On December 6, 2021 Novocure (NASDAQ: NVCR) reported the 4th Annual AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research Program. The program represents a joint effort with the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to promote and support innovative research on Tumor Treating Fields (TTFields) to help deepen the understanding of the mechanism of action and to accelerate the development of new treatment strategies (Press release, NovoCure, DEC 6, 2021, View Source [SID1234596510]). The program includes research grants and career development awards totaling more than $2 million over the next three years.

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The research grants will include five AACR (Free AACR Whitepaper)-Novocure Tumor Treating Fields Research Grants and two AACR (Free AACR Whitepaper)-Novocure Career Development Awards for Tumor Treating Fields Research. Recipients of the research grants will receive a total of $250,000 over two years. Recipients of the career development awards will receive a total of $225,000 over three years.

"We are thrilled to continue our partnership with Novocure," said Mitch Stoller, the AACR (Free AACR Whitepaper)’s Chief Philanthropic Officer. "These two grant mechanisms represent an important means for advancing the science of TTFields research and attracting talented investigators. We once again look forward to learning about the outstanding projects that will result from these grants and to meeting next year’s class of grantees."

Novocure and the AACR (Free AACR Whitepaper) encourage applicants to focus their proposals on translational approaches, promoting the transition of in vitro work into in vivo systems; combination therapies involving Tumor Treating Fields; and bringing treatments involving Tumor Treating Fields to the clinic. The application deadline is January 20. Recipients will be announced in April at the AACR (Free AACR Whitepaper) Annual Meeting 2022 in New Orleans.

"Deepening our understanding of the mechanism of action of Tumor Treating Fields can potentially advance our efforts to extend survival in some of the most aggressive forms of cancer," said Dr. Uri Weinberg, Novocure’s Chief Science Officer. "We are excited to partner with the AACR (Free AACR Whitepaper) to offer this innovative research program for the fourth year and look forward to the announcement of recipients at the AACR (Free AACR Whitepaper) Annual Meeting."

To apply for the AACR (Free AACR Whitepaper)-Novocure Grants for Tumor Treating Fields Research, visit www.aacr.org/funding.

About Tumor Treating Fields

Tumor Treating Fields, or TTFields, are electric fields that disrupt cancer cell division. Fundamental scientific research on TTFields extends across more than two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. TTFields therapy is intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields therapy has exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, including four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields therapy.

On December 6, 2021 Hummingbird Bioscience, an innovative clinical-stage biotech company focused on developing precision therapies against hard-to-drug targets in cancer and autoimmune disease, and Cancer Research UK, the world’s leading cancer charity, reported that the first patient has been dosed in a Phase 1 clinical trial of HMBD-001 for the treatment of patients with advanced HER3-expressing solid malignancies (NCT05057013) (Press release, Hummingbird Bioscience, DEC 6, 2021, View Source [SID1234596530]).

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The Phase 1 clinical trial in the United Kingdom is being sponsored and managed by Cancer Research UK’s Centre for Drug Development and led by Chief Investigator, Professor Johann De Bono at the Royal Marsden Hospital and The Institute of Cancer Research, London. The trial intends to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and explore preliminary evidence of HMBD-001 activity in patients with advanced HER3-expressing solid malignancies, including NRG1 fusion-driven cancers.

HMBD-001 is the first of Hummingbird Bioscience’s deep pipeline of antibody drug candidates to enter clinical trials. Rationally developed using Hummingbird Bioscience’s proprietary Rational Antibody Discovery (RAD) platform, HMBD-001 is the only reported anti-HER3 antibody in clinical development that uses a highly differentiated mechanism of action designed to block the formation of all active HER3 dimers, regardless of NRG1 ligand binding or HER2/EGFR overexpression.

"Dosing of the first patient in the clinical trial of HMBD-001, Hummingbird’s most advanced program, marks the beginning of a potentially transformative approach to treating HER3-driven cancers," said Dr. Jerome Boyd-Kirkup, Chief Scientific Officer, Hummingbird Bioscience. "I am immensely proud of the teamwork that has brought our differentiated program to this point. Hummingbird Bioscience is dedicated to discovering and developing important medicines for cancer and autoimmune disease with our unique Rational Antibody Discovery platform."

