On August 14, 2023 Bio-Techne (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities, reported that the company will end their collaboration with Akoya Biosciences to co-develop an automated RNAscope workflow for use with the PhenoCycler-Fusion System (Press release, Bio-Techne, AUG 14, 2023, View Source [SID1234634372]). The decision was made following best efforts to achieve the intended program goals.

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"Bio-Techne remains focused on providing the greatest value to the spatial biology community," said Kim Kelderman, President of Bio-Techne’s Diagnostics and Genomics Segment. "We are actively expanding the capabilities of our gold-standard RNAscope technology to enable greater utility in multiomic spatial applications and plan to accelerate the development and commercialization of the first fully automated and scalable spatial multiomics workflow on the Lunaphore COMET system."

Bio-Techne will continue to support its customers utilizing RNAscope assays in conjunction with Opal reagents and PhenoImager HT systems purchased from Akoya.

On August 14, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy company, reported financial results and recent highlights for the second quarter ended June 30, 2023 (Press release, 2seventy bio, AUG 14, 2023, View Sourcenews-releases/news-release-details/2seventy-bio-reports-second-quarter-financial-results-and-0" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-reports-second-quarter-financial-results-and-0" rel="nofollow">View Source [SID1234634371]).

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"We launched 2seventy in late 2021 with the stated mission of delivering more time for people living with cancer through the transformative power of cell therapy," said Nick Leschly, chief kairos officer. Since the creation of 2seventy, our mission has always been dual-pronged: to deliver on the commercial potential of Abecma and to leverage our translational engine to develop an innovative cell therapy pipeline. Over the course of this year, we continue to make progress against this goal. We have successfully delivered Abecma to an extensive and growing number of patients in need of new treatment options. While the competitive intensity has increased and will have an impact on revenue in the 2nd half of 2023, we believe in the long-term commercial potential of this important therapy, particularly as we move toward earlier lines. On the development side, in June, we paused our PLAT-08 study in AML due to a Grade 5 safety event and this has since been followed by a clinical hold by FDA. We’ve collaborated with Seattle Children’s to conduct a root-cause analysis and developed amendments to the protocol. Seattle Children’s will review these amendments with FDA with the goal of resuming the study as soon as possible."

SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS

Second quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $115 million. Based on BMS reporting an expected decline in Abecma sales in the third quarter, the Company believes Abecma will achieve the lower end of U.S. revenue guidance of $470-570 million.
2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the U.S. 2seventy bio reported collaborative arrangement revenue of $24.5 million and $47.5 million for the three months and six months ended June 30, 2023, respectively.
2seventy bio believes Abecma has potential peak U.S. revenues of $2 to 3 billion.
The Company ended the second quarter of 2023 with cash, cash equivalents and marketable securities of $307 million. 2seventy bio believes that this cash position, combined with growing Abecma cashflow and disciplined expense management, provides financial runway into 2026.
"With the revenue from our Abecma collaboration and careful expense management, we significantly reduced our net loss to $42.1 million in the second quarter from $77.4 million for the same period last year," said Chip Baird, chief financial officer. "We are committed to advancing toward breakeven operations for the business while prudently investing in innovation."

ABECMA CLINICAL, REGULATORY, AND MANUFACTURING UPDATE

2seventy bio, in collaboration with BMS, continues to build on established manufacturing capacity of Abecma with an additional ramp-up planned for later this year.
The collaboration remains on track for introduction of suspension-based lentiviral vector (sLVV) in 1st half 2024.
Manufacturing performance metrics remain strong, with greater than 90% in spec rates and an average turnaround time of ~29 days.
The planned maintenance shutdown of the S12 drug product manufacturing plant was successfully completed in June and the facility is fully operational.
In addition to increasing manufacturing capacity, commercial efforts are underway to expand the U.S. treatment center footprint.
We continue to anticipate the December 16 PDUFA goal date for potential label expansion based on the KarMMa-3 data.
The Company, with BMS, is planning to initiate the KarMMa-9 study in patients with newly diagnosed multiple myeloma later this year.
UPDATE ON PLAT-08 CLINICAL STUDY OF SC-DARIC-33 IN ACUTE MYELOID LEUKEMIA (AML)

In June, the Company announced that because of a fatal (Grade 5) serious adverse event (SAE) in a patient enrolled in the Phase 1 trial of the PLAT-08 study of SC-DARIC33 in AML, the study met protocol-defined pausing rules, pending review of the event by the appropriate regulatory and monitoring boards. On Friday, August 11, 2023, the U.S. Food and Drug Administration (FDA) formally placed the study on clinical hold via email communication. Since the study pause in June, 2seventy bio and Seattle Children’s have been conducting an internal investigation and root cause analysis of the SAE. This investigation provided insights into the potential pathobiology of this toxicity which led to several study protocol changes, which the team believes may mitigate this toxicity and allow for the continuation of the PLAT-08 study. 2seventy bio and Seattle Children’s will continue to work with FDA to provide the root cause analysis and proposed changes for the clinical study. Based on upcoming discussions with FDA, 2seventy bio and Seattle Children’s plan to amend the study accordingly and resume this study as soon as possible.

