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Breast cancer cells

Athenex’s lead drug candidate, an oral formulation of the chemotherapy paclitaxel, is intended to bring patients comparable, if not better, efficacy and fewer side effects than the intravenous version. But the company now faces questions about the drug’s safety in the wake of an FDA rejection.

Buffalo, New York-based Athenex announced the rejection of the cancer drug Monday. According to the company, the regulator recommended the biotech conduct a new clinical trial in metastatic breast cancer patients. The agency also suggested the company take steps to mitigate the drug’s toxicity.

Shares of Athenex fell sharply after the FDA rejection was announced, and closed Monday at $5.46 apiece, down nearly 55% from Friday’s closing stock price.

Paclitaxel, also known as Taxol, is a widely used chemotherapy for treating breast, ovarian, and lung cancers. Intravenous dosing of the drug can cause adverse reactions. To mitigate those effects, cancer patients are given steroids and antihistamines prior to dosing of the chemotherapy. Other side effects of intravenous paclitaxel include nerve damage, hair loss, and neutropenia, which is an abnormally low level of a type of white blood cell called neutrophils. Those side effects may reduce how much of a dose of the chemotherapy a patient can receive.

Athenex’s version of paclitaxel is given in combination with another drug, encequidar. According to the company, this compound blocks a protein in the intestinal wall that limits the absorption of chemotherapies. In results of a Phase 3 study testing Athenex’s oral paclitaxel in patients with metastatic breast cancer, the company reported its drug met the main goal of showing statistically significant improvement in the overall response rate compared against treatment with the IV version of the chemotherapy.

The company also reported that its drug can reach levels in the blood comparable to IV paclitaxel, and for a longer period of time. The company said in securities filings that this capability may translate to a better clinical response to the therapy. In the 402-patient Phase 3 study, Athenex observed a higher tumor response rate along with lower incidence and severity of nerve problems compared to IV paclitaxel.

Athenex said that the agency’s complete response letter cited the risk of an increase in problems related to neutropenia in the oral paclitaxel arm compared with the group treated with the IV formulation. The FDA also expressed concern about how the results of the study primary endpoint were evaluated under blinded independent central review, a group of independent physicians. According to Athenex, the FDA said there may have been “unmeasured bias and influence” on the review.

Speaking on a conference call, CEO Johnson Lau said the company was “surprised and extremely disappointed” by the FDA’s rejection. The neutropenia concerns cited are a known risk of paclitaxel, he said. Lau added that the review remained blinded, was conducted by independent radiologists, and the regulator had not issued any formal warnings flagging problems at the imaging lab.

The FDA’s recommendation that Athenex conduct another clinical trial specified that the study should include patients more representative of the U.S. population. Rudolf Kwan, the company’s chief medical officer, said on the call that none of the clinical trial sites were in the U.S. But he added that the company had discussed the clinical trial design with the regulator, and the single study, as proposed by the company, was understood to be sufficient to support approval if the results were positive.

Lau said that the company plans to request a meeting with the FDA to discuss the letter and clarify the scope of the new clinical trial needed to address the agency’s concerns.

“Whether it requires the whole study be done in U.S., we’ll have to clarify in the meeting,” Lau said.

Though Athenex has a pipeline of clinical-stage cancer therapies, company currently generates most of its revenue from the sales of generic injectable products. In 2020, it reported more than $105 million in product sales, a 73% increase over 2019 sales. In its financial report of fourth quarter 2020 and full-year results, Athenex attributed the revenue increase to growing sales of specialty pharmaceutical products used to treat hospitalized Covid-19 patients. As of Dec. 31, 2020, Athenex had $86.1 million in cash and $138.6 million in short-term investments.

Photo by American Cancer Society/Getty Images

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Pfizer and BioNTech are asking the FDA to approve a change that would permit storage of their Covid-19 vaccine within a temperature range found in medical-grade freezers.

To be clear, this proposed change doesn’t eliminate the need for ultra-cold temperatures as the vaccine moves throughout the supply chain—temperatures that require specialized equipment. Those storage requirements are a barrier to its distribution because not all facilities have equipment that can achieve the required temperatures. What Pfizer and BioNTech are proposing is that when the vaccine reaches its destination, such as a hospital or pharmacy, it could be stored for up to two weeks at (relatively) warmer freezer temperatures.

