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covid-safer-hotties · 3 months ago

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by Rowan Walrath

Public and private funding is lacking, scrambling opportunities to develop treatments

In brief Long COVID is a difficult therapeutic area to work in. It’s a scientifically challenging condition, but perhaps more critically, few want to fund new treatments. Private investors, Big Pharma, and government agencies alike see long COVID as too risky as long as its underlying mechanisms are so poorly understood. This dynamic has hampered the few biotechnology and pharmaceutical companies trying to develop new medicines. The lack of funding has frustrated people with long COVID, who have few options available to them. And crucially, it has snarled research and development, cutting drug development short.

When COVID-19 hit, the biotechnology company Aim ImmunoTech was developing a drug for myalgic encephalomyelitis/chronic fatigue syndrome, better known as ME/CFS. As more people came down with COVID-19, some began to describe lingering problems that sounded a lot like ME/CFS. In many cases, people who got sick simply never seemed to get better. In others, they recovered completely—or thought they had—only to be waylaid by new problems: fatigue that wouldn’t go away with any amount of rest, brain fog that got in the way of normal conversations, a sudden tendency toward dizziness and fainting, or all the above.

There was a clear overlap between the condition, which patients began calling long COVID, and ME/CFS. People with ME/CFS have a deep, debilitating fatigue. They cannot tolerate much, if any, exercise; walking up a slight incline can mean days of recovery. Those with the most severe cases are bedbound.

Aim’s leaders set out to test whether the company’s drug, Ampligen, which is approved for ME/CFS in Argentina but not yet in the US, might be a good fit for treating long COVID. They started with a tiny study, just 4 people. When most of those participants responded well, they scaled up to 80. While initial data were mixed, people taking Ampligen were generally able to walk farther in a 6 min walk test than those who took a placebo, indicating improvement in baseline fatigue. The company is now making plans for a follow-on study in long COVID.

Aim’s motivation for testing Ampligen in long COVID was twofold. Executives believed they could help people with the condition, given the significant overlap in symptoms with ME/CFS. But they also, plainly, thought there’d be money. They were wrong.

“When we first went out to do this study in long COVID, there was money from . . . RECOVER,” Aim scientific officer Chris McAleer says, referring to Researching COVID to Enhance Recovery (RECOVER), the National Institutes of Health’s $1.7 billion initiative to fund projects investigating causes of, and potential treatments for, long COVID. McAleer says Aim attempted to get RECOVER funds, “believing that we had a therapeutic for these individuals, and we get nothing.”

Instead of funding novel medicines like Ampligen, the NIH has directed most of its RECOVER resources to observational studies designed to learn more about the condition, not treat it. Only last year did the agency begin to fund clinical trials for long COVID treatments, and those investigate the repurposing of approved drugs. What RECOVER is not doing is funding new compounds.

RECOVER is the only federal funding mechanism aimed at long COVID research. Other initiatives, like the $5 billion Project NextGen and the $577 million Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern, put grant money toward next-generation vaccines, monoclonal antibodies, and antivirals for COVID-19. They stop short of testing those compounds as long COVID treatments.

Private funding is even harder to come by. Large pharmaceutical companies have mostly stayed away from the condition. (Some RECOVER trials are testing Pfizer’s COVID-19 antiviral Paxlovid, but a Pfizer spokesperson confirms that Pfizer is not sponsoring those studies.) Most investors have also avoided long COVID: a senior analyst on PitchBook’s biotech team, which tracks industry financing closely, says he isn’t aware of any investment in the space.

“What you need is innovation on this front that’s not driven by profit motive, but impact on global human health,” says Sumit Chanda, an immunologist and microbiologist at Scripps Research who coleads one of the AViDD centers. “We could have been filling in the gaps for things like long COVID, where pharma doesn’t see that there’s a billion-dollar market.”

The few biotech companies that are developing potential treatments for long COVID, including Aim, are usually funding those efforts out of their own balance sheets. Experts warn that such a pattern is not sustainable. At least four companies that were developing long COVID treatments have shut down because of an apparent lack of finances. Others are evaluating a shift away from long COVID.

“It is seen by the industry and by investors as a shot in the dark,” says Radu Pislariu, cofounder and CEO of Laurent Pharmaceuticals, a start-up that’s developing an antiviral and anti-inflammatory for long COVID. “What I know is that nobody wants to hear about COVID. When you say the name COVID, it’s bad . . ., but long COVID is not going anywhere, because COVID-19 is endemic. It will stay. At some point, everyone will realize that we have to do more for it.”

‘Time and patience and money’ Much of the hesitancy to make new medicines stems from the evasive nature of long COVID itself. The condition is multisystemic, affecting the brain, heart, endocrine network, immune system, reproductive organs, and gastrointestinal tract. While researchers are finding increasing evidence for some of the disease’s mechanisms, like viral persistence, immune dysregulation, and mitochondrial dysfunction, they might not uncover a one-size-fits-all treatment.

“Until we have a better understanding of the underlying mechanisms of long COVID, I think physicians are doing the best they can with the information they have and the guidance that is available to them,” says Ian Simon, director of the US Department of Health and Human Services’ Office of Long COVID Research and Practice. The research taking place now will eventually guide new therapeutic development, he says.

