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.

On May 16, 2024 Novartis BidCo AG, an (indirect) wholly owned subsidiary of Novartis AG, reported the result of its voluntary public takeover offer (the "Offer") for the shares of MorphoSys AG ("MorphoSys"), including all shares represented by MorphoSys American Depositary Shares ("ADS") (Press release, Novartis, MAY 16, 2024, View Source [SID1234643399]). As of the expiry of the acceptance period at 24:00 hours CEST on 13 May 2024, the Offer has been accepted by approximately 79.6 percent of the total share capital of MorphoSys, including purchases by Novartis BidCo AG outside the Offer for approximately 11.6 percent of the share capital. All conditions of the Offer, including the minimum acceptance threshold of 65%, were fulfilled by the end of the acceptance period. The settlement of the shares tendered during the initial acceptance period is scheduled for 23 May 2024.

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The statutory two-week additional acceptance period for the Offer will commence on 17 May 2024 and end on 30 May 2024 at 24:00 hours CEST and 18:00 hours EDT (also on 30 May 2024). During this time, shareholders who have not tendered their MorphoSys shares, including shares represented by MorphoSys ADS, can still accept the Offer.
With all offer conditions fulfilled, Novartis can now begin the necessary steps to progress the integration of MorphoSys, including full access to pelabresib (CPI-0610), a novel BET inhibitor in combination with ruxolitinib for patients with myelofibrosis. The integration also allows full access to tulmimetostat (CPI-0209), an early-stage investigational dual inhibitor of EZH1 and EZH2 currently being tested in patients with solid tumors or lymphomas, as well as a broad portfolio of partnered assets, some of which are in partnership with Novartis, including ianalumab (VAY736). In the context of the integration Novartis continues to progress the workstreams for implementation of both a delisting of MorphoSys and a domination and profit and loss transfer agreement with MorphoSys.

Georgeson is acting as information agent for Novartis for the Offer. Deutsche Bank is acting as share tender agent and The Bank of New York Mellon is acting as ADS tender agent for the Offer.

The offer document for the Offer and additional information are available at www.novartis.com/investors/morphosys-acquisition. A takeover offer hotline for retail shareholders is available between 9:00-18:00 hours CEST from Monday through Friday at +49 89 38038187 (for German callers) and +44 203 005 6716 (for international callers). A takeover offer hotline for ADS holders is available between 9:00-23:00 hours EDT from Monday through Friday and 12:00-18:00 hours EDT on Saturdays at +1 (866) 356-7344 (for U.S. callers) and +1 (781) 236-4704 (for callers outside the U.S.).

Additional Information and Where to Find it
This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of MorphoSys. The final terms and further provisions regarding the Offer are available in the offer document published by Novartis BidCo AG (formerly known as Novartis data42 AG) (the "Bidder"). The offer document has been approved by the BaFin and has been filed with the U.S. Securities and Exchange Commission (the "SEC"). The solicitation and offer to buy shares of MorphoSys is only being made pursuant the offer document. In connection with the Offer, the Bidder and Novartis AG have filed Tender Offer Statement on Schedule TO with the SEC (together with the offer document, an Offer to Purchase including the means to tender and other related documents, the "Offer Documents"), the management board and supervisory board of MorphoSys have issued a joint reasoned statement in accordance with sec. 27 of the German Securities Acquisition and Takeover Act and MorphoSys has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC (together with the joint reasoned statement, the "Recommendation Statements"). THE MORPHOSYS SHAREHOLDERS AND OTHER INVESTORS ARE URGED TO READ THE OFFER DOCUMENTS AND THE RECOMMENDATION STATEMENTS BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY BEFORE ANY DECISION IS MADE WITH RESPECT TO THE OFFER. The Offer Documents and the Recommendation Statements will be distributed to all stockholders of MorphoSys in accordance with German and U.S. securities laws. The Tender Offer Statement on Schedule TO and the Solicitation/Recommendation Statement on Schedule 14D-9 are available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting the Bidder or MorphoSys. Free copies of these materials and certain other offering documents are available on the Bidder’s website at www.novartis.com/investors/morphosys-acquisition or by contacting the Bidder’s investor relations department at +41 61 324 7944.

