cancer cells.
• Tyme has developed a technology by which the tyrosine isomer racemetyrosine (a-methylparatyrosine) can be fused with a second therapeutic agent in a manner that creates a fusion compound that may allow targeted delivery to the cancer cells in a novel manner. This method of delivery, is predicated on the metabolic phenomenon in which cancer cells consume higher quantities of non-essential amino acids, including tyrosine, from their surrounding environment to support their growth because they cannot make enough of these amino acids.

Company Overview

0Tyme Technologies, Inc. (TYME) is a New York City based biotechnology company focused on developing cancer metabolism-based therapies (CMBTs) intended to be efficacious with relatively low toxicity profiles. The company was founded in 2014 and became publicly traded in 2015 when it executed a reverse merger into Global Group Enterprises and executed a private placement at $2.50 a share. Tyme is primarily owned by its two co-founders Steve Hoffman and Michael Demurjian, who between them control over 47% of the outstanding shares. 

Kindred Biosciences (KIN) : positive results from a pivotal efficacy study of KIND-030 in dogs infected by parvovirus

  

 

 

 

SAN FRANCISCO, June 2, 2021 /PRNewswire/ -- Kindred Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company focused on saving and improving the lives of pets, today announced positive results from a pivotal efficacy study of KIND-030 in dogs infected by parvovirus. The primary endpoint was survival and the results showed 100% survival in the treated group versus 43% survival in the placebo group.

KIND-030, a monoclonal antibody targeting canine parvovirus (CPV), is partnered with Elanco Animal Health (NYSE: ELAN).

In this randomized, blinded, placebo-controlled study, KIND-030 was administered to dogs after they tested positive for CPV infection. The primary endpoint of the study was met. The parvovirus challenge resulted in 57% mortality rate in the control dogs compared to 0% mortality rate in the KIND-030 treated dogs. The dogs did not receive any supportive care or other treatments.

"Parvovirus is a devastating disease currently without any available treatment," said KindredBio's Chief Executive Officer, Richard Chin, M.D. "With 100% efficacy, we believe KIND-030 has the potential to revolutionize the care of these dogs. Instead of a lengthy and expensive hospitalization that is frequently ineffective and can leave the dog with permanent disabilities, the infected dogs can now be treated with a single injection without need for additional supportive care or hospitalization."

"We are excited to partner with KindredBio on this revolutionary treatment that can significantly improve the health and well-being of dogs," said Jeff Simmons, president and CEO of Elanco Animal Health. "With our significant global reach and access to veterinarians and pet owners around the world, Elanco looks forward to leveraging our capabilities and skilled team of experts to advance and commercialize this novel treatment for pets globally."

With this positive study, KIND-030 has now demonstrated efficacy in both indications being pursued: prophylactic therapy to prevent clinical signs of canine parvovirus infection, and treatment of established parvovirus infection. Results from the pivotal efficacy study for the therapeutic claim are expected to be submitted to the United States Department of Agriculture (USDA) in June, with possible approval by year-end 2021.

CPV is the most significant and contagious viral cause of enteritis in dogs, especially puppies, with mortality rates as high as 91% if untreated. There are currently no Food and Drug Administration or USDA approved treatments for CPV, nor any other available treatment. Veterinary intervention is limited to supportive care, which can cost owners up to thousands of dollars per puppy, with an average cost of $1,200.

Canine parvovirus is most often seen in puppies less than 6 months of age, but can occur in unvaccinated dogs of any age. Clinical signs often include depression, not eating, vomiting, and profuse diarrhea which is often blood tinged.1 Banfield estimates that there are approximately 250,000 parvo cases in the U.S. each year, excluding emergency hospitals, shelters, specialty hospitals, or undiagnosed cases.2

KIND-030 binds to critical portions of the virus, preventing the virus from entering into cells.