Meanwhile, time marches on.

By the end of 2023, more than 409 million people worldwide had long COVID, according to a recent review coauthored by two cofounders of the Patient-Led Research Collaborative (PLRC) and several prominent long COVID researchers (Nat. Med. 2024; DOI: 10.1038/s41591-024-03173-6). Most of those 409 million contracted COVID-19 and then long COVID after vaccines and antivirals became available. That fact undercuts the notion that the condition results only from severe cases of COVID-19 contracted before those interventions existed. (Vaccination and treatment with antivirals do correlate with a lower incidence of long COVID but don’t prevent it outright.)

“There is that narrative that long COVID is over,” says Hannah Davis, cofounder of the PLRC and a coauthor of the review, who has had long COVID since 2020. “I think that’s fairly obviously not true.”

The few biotech companies that have taken matters into their own hands, like Aim, are often reduced to small study sizes with limited time frames because they can’t get outside funding.

InflammX Therapeutics, a Florida-based ophthalmology firm headed by former Bausch & Lomb executive Brian Levy, started testing an anti-inflammatory drug candidate called Xiflam after Levy’s daughter came down with long COVID. Xiflam is designed to close connexin 43 (Cx43) hemichannels when they become pathological. The hemichannels, which form in cell membranes, would otherwise allow intracellular adenosine triphosphate (ATP) to escape and signal the NLRP3 inflammasome to crank up its activity, causing pain and inflammation.

InflammX originally conceived of Xiflam as a treatment for inflammation in various eye disorders, but after Levy familiarized himself with the literature on long COVID, he figured the compound might be useful for people like his daughter.

InflammX set up a small Phase 2a study at a site just outside Boston. The trial will enroll just 20 participants, including Levy’s daughter and InflammX’s chief operating and financial officer, David Pool, who also has long COVID. The study is set up such that participants don’t know if they’re taking Xiflam or a placebo.

Levy says the company tried to communicate with NIH RECOVER staff multiple times but never heard back. “We couldn’t wait,” he says.

Larger firms are similarly disconnected from US federal efforts. COVID-19 vaccine maker Moderna appointed a vice president of long COVID last year. Bishoy Rizkalla now oversees a small team studying how the company’s messenger RNA shots could mitigate problems caused by new and latent viruses, including SARS-CoV-2. But Rizkalla says Moderna has no federally funded projects in long COVID.

Federal bureaucracy has slowed down research in other ways. When long COVID appeared, Tonix Pharmaceuticals was developing a possible drug called TNX-102 SL to treat fibromyalgia. The two conditions look similar: they’re painful, fatiguing, and multisystemic, and fibromyalgia can crop up after a viral infection.

But it wasn’t easy to design a study to test the compound in long COVID. Among other issues, the US Food and Drug Administration initially insisted that participants have a positive COVID-19 test confirmed by a laboratory, like a polymerase chain reaction test, to be included in the study. At-home diagnostics wouldn’t count.

“We spent a huge amount of money, and we couldn’t enroll people who had lab-confirmed COVID because no one was going to labs to confirm their COVID,” cofounder and CEO Seth Lederman says. “We just ran out of time and patience and money, frankly.”

Tonix had planned to enroll 450 participants. The company ultimately enrolled only 63. The study failed to meet its primary end point of reducing pain intensity, a result Lederman attributes to the smaller-than-expected sample size.

TNX-102 SL trended toward improvements in fatigue and other areas, like sleep quality and cognitive function, but Tonix is moving away from developing the compound as a long COVID treatment and focusing on developing it for fibromyalgia. If it’s approved, Lederman hopes that physicians will prescribe it to people who meet the clinical criteria for fibromyalgia regardless of whether their condition stems from COVID-19.

“I’m not saying we’re not going to do another study in long COVID, but for the short term, it’s deemphasized,” Lederman says.

Abandoned attempts Without more public or private investment, it’s unclear how research can proceed. The small corner of the private sector that has endeavored to take on long COVID is slowly becoming a graveyard.

Axcella Therapeutics made a big gamble in late 2022. The company pivoted from trying to treat nonalcoholic steatohepatitis, a liver disease, to addressing chronic fatigue in people with long COVID. In doing so, Axcella reoriented itself exclusively around long COVID, laying off most of its staff and abandoning other research activities. People in a 41-person Phase 2a trial of the drug candidate, AXA1125, showed improvement in fatigue scores based on a clinical questionnaire (eClinicalMedicine 2023, DOI: 10.1016/j.eclinm.2023.101946), but Axcella shut down before it could get its planned 300-person follow-on study up and running.

The fate of AXA1125 may be to gather dust. Axcella’s former executives have moved on to other pursuits. Erstwhile chief medical officer Margaret Koziel, once a champion of AXA1125, says by email that she is “not up to date on current research on long COVID.” Staff at the University of Oxford, which ran the Phase 2a study, were not able to procure information about the planned Phase 2b/3 trial. A spokesperson for Flagship Pioneering, the venture firm that founded Axcella in 2011, declined to comment to C&EN.

