On July 15, 2024 Enveric Biosciences (NASDAQ: ENVB) ("Enveric"), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders, and Aries Science & Technology ("Aries"), a developer of encapsulation technologies, reported a licensing agreement for the clinical development of Enveric’s patented radiation dermatitis topical product (Press release, Enveric Biosciences, JUL 15, 2024, View Source [SID1234644868]).

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Radiation dermatitis is a side effect of radiation treatment that impacts roughly two million cancer patients per year and has a market opportunity estimated at $400 million annually. The formulation licensed to Aries is protected by an allowed US patent application, as well as a pending PCT application.

"This product offers the potential to provide much needed relief to cancer patients suffering from the painful side effects of radiation therapy," said Ram Lalgudi, Ph.D., CEO of Aries. "We are excited by the opportunity to advance this promising molecule to clinical trials."

Dr. Lalgudi announced: "Aries has nominated Hari Harikumar, Ph.D., as Chairman-elect of an Aries subsidiary being formed to advance this opportunity. Dr. Harikumar is a techno-commercial entrepreneur having experience with multiple companies, including his current role as VP for Performance Additives in CHASM Advanced Materials and earlier roles as CEO of QM Power, and VP, Innovation, Sustainability and Technology for Ingersoll Rand/TRANE, and President & CTO for USHA, a leading consumer brand in India. We look forward to great success under his leadership."

Joseph Tucker, Ph.D., CEO of Enveric, stated: "With its proven expertise in encapsulation solutions and strong management team, we believe Aries is the ideal partner to continue the development of this cancer support care product while Enveric sharpens its focus on neuropsychiatric indications."

Under the terms of the agreement, executed through Enveric’s subsidiary, Akos Biosciences, Inc., Enveric will be eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties ranging from 2.5% to 10% on future sales, if all conditions are met.

On July 15, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its Board of Directors has authorized a share repurchase program of up to $5 million of the Company’s outstanding common stock (Press release, Anixa Biosciences, JUL 15, 2024, View Source [SID1234644866]).

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"This share repurchase program reflects our confidence in the future outlook of our business, the soundness of our balance sheet, the strength of our clinical development pipeline and Anixa’s long-term value. We believe that Anixa’s stock is currently undervalued and this program provides an opportunity to enhance long-term shareholder value," stated Dr. Amit Kumar, Chairman and CEO of Anixa.

Repurchases may be made from time to time at the discretion of the Board of Directors through open-market transactions in accordance with applicable securities laws. The repurchase program expires in twelve months and can be suspended or discontinued at any time. No shares have been repurchased under the program to date. There can be no assurance as to the timing or number of shares of any repurchases, if any.

On July 15, 2024 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the second quarter of 2024 after the market closes on Monday, August 5, 2024 (Press release, Akoya Biosciences, JUL 15, 2024, View Source [SID1234644865]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

Akoya also announced that management will be presenting or doing fireside chats at two upcoming investor conferences.

Canaccord Genuity 44th Annual Growth Conference
Tuesday, August 13 at 2:30 PM ET
Morgan Stanley 22nd Annual Global Healthcare Conference
Friday, September 6 at 1:05 PM ET
A live and archived webcast of the events will be available on the "Investors" section of the Akoya website at View Source

On July 15, 2024 GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics ("Checkpoint") (Nasdaq: CKPT) reported a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint’s anti-PD-L1 antibody with dual mechanism of action, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer ("CIK") T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells (Press release, Checkpoint Therapeutics, JUL 15, 2024, View Source [SID1234644860]).

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This collaboration will initially focus on conducting in vitro combination studies to evaluate the synergistic effects of these two therapies on cancer cell destruction. Positive preliminary data from these studies could potentially pave the way for future in vivo research and clinical studies.

The anticipated synergy between cosibelimab’s antibody-dependent cellular cytotoxicity ("ADCC") mechanism of action and Immuncell-LC’s robust autologous CIK T cell response is supported by extensive research. This combination is expected to leverage immune system components more effectively in targeting and eliminating cancer cells.

James Park, CEO of GC Cell, highlighted the agreement’s potential: "This collaboration is a pivotal step towards significant technological collaborations. The integration of cosibelimab’s clinical efficacy and safety profile with our Immuncell-LC could set new therapeutic standards in immuno-oncology. We are optimistic that this partnership will lead to effective commercial licensing or joint development in the future."

