BioCardia Gets Nod on IND Application for Stem Cells for Ischemic Heart Failure

BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced Food and Drug Administration (FDA) approval of its Investigational New Drug (IND) application to initiate a first-in-human Phase I/II clinical trial of its Neurokinin-1 receptor positive (NK1R+) allogeneic human mesenchymal stem cell (MSC) therapy for the treatment of patients with ischemic heart failure.

This trial is designed for patients with New York Heart Association Class II and III ischemic heart failure with reduced ejection fraction (ischemic HFrEF) whose own cell composition makes them ineligible for the Company’s Phase III CardiAMP® Heart Failure Trial studying autologous cell therapy that has received FDA Breakthrough Device Designation.

https://finance.yahoo.com/news/biocardia-announces-fda-approval-ind-120000674.html

Summiy, Akeo in Deal for Up to $5 Billion to In-License Innovative Bispecific Antibody

 Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced a definitive agreement of its partnership with Akeso Inc. (HKEX Code: 9926.HK, “Akeso”), to in-license its breakthrough bispecific antibody, ivonescimab. Akeso is a pioneer and source originator in developing innovative antibodies. The agreement supports Summit’s mission of developing and commercializing groundbreaking oncology pipeline products aimed at improving the quality of life of patients with serious unmet medical needs. For Akeso, the deal represents an opportunity to introduce its highly innovative antibodies to markets, including the United States, Canada, Europe, and Japan – an important step towards Akeso’s strategic intention of becoming a global biopharma organization.

Ivonescimab, known as AK112 in China and Australia, and also as SMT112 in the United States, Canada, Europe, and Japan, is a novel, potential first-in-class bispecific antibody combining the power of immunotherapy via a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF into a single molecule. Ivonescimab is believed to be the PD-1 / VEGF bispecific antibody that is most advanced in the clinic: there are no known PD-1-based bispecific antibodies approved by the US Food and Drug Administration (“FDA”) or the European Medicines Agency (“EMA”). Akeso has already demonstrated success by commercializing the only PD-1 bispecific approved in China. Its product 开坦尼 (pronounced “Kaitanni”) (cadonilimab), a PD-1 / CTLA-4 bispecific, was approved by the Chinese National Medical Products Administration (“NMPA”) earlier this year for the treatment of relapsed or metastatic cervical cancer patients who progressed on or after platinum-based chemotherapy.

Ivonescimab was engineered to bring two well established oncology targeted mechanisms together. It is our belief that the novel design has the potential to reduce side effects and safety concerns.

https://finance.yahoo.com/news/summit-therapeutics-partners-akeso-inc-123000126.html

Editas: Positive Safety and Efficacy Data for Sickle Cell Therapy

 EDIT-301 was well-tolerated and demonstrated a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant

Both patients treated with EDIT-301 successfully engrafted and are free of vaso-occlusive events during the follow-up period

First patient treated has a total hemoglobin level of 16.4 g/dL and 45.4% fetal hemoglobin five months after treatment with EDIT-301

Company to host a webinar today at 8:00 a.m. ET

Editas Medicine will host a webinar today, Tuesday, December 6, at 8:00 a.m. ET to present the data. The live and archived webcast of the presentation will be accessible through this webcast link, or through the Events & Presentations page of the “Investors” section of the Company’s website. The presentation will also be available for download shortly after the webinar.

https://finance.yahoo.com/news/editas-medicine-announces-positive-safety-113000691.html

SQZ fast tracked for HPV16+ Tumor therapy

 

• Designation Represents Potential to Bring Important New Therapy to Patients Earlier

• Stable Disease Observed in Two Out of Four Evaluable Patients in eAPC Phase 1/2 Trial Including a Pronounced Pharmacodynamic Response in a Patient with Prolonged Stable Disease

• Interim Results from Ongoing SQZ® eAPC Phase 1/2 Trial Showed Favorable Safety Data and Investigational Therapy was Generally Well Tolerated

• Median Drug Viability of Greater than 90 Percent for Both SQZ® eAPC and SQZ® APC Clinical Trials

https://finance.yahoo.com/news/sqz-biotechnologies-receives-fda-fast-114500828.html

