ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to evorpacept, a next generation CD47 blocker, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for the first-line treatment of adult patients with PD-L1 positive advanced head and neck squamous cell carcinoma (“HNSCC”).
The FDA’s decision is informed by the results of ALX Oncology’s phase 1 clinical trial, ASPEN-01, that showed preliminary antitumor activity and a favorable safety profile in checkpoint inhibitor-naïve patients with second-line or greater advanced HNSCC treated with evorpacept and pembrolizumab (n=10). The preliminary objective response rate of 40% in this limited population represents an improvement over historical anti-PD-1 monotherapy activity in a similar population and supported the initiation of the ASPEN-03 (NCT04675294) study in May 2021 in collaboration with Merck (known as MSD outside the US and Canada). ASPEN-03 is a randomized phase 2 multi-center study to investigate the anti-tumor efficacy of evorpacept plus pembrolizumab in patients with first-line metastatic or unresectable, recurrent PD-L1 positive HNSCC.
Kazia Therapeutics Limited (NASDAQ: KZIA) said GBM AGILE, a pivotal study for paxalisib in newly diagnosed glioblastoma, did not meet pre-defined criteria for continuing to a second stage.
Patients enrolled in the first stage of the paxalisib arm will continue on treatment as per protocol, and in follow-up, until completion of the final analysis, which Kazia anticipates receiving in 2H of 2023.
Given that recruitment is complete, the study will not open to the paxalisib arm in Germany or China.
Kazia will work with its licensing partner to determine the way forward in China.
All Kazia personnel remain blinded to efficacy and safety data from the ongoing study.
Kazia CEO, James Garner, commented, "Today's news defines the remaining trajectory of the study, with modestly positive implications for both costs and timelines, and with some specific consequences for regulatory strategy in China. It does not allow us to draw any meaningful inferences about the outcomes of the study, and indeed it is critical for regulatory purposes that we remain blinded to the evolving data."
The FDA has lifted the clinical hold on Celyad Oncology SA's (NASDAQ: CYAD) CYAD-101-002 (KEYNOTE-B79) Phase 1b trial after the company made changes to the eligibility criteria for the trial.
"We remain confident in the potential development of not only the candidate itself, but the continued development with our proprietary TIM technology. CYAD-101 is currently our only clinical candidate co-expressing NKG2D and TIM, and we hope to continue to showcase our expertise with our non-gene edited technologies and explore additional opportunities to utilize NKG2D in allogeneic CAR T," said Charles Morris, Chief Medical Officer of Celyad Oncology.
In February, the company voluntarily paused the CYAD-101-002 trial to investigate reports of two fatalities in the study.
The CYAD-101-002 Phase 1b trial evaluates CYAD-101 with Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) in refractory metastatic colorectal cancer with microsatellite stable (MSS) / mismatch-repair proficient disease.
Shares ofVirax Biolabs(NASDAQ: VRAX) dropped 74% on Friday. The stock closed on Thursday at $20.80, then opened on Friday at $19.92 before climbing to its all-time high of $29 shortly before noon. Soon after that, it began falling and dropped to a low of $9 around 2 p.m. Then, shortly before the market closed, it fell again to $5.40 a share. So, for the day, the stock was initially up 39.4%, and by the end of the day, it was down 74%. The volatility led to theNASDAQhalting trading in the stock several times during the day.
The biotech company, which specializes in the detection and treatment of viral diseases, just began trading on the NASDAQ on July 21 after an initial public offering (IPO).
The share price of the IPO shares was $5, but the IPO didn't fully finish until July 25. Owners of those shares, once they hit $29, began to dump them, doing the classic "sell on the good news" method. That sent the stock into a tailspin amid a flurry of rumors. When it was revealed that the company had told the SEC its annual report, due July 31, would be late by up to 15 days, that added further fuel to the fire.