In addition to the Offer to Purchase, including the means to tender and certain other Offer Documents, as well as the Solicitation/Recommendation Statement, MorphoSys and the Bidder will file other information with the SEC. Filings by Novartis AG and the Bidder with the SEC are also available for free to the public from commercial document-retrieval services and at the website maintained by the SEC at www.sec.gov.

In order to reconcile certain areas where German law and U.S. law conflict, Novartis AG and the Bidder have requested and received no-action and exemptive relief from the SEC to conduct the Offer in the manner described in the offer document.

Acceptance of the Offer by stockholders residing outside Germany and the U.S. may be subject to further legal requirements. With respect to the acceptance of the Offer outside Germany and the U.S., no responsibility is assumed for the compliance with such legal requirements applicable in the respective jurisdiction.

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 NuCana plc (NASDAQ: NCNA) reported financial results for the first quarter ended March 31, 2024 and provided an update on its broad clinical development program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAY 16, 2024, View Source [SID1234643400]).

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As of March 31, 2024, NuCana had cash and cash equivalents of £12.9 million compared to £17.2 million at December 31, 2023. NuCana continues to advance its numerous clinical programs and reported a net loss of £6.8 million for the quarter ended March 31, 2024, as compared to a net loss of £7.9 million for the quarter ended March 31, 2023. Basic and diluted loss per share was £0.13 for the quarter ended March 31, 2024, as compared to £0.15 per share for the comparable quarter ended March 31, 2023.

"Our focus remains on advancing our innovative ProTide pipeline to develop more efficacious and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "NUC-3373, a transformation of 5-FU, is currently being investigated in three ongoing clinical studies. Our randomized Phase 2 study (NuTide:323) is now fully enrolled with 182 patients, and compares NUC-3373 in combination with irinotecan, leucovorin and bevacizumab (NUFIRI + bev) with the standard of care, 5-FU in combination with irinotecan, leucovorin and bevacizumab (FOLFIRI + bev) for the second-line treatment of patients with metastatic colorectal cancer. We look forward to announcing initial data from this study in 2024. We also plan to announce additional data from our ongoing Phase 1/2 study (NuTide:302) of NUFIRI + bev and NUFOX + bev in patients with metastatic colorectal cancer this year. Our Phase 1b/2 study (NuTide:303) of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer also remains on track with data readouts expected in 2024."

Mr. Griffith continued: "Moving to NUC-7738, we recently presented exciting data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These data highlighted NUC-7738’s ability to disrupt RNA polyadenylation, leading to profound alterations in the tumor biology of the patients’ cancers. We believe that this finding provides a rationale as to why NUC-7738 plus pembrolizumab has achieved encouraging anti-cancer activity in several patients who were resistant to PD-1 inhibitors. We are evaluating NUC-7738 in an ongoing Phase 1/2 study (NuTide:701) as a monotherapy in patients with advanced solid tumors and in combination with pembrolizumab in PD-1 inhibitor-resistant patients with melanoma. We plan to announce additional data from this study in 2024."

Mr. Griffith concluded, "We look forward to providing updates from all of our ongoing clinical studies this year as we continue working towards our mission of improving treatment outcomes for patients with cancer."

2024 Anticipated Milestones

NUC-3373 (a ProTide transformation of 5-FU)

In 2024, NuCana expects to:

Announce data from the randomized Phase 2 (NuTide:323) study of NUFIRI + bev compared to the standard of care FOLFIRI + bev for the second-line treatment of patients with metastatic colorectal cancer;
Announce data from the Phase 1b/2 (NuTide:302) study of NUFIRI + bev and NUFOX + bev for the second-line treatment of patients with metastatic colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with pembrolizumab in patients with solid tumors and in combination with docetaxel in patients with lung cancer.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2024, NuCana expects to:

Announce data from the Phase 2 part of the Phase 1/2 study (NuTide:701) of NUC-7738 in combination with pembrolizumab in patients with melanoma.

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."