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Wednesday, October 19, 2022

Ambrx Biopharma Stops Working On Breast Cancer Candidate, Cites Competition

 

  • Ambrx Biopharma Inc  will prioritize ARX517 as the company's new lead asset. The company believes ARX517 has the potential to be the first ADC therapy that specifically targets Prostate Specific Membrane Antigen (PSMA) to treat prostate cancer. 
  • In August 2021, Ambrx dosed the first patient with ARX517 in a Phase 1a clinical trial in subjects with PSMA-expressing tumors.
  • With this, the company will pause the development of Ambrx-sponsored clinical trials involving ARX788. 
  • Instead, Ambrx will continue to work collaboratively with NovoCodex and seek a partner(s) ex-China to progress ARX788.
  • Additional pipeline programs, ARX305 (anti-CD70 ADC) and ARX102 (smart PEG-IL2), will continue developing. 
  • Ambrx will reduce its workforce by approximately 15%.
  • The company's search for a permanent Chief Executive Officer to lead Ambrx is ongoing. Until then, Kate Hermans will continue to serve as interim CEO.
  • Ambrx expects its cash balance of $129.7 million as of June 30 to fund operations into 2025.

INmune Bio's INKmune Shows Positive Efficacy In Multiple Cancer Cell Lines

 

  • INmune Bio Inc  has announced solid tumor data in multiple cancer lines resistant to NK killing that can be overcome with the administration of INKmune.
  • The Tumor Microenvironment (TME) interaction with cancer cells and immune cells can drive tumor progression and prevent many cell therapies from being effective. 
  • INKmune converts the patient's normal resting NK (rNK) cells into potent memory-like NK cells that target solid tumors directly, even in the presence of immunosuppressive immunoregulatory cells and hypoxia associated with the TME.
  • The company's preclinical data show that INKmune primes NK cells from patients and healthy donors to lyse NK-resistant ovarian (CaOva), prostate (CaPros), renal (RCC), and nasopharyngeal (NPC) cancer cells.
  • Compared to rNK cells, which are normal NK cells from healthy donors or patients before treatment with INKmune, the INKmune-primed NK cells demonstrated an enhanced ability to kill these resistant tumor cell lines.
  • The company identified more than 1,500 proteins that are upregulated in NK cells following INKmune priming and subsequent analysis compared them to NK cells primed with a cytokine cocktail of IL-12, IL-15 and IL-18. 

Elevance raises annual profit forecast

 Health insurer Elevance Health Inc ELV.N on Wednesday raised its annual profit forecast, after reporting a rise in quarterly earnings helped by strong performance of its unit that sells government-backed health plans.

The upbeat forecast comes after larger rival UnitedHealth Group Inc UNH.N raised its annual profit forecast for the third straight quarter last week.

Health insurers have been able to soften the blow from costs related to COVID-19 testing and treatment, as elective procedures recover slowly and coronavirus cases decline.

Elevance, which was previously known as Anthem, now expects annual adjusted earnings to be higher than $28.95 per share, compared with its prior forecast of more than $28.70 per share.

Elevance said shareholders' net income rose to $1.62 billion, or $6.68 per share, in the three months ended Sept. 30, from $1.51 billion, or $6.13 per share, a year earlier.

https://www.nasdaq.com/articles/health-insurer-elevance-raises-annual-profit-forecast-0

Fauci's Agency Now Scrutinizing University Study Of Hybrid COVID Strain That Killed '80%' Of Mice

 by Jack Phillips via The Epoch Times (emphasis ours),

A National Institute of Allergy and Infectious Diseases official said the agency will further evaluate a controversial Boston University-commissioned preprint study that developed a COVID-19 hybrid that killed “80 percent” of lab mice, saying the team involved didn’t clear the work with the federal agency.

Speaking to STAT News, Emily Erbelding, the head of NIAID’s division of microbiology and infectious diseases, suggested that BU researchers did not properly disclose what their study would entail and did not say they would carry out that specific work. The grant proposal, Erbelding stated, also didn’t make it clear that scientists would be possibly enhancing a COVID-19 strain in reports that were handed to NIAID, the agency headed by Dr. Anthony Fauci.

