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.

On June 29, 2023 K36 Therapeutics ("K36"), a privately held clinical-stage biotech company developing KTX-1001, an investigational small molecule methyltransferase inhibitor of multiple myeloma SET (MMSET) domain, reported a $70M Series B financing (Press release, K36 Therapeutics, JUN 29, 2023, View Source [SID1234632989]). The round was led by Nextech Invest, Ltd, a precision medicine focused investment firm, on behalf of one or more funds managed by it, with participation from Bristol Myers Squibb Company (NYSE:BMY), and other undisclosed investors. All existing investors including Atlas Venture, F-Prime Capital, and Eight Roads Ventures participated in the round.

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The funds will support the ongoing Phase 1 study of KTX-1001, planned clinical studies of KTX-1001 in combination with existing standard-of-care agents in multiple myeloma, and the expansion of KTX-1001 into additional hematological and solid tumor indications. KTX-1001 is a novel, first-in-class, potent, and selective catalytic inhibitor of the H3K36 methyltransferase MMSET. It is an orally administered small molecule being developed initially for treating relapsed and refractory multiple myeloma, focusing on patients with the genetic translocation t(4;14).

"We are committed to developing KTX-1001 for t(4;14) multiple myeloma patients, a large patient population with chronic disease who are relatively unresponsive to existing and emerging therapeutics," said Terry Connolly, Ph.D., Chief Executive Officer of K36 Therapeutics. "We welcome our new investors who bring extensive expertise in cancer drug development as well as company building, and we are proud of the continued commitment from of our existing investors. This financing comes at a key time for K36 as we look forward to establishing KTX-1001 clinical proof of concept in multiple dosing regimens and demonstrating the expanded opportunity for KTX-1001 in additional hematologic and solid tumor malignancies."

K36 also announced that in conjunction with the Series B financing, Melissa McCracken, Ph.D., Partner at Nextech, will be joining K36’s Board of Directors.

"Nextech invests in emerging biotechnology companies that are developing transformative cancer medicines," said Dr. McCracken, "The K36 team has made remarkable progress since the company’s formation, advancing the only known selective inhibitor of MMSET into clinical development. I am excited to be a part of the K36 Board of Directors, and look forward to the continued clinical progress with KTX-1001 for the treatment of t(4;14) multiple myeloma, and beyond."

About KTX-1001
KTX-1001 is an investigational product and is the only clinical-stage inhibitor of MMSET, an oncogenic driver of multiple myeloma in patients with genetic translocation t(4;14). A phase 1 clinical trial in adult subjects with relapsed and refractory multiple myeloma is on-going. The Phase 1 clinical trial is a single-arm, open-label, multi-part study with dose escalation followed by an expansion cohort in patients with the genetic translocation t(4;14) to evaluate the safety, tolerability, and preliminary efficacy of different doses of KTX-1001.

On June 29, 2023 Triumvira Immunologics, a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with solid tumors, reported that it will be presenting clinical data on its lead asset TAC01-HER2 for the treatment of human epidermal growth factor receptor 2 (HER2) positive solid tumors at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer taking place in Barcelona, Spain, June 28 – July 1, 2023 (Press release, Triumvira Immunologics, JUN 29, 2023, View Source [SID1234632988]). The upcoming presentation will feature the latest clinical findings obtained from the ongoing Phase I/II trial of TAC01-HER2 (NCT04727151) among patients with relapsed or refractory solid tumors.

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"We are honored to share our latest advancements in precision cell therapy at ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer. Our innovative and well differentiated TAC01-HER2 cell therapy holds great promise in the treatment of HER2 positive solid tumors." said Deyaa Adib, M.D., Chief Medical Officer of Triumvira Immunologics. "This phase 1 data presentation represents a significant step forward in our mission to transform cancer care through the natural potential of T cells. We look forward to contributing to the scientific dialogue and working towards a future where targeted T cell therapeutics redefine the landscape of cell therapies in solid tumors, specifically in late stage gastric and esophageal cancers which has been an area of significant unmet need for a long time."

"These positive results are encouraging for the potential safety and efficacy of TAC01-HER2 in patients with relapsed or refractory solid tumors," said Dr. Ecaterina Dumbrava, assistant professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and investigator of the study. "These outcomes also warrant further investigation on the potential of TAC01-HER2 in this significant area of unmet clinical need."

ESMO World Congress on Gastrointestinal Cancer Presentation Details:

Title: A phase I/II trial investigating safety and efficacy of autologous TAC01-HER2 in relapsed or refractory solid tumors
Authors: Ecaterina Dumbrava
Category: Clinical Gastric Cancer
Subcategory: Metastatic Disease
Date and Time: June 29, 9:30 am – 17:40 pm
Abstract Number: P-31

Abstracts are currently available on the World Congress of Gastrointestinal Cancer website under the abstracts section. All abstracts will be published to the Annals of Oncology website on Saturday, July 1, 2023, at 16:30 p.m. CEST.

On June 29, 2023 Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported that six patients have been dosed with Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, in the ongoing Phase 2 I-SPY 2 clinical trial. (Z)-endoxifen is being evaluated as a neoadjuvant treatment for patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit (Press release, Atossa Therapeutics, JUN 29, 2023, View Source [SID1234632987]).

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The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. The (Z)-endoxifen treatment arm, which is expected to enroll approximately 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP). Patients will receive 10 mg of (Z)-endoxifen daily for up to 24 weeks prior to surgery. Currently, there are 41 I-SPY 2 sites, all of which have the EOP program open.

"Reaching 30% enrollment in the I-SPY 2 study is another important milestone in our ambitious (Z)-endoxifen development program," said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. "These patients have substantial risk for recurrence and need novel treatments options that are more tolerable and more efficacious than currently approved drugs. (Z)-endoxifen has the potential to slow the progression of ER-positive breast cancer in the neoadjuvant setting, making surgery more effective and reducing the risk of recurrence. We look forward to seeing data from this trial, which along with data from our Phase 2 EVANGELINE trial, will inform conversations with the FDA and our planned Phase 3 protocol."

"With the ISPY 2.2 TRIAL, we have focused on optimizing treatments for the fast-growing breast cancers; that focus has allowed us to make great progress. But one of the biggest challenges in breast cancer is the hormone positive breast cancers that are slow growing. They can recur for up to 15 years or more, and we urgently need to find predictors of response so that we can prevent late recurrence. And we know that women suffer from the side effects of years of extended endocrine therapy, especially when they have larger tumors. So, we have a great need to find more effective and more tolerable agents so that women with live longer and better. The goal of the endocrine optimization pilot is to test these new and exciting hormone directed therapies like endoxifen," said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY TRIAL.

About Premenopausal Patients with ER+ / HER2- Breast Cancer
Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. An overwhelming majority (75%) of premenopausal breast cancer falls under luminal A (ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function suppression, when combined with either tamoxifen or an aromatase inhibitor, is the standard of care for the endocrine management of stage 2 and 3 premenopausal ER+/HER2- breast cancer. The I SPY Endocrine Optimization Pilot (EOP) specifically targets women of all ages with molecularly low risk stage 2 and 3 breast cancer.

About (Z)-Endoxifen
(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. The Company is currently studying (Z)-endoxifen in three Phase 2 studies: one in healthy women with measurable breast density and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three issued U.S. patents and numerous pending patent applications.