RECENT DATA HIGHLIGHTS

Abecma Data at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper): The Company presented four abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and six abstracts at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress. The presentations highlighted clinical and correlative data from the KarMMa-2 and KarMMa-3 clinical trials evaluating Abecma in patients with relapsed and/or refractory multiple myeloma (RRMM) or newly diagnosed multiple myeloma, reinforcing Abecma’s strong clinical profile. Additional data on patient-reported outcomes from the KarMMa-3 trial were also presented. Results showed that patients with triple-class exposed RRMM treated with Abecma demonstrated statistically significant and clinically meaningful improvements in health-related quality of life, including key multiple myeloma symptoms and overall functions compared to standard regimens.
New Preclinical and Clinical Data at ASGCT (Free ASGCT Whitepaper): 2seventy bio presented five abstracts, including one late-breaking oral presentation, at this year’s American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting.
UPCOMING ANTICIPATED PIPELINE MILESTONES

Update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023.
Submission of an Investigational New Drug (IND) application for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron anticipated by end of 2023.
Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023.
SELECT SECOND QUARTER FINANCIAL RESULTS

Total 2seventy bio revenues were $36.0 million for the three months ended June 30, 2023, compared to $13.5 million for the three months ended June 30, 2022. Total revenues were $77.7 million for the six months ended June 30, 2023, compared to $21.9 million for the six months ended June 30, 2022.
Research and development expenses were $60.0 million for the three months ended June 30, 2023, compared to $64.6 million for the three months ended June 30, 2022. Research and development expenses were $128.2 million for the six months ended June 30, 2023, compared to $130.4 million for the six months ended June 30, 2022.
Selling, general and administrative expenses were $19.5 million for the three months ended June 30, 2023, compared to $17.3 million for the three months ended June 30, 2022. Selling, general and administrative expenses were $40.2 million for the six months ended June 30, 2023, compared to $41.1 million for the six months ended June 30, 2022.
Net loss was $42.1 million for the three months ended June 30, 2023, compared to $77.4 million for the three months ended June 30, 2022. Net loss was $89.1 million for the six months ended June 30, 2023, compared to $163.1 million for the six months ended June 30, 2022.
Conference Call Information

2seventy bio will host a conference call and live webcast today, August 14, at 8:00 a.m. ET to discuss 2Q 2023 financial results and recent business highlights. To join the live conference call, please register at: https://register.vevent.com/register/BIa4096e5acd24407e8d1e2a5e32ba2e14. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source A replay of the webcast may be accessed from the "News and Events" page in the Investors and Media section of the Company’s website at View Source and will be available for 30 days following the event.

On August 14, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase or Company), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease ("PD"), Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported financial results for the second quarter ended June 30, 2023 and highlighted recent developments (Press release, Inhibikase Therapeutics, AUG 14, 2023, View Source [SID1234634370]).

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"We have made significant clinical progress in the first half of 2023," said Dr. Milton H. Werner, President and Chief Executive Officer of Inhibikase. "Our Phase 2 ‘201’ trial of IkT-148009 for the treatment for Parkinson’s disease is progressing, with screening ongoing at 22 sites and up to 32 sites expected to be open and screening by close of the third quarter. Patients are enrolling and the first patient has completed 12 weeks dosing as of the date of this release. Our newly launched patient portal provides a central hub for patient engagement with our clinical sites, allows patients to test their suitability for participation in the study and acts as a launching point for engagement with community neurologists, caregivers and support groups. The ‘501’ trial evaluating IkT-001Pro, our imatinib prodrug, has also reached important milestones, including the completion of the pivotal trial phase to confirm the bioequivalent dose. Following discussions with the FDA, we are considering the addition of a high dose bioequivalence cohort between IkT-001Pro and 600 mg imatinib to further substantiate the safety benefit of imatinib delivered as prodrug. As we look ahead, our focus remains on execution in our clinical programs, and we expect to provide additional updates as enrollment progresses in our ‘201’ trial later this year and a full data description from the ‘501’ trial."

