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Caribou eyes $100M IPO as it aims off-the-shelf CAR-Ts at the clinic

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.

HERMES PHARMA announces spin-out from HERMES Arzneimittel

On July 1, 2021 HERMES PHARMA, previously a division of HERMES Arzneimittel GmbH,reported that it has formed a separate legal entity named HERMES PHARMA GmbH (Press release, Lifescience Newswire, JUL 1, 2021, View Source [SID1234584563]). The forward-looking change will see both HERMES PHARMA GmbH and HERMES Arzneimittel GmbH operating independently but remaining part of the Johannes Burges Family Foundation. The move marks a new phase for HERMES PHARMA bringing greater independence while retaining long-term stability for the company’s third-party business.

HERMES PHARMA is a CDMO specializing in the development and manufacture of user-friendly oral dosage forms for healthcare companies around the world. Services cover the entire pharmaceutical value chain – from new product development through to manufacturing and regulatory support. As a division, HERMES PHARMA has continued to see steady growth over the last 20 years. Annual turnover has increased sevenfold, achieving more than €140 million in 2020, and the division has quadrupled the size of its team.

Hermes Pharma Turnover

The consistent growth and maturity of the organization has made it necessary to adjust its structure to better meet future needs. Dr Thomas Hein, Senior Vice President Commercial & Regulatory Affairs, commented, "Becoming an independent company will provide HERMES PHARMA with increased flexibility, making us more agile in our management decisions. We will be able to focus our investments to best meet the needs of our customers, whether that’s through new technology, enhanced sustainability, or optimized supply agreements. We highly value our long-term customer relations, which we regard as a strategic asset, and look forward to a long future of open and trust-based partnerships."

HERMES PHARMA GmbH will move forward with the existing management team in place. Dr Andreas Schrepfer, Managing Director, said, "HERMES Arzneimittel has a long history of pharmaceutical excellence – more than 100 years, in fact. This reorganization is part of a long-term strategy that will build on our heritage and position us to foster future growth. Remaining in the Johannes Burges Family Foundation will help ensure our financial stability.

Nordic Nanovector Appoints Malene Brondberg as Interim Chief Executive Officer

On July 1, 2021 Nordic Nanovector ASA (OSE: NANOV) reported that Ms. Malene Brondberg has been appointed interim Chief Executive Officer with immediate effect (Press release, Nordic Nanovector, JUL 1, 2021, View Source [SID1234584561]).

Ms. Brondberg, who is currently the Company’s Chief Financial Officer, replaces Peter Braun who has decided to leave his position with Nordic Nanovector for personal reasons. Ms. Brondberg will continue in her role as CFO. The Board has initiated a search for a new CEO.

Ms. Brondberg joined Nordic Nanovector as Vice President Investor Relations in February 2018 and was appointed CFO in May 2020. She brings over 20 years’ operational experience in the financial services sector from a career that included being Global Head of Research, managing a team of over 65 people, and a member of the Executive Committee of the Nordic investment bank ABG Sundal Collier. Ms. Brondberg has also worked as a management consultant within the financial sector, acting as an advisor in relation to investor relations and funding. In addition, she has held interim CEO, COO and Head of Compliance/HR/Finance management positions at several companies.

Jan H. Egberts, MD, Chairman of Nordic Nanovector, commented: "The Board is pleased to appoint Malene Brondberg as Nordic Nanovector’s interim CEO. As CFO, Malene has proved to be a highly competent leader and has played a key role in the overall management of the business, including raising the funding needed to progress the on-going PARADIGME study with Betalutin. On behalf of the Board, I would like to wish Peter well in his future endeavours."

Hansa Biopharma to host conference call to provide interim results for first half 2021 and Business Update

On July 1, 2021 Hansa Biopharma AB (Nasdaq Stockholm: HNSA) reported that it will publish its interim report for January-June 2021 at 8:00 CET on July 15, 2021 (Press release, Hansa Biopharma, JUL 1, 2021, https://www.prnewswire.com/news-releases/hansa-biopharma-to-host-conference-call-to-provide-interim-results-for-first-half-2021-and-business-update-301324007.html [SID1234584560]). All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 14:00 CET/8:00am EST. The event will be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, and CFO, Donato Spota, and the presentation will be held in English.

