On May 16, 2024 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that members of the Company’s senior management team will participate in the following investor conferences in May and June 2024 (Press release, Zai Laboratory, MAY 16, 2024, View Source [SID1234643419]):

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J.P. Morgan 20th Annual Global China Summit
Panel Discussion: Thursday, May 23, 2024, 10:00 a.m. HKT
Location: Shanghai, China

Jefferies Global Healthcare Conference
Fireside Chat: Wednesday, June 5, 2024, 3:30 p.m. ET in Track 2
Location: New York, New York

Goldman Sachs 45th Annual Global Healthcare Conference
Presentation: Wednesday, June 12, 2024, 1:20 p.m. ET
Location: Miami Beach, Florida

On May 16, 2024 Nutcracker Therapeutics, Inc., a biotechnology company dedicated to developing transformative RNA therapies through its proprietary technology platform, reported it will introduce its new preclinical drug candidate, NTX-472, at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held in Chicago from May 31 to June 4 (Press release, Nutcracker Therapeutics, MAY 16, 2024, View Source [SID1234643418]).

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NTX-472 uses engineered mRNA-encoded proteins to simultaneously engage CD20, CD19, and CD47. Nutcracker Therapeutics is currently developing the candidate for the treatment of B cell lymphoma.

Additionally, Dr. Nicole Fay, director of pharmacology and product lead for NTX-250 (the company’s lead candidate), will be presenting and participating in a panel discussion at the 10th Sachs Oncology Innovation Forum (OIF) on May 31, which runs concurrently with the ASCO (Free ASCO Whitepaper) annual meeting.

Poster Presentation at ASCO (Free ASCO Whitepaper) 2024

Title: Development of NTX-472, a formulated mRNA therapy targeting CD20, CD19, and CD47, for treatment of B-cell lymphoma
Abstract Number: 2537
Session Title: Developmental Therapeutics — Immunotherapy
Session Location: Hall A
Session Date and Time: June 1, 9:00 a.m. – 12:00 p.m. CDT

Lead Author: Adrienne Sallets

Abstract titles are available on the ASCO (Free ASCO Whitepaper) conference website. More information about the conference can be found on ASCO (Free ASCO Whitepaper)’s website.

Sachs OIF Activities

Location:
Waldorf Astoria Chicago Hotel
11 E Walton St, Chicago, IL 60611

Panel Discussion: New Methods of Therapeutic Delivery for Oncology
Date and Time: May 31, 2:40 p.m. CDT
Speaker: Nicole Fay

Corporate Presentation
Presentation Track: A, Room Faulkner
Date and Time: May 31, 11:50 a.m. CDT
Speaker: Nicole Fay

More details about the event can be found on the OIF website, along with the full agenda.

On May 16, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that an abstract about its Phase 2 THIO-101 clinical trial named "A phase 2, multicenter, open-label, dose-optimization study evaluating telomere-targeting agent THIO sequenced with cemiplimab in patients with advanced NSCLC: Updated results" was accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting, to take place May 31-June 4, 2024, in Chicago, Illinois (Press release, MAIA Biotechnology, MAY 16, 2024, View Source [SID1234643417]). The poster is scheduled for presentation on June 3, 2024, from 1:30pm to 4:30pm CST.

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"We are proud to accept ASCO (Free ASCO Whitepaper)’s invitation to present at its 2024 Annual Meeting, the most significant gathering of oncology professionals worldwide," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "We look forward to revealing the newest efficacy results from THIO-101 and discussing our pioneering telomere targeting science underlying THIO, the first and only cancer treatment of its kind in clinical development."

MAIA’s abstract will be available online at the ASCO (Free ASCO Whitepaper) Annual Meeting 2024 website during the week prior to the conference start date, and the poster will be published on maiabiotech.com on the day of the presentation, June 3, 2024.

The 2024 ASCO (Free ASCO Whitepaper) Annual Meeting will feature more than 200 sessions and 5,000 posters complementing the theme, "The Art and Science of Cancer Care: From Comfort to Cure."

On May 16, 2024 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported dosing of the first patient in the Phase 1 clinical trial of A2B694 (Press release, A2 Biotherapeutics, MAY 16, 2024, View Source [SID1234643416]). The multi-center Phase 1 dose escalation clinical trial, EVEREST-2 (NCT06051695), will evaluate safety and determine the recommended dose of A2B694 in patients with solid tumors that express mesothelin, including ovarian, mesothelioma, pancreatic, colorectal and non-small cell lung cancer, and have lost HLA-A*02 expression.