Pfizer ,Clear Creek Bio to Collaborate on Targeting SARS-CoV-2 Papain-Like Protease

 

• Agreement aims to advance discovery and development of novel papain-like protease (PLpro) inhibitors and potentially introduce a new class of oral antivirals in the fight against COVID-19

• Expands Pfizer’s innovative anti-infective pipeline, complementing the company’s existing portfolio of COVID-19 products

https://finance.yahoo.com/news/pfizer-clear-creek-bio-collaborate-114500791.html

Mirati to focus adagrasib/Keytruda study in low PDL1 lung cancer patients

 Early trial data shows that a combination of Mirati Therapeutics experimental drug adagrasib and Merck & Co's immunotherapy Keytruda helped about half of previously untreated metastatic lung cancer patients, with manageable side effects, Mirati said on Monday.

The company expects the largest advantage in patients with lower levels of PDL1, the protein targeted by Keytruda, and plans to launch a phase-three trial enrolling only those patients soon, Mirati chief executive officer David Meek told Reuters.

Wall Street analysts called the early results encouraging, but shares of Mirati were down more than 8% at $84.50 after hours on Monday. More trial details will be presented on Wednesday.

"We believe the data continue to support the regimen's differentiated positioning relative to standard of care and are far more favorable than that of Lumakras plus (immunotherapy)," JP Morgan analyst Eric Joseph said in a research note on Monday, referring to a rival drug sold by Amgen Inc.

Both drugs target a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common form of the disease.

Mirati's phase-three trial will compare adagrasib and Keytruda with chemotherapy plus Keytruda. The initial treatment for patients with higher levels of PDL1 is Keytruda alone, and Mirati will likely begin planning next year for a combination study in those patients, Meek said.

Recent data shows that 19% of NSCLC patients treated with Keytruda plus chemotherapy were alive after five years, compared with 11% of patients treated with a placebo and chemotherapy.

Out of seven phase-two trial patients given the adagrasib combination, four (57%) had tumor shrinkage, and none had tumor growth, Mirati said.

A preliminary analysis of 53 patients showed that 49% of them had responded to the combination treatment.

https://finance.yahoo.com/news/1-mirati-focus-adagrasib-keytruda-064236114.html

Forget crypto winter, this is a bitcoin 'bloodbath'

 "I'm nearly bankrupt," says Jad Fawaz, a crypto trader in Abu Dhabi. "I'm laughing because there's no point in exerting more depression and more frustration about it."

The 45-year-old, who quit his real-estate job a year ago to focus on trading, has seen his holdings evaporate in recent months. He hasn't slept in a week because of the stress.

"I had about 40 coins and then I came down to 20 coins then I came down to 10 coins, came down to five coins and now I'm down to the last two coins, and it's bitcoin and ripple XRP," he says.

"So these are the last two coins and I will die before selling them."

For many retail traders and investors, enough is enough.

Bitcoin balances on crypto exchanges - where retail investors typically transact - have fallen to around 2.3 million from its 2020 all-time high of 3.1 million, exchange Bitfinex said. Self-custody wallet balances have not grown at the same pace, indicating more selling than storage, it added.

"There are signs that a significant number of retail investors have been discouraged to the point of exiting crypto entirely," Bitfinex analysts said.

Indeed, Fawaz is not alone.

It's been a brutal year for investors. Bitcoin's price has dropped 63%, while the overall cryptocurrency market capitalization has lost $1.63 trillion in value.

The collapse of Sam Bankman-Fried's FTX exchange hammered a long nail into the market.

November saw a 7-day realized loss of $10.16 billion in bitcoin investments as investors were forced to exit long-term positions, the fourth-largest loss on record by this measure, according to Glassnode data.

"This is not the winter season anymore, this is a bloodbath, because the FTX crisis was like a domino that toppled so many companies," said Linda Obi, a crypto investor in the Nigerian city of Lagos who works at blockchain firm Zenith Chain.

https://www.yahoo.com/now/cryptoverse-forget-crypto-winter-bitcoin-061000520.html