Adaptive Biotech Plans $230 Million IPO to Advance Immune Sequencing Tech

Seattle-based Adaptive Biotechnologies announced plans for an initial public offering (IPO) to raise up to $230 million.

Founded in 2009 by brothers Chad and Harlan Robins, the company utilizes high-throughput gene sequencing with computer infrastructure that allows scientists to minutely analyze T-cell receptors (TCR). Prior to this breakthrough, it was possible to catalog about 30,000 unique TCRs out of 100 million. The new tech allows scientists to identify 10 to 15 million in a single individual.

“Our goal is to understand the adaptive immune system and translate it into new products with unprecedented scale, precision and speed,” Adaptive stated in its preliminary prospectus for the IPO. As such, it is focused on cancers, autoimmune and infectious diseases.

The company has 346 staffers and to date has raised more than $400 million in private funding. Its largest shareholders are Viking Global Entities, which holds 36%, and Matrix Capital Management with 16.4%. In 2018, the company had a net loss of $46.4 million on revenues of $55.6 million, and as of March 31 reported having $440 million in cash and cash equivalents. About two-thirds of the revenue derived from sequencing services. Its accumulated deficit as of March 2019 was $314 million.

In early 2018 Adaptive partnered with Microsoft to develop a blood test that could diagnose multiple diseases in a single assay. The idea was to utilize artificial intelligence to map the immune system’s response to foreign substances and toxins. In January 2019, the companies announced they were ready to roll and placed an open call for collaborators to help sequence immune data from 25,000 people with five diseases: type 1 diabetes, celiac disease, ovarian cancer, pancreatic cancer and Lyme disease.

In January 2019, Adaptive inked a deal with Genentech, a Roche company, to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for a number of cancers. This partnership combines Genentech’s cancer immunotherapy R&D with Adaptive’s T-cell receptor (TCR) discovery and immune profiling platform (TruTCR). Adaptive’s technology platform quickly identifies TCRs that may be the most effective at recognizing and targeting specific neoantigens, proteins created by tumor-specific mutations not observed in normal tissues. Genentech paid Adaptive $300 million up front for that deal.

The prospectus indicates the $440 million in cash and the proceeds from the IPO will fund the company’s activities for the next two years.

At the American Society of Clinical Oncology (ASCO) Annual Meeting being held this weekend, the company is presenting data from more than 15 studies for clonoSEQ and immunoSEQ.

“At Adaptive, we are decoding the adaptive immune system to help diagnose and treat disease,” stated Chad Robins, co-founder and chief executive officer of Adaptive. “With our FDA-cleared NGS MRD Assay, clonoSEQ, we are enabling physicians in clinical practice to monitor and track a patient’s minimal residual disease (MRD) status to predict outcomes and guide treatment decisions. Additionally, our immunoSEQ research tool is helping to validate response to immunotherapies and assess toxicity. We remain committed to expanding the clinical applications of our immune medicine platform to reach greater numbers of patients.”

https://www.biospace.com/article/adaptive-biotechnologies-files-for-230-million-ipo/

Genocea Call Monday on Top 10 Featured Immuno-oncology Abstract

Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, today announced that the Journal of Clinical Oncology^® (An American Society of Clinical Oncology Journal) has selected the company’s GEN-009 clinical results presentation at the 2019 ASCO Annual Meeting as a top 10 featured abstract in immuno-oncology. The full poster will be available on the Genocea website here concurrent with its presentation tomorrow:

ASCO 2019 POSTER SESSION: Developmental Immunotherapy and Tumor Immunobiology
Poster Board: #255 • Abstract 2611

	Title:		A phase 1/2a study of GEN-009, a neoantigen vaccine based on autologous peptide immune responses
	Presenters:		Roger B. Cohen, M.D., University of Pennsylvania Perelman School of Medicine and principal investigator in the trial, and Przemyslaw W. Twardowski, M.D., John Wayne Cancer Institute
	Date:		Saturday, June 1, 8:00 AM – 11:00 AM Central Time
	Location:		Hall A

Conference Call and Webcast – Monday, June 3^rd at 8:30 am ETGenocea will host a conference call and webcast to discuss the clinical results presented at ASCO at 8:30 am ET on Monday, June 3, 2019. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 9068006. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

https://www.globenewswire.com/news-release/2019/05/31/1861059/0/en/Genocea-s-GEN-009-Clinical-Results-Presentation-Selected-by-ASCO-s-Journal-of-Clinical-Oncology-as-a-Top-10-Featured-Immuno-oncology-Abstract.html

ASCO 2019: Delays lead to late-stage colorectal cancer diagnosis in young

The incidence of early onset colorectal cancer has increased nearly 50 percent in the last 30 years. A University of Colorado Cancer Center study presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago aimed to identify factors that may aid in earlier diagnosis and treatment of the disease.