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A2B694 is the second autologous cell therapy in clinical development by A2 Bio using its proprietary Tmod platform. The Tmod platform utilizes a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. This dual-receptor design is intended to provide selective killing of tumor tissues that express mesothelin and have lost the HLA-A*02 gene permanently. This novel design is aimed at tackling the fundamental challenge in solid tumor cancer medicines – the ability to selectively kill tumor cells and protect normal cells.

"Dosing our first patient in this trial is a key step to provide a precise, novel CAR T therapy to patients with solid tumors that express mesothelin with no curative treatment options. Sadly, current treatment options for these patients are palliative and limited by toxicity in the recurrent, unresectable, locally advanced or metastatic setting. All of us at A2 Bio would like to thank participating patients, investigators, and clinical care providers," said Dr. William Go, chief medical officer of A2 Bio.

​​In addition to A2B694, A2 Bio continues to advance its clinical development of A2B530 as well as other preclinical programs as the company pursues additional pipeline expansion opportunities using its proprietary Tmod platform.

About EVEREST-2

EVEREST-2 (NCT06051695) is a seamless Phase 1/2 study for A2B694, an autologous logic-gated investigational cell therapy developed from A2 Bio’s proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets mesothelin (MSLN) and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. The study is recruiting patients with lung, colorectal, pancreatic, ovarian and mesothelioma cancers.

About the Tmod Platform

A2 Bio has pioneered a precision-targeting cellular system – the Tmod mechanism – that incorporates two receptors, an activator and a blocker, to aim the powerful armaments of immune cells directly at tumors to unequivocally differentiate tumors from normal tissues. The activator recognizes antigens on tumor cells that trigger their destruction, while the blocker recognizes antigens on normal cells that protect them. This novel blocker technology enables precise, personalized and effective T cell targeting. The blocker component equips Tmod cells with the capacity to identify tumors as distinct from normal cells.

On May 16, 2024 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2024, as well as key recent clinical and corporate developments (Press release, Cel-Sci, MAY 16, 2024, View Source [SID1234643415]).

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Clinical and Corporate Developments include:

In May 2024, CEL-SCI received the go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer based on very strong safety and efficacy data from the completed Phase 3 study which enrolled 928 patients. The survival benefit for the target population treated with Multikine vs standard of care alone was so strong and clear that the confirmatory study only needs to enroll 212 people. The FDA agreed with the pre-surgical selection of patients most likely to benefit from Multikine—those with newly diagnosed advanced primary head and neck cancer with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).

According to statisticians, the Registration Study is highly likely to succeed because it aims to confirm prior findings and to show a 10% absolute survival benefit vs control at 5 years following treatment. In the Phase 3 study, Multikine demonstrated the following in the target population:
28% absolute survival benefit vs control at 5 years
Risk of death cut in half compared to control at 5 years
73% survival for Multikine vs 45% in the control at 5 years
No safety signals or toxicities vs standard of care
More detailed results may be viewed here: LINK
In February 2024, CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed, a significant milestone toward a regulatory approval of Multikine.
In January 2024, the European Medicines Agency’s Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union. The waiver is a significant step forward for Multikine, as it removes a major hurdle on the path towards commercialization in Europe.
CEL-4000, CEL-SCI’s LEAPS vaccine technology, was featured in an article titled "Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines" published in the peer reviewed journal Frontiers in Immunology. The article articulates how CEL-4000 may deliver a safe and effective therapy for rheumatoid arthritis by rebalancing inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may.
"We are eager to commence our FDA Registration Study to confirm the remarkable overall survival benefits Multikine delivered for patients in our target population. The FDA has acknowledged the great unmet need in this patient population. Through the wealth of data produced in our Phase 3 trial, we were able to identify the precise selection criteria for patients and the corresponding diagnostics to identify these patients prior to surgery. This achievement paved the way for us to get FDA agreement to conduct a study on what could become a pre-surgical standard of care in head and neck cancer," stated CEL-SCI CEO, Geert Kersten. "We believe the Registration Study is de-risked, thereby building even more confidence in CEL-SCI and our prospects for Multikine in other solid-tumor cancers."

Financial Results

Research and development expenses decreased by $2.5 million, or 22%, to approximately $9 million during the six months ended March 31, 2024, compared to $11.5 million for the six months ended March 31, 2023. General and administrative expenses in the six months ended March 31, 2024 were $4.6 million compared to $4.4 million in the six months ended March 31, 2023. During the six months ended March 31, 2024, net loss narrowed by $2.2 million or 14% to $14.0 million, approximately $5.3 million of which are non-cash expenses, from $16.4 million in the prior year period. CEL-SCI raised gross proceeds of approximately $7.75 million through a public offering of common stock during the second fiscal quarter.