"This significant milestone brings us a step closer to provide a much-needed and highly differentiated therapy for patients with HER3-driven cancers," said Dr. Eric Rowinsky, Chief Medical Officer, Hummingbird Bioscience. "We are pleased to partner with Cancer Research UK for this trial, and we look forward to advancing the clinical development of HMBD-001 for cancer patients."

Dr. Nigel Blackburn, Director of Cancer Research UK’s Centre for Drug Development, said, "We are thrilled to be working with Hummingbird Bioscience to advance its novel drug candidate into clinical trials. Although HER3 was discovered over 30 years ago, no therapies able to block its cancer-promoting action have been approved. Hummingbird Bioscience has taken fresh aim at a difficult drug target and has come up with a novel, potentially transformative antibody for cancer patients who desperately need new treatments."

Initial data from the Phase 1 dose escalation is expected in the second half of 2022.

About HMBD-001

HMBD-001 is a clinical-stage IgG1 antibody designed to target HER3. Discovered using our proprietary RAD platform, HMBD-001 is now in development for the treatment of multiple solid tumors. We believe HMBD-001 is the only anti-HER3 antibody in development that has the potential to fully block both ligand-dependent and independent HER3 activation and oncogenic signaling, by targeting a key epitope located at the interface where HER3 forms heterodimers with HER2 or EGFR, independent of the process leading to such dimerization. In preclinical models evaluating HMBD-001, we have observed superior affinity and more potently inhibited tumor growth compared to other existing anti-HER3 antibodies. Our near-term development plan for HMBD-001 focuses on four priority, high-value indications with strong scientific rationale and supporting preclinical data: NRG1 fusion-driven cancers, metastatic castrate resistant prostate cancer (mCRPC), metastatic colorectal cancer (mCRC), and squamous cell carcinoma of the head and neck (SCCHN).

On December 6, 2021 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported that it has entered into a third clinical trial collaboration and supply agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada), through a subsidiary (Press release, IO Biotech, DEC 6, 2021, View Source [SID1234596479]). The purpose of the collaboration is to evaluate IO Biotech’s lead candidate, IO102-IO103, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in previously untreated patients with three different tumor types— metastatic non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and metastatic urothelial bladder cancer (UBC). IO102-IO103 is an investigational novel immunotherapeutic agent designed to target the mechanisms mediated by key immunosuppressive proteins such as Indoleamine 2,3-dehydrogenase (IDO) and PD-L1.

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"We are pleased to be collaborating once again with Merck to study the potential of our IDO and PD-L1 derived immune-modulating therapy in combination with pembrolizumab as part of our broad, late-stage development program," said Mai-Britt Zocca, PhD, CEO and founder of IO Biotech. "We believe IO102-IO103 has the potential to show utility for multiple cancer indications, and we look forward to expanding our dataset in these additional settings."

The planned Phase 2 trial will evaluate the safety and efficacy of the combination of IO102-IO103 with pembrolizumab in patients with previously untreated metastatic NSCLC, SCCHN, or UBC. Additional correlative endpoints will also be explored to elucidate the mechanism of action. Under the terms of the agreement, IO Biotech will sponsor the Phase 2 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IO102-IO103/IOB-022

Based on the results from a Phase 1/2 clinical trial, IO102-IO103, in combination with pembrolizumab, was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for treatment of unresectable/metastatic melanoma. IO Biotech plans to initiate a Phase 3 combination trial of IO102-IO103 and KEYTRUDA (pembrolizumab), as first-line treatment in metastatic melanoma patients which is designed to be potentially registrational for IO102-IO103.

On December 6, 2021 Adicet Bio, Inc. (Nasdaq: ACET), a biotechnology company discovering and developing first-in-class allogeneic gamma delta CAR T cell therapies for cancer and other diseases, reported positive interim data from its dose escalation Phase 1 study evaluating the safety and tolerability of ADI-001, Adicet’s investigational therapy targeting CD20 for the potential treatment of B-cell Non-Hodgkin’s Lymphoma (Press release, Adicet Bio, DEC 6, 2021, View Source [SID1234596495]).