Other firms have met similar ends. Ampio Pharmaceuticals dissolved in August after completing only a Phase 1 study to evaluate an inhaled medication called Ampion in people with long COVID who have breathing issues. Biotech firm SolAeroMed shut down before even starting a trial of its bronchodilating medicine for people with long COVID. “Unfortunately we were unable to attract funding to support our clinical work for COVID,” CEO John Dennis says by email.

Another biotech company, Aerium Therapeutics, did manage to get just enough of its monoclonal antibody AER002 manufactured and in the hands of researchers at the University of California, San Francisco, before it ended operations. The researchers are now testing AER002 in a Phase 2 trial with people with long COVID. Michael Peluso, an infectious disease clinician and researcher at UCSF and principal investigator of the trial, says that while AER002 may not advance without a company behind it, the study could be valuable for validating long COVID’s mechanisms of disease and providing a proof of concept for monoclonal antibody treatment more generally.

“[Aerium] put a lot of effort into making sure that the study would not be impacted,” Peluso says. “Regardless of the results of this study, doing a follow-up study now that we’ve kind of learned the mechanics of it with modern monoclonals would be really, really interesting.”

‘A squandered opportunity’ In 2022, the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) put about $577 million toward nine research centers that would discover and develop antivirals for various pathogens. Called the Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern, the centers were initially imagined as 5-year projects, enough time to ready multiple candidates for preclinical development. The NIH allocated money for the first 3 years and promised more funds to come later.

The prospect excited John Chodera, a computational chemist at the Memorial Sloan Kettering Cancer Center and a principal investigator at an AViDD center called the AI-Driven Structure-Enabled Antiviral Platform. Chodera figured that if his team were able to develop a potent antiviral for SARS-CoV-2, it could potentially be used to treat long COVID as well. A predominant theory is that reservoirs of hidden virus in the body cause ongoing symptoms.

But Chodera says NIAID told him and other AViDD investigators that establishing long COVID models was out of scope. And last year, Congress clawed back unspent COVID-19 pandemic relief funds, including the pool of money intended for the AViDD centers’ last 2 years. Lawmakers were supposed to come through with additional funding, Chodera says, but it never materialized. All nine AViDD centers will run out of money come May 2025.

“When we do start to understand what the molecular targets for long COVID are going to be, it’d be very easy to pivot and train our fire on those targets,” says Chanda from Scripps’s AViDD center. “The problem is that it took us probably 2 years to get everything up and going. If you cut the funding after 3 years, we basically have to dismantle it. We don’t have an opportunity to say, ‘Hey, look, this is what we’ve done. We can now take this and train our fire on X, Y, and Z.’ ”

Researchers at multiple AViDD centers confirm that the NIH has offered a 1-year, no-cost extension, but it doesn’t come with additional funds. They now find themselves in the same position as many academic labs: seeking grant money to keep their projects going.

Worse, they say, is that applying for other grants will likely mean splitting up research teams, thus undoing the network effect that these centers were supposed to provide.

“Now what we’ve got is a bunch of half bridges with nowhere to fund the continuation of that work,” says Nathaniel Moorman, cofounder and scientific adviser of the Rapidly Emerging Antiviral Drug Development Initiative, which houses an AViDD center at the University of North Carolina at Chapel Hill.

“This was a squandered opportunity, not just for pandemic preparedness but to tackle these unmet needs that are being neglected by biotech and pharma,” Chanda says.

Viral persistence Ann Kwong has been here before. The virologist was among the first industry scientists trying to develop antivirals for hepatitis C virus (HCV) back in the 1990s. Kwong led an antiviral discovery team at the Schering-Plough Research Institute for 6 years. In 1997, Vertex Pharmaceuticals recruited her to lead its new virology group.

Kwong and her team at Vertex developed a number of antivirals for HCV, HIV, and influenza viruses; one was the HCV protease inhibitor telaprevir. She recalls that a major challenge for the HCV antivirals was that scientists didn’t know where in the body the virus was hiding. Kwong says she had to fight to develop an antiviral that targeted the liver since it hadn’t yet been confirmed that HCV primarily resides there. People with chronic hepatitis C would in many cases eventually develop liver failure or cancer, but they presented with other issues too, like brain fog, fatigue, and inflammation.

She sees the same dynamic playing out in long COVID.

“This reminds me of HIV days and HCV days,” Kwong says. “This idea that pharma doesn’t want to work on this because we don’t know things about SARS-CoV-2 and long COVID is bullshit.”

Since January, Kwong has been cooking up something new. She’s approaching long COVID the way she did chronic hepatitis C: treating it as a chronic infection, through a start-up called Persistence Bio. Persistence is still in stealth; its name reflects its mission to create antivirals that can reach hidden reservoirs of persistent SARS-CoV-2, which many researchers believe to be a cause of long COVID.

“Long COVID is really interesting because there’s so many different symptoms,” Kwong says. “As a virologist, I am not surprised, because it’s an amazing virus. It infects every tissue in your body. . . . All the autopsy studies show that it’s in your brain. It’s in your gut. It’s in your lungs. It’s in your heart. To me, all the different symptoms are indicative of where the virus has gone when it infected you.”

Kwong has experienced some of these symptoms firsthand. She contracted COVID-19 while flying home to Massachusetts from Germany in 2020. For about a year afterward, she’d get caught off guard by sudden bouts of fatigue, bending over to catch her breath as she walked around the horse farm where she lives, her legs aching. Those symptoms went away with time and luck, but another round of symptoms roared to life this spring, including what Kwong describes as “partial blackouts.”

