On June 29, 2023 ArteraAI, the developer of multimodal artificial intelligence-based predictive and prognostic cancer tests, reported the publication of data in the NEJM Evidence, validating the first-ever predictive AI biomarker of androgen deprivation therapy (ADT) benefit in prostate cancer (Press release, Artera, JUN 29, 2023, View Source [SID1234632994]).

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The study used novel deep learning methodology and histopathology image data from more than 5,000 patients across five Phase 3 randomized trials, with long-term follow-up. Patients in these trials were enrolled from over 100 centers across the US and Canada. The predictive AI biomarker was developed using datasets comprising about 20% African American patients. In past U.S.-based clinical trials, African American men have made up only 10.8% of prostate cancer trial participants.

"This is truly a milestone in the treatment for prostate cancer," said Dr. Daniel Spratt, MD, chairman and professor of radiation oncology at University Hospitals (UH) Seidman Cancer Center and Case Western Reserve University (CWRU), and one of the corresponding authors on the study. "With the first-ever predictive biomarker of ADT benefit in prostate cancer, created with AI, we are able to further realize the ability to create a personalized approach for the treatment of cancer."

In patients with localized prostate cancer, ADT can be added to radiotherapy if improved patient outcomes are anticipated. However, ADT is also known to have negative side effects ranging from loss of sexual function to potentially detrimental effects on cardiac and brain health. Some studies suggest many men do not need ADT as part of their treatment plan, and that radiotherapy alone is effective. If given the opportunity to leverage the biomarker, most intermediate-risk patients could potentially avoid the morbidity and financial burden associated with ADT.

"Keeping patients from undergoing a treatment that would not provide therapeutic benefit, especially one that could do more harm than good, is everything to a clinician," said Felix Feng, MD, Scientific Advisor to ArteraAI, Professor of Radiation Oncology, Urology, and Medicine at the University of California San Francisco, and corresponding author of the study. "The validation of this biomarker by this highly credible and trusted publication is a milestone. We celebrate this achievement while also looking ahead to how we can build upon this evidence to continue transforming care for men diagnosed with localized prostate cancer."

On June 29, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the first patient has been dosed in its Phase I clinical trial that will test the safety and tolerability of the Company’s lead product candidate, CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M) in combination with Merck’s anti-PD1 therapy KEYTRUDA (pembrolizumab) for the treatment of HER2 overexpressing cancers (Press release, Carisma Therapeutics, JUN 29, 2023, View Source [SID1234632993]).

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Pre-clinical data presented at SITC (Free SITC Whitepaper) in 2022 demonstrated that the mice that received both therapies had improved tumor control, overall survival, and tumor microenvironment (TME) activation as compared to either treatment alone, indicating synergy and the capacity for CAR-M to sensitize solid tumors to checkpoint blockade.

This first patient’s cells were manufactured at the Novartis Cell Therapy Site in Morris Plains, New Jersey, following the successful completion of the tech transfer of CT-0508 to Novartis earlier this year. This is Carisma’s first clinical product to be manufactured and administered from this collaboration.

"We are excited by the progress being made on our CT-0508 clinical program with the dosing of the first patient in the combination study with KEYTRUDA," said Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer at Carisma Therapeutics. "The CT-0508 monotherapy trial has demonstrated early clinical validation of the CAR-M mechanism of action, and we are eager to explore this sub-study to assess the potential synergistic effect of CAR-M therapy in combination with KEYTRUDA. The initiation of clinical manufacturing at Novartis’ GMP cell therapy site is also a meaningful step forward in progressing our overarching manufacturing strategy, and demonstrates our desire to work alongside best-in-class companies."

In January 2023, Carisma appointed nationally regarded cancer immunologist and oncologist, Dr. Padmanee Sharma, MD, PhD, to the company’s Scientific Advisory Board. The Company expects that Dr. Sharma’s scientific knowledge in immunotherapy will provide valuable guidance in the studies of CT-0508 and KEYTRUDA.

The clinical trial sub-study of CT-0508 in combination with KEYTRUDA has been initiated at multiple site locations in the U.S. and will enroll patients with different types of recurrent or metastatic cancers with HER2 overexpressing solid tumors. To learn more about this, please visit ClinicalTrials.gov (NCT04660929) or Carisma’s clinical trial website.

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

About CT-0508

CT-0508 is a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M). It is being evaluated in a landmark Phase 1 multi-center clinical trial that focuses on patients with recurrent or metastatic HER2-overexpressing solid tumors whose cancers are not eligible for treatment with currently available HER2-targeted therapies or who do not respond to treatment. The trial is enrolling participants who have tumors of any anatomical origin, but with the commonality of overexpressing the HER2 receptor on the cell surface, which is the target for our CAR-M. The Phase 1 clinical trial is first-of-its-kind, marking the first time that genetically engineered macrophages are being studied in humans. The trial continues to enroll patients at seven clinical sites in the U.S., including (i) the University of Pennsylvania Abramson Cancer Center, (ii) the University of North Carolina Lineberger Comprehensive Cancer Center, (iii) the City of Hope National Medical Center, (iv) the MD Anderson Cancer Center, (v) the Sarah Cannon Cancer Research Institute, (vi) Oregon Health & Science University and (vii) Fred Hutchinson Cancer Center.

