On July 1, 2021 Caribou Biosciences reported that it filed on Thursday to raise $100 million in its Wall Street debut (Press release, Caribou Biosciences, JUL 1, 2021, View Source [SID1234584565]). The proceeds will propel three off-the-shelf CAR-T therapies into and through the clinic and boost Caribou’s work in natural killer (NK) cell therapies.

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Caribou is developing all three programs for patients with blood cancers whose disease has come back despite undergoing other treatments or did not respond to those treatments in the first place.

The company’s most advanced program, CB-010, is an anti-CD19 CAR-T that’s in a phase 1 trial in B-cell non-Hodgkin lymphoma. Some of the IPO proceeds will support this trial through initial data, which are expected in 2022.

RELATED: Caribou nets $115M to boost CRISPR tech, advance off-the-shelf cell therapies

The funds will also bankroll IND-enabling activities for two other programs: CB-011, a BCMA-targeting CAR-T in development for the treatment of multiple myeloma and CB-012, a CAR-T targeting CD371 for the treatment of acute myeloid leukemia. The company hopes to start human trials for these programs in 2022 and 2023, respectively.

All three programs are allogeneic CAR-T treatments, meaning they are made from donor cells, rather than a patient’s own cells like the four approved CAR-T therapies from Novartis, Gilead’s Kite unit and Bristol Myers Squibb.

Those types of treatments, called autologous, can be complex and time-consuming to make: cells must be taken out of the patient, modified to fight cancer and then put back into the patient. Some patients don’t have enough T cells, or T cells of good enough quality, to make those treatments. Others simply don’t have much time.

RELATED: Blackstone, Cellex and Intellia form $250M CAR-T startup

Though Caribou’s CAR-T programs all target blood cancer, the company is working on allogeneic NK cell therapies based on induced pluripotent stem cells for solid tumors. Some of the IPO haul will support R&D in this area, as well as the development of the CRISPR technology it uses to make its cell therapies.

In recent years, the cell therapy space has been teeming with new entrants looking to break the barriers seen in the first generation of cell therapies. In 2018, a pair of former Kite Pharma executives unveiled Allogene, a biotech that started out with $300 million and 17 off-the-shelf CAR-T assets licensed from Pfizer.

France-based Mnemo Therapeutics is trying to make CAR-T work for solid tumors by identifying better targets. Other companies, like Catamaran Bio, are going after that same piece of the pie, but via NK cell treatments instead.

On July 1, 2021 QIAGEN (NYSE:QGEN; Frankfurt Prime Standard:QIA) reported a global strategic alliance with Japan’s Sysmex Corporation (Tokyo Stock Exchange, First Section [Ticker Code: 6869]) for the development and commercialization of cancer companion diagnostics, which will leverage both QIAGEN’s leadership in this field and Sysmex’s Plasma-Safe-SeqS technology for next generation sequencing (NGS) (Press release, Sysmex, JUL 1, 2021, View Source [SID1234584531]).

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The alliance aims to foster collaborations with pharmaceutical companies for the development of drug treatments for cancer and promote early clinical adoption of ultra-sensitive liquid biopsy companion diagnostics. QIAGEN and Sysmex have a longstanding partnership, which, for example, provides the ipsogen JAK2 blood-cancer test in Japan. Cancer companion-diagnostics products will be launched by QIAGEN and Sysmex in various regions of the world.

Genetic analysis of tumors makes it possible to identify the genes responsible for the development and spread of a tumor and to target treatment accordingly. But the traditional analysis of solid tumors is constrained by their heterogeneity – varying concentrations of cancer cells, for example – and by sample availability. Liquid biopsy addresses these challenges and, in combination with sensitive NGS, allows the evaluation of patients at different points of their cancer treatment. It enables doctors to spot new anomalies and adjust treatments to make them more precise, and to develop novel targeted therapies.

"Combining QIAGEN’s global reach with Sysmex’s NGS capabilities is an important milestone in advancing the use of NGS technologies in clinical decision-making and is a testament to our shared vision of using this powerful technology to improve outcomes for patients worldwide," said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. "This alliance will add strong NGS capabilities to our regulatory and clinical expertise and commercialization, and help our partners in the pharmaceuticals industry by expanding our strong position and product offering in companion diagnostics. We look forward to this alliance creating significant benefits for our pharma partners – and ultimately for treating patients."

"The alliance with QIAGEN promises Sysmex a great application for Sysmex’s Plasma-Safe-SeqS technology, which can detect gene mutations of cancer in blood with ultra-high sensitivity. We believe that QIAGEN is the best for Sysmex to expand this globally," said Hiroshi Kanda, Member of the Managing Board and Senior Executive Officer, Head of Corporate Business Development at Sysmex.

QIAGEN is a pioneer in precision medicine. It is the global leader in collaborating with pharmaceuticals and biotechnology companies to co-develop companion diagnostics that detect genetic abnormalities and guide clinical decision-making. QIAGEN has an unmatched breadth and depth of technologies – from NGS to polymerase chain reaction (PCR) – for companion-diagnostics development. QIAGEN’s portfolio includes ten PCR-based companion-diagnostics products that are approved by the FDA. They include therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer and NSCL (including the G12C mutation), therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples, and the therascreen BRAF kit for colorectal cancer.

