On March 11, 2024 The Catalan biopharmaceutical company Ability Pharmaceuticals, SA (AbilityPharma), focused on the development of innovative oral autophagy-inducing anticancer compounds, reported a €7M investment from a European-Canadian syndicate of life sciences investors, including CTI Life Sciences Fund, Inveready, the EIC Fund, Fitalent and CDTI Innvierte (Press release, Ability Pharmaceuticals, MAR 11, 2024, View Source;7-million-financing-round-to-advance-development-of-its-clinical-phase-2b-autophagy-inducer-abtl0812-in-metastatic-pancreatic-cancer-302085276.html [SID1234641034]). The funding will allow the Company to fully finance its phase 2b clinical study of antitumor compound ABTL0812 in patients with pancreatic cancer.

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AbilityPharma is completing a Phase 2b clinical trial with ABTL0812 in metastatic pancreatic cancer (all 140 patients recruited) with the aim of demonstrating greater efficacy than standard treatment FOLFIRINOX. The double-blind, placebo-controlled, first-line study in combination with FOLFIRINOX is ongoing in 23 hospitals in Spain, USA, France, and Israel. Efficacy results are expected by year-end.

Significant superior efficacy results will allow AbilityPharma to obtain financing for final development of ABTL0812 or to license it to a multinational pharmaceutical or biotechnology company, with the goal of making ABTL0812 available to pancreatic cancer patients in 2028.

"We are very pleased to complete this financing round and welcome CTI Life Sciences Fund’s Shermaine Tilley to our board of directors, which will enable us to accelerate the development of ABTL0812 in the short term", stated Carles Domènech, PhD, Executive Chairman and CEO at AbilityPharma. "We are thankful to CTI Life Sciences, Inveready and the EIC Fund for completing this financing round, and to all our new and existing investors for their confidence in our team and for their support to our goals. This investment will allow us to continue working tirelessly on taking ABTL0812 to patients with pancreatic cancer".

Shermaine Tilley, PhD, MBA, Managing Partner at CTI Life Sciences Fund, said "We are delighted to provide financing for late-stage development of Ability Pharma’s innovative and highly promising treatment for pancreatic cancer. I am pleased to assume a position on their board of directors and will work with management and the board to optimize the value of ABTL0812 for patients and for investors".

Sara Secall, MSc, MBA, General Partner Inveready, said "We are excited to bring in savvy investors that can help move forward AbilityPharma’s treatment for cancer patients".

Svetoslava Georgieva, Chair of the EIC Fund Board, said: "The EIC Fund has become a strong player in EU deep-tech investments. The unique financing approach through the EIC, combining grants and equity, is attracting significant interest from Europe’s most promising start-ups and provides them with the means to develop and scale their businesses in Europe. Our investment will help Ability Pharma with the development of their product for patients with metastatic pancreatic cancer."

On March 11, 2024 enGene Holdings Inc. (Nasdaq: ENGN or "enGene" or the "Company"), a clinical-stage genetic medicines company whose non-viral, intravesical lead product candidate, EG-70, is in a pivotal study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), reported its financial results for the first quarter ended January 31, 2024 (Press release, enGene, MAR 11, 2024, https://www.prnewswire.com/news-releases/engene-reports-first-quarter-2024-financial-results-and-recent-corporate-progress-302085823.html [SID1234641033]).

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"This is an exciting time for the Company as we move closer to realizing our vision of mainstreaming genetic medicines to address diseases with high unmet clinical needs. EG-70 was designed from the ground up to achieve this vision as a readily scalable, easy to use product candidate without the onerous storage and handling requirements typical of viral approaches. Our previously announced Phase 1 data for EG-70 in BCG-unresponsive NMIBC demonstrated an encouraging safety profile and a 73% complete response rate at any time, which has garnered significant enthusiasm from patients, the urology community, and investors," said Jason Hanson, Chief Executive Officer of enGene. "We are proud to enter our second quarter as a public company with significant momentum, having raised $200 million from top tier investors in a private financing in February. With existing cash and cash equivalents expected to fund the current operating plan into 2027, we believe enGene is well-positioned to complete the ongoing pivotal-stage LEGEND study of EG-70 in BCG-unresponsive NMIBC, execute on our plan to file our BLA in the first quarter of 2026, and pursue pipeline expansion via additional EG-70 development opportunities and potential new R&D programs."

Recent Business Highlights:

Completed $200 Million Oversubscribed Private Placement: On February 20, 2024, enGene completed the private placement of 20 million common shares at a price per share of $10.00, representing a 31% premium over the closing price prior to pricing the transaction (the "February 2024 PIPE Financing"). The financing included participation from new and existing investors.
Expanded Hercules Capital Debt Facility: On December 22, 2023, enGene announced the expansion of its existing debt facility with Hercules to up to $50 million, subject to certain milestones, with $22.5 million advanced at closing, of which approximately $8.6 million was applied to refinance in full the term loans outstanding under the prior loan agreement with Hercules.
Key Leadership Hires, Board Additions and Succession Planning: enGene continued to build out its executive leadership with the appointment of Ryan Daws as Chief Financial Officer and Lee Giguere as Chief Legal Officer and Corporate Secretary. Additionally, Lota Zoth, CPA, was appointed to the Company’s Board of Directors and serves as the Company’s Audit Committee Chair.
On February 14, 2024, enGene announced that due to personal family and health reasons, Jason Hanson intends to resign from his role as Chief Executive Officer and a member of the Board of Directors upon the appointment of a successor CEO. The Board of Directors is conducting a search for his successor. Following the hiring of a new CEO, Mr. Hanson will support the Company and the new CEO as a strategic advisor.

