On October 5, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the lacutamab IND leading to a pause in new patient enrollment to the Company’s ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL). The partial clinical hold follows one fatal case of hemophagocytic lymphohistiocytosis (HLH), a rare hematologic disorder. Patients already on study treatment who are deriving clinical benefit may continue treatment after being reconsented.

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TELLOMAK, Innate Pharma’s ongoing Phase 2 trial of lacutamab in cutaneous T-cell lymphoma (CTCL), completed enrollment in Q2 2023 (n=170 patients). Enrollment is also completed to the initial cohort (n=20 patients) of the Phase 1b PTCL trial and is awaiting a futility interim analysis to progress to the next stage. Innate Pharma is on track for final data from the Phase 2 TELLOMAK trial and preliminary data on PTCL in Q4 2023.

"Patient safety is of paramount importance to us, and we are currently undertaking efforts to address the FDA requests, which include incorporation of risk mitigation and management strategies for hemophagocytic lymphohistiocytosis in ongoing lacutamab studies." said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "Additionally, with all patients recruited into the Phase 2 TELLOMAK study, we do not currently anticipate any delay for the TELLOMAK Phase 2 final data due shortly."

About Lacutamab

Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages.

KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular, Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues.

Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL.

About TELLOMAK:

TELLOMAK (NCT03902184) is a global, open-label, multi-cohort Phase 2 clinical trial recruiting patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically:

Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication.
Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design.
Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon-2 stage design.
All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic.
The trial is now fully enrolled. The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events.

About the Phase 1b in PTCL:

The Phase 1b clinical trial (NCT05321147) is investigating lacutamab monotherapy in KIR3DL2-expressing patients with relapsed/refractory PTCL who have received at least one prior systemic therapy (N=20, with futility interim ungating N=20 expansion). The trial is designed to evaluate safety, as well as characterize clinical outcomes, pharmacokinetics and immunogenicity of lacutamab alone in PTCL. Further expansion will be determined based on preliminary efficacy signals.

On October 5, 2023, Equillium, Inc. (the "Company") reported to have entered into an Open Market Sale AgreementSM (the "Sale Agreement") with Jefferies LLC ("Jefferies"), pursuant to which the Company may, from time to time, offer and sell shares of the Company’s common stock, par value $0.0001 per share (the "Shares"), through Jefferies, as the Company’s sales agent and/or principal (Filing, 8-K, Equillium, OCT 5, 2023, View Source [SID1234635680]).

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The Shares will be offered and sold pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-269153) (the "Registration Statement"), which was originally filed with the Securities and Exchange Commission ("SEC") on January 6, 2023, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on October 5, 2023 in connection with the offer and sale of the Shares pursuant to the Sale Agreement. The Shares may only be offered and sold by means of a prospectus, including a prospectus supplement, forming part of the effective Registration Statement.

The Company is not obligated to make any sales under the Sale Agreement and may at any time suspend sale of the Shares under the Sale Agreement. Any sales of Shares will be made by methods deemed to be an "at the market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including privately negotiated transactions with the consent of the Company, block transactions, sales made directly on the Nasdaq Capital Market or sales made into any other existing trading market for the Company’s common stock. The Company intends to use the net proceeds of the offering to fund the continued development of any product candidates in the Company’s pipeline, and for working capital, capital expenditures and general corporate purposes.

Jefferies will act as sales agent and/or principal and will use commercially reasonable efforts consistent with its normal trading and sales practices to place all of the Shares requested to be sold by the Company. The Company will pay Jefferies a commission rate of 3.0% of the gross proceeds from the sales of Shares sold pursuant to the Sale Agreement. In addition, the Company has agreed to pay certain expenses incurred by Jefferies in connection with the offering. The Company has also provided Jefferies with customary representations, warranties, covenants, and indemnification rights. Both parties have the right to terminate the Sale Agreement upon written notice to the other party as specified in the Sale Agreement.

The foregoing description of the Sale Agreement does not purport to be complete and is qualified in its entirety by reference to the full Sale Agreement, a copy of which is attached hereto as Exhibit 1.1 and is incorporated herein by reference.

The legal opinion of Cooley LLP relating to the Shares being offered pursuant to the Sale Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K.

This Current Report on Form 8-K does not constitute an offer to sell the Shares or a solicitation of an offer to buy the Shares, nor shall there be any sale of the Shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 5, 2023 EpicentRx and nibrozetone (RRx-001) reported "talkabout (Press release, EpicentRx, OCT 5, 2023, View Source [SID1234635679])."

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In the morning, Dr. Tony Reid, CEO of EpicentRx, presented a poster in person on RRx-001 (nibrozetone) at the American Society for Radiation Oncology (ASTRO) annual meeting. The poster, shown below, was entitled, "Secondary analysis of RRx-001 (nibrozetone) on the incidence of related toxicities in patients treated with concomitant chemoradiation for locally advanced head and neck cancer." It covered results from the PREVLAR Phase 2a trial in which RRx-001 (nibrozetone), administered with chemotherapy and radiation to patients with locally advanced head and neck cancer, dramatically reduced the incidences of several toxicities including oral mucositis, dysphagia, anorexia, and skin injury.

In the evening, California time, Dr. Bryan Oronsky and Scott Caroen from EpicentRx gave a presentation over Zoom to an audience at the OneTri Conference in Brisbane, Australia. Their presentation was on RRx-001 (nibrozetone) and the collaborative relationship that the company has forged with Dr. Richard Gordon, an inflammasome expert and key opinion leader (KOL) from the Queensland University of Technology (QUT) in Brisbane, Australia. Their virtual talk was followed by an in-person one from Dr. Gordon who gave a brief overview and history on Parkinson’s Disease (PD) and presented compelling data on the anti-inflammatory and antioxidant effects of RRx-001 (nibrozetone) in PD. See slide from the EpicentRx talk below and screenshot of the EpicentRx presentation over Zoom.