Kwong hasn’t been formally diagnosed with long COVID, but she says she “strongly suspects” she has it. Others among Persistence’s team of about 25 also have the condition.

“Long COVID patients have been involved with the founding of our company, and we work closely with them and know how awful the condition can be,” Kwong says. “It is a big motivator for our team.”

Persistence is in the process of fundraising. Kwong says she’s in conversations with private investors, but she and her cofounders are hoping to get public funding too.

On Sept. 23, the NIH is convening a 3-day workshop to review what RECOVER has accomplished and plan the next phase of the initiative. Crucially, that phase will include additional clinical trials. RECOVER’s $1.7 billion in funding includes a recent award of $515 million over the next 4 years. It’s not out of the question that this time, industry players might be invited to the table. Tonix Pharmaceuticals’ Lederman and Aim ImmunoTech’s McAleer will both speak during the workshop.

The US Senate Committee on Appropriations explicitly directed the NIH during an Aug. 1 meeting to prioritize research to understand, diagnose, and treat long COVID. It also recommended that Congress put $1.5 billion toward the Advanced Research Projects Agency for Health (ARPA-H), which often partners with industry players. The committee instructed ARPA-H to invest in “high-risk, high-reward research . . . focused on drug trials, development of biomarkers, and research that includes long COVID associated conditions.” Also last month, Sen. Bernie Sanders (I-VT) introduced the Long COVID Research Moonshot Act, which would give the NIH $1 billion a year for a decade to treat and monitor patients.

It’s these kinds of mechanisms that might make a difference for long COVID drug development.

“What I’ve seen a lot is pharma being hesitant to get involved,” says Lisa McCorkell, a cofounder of the PLRC and a coauthor of the recent long COVID review. “Maybe they’ll invest if NIH also matches their investment or something like that. Having those public-private partnerships is really, at this stage, what will propel us forward.”

#mask up #covid #pandemic #wear a mask #covid 19 #public health #coronavirus #sars cov 2 #still coviding #wear a respirator #long covid #covid conscious #covid is not over #wear a fucking mask

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fmarkets · 7 months ago

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Aim'Immunotech'Inc'Reports'Loss'on'Weak'Sales'in'the'most'recent'fiscal'period $AIM #Biotechnology and Pharmaceuticals #NYSEAMER

Declining revenues force Aim Immunotech Inc to reassess strategies in face of financial challengesAIM ImmunoTech Inc. has recently announced a registered direct offering to raise $2.0 million. The company entered into an agreement with a single institutional investor, who will purchase 5,640,958 shares of common stock at $0.363 per share. This initiative also includes unregistered Class A and Class B warrants, granting the investor the ability to purchase additional shares in the future. These funding maneuvers b

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abtl-enzymes · 10 months ago

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columbianewsupdates · 2 years ago

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Ovarian Cancer Market expected to rise, Chipscreen Biosciences, DCPrime BV, AIM ImmunoTech, Shattuck Labs,Laekna Limited, Celsion, expected to drive market

http://dlvr.it/SqG5p6

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technewspoint · 2 years ago

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Ovarian Cancer Market expected to rise, Chipscreen Biosciences, DCPrime BV, AIM ImmunoTech, Shattuck Labs,Laekna Limited, Celsion, expected to drive market

http://dlvr.it/SqFNym

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newsheadlinesnow · 2 years ago

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Ovarian Cancer Market expected to rise, Chipscreen Biosciences, DCPrime BV, AIM ImmunoTech, Shattuck Labs,Laekna Limited, Celsion, expected to drive market

http://dlvr.it/SqFNlV

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conversationpoint · 2 years ago

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Cytomegalovirus Infection Market expected to rise, Moderna, China Immunotech, Nobelpharma, Hookipa Biotech GmbH, Biotest, AlloVir, Merck Sharp & Dohme LLC, Chimerix, VBI Vaccines

http://dlvr.it/SpzWfl

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globaldatacom · 2 years ago

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Fourth-generation chimeric antigen receptor T Cells for hepatocellular carcinoma

Results for multiple hepatocellular carcinoma (HCC) clinical trials were presented at the 2021 American Society of Clinical Oncology (ASCO) virtual yearly meeting held June 4-8 June. CARsgen Therapeutics presented data from a Stage I trial (NCT03980288) of its fourth-generation fanciful antigen receptor T (Vehicle T) cells targeting glypican-3 (GPC3). Fourth-generation Vehicle T cells are additionally designed to secrete a transgenic cytokine upon Vehicle motioning in the targeted tumor tissue. As a result, in addition to the direct antitumor attack, they can trigger T cells to eliminate antigen-negative malignant growth cells at the target site. GPC3 is a cell-Cells Expressing T Cell Surface Glycoprotein CD5 Drugs Development Market that is profoundly communicated in HCC and is thus being evaluated as a target for HCC immunotherapy. CARsgen's original pipeline therapy for cutting edge HCC stands out for being a first-in-class approach with an extraordinary system of action that targets vigorously pretreated progressed HCC patients.

