On October 8, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable ongoing efficacy results from follow-up visits for Patient 4 and Patient 6 in its Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, OCT 8, 2024, View Source [SID1234647086]). 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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At the six-month follow-up visit, Patient 4 maintained stable disease with a 5.3% reduction in tumor size compared to the pre-treatment size. At the two-month follow-up visit, Patient 6 demonstrated stable disease with no new lesions detected and no signs of disease progression. Both of these patients are being treated at the Beverly Hills Cancer Center.

As a result of these updates, the median progression-free survival (PFS) across the trial has now increased to 6 months, highlighting the potential of Deltacel-01 to delay disease progression in advanced lung cancer patients. The median follow-up duration for all patients in the trial is now 7.7 months.

"We are encouraged by the consistency in disease stabilization seen across the patients enrolled in this study as well as the emerging signs of tumor reduction, which further support the potential clinical benefits of Deltacel," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "These latest results continue to validate the therapeutic potential of gamma-delta T cells and their ability to provide meaningful outcomes for patients with advanced cancer."

"The follow-up results we are seeing in the Deltacel-01 trial are encouraging, especially for patients with limited treatment options. The stabilization of disease, combined with early signs of tumor reduction in some cases, speaks to the potential of this therapy to make an impact in the treatment of advanced solid tumors. We are hopeful that continued follow-up will support the promising outcomes we’ve seen to date," added Afshin Eli Gabayan, M.D., Medical Oncologist, Medical Director and Deltacel-01 Principal Investigator at the Beverly Hills Cancer Center.

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.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.

On October 8, 2024 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported financial results for its fiscal fourth quarter ended June 30, 2024, and provided a corporate update (Press release, Kintara Therapeutics, OCT 8, 2024, View Source [SID1234647085]).

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Recent Corporate Developments

As previously disclosed, in April 2024 Kintara entered into a definitive merger agreement (the "Merger Agreement") with TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, and Kayak Mergeco, Inc., Kintara’s wholly-owned subsidiary, whereby Kayak Mergeco will merge with and into TuHURA with TuHURA surviving the merger and becoming Kintara’s direct, wholly-owned subsidiary (the "Merger").

At Kintara’s special meeting of stockholders held on October 4, 2024, Kintara’s stockholders approved the requisite proposals to effect the completion of the proposed Merger with TuHURA. The proposed Merger is expected to be consummated in mid-October 2024, subject to the satisfaction of the remaining closing conditions under the Merger Agreement.

As of October 7, 2024, four patients have been dosed in Kintara’s open label 15-patient REM-001 study (the "REM-001 Study") in cutaneous metastatic breast cancer (CMBC). The majority of the costs to run the REM-001 Study will be covered by the $2.0 million Small Business Innovation Research grant Kintara was awarded from the National Institutes of Health.
Summary of Financial Results for Fiscal Year 2024 Ended June 30, 2024

As of June 30, 2024, Kintara had cash and cash equivalents of approximately $4.9 million.

For the three months ended June 30, 2024, Kintara reported a net loss of approximately $2.3 million, or $0.04 per share, compared to a net loss of approximately $3.3 million, or $1.97 per share, for the three months ended June 30, 2023. The decreased net loss for the three months ended June 30, 2024, compared to the three months ended June 30, 2023, was largely attributed to lower research and development expenses which was primarily due to lower clinical development costs. General and administrative costs were higher during the same period primarily due to an increase in professional fees related to the proposed transaction with TuHURA.

On October 8, 2024 Kineta, Inc. (OTC Pink: KANT) ("Kineta" or the "Company"), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that it has completed the enrollment of new patients into the monotherapy arm of the VISTA-101 phase 1 clinical trial evaluating KVA12123, Kineta’s novel VISTA blocking immunotherapy, in patients with advanced solid tumors (Press release, Kineta, OCT 8, 2024, View Source;utm_medium=rss&utm_campaign=kineta-announces-completion-of-enrollment-in-the-monotherapy-arm-of-the-vista-101-phase-1-clinical-study-in-advanced-solid-tumors [SID1234647084]). The monotherapy portion of the trial enrolled patients in 6-dose cohorts ranging from 3mg to 1000mg every two weeks and no dose limiting toxicities or cytokine related adverse events have been observed in the study. The Company is continuing to enroll patients into cohorts evaluating KVA12123 in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab).

