On October 31, 2023 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported that it has entered into an exclusive agreement to license certain intellectual property (IP) from Georgetown University to advance Shuttle Pharma’s predictive biomarker program for prostate cancer (Press release, Shuttle Pharmaceuticals, OCT 31, 2023, View Source [SID1234636587]).

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The intellectual property was originally developed through a collaboration of Shuttle Pharma scientists with investigators from Georgetown University. The intellectual property consists of patent applications prepared and filed by Georgetown University titled: "Predictive Biomarkers for Adverse Effects of Radiation Therapy."

Shuttle Pharma’s predictive marker strategy is to develop a predictive diagnostic test for prostate cancer patients who are considering elective radiation therapy which will allow them to assess their risk for treatment success or failure, while informing therapeutic decision making and follow-up management. Shuttle Pharma believes a predictive diagnostic test for the effects of radiation therapy would be a cost-effective approach to inform clinicians in their treatment choices and provide patients with a better understanding of the benefits and risks of radiation therapy.

Anatoly Dritschilo, M.D., CEO of Shuttle Pharma, commented, "Prostate cancers vary in their aggressiveness and in their responses to treatment. Some prostate cancers spread quickly to other parts of the body, while others grow slowly and can be effectively managed by radiation therapy or other conservative medical measures. While diagnostic tests are available, presently there are no predictive diagnostics tests to identify potential outcomes of available therapies. The key unmet need of the diagnostic market is having a predictive, minimally invasive blood test that provides the clinician and patient with a measurement of the potential success of radiation therapy for their cancer treatment. This unmet need in the market is what Shuttle’s predictive biomarker program looks to address."

The American Cancer Society estimates that 1 in 8 men will be diagnosed with prostate cancer during his lifetime. The National Cancer Institute of the National Institutes of Health (NIH) Surveillance, Epidemiology, and End Results (SEER) database estimated that approximately 268,000 men were diagnosed with prostate cancer in the U.S. in 2022 and approximately 30% of prostate cancer patients (~66,000) with localized disease received radiation therapy for cancer treatment.

Dr. Dritschilo expanded, "Our mission is to accelerate investigation of the prostate cancer metabolite-based predictive assay to improve outcomes of radiation therapy. Shuttle Pharma aims to change the way that clinicians select patients for radiation therapy and provide informed consent. The potential market for these predictive assays includes clinicians offering radiation therapy for prostate cancer treatment in the initial selection process and in personalizing follow up management of patients by considering anticipated late effects."

Shuttle Pharma scientists have collaborated with investigators from Georgetown University to complete Phase I and Phase II NIH SBIR contracts to develop predictive biomarkers of radiation therapy outcomes and late effects. Shuttle Pharma will also seek to leverage eligibility to apply for project bridge funding via an NIH Phase IIb SBIR mechanism.

On October 31, 2023 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported that a poster highlighting data from pre-planned biomarker analyses in second line Non-Small Cell Lung Cancer (NSCLC) patients treated with bemcentinib, a highly selective AXL inhibitor in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) will be presented at the Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) meeting being held on November 1-5, 2023 in San Diego, California (Press release, BerGenBio, OCT 31, 2023, View Source [SID1234636586]).

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The poster abstract was published today in the Journal for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (JITC), an open-access journal. The full poster will be available on BerGenBio’s website shortly following presentation on November 4th.

Poster Details

Title: Bemcentinib + Pembrolizumab show promising efficacy in metastatic NSCLC patients harboring mutations associated with poor prognosis: exploratory sub-analysis from the BGBC008 trial

Poster Board Number: 598

Presentation Time: Saturday, Nov. 4, 2023 beginning at 0900 Pacific Time

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

On October 31, 2023 Curocell, South Korea based CAR-T specialized company (CEO: Gunsoo Kim), reported that it has completed Phase 2 clinical trial for its next-generation CD19 CAR-T therapy "Anbal-cel" that targets relapsed or refractory DLBCL (Diffuse Large B-cell Lymphoma) (Press release, Curocell, OCT 31, 2023, View Source [SID1234636585]).