QIAGEN has master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostics for drugs in development – a pipeline of potential products to advance precision medicine and benefit patients. QIAGEN has partnered with Illumina to broaden the use of NGS-based companion and other in-vitro diagnostics (IVD) kits in patient management.

On July 1, 2021 Sirnaomics Ltd., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that it has sealed $105 million in a Series E financing (Press release, Sirnaomics, JUL 1, 2021, View Sourcesirnaomics-secures-105-million-series-e-financing/" target="_blank" title="View Sourcesirnaomics-secures-105-million-series-e-financing/" rel="nofollow">View Source [SID1234584548]). This round of funding was led by Rotating Boulder Fund, an investor that has been supporting the company since its Series B round, with participation from existing investors and a well-recognized syndicate of new investors.

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Proceeds from the financing will be used to fund the continued development of Sirnaomics’ novel RNAi therapeutics for treating diverse human disorders, which include cancers, viral infections, fibrosis, and metabolic diseases. Sirnaomics will also further advance its delivery technology platforms and strengthen its large-scale manufacturing capacity to support the company’s fast-growing product pipeline at different clinical stages (See: View Source).

Sirnaomics’ product candidates, STP705 and STP707, are dual targeting siRNA therapeutics against TGF-β1 and COX-2 for either local or systemic administration to treat various types of cancers and fibrotic diseases. Based on successful clinical and preclinical studies, a future clinical focus will be targeted towards immune oncological evaluation, with combination design of the novel RNAi drug candidate and immune checkpoint inhibitors, such as PD-1/PD-L1 monoclonal antibodies. With further expansion of the company’s systemic RNAi drug delivery platforms, encompassing siRNA-chemodrug conjugates and proprietary GalNAc-siRNA conjugates, Sirnaomics is poised to address multiple therapeutic areas.

"We are pleased to close the Series E round of financing with oversubscription from a very diversified and strong investor base," commented Patrick Lu, Ph.D., Founder, President and Chief Executive Officer. "This is another powerful validation that the RNAi therapeutics, fuelled by innovative delivery platforms, ground-breaking CMC technologies, and fast expansion of multiple clinical programs with positive results, are attracting significant interests from the investment community. We appreciate strong trust and persistent support from our existing investors, and we are very excited with this addition of a well-regarded syndicate of investors for the Series E financing. This combination of existing and new investors will not only strengthen our financial foundation, but also bring tremendous experience and expertise to Sirnaomics as it enters the next phase of growth."

On June 30, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported a clinical trial collaboration and supply agreement with Merck (Press release, Alpine Immune Sciences, JUN 30, 2021, View Source [SID1234584500]). This collaboration will evaluate the safety and efficacy of Alpine’s ALPN-202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States. The clinical trial, NEON-2, began dosing study participants in June 2021.

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"We are extremely pleased to collaborate with Merck, one of the world’s leading immuno-oncology companies," said Stanford Peng, M.D., Ph.D., President and Head of R&D of Alpine. "Our prior preclinical studies demonstrated that the combination of ALPN-202 and a PD-1 inhibitor can be particularly advantageous, and this collaboration will greatly enable our ability to pursue this opportunity in the clinic. This study, in conjunction with NEON-1, ALPN-202’s ongoing first-in-human monotherapy trial, will provide insights across a broad spectrum of cancers and lines of therapy."

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

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a monotherapy study of ALPN-202 in patients with advanced malignancies, and NEON-2 (NCT04920383), a study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, are currently enrolling.

On June 30, 2021 Again Life Italia S.r.l. ("ALI"), a pharmaceutical biotechnology company headquartered in Italy, and TannerLAC UK Limited ("TannerLAC"), a subsidiary of Tanner Pharma Group and commercialization leader in Latin America, reported the signing of a business partnership agreement for Latin America (Press release, Tanner Pharma Group, JUN 30, 2021, View Source [SID1234584516]).

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With their global presence, ALI is dedicated to supporting cancer patients undergoing chemo and radiation therapy. Similarly, TannerLAC supports patients and biopharma companies by providing access to medicines in targeted markets.

Carolina Cortez, EVP of TannerLAC, commented, "We are very excited about the opportunity to work with Again Life Italia to improve the quality of life of patients in Latin America who experience side effects from chemo and radiation therapies."

Antonella Sardei, CEO of Again Life Italia, added, "Our partnership with TannerLAC is strategic to promote the products and the philosophy of Again Life Italia in Latin American countries and is in line with the company’s mission in supporting patients, especially those affected by side effects related to anticancer treatments, giving them the respect due to those who suffer."

The objective of the partnership is to leverage TannerLAC’s 18 years of experience to provide ALI’s innovative treatments to markets such as Argentina, Brazil, Chile, Colombia, Ecuador, Mexico and Peru.