On April 28, 2021 KindredBio announced acceptance of the parvovirus antibody prophylaxis study data and approval of the efficacy indication by the USDA Center for Veterinary Biologics. The pivotal efficacy data for the prophylactic indication demonstrated that 0% of the KIND-030 treated dogs developed parvovirus infection while 100% of the placebo-control dogs developed the disease, and also showed 100% survival rate in KIND-030.

Regulatory approval and review timeline are subject to the typical risks inherent in such a process. The results of the pivotal efficacy study for the therapeutic claim stated in this press release have not been reviewed by the USDA Center for Veterinary Biologics.

-=Lucira Health (LHDX) : COVID-19 test kit now available on Amazon.com

• Lucira Health (LHDX) announced that its LUCIRA CHECK IT COVID-19 test kit is now available on Amazon.com in the US. Each LUCIRA CHECK IT test kit provides a PCR quality test result at home in 30 minutes or less. After testing, users can also receive a free, text based digital LUCI PASS verified test result on their phone for work or travel. The product costs $55 and includes free standard shipping.
  

The test kit provides a PCR-quality test result in less than 30 minutes, from the comfort of one’s home. Furthermore, users of the test can receive a free, text-based test result on their phones which can be used for work or travel.

Lucira Health CEO Erik Engelson said, “We are excited to offer the first at-home COVID-19 self-test to provide an on-the-spot result with molecular accuracy available to millions of U.S. customers on Amazon.”

The test kit is also available over the counter in the U.S.

While the laboratory tests that are currently available take between 2 and 14 days to generate results, Lucira’s test kits provided results in less than 2 minutes to all of its clinical trial participants.

-=Cassava Sciences (SAVA) : Alzheimer's drug trial results

 

Cassava Sciences announces results of an interim analysis from an open-label study of simufilam, its lead drug candidate for the treatment of Alzheimer's disease

• Patients' cognition improved 1.6 Points on ADAS-Cog11.
• Patients' behavior improved 1.3 Points on NPI.
• Improvements maintained at 6 months.
• Results support advancing simufilam into Phase 3 clinical program.

-=Vir Biotechnology (VIR) : hepatitis B drug trial results

 

Vir Biotechnology reports initial data from ongoing Phase 1 trial of VIR-3434 for chronic hepatitis B Virus infection demonstrates significant and rapid reduction in hepatitis B surface antigen

Data from the first blinded cohort of eight patients, two of whom received placebo and six of whom received a single dose of 6 mg of VIR-3434, showed that six of eight patients achieved a mean reduction of 1.3 log10 IU/mL in serum hepatitis B virus surface antigen (HBsAg) by day eight, the day when nadir was achieved in most patients.

A Phase 2 trial combining VIR-3434 with Vir's HBV-targeting siRNA, VIR-2218, is expected to commence in the second half of this year.

-=Adamis Pharma (ADMP) submits a Covid drug to FDA

• Adamis is requesting the FDA's permission for investigational use of its Covid treatment drug Tempol. 

Tempol has demonstrated both potent anti-inflammatory, anticoagulant, and antioxidant activity. Both inflammatory cytokines and reactive oxygen species (ROS) from cells of the immune system called macrophages and neutrophils damage the lung in Acute Respiratory Distress Syndrome (ARDS). In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation, a problem observed in many COVID-19 patients. Numerous published articles describing animal models of ARDS show Tempol to cause a decrease in lung inflammation and preserve lung pathology associated with acute and chronic lung injury. To this end, Tempol has been shown to decrease the genes (HIF-la and HIF-2a) associated with hypoxia. Hypoxia is a key indicator often associated with severe disease and a poor outcome. Controlling hypoxia and the cytokine storm can be considered essential to the successful treatment of COVID-19.

Dr. Dennis J. Carlo, President and CEO of Adamis commented: “With over 23 million COVID-19 infections in the US and over 394,000 deaths in the US (according to the CDC), additional treatments are urgently warranted. We believe that Tempol could play a pivotal role not only in the treatment of COVID-19, but actually in preventing hospitalization. With new mutations occurring in the virus, it is apparent there is an ongoing need for new therapies. 

