Cancer Vaccines Are the N.I.H.’s Next ‘Big Bet’ (2/2)
New details have emerged about an initiative that starts
in December to fast-track the vaccines, similar to the successful push for the
Covid-19 vaccine.
The NYT - By Gina Kolata
Oct. 9, 2026
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Though the public-private partnership will draw inspiration
and lessons from the global development of the Covid-19 vaccine, the timeline
for the cancer vaccines will be nowhere near as fast. Phase 1 of the
initiative, which will consist of small studies, is expected to take about
three years and lead to “go-to information on different technical approaches to
vaccines,” Dr. Letai said.
Larger trials in Phase 2 are expected to take at least four years, involve a national network of clinical trial sites and lead to definitive results. The ultimate goal, Dr. Adam said, is that “in seven to 10 years, anyone who walks into a doctor’s office can get a vaccine.”
That is still faster than would be expected without the initiative where it can take eight to 15 years to get F.D.A. approval, Dr. Adam said. And work would have been fragmented and uncoordinated.
It was small, fragmented studies with promising results that inspired the initiative.
They included, for example, one involving patients with kidney cancer that was led by Dr. Catherine J. Wu of the Dana-Farber Cancer Institute and her colleagues. The researchers took tumor cells from patients with advanced kidney cancer at the time of their initial surgery. Then, for each patient, they created a vaccine designed to attack the tumor’s unique mutations.
It is impossible to know if the patients were entirely cured in such a small study, but all nine were cancer-free after 40 months. Ordinarily, 30 to 50 percent would have relapsed within two years.
Dr. Wu and her colleagues are now developing vaccines for patients with glioblastoma, as well as for those with ovarian cancer.
Another encouraging early study focused on pancreatic cancer. Even with the best treatments, close to 90 percent of patients die within five years, said Dr. Vinod Balachandran of Memorial Sloan Kettering Cancer Center.
His group conceived the idea for a small study in 2017 and began it in 2019. When a patient had surgery to remove their pancreatic cancer, the investigators collected tumor tissue and shipped it to Genentech and BioNTech, a company that later produced Covid vaccines. The companies pinpointed the mutations unique to a patient’s cancer and then made a customized vaccine.
The investigators treated 16 patients and followed them for up to six years. Seven out of eight who responded to the vaccine are still alive, compared with just two out of the eight who did not respond.
That initial study, though — promising as it was — was not definitive.
“We cannot prove that vaccines are making patients live longer,” Dr. Balachandran said. His group and its industry partners began a much bigger study in 2023, enrolling 260 patients.
Based on what he has seen so far, Dr. Balachandran is hopeful about the future of vaccine therapy. With pancreatic cancer, he took on a cancer thought to be impervious to immune system attacks: “If we crack the toughest nut,” he said, “we can crack the rest.”
Translation
癌症疫苗是美國國立衛生研究院的下一個「重大押注」(2/2)
一項旨在加速癌症疫苗研發的計劃將於12月啟動,其模式與成功推動新冠疫苗研發的模式類似。該計劃的最新細節已經浮現
(繼續)
儘管這項公私合作計劃將從全球新冠疫苗的研發中汲取靈感和經驗,但癌症疫苗的研發速度遠不及新冠疫苗。Letai 博士表示該計劃的第一階段將包括一些小型研究,預計耗時約三年,並導致「成為關於不同疫苗技術方法的參考資訊」。
第二階段的大規模試驗預計至少需要四年時間,將涉及一個覆蓋全國的臨床試驗中心網絡,並最終得出確切結果。Adam 博士表示,最終目標是「在七到十年內,任何走進診所的人都能接種疫苗」。
Adam 博士說,即便如此,速度仍然比在沒有這項計劃下預期的要快得多,因為如果沒有這項計劃,獲得 FDA 批准可能需要8到15年。而且,如果沒有這項計劃,工作將會非常分散且缺乏協調。
正是那些取得令人鼓舞的小型、分散的研究成果促成了這項計劃的誕生。
例如,其中一項研究涉及腎癌患者,由 Dana-Farber 癌症研究所的 Catherine J. Wu 博士及其同事領導。研究人員在患者首次手術時從晚期腎癌患者身上提取了腫瘤細胞。然後,他們為每位患者開發了一種疫苗,旨在攻擊腫瘤特有的突變。
在這樣一項小型研究中,我們無法確定患者是否完全治愈,但所有九名患者在40個月後均未出現癌症復發。通常情況下,30%到50%的患者會在兩年內復發。
Wu博士及其同事目前正在研發針對膠質母細胞瘤和卵巢癌患者的疫苗。
另一項令人鼓舞的早期研究聚焦於胰臟癌。Memorial Sloan Kettering 癌症中心的 Vinod Balachandran 博士表示,即使接受最好的治療,近90%的患者也會在五年內死亡。
他的團隊在2017年構思了一項小型研究,並於2019年啟動。當患者接受胰臟癌切除手術時,研究人員會收集腫瘤組織並將其送到 Genentech 和 BioNTech, 即那家後來研發出新冠疫苗的公司。這兩家公司會確定患者癌症特有的突變,然後研發度身定做的疫苗。
研究人員對16名患者進行了治療,並對他們進行了長達六年的追蹤。 8名對疫苗有反應的患者中,7名仍存活;而8名沒有反應的患者中,只有2名仍存活。
然而,這項初步研究 - 儘管前景可觀 - 卻並非是最終定論。
Balachandran 博士說: 「我們無法證實疫苗是能真的延長患者的壽命」。他的團隊及其產業夥伴於2023年啟動了一項規模更大的研究,招募了260名患者。
根據目前所見,Balachandran 博士對疫苗療法的未來充滿希望。他曾攻克胰腺癌,這種癌症一度被認為能抵禦免疫系統攻擊的癌症 - 他說:“如果我們能攻克最難攻克的難題”,“我們就能攻克其他難題。”
So, a new type of cancer treatment
by using vaccines is so promising that it demands a national effort to expedite
researches that will involve many medical institutes in the US to work together
to develop and test the new vaccines. The ultimate goal is that in seven
to 10 years, anyone who walks into a doctor’s office can get a vaccine.
Apparently, this is good news for everyone.
Note:
1.Genentech
and BioNTech are two separate, independent companies. Although they have
partnered on major medical research projects, they have completely distinct
corporate identities, history, and parent structures. The two companies
are frequently mentioned together because they entered into a high-profile,
multi-million-dollar strategic collaboration to co-develop individualized
mRNA-based cancer immunotherapies. (Google)