The FDA granted emergency use authorization to the messenger RNA vaccine, named Comirnaty, last December. According to the product’s label, the vaccine must be stored in ultra-cold temperatures between minus 112 degrees and minus 76 degrees Fahrenheit (minus 80 degrees and minus 60 degrees Celsius). At those temperatures, the vaccine can last up to six months. Pfizer ships the vaccines in specially designed containers that can be refilled with dry ice every five days. Those containers can serve as temporary storage for up to 30 days.

The vaccine can be stored at refrigerator temperatures for up to five days. Pfizer and BioNTech are asking the FDA to approve an additional option to store the vaccine at minus 13 degrees to 5 degrees Fahrenheit (minus 25 degrees to minus 15 degrees Celsius) for two weeks. That range would put it closer to the storage requirements for the mRNA vaccine from Moderna. The temperature range Pfizer and BioNTech are proposing would be in addition to the five days at refrigerator temperatures that is currently permitted under the authorization.

“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer CEO Albert Bourla said in a prepared statement.

Pfizer and BioNTech are proposing the additional temperature option based on new data about their vaccine’s stability. The data span from the earliest clinical trials up to batches currently in production.

Messenger RNA vaccines are a new technology that employ a snippet of genetic material from the novel coronavirus. This mRNA serve as a blueprint that a cell’s protein-making machinery use make the characteristic spike protein found on the surface of the novel coronavirus. That protein is what triggers an immune response and confers immunity.

Though mRNA vaccines are administered at room temperature, they must be kept at ultra-cold temperatures in the supply chain because mRNA is fragile. The extremely cold temperatures keep the components of the vaccine from breaking down. As mRNA companies study the storage data they have for vaccines, they are getting a better understanding of how long these vaccines can last at certain temperatures. Last November, Moderna released data that it said supported storage of its vaccine at refrigerator temperatures for up to 30 days.

Temperature requirements can be a barrier to the distribution of the vaccine to rural areas, which may not have facilities with appropriate freezers. In that regard, the Johnson & Johnson Covid-19 vaccine is seen as offering an advantage. In addition to requiring only a single shot (both authorized mRNA vaccines require two), the J&J vaccine can be stored at standard refrigerator temperatures. An FDA advisory committee is scheduled to hold a hearing about that vaccine on Feb. 26.

Photo by BioNTech

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Paige, A computational pathology startup spun out of Memorial Sloan Kettering, raised $100 million in a series C funding round. The New York-based company is developing clinical decision support tools for pathologists, and plans to use the funds to further advance its technology.

Paige was started in 2018 by Dr. Thomas Fuchs, who spun out the company from research at Memorial Sloan Kettering Cancer Center. The startup had a research agreement to receive de-identified images of digitized pathology slides, which it is using to make AI tools across multiple cancer subtypes, and the Memorial Sloan Kettering holds an equity stake in the company.

Earlier this year, Paige received 510(k) clearance from the Food and Drug Administration for a digital pathology image viewer. It also received a Breakthrough Device designation from the FDA for an AI tool for cancer diagnosis.

None of Paige’s clinical decision support tools are yet cleared to be used for diagnostics in the U.S. But in Europe, it has two CE-marked solutions to detect areas of suspected prostate cancer or breast cancer.

With the new funds, Paige plans to double its headcount, with roughly 70 new employees across its engineering and commercial teams.

“This investment reaffirms the vast potential of the Paige platform for clinical and biopharmaceutical drug development applications,” Paige CEO Leo Grady said in a news release. “These funds will enable us to build additional AI-based products within and outside of oncology, deliver these products to laboratories and clinicians globally, and invest in our talent across engineering and commercial functions.”

Photo credit: Abscent84, Getty Images

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Though doses of the long-awaited Covid-19 vaccine are making their way around the country, the rollout is moving slowly and there have been countless reports of doses being thrown away in situations that could have been avoided, including labeling errors. Now, states such as New York, California and Florida, are threatening to penalize providers that are not efficiently and appropriately distributing vaccine doses.

More than 15 million doses of the vaccine have been distributed across the country so far, but only about 4.5 million people have received their first dose, data from the Centers for Disease Control and Prevention shows.