On June 29, 2023 Shasqi, Inc. ("Shasqi") a clinical stage biotech company, whose mission is to revolutionize cancer treatment with click chemistry, reported the expansion of its Click Activated Protodrugs Against Cancer (CAPAC ) platform with a pivotal manuscript describing the preclinical development of SQ2201, a novel cancer therapy (Press release, Shasqi, JUN 29, 2023, View Source [SID1234632992]). SQ2201 comprises a systemically administered tumor targeting agent that binds to the HER2 receptor (SQT01), paired with an MMAE protodrug (SQP22), which is activated at the site of the tumor via a click chemistry reaction. SQ2201 showed potent anti-tumor effects in mice that surpassed those seen with a biosimilar of disitamab vedotin, a conventional ADC which targets the same antigen and delivers the same payload. The manuscript is published in the peer-reviewed journal ACS Central Science.

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"By decoupling the targeting agent from the payload, our unique approach has the potential to expand on the promise of ADCs," said José M. Mejía Oneto, M.D., Ph.D., Shasqi CEO and founder. "Our systemic HER2 antigen targeting agent opens up a new area for our CAPAC platform, unlocking our library of payloads to the world of targeted therapeutics. We are excited to continue expanding the possibilities of our technology."

This work builds on the clinical validation achieved with SQ3370. In a phase 1 study, click chemistry was used to activate up to 12-times the conventional dose of doxorubicin, with a more favorable toxicity profile. Tumor localization of click chemistry in this instance was achieved through an intratumorally injected biopolymer. A phase 2 study is ongoing.

On June 29, 2023 HaemaLogiX Ltd, a clinical stage Australian biotech company developing novel immunotherapies for multiple myeloma, reported positive final results from a Phase IIb clinical study of its monoclonal antibody KappaMab in combination with lenalidomide and dexamethasone in kappa-type multiple myeloma patients who had relapsed or become refractory to other treatment options (Press release, HaemaLogiX, JUN 29, 2023, View Source [SID1234632991]).

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The final data has been published in the British Journal of Haematology. Key findings include:

A statistically significant overall response rate (ORR) of 83% and clinical benefit rate (CBR) of 93% in KappaMab + lenalidomide / dexamethasone (Case) was achieved compared to the matched Control cohort of lenalidomide + dexamethasone alone (ORR = 45%).
The median Overall Survival was not reached, with two patients remaining on therapy and continuing to respond, and with no evidence of detectable disease.
KappaMab’s previously established safety profile was reaffirmed, with no KappaMab related haematological toxicities or serious adverse effects.
KappaMab targets a receptor called Kappa Myeloma Antigen (KMA) found only on the surface of myeloma cells in kappa-type multiple myeloma patients and not on normal immune cells, which means normal immune cells are not damaged by the treatment.

The phase IIb study was initiated off the back of phase I, IIa, and preclinical data suggesting KappaMab may have a synergistic mechanism of action with lenalidomide, a drug sold under the trade name Revlimid, that forms standard of care for multiple myeloma. Lenalidomide is administered as both a monotherapy and with other drugs including dexamethasone, depending on the treatment approach and disease status.

"This study validates KMA as a highly specific target, and the ability to safely deliver KappaMab in combination with a mainstay treatment for multiple myeloma," HaemaLogiX CEO, Bryce Carmine, said:

"Patient response shows the combination of KappaMab with one of the most common multiple myeloma treatment approaches – lenalidomide and dexamethasone – outperforms that treatment approach alone.

"We are tremendously grateful to the investigators and to the patients who participated.

"We look forward to furthering the clinical progress of KappaMab with a clinical trial at a higher dose of KappaMab which will flow into a Phase IIb study investigating KappaMab in combination with pomalidomide and dexamethasone in patients who have relapsed or become refractory to other standard of care treatments."

This Phase IIb trial followed a Phase IIa open-label multiple dose trial to determine the safety and efficacy of multiple doses of KappaMab monotherapy in 19 relapsed and / or refractory patients who had received multiple prior treatments.

The phase IIb trial was a multi-centre trial led by Professor Andrew Spencer, which evaluated patient responses to KappaMab when combined with standard of care treatment compared to the standard of care drugs alone. The trial enrolled 40 patients with kappa-type myeloma who had previously been treated with one to three lines of drugs, and in which the disease was progressing. Along with positive efficacy results, the trial demonstrated an excellent safety profile with no patients experiencing KappaMab related serious side effects.

On June 29, 2023 Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported the pricing of its upsized initial public offering of 3,900,000 shares of common stock at a public offering price of $5.00 per share (Press release, Intensity Therapeutics, JUN 29, 2023, View Source [SID1234632990]). In addition, Intensity has granted the underwriters a 45-day option to purchase an additional 585,000 shares of its common stock at the initial public offering price, less the underwriting discounts and commissions.

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In connection with the offering, the Company’s common stock is expected to begin trading on The Nasdaq Capital Market on June 30, 2023, under the ticker symbol "INTS" subject to final approval by Nasdaq. The offering is expected to close on July 5, 2023, subject to the satisfaction of customary closing conditions.

The net proceeds to Intensity from the offering (prior to any exercise of the underwriter’s over-allotment option), after deducting the underwriting discounts, commissions and transaction expenses, are expected to be approximately $16.2 million.

The Benchmark Company and Freedom Capital Markets are acting as the joint book-running managers for the offering.

The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (Registration No. 333-260565) that was previously filed with the U.S. Securities and Exchange (the "SEC") and declared effective on June 29, 2023. This offering is being made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus relating to the initial public offering can be obtained, when available, through the SEC’s website at www.sec.gov or from: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th floor, New York, NY 10155 at 212-312-6700 or by email at [email protected] and Freedom Capital Markets, 40 Wall Street, 58th Floor, New York, NY 10005, via email at [email protected] and via telephone at (800) 786-1469.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful.