Cancers of the head and neck can be treated with several drugs on the market, but for certain patients diagnosed with this this common type of cancer, outcomes are worse and better therapeutic options are needed. Bicara Therapeutics is developing a therapy that could provide a treatment alternative and the company now has $315 million in IPO cash to finance a pivotal study..

头颈部癌症可以用市场上的几种药物治疗，但对于某些被诊断患有这种常见类型癌症的患者，结果更差，需要更好的治疗选择。Bicara Therapeutics正在开发一种可以提供治疗替代方案的疗法，该公司目前拥有3.15亿美元的IPO现金，用于资助一项关键研究。。

Boston-based Bicara was able to raise more than it planned. In preliminary IPO terms set on Monday, the company aimed to offer 11.7 million shares priced in the range of $16 to $18 each. On Wednesday, Bicara increased the proposed stock sale to 14.7 million shares offered in the same targeted price range.

总部位于波士顿的比卡拉能够筹集到比计划更多的资金。在周一确定的初步IPO条款中，该公司计划发行1170万股，每股价格在16至18美元之间。周三，比卡拉将拟议的股票销售增加到1470万股，在相同的目标价格范围内发行。

When shares finally priced late Thursday, Bicara boosted the deal size yet again, offering 17.5 million shares for $18 each, right at the top of the targeted price range. Those shares now trade on the Nasdaq under the stock symbol “BCAX.”.

周四晚些时候，当股票最终定价时，比卡拉再次扩大了交易规模，以每股18美元的价格发行了1750万股，正处于目标价格区间的顶部。这些股票现在在纳斯达克交易，股票代码为“BCAX”。

Most head and neck squamous cell carcinoma (HNSCC) cases come from exposure to carcinogens such as tobacco smoke or from human papillomavirus (HPV), Bicara says in its IPO filing. That virus can lead to cellular changes that over time, become precancerous and then cancerous. However, an estimated 80% of recurrent or metastatic HNSCC cases are HPV-negative.

Bicara在其首次公开募股文件中表示，大多数头颈部鳞状细胞癌（HNSCC）病例来自暴露于致癌物质，如烟草烟雾或人乳头瘤病毒（HPV）。这种病毒可以导致细胞变化，随着时间的推移，细胞会变成癌前病变，然后癌变。然而，估计80%的复发或转移性HNSCC病例是HPV阴性的。

These tumors are associated with an increased risk of fatal tumor bleeding, excruciating pain, and difficulty swallowing..

这些肿瘤与致命的肿瘤出血，剧烈疼痛和吞咽困难的风险增加有关。。

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Accelerating Claim Processing: Strategies to Shorten the Life of a Claim

加速索赔处理：缩短索赔期限的策略

These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes.

这些战略和做法可以大大缩短索赔的生命周期，从而更快地解决问题，改善财务成果。

By Greenway Health

绿道健康

Bicara’s drugs are antibodies engineered to address solid tumors by hitting two validated cancer targets. The company’s lead program, ficerafusp alfa, is a bifunctional antibody drug designed to bind to epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-beta).

Bicara的药物是通过击中两个经过验证的癌症靶标来解决实体瘤的抗体。该公司的领先项目ficerafusp alfa是一种双功能抗体药物，旨在结合表皮生长因子受体（EGFR）和人转化生长因子β（TGF-β）。

TGF-beta is an important target because high signaling from this protein is associated with resistance to the class of immunotherapies called checkpoint inhibitors. For that reason, drugs that hit this target have been tested as a way to potentially overcome this resistance. GSK and Merck KGaA tried this approach with a bifunctional protein, bintrafusp alfa.

TGF-β是一个重要的靶点，因为该蛋白的高信号传导与对称为检查点抑制剂的免疫疗法的抗性有关。因此，已经测试了达到这一目标的药物，作为潜在克服这种耐药性的方法。GSK和默克KGaA用双功能蛋白bintrafusp alfa尝试了这种方法。

But clinical trial results showed the experimental therapy fell short on measures of efficacy. In its IPO filing, Bicara said such failures may be due to insufficient anti-tumor activity, possibly because the immunotherapy is being expressed in immune tissue rather than the tumor microenvironment (TME) where it’s needed..