This week, BU’s National Emerging Infectious Diseases Laboratories drew condemnation and controversy when it published (pdf) the non-peer-reviewed paper showing researchers took the spike protein for the COVID-19 Omicron strain and grafted it to the original, Wuhan COVID-19 strain. They found that when tested on lab mice, the newly created strain is more lethal than the original Omicron variant—killing 80 percent of mice—although Erbelding noted that the original Wuhan strain killed 100 percent of those mice.

I think we’re going to have conversations over upcoming days,” Erbelding told STAT on Tuesday, suggesting the BU team did not inform NIAID about what they were planning to do. “We wish that they would have, yes.

Refutation

In response to a request for comment from The Epoch Times on Tuesday, a spokesperson for Boston University pointed to an updated statement issued by the college on Tuesday. The Epoch Times has also contacted NIAID for comment.

The university defended the research and pilloried what it described as misleading and false reports about the study, asserting that no gain-of-function research, which could enhance the lethality or transmissibility of a pathogen, was carried out during the research.

It also refuted claims made by Erbelding and NIAID in the STAT News articles, saying that it “fulfilled all required regulatory obligations and protocols,” and “following NIAID’s guidelines and protocols, we did not have an obligation to disclose this research for two reasons.”

“The experiments reported in this manuscript were carried out with funds from Boston University. NIAID funding was acknowledged because it was used to help develop the tools and platforms that were used in this research; they did not fund this research directly,” the statement said. “[National Institutes of Health] funding was also acknowledged for a shared instrumentation grant that helped support the pathology studies. We believe that funding streams for tools do not require an obligation to report.”

https://www.zerohedge.com/covid-19/faucis-agency-now-scrutinizing-university-study-hybrid-covid-strain-killed-80-percent-mice

Buyers of bispecifics continue to emerge

 Bispecifics antibodies are already big business, and the emergence of two deals this week has investors predicting that more will follow as new iterations of this technology reach the market. Today Jazz paid $50m to corner Zymework’s zanidatamab, a project that hits two Her2 epitopes; a further $325m will be paid should Jazz decide to push on with the licence after a registrational biliary tract cancer trial reads out. Data are expected before year end. The sellside has punchy numbers for zanidatamab – $639m by 2028 according to Evaluate Pharma’s consensus – and with breakthrough therapy designation in place, the project could be one of the next bispecifics to reach the market. The other deal this week was earlier stage, with Gilead taking an option over Macrogenics’ phase 1-stage CD123 x CD3-directed MGD024, and two other research projects. That involved a $60m up-front fee, showing that even projects that have yet to prove their worth can attract healthy sums. But there is also scarcity value in this space, with many small specialist players already tied up by partnerships. The next wave, some of which Evaluate Vantage has highlighted below, might be on the radars of larger developers.

Selected bispecifics in the hands of biotech
ProjectCompanyTargets
Phase 3
Ivonescimab (AK112)Akeso BiopharmaPD-1 x VEGF
Phase 2
VudalimabXencorPD-1 x CTLA-4
AFM13AffimedCD30 x CD16A
CTX-009 (ES104)Compass Therapeutics/Elpiscience  BiopharmaceuticalsDLL4 x VEGF-A
LorigerlimabMacrogenicsPD-1 x CTLA-4 
Phase 1/2
HLX301Shanghai Henlius BiotechPD-L1 x Tigit
ISB 1442Ichnos SciencesCD38 x CD47
MCLA-129Merus/Betta PharmaceuticalsEGFR x c-MET
EMB-06Epimab BiotherapeuticsBCMA x CD3
FS118Sino Bio (via F-star)PD-L1 x Lag3
Source: Evaluate Pharma.

https://www.evaluate.com/vantage/articles/news/deals-snippets/buyers-bispecifics-continue-emerge