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As of the November 22, 2021 data cutoff, six patients had been enrolled and received ADI-001. The first two patients enrolled in the lowest dose level tested did not reach the day 28 assessment and were not evaluable for efficacy per protocol. Three of the four evaluable patients achieved responses, including two complete responses (CR) and one partial response (PR) that investigators characterized as near complete response. Patients were heavily pre-treated, with a median of five lines of prior systemic therapy, including a patient who had received prior autologous CD19 CAR T,​ and achieved complete response following a single infusion of ADI-001 administered at the lowest dose level.

"We are extremely excited to see such profound early complete responses in our Phase 1 dose-finding study evaluating ADI-001 as monotherapy among patients with very advanced cancer starting at our first dose level of 30 million CAR+ cells," said Chen Schor, President and Chief Executive Officer of Adicet Bio. "Data to-date suggest that ADI-001 is highly clinically active. We look forward to reporting additional data in the first half of 2022 and to rapidly progressing our pipeline to realize the full potential of our gamma delta CAR T cell platform for patients."

"The unequivocal responses to ADI-001 in this heavily pre-treated patient population at such low dose levels are highly promising," said Sattva Neelapu M.D., Professor in the Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. "These data suggest that ADI-001 has the potential to be an effective treatment option for B cell malignancies if confirmed in further clinical testing. ADI-001 does not require gene editing and provides complementary innate, adaptive, and CAR mediated antitumor effects which may improve durability and minimize emergence of tumor resistance."

Of the four efficacy evaluable patients, three received ADI-001 at dose level one (30 million CAR+ cells) and one received ADI-001 at dose level two (100 million CAR+ cells). In dose level one, one patient achieved a CR, one patient achieved a PR that was characterized as near CR and one patient had progressive disease (PD). In dose level two, the first patient achieved a CR.

All evaluable patients had been heavily pre-treated with a median of five lines of prior systemic therapies. Of the three patients who achieved PR or better under Lugano 2014 criteria (ORR=75%, CR=50%), one had diffuse large B-cell lymphoma (DLBCL) with five prior lines of therapy including two cycles of anti-CD19 CAR T cell therapy, one had follicular lymphoma transformed into a large B-cell tumor with four prior lines of therapy, and the third had mantle cell lymphoma with five prior lines of therapy. These patients achieved two CRs and a near CR.

Overall, ADI-001 infusions were generally well-tolerated. No dose-limiting toxicities, graft vs host disease (GvHD), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) or grade 3 or higher Cytokine Release Syndrome (CRS) have been reported to-date, suggesting a potentially wide therapeutic window for ADI-001.

A significant increase in circulating IL-15 was observed during the 28-day window following lymphodepletion, potentially providing cytokine support for the proliferation of ADI-001​. Emergence of circulating ADI-001 in the blood was observed by quantitative polymerase chain reaction and by flow cytometry, demonstrating expansion of ADI-001 in patients​. Elevations in additional circulating cytokines, primarily IL-2 and IL-8 were observed during the first 14 days from dosing, consistent with the activation profile of ADI-001 and similar to the observed time-to-peak for cytokines previously reported in association with autologous alpha-beta CAR T cells. Importantly, no meaningful increases in IL-6 were seen in association with ADI-001, except for one patient who experienced COVID-19 infection, suggesting reduced likelihood for ICANS and high-grade CRS.

"It is remarkable to see our early preclinical studies translate to the clinic. The preliminary safety and efficacy data from low-dose ADI-001 collected to date indicate the potential for a broad therapeutic window. Without the need for gene editing and its associated safety concerns, our platform is designed to preserve the natural innate and adaptive anti-tumor activity of gamma delta CAR T cells, which we believe may lead to better durability," said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. "As we look to expand into additional cohorts, we plan to leverage our scalable off-the-shelf manufacturing process to meet future needs. We look forward to advancing our novel allogeneic gamma delta T cell pipeline for cancer patients."