Earlier this week, Virax said that it had begun distribution of its monkeypox and Varicell-Zoster Viruses PCR detection kits in Europe. On July 23, the World Health Organization declared monkeypox to be a global health emergency, saying more than 16,000 cases had been reported across 75 countries and territories.
As a newly traded company, it may take some time for the biotech stock to find a truer level, so it's likely to stay volatile for a while. There's little question the trading of the $5 shares helped bring the price down, but Virax hasn't issued a quarterly report yet, so it's hard to say what the stock is worth.
The news regarding its PCR tests is certainly positive, and Virax learned through its COVID-19 tests that quick action is needed when an outbreak occurs to have a more viable product.
Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, today announced the publication of a peer-reviewed journal article inPLOS ONE. The article, titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin," contains data demonstrating that the proprietary GNA affinity resin of the Aethlon Hemopurifier® efficiently captures seven clinically relevant variants of the SARS-CoV-2 virus responsible for the COVID-19 pandemic. Viral capture efficiency ranged from 53% to 89% for the variants tested.
"These data demonstrate that the Hemopurifier can effectively capture a wide range of clinically relevant SARS-CoV-2 variants," said Charles J. Fisher, M.D., Chief Executive Officer of Aethlon Medical. "As new variants and subvariants of this virus continue to emerge and induce new waves of the pandemic, health systems need innovative technologies that are agnostic to viral variations. The Hemopurifier may represent an opportunity to overcome this challenge and provide treatment to patients with severe COVID-19."
The Aethlon Hemopurifier, a clinical stage product candidate, is a therapeutic blood filtration system that has been demonstrated to bind and remove life-threatening viruses and harmful exosomes from blood. Aethlon currently is evaluating the safety and feasibility of the Hemopurifier in an active Early Feasibility Study (EFS), analogous to a Phase 1 clinical trial for a drug or biologic, which is designed to enroll up to 40 severe COVID-19 patients [NCT04595903]. The first patient in the study completed Hemopurifier treatment in the trial and nine hospitals are actively screening patients. Aethlon recently announced that the U.S. Food and Drug Administration (FDA) accepted a protocol amendment to the study, notably eliminating the requirement of previous dialysis treatment, which will potentially enable accelerated enrollment in the ongoing study.
New York’s Cannabis Control Board is slow-walking the start of the state’s retail legal-pot sales, possibly to next year. But we’ve already seen how limited are its ideas of public-health alerts. Posters on commuter trains advise that only those 21 and over may use the drug — and that you can’t consume it in public. Anyone walking through Gotham knows how well those’ve worked.
But as the board continues to emphasize social justice in awarding weed-distribution licenses to ex-felons and Gov. Kathy Hochul salivates over a new sin-tax windfall, both should instead start paying urgent attention to the experience of California, which legalized recreational marijuana in 2016. That state is now contemplating another type of pot lesson: one about mental-health dangers.
A Democratic lawmaker-pediatrician has filed state legislation that would require “product labels and inserts to include a clear and prominent warning” that “cannabis use may contribute to mental health problems.” The Legislature will hold a hearing on it this week.
The bill, which state Sen. Richard Pan wrote with two liberal Democratic Assembly co-sponsors, Jacqui Irwin and Kevin McCarty, suggests chilling language reminiscent of the cancer warnings on cigarette packages. One warning: Cannabis use may contribute to “psychotic disorders such as schizophrenia. Risk is greatest for frequent users.”
California state Sen. Richard Pan wrote the bill, which pushes for warnings on drug-induced psychotic disorders.AP/Rich Pedroncelli
This is not some contemporary version of the notorious 1936 film “Reefer Madness.” Oakland’s Public Health Institute says such legislation “would address a gaping regulatory hole by requiring more prominent and accurate health warnings on cannabis products.”