In this study, CARSgen's fourth-generation Vehicle GPC3 T cells in combination with the tyrosine kinase inhibitors (TKIs) Nexavar (sorafenib) or Stivarga (regorafenib) demonstrated sensible safety and potential antitumor activity for hepatitis B infection (HBV)- related metastatic HCC patients who have been recently treated with systemic therapy. Safety results showed a shortfall of portion limiting toxicity, treatment-related serious unfavorable events (AEs), AE-related death or study withdrawal, and neurotoxicity. Three out of the six patients in the study experienced grade 3 cytokine discharge condition (CRS), a typical AE found because of Vehicle T cell therapy. Fundamental viability results uncovered the objective reaction rate and infectious prevention rate were 16.7% and half, respectively. The middle movement free endurance was 4.2 months. The middle pinnacle Vehicle GPC3 duplicate number in patients' fringe blood on day 7 after treatment was 5,067 duplicates for each μg genomic DNA and Vehicle GPC3 duplicates were still detectable on day 28 at levels running between 113 and 2,071 duplicates for every μg genomic DNA. Prior Stage I trials for the second-generation variant of this therapeutic agent (NCT02395250 and NCT03146234) likewise reported clinical benefit and tolerability.

KOLs interviewed by GlobalData noted that Vehicle T cells or adoptive cellular therapy is an arising region that might change HCC treatment practice from here on out. The majority of late-stage pipeline drugs for cutting edge HCC are for use in the first-line setting, which has the highest number of treated cases. Therefore, subsequent lines of therapy are being neglected by drug designers, despite high unmet need. Notwithstanding, CARsgen Therapeutics conducted the study of their Vehicle T cell therapy on patients who advanced on at least two lines of systemic therapy, having tried at least one TKI joined with anti-modified death-1 (PD-1)/customized death ligand 1 (PD-L1) immunotherapy or FOLFOX4 (5-fluorouracil, leucovorin, and oxaliplatin) chemotherapy. A comparative strategy of zeroing in on subsequent lines of therapy was utilized by other organizations studying adoptive cellular therapy for HCC in the beginning phase development including Immunotech Biopharm, Immunicum Stomach muscle, Aha Therapeutics, Adaptimmune Therapeutics, Fate Therapeutics, and Origincell Therapeutics. Therefore, investigation of vigorously pretreated progressed HCC patients is by all accounts a general trend with Vehicle T cell designers in HCC.

The HCC clinical pipeline is packed with me-too drugs targeting patients in the first-line setting. CARsgen's Vehicle GPC3 T cell therapy is a first-in-class targeted drug tending to cutting edge HCC patients who have advanced on or created resistance to past therapy — a patient population with little to no treatment options. GlobalData expects that assuming effective in later stage trials, CARsgen's therapy will be advantageous to underserved patients in late-stage progressed HCC.

Cell and Quality Therapy Inclusion on Clinical Trials Field supported by Cytiva.

Editorial content is independently created and keeps the highest guidelines of journalistic integrity. Topic supports are not associated with the creation of editorial content.

#Cells Expressing T Cell Surface Glycoprotein CD5 Drugs Development Market

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cavixorg · 2 years ago

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Using its unique expanded genetic code technology platform, Ambrx Biopharma Inc.(AMAM stock) , a clinical-stage biologics firm, discovers and creates tailored precision biologics. Its lead product candidate, ARX788, is an anti-HER2-drug conjugate (ADC) that is being studied in numerous clinical trials to treat of breast cancer, stomach junction cancer, as well as other solid tumors. These trials, which are currently in Phase 2 and Phase 3, are also being conducted for the treatment of gastric and breast cancers that have metastasized and are HER2-positive. The company is also working on two earlier-stage product candidates: ARX305, an anti-CD70 ADC in investigational new chemical studies for the treatment of kidney cell carcinoma and other cancers. And ARX517, an anti-PSMA ADC in a Phase 1 clinical trial for the therapy of prostate cancer and other tumors. It is also creating additional multiple product candidates with an eye toward immuno-oncology applications, such as ARX102, an immuno-oncology IL-2 path agonist that targets and gamma receptors on cytotoxic T cells to activate the patient's own immune system, and ARX822, a fab-small macromolecular bispecific that is used in preclinical phase for cancers. Bristol Myers Squibb Company, AbbVie Inc., BeiGene, Sino Biopharmaceutical Co., Ltd., NovoCodex, and Elanco Animal Health are all partners of Ambrx Biopharma Inc. The business was founded in 2003, and its main office is in La Jolla, California. Who Are The Major Owners Of AMAM Stock? 17 investment banks and fund managers owned AMAM stock in Ambrx Biopharma over the previous two years. Fosun International Ltd ($37.88M), Adage Capital Partners GP L.L.C. ($17.37M), BlackRock Inc. ($11.75M), FMR LLC ($10.22M), Octagon Capital Advisors LP ($8.82M), Suvretta Capital Management LLC ($6.15M), and Millennium Management LLC ($2.82M) were the institutional investors with the largest investments. AMAM stock is held by institutions 44.21% of the time. In the past 24 months, institutional investors have purchased 9,197,182 shares altogether. This volume of purchases entails about $158.86M in transactions. In the past 24 months, investment banks have sold 274,909 shares in total. This share sale volume equates to roughly $1.55M in business. Institutional shareholders Cormorant Asset Management LP ($0.15M), BlackRock Inc. ($48.46K), Tudor Investment Corp Et Al ($39.86K), Ghisallo Capital Management LLC ($25K), and Renaissance Technologies LLC ($11.60K) all sold shares of Ambrx Biopharma in the past 24 months. Short Sellers Of Ambrx Biopharma? November saw a decrease in short interest in Ambrx Biopharma. 3,800 shares totaled short interest as of November 15th, which is a decrease of 20.8% from the 4,800 share total as of October 31st. The days-to-cover ratio is currently 0.1 days based on an average daily trading volume of 30,600 shares. Short sales of the company's shares make up about 0.0% of the total. Any online trading account can be used to buy shares of AMAM stock. WeBull, Vanguard Brokerage Services, TD Ameritrade, E*TRADE, Robinhood, Fidelity, and Charles Schwab are a few well-known online brokerages providing access to the American stock market. Competitors Of AMAM The top rivals of Ambrx Biopharma include Elevation Oncology (ELEV), Cortexyme, Idera Pharmaceuticals (IDRA), Rubius Therapeutics (RUBY), Jasper Therapeutics (JSPR), Entera Bio (ENTX), AIM ImmunoTech (AIM), ERYTECH Pharma (ERYP), Genetic Technologies (GENE), Surrozen (SRZN), and (CRTX). All of these businesses fall under the "medical" category. Ambrx Biopharma is not as well-liked by analysts as other Medical companies. AMAM stock has a consensus rating of Moderate Buy, whereas the typical consensus rating for healthcare firms is Buy. Ambrx Biopharma is disliked by customers more than other Medical businesses. Ambrx Biopharma had an outperform vote from 52.38% of people, versus an average of 66.26% for medical firms. Entera Bio And Ambrx Biopha

