On June 15, 2021 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported it has received FDA authorization to conduct a Phase 1b/2 open-label study to evaluate the safety and preliminary efficacy of its superagonist Anktiva (N-803, an IL-15 superagonist) and PD-L1 targeted high-affinity natural killer (t-haNK) cells in combination with standard chemo and Trodelvy (sacituzumab govitecan-hziy), in subjects with advanced triple-negative breast cancer (TNBC) (Press release, NantKwest, JUN 15, 2021, View Source [SID1234584016]). The study may provide data indicating whether this combination can increase the effectiveness of Trodelvy in patients who have failed to respond to other treatments.

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Triple-negative breast cancer is a serious, aggressive cancer with a high mortality rate. While Trodelvy displayed efficacy against TNBC in phase 3 testing, only a third of third-line patients respond to it, and less than 17% of them continue to respond after a year. ImmunityBio proposed this new study based on data from a Phase 1 trial (NCT03387085) with Anktiva and the company’s haNK cells that elicited a significant response rate in refractory TNBC. Anktiva and PD-L1 t-haNK when used in combination with Trodelvy may show additive or even synergistic effects, greatly increasing the response rate and, importantly, durability of responses.

"Antibody-drug conjugates like Trodelvy have made tremendous progress in giving patients with TNBC more and higher-quality time, but we believe Anktiva could potentially fill remaining treatment gaps and offer patients additional hope," said Patrick Soon-Shiong, M.D., Founder and Executive Chairman of ImmunityBio. "We’re conducting multiple studies with Anktiva across different tumor types, in some cases in combination with our NK cell line, that are designed to determine if they can enhance the activity of therapeutic monoclonal antibodies like Trodelvy—and, ultimately, provide patients with longer, progression-free survival."

The strategy behind this approach is to attack the tumor in two distinct, complementary ways—with Trodelvy delivering the initial blow by targeting the protein Trop-2 displayed by many TNBC cells and delivering a chemotherapy payload while Anktiva recruits key cells of the immune system, including NK and T cells, to continue fighting the tumor. To further unleash the power of the immune system, PD-L1 t-haNK will be introduced.

QUILT 3.058 Study Details

This phase 1b/2 open-label study will evaluate the safety and efficacy of sacituzumab govitecan-hziy in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects with TNBC after at least two prior treatments for metastatic disease.

The study consists of two phases and the maximum total enrollment for this study is 79 subjects.

The phase 1b portion of the study will be conducted in 2 parts: part 1 will involve dose escalation using a 3 + 3 design, and part 2 will involve the expansion of the recommended phase 2 dose (RP2D) to further evaluate the safety and efficacy of sacituzumab govitecan-hziy plus chemoimmunotherapy. The phase 2 portion of the study will be based on Simon’s two-stage optimal design.
In phases 1b and 2, all subjects will receive sacituzumab govitecan-hziy plus chemo- and immuno-therapy: cyclophosphamide, N-803, and PD-L1 t-haNK on a 3-week schedule. . The dose of sacituzumab govitecan-hziy will be dependent on dose level cohort for phase 1b and will be set at the RP2D for phase 2. The doses of cyclophosphamide, N-803, and PD‑L1 t haNK will remain the same in all dose level cohorts and phases.
An estimated 2.3 million women globally were diagnosed with breast cancer last year and 685,000 died from it. Triple negative breast cancer is an especially aggressive form of the disease and accounts for 10% to 15% of breast cancers, according to the American Cancer Society. TNBC tests negative for estrogen receptors (ER), progesterone receptors (PR) and human epidermal growth factor receptor 2 (HER2) protein. Therefore, TNBC does not respond to hormonal therapy or medicines that target ER, PR, or HER2 and other treatment options are limited, particularly after initial lines of therapy have failed. Innovative treatment approaches, such as the combination of Trodelvy, Anktiva, and PD-L1 t-haNK with chemotherapy described here may offer new hope to these advanced TNBC patients.

On June 15, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that as part of the annual reconstitution of the Russell stock indexes, Moleculin has been selected to be added to the Russell 2000 Index effective after the close of the U.S. equity markets on June 25, 2021 (Press release, Moleculin, JUN 15, 2021, View Source [SID1234584015]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"We are pleased to have been included in this year’s reconstitution of the Russell 2000 Index. Our team has worked tirelessly to advance the Company on multiple fronts and we believe this inclusion is further evidence of those efforts. We are grateful for the opportunity to access increased market exposure to help drive awareness of our development programs seeking to solve the toughest challenges in highly resistant cancers and viruses," commented Walter Klemp, Chairman and CEO of Moleculin.

The Russell 2000 Index measures the performance of the small-cap segment of the US equity market. The Russell 2000 Index is a subset of the Russell 3000 Index representing approximately 10% of the total market capitalization of that index. It includes approximately 2,000 of the smallest securities based on a combination of their market cap and current index membership.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell’s U.S. indexes which are part of FTSE Russell, a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide.

On June 15, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported the U.S. Food and Drug Administration’s (FDA) clearance of its Investigational New Drug (IND) application for JTX-1811, an anti-CCR8 antibody, for which Gilead Sciences, Inc. (Nasdaq: GILD) has exclusive rights to develop and commercialize (Press release, Jounce Therapeutics, JUN 15, 2021, View Source [SID1234584014]). The IND clearance triggers a $25.0 million milestone payment to Jounce.

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JTX-1811, which will be referred to as GS-1811 in Gilead’s pipeline, is a monoclonal antibody created by Jounce and designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory (TITR) cells. The target of JTX-1811 is CCR8, a chemokine receptor enriched on TITR cells. When JTX-1811 binds to CCR8, it targets TITR cells for depletion by enhancing an antibody-dependent cellular cytotoxicity mechanism.

"The clearance of the JTX-1811 IND marks an important and validating milestone for Jounce in our approach to cancer immunotherapy treatment. We have now been able to bring multiple novel and diversified immunotherapy development candidates into clinical development, further enhancing our opportunity to bring benefit to cancer patients who have few options. Specifically, this is our fourth internally-developed antibody in five years and is testament to the power of our discovery to early development engine" said Richard Murray, PhD, Chief Executive Officer and President of Jounce Therapeutics. "We look forward to JTX-1811’s continued advancement as Gilead progresses this program into the clinic."

Under the terms of the September 2020 agreement, Gilead invested $35.0 million in Jounce’s common stock and made an $85.0 million upfront payment to Jounce. Jounce has led the development of JTX-1811 through IND clearance, after which Gilead now has the sole right to develop and commercialize the program. After receiving this $25.0 million milestone payment, Jounce may receive up to an additional $660.0 million in future clinical, regulatory and commercial milestone payments and will also be eligible to receive royalties ranging from high single digit to mid-teens based upon worldwide sales. Any milestone or royalty paid to Jounce is subject to certain reductions as described in the license agreement

On June 15, 2021 Umoja Biopharma, an oncology company leveraging its proprietary integrated technologies to reprogram immune cells in vivo to create next-generation immunotherapies for the treatment of solid tumors and hematologic malignancies, reported the completion of an oversubscribed $210 million Series B financing (Press release, Umoja Biopharma, JUN 15, 2021, View Source [SID1234584013]). The proceeds will enable Umoja to continue development of its integrated technologies, advance its product candidates based on CAR T-cell adapter-mediated tumor-targeting (TumorTag) and the in vivo modification of immune cells (VivoVec and RACR/CAR) into clinical development, and build internal manufacturing capabilities to support preclinical and clinical development of its pipeline programs.

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The financing was co-led by SoftBank Vision Fund 2 and Cormorant Asset Management with participation from new investors, including RTW Investments, LP; Temasek; Presight Capital (the international venture arm of Christian Angermayer’s Apeiron Investment Group); Caas Capital; and an investment fund associated with SVB Leerink. They were joined by all the company’s existing investors: MPM Capital, DCVC Bio, Qiming Venture Partners USA, Casdin Capital, The Emerson Collective, and Alexandria Venture Investments.

"Umoja has made tremendous strides in the past year, including advancing our preclinical programs, expanding manufacturing capabilities, and bringing on key hires to prepare for our next phase of development and growth," said Andrew Scharenberg, M.D., co-founder and Chief Executive Officer of Umoja Biopharma. "We are excited to continue this momentum, with ongoing efforts to further validate our in vivo-based approach for maximum patient impact in both solid tumors and hematologic malignancies."