In New York, 274,713 people have received the first dose of the vaccine out of the 895,925 doses distributed to the state. This represents a vaccination rate of 1,412 per 100,000 people, according to the data.

On Sunday, New York State Health Commissioner Dr. Howard Zucker issued a letter to vaccine providers outlining expectations for distribution, including requiring that all vaccine doses in the providers’ inventory prior to Jan. 4 be administered to eligible recipients by Jan. 7.

“Any doses that are not administered by end of day on January 7 will be redistributed to another facility and future allocations to such facilities will be limited, and possibly eliminated,” the letter reads.

At a news conference Monday, New York Gov. Andrew Cuomo said that going forward, facilities in the state must administer their entire vaccine allotment within seven days of receiving it or risk facing a fine of up to $100,000.

In addition, providers “who do not comply or are found to be seriously deficient” may incur more serious sanctions and fines, including being disqualified from future vaccine distribution.

Florida Gov. Ron DeSantis made similar remarks at a press conference Monday, stating that “hospitals that do not do a good job of getting the vaccine out will have their allocations transferred to hospitals that are doing a good job in getting the vaccine out.”

Though he did not threaten to levy fines, DeSantis said that hospitals have been asked to submit their vaccine distribution plans to the state.

“We do not want a vaccine to just be idle at some hospital system,” he said.

Florida’s vaccination rate is similar to New York’s at 1,232 per 100,000 people. The state received 1.13 million doses of the vaccine, but only 264,512 Floridians have gotten their first dose, CDC data shows.

In California — where the current Covid-19 vaccination rate is 1,143 per 100,000 people — Gov. Gavin Newsom confirmed that healthcare providers that violate priority guidelines for vaccine distribution will have their licenses revoked.

“I just want to make this crystal clear,” he said at a news conference last week. “If you skip the line or you intend to skip the line, you will be sanctioned, you will lose your license.”

California’s vaccine distribution plan is divided into three phases, beginning with vaccinating healthcare workers and long-term care residents.

The governor’s office plans to work with the California Medical Association to create an enforcement plan “to make sure that someone’s not passing a few vials over to their cousin or aunt or uncle, or God forbid, making a buck or two on the backs of a vaccine that should be distributed to someone who is at high risk or at higher need,” Newsom said.

Photo credit: Pornpak Khunatorn, Getty Images

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Headway’s platform lets users search for in-network therapists. The company manages back-end paperwork and billing, and hires therapists as independent contractors.

When Andrew Adams moved to New York five years ago, he struggled to find a therapist that would take his insurance. He’s not alone — a little over one in four people struggled to find a therapist in their network, according to a survey conducted by the National Alliance on Mental Illness in 2015.

A shortage of healthcare professionals, coupled with a crippling pandemic, has exacerbated a longstanding problem with access to mental healthcare. Another challenge is that many therapists have independent practices, which can make processing claims and negotiating with insurers more difficult.

Adams started Headway with the idea of building his own network of therapists by creating a system to manage the administrative burden, such as claims and insurance credentialing. In turn, they become independent contractors of Headway, which is paid by insurers every time they see a patient.

“Pre-pandemic, there was a crippling access shortage. There’s a real shortage of therapists accepting insurance,” he said in a phone interview. “We’re proud to be radically growing that.”

Since March, the company has seen a surge of patient demand. Visits nearly quadrupled, Adams said. But Headway also saw increased interest from providers. Many of them referenced a “call to arms feeling,” he added.

Headway claims to have more than 1,600 therapists and psychiatrists on its platform. Roughly two-thirds of them didn’t accept insurance beforehand.

Users can search on Headway’s platform to see if a therapist is covered in-network. Its services are covered by several major insurers, including Aetna, UnitedHealthcare, Cigna, and startup Oscar.

The company recently raised a $26 million series A round led by Thrive and GV (formerly known as Google Ventures). Accel, which led Headway’s seed round, as well as GFC and IA Ventures also participated in the round. To date, it has raised a total of $32 million.

Adams plans to use the funds to expand Headway’s services into other states. Although many patients are currently seeing mental health providers of telehealth visits, they might want to see them in-person in the future.

“We do see our patients typically want to go in person when they can, which is why we’re building a large, geographically dense network,” he said. “We’re really excited to use this capital to expand across the U.S. and do what we’re doing now, not just in the market of New York.”

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