“The rising incidence of colorectal cancer in young adults is concerning,” says Gurprataap Sandhu, MD, fellow at the CU Cancer Center. “In addition to trying to identify the cause of this increase, it is crucial to diagnose these patients at an earlier stage to improve clinical outcomes.”

The results of the study found that there was a high incidence of advanced stage cancer and prolonged rectal bleeding history before diagnosis in young-onset patients with colorectal cancer. More than half of the 173 patients presented with rectal bleeding before diagnosis. On average, 294 days passed between the first time the patient noticed rectal bleeding and the time they were diagnosed. By the time of diagnosis, 37.8 percent of the patients were Stage IV.

“Our results show that young adult patients present with a much higher rate of Stage IV colorectal cancer compared to patients who are older than years of age,” says Sandhu. “This is especially significant as Stage IV patients have a much worse prognosis and are typically incurable with a few exceptions.”

Traditionally colorectal cancer screening starts at 50 years of age. However, the American Cancer Society (ACS) dropped the recommended screening age for average risk patients to 45 in response to the increase of early onset diagnoses.

“The finding of prolonged bleeding prior to diagnosis was a surprising. It is possible that the bleeding was attributed to hemorrhoids initially, leading to potential delay in seeking medical attention and ultimately diagnostic workup,” says Sandhu. “Patients and primary care physicians should be made aware this finding in order to facilitate timely referral for colonoscopy which may lead to earlier diagnosis, less advanced disease at diagnosis, and improved outcomes.”

More about early onset colorectal cancer

Colorectal cancer diagnoses in young people (under 50 years old) have been increasing significantly in the last decades. The reasons behind this are unclear but theories include the rising obesity in children, a decrease in childhood physical activity, and changes in the microbiome due to exposure to antibiotics.

According to a survey conducted by the Colorectal Cancer Alliance;

• 82% of young cancer survivors were initially misdiagnosed
• 73% were diagnosed at a later stage
• 50% felt their symptoms were ignored
• 62% did not have a family history
• 67% saw at least two doctors before being diagnosed

If caught early, the average five-year survival rate for patients with colorectal cancer is 90 percent. This drops to 14 percent if diagnosed at later stages.

https://eurekalert.org/pub_releases/2019-05/uoca-a2d052919.php

Medical Marijuana ‘Useful Tool’ For Cancer Treatment: ASCO Study

Medicinal marijuana has long been a topic of controversy in the medical community. Issues about weed range from its legality to whether or not enough extensive studies have been done.

However, many experts acknowledge the benefits of medicinal marijuana and even feel that it could be a useful tool in treating cancer.

A study presented by the University of Colorado Cancer Center at the ASCO, American Society for Clinical Oncology, Annual Meeting 2019 showed that while 73 percent of surveyed oncology providers believe in the benefits that medicinal marijuana provides for cancer patients, only 46 percent of them were comfortable recommending it to patients. Survey respondents included 53 registered nurses, 48 specialized oncologists, 47 physicians, 17 pharmacists, and 7 oncology providers.

According to the report, 79 percent of survey respondents expressed that while they were uncomfortable prescribing medicinal marijuana as a tool for cancer treatment, additional educational programs during training and as continuing medical education courses could increase how comfortable they were in prescribing medicinal marijuana. Interestingly enough, around 68 percent of survey respondents reported that they received information about medicinal marijuana from their patients.

This discomfort could stem from the fact that most providers don’t train in states where medicinal marijuana is legal. Adapting the healthcare education to include medicinal marijuana, and providing training on medicinal marijuana could help to increase the comfortability of current providers in prescribing medicinal marijuana as a useful tool for cancer treatment.

Providers also brought up another issue they had with prescribing medicinal marijuana in the form of legal and regulatory concerns. Those working in academic medical centers expressed concerns about prescribing medicinal marijuana as it could jeopardize federal funding since marijuana remains to be a U.S Drug Enforcement Agency Schedule 1 drug.

Providers reported that if additional clinical data regarding the effectiveness of medicinal marijuana were provided, and if there were to be endorsed guidelines that would dictate the conditions and situations in which medicinal marijuana is to be prescribed, they would feel more at ease prescribing medicinal marijuana.