James F. Oliviero, CEO of Checkpoint Therapeutics, concurred: "Both cosibelimab, with its dual mechanism of action, and Immuncell-LC show great promise as potential immuno-oncologic therapies. We are pleased to work in collaboration with GC Cell to determine if using the two therapies in combination may offer even greater potential benefits than being used singly."

About Immuncell-LC
Immuncell-LC stands as the sole commercially approved adoptive T cell therapy for hepatocellular carcinoma adjuvant treatment. Comprising autologous, significantly expanded CIK (Cytokine Induced Killer) T lymphocytes, it has demonstrated proven efficacy in a large-scale Phase 3 clinical trial—reducing the risk of recurrence by 37% and decreasing mortality by 79% compared to the active surveillance group. Administered to over 10,000 patients in South Korea, Immuncell-LC has shown an excellent safety profile without treatment-related serious adverse events.

About Cosibelimab
Cosibelimab is a potential differentiated, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained high tumor target occupancy of PD-L1 to reactivate an antitumor immune response and the additional potential benefit of a functional Fc domain capable of inducing ADCC for potential enhanced efficacy.

On July 12, 2024 Senhwa Biosciences’ reported that its new drug Pidnarulex (CX-5461) has demonstrated efficacy in treating various solid tumors with BRCA2 or PALB2 gene defects (Press release, Senhwa Biosciences, JUL 12, 2024, View Source;data-abstract-of-pidnarulex-accepted-for-presentation-at-2024-esmo-congress-302195586.html [SID1234644809]). The abstract of this clinical trial has been selected for presentation at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress. This achievement is a significant milestone for Senhwa Biosciences and the Canadian clinical team, as it includes terminal cancer patients who although have undergone various prior treatments are found in stable condition, continuously receiving Pidnarulex (CX-5461) treatment in this trial. This highlights that Pidnarulex (CX-5461) aligns with the trend of developing new drugs for precision medicine.

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The clinical trial is an open-label, multinational, multicenter study, divided into a Main Study Cohort and an Exploratory Cohort. The Main Study Cohort includes patients with various tumors (pancreatic cancer, breast cancer, ovarian cancer, and prostate cancer) with BRCA2 and/or PALB2 gene defects. The Exploratory Cohort includes ovarian cancer patients with BRCA1 gene defects and/or other homologous recombination deficiency (HRD) genes. The primary objective of the trial is to determine the optimal dose for patients with specific gene defects while the secondary objectives are set to assess the safety and tolerability of Pidnarulex (CX-5461), and to evaluate late-onset toxicity, antitumor activity as well as improvement in patients’ quality of life. Patients enrolled in this clinical trial have undergone 2 to 10 different treatment regimens; some of them are even resistant to platinum-based chemotherapy and PARP inhibitors, leaving no other treatment options available. Encouragingly, these terminal patients have shown clinical benefits provided by the Pidnarulex (CX-5461) treatment.

The 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress will be held from September 13 to 17, 2024, in Barcelona, Spain, welcoming both in-person and online participations. This congress will showcase the latest cutting-edge cancer translational data and provide a platform for oncology professionals and scientists to network and share research and innovations. The ESMO (Free ESMO Whitepaper) Congress is a cornerstone event in oncology, recognized globally for its significant contributions to cancer treatment and research. It is one of the top three cancer medical conferences worldwide, alongside ASCO (Free ASCO Whitepaper) and AACR (Free AACR Whitepaper). The abstract for the clinical trial of Pidnarulex (CX-5461) treating various solid tumors with BRCA1, BRCA2, and/or PALB2 gene defects (1b) was written and submitted by the Canadian clinical partner, Princess Margaret Cancer Centre. The abstract title is expected to be available online by the end of July, with the full abstract and related data to be published on September 9.

Senhwa Biosciences’ new drug, Pidnarulex (CX-5461), is currently being applied in breast cancer, ovarian cancer, pancreatic cancer, hematologic malignancies, and prostate cancer. As a new drug candidate for solid tumors in collaboration with National Institutes of Health (NIH), the first stage of clinical trials will begin in 2024. With the remarkable efforts of NIH’s professionals and medical network, Senhwa Biosciences expects the clinical outcomes of Pidnarulex (CX-5461) treating multiple cancers will make significant strides in the fight against various types of cancer.