Slides used in the presentation will be live on the company website during the call under "Events & Webcast," and will also be made available online after the call. Link to presentation

I-Mab Announces Multiple Advancements of 4-1BB Bispecific Antibody Portfolio

On July 1, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported multiple advancements in its 4-1BB bispecific antibody portfolio (Press release, I-Mab Biopharma, JUL 1, 2021, View Source [SID1234584559]). Stimulation of 4-1BB is a promising therapeutic strategy for improving the current immunotherapy for cancers. I-Mab’s lead bi-specific antibody assets TJ-CD4B/ABL111 and TJ-L14B/ABL503, both jointly developed with ABL Bio, Inc. (Kosdaq: 298380), are undergoing clinical development in the United States.

TJ-CD4B/ABL111 is the only clinical-stage bispecific antibody that binds to Claudin 18.2 (CLDN18.2)-expressing cancer cells and co-stimulatory molecule 4-1BB on immune cells to elicit a localized and combined immune response against solid tumors. Preclinical studies have demonstrated superior CLDN18.2-dependent immune activation with TJ-CD4B/ABL111 compared to 4-1BB monoclonal antibodies. The anti-tumor activity is achieved locally at the tumor site with no hepatotoxicity or systemic side effects that are commonly seen with 4-1BB monoclonal antibodies when used alone. Studies have also demonstrated a memory response that can resist tumor rechallenge for a long-lasting treatment effect.

A U.S. phase 1 clinical trial of TJ-CD4B/ABL111 in advanced or metastatic solid tumors (NCT04900818) has been initiated with the first patient being dosed on June 29, 2021. The phase 1 clinical study is a multi-center dose escalation and dose expansion study. To accelerate TJ-CD4B/ABL111 development, China sites will join the dose expansion part of the study. Patients with gastric cancer, esophageal adenocarcinoma and pancreatic cancer in China will be enrolled later this year.

TJ-L14B/ABL503 is another novel bispecific antibody uniquely designed to activate 4-1BB signalling in the presence of PD-L1, while simultaneously blocking PD-1/PD-L1 signalling. Preclinical studies have demonstrated superior anti-tumor activity for TJ-L14B/ABL503 compared to equimolar doses of 4-1BB and PD-L1 monoclonal antibodies single agents alone or in combination. The data suggest that TJ-L14B/ABL503 induced anti-tumor response was protective against tumor rechallenge in animal studies. These results have now been accepted for publication by the Journal for ImmunoTherapy of Cancer (JITC), titled "Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade." A phase 1 clinical trial for TJ-L14B/ABL503 was initiated in the U.S. earlier in April 2021 in patients with locally advanced or metastatic solid tumors (NCT04762641).

"As the next-wave of innovation in immuno-oncology, bispecific antibodies could be a promising solution to cancers that are resistant to the existing standard of care," said Dr. Joan Shen, CEO of I-Mab. "With the rapid development of our bispecific antibody portfolio, we are excited to progress one of the world’s first echelon of 4-1BB bispecific antibodies in the clinic."

About TJ-CD4B/ABL111

TJ-CD4B, also known as ABL111, is a Claudin 18.2 and 4-1BB bispecific antibody capable of binding to tumor cells expressing Claudin 18.2, i.e., gastric cancer and pancreatic cancer cells, and stimulating intra-tumoral T cells by the 4-1BB arm designed to be activated only upon tumor engagement whilst silent elsewhere. TJ-CD4B effectively maintains a strong tumor binding property and anti-tumor activity attributable to a synergistic effect of both Claudin 18.2 antibody and 4-1BB antibody while it avoids or minimizes liver toxicity and systemic immunotoxicity commonly seen with 4-1BB antibodies as a drug class. TJ-CD4B is being developed under collaboration between I-Mab and ABL.

About TJ-L14B/ABL503

Being developed jointly with ABL, TJ-L14B/ABL503 is a differentiated PD-L1-based bispecific antibody with the PD-L1 arm as the tumor-dependent T-cell activator and the 4-1BB arm as the conditional T cell activator upon tumor engagement. Using ABL’s ‘Grabody-T’ bispecific antibody platform technology, TJ-L14B/ABL503 stimulates 4-1BB activation only in the presence of PD-L1 expressing tumor cells to minimize the risk of off-tumor toxicity. Preclinical studies have demonstrated that the bispecific antibody shows better anti-tumor activity than equimolar doses of single agents alone or in combination.