rma? Compared to Ambrx Biopharma, Entera Bio has smaller revenue but larger earnings. Shares in Ambrx Biopharma are held by institutions 44.2% of the time. Comparatively, institutional investors own 17.1% of the shares in Entera Bio. Shares of Ambrx Biopharma are held by company insiders to a 5.1% stake. Comparatively, insiders own 5.2% of the shares in Entera Bio. Solid organizational ownership is a sign that endowments, hedge funds, and big money managers are betting on a company's long-term ability to outperform the market. Compared to Entera Bio's profit income of -1,796.49%, Ambrx Biopharma has a net margin of 0.00%. Entera Bio's return on equity was beaten by Ambrx Biopharma's equity return of 0.00%. When compared by users, Entera Bio earned 157 more votes for outperformance than Ambrx Biopharma. Similarly, while just 52.38% of people gave Ambrx Biopharma an outstanding vote, 66.14% of users awarded Entera Bio an outperform rating. With a beta of 1.34, AMAM stock price is 34% less volatile than that of the S&P 500. Compared to the S&P 500, Entera Bio's share price is 84% more unpredictable with a beta of 1.84. Ambrx Biopharma received 48 more media mentions than Entera Bio in the past week. Ambrx Biopharma received 49 mentions according to us, while Entera Bio received just one. Shares Of Ambrx Rise After Promoting Early Safety Preliminary safety and effectiveness findings from the Phase 2 ACE-Breast-03 study were released by Ambrx Biopharma Inc. (NASDAQ: AMAM), which encouraged early safety data from the breast cancer candidate. In patients with HER2-positive mBC who are resistant or refractory to T-DM1, the data showed a 51.7% overall response rate (ORR) and a 100% disease control rate (DCR) after therapy with ARX788. Patients received therapy for a median of 7.2 months, as treatment is still ongoing. In China, Amrbrx's partner NovoCodex Biopharmaceuticals is currently conducting two Phase 3 trials so one registration-enabled Phase 2 study with ARX788, with readouts expected in 2023. The last check Friday's premarket session saw AMAM shares up 180.6% to $1.15. How Simple Is It For Ambrx Biopharma To Raise Money? Many people may be thinking that Ambrx Biopharma has to raise more money in the future because its income is falling and its operating cash flow is rising. Companies have the option of raising capital through debt or equity. Publicly traded corporations benefit greatly from the ability to sell investors shares in order to raise capital and finance expansion. By comparing a company's cash burn to its market capitalization, we may determine how much investors would be affected if the business had to issue capital to pay for the cash burn for an additional year. Ambrx Biopharma seems to have a market value of $20 million and spent $7 million last year, or 350% of its market value. We believe there is a substantial risk of financial hardship given how big that expenditure is in comparison to the company's market value, and we would be extremely cautious about keeping the AMAM stock. What Are The Average Rating And Price Objective For Ambrx Biopharma? Based on the current 1 controlled transaction and 1 buy rating for AMAM, the consensus opinion for AMAM stock is Moderate Buy, according to the 2 analysts who have issued ratings in the past year. Ambrx Biopharma's average 12-month price objective is $4.00, with a premium price target of $4.00 and a low cost target of $4.00. According to two Wall Street experts who have predicted the price of AMAM for the next year, the average price target is $11.00, with the maximum prediction for the company being $16.00 and the lowest prediction being $6.00. By April 2023, according to the majority of Wall Street analysts, the share price of Ambrx Biopharma might be $11.00. Is AMAM A Successful Business? The cash burn for AMAM is $70163000. It has at least a year's worth of coverage in the form of cash and short-term investments. AMAM has cash and short-term investments of

