- The Independent Data Safety Monitoring Board identified no safety concerns and issued a recommendation to continue trial enrollment.
- No treatment-related Serious Adverse Events with first 50 enrolled clinical trial participants
Thursday, February 2, 2023
NRx: Safety board finds no concerns with bipolar candidate
Purple Biotech Acquires Immunorizon, Tri-Specific Antibodies for Cancer
Purple Biotech Ltd. (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, today announced that it has entered into an agreement for the acquisition of Immunorizon Ltd., a private company developing potential multi-specific T and NK cell engager oncology therapies that selectively activate the immune response within the tumor microenvironment. The acquisition will provide Purple Biotech with an expanded portfolio of investigational tri-specific antibody compounds that target multiple antigens and offer the potential to further expand to additional targets.
Immunorizon’s lead asset is a conditionally-activated tri-specific antibody that engages both T cells and NK cells to mount a strong, localized immune response within the tumor microenvironment. The third arm of the lead compound specifically targets the Tumor Associated Antigen (TAA) 5T4, that is expressed in a variety of solid tumors and is correlated with advanced disease, increased invasiveness and poor clinical outcomes. 5T4 is a well-known target that has been validated by multiple pre-clinical and clinical programs. The drug candidates Purple Biotech is acquiring are differentiated from other multi-specific cell therapies targeting 5T4+ tumors by its cleavable capping technology, which confines the compound’s therapeutic activity to the local tumor microenvironment, and thereby potentially increases the anticipated therapeutic window in patients. The acquisition will also provide Purple Biotech with additional preclinical assets targeting other TAAs through this technology platform.
Arrowhead Starts Phase 1/2a Study of ARO-MMP7 for Idiopathic Pulmonary Fibrosis
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) announced today that it has dosed the first subjects in a Phase 1/2a clinical trial of ARO-MMP7, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce the expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF).
“MMP7 is thought to play multiple roles in IPF pathogenesis, including promoting inflammation and aberrant epithelial repair and fibrosis,” said James Hamilton, M.D., MBA, chief of discovery and translational medicine at Arrowhead. “ARO-MMP7 offers a novel approach to potentially address the significant unmet medical need that exists for patients with IPF, who experience progressive decline of lung function, despite currently available therapies.”
AROMMP7-1001 (NCT05537025) is a Phase 1/2a single ascending dose and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MMP7 in up to 56 healthy volunteers and up to 21 patients with IPF.
Roche Flags Lower 2023 Sales On Declining Demand For COVID-19 Treatment, Diagnostics
- Roche Holdings AG released FY22 sales growth of 2% (+1% in CHF) to CHF 63.3 billion.
- Core operating profit increased by 3% (+1% in CHF), reflecting the good underlying business performance.
- The company warned that in 2023, a sharp decline in COVID-19 products would knock sales by around CHF 5 billion.
- Sales and core earnings per share were expected to decrease at a "low single-digit" percentage this year, the company said.
- "For the current year, we expect solid underlying growth in both divisions, which will largely compensate for the further significant drop in sales of roughly CHF 5 billion in COVID-19 products," Roche's CEO said.
- Pharmaceuticals Division sales increased by 2% to $45.6 billion on the solid growth of newer medicines, more than compensated for the impact of biosimilars and lower sales of Actemra/RoActemra (severe COVID-19).
- Roche's bestseller multiple sclerosis drug Ocrevus gained a currency-adjusted 17% in sales to just over CHF 6 billion in 2023, while its hemophilia treatment Hemlibra jumped 27% to CHF 3.8 billion.
- Newly approved Vabysmo for 'wet' age-related macular degeneration and diabetic macular edema generated CHF 591 million in sales.
- Diagnostics Division sales grew by 3% to CHF 17.7 billion on ongoing strong momentum in base business (+7%), more than compensating for the continuing decline in the demand for COVID-19 tests in 2H 2022.
Silo Pharma Expands Intellectual Property Portfolio
Silo Pharma, Inc. (Nasdaq: SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced that the U.S. Patent and Trademark Office (USPTO) today issued U.S. Patent 11,491,120, titled “Pharmacological Prophylactics Against Stress-Induced Affective Disorders In Females.” The allowed claims protect the use of portfolio drug SPC-15 in a method of treating stress-induced affective disorders including anxiety and post-traumatic stress disorder (PTSD).