但临床试验结果表明，实验疗法在疗效方面存在不足。在首次公开募股文件中，比卡拉表示，这种失败可能是由于抗肿瘤活性不足，可能是因为免疫疗法是在免疫组织中表达的，而不是在需要的肿瘤微环境中表达的。。

Bicara says the dual approach of its drug blocks survival signaling from EGFR as well as immunosuppressive TGF-beta signaling in the TME. Bicara has been testing its experimental drug in combination with the blockbuster Merck immunotherapy pembrolizumab, brand name Keytruda, whose approved indications include HNSCC.

Bicara说，其药物的双重方法阻断了来自EGFR的存活信号以及TME中的免疫抑制性TGF-β信号传导。Bicara一直在测试其实验药物与畅销的默克免疫疗法pembrolizumab（品牌Keytruda）的组合，其批准的适应症包括HNSCC。

An ongoing Phase 1/1b study of the Bicara drug includes a group of HNSCC patients who had not previously received treatment after their cancer had advanced. In this cohort, Bicara said the combination of the study drug and Keytruda led to a 54% overall response rate in patients who could be evaluated for efficacy.

正在进行的比卡拉药物1/1b期研究包括一组HNSCC患者，这些患者在癌症进展后之前没有接受过治疗。在这个队列中，Bicara说，研究药物和Keytruda的组合导致可以评估疗效的患者的总有效率为54%。

In patients whose disease was HPV negative, the overall response rate was 64%. For context, the historical response rate in a Phase 3 test of Keytruda monotherapy in HNSCC was 19%, the company said in the filing. The company expects to report more Phase 1/1b data at a medical meeting in 2025..

。该公司在文件中表示，在HNSCC的Keytruda单一疗法的3期测试中，历史反应率为19%。该公司预计在2025年的医疗会议上报告更多的1/1b期数据。。

“Based on the clinical data generated to date, we believe that ficerafusp alfa in combination with pembrolizumab has the potential to become a first-line standard of care therapy in HPV-negative [recurrent/metastatic] HNSCC,” Bicara said in the filing. “We also believe ficerafusp alfa has the potential to provide meaningful clinical benefit in other solid tumors where there is a strong biologic rationale for the dual inhibition of both EGFR and TGF-beta, such as colorectal cancer and other squamous cell carcinomas which typically overexpress EGFR and TGF-beta pathways.”.

“根据迄今为止产生的临床数据，我们认为ficerafusp alfa联合pembrolizumab有可能成为HPV阴性[复发/转移性]HNSCC的一线标准治疗，”Bicara在文件中说。“我们还认为，ficerafusp alfa有可能在其他实体瘤中提供有意义的临床益处，在这些实体瘤中，EGFR和TGF-β的双重抑制具有强大的生物学原理，例如结直肠癌和其他通常过度表达EGFR和TGF-β途径的鳞状细胞癌。”。

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What Healthcare Can Learn from Costco

好市多可以向医疗保健公司学习什么

The path forward is clear: employers must evaluate their health plan the same way they do their Saturday shopping excursion.

前进的道路是明确的：雇主必须像周六购物一样评估他们的健康计划。

By Jeff Bak, Imagine360 CEO and President

作者Jeff Bak，Imagine360首席执行官兼总裁

A pivotal Phase 2/3 clinical trial is planned that will test the Bicara therapy in combination with the Merck immunotherapy pembrolizumab, brand name Keytruda, as a first-line treatment for advanced HNSCC. Bicara expects this study will start by the end of this year or in the first quarter of 2025.

计划进行一项关键的2/3期临床试验，该试验将测试Bicara疗法与默克免疫疗法pembrolizumab（品牌Keytruda）的组合，作为晚期HNSCC的一线治疗。比卡拉预计，这项研究将于今年年底或2025年第一季度开始。

Bicara formed in 2018. The following year, the company licensed certain fusion proteins from Biocon Limited. The most advanced of those fusion proteins was ficerasfusp alfa. There are no future milestone payments or royalties tied to the deal, Bicara said in the filing. The prospectus says Bicara has raised $353.1 million since its inception.