The Series B funding will be used in part to advance Umoja’s two lead programs into the clinic: TumorTag UB-TT170 for folate receptor-expressing solid tumors, and VivoVec UB-VV100 for CD19+ hematological cancers.

"Umoja’s fully integrated approach is capable of engineering a patient’s own immune system to attack and destroy tumors with a simplicity and cost that enables widespread implementation," said Ryan Crisman, Ph.D., co-founder and Chief Technical Officer. "We believe our team is well positioned to deliver on the next wave of immuno-oncology therapies, providing transformative benefits as well as improving access to all patients."

Umoja will continue adding to its team to support the company’s rapid growth, building upon the recently announced leadership appointments of Nushmia Khokhar, M.D., as Chief Medical Officer, Irena Melnikova, Ph.D., as Chief Financial Officer, and David Fontana, Ph.D., as Chief Business and Strategy Officer, while also expanding its footprint to include a manufacturing operations site in Boulder, Colo.

On June 15, 2021 Alentis Therapeutics, the Swiss biotech developing breakthrough treatments for fibrotic diseases, reported that it has raised USD67 (CHF60) million in a Series B financing round (Press release, Alentis Therapeutics, JUN 15, 2021, View Source [SID1234584012]). The funding will be used primarily for proof-of-concept clinical trials of Alentis’ first in class, Claudin-1 targeting, anti-fibrotic molecules in advanced liver and kidney fibrosis, and support ongoing drug discovery programs targeting other fibrotic diseases and hepatobiliary cancers.

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Morningside Venture Investments led the financing, joined by Jeito Capital and Series A investors BioMed Partners, BB Pureos Bioventures, Bpifrance through its InnoBio 2 fund, High-Tech Gründerfonds and Schroders Capital.

"Our investors recognize the high unmet medical need," said Dr. Roberto Iacone, CEO of Alentis, "They feel a great sense of urgency to develop innovative treatments for patients with life-threatening fibrotic diseases as well as related deadly cancers such as hepatocellular carcinoma and cholangiocarcinoma." Dr. Iacone added, "This will fuel our strategy of expanding the indications for Claudin-1 targeting agents and further build our pipeline of proprietary product candidates.

Prof. Thomas Baumert, founder of Alentis, said that in the US and Europe alone, about 45% of deaths can be attributed to fibrotic disorders. He said that fibrosis affects nearly all tissues and organ systems such as the liver, kidneys and lungs.

"Fibrosis is an important risk factor for cancer, and Claudin-1 has a well-established role in cancer biology including tumor invasion and metastasis," Prof. Baumert said. "Given the absent and unsatisfactory treatment options, it’s critical that we deliver new therapeutics for patients suffering from fibrosis and cancer."

In addition, Alentis welcomed Jason Dinges of Morningside and Rafaèle Tordjman, founder and CEO of Jeito Capital, to its Board of Directors, effective immediately.

"We are excited about Alentis’ first-in-class approach to potentially enable effective treatments for fibrotic diseases with significant unmet medical need," said Dr. Dinges. "We look forward to supporting this exceptional team as they pioneer modulation of Claudin-1, an important and highly promising target in fibrosis and oncology."

"Our investment in Alentis is very much in line with Jeito’s goal to accelerate the growth of companies developing treatments for severely ill patients with no other options. We provide input into the science right through to the product’s market access," said Dr. Tordjman. "Alentis has an outstanding and experienced team from pharma and biotech and is focused on a unique target, based on the founder’s work and his team of more than 10 years."

Alentis’ unique therapeutic approach focuses on the inhibition of Claudin-1 outside the tight junction and its downstream signalling acting on cell fate and plasticity. Alentis’ lead molecules ALE.F02 and ALE.C04 are highly selective anti-Claudin-1 mAb that recognize pathological overexpressed and conformation-dependent Claudin-1 epitopes in fibrotic disease and cancer. In preclinical studies, the lead molecule ALE.F02 modulates the function of non-junctional Claudin-1, preventing, and possibly reversing, the growth of fibrotic tissue within the liver and kidney by changing the plasticity of key cell types mediating fibrosis. Safety studies in non-human primates have supported translatability of the approach into patients. Alentis expects to initiate its first clinical trial in Q4 2021.