“After a comprehensive review by USPTO, we are pleased with the scope of the granted claims offering further protection for our novel SPC-15 technology and its market potential for anxiety, PTSD, and related disorders,” said Eric Weisblum, Chief Executive Officer
Through its commercial evaluation license agreement with Columbia University, the Company holds an option to license certain assets currently under development by Columbia, including potential treatments for stress-induced affective disorders and Alzheimer’s disease.
SPC-15 is a targeted prophylactic using ketamine compositions as a method of treatment and prevention for stress-induced affective disorders including PTSD. The treatment predicts levels of severity or progression of such disorders and their metabolomic biomarkers’ response to pharmacological treatments.
With the patent announced today, the Company expands its intellectual property and technology rights for the treatment of rare diseases,
https://finance.yahoo.com/news/silo-pharma-announces-expansion-intellectual-135000252.html
Biden economic adviser Deese is stepping down
President Joe Biden on Thursday said Brian Deese, who heads the White House's National Economic Council, is departing. Biden said in a statement that he's grateful to Deese's family "for letting us borrow Brian" and he knows "they're excited to welcome him home." Lael Brainard, the vice chair of the Federal Reserve, has emerged as a contender to take Deese's job, though others are also under consideration.
Most Shorted Companies All Exploding Higher
We may not (yet) be at Jan 2021, when an army of Reddit apes sniffed out some of the most shorted names in the market (such as GME, AMC) and with the financial benefit of trillions in freshly printed stimmies, sparked unprecedented short squeeze havoc in capital markets, including the obliteration of one of the marquee hedge funds du jour: that of Steve Cohen protege Gabe Plotkin's Melvin Capital, who was aggressively (with leverage) short most of these companies... but we are not that far off, either.
After some of the highest beta names suffered a historic obliteration in 2022 courtesy of the Fed's fastest tightening campaign since Volcker, yesterday's unexpectedly dovish presentation by Jerome Powell has sparked a historic meltup, one that is straight out of the Jan 2021 playbook, and the result has been that the most heavily shorted names such as Silvergate...
... and Carvana...
... are soaring the most on record.
Of course, none of this should be a surprise to regular readers in a market where technicals, positioning and liquidity are all that matter - as we won't tire of repeating again and again. In fact, it was the technicals and positioning that led us to correctly predict that "We Are Setting Up For A Tech-led Squeeze Higher As Shorting Gets Extreme" one month ago, even as everyone on Wall Street - including such "reputable" banks as JPM, GS, MS and so on - were urging clients to sell and go short, while those who listened to us are up 33% in 3 weeks!
And while there may not be fiscal stimmies this time, the monetary spigots are starting to turn. Consider the following:
- Powell says "disinflation" 13 times
- BOC pausing
- BOE pausing
- ECB one more and done, turns to "climate QE"
Furthermore, since there will not be a fiscal boost this time (thank you divided Congress) it means the Fed will have to work overtime to offset the slowdown.
Yet what is strange is how stubborn the bears have become in light of clearly shifting monetary sands, instead focusing entirely on the shitty fundamentals, as if those have ever matters. Consider what Goldman's John Flood said last night: while hedge funds are starting to turn bullish, vanilla "Long Onlies" still refuse to chase:
Slight uptick in HF buy skew post fed with HF 430bps to buy - clear pain trade to the upside here with signs of covering and HFs buying Supercap tech to get on some exposure. Our most short basket squeezed another +305bps...
[ZH: Most Shorted basket is now up 12% from the start of the Powell press conference]
...
We have seen large buy tickets in GOOGL (bought ~1mn and reloading) and AMZN (bought 500k between multiple buyers...mostly HFs). LOs surprisingly still in sell mode at 480bps better for sale (will see if this changes tomorrow after today's developments).
But while bears remain in denial, those who bought the November bottom (in names such as Facebook, for example, which has doubled in two months!) have made their year and then some, prompting investors in the laggards to ask what is going on and why are all these "value investors" once again sucking.
And so, as the LOs realize that whether they want to or not they will have to - kicking and screaming - chase higher, just as we warned last night...
... here, for their benefit, is a list of the most shorted names in the market, those with a short interest as % of their float between 30% and a Volkswagen-like 65%! As shown below, virtually all of these are already up double digits YTD and in some cases triple.
https://www.zerohedge.com/markets/here-are-most-shorted-companies-they-are-all-exploding-higher
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