$111.72 million. This is sufficient to fund its $70.16M yearly cash burn. AMAM has a small 0.28 debt to equity ratio. On the balance sheet of AMAM, short-term assets outnumber long-term liabilities. On the balance sheet of AMAM, short-term assets exceed short-term liabilities. Cons: Over the past year, AMAM's profit margin has decreased from 325.6% to 1.729.9%. According to our examination of Ambrx Biopharma's cash position, its cash runway was comforting, but the ratio of its cash burn to market value has us a little concerned. We have very little faith in the company's capacity to control its cash burn after taking all the data stated in this article into account, and we predict it will need additional money. The Basics Of Ambrx Biopharma The value of AMAM stock is 43, which is higher than the average for the Biotechnology sector. Currently, 3 out of 7 due diligence tasks are being passed by AMAM. AMAM's Financials rating is 0, which is the same as the industry average for the Biotechnology sector. AMAM stock is presently failing 0 of 7 checks for due diligence. The AMAM stock forecast score is 0, which is the same as the sector average for biotechnology. AMAM stock is presently failing 0 of 9 checks for due diligence. The Performance score for AMAM stock is 71, which is higher than the industry average for biotechnology. Five out of ten due diligence checks are passing for AMAM. We disregard this dimension because Ambrx Biopharma has little or no historical dividend history. Recommendations Most Recent From AMAM Analysts On May 24, 2022, a Goldman Sachs analyst decreases their price objective for AMAM stock from $6 to $4 while maintaining a hold rating. On April 7, 2022, Joel Beatty, a high 17% analyst from Baird, commences covering on AMAM with a buy recommendation and publishes their $16.00 price target. On February 28, 2022, Corinne Jenkins of Goldman Sachs, a top 48% analyst, announces the beginning of covering on AMAM with such a hold recommendation and a $6.00 price target. In 2022, Should I Buy Or Sell Ambrx Biopharma Stock? In the past year, Ambrx Biopharma has received "buy," "hold," and "sell" evaluations from 2 Wall Street research analysts. For the stock, there is presently 1 hold rating and 1 buy rating. Wall Street research experts generally agree that investors should "buy" AMAM stock. On Friday, June 18th 2021, (AMAM) raised $126 million through an initial public offering. At a price of $17.00–$19.00 per share, the corporation issued 7,000,000 shares. The underwriters for the initial public offering were Goldman Sachs, BofA Securities, and Cowen. The time it would take for a corporation to exhaust its cash on hand at its current cash burn rate is known as its cash runway. Ambrx Biopharma had 111 million dollars in cash and no debt as of June 2022. Looking back at the previous year, the business spent $70 million. So, starting in June 2022, AMAM stock forecast had a financial runway of about 19 months. This is not too bad, and unless cash burn substantially decreases, it is safe to assume the financial runway is coming to an end. Ambrx Biopharma Stock Forecast 2022 While it is not anticipated that AMAM stock forecast annual earnings rate of growth of N/A will surpass the statistically important earnings growth rate of 9.29% for the US biotechnology industry, neither is it anticipated to surpass the average AMAM stock forecast earnings rate of growth of 70.08% for the US market. The revenue for AMAM stock forecast in 2022 is -$90,558,000. One Wall Street analyst predicted that AMAM stock forecast earnings would be -$75,691,975 on average in 2022, with the highest AMAM earnings prediction being -$75,691,975 and the top AMAM stock forecast being -$75,691,975. The current Earnings Per Share (EPS) for Ambrx Biopharma is $6.72. Analysts expect AMAM stock forecast EPS to be -$0.28 on average for 2022, with the lowest and highest estimates both coming in at -$0.28. Ambrx Biopharma Stock Forecast

2023 AMAM stock forecast is anticipated to make -$67,582,121 in 2023, with the smallest earnings estimate being -$67,582,121 and the actual figure being -$67,582,121. By April 7, 2023, analysts on Wall Street believe the share price of Ambrx Biopharma might reach $11.00. From the present share price of $4.54 for AMAM, the average AMAM stock forecast predicts a possible increase of 142.29%. AMAM stock forecast EPS is anticipated to be negative $0.25 in 2023.

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stocklivemarket · 2 years ago

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biodiscovery-group · 4 years ago

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abtlenzymes · 4 years ago

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Role of Immuno-Modulators in Promoting Bird Health

In large scale intensive poultry production, only fast growing and high yielding hybrid birds are reared; which are generally more prone for infections, due to lesser disease resistance power and break down of immunity. Well developed immunity is very much important to increase the general disease resistance power of the birds and thereby improve its productivity. Therefore in commercial poultry production, the farmer must pay maximum attention, to develop immunity in the flock. Hence the farmer has to take into consideration several measures, not only to prevent break down of immunity, but also to boost the immunity building process. Vaccination alone is not sufficient to boost immunity. Moreover, they are specific for a particular disease and vaccines are not available for many diseases. Vaccination failures and break down of immunity are more common, due to improper vaccination, poor nutrition, mycotoxins, stress of various kinds, overcrowding, insufficient ventilation, poor flock management, improper housing, poor quality drinking water and many more reasons. There are several immunosuppressive diseases; which will not only cause that particular disease; but also results in general breakdown of immunity. Overall general immunity will not only prevent disease outbreaks, but also results in higher rate of production. Nutritionally balanced, toxin-free feed along with use of immunomodulators in poultry feed will boost the immunity in the poultry.