Recent Developments and Upcoming Milestones:

The Phase 2 ‘201’ clinical trial of IkT-148009 is screening and enrolling patients: 22 of 35 planned clinical sites are screening and enrolling patients, with the first patient having completed the 12 week dosing regimen. Up to 32 clinical sites are anticipated to be open for enrollment and screening patients by close of the third quarter. Additionally, the Company has launched a medical and patient awareness campaign to advance the pace of enrollment in the trial as well as provide patients with a central hub to learn about the trial through www.the201trial.com.
Completed bioequivalence phase of the ‘501’ trial of IkT-001Pro: In June 2023, Inhibikase completed the pivotal phase of the ‘501’ trial and selected a bioequivalent dose of IkT-001Pro. The Company expects to report data in the near term. With agreement on trial design finalized with the FDA, Inhibikase is considering to expand the 501 trial to evaluate the potential safety benefit of high dose imatinib delivered by IkT-001Pro in the third quarter.
Advancing preclinical development of IkT-148009 in MSA: Two models have been evaluated, one that measures the ability of IkT-148009 to block progression early in the course of disease, and a second that evaluates the ability to correct functional loss and neurodegeneration late in the course of disease. The Company has nearly completed the evaluation of the first model, which showed that IkT-148009 dosed once daily for 20 weeks blocked functional loss and preserved neural anatomy when IkT-148009 administration occurred early in the course of disease. Prevention of functional loss in this model was accompanied by significant reduction of the underlying alpha-synuclein pathology. Outcomes from the study of IkT-148009 when treatment begins late in the course of disease is expected to be completed by the end of 2023.
Regained Compliance with Nasdaq Listing Requirements: In June 2023, the Company effected a 1-for-6 reverse stock split of its common stock. The reverse split was approved by Inhibikase shareholders and came into effect on June 30, 2023. The reverse stock split and subsequent trading performance resulted in restoration of full compliance with the minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2); the Company is in compliance with all other applicable listing standards.
Second Quarter Financial Results

Net Loss: Net loss for the quarter ended June 30, 2023 was $5.8 million, or $1.11 per share, compared to a net loss of $4.6 million, or $1.10 per share in the quarter ended June 30, 2022.

R&D Expenses: Research and development expenses were $4.5 million for the quarter ended June 30, 2023 compared to $3.0 million in the quarter ended June 30 2022. The increase was primarily due to the Company’s ongoing Phase 2 ‘201’ PD clinical trial costs.

SG&A Expenses: Selling, general and administrative expenses for the quarter ended June 30, 2023 were $1.8 million compared to $1.7 million for the quarter ended June 30, 2022. The increase was driven by a net increase in normal selling, general and administrative expenses.

Cash Position: Cash and cash equivalents and marketable securities were $20.9 million as of June 30, 2023. The Company expects that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024.

Conference Call Information

The conference call can be accessed by dialing 1-833-816-1414 (United States) or 1-412-317-0506 (International) with the conference code 7774190. A live webcast may be accessed using the link here, or by visiting the investors section of the Company’s website at www.inhibikase.com. After the live webcast, the event will be archived on Inhibikase’s website for approximately 90 days after the call.

On August 14, 2023 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), reported financial results for the second quarter ended June 30, 2023 (Press release, Alaunos Therapeutics, AUG 14, 2023, View Source [SID1234634369]). The Company also announced a strategic reprioritization to focus on its hunTR TCR discovery platform, wind down its TCR-T Phase 1/2 Library trial and explore broad strategic alternatives for the Company. Alaunos is implementing a cost-savings plan that includes a reduction in workforce by approximately 60%.

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"Over the past two years, we have advanced the medical field’s understanding of TCR-T cell therapies using our innovative Sleeping Beauty technology targeting high-frequency driver mutations," said Kevin S. Boyle, Sr., Chief Executive Officer of Alaunos. "We continue to believe that this approach has potential in targeting the heart of cancer growth. However, after a review of the funding needs of our TCR-T Library Phase 1/2 trial and the current financial markets, the Board of Directors has made the difficult decision to limit further drug development under our clinical trial and to focus on our promising hunTR TCR discovery platform as we explore all strategic alternatives."

Operational & Corporate Update

Interim Clinical Data from TCR-T Library Phase 1/2 Trial: Eight patients have been treated in the Company’s TCR-T Library Phase 1/2 trial to date, six of which are evaluable as of today. The trial showed that the Company’s T-cells were generally well-tolerated in all evaluable participants and achieved an 83% disease control rate in evaluable patients with metastatic, refractory solid tumors. Disease control is measured by objective responses and stable disease. Persistence of TCR-T cells in peripheral blood was detected in all evaluable patients at last follow-up.

hunTR TCR Discovery Platform Identifies Proprietary TCRs: Alaunos has discovered multiple proprietary TCRs targeting driver mutations through its hunTR TCR discovery platform. The hunTR platform can rapidly interrogate T-cell responses and has the potential to expand to multiple targets or cancer indications. Using hunTR, the Company has demonstrated the ability to isolate neoantigen specific TCRs from tumor resident T-cells. The presence of these driver mutation specific T-cells in the tumor potentially validates the relevance of the mutated target and safety of the TCR for use in other cancer patients expressing the same neoantigen.