比卡拉成立于2018年。第二年，该公司从Biocon Limited获得了某些融合蛋白的许可。这些融合蛋白中最先进的是ficerasfusp alfa。比卡拉在文件中表示，未来不会有里程碑式的付款或与该交易相关的版税。招股说明书称，自成立以来，比卡拉已经筹集到3.531亿美元。

The most recent financing was a $165 million Series C round announced last December. Biocon is Bicara’s largest shareholder, owning an 11.28% post-IPO stake, according to the filing. RA Capital Management owns a 10.5% stake after the IPO..

最近的融资是去年12月宣布的1.65亿美元的C轮融资。。RA Capital Management在IPO后拥有10.5%的股份。。

As of the end of the second quarter of this year, Bicara reported a cash position of $203.9 million. Combined with the IPO proceeds, the company plans to spend about $265 million on the development of ficerafusp alfa in HNSCC, including the pivotal study and the filing of a biologics license application.

截至今年第二季度末，比卡拉报告的现金头寸为2.039亿美元。结合IPO收益，该公司计划花费约2.65亿美元在HNSCC开发ficerafusp alfa，包括关键研究和提交生物制剂许可证申请。

Another $30 million is earmarked for the expansion of its lead drug candidate in additional HNSCC patient groups. And $25 million is set aside for advancing clinical development of the drug in additional types of solid tumors, such as colorectal cancer and other squamous cell carcinomas..

另外3000万美元专门用于在其他HNSCC患者群体中扩大其主要候选药物。另外，2500万美元用于推进该药物在其他类型实体瘤（如结直肠癌和其他鳞状细胞癌）中的临床开发。。

Zenas’s IPO Pulls in $225M for Pipeline in a Product Opportunity in I&I

Zenas的首次公开募股（IPO）为I＆I的产品机会中的管道带来了2.25亿美元

Zenas Biopharma, a company developing antibody drugs to treat immunology and inflammation (I&I) disorders, raised $225 million. The company late Thursday priced more than 13.23 million shares at $17 each. When Zenas set preliminary financial terms this week, it aimed to offer 11.76 million shares in the range of $16 to $18 apiece, which would have raised $199.9 million at the pricing midpoint.

Zenas Biopharma是一家开发抗体药物治疗免疫和炎症（I＆I）疾病的公司，筹集了2.25亿美元。周四晚些时候，该公司将1323万股股票定价为每股17美元。。

Zenas’s shares will trade on the Nasdaq under the stock symbol “ZBIO.”.

Zenas的股票将在纳斯达克交易，股票代码为“ZBIO”。

Excessive activity of B cells, a type of immune cell, is associated with a range of autoimmune disorders. While antibody drugs are currently available that treat these conditions by depleting B cells, Zenas contends they don’t fully affect B cells in relevant tissue and the dosing regimen of these therapies can be improved.

B细胞（一种免疫细胞）的过度活动与一系列自身免疫性疾病有关。虽然目前可以通过消耗B细胞来治疗这些疾病的抗体药物，但Zenas认为它们不会完全影响相关组织中的B细胞，并且可以改进这些疗法的给药方案。

Another concern is that antibody drugs that target and block the proteins CD19 and CD20 on B cells may deplete these cells for six months or longer, which raises the risk of infection and could reduce a patient’s ability to respond to and benefit from vaccines..

另一个担忧是，靶向并阻断B细胞上CD19和CD20蛋白的抗体药物可能会耗尽这些细胞六个月或更长时间，这会增加感染风险，并可能降低患者对疫苗的反应能力和受益能力。。

Zenas’s lead drug candidate is obexelimab, a bifunctional antibody designed to bind to CD19 and Fc gamma receptor IIb, both targets that are broadly expressed on B cells. According to Zenas, this approach mimics a natural antigen-antibody complex for inhibiting B cells. This mechanism of action is intended to inhibit the activity of B cells without completely depleting them.