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This announcement is a significant milestone and is paving the way towards the launch and approval of Korea’s first CAR-T therapy. It has also provied typo new hope for the treatment of patients with DLBCL, an aggressive form of cancer that is growing in prevalence within Korea.

The Phase 2 clinical trial evaluated the safety, efficacy and tolerability of "Anbal-cel" in patients with relapsed or refractory DLBCL. It was conducted over a period of 20 months starting in February 2022, enrolling a total of 80 patients from six hospitals across Korea, including Samsung Medical Center, Asan Medical Center, Seoul National University Hospital, National Cancer Center, Chonnma typo National University Hospital, and Pusan National University Hospital.

"Anbal-cel" is a next-generation CAR-T therapy based on Curocell’s OVIS technology that significantly inhibits the expression of PD-1 and TIGIT, two types of immune checkpoint receptors, which are known to inhibit anti-tumor function/activity of CAR-T cells. This technology has substantially improved the therapeutic performance of CAR-T therapy in patients with relapsed or refractory DLBCL with a poor prognosis.

Curocell made international headlines during the company’s oral presentation of its Phase 2 clinical trial interim results at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland back in June. The interim results analyzed the efficacy and safety of its CAR-T treatment in 41 patients participating in the Phase 2 trial. The complete response rate (CRR: Rate at which the cancer enters into full remission) observed in the interim results was 71%, showing an improved therpeutic effect compared to the 40 to 50% CRR range for three FDA-approved CAR-T therapies currently on the market.

Curocell plans to officially announce the final results of its Phase 2 clinical trial for "Anbal-cel" in the first half of next year and submit an BLA application to Korea’s Ministry of Food and Drug Safety for approval next September. Starting from the expected year of approval in 2025, the company is planning to launch the supply of commercial products from Korea’s only large-scale GMP facility dedicated to the production of CAR-T boasting state-of-the-art equipment.

CEO of Curocell, Gunsoo Kim said that, "I am extremely proud that we were able to complete Korea’s first clinical Trial or study for CAR-T therapy in such a short period of time, which I believe is one of the most remarkable achievement in the history of drug development in Korea." He added, "We will make every effort to obtain approval for Anbal-cel in 2025 and ensure sustained growth for the company through future expansion in our overseas business."

The clinical trial for "Anbal-cel" was officially selected by the Korea Drug Development Fund (KDDF) in 2021 as the target of a government grant. It was conducted with the support of the National New Drug Development Project Team, funded by the Ministry of Science, ICT, and Future Planning, the Ministry of Trade, Industry and Energy, and the Ministry of Health and Welfare. (Project Number: HN21C0653)

On October 31, 2023 PacBio (NASDAQ: PACB) reported financial results for the quarter ended September 30, 2023 (Press release, Pacific Biotech, OCT 31, 2023, View Source [SID1234636584]).

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Third quarter results

Revenue of $55.7 million, a 72% increase compared with $32.3 million in the prior-year period.
Instrument revenue of $34.7 million compared with $11.4 million in the prior-year period. Instrument revenue in the third quarter of 2023 included revenue recognized from 52 RevioTM sequencing systems.
Consumables revenue of $16.9 million compared with $16.1 million in the prior-year period.
Service and other revenue of $4.1 million compared with $4.8 million in the prior-year period.
Gross profit for the third quarter of 2023 was $17.9 million, representing a 32% increase compared with $13.5 million for the third quarter of 2022 and a gross margin of 32% in the third quarter of 2023 compared to 42% for the third quarter of 2022. Non-GAAP gross profit for the third quarter of 2023 was $18.1 million and represented a non-GAAP gross margin of 32% in the third quarter of 2023, compared to a non-GAAP gross profit of $13.7 million in the third quarter of 2022, which represented a non-GAAP gross margin of 42% (see accompanying tables for reconciliations of GAAP and non-GAAP measures).

Operating expenses totaled $100.4 million for the third quarter of 2023, compared to $88.2 million for the third quarter of 2022. Non-GAAP operating expenses totaled $90.9 million for the third quarter of 2023, compared to $83.8 million for the third quarter of 2022. Operating expenses for the third quarter of 2023 and the third quarter of 2022 included non-cash share-based compensation of $18.6 million and $18.0 million, respectively.