Restructuring Organization and Winding Down TCR-T Library Phase 1/2 Trial: Alaunos has decided to wind down its TCR-T Library Phase 1/2 trial and prioritize the hunTR platform to explore potential partnering opportunities. Concurrently, the Company is exploring strategic alternatives and has engaged Cantor Fitzgerald & Co. to act as a strategic advisor for this process. Strategic options may include but are not limited to, an acquisition, merger, reverse merger, sale of assets, strategic partnerships, capital raises or other transactions. The Company will reduce its workforce by approximately 60% to streamline the organization, while retaining key R&D capabilities for the hunTR platform and to assist in the strategic alternatives review process. Alaunos does not intend to comment further on this process unless or until its Board of Directors has approved a definitive course of action or it is determined that other disclosure is appropriate.

Second Quarter Ended June 30, 2023, Financial Results

Research and Development Expenses: Research and development expenses were $5.2 million for the second quarter of 2023, compared to $5.9 million for the second quarter of 2022, a decrease of approximately 13%. The decrease was primarily due to an accrual adjustment related to one of our de-prioritized clinical programs of $0.7 million.

General and Administrative Expenses: General and administrative expenses were $3.0 million for the second quarter of 2023, compared to $3.4 million for the second quarter of 2022, a decrease of approximately 11%. The decrease was primarily due to lower employee-related expenses of $0.1 million due to our reduced headcount, a $0.1 million decrease in consulting and professional services related to lower legal fees and the reduced use of consultants, and a $0.2 million decrease in insurance fees.

Net Loss: Net loss was $8.8 million, or $(0.04) per share, for the second quarter of 2023, compared to a net loss of $9.9 million, or $(0.05) per share, for the second quarter in 2022.

Cash, Cash Equivalents and Restricted Cash: As of June 30, 2023, Alaunos had approximately $18.3 million in cash balances. The Company expects to have sufficient cash resources to fund operations into the fourth quarter of 2023, after implementing the strategic reprioritization laid out above.

On August 14, 2023 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported positive pre-clinical in vivo data for three immuno-oncology candidates, anti-EGFRvIII, CCR8 and a bispecific TROP-2 x CD3, advancing these programs to clinical candidate selection stage (Press release, iBioPharma, AUG 14, 2023, View Source [SID1234634368]).

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The anti-EGFRvIII antibody was specially engineered to enhance its ability to attack cancer cells and has proven effective in a mouse model for head and neck cancer. In preclinical studies, iBio’s anti-EGFRvIII antibody demonstrated a 43 percent reduction in tumor growth compared to untreated animals. iBio developed the antibody using its patented AI epitope steering technology. This innovative approach allows iBio to target a specific variant of the Epidermal Growth Factor Receptor (EGFR) found in tumors without affecting the normal version of the receptor present in healthy tissue. By focusing solely on the tumor-specific variant, iBio aims to reduce potential side effects.

In addition to the anti-EGFR program, iBio’s CCR8 antibody has proven effective in a mouse model for colon cancer. Preclinical studies show the anti-CCR8 molecule inhibited tumor growth and achieved a 22 percent reduction in tumor size compared to its pre-treatment dimensions. Using its patented AI epitope steering platform, iBio specifically engineered the anti-CCR8 molecule to enhance its ability to attack cancer cells without affecting its close relative, CCR4, even though their binding regions are highly similar. This selective targeting demonstrates the power of iBio’s epitope steering platform and is believed to minimize potential side effects.

In a recent study involving a humanized mouse model of squamous cell carcinoma, iBio’s TROP-2 x CD3 bi-specific antibody demonstrated a significant 36 percent reduction in tumor size within just 14 days after tumor implantation, and after only a single dose. iBio’s TROP-2 x CD3 was engineered using its proprietary EngageTx T-cell engager antibody platform, which represents a cutting-edge approach to developing next-generation bispecific antibodies for immuno-oncology applications. TROP-2 x CD3 is a bispecific antibody targeting an overexpressed cell surface protein in multiple solid tumors, including breast, lung, colorectal, and pancreatic cancers. iBio is currently exploring whether the molecule also shows efficacy in other solid tumors.

Dillon Phan, PhD, iBio’s VP and Head of Early R&D, commented, "The swift and concurrent achievement of in vivo proof-of-concept for three of our pre-clinical programs showcases the power of our AI-enabled technology and the relentless dedication and focus of our drug discovery team. The development of bispecific antibodies, such as TROP-2 x CD3, is particularly challenging, so we are especially pleased with the recent addition of the T-cell engager platform, EngageTx, to our tech stack, which has enabled the discovery and advancement of this candidate so quickly. We are excited about the potential to further develop and initiate IND-enabling studies for all three molecules to support the continued advancement of iBio’s therapeutic pre-clinical pipeline."