Intrepid Potash (IPI) provides update on its potash and Trio pricing and its 2021 outlook

 

 

Intrepid Potash provides update on its potash and Trio pricing and its 2021 outlook; reports fertilizer market has improved in recent weeks

Potash price into agricultural markets has increased $90 per ton, or 31%, above 2020 summer-fill pricing after a $40 per ton increase announced in December. Current potash price into agricultural markets is $65 per ton above the January 2020 winter-fill price.

Trio price into agricultural markets has increased $60 per ton, or 27%, above 2020 summer-fill pricing after a $20 per ton increase in December. Current Trio price into agricultural markets is $50 per ton above the January 2020 winter-fill price.

Oilfield outlook continues to improve in the Northern Delaware Basin driven by an increase in drilling and fracking activity. IPI currently forecasts first quarter 2021 and full year 2021 water volumes in excess of same time last year in the Intrepid and NGL Energy Partners three-ranch area of mutual interest.

• Current indications from operators for water needs during the calendar year 2021 are in excess of the total water available for sale under Intrepid and NGL's Joint Marketing Agreement affording Intrepid the opportunity to exploit optionality in its water portfolio.

"A strong agricultural commodity environment across a wide range of crops that includes corn, soybeans, wheat, cotton, coffee and sugar, combined with a reduced potash supply has driven the improvements in the fertilizer market in recent weeks. After announcing the price increases in December, we quickly filled the rest of our Q1 2021 order book before the higher price took effect and expect the benefits of higher pricing will be seen in the second quarter of next year. We continue to see good value across the fertilizer supply chain and have already sold select spot tons at the higher price levels."

BlackBerry (BB) teams up with Amazon Web Services to manage vehicle sensor data

• Having long ago moved on from its once-iconic mobile phones, BlackBerry (ticker: BB) Tuesday morning announced a deal with Amazon.com’s (AMZN) Amazon Web Services to jointly develop and market Ivy, which BlackBerry describes as “a scalable, cloud-connected software platform that will allow automakers to provide a consistent and secure way to read vehicle sensor data.

** BB ** 

 

The BlackBerry IVY system is a scalable software platform with deep roots on AWS cloud computing services. This vehicle data platform provides consistent and secure methods for gathering vehicle sensor information, packaging it into a normalized format, and preparing the data blobs for real-time analysis running on the car's own processors as well as deeper dives through AWS-based cloud computing services.

BlackBerry's role in this partnership consists of using machine learning tools to collect and normalize data from thousands of parts made by dozens of different manufacturers. In many cases, there are no industry standards available, and BlackBerry IVY will need to build its own data-access models for every undocumented sensor. Amazon's high-powered AWS systems will provide number-crunching muscle on the cloud-based side of the data analysis, augmented by direct access to the vehicle's embedded processing systems.

-=Rigel Pharma (RIGL) initiates a COVID-19 trial

Rigel Pharma and Imperial College London initiates two-stage trial to evaluate the efficacy of fostamatinib for the treatment of COVID-19 pneumonia

Announced the initiation of an investigator-sponsored trial being conducted by Imperial College London to evaluate the efficacy of oral SYK inhibitor fostamatinib for the treatment of COVID-19 pneumonia. The primary objective of the two-stage trial, which is to be supported by co and Novartis (NVS), will be to determine the efficacy of fostamatinib and of ruxolitinib vs standard of care.

Equillium (EQ) : Positive Covid-19 results

Equillium (EQ) announced that a clinical trial conducted in India by its partner Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19.

 

Equillium reports data for Itolizumab demonstration reduction in mortality in patients hospitalized with COVID-19

Co announced that as reported by its partner, Biocon Limited, a clinical trial conducted in India by Biocon demonstrated that itolizumab significantly reduced mortality in patients hospitalized with COVID-19. Biocon has announced that the Drugs Controller General of India (DCGI), the regulatory agency that oversees drug approvals, has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India. Based on the encouraging topline results of the study reported by Biocon and subsequent DCGI approval to treat COVID-19 patients, Equillium is planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).

Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month. As reported by Biocon:

• In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered.
• The mortality benefit observed in the itolizumab arm was statistically significant.
• Consistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFa.

-=Corvus Pharma (CRVS) initiated a Phase 1 study for patients with COVID-19

Corvus Pharmaceuticals initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19
The first cohort of five patients enrolled in the study was treated at Temple University Hospital in Philadelphia, PA. The study is expected to enroll up to 30 patients at several sites in the United States. This follows the U.S. Food and Drug Administration's (FDA) review and acceptance of the Company's investigational new drug (IND) application for the COVID-19 study.

Becton Dickinson (BDX) : Rapid antigen test for COVID-19 authorized by FDA

Becton Dickinson launches portable, rapid point-of-care antigen test to detect SARS-CoV-2 in 15 minutes, dramatically expanding access to COVID-19 testing.

• Co is leveraging its global manufacturing network and scale and expects to increase capacity to be able to produce 2 million tests per week by the end of September. The company already expects to produce up to 10 million tests from July through September. This is the company's third diagnostic test to receive Emergency Use Authorization by U.S. FDA for detecting COVID-19 . 

Becton Dickinson's test can be used on its existing BD Veritor System platform, which is employed in about 25,000 healthcare facilities across the United States.

Antigen tests are a relatively new type of test for COVID-19 that work by scanning for proteins that can be found on or inside a virus.

The authorization was based on a robust sample size of 226 specimens from sites across the United States, Evercore ISI analyst Vijay Kumar said in a research note.

"We think the new antigen test will play a big role in the coming flu season as a rapid, rule out test," Kumar said.

The FDA has touted the rapid tests as an important tool for combating the pandemic because they can be produced quickly, at relatively low costs, and test patients in a variety of settings.

The regulator in May approved the first COVID-19 antibody test, which is made by Quidel Corp.

-=T2 Biosystems (TTOO) announces US launch of molecular diagnostic test for COVID-19

T2 Biosystems announces US launch of molecular diagnostic test for COVID-19

T2 Biosystems today announced the completion of validation of its COVID-19 molecular diagnostic test, the T2SARS-CoV-2 Panel. The test was developed by T2 Biosystems under a license agreement with the Center of Discovery and Innovation at Hackensack Meridian Health and is being commercially distributed after validation meeting requirements for an Emergency Use Authorization request to FDA.

The T2SARS-CoV-2 Panel, designed to detect SARS-CoV-2, provides sample-to-answer results in less than two hours, utilizing a nasopharyngeal swab sample. Clinical testing on known positive and negative patient samples showed a sensitivity of 95% and specificity of 100%. The T2SARS-CoV-2 Panel runs on the company's FDA-cleared T2Dx Instrument.

Adaptimmune Therapeutics (ADAP) : positive data on experimental cell therapy

• The company said that trials of its SPEAR T-cell therapy showed a 50% response rate in patients with synovial sarcoma. The company also reported confirmed responses in lung cancer patients, and had previously reported confirmed responses in head and neck cancer patients. 

 

Adaptimmune Therapeutics presented updated data from its ADP-A2M4 Phase 1 trial at the American Society for Clinical Oncology Annual Meeting

New Phase 2 trial in EGJ cancer planned for 1H 2021, after first two patients treated responded to next-generation ADP-A2M4CD8 therapy.

Durability and efficacy data presented at ASCO support potential for SPEARHEAD-1 as a registrational trial for sarcoma - commercial launch planned in the US in 2022.

Phase 2 trial combining ADP-A2M4 with pembrolizumab in head and neck cancer (SPEARHEAD-2) will be the first time a SPEAR T-cell therapy is used in sequence with first line systemic therapy.

The company also announced new responses in the SURPASS trial, confirming the potential for SPEAR T-cell therapies targeting MAGE-A4 to treat a broad range of cancers in addition to sarcoma. These data further support the rationale for two new Phase 2 trials -- SPEARHEAD-2 in head and neck cancer, which will begin later this year, and a second trial in esophagogastric junction (EGJ) cancer planned for 1H 2021.

