On June 6, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported favorable six-month follow-up results from the first patient enrolled in the Deltacel-01 Phase 1 clinical trial (Press release, Kiromic, JUN 6, 2024, View Source [SID1234644172]). 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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Scans taken six months post-treatment showed the patient’s tumor size had decreased by 13% compared with the pre-treatment size, and no new tumor lesions were detected, which translates into a six-month progression-free survival. In addition, no dose-limiting toxicities were reported, reinforcing the safety profile of Deltacel observed in previous follow-up visits. This patient is being treated at the Beverly Hills Cancer Center (BHCC).

"We are delighted to report that Patient 1 in the Deltacel-01 clinical trial has achieved six-month progress-free survival, and that they continue to do well with no side effects. This is an important clinical milestone that underscores the potential of Deltacel in treating advanced cancers," said Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "Notably, we observed a 13% decrease in tumor size. These results are encouraging and support our belief in the potential of Deltacel to provide an effective new treatment for patients with advanced cancers. We are committed to advancing this trial and bringing hope to those with limited treatment options."

Kiromic continues to expect to report long-term follow-up results for the other two subjects in the first cohort and the first subject in the second cohort by the end of June.

Additionally, the fifth patient in Deltacel-01 began treatment in May, is currently doing well without any signs of toxicity and is expected to have their first efficacy assessment in July. The sixth patient is currently undergoing pre-enrollment screening and is projected to start treatment in mid-June.

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.

GSK plc (LSE/NYSE: GSK) reported that it has acquired Elsie Biotechnologies, a San Diego-based private biotechnology company dedicated to unlocking the full potential of oligonucleotide therapeutics, for up to $50 million (approximately £39 million) (Press release, GlaxoSmithKline, JUN 6, 2024, View Source [SID1234644170]).

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Oligonucleotides have a unique ability to modulate gene expression, making them an attractive modality to address a significant proportion of therapeutic targets that are not amenable to traditional small molecules or biologics.

This acquisition allows GSK to integrate Elsie’s oligonucleotide discovery, synthesis, and delivery technologies to enhance GSK’s platform R&D capabilities. This follows a successful research collaboration with Elsie, announced in July 2023, in which GSK was able to explore and validate the technology.

Tony Wood, Chief Scientific Officer, GSK, said: "We have already made great strides in oligonucleotide drug development through our work in chronic hepatitis B and steatotic liver disease, and are thrilled to work alongside the talented team at Elsie to accelerate a next-generation oligonucleotide platform. By bringing together Elsie’s expertise and our internal capabilities, we can design and develop oligonucleotides for difficult-to-treat diseases of scale with larger patient populations."

Data generated with the Elsie platform, combined with GSK’s expertise in the use of artificial intelligence and machine learning, will support the development of predictive models for future oligonucleotide design.

Kevin Green, Chief Operating Officer, Elsie, said: "We are thrilled to be a part of GSK and work alongside the talented R&D team dedicated to oligonucleotide drug development. We believe our platform will make significant contributions to the field and we believe GSK is the best partner to help advance this effort."

The acquisition is aligned to GSK’s approach of uniting Science and Technology, including advancing novel platform technologies, to accelerate drug development and ultimately deliver innovative medicines to patients, better and faster. Currently GSK is advancing oligonucleotide therapeutics in chronic hepatitis B and steatotic liver disease as well as other therapeutic areas beyond liver disease.

This agreement is not subject to closing conditions and the acquisition has been completed.

On June 6, 2024 FORE Biotherapeutics reported that the Company will be presenting at the 2024 Goldman Sachs 45th Annual Global Healthcare Conference (Press release, Fore Biotherapeutics, JUN 6, 2024, View Source [SID1234644169]). The presentation will take place on Thursday, June 13, 2024, at 9:20-9:55 AM ET.

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William Hinshaw, Chief Executive Officer, and Jeffrey Sacher, Interim Chief Financial Officer, will host and participate in one-on-one meetings. Please contact your Goldman Sachs salesperson or Argot Partners to schedule one-on-one meetings with the management team.