To that point, the Centers for Disease Control and Prevention has nothing positive to say about pot — and affirms its link to mental illness. “People who use marijuana are more likely to develop temporary psychosis (not knowing what is real, hallucinations, and paranoia) and long-lasting mental disorders, including schizophrenia.” What’s more, the CDC continues, the “association between marijuana and schizophrenia is stronger in people who start using marijuana at an earlier age.”
State law may limit pot sales to those at least 21, but in California, notes supporting text in Pan’s bill, “the percentage of California teens 12 to 17 years of age using cannabis increased significantly between 2016 and 2019 in the National Survey on Drug Use and Health.” Those are the first three years following legalization.
That’s true not just because pot became legal — but because it’s been commercialized. As was once true of cigarette-makers, pot marketers can promote its use. Anyone who thinks such messages will reach only those 21 and older has been smoking something. As the bill notes, “Perceptions of harm from use of cannabis by consumers of all ages, including teens, has declined dramatically.”
Hochul and the Cannabis Control Board need to stop cheerleading the advent of legal pot. That doesn’t mean the legalization genie can be put back in the pipe. It does mean focusing on mitigating legalization’s looming harms. Legalization should not mean encouragement — not when drug-overdose deaths top 100,000 a year and the CDC warns that marijuana use is associated with addiction.
State hospital data show that three years after legalization, emergency-room visits for cannabis-induced psychosis went up 54% across California, from 682 to 1,053. These are potential mass shooters and subway psychos.
Gov. Kathy Hochul has applauded the legalization of marijuana.AP/Hans Pennink
The Cannabis Control Board needs to get busy producing infomercials warning of pot’s mental-health risks. The state needs to give up its dream of pot tax revenues and instead set taxes low so that adulterated black-market weed doesn’t flood the market and spike overdoses. In California, illicit suppliers “still account for somewhere between two-thirds and three-quarters of sales” thanks, in great part, to high taxes, Jacob Sullum recently noted in these pages.
Public health is more important than feeding the public till — in New York, New Jersey, Connecticut and all 19 states that have legalized recreational pot. It’s simply wrong for state and local governments to rely on a risky product that harms the health of their own citizens. Let’s heed California’s warning.
Howard Husock is a senior fellow at the American Enterprise Institute.
A couple with ties to a firm that’s been awarded hundreds of millions in Medicaid transportation contracts over the years has driven more than $300,000 combined into the campaign coffers offormer Gov. Andrew Cuomoandcurrent Gov. Kathy Hochul, records reviewed by The Post reveal.
Critics say the donations are a textbook case of Albany’s pay-to-play culture that allows bidders and contractors to give massive campaign contributions to the governor whose agencies oversee them. By comparison, New York City law limits donations from bidders and contractors to the mayor and have business Big Apple agencies to $400.
The firm, Medical Answering Services, founded by president Russ Maxwell in 2004, was awarded eight contracts totaling $403.7 million by the state Health Department from 2011 through 2018. Four of the contracts don’t expire until next year.
Maxwell and his spouse, Morgan McDole, dropped $236,000 into Cuomo’s campaign coffers over those years.
The couple has also dumped more than $100,000 combined into the campaign coffers of Hochul, as governor and lieutenant governor under Cuomo — and the Hochul-controlled state Democratic Committee.
McDole, for instance, gave three contributions totaling $52,600 to Hochul over the past year — $22,600 on Jan. 8, 2021, $10,000 on Sept. 9, 2021 shortly after she became governor and $20,000 on April 24 of this year.
McDole donated another $20,000 to the Hochul-influenced state Democratic Party on April 27 of this year.
Meanwhile, Maxwell has donated $32,100 to Hochul since 2018 and $176,000 to Cuomo during his tenure. McDole donated another $60,000 to Cuomo.
“It’s a perfect example that shows how lax state campaign finance laws are,” said John Kaehny, director of the government watchdog group Reinvent Albany.
Former Gov. Andrew Cuomo received $236,000 in campaign donations from the couple over the years.AP/Richard Drew
“It looks like pay to play. It destroys public trust in government. New York City government is way head of the state on this.”
