On October 1, 2024 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company focused on innovative gamma-delta T cell therapies, reported that it has entered into a definitive securities purchase agreement with accredited investors for a private placement that is expected to result in gross proceeds of approximately $12.4 million to IN8bio, before deducting placement agent fees and other offering expenses (Press release, In8bio, OCT 1, 2024, View Source [SID1234646978]). The net proceeds from this financing are expected to fund the Company’s current operating plan into 2026.

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The private placement was led by an existing healthcare-focused institutional investor and included a large mutual fund company and other existing and new institutional investors.

Under the terms of the securities purchase agreement, the Company will sell units comprised of an aggregate of 25,759,595 shares of the Company’s common stock, par value $0.0001 per share, pre-funded warrants to purchase 5,646,853 shares of common stock and warrants to purchase up to 31,406,448 shares of common stock (the "Series C Warrants"). The units will be sold at a purchase price of $0.395 per unit (or $0.3949 per unit with respect to units that include pre-funded warrants in lieu of common stock). The pre-funded warrants will have an exercise price of $0.0001 per share. The Series C Warrants will have an exercise price of $0.27 per share.

IN8bio intends to use the net proceeds from the private placement to fund the clinical development of INB-100 and future product candidates and for working capital and other general corporate purposes. The proceeds will support the continued enrollment of patients in the expansion cohort with a new target total enrollment of approximately 25 patients at the recommended Phase 2 dose. IN8bio expects to complete this additional enrollment in the first half of 2025, with long-term follow-up results anticipated in late 2025 and in 2026. To affirm the improvements in relapse free and overall survival observed to date and to further de-risk a future registrational randomized control trial, IN8bio will also seek to add a parallel control cohort to prospectively assess leukemia patients and enable comparison between patients receiving INB-100 to those who only receive standard haplotransplantation.

The closing of the private placement is subject to customary closing conditions and is expected to occur on or about October 4, 2024.

Newbridge Securities Corporation acted as the sole placement agent for the private placement.

The offer and sale of the foregoing securities is being made in a private placement pursuant to an exemption under the Securities Act of 1933, as amended (the "Securities Act"), and the Securities have not been registered under the Securities Act or applicable state securities laws. The Securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy the Securities, nor shall there be any sale of the Securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On October 1, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported good safety and favorable ongoing efficacy results from the 10-month follow-up visit of the first patient treated in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, OCT 1, 2024, View Source [SID1234646980]). This trial is evaluating Deltacel (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) who have failed to respond to standard therapies.

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In this patient, the tumor size was reduced by approximately 27% compared with the pre-treatment size, and no new sites of disease were identified. As a result, the progression-free survival (PFS) has reached 10 months with no reported adverse events. These results follow an approximate 20% reduction in tumor size detected at eight months post-treatment and an approximate 13% reduction at six months post-treatment. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

"As this patient is the most advanced in our ongoing Deltacel-01 clinical trial, we are particularly encouraged by these latest follow-up results that continue to validate the potential of Deltacel as a safe and effective treatment for patients with later-stage cancers," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "We believe these findings underscore the promise of our allogeneic GDT therapy in providing durable clinical benefit."

"The latest results from this patient are highly promising, particularly given the durable progression-free survival and tumor reduction we observed," said Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Deltacel-01 Principal Investigator at BHCC. "This patient’s response to Gama Delta T-Cell Treatment continues to provide optimism as we evaluate Deltacel’s therapeutic potential. Continued meaningful results could represent a significant breakthrough for these late-stage cancer patients with limited treatment options."

Kiromic expects to report additional follow-up results from the fourth patient enrolled in this study in October.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

On October 1, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported the completion of the acquisition of CN201 from Curon Biopharmaceutical (Curon), a novel investigational clinical-stage bispecific antibody for the treatment of B-cell associated diseases (Press release, Merck & Co, OCT 1, 2024, View Source [SID1234646981]).

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"By actively depleting B-cells, CN201 offers applications spanning both B-cell malignancies and autoimmune diseases. We look forward to building upon the foundational work started by the Curon team," said Dr. Dean Y. Li, president, Merck Research Laboratories.

CN201 is currently being investigated in Phase 1 and Phase 1b/2 clinical trials for the treatment of patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and relapsed or refractory B-cell acute lymphocytic leukemia (ALL), respectively. Preliminary data suggest CN201 has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well tolerated, potentially leading to significant and sustained reductions in B-cell populations.

Transaction details

Under the agreement, Merck, through a subsidiary, has acquired full global rights to CN201. As previously disclosed, the transaction is being accounted for as an asset acquisition. Merck is recording a pre-tax charge of approximately $750 million (reflecting the upfront payment and other related costs), or approximately $0.28 per share, which will be included in third-quarter non-GAAP results and was not included in Merck’s full-year financial outlook issued on July 30. As a matter of policy, Merck provides updates to its financial outlook once each quarter and will provide an update to its full-year financial outlook when it reports third-quarter 2024 results on October 31.

About CN201

CN201 is a novel CD3xCD19-targeting T-cell-engager bispecific antibody, designed to target B cells for elimination by T cells. CN201 is currently being evaluated in Phase 1 and Phase 1b/2 clinical trials for the treatment of relapsed or refractory non-Hodgkin’s lymphoma and relapsed or refractory acute lymphocytic leukemia, respectively.

On October 1, 2024 Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that members from the Replimune management team will present and host investor meetings at the following two conferences (Press release, Replimune, OCT 1, 2024, View Source [SID1234646982]):

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BMO 2024 Oncology Summit
Date: Tuesday, October 8, 2024

3rd Annual Roth Healthcare Opportunities Conference
Date: Wednesday, October 9, 2024

On October 1, 2024 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), alongside its artificial intelligence ("AI") subsidiary InstaDeep Ltd. ("InstaDeep"), reported an overview of its AI approach during an edition of the Company’s Innovation Series, AI Day (Press release, BioNTech, OCT 1, 2024, View Source [SID1234646969]).

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"At BioNTech, we are at the forefront of integrating advanced AI to revolutionize individualized medicine. With our in-house AI specialist, InstaDeep, we are pioneering the use of artificial intelligence to develop personalized vaccines and targeted therapies," said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. "By introducing state-of-the-art technologies such as our BFN generative protein model and incorporating AI capabilities across our immunotherapy pipeline, we are unlocking the full potential of AI to deliver innovative vaccines and cancer treatments to patients worldwide".

"BioNTech and InstaDeep, as a biotechnology powerhouse with a dedicated AI unit, are uniquely positioned at the intersection of biotechnology and AI," said Karim Beguir, CEO and Co-Founder of InstaDeep, a BioNTech company. "Working closely together and combining expertise from AI research, high performance computing, software and biology is accelerating innovation. A key focus of this collaboration is our DeepChain multiomics design platform. DeepChain is now open for external partnerships, after successful application to several projects, including the mRNA-encoded antibody RiboMab platform. We are excited to harness breakthroughs in both AI and biotechnology synergistically.’’

As part of the event, BioNTech will showcase the Company’s approach to AI capability scaling and deployment across BioNTech’s pipeline. These updates will cover the introduction of a new near exascale supercomputer, the launch of a novel BFN generative model, and multiple updates on the deployment of AI across BioNTech’s immunotherapy pipeline.

The live webcast of the event will be available via this link and will begin at 3:00 pm CEST (2:00 pm BST). A replay of the webcast will be available shortly after the event’s conclusion and archived on BioNTech’s website for one year.