Zenas的主要候选药物是obexelimab，一种双功能抗体，旨在结合CD19和Fcγ受体IIb，这两种靶标均在B细胞上广泛表达。据Zenas称，这种方法模仿天然抗原-抗体复合物来抑制B细胞。这种作用机制旨在抑制B细胞的活性而不完全消耗它们。

Zenas acquired global rights to obexelimab from Xencor in 2021. The company had previously licensed other programs from Xencor; those programs are still preclinical..

Zenas于2021年从Xencor获得了obexelimab的全球权利。该公司之前已经从Xencor许可了其他程序；这些计划仍处于临床前阶段。。

While Zenas believes obexelimab has broad potential in I&I, the company is initially focusing on four indications: immunoglobulin G4-related disease (IgG4-RD), multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia (wAIHA). Zenas’s drug is furthest along in IgG4-RD, a chronic inflammatory condition that affects multiple organs.

虽然Zenas认为奥贝昔单抗在I＆I方面具有广泛的潜力，但该公司最初专注于四种适应症：免疫球蛋白G4相关疾病（IgG4-RD），多发性硬化症，系统性红斑狼疮和温热自身免疫性溶血性贫血（wAIHA）。Zenas的药物在IgG4-RD中最为重要，IgG4-RD是一种影响多个器官的慢性炎症。

Standard of care includes corticosteroids. Roche’s CD20-targeting antibody drug, Rituxan, can also be used to treat the condition. Zenas is continuing a Phase 3 test of its lead drug in IgG4-RD..

护理标准包括皮质类固醇。。Zenas正在继续对其IgG4-RD中的先导药物进行3期试验。。

Since inception, Zenas said it had raised $358.3 million from investors. The company’s most recent financing was a $200 million Series C round in May led by SR One. That investor owns a 7% post-IPO stake in Zenas, according to the filing. Xencor is Zenas’s largest shareholder with an 8.1% post-IPO stake..

Zenas表示，自成立以来，已从投资者那里筹集到3.583亿美元。该公司最近的融资是5月份由SR One牵头的两亿美元C轮融资。根据备案文件，该投资者在上市后拥有Zenas 7%的股份。Xencor是Zenas的最大股东，在IPO后持有8.1%的股份。。

As of the end of June, Zenas reported having $183.9 million in cash. That capital, along with the IPO proceeds, will broadly support the advancement of obexelimab. Zenas plans to spend about $100 million on clinical development of the drug, including the completion of a Phase 3 study in patients with IgG4-RD.

截至6月底，Zenas报告称拥有1.839亿美元现金。这笔资金以及IPO收益将广泛支持奥贝昔单抗的发展。Zenas计划花费约1亿美元用于该药物的临床开发，包括完成IgG4-RD患者的3期研究。

This drug candidate will also be evaluated in separate Phase 2 tests in multiple sclerosis, lupus, and wAIHA. The company expects its capital will last for the next two years..

该候选药物还将在多发性硬化症，狼疮和wAIHA的单独2期测试中进行评估。该公司预计其资本将持续两年。。

MBX Bio’s Longer-Acting Peptide Drugs Land $163M for Clinical Trials

MBX Bio的长效肽类药物临床试验耗资1.63亿美元

MBX Biosciences’ IPO raised $163 million for a pipeline that includes a lead program in the clinic for a rare hormone deficiency with few FDA-approved treatments. Carmel, Indiana-based MBX priced its offering of 10.2 million shares at $16 each, which was the top of $14 to $16 per share price range it set earlier this week.

MBX Biosciences的首次公开募股筹集了1.63亿美元，用于一个管道，其中包括一个针对罕见激素缺乏症的临床领先项目，该项目几乎没有FDA批准的治疗方法。总部位于印第安纳州卡梅尔的MBX将其1020万股的发行价定为每股16美元，这是其本周早些时候设定的每股14至16美元的最高价格区间。

The company was able to boost the deal size, offering 1.7 million more shares than it had initially planned. MBX’s shares will trade on the Nasdaq under the stock symbol “MBX.”.