Table 1: Summary of ADI-001 interim data from two dosing cohorts*:

Dose Level Age/Sex B-cell lymphoma subtypes # Prior lines of therapies Prior CAR T? Best Response (BOR) by Lugano Criteria (2014)
30 million CAR+ cells

62/F Transformed DLBCL​
(from chronic lymphocytic leukemia) 5 prior lines No PD
66/F Transformed high grade​
B cell tumor (from follicular lymphoma) 4 prior lines

No PR
(Near CR)
75M DLBCL 5 prior lines Yes (liso-cel) CR
100 million CAR+ cells 62/M Mantle cell lymphoma 5 prior lines No CR
*Efficacy evaluable patients as of November 22, 2021 database entry. Data are subject to further review and verification.

Webcast/Conference Call Information
Adicet will host a live presentation on Monday, December 6 at 8:30am EST to discuss the results. Dr. Sattva Neelapu from the University of Texas MD Anderson Cancer Center will participate in the event.

The live webcast of the presentation can be accessed under "Presentations & Events" in the investors section of the Company’s website at www.adicetbio.com or by dialing (877) 800-3802 (domestic) or (615) 622-8057 (international) and reference the conference ID 6952318. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About ADI-001
ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a treatment for B-cell non-Hodgkin’s lymphoma. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent antitumor activity in preclinical models, leading to long-term control of tumor growth.

About the GLEAN Study
This Phase I study is an open-label, multi-center study of ADI-001 enrolling adults diagnosed with B cell malignancies who have either relapsed, or are refractory to at least two prior regimens. The primary objectives of the study are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ADI-001, and to determine optimal dosing as a monotherapy. The study is expected to enroll approximately 75 patients. For more information about the clinical study design, please visit: www.clinicaltrials.gov (NCT04735471).

On December 6, 2021 Helio Health ("Helio") and its commercial partner, Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent"), reported the commercial launch of HelioLiver, a multi-analyte blood test that incorporates cell free DNA (cfDNA) methylation patterns and serum protein markers for the detection of hepatocellular carcinoma (HCC) – the most common form of liver cancer (Press release, Fulgent Genetics, DEC 6, 2021, View Source [SID1234596511]). HelioLiver can detect HCC at its earliest stages when lesions are still very small, an area where traditional standard-of-care imaging tools often fall short, with the potential to enable more curative treatment options known to increase five-year survival rates by up to 13 times compared to when cancer has metastasized.1,2

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Recent data presented at The Liver Meeting 2021 outlined HelioLiver’s superior sensitivity over currently available blood-based tests. With a specificity of 91%, HelioLiver demonstrated 76% sensitivity in detecting early-stage HCC, significantly outperforming other detection tools such as AFP (57%), GALAD (65%), and ultrasound (47%).3,4

"We are excited to offer patients at high risk of developing liver cancer a convenient and sensitive serial testing option to catch cancer early when it counts the most," said Justin Chen Li, U.S. Chief Executive Officer, Helio Health. "We are proud to partner with Fulgent to launch this innovative, simple, and reliable test that has the potential to redefine the future of cancer testing and foster better patient outcomes."

HelioLiver offers a simplified process for patients with a blood draw that can be conducted during a routine check-up, providing a quick and accurate way to receive regular surveillance for people at risk of developing liver cancer. While the American Association for the Study of Liver Diseases (AASLD) guidelines recommend ultrasound screening every six months for patients who are at risk, studies have shown that as few as 20% of patients actually receive regular surveillance due to the inconvenience of accessing testing via ultrasound.5 Helio believes this number can dramatically increase with this new, blood-based test.

"Through our partnership with Helio, our joint priority is to bring HelioLiver to providers and patients in a seamless manner," said Brandon Perthuis, Chief Commercial Officer, Fulgent Genetics. "Leveraging our extensive commercial infrastructure, we are well-positioned to deliver an easy ordering experience for providers with our representatives at the ready to provide the best-in-class white glove service throughout the entire experience."

Providers can place orders online at HelioLiver.com/how-to-order, via phone (+1 626-350-0537) or email at [email protected] to get connected with a representative.

For more information about HelioLiver and its clinical performance, please visit www.HelioLiver.com.