Need of Immunomodulators in poultry feed under stress conditions

In poultry, homeostasis results in physiological changes of an individual causing stress reduces the overall performance. Various kinds of stress among which, heat stress is more common and badly affects bird performance if proper nutritional and managemental care is not taken into consideration. The heat stressed birds may fall short to perform with respect to the body weight, feed efficiency, laying performance and mortality. However, the heat stress susceptibility of a breed depends upon various factors such as strain, feathering pattern, nutritional plane and production system. Further, it can be considered as a factor responsible for immune suppression in birds, resulting in infectious diseases and reduced performance in the flock. This causes potential economic losses and the farmer need to face the debts in the business. So, to counteract this heat stress induced immune suppression, one should follow certain strategies including supplementation of some nutrients like vitamins, minerals, electrolytes and some additives like probiotics, prebiotics, essential oils, polyherbal preparations, aspirin, betaine, systemic enzymes and acetic acid. These substances bring about the change in the internal environment of gastrointestinal tract and enhances the immunity.

Commonly used Immunomodulators in Poultry

Direct-Fed Microbials (DFMs)/Probiotics have been used as prophylactic agents against enteric pathogens, presumably by balancing microbiota, by modulating host immunity, or both. The dietary Bacillus subtilis, when used in a broiler as a potential growth promoter, can provide beneficial effects on broiler performance and modulate host humoral and cellular immune responses to enteric pathogens.

Butyrate have been appreciated for its beneficial effects on the host, including anti-inflammatory effects on epithelial cells. A scientific study indicated that dietary butyrate supplementation can improve the growth performance in chickens under stress, and that this could be used to moderate the immune response and reduce tissue damage.

Essential oils exert their mode of action mainly with bactericidal effect, enhances the activity of endogenous digestive enzymes and modulation of the immune system.

Prebiotics are non-digestible feed ingredients that are metabolized by specific (beneficial) members of intestinal microbiota and provide health benefits for the host. Prebiotics are capable of modulating gut microbiota and the immune interactions in favour of chicken health.

Vitamin A is a fat soluble vitamin having significant role in immune function and reproduction process. In layer, it reduces heat stress and increases egg production while in broiler it helps in improving overall growth and performance. It is very effective if given in combination with zinc to minimize heat stress.

Vitamin C is a water soluble vitamin and can be synthesized in poultry and not required as a supplement under normal condition. However, in heat stressed chicken, it is proven to be beneficial by reducing corticosterone production with simultaneous increase in insulin and thyroid levels. In case of broiler breeders, it increases egg weight, fertility and hatchability. In heat stressed broiler, Vit.C requirement is more, as it also acts as antioxidant. It improves carcass yield and quality, feed efficiency, carcass protein content and reduces crude fat.

Vitamin E is a fat soluble vitamin and its dietary intake reduces heat stress and improves egg production. It increases plasma concentration of yolk lipids by production and release from liver. It protects the liver and body cells from oxidative injuries also. Vitamin E shall be supplemented before, during and after any stressful condition.

Herbal plants feed additives and their derivatives like secondary metabolites are being used traditionally for their therapeutic and immunomodulatory functions. These herbal principles or metabolites include saponins, glyacoproteins, polysaccharides, and flavonoids etc. These metabolites have a wide variety of medicinal actions like lymphocyte stimulation.

Systemic enzymes (Immunotech)

Immunotech is a unique systemic enzyme based immunomodulator which comprises a synergistic combination of Serratiopeptidase, Nattokinase, Bromelain, Papain, & Bioflavonoids (Rutin). Immunotech have its application through feed (Immunotech Powder) as well as through drinking water (Immunotech Liquid) and its cost effectiveness makes it as a versatile solution for poultry farmers. In low risk condition (continuous application), it is recommended as a preventive measure to stimulate the immunomodulation process and the overall immune function. In high risk condition (intermittent application), it is flexible and recommended to identify stress periods with precision. Immunotech is a versatile solution having anti-inflammatory, anti-oxidative and fibrinolytic properties that helps in improved immunomodulation and better performance.

Product Specification

Recommended Inclusion Levels :

Immunotech (Feed)

For Broiler : Pre-starter & starter : 500 g/ton of feed

Finisher : 250 g/ton of feed

For Layer/Breeder : 250 g/ton of feed

Immunotech (Liquid)

Continuous Application : 250 ml/1000 birds in drinking water twice a day for first two days of application, followed by 100 ml/1000 birds twice in a day third day onwards.

Intermittent Application : 250 ml/1000 birds in drinking water twice a day.

Presentation :

Immunotech powder : 1 kg

Immunotech Liquid : 1. 5 lit

#Immunotech #Immunomodulators in poultry #Immunomodulatorsinchicken

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