Net loss for the third quarter of 2023 was $66.9 million, compared to a net loss of $77.0 million for the third quarter of 2022. Non-GAAP net loss was $67.9 million for the third quarter of 2023, compared to $72.5 million for the third quarter of 2022.

Net loss per share for the third quarter of 2023 was $0.26 compared to net loss per share of $0.34 for the third quarter of 2022. Non-GAAP net loss per share for the third quarter of 2023 was $0.27 compared to $0.32 for the third quarter of 2022.

Cash, cash equivalents, and investments, excluding short- and long-term restricted cash, at September 30, 2023, totaled $767.8 million, compared to $772.3 million at December 31, 2022.

Updates since PacBio’s last earnings release

Launched PacBio WGS Variant Pipeline, a standardized computational method consolidating over ten separate secondary and tertiary analysis tools into a single user-friendly workflow, further enabling users with all levels of bioinformatics experience to access HiFi whole genome sequencing (WGS).
Collaborated with automation providers Hamilton, Integra, Revvity, and Tecan to create fully automated sample preparation protocols for Revio and Sequel II/IIe systems.
Collaborated with GeneDx and the University of Washington to study the potential capabilities of HiFi long-read WGS to increase diagnostic rates in pediatric patients with genetic conditions.
Announced PacBio Capital, a program that allows customers greater flexibility and a streamlined process for leasing PacBio sequencing systems.
Appointed David Meline, former CFO of Moderna Inc., Amgen Inc., and 3M Company, to PacBio’s Board of Directors.
"PacBio had another successful quarter as we continued to drive Revio adoption and exceeded $50 million in quarterly revenue for the first time in company history," said Christian Henry, President and Chief Executive Officer. "We also had record consumable revenue in the quarter, with Revio consumables exceeding Sequel II/IIe consumables, underscoring our customers’ enthusiasm and ability to ramp up sequencing volumes on the new platform. Additionally, we shipped the first Onso systems, and I’m encouraged by the initial customer reception of the platform and the Sequencing by Binding chemistry."

Quarterly Conference Call Information

Management will host a quarterly conference call to discuss its third quarter ended September 30, 2023, results today at 4:30 p.m. Eastern Time. Investors may listen to the call by dialing 1-888-349-0136, if outside the U.S., by dialing 1-412-317-0459, requesting to join the "PacBio Q3 Earnings Call". The call will be webcast live and available for replay at PacBio’s website at View Source

On October 31, 2023 HDT Bio Corp., a clinical-stage private company developing advanced RNA products to treat and prevent infectious diseases and cancer, reported that Dr. Steven Reed, Chief Executive Officer of HDT Bio, will present at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2023 Annual Meeting in San Diego, California, on November 3 (Press release, HDT Bio, OCT 31, 2023, View Source [SID1234636583]). Dr. Reed will deliver a presentation on the AMPLIFY vaccine platform as a novel technology for cancer immunoprevention.

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HDT’s AMPLIFY vaccine platform is based on its self-amplifying RNA (repRNA) combined with LION, its patented nanoparticle-based formulation technology. LION not only stabilizes, protects, and transports RNA during formulation and administration, but also enhances safety. This approach, compared to current RNA vaccines, allows for simplified manufacturing processes, improved temperature stability, and heightened safety, thereby enabling multivalency for more effective and efficient vaccine products.

"Cancer is a formidable adversary. Our presence at the SITC (Free SITC Whitepaper) 2023 Annual Meeting underscores our commitment to advancing the field of immunoprevention," said Dr. Steven Reed, CEO of HDT Bio. "With the AMPLIFY vaccine platform and products derived thereof, we are committed to transforming the landscape of cancer care, marking a monumental leap towards a future where cancer is no longer a looming threat but a preventable condition."

Details of the presentation are as follows:

Title: Novel Technologies for Cancer Immunoprevention
Presenter: Steven Reed, Ph.D.
Category: Immunoprevention of Cancer
Session: Concurrent Session 106c
Date: Friday, November 3 at 2:15 p.m. Pacific Time
Location: Ground Level, Exhibit Hall D, San Diego Convention Center