While there are numerous cancer medication used to treat different symptoms, medicinal marijuana has the benefit of treating numerous symptoms simultaneously. Medicinal marijuana has been found to be especially helpful to cancer patients undergoing chemotherapy as it helps to quell many of the side effects that come with undergoing the treatment.

https://www.ibtimes.com/medical-marijuana-useful-tool-cancer-treatment-asco-study-reveals-2796710

ASCO: Primary care has crucial role in diagnosis, survival of cancer patients

Diagnosis, screening, risk reduction, managing comorbidities, helping to coordinate specialty care, long-term toxicities, palliative care, survivorship, and vaccination are just a few of the roles for primary care physicians related to the diagnosis and care of cancer patients.

The message, delivered today during a panel discussion at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, sought to address myriad of challenges faced when coordinating care after a person is first diagnosed with cancer, during treatment, after care, and in survivorship.

“We are on the front lines for diagnosing cancer, coordinating treatment phases leading to survivorship, and end-of-life care,” says Larissa Nekhlyudov, MD, MPH, an internist and survivorship care provider at Dana-Farber/Brigham and Women’s Hospital in Boston.

Piyush Srivastava, MD, an oncologist for Kaiser Permanente in Walnut Creek, Calif., says survivorship studies have shown that Stage I and Stage II cancer patients are more likely to die from hypertension or modifiable risks like cigarette smoking than cancer. Who would you prefer to manage high blood pressure, diabetes, or other chronic diseases? “The answer is that primary care physicians need to be an active member of the cancer-care team,” he says.

Consider that every 10 additional primary care physicians per 100,000 of population are associated with 51.5 days of additional life expectancy, versus 19.2 days for additional life expectancy with specialists. (JAMA Intern Med. 2019; 179(4) 506-514)

Every 10 additional primary care providers per 100,000 of population are also associated with reduced cardiovascular, cancer and respiratory mortality.

As oncologic therapies advance, it signals a need to adopt a more collaborative approach to patient care, during treatment and when a patient enters remission.

Trevor Jolly, MBBS, a medical oncologist at the University of North Carolina at Chapel Hill, adds the primary care physician should serve as the medical quarterback. He encourages primary care physicians and oncologists to pick up the phone and communicate about cases and better collaborate on treatment decisions, especially for those patients undergoing chemotherapy or radiation.

“During treatment, patients tend to rely on the specialist,” Jolly says. “But in my office, we are referring back to the primary care physician.”

Elizabeth Shiff, a cancer survivor and patient advocate at the University of Cincinnati, adds, when a patient is diagnosed with cancer, he or she is only thinking about next steps in the treatment plan. “It is important,” Shiff says, “to stress to the patient that his or her care will be like a triangle—between the oncologist, primary care physician, and patient. “Empower your patients with communication about the treatment plan and the role of providers,” she adds.

Jolly agrees. “I think we need to have a more collaborative approach where treatment decisions are shared, especially with comorbidities and when hypertension or diabetes is uncontrolled.”

As cancer therapies advance, survivorship numbers have been climbing as well. Consider that 1.7 million new cases of cancer are diagnosed each year, but there are 16.9 million survivors. It signals a growing need for improved collaboration between oncologists and primary care physicians.

https://www.medicaleconomics.com/news/asco-primary-care-physicians-play-crucial-role-diagnosis-survivorship-cancer-patients

ASCO 2019 Preview: Presentations to Keep An Eye On

American Society of Clinical Oncology (ASCO) meeting is always an exciting week in the pharma industry as multiple companies showcase their clinical research into various cancers.

The excitement gets underway on Friday in Chicago as companies unveil data from recent trials that could potentially change the way in which providers treat cancer. Below are a few presentations that will bear watching at ASCO.

Novartis – Swiss pharma giant Novartis will present data from across its oncology portfolio at ASCO for multiple cancers, including breast cancer, melanoma, lung cancer and other solid tumors. Novartis will walk into ASCO with its head held high after winning approval from the U.S. Food and Drug Administration for a first-of-its-kind breast cancer treatment. The FDA gave the nod to Piqray, the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer. Piqray works by inhibiting the PI3K pathway, predominantly the PI3K-alpha isoform, to address the effect of PIK3CA mutations. Piqray (alpelisib, formerly known as BYL719) in combination with fulvestrant, was approved by the FDA for the treatment of postmenopausal women, and men, with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-),PIK3CA-mutated, advanced or metastatic breast cancer. Novartis will present data from the Phase III SOLAR1 trial which earned Piqray its FDA approval.