In the Q&A session at the end of the presentation, someone in the audience asked about how the industry-academic partnership between EpicentRx and Dr. Gordon at QUT happened. Bryan Oronsky replied, "Well, we had a Casablanca moment when we first talked where we felt that "this could be the start of a beautiful friendship."

On October 5, 2023 Combotope Therapeutics and CiMaas reported an oncology research and license option agreement (Press release, CiMaas, OCT 5, 2023, View Source [SID1234635678]). Under this agreement, CiMaas has the option to select three tumor glycoform protein targets, with the aim of discovering and developing next-generation CAR-NK and CAR-T antibody-based therapeutics for cancer treatment. The first selected target is the Mucin-1 tumor glycoform. CiMaas will provide funding for the preclinical and clinical development of these candidates up to clinical proof of concept.

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Ola Blixt, CEO of Combotope Therapeutics, expressed enthusiasm about the partnership with CiMaas for co-developing these antibody sequences into more effective CAR-NK and CAR-T cells for immunotherapy. The sequences are discovered using Combotope Therapeutics’ proprietary antibody development platform, iDEAL. This platform facilitates the rapid selection and optimization of tumor-specific antibodies that target aberrantly glycosylated proteins found solely on cancer cells. iDEAL has the potential to revolutionize cancer treatment by offering targeted therapy that is both safe and effective.

Søren N. Jakobsen, COO of Combotope Therapeutics, highlights that this strategic partnership exemplifies a win-win scenario, showcasing how Combotope intends to expedite the development and commercialization of a wide array of innovative scFv-based anti-cancer therapies, both off-the-shelf and personalized, through mutually beneficial pharmaceutical collaborations.

Wilfred Germeraad, CSO of CiMaas, highlighted the significance of Mucin-1 as a cancer cell target. CiMaas aims to utilize the antibodies developed by Combotope Therapeutics to create optimized CAR-NK cells with enhanced specificity for stronger binding activity against solid tumor cells. This enhancement will activate Natural Killer cells more effectively, enabling them to enhance their killing capacity. CiMaas has already demonstrated that such CAR-NK cells can eliminate more breast cancer cells than non-modified NK cells. Through this collaboration, CiMaas aims to bring this improved concept to clinical practice as swiftly as possible.

Gerard Bos, CEO of CiMaas, emphasized that this collaboration and exclusive license option enable them to further leverage NK cells against cancer. CiMaas, in conjunction with university partners in Maastricht (NL) and Utrecht (NL), is currently researching the role of Mucin-1 as a target in pre-clinical breast cancer models as a final step toward clinical application. In addition, tumor cells originating from T cell Non-Hodgin lymphoma are more sensitive to CAR-NK cell killing.

Financial Terms: According to the agreement, CiMaas will provide Combotope Therapeutics with an upfront payment. Combotope Therapeutics will be eligible for potential milestone payments per therapeutic candidate exclusively licensed, developed and commercialized by CiMaas, as well as tiered royalties.

On October 5, 2023 BullFrog AI Holdings, Inc. (NASDAQ: BFRG; BFRGW) ("BullFrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, reported that it has identified multiple potential therapeutic targets, including three novel targets, for colorectal cancer using the Company’s proprietary AI-driven platform, bfLEAP (Press release, Bullfrog AI, OCT 5, 2023, View Source [SID1234635677]). The newly identified targets will be validated through BullFrog AI’s ongoing collaboration with the J. Craig Venter Institute (JCVI), a world-leading genomics research and innovation institution. JCVI will utilize its expertise in target validation and functional genomic screening to further investigate the potential of these targets in colorectal cancer.

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"Using bfLEAP to interrogate pan-cancer multi-modal data from The Cancer Genome Atlas (TCGA), we were able to rapidly identify new colon adenocarcinoma markers, yielding 14 candidates that were significantly over-expressed in tumors relative to healthy tissues, a remarkably smaller and more actionable gene set compared to traditional differential expression analysis, which yields more than 3,000 candidates for the same comparison. After further analyzing the 14 candidates, we were able to categorize three as novel, with no previous association with colon adenocarcinoma in the scientific literature, and six as near novel with little existing literature documenting such an association," said Enrique García-Rivera, Ph.D., Vice President of Artificial Intelligence for BullFrog AI.

"TCGA has been extensively analyzed by scientists for more than a decade, yet in a matter of weeks, we were able to identify multiple new drug target candidates with previously undocumented potential in colorectal cancer from this same dataset," stated Vin Singh, Chairman and CEO of BullFrog AI. "These findings demonstrate the power and potential of our bfLEAP platform, which combines advanced AI algorithms with rich biological data to identify novel targets for a wide range of diseases. Our platform has a remarkable ability to detect patterns, make predictions, and identify anomalies, and it can do this with multi-modal data, all while providing explanations of the results generated from its rapid analysis. Our ability to identify novel drug targets in a complex data set represents significant potential value for our internal programs, clients and partners."

According to the American Cancer Society, colorectal cancer is the third most common cancer diagnosed in both men and women in the U.S., excluding skin cancers, and is the third leading cause of cancer-related deaths in the U.S. The worldwide market for colorectal cancer treatments was valued at $11.5 billion in 2022 and is forecast to grow at a compound annual growth rate of 4.7% through 2030, according to Grand View Research.