The SURPASS trial (a Phase 1 trial with ADP-A2M4CD8) will focus on lung, EGJ, head and neck, and bladder cancers.

Confirmed complete response in a patient with liver cancer in the Phase 1 ADP-A2AFP trial (reported as partial response in January).

Arca Biopharma (ABIO) to develop a coronavirus treatment

 

Arca said it will study an experimental drug called AB201 in patients with Covid-19 and abnormal blood clotting. Abnormal blood clotting is one of the serious complications of Covid-19. Arca has already tested AB201 in more than 700 patients with other conditions.

The drug already has "substantial safety data, which the company believes may enable more rapid development," Arca said in a news release. The biotech company plans to ask the Food and Drug Administration for permission to begin testing as a coronavirus treatment during the third quarter.

Why It Could Work In Coronavirus Treatment
Arca's potential coronavirus treatment works by blocking the tissue factor, or TF, protein, which is tied to the inflammatory response to viral infections. The biotech company has already studied AB201 in more than 700 patients for various conditions in Phase 1 and Phase 2 tests.

Recent research suggests Covid-19 has several factors in common with blood disorders in which the blood's ability to clot has been impaired, Arca said. There's also evidence to indicate AB201 could have natural and anti-inflammatory abilities, the company said.

"Collectively, the company believes these observation provide a strong rationale for investigating AB201 as a treatment for Covid-19, the disease caused by SARS-CoV-2 virus," Arca said.

The need for an effective coronavirus treatment continues to grow alongside the number of cases. As of Thursday morning, there were more than 5.8 million confirmed cases of Covid-19 globally. The U.S. accounts for about 30% of the caseload.

Exelixis (EXEL), Bristol-Myers (BMY) : upbeat trial results of a Kidney cancer treatment

the companies said a phase 3 study of a treatment for kidney cancer met its primary and secondary endpoints. "The results from the pivotal CheckMate -9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients," said Dr. Toni Choueiri, Director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute.

Bristol-Myers announces announced that CheckMate -743, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) in combination with Yervoy in previously untreated malignant pleural mesothelioma met its primary endpoint of overall survival

Opdivo plus Yervoy prolonged survival compared to chemotherapy at interim analysis in CheckMate -743.
Malignant pleural mesothelioma is a rare and aggressive cancer with limited treatment options.
Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, Opdivo in combination with Yervoy resulted in a statistically significant and clinically meaningful improvement in OS compared to chemotherapy (pemetrexed and cisplatin or carboplatin).

=XPO Logistics (XPO) : CEO seeks to break up company

Late Wednesday, XPO Logistics announced it's undertaking the review to enhance shareholder value. XPO stock continues to trade well below the sum-of-the-parts value and at a big discount to pure-play peers, CEO Bradley Jacobs noted in a statement.

It has not set a timetable for completing the review process.

But the company ruled out selling or spinning off its North American less-than-truckload unit, which is key to XPO Logistics' growth.

In the first nine months of 2019, the segment contributed to 36% of total revenue, up from 34% in the year-ago period. In 2021, company expects it to generate $1 billion in EBIT from the less-than-truckload business.

In February 2019, XPO Logistics warned that its largest customer was downsizing the amount of business it does with XPO. That customer was widely believed to be e-commerce giant Amazon, which is building out its own fleet of delivery vehicles and aircraft. The warning took XPO stock down to a two-month low.

-=SmileDirectClub (SDC) to sell oral care products at Walmart

SmileDirectClub (SDC) announced the launch of oral care products available exclusively at Walmart US stores and Walmart.com. SmileDirectClub's inaugural retail rollout includes a state-of-the-art electric toothbrush and bright on, a premium teeth whitening system complete with LED light. This quarter, the brand will also introduce three additional new smile-enhancing products with Walmart, including toothpaste in whitening and sensitivity varieties, a water flosser, and smile spa, the first ultrasonic UV cleaner on the market.