The company will also provide additional clinical analyses from its key radioligand therapy – Lutathera, the first ever approved Peptide Receptor Radionuclide Therapy. Lutathera was approved in January for the treatment of somatostatin-receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), an orphan disease.

Oncoceutics, Inc. – Philadelphia-based Oncoceutics, Inc. will showcase data from its ongoing trial assessing ONC201 in adult recurrent H3 K27M-mutant glioma. The oral abstract session presentation, entitled “Single agent ONC201 in adult recurrent H3 K27M-mutant glioma” will describe the clinical experience of ONC201, in adults with recurrent H3 K27M-mutant glioma. ONC201 is an orally active small molecule DRD2 antagonist. The presentation will discuss a cohort of adults with H3 K27M-mutant glioma patients who have received ONC201 after failure of available therapies. The results will include assessments of radiographic response, progression-free survival and overall survival, as well as safety and clinical benefit. In addition, there will be an update on ONC201 in previously irradiated pediatric H3 K27M-mutant glioma that will be presented in a poster session.

OncoNano Medicine, Inc. – Texas-based OncoNano will share full data from its first-in-human study of ONM-100, an intravenously administered imaging agent. The agent was well tolerated and enables fluorescent visualization of tumor-positive margins and occult disease in solid tumors during surgery, the company said. Low pH is a well-known indicator of diseased tissue and ONM-100 has the potential to act as a broadly indicated tumor agnostic imaging agent, OncoNano said. When used by surgeons, ONM-100 is delivered to the tumor and fluoresces in the acidic tumor microenvironment. This enables surgeons to visualize the tumor during surgery using existing near infrared surgical cameras. OncoNano recently concluded a Phase 1 clinical trial for ONM-100.

AstraZeneca – British pharma giant AstraZeneca will also showcase some of its oncology assets during the conference. Of note is data regarding the company’s Phase III POLO trial showing its market-leading PARP inhibitor Lynparza (olaparib) as a possible first-line treatment in metastatic pancreatic cancer (mPC) patients with a germline BRCA mutation. In February, the company announced the data from the late-stage trial that showed Lynparza provided a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as first-line maintenance therapy. Lynparza received Orphan Drug designation from the FDA for pancreatic cancer in 2018, and AstraZeneca plans to file for approval in the second half of 2019.

Another study of note that AstraZeneca will share is the PACFIC trial demonstrating Imfinzi three-year overall survival in Stage III non-small cell lung cancer. Imfinzi is the first immunotherapy approved for stage III lung cancer. Last fall AstraZeneca released results that showed Imfinzi (durvalumab) significantly improved OS. Regardless of PD-L1 expression compared to placebo, the drug decreased the risk of death by 32 percent, the company said. Data also showed positive results in progression-free survival.

https://www.biospace.com/article/asco-2019-preview-presentations-to-keep-an-eye-on/

ASCO 2019 day one

Exclusive live coverage from day one of the American Society of Clinical Oncology’s annual meeting in Chicago.

• To view all of our coverage from the preeminent cancer event, produced in association with Kantar Health, as well as additional content, visit the Spotlight on ASCO 2019 and the future of oncology

ASCO 2019 kicks off this year with a strong focus on prostate cancer, as several pharma companies are attempting to find ways to treat the disease earlier, or find better ways to prevent it spreading.

Key readouts to look for on Friday 31^st May:

• Data from Johnson & Johnson’s Erleada (apalutamide) in patients with metastatic castration-sensitive prostate cancer (mCSPC). This will be the first time that we get the chance to see detailed data from the phase 3 TITAN study.
• AstraZeneca and Merck & Co have data from the phase 2 TOPARB-B trial, testing their PARP inhibitor Lynparza (olaparib) for metastatic castration resistant prostate cancer.
• AstraZeneca and Merck & Co are also due to present data from a phase 3 study testing Lynparza in pancreatic cancer, in patients with an inherited BRCA gene mutation.

View the live coverage from day one at ASCO 2019 below (the live blog may take a few seconds to load) and we will also have live coverage from day two at ASCO:

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That’s a wrap (for day one)

 Dominic_Tyer

And that’s it for our live coverage of day one at ASCO 2019, presented in association with Kantar Health.

We’ll be back tomorrow with expanded news coverage of some of today’s key events as well as a live blog from day two of ASCO 2019.

In the meantime if you are on site tomorrow there’s an interesting looking session on social media for authors from 2-3pm.

https://pharmaphorum.com/spotlight/asco-2019-live-coverage/asco-2019-day-one/