该公司得以扩大交易规模，发行的股票比最初计划的多170万股。MBX的股票将在纳斯达克交易，股票代码为“MBX”。

MBX’s drugs come from a platform technology that engineering peptides with a longer duration of action that enables less frequent dosing intervals. This technology is based on research from Indiana University. Lead program MBX 2109 is a potential treatment for chronic hypoparathyroidism, a condition in which the parathyroid glands do not produce enough parathyroid hormone to regulate levels of calcium and phosphate in the blood..

MBX的药物来自一种平台技术，该技术可以设计作用持续时间更长的肽，从而减少给药间隔。。领先项目MBX 2109是慢性甲状旁腺功能减退症的潜在治疗方法，甲状旁腺不能产生足够的甲状旁腺激素来调节血液中的钙和磷酸盐水平。。

The first FDA-approved therapy for this condition is Takeda Pharmaceutical’s Natpara, an engineered version of the hormone. But Takeda has said it will stop offering Natpara due to ongoing manufacturing problems. Patients have a new alternative following FDA approval last month of Ascendis Pharma’s Yorvipath, a peptide injected once-daily to bring parathyroid hormone levels within the normal range..

第一个FDA批准的治疗这种疾病的药物是武田制药的Natpara，一种工程化的激素。但武田表示，由于持续的制造问题，它将停止提供Natpara。在上个月FDA批准Ascendis Pharma的Yorvipath后，患者有了一种新的替代方案，这种肽每天注射一次，可以使甲状旁腺激素水平保持在正常范围内。。

With MBX 2109, MBX aims to offer chronic hypoparathyroidism patients less burdensome once-weekly dosing. In Phase 1 testing, the company reported its engineered peptide achieved parathyroid hormone levels comparable to those achieved by a continuous infusion. A Phase 2 study dosed its first patient last month; preliminary data are expected in the third quarter of next year..

使用MBX 2109，MBX旨在为慢性甲状旁腺功能减退症患者提供每周一次的剂量。在第一阶段测试中，该公司报告称其工程肽达到了甲状旁腺激素水平，与连续输注所达到的水平相当。上个月，一项2期研究给第一名患者服用了药物；初步数据预计将在明年第三季度公布。。

Another engineered peptide, MBX 1416, in Phase 1 development for post-bariatric hypoglycemia (PBH). In this rare condition, bariatric surgery patients go on to develop dangerously low blood sugar levels. There are no FDA-approved therapies for this rare condition, but MBX isn’t alone in the pursuit for one.

另一种工程肽MBX 1416处于减肥后低血糖（PBH）的第一阶段开发中。在这种罕见的情况下，减肥手术患者会出现危险的低血糖水平。目前还没有FDA批准的治疗这种罕见疾病的疗法，但MBX并不是唯一一个寻求这种疗法的人。

Amylyx Pharmaceuticals picked up its Phase 3-ready PBH peptide drug from the bankruptcy auction of Eiger BioPharmaceuticals. Another engineered peptide, MBX 4291, is in preclinical development for obesity..

Amylyx Pharmaceuticals从Eiger BioPharmaceuticals的破产拍卖中获得了其3期就绪的PBH肽药物。。。

According to the IPO filing, MBX’s cash position at the end of June was $55.3 million. That capital, along with the IPO proceeds, will support clinical trials. MBX plans to spend $148.6 million to take its lead program through mid-stage development and into Phase 3 testing in chronic hypoparathyroidism and to advance its PBH drug through Phase 1 and Phase 2 testing.

根据首次公开募股文件，MBX在6月底的现金头寸为5530万美元。这笔资金以及IPO收益将支持临床试验。MBX计划花费1.486亿美元，通过中期开发和慢性甲状旁腺功能减退症的3期测试，并通过1期和2期测试推进其PBH药物。

Another $31.2 million is set aside to advance the obesity program into the clinic..

另外拨出3120万美元用于将肥胖计划推进诊所。。

Photo: Getty Images

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