On June 6, 2024 Defence Therapeutics Inc. ("Defence" or the "Company"), (CSE: DTC, OTCQB: DTCFF, FSE: DTC), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies, reported the publication of a peer-reviewed study on the anticancer properties of its unconjugated AccuTOX, one of Defence’s lead products engineered to treat established solid tumors (Press release, Defence Therapeutics, JUN 6, 2024, View Source;utm_medium=rss&utm_campaign=defences-accutox-published-in-the-prestigious-journal-of-translational-medicine-its-peer-study-with-preclinical-data-on-accutox-as-an-anti-cancer-molecule [SID1234644164]). The study, which was published in the prestigious Journal of Translational Medicine, is entitled, "Local delivery of AccuTOX synergises with immune-checkpoint inhibitors at disrupting tumor growth", and can be directly accessed at the following address: View Source

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The Accum platform was initially designed to accumulate biomedicines in target cells by inducing endosomal-to-cytosol escape. Interestingly however, the use of unconjugated Accum was observed to trigger cell death in a variety of cancer cell lines; a property further exploited in the development of Accum-based anti-cancer therapies. Despite the impressive pro-killing abilities of the parent molecule, some cancer cell lines exhibited resistance. This prompted us to test additional Accum variants, which led to the identification of the AccuTOX molecule. From that perspective, AccuTOX holds many advantages over the parent Accum entity: i) it exhibits enhanced killing potency while retaining the innate function of endosomal-to-cytosol escape, ii) the molecule can be easily manufactured, iii) it can be linked to antibodies as an in situ cleavable anticancer molecule (to increase its specificity), and iv) it is highly versatile, as it targets multiple intracellular pathways that are highly relevant to cancer growth and progression.

"This study presents insights of how the unconjugated AccuTOX molecule works. More specifically, we demonstrate that AccuTOX displays improved killing efficiency, triggers immunogenic cell death and production of toxic byproducts while inducing endosomal breaks. Moreover, AccuTOX enhances cancer cell visibility to the immune system. It is very rare to have a drug capable of fighting cancer at multiple fronts simultaneously." says Dr. Rafei, the Chief Scientific Officer of Defence Therapeutics.

The key highlights of the AccuTOX study are:

AccuTOX is therapeutically superior to parent Accum (both in vitro and in vivo)

The molecule induces cell death of various murine and human cancer cell lines (T-cell lymphoma, colon, melanoma, lung and breast)

AccuTOX triggers the intracellular production of reactive oxygen species and disrupts endosomal membranes

Following contact with AccuTOX, cancer cells die through a process called immunogenic cell death

The compound leads to similar responses in both male and female animals with no apparent toxicity

AccuTOX enhances antigen presentation (tumor becomes visible to immune cells)

Intratumoral administration of AccuTOX to lymphoma, melanoma or breast cancer synergises with common immune-checkpoint inhibitors leading to efficient tumor growth control

"In addition to providing an important validation of the antitumoral properties of unconjugated AccuTOX, this compound represents currently the lead core technology at Defence as the same molecule can be used to generate three different lines of therapies with distinct modes of action (anti-cancer injectable, cell-based vaccine and as a payload for ADCs). This unique versatility could pave the path for additional lines of investigations, and it represents a "one solution for three major problems" at once," said Mr. Plouffe, Chief Executive Officer of Defence Therapeutics.

In summary, unconjugated AccuTOX could be used as an anti-cancer molecule. The triggered effects are interesting and unexpected as the induction of immunogenic cell death brings an additional immune component to the equation, which may turn a "cold" into a "hot" tumor with increased infiltration of immune cells as shown in the published study. With FDA clearance to initiate a Phase I trial, Defence recently submitted a CTA application to Health Canada to widen the scope of clinical testing.

Marketing:

Defence has entered into an agreement with Martin City Studios LLC, where Martin City Studios will produce two audio interviews with Defence’s CSO, Dr. Moutih Rafei, with Ellis Martin to be aired on Money Talk Radio and The Ellis Martin Report. Martin City Studios is a company headquartered in New Mexico, United States, dedicated to audio interviews. The cost of the services is $6,500 (U.S.). Martin City Studios does not currently hold any common shares in the company. Martin City Studios and the Company are unrelated and unaffiliated entities. Martin City Studios will be producing an audio interview segment featuring the Company to be updated and aired across Martin City Studios’ platforms (as well as posted on the VoiceAmerican.com’s Business Channel and Martin City Studios’ YouTube channel). A recording of the interviews will be shared when available.

On June 6, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that Neil Kumar, Ph.D., founder and CEO of BridgeBio, will present at the Goldman Sachs Annual Global Healthcare Conference in Miami, FL on Wednesday, June 12 at 3:20 pm EDT (Press release, BridgeBio, JUN 6, 2024, View Source [SID1234644162]).

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To access the live webcast of BridgeBio’s presentation, please visit the "Events & Presentations" page within the Investors section of the BridgeBio website at View Source A replay of the webcast will be available on the BridgeBio website for 90 days following the event.