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Initial results demonstrating partial response and stable disease in the cohorts evaluating KVA12123 in combination with pembrolizumab and durable stable disease in the monotherapy cohorts were reported earlier this year at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024. Additionally, the initial results of KVA12123 showed a favorable clinical safety and tolerability profile with no dose limiting toxicities and no evidence of CRS-associated cytokines at any dose level. "We are pleased to successfully complete patient enrollment in the monotherapy arm, and we remain on target for completing full enrollment into this study before year end," said Craig W. Philips, President of Kineta.

On July 8, 2024, Kineta announced that it had entered into an exclusivity and right of first offer agreement (the "Agreement") with TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. As part of the Agreement, Kineta received a $5 million nonrefundable payment from TuHURA in July 2024. In August 2024, Kineta announced that in collaboration with TuHURA, it reopened enrollment in the VISTA-101 clinical trial. Kineta and TuHURA continue to collaborate on the ongoing Phase 1 clinical program in patients with advanced solid tumor cancer. On October 2, 2024, Kineta announced that TuHURA was exercising its right to extend their exclusivity and right of first offer pursuant to the terms of the Agreement.

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

On October 8, 2024 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported that it intends to offer and sell, subject to market and other conditions, $400.0 million of shares of its common stock in a proposed underwritten public offering (Press release, Crinetics Pharmaceuticals, OCT 8, 2024, View Source [SID1234647083]). In addition, Crinetics intends to grant the underwriters a 30-day option to purchase up to an additional $60.0 million of shares of common stock. All of the shares to be sold in the proposed offering are to be sold by Crinetics. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Crinetics intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and investment securities, to fund research and development of its clinical-stage product candidates, other research programs, pre-commercialization activities and other general corporate purposes, which may include, among other things, capital expenditures or working capital. Crinetics may also use a portion of the remaining net proceeds, together with its existing cash, cash equivalents and investment securities, to in-license, acquire, or invest in complementary businesses, technologies, products or assets; however, it has no current commitments or obligations to do so.

Leerink Partners and Morgan Stanley are acting as joint bookrunning managers for the proposed offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with the Securities and Exchange Commission (SEC). The proposed offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

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

On October 7, 2024 BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, and the University of Oxford’s Centre for Medicines Discovery, reported a five-year research collaboration focused on advancing novel protein degradation technologies, particularly in oncology and central nervous system (CNS) diseases, with the goal of unlocking new therapeutic pathways for conditions with limited treatment options (Press release, BPGbio, OCT 7, 2024, View Source [SID1234647077]). The organizations will work in phases, starting with the validation of BPGbio’s novel E2 TPD technology, and expanding into future study of the degradable target space, to identify novel targets and generate high quality publications.

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This collaboration builds on BPGbio’s first-in-class E2-based protein degradation program, which features a proprietary library of more than 1,000 Ro3 fragments discovered by BPGbio that are potential ligands and seed compounds to a variety of E2 targets. The collaboration will also utilize BPGbio’s proprietary ternary structures, its computational toolkit for E2 ligand design, and assays for rapidly attaining selectivity and specificity.

The partnership will leverage the Centre for Medicines Discovery’s expertise in translational research, including their groundbreaking efforts in neurological diseases such as Parkinson’s Disease. The team will utilize BPGbio’s proprietary NAi Interrogative Biology Platform, which integrates patient biology with AI-driven analysis, to accelerate biomarker discovery and therapeutics development.

"This collaboration represents a powerful alliance of biology-first science and cutting-edge translational research," said Niven R. Narain, Ph.D., President and CEO of BPGbio. "By harnessing our NAi Interrogative Biology Platform alongside the University of Oxford’s expertise, we aim to push the boundaries of protein degradation science and deliver transformative therapies for diseases like cancer and CNS disorders, where unmet medical needs remain significant."

"By partnering with BPGbio, we’re combining our world-class translational research expertise with their pioneering approach to protein degradation," said Prof. Paul Brennan, Ph.D., FRSC, Director of the Centre for Medicines Discovery at University of Oxford. "This collaboration has the potential to unlock new therapeutic strategies for diseases that have long resisted treatment, including challenging cancers and CNS disorders. We are excited to explore novel targets and bring forward breakthrough therapies that could make a profound difference for patients."