Senate Elections Committee Chairman Zellnor Myrie (D-Brooklyn) passed a bill that would ban campaign contributions during a bidding process and six months after an award was given to a winning bidder. But the legislation stalled in the state Assembly.
“New York State’s purse is massive. Any bidder seeking taxpayer dollars should be free of political influence,” Myrie said.
“The proposal is about restoring trust in the bidding process that has been lacking. The current system looks like people have to give campaign donations to grease the wheels. It’s unacceptable.”
A rep for Maxwell insisted that the contractor and his spouse’s donations were not connected to the contracts his firm was awarded. The eight contracts range from $15 million to $120 million to provide transportation to Medicaid recipients in all parts of the state, including New York City, records with the comptroller’s office show.
The Health Department said Medical Answering Services was awarded another contract in the 2020-21 budget after a request for proposal was put out in accordance with state law.
Maxwell’s firm acts as a contractor or broker that works with transportation providers to pick up and drop off Medicaid recipients, meaning his company doesn’t pocket the total amount in the contract.
“Russ Maxwell has been involved in state and local politics for more than 30 years, including a run for State Assembly in 1992. He’s supported many candidates and political causes over the years,” said Maxwell spokesman Patrick McCarthy.
“Russ and his husband supported former Gov. Cuomo’s efforts to legalize gay marriage in New York, and he’s known Gov. Hochul for decades dating back to her days on the Hamburg Town Board, and as [Erie] County Clerk. Russ supports candidates for office who have a vision for New York’s future, that future is important to Russ, his family, and the hundreds of men and women who work at MAS.”
The rep also said that Maxwell has helped the state achieve savings and efficiencies in New York’s highest-in-the-nation $92.7 billion Medicaid budget, which provides publicly-funded health insurance coverage to the needy.
Prior to the first state contract award, Maxwell’s contributions were more modest. For example, he gave two contributions to gubernatorial candidate Eliot Spitzer for $1,000 and $500 in 2005.
Subsequently, Maxwell donated $25,000 to Cuomo’s campaign committee on July 9, 2012 and he continued to make fat contributions to Cuomo as more contracts were renewed or awarded.
Hochul and Cuomo, both criticized for their aggressive fundraising of people with business before the state, insisted they’re not influenced by campaign donations.
“Consistent with Governor Hochul’s commitment to maintain high ethical standards, campaign contributions have no influence on government decisions,” said Hochul’s campaign spokesman Jerrel Harvey.
Cuomo spokesman Richard Azzopardi said, “Can’t speak to how things are currently, but contracting was always done on the agency level – period. The two unmovable rules in Albany are that critics like to criticize and love reading their names in the paper.”
The Health Department said Maxwell’s firm was awarded contracts on the merits after competitive bidding — without involvement from the governor’s office.
Russ Maxwell was awarded eight contracts totaling $403.7 million by the state Health Department from 2011 through 2018.
“The Department of Health has contracted with this vendor for more than a decade to provide critical transportation services to Medicaid patients and, after a competitive bidding process, awarded this vendor a procurement authorized under the State Fiscal Year 2020-21 Budget to provide nonemergency medical transportation brokerage management services for New Yorkers enrolled in the Medicaid program,” said state Health Department spokesman Cort Ruddy.
“The procurement evaluated both technical and cost considerations as outlined in the RFP and in accordance with State Finance Law. The Executive Chamber does not provide input on procurements managed by the Department and had no involvement in the selection of the awardee.”
Hochul has faced scrutiny for renewing a state of emergency for COVID-19 for months that has suspended state purchasing rules which, the Times Union recently reported, let a rapid testing company called Digital Gadgets — led by a campaign donor — secure $637 million in no-bid business from the state Department of Health since December.
Hochul has also collected hefty contributions from other other firms with business before the state — cannabis operators, film companies, casino operators and the real estate industry.