Anticipated Milestones and Corporate Updates

Announce a new indication and development plans for EG-70 in the first half of 2024.
Interim data readout from the ongoing pivotal Phase 2 LEGEND study of EG-70 in BCG-unresponsive NMIBC with carcinoma-in-situ (Cis) in mid-2024.
Initial efficacy data from the ongoing Phase 2 LEGEND study in a BCG-naive NMIBC cohort in the second half of 2024.
First Quarter 2024 Financial Results

Cash and cash equivalents, as of January 31, 2024, were $85.6 million, compared to $81.5 million as of October 31, 2023. The Company expects that its existing cash and cash equivalents together with the recent net proceeds of $187.5 million from its February 2024 PIPE Financing will fund operating expenses and capital expenditures into 2027.

Three Months ended January 31, 2024

Total operating expenses were $10.8 million for the three months ended January 31, 2024, compared to $4.6 million for the three months ended January 31, 2023. Research and development expenses increased by $2.0 million, mainly due to increasing CMC and clinical costs related to our pivotal EG-70 study. General and administrative expenses increased by $4.2 million, primarily driven by headcount costs and professional fees such as legal, accounting and audit as the Company scales its G&A function to support the operation of a public company.
For the three months ended January 31, 2024, net loss attributable to common shareholders was $10.7 million, or $0.46 per share, compared to $8.6 million, or $13.29 per share, for the same period for the three months ended January 31, 2023. The increase in net loss is mainly attributed to the increase in operating expenses partially offset by net interest income earned during the period.

On March 11, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported that it has been selected to give two oral presentations at the Keystone Symposium on Cancer Immunotherapy: Beyond Immune Checkpoint Blockade and Overcoming Resistance, taking place March 17-21, 2024, in Whistler, Canada (Press release, Compugen, MAR 11, 2024, View Source [SID1234641032]).

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"We are delighted to be selected to give two oral presentations at the upcoming Keystone Symposium on Cancer Immunotherapy this year," said Anat Cohen-Dayag, Ph.D., President, and CEO of Compugen. "We believe our selection to present at a Keystone Symposium reflects the significant discovery, research and development taking place at Compugen as we are working to advance our vision to transform patient lives by developing first-in class therapeutics based on our computational target discovery platform."

Presentation & poster details

Oral presentation date:

Tuesday, March 19, 2024

Session title:

Novel insights into T Cell Biology

Lead author and presenter:

Dr. Assaf Menachem, Ph.D., Compugen

Presentation & poster title:

Unleashing Natural IL-18 Activity Using an Anti-IL-18BP Blocker Antibody Induces Potent Immune
Stimulation and Anti-tumor Effects

Poster date:

Tuesday, March 19, 2024

Poster number:

Poster #2042

Oral presentation date:

Tuesday, March 19, 2024

Oral session title:

Progress in Drugging the TIGIT and VISTA Pathways

Lead author and presenter:

Dr. Zoya Alteber, Ph.D., Compugen

Presentation & poster title:

PVRIG is Uniquely Expressed in Tumor Dendritic Cell-rich Niches on Stem-like Memory T Cells and
its Blockade May Induce Immune Infiltration and Activation in Non-inflamed Tumors

Poster date:

Monday, March 18, 2024

Poster number:

Poster #1001

The abstracts are available on the publication section of Compugen’s website www.cgen.com.

The presentations and posters will be made available on www.cgen.com, on the day of presentation.

On March 11, 2024 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and CEO: Gyo Sagara; "Ono") reported that it entered into a five-year, university-wide strategic research alliance agreement with Harvard University (Cambridge, MA, USA; "Harvard") aiming at validating novel therapeutic targets (Press release, Ono, MAR 11, 2024, View Source [SID1234641031]).

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In this alliance, as part of our ongoing open innovation initiative to collaborate with external partners, the request for proposals will be for research projects focused on the validation of novel therapeutic targets from labs across Harvard University in Ono’s priority research areas of oncology, immunology, neurology, and specialty with high unmet medical needs. Working together with Harvard’s Office of Technology Development (OTD), Ono will support and fund research projects that are jointly selected. With the combined expertise and resources of both Ono and Harvard, this strategic alliance will promote our innovative drug discovery efforts.

Ono has been dedicated to the drug discovery and development of innovative drugs, focusing on priority areas of oncology, immunology, neurology, and specialty areas to fulfill unmet medical needs. Ono has generated a number of innovative medicines, by proactively promoting "open innovation" by working with external partners. Through our unique drug discovery approach based on open innovation, we will be committed to creating innovative drugs.

"We are pleased to work together with Harvard University, a leading institution developing cutting-edge technologies and advancing research through strategic alliances such as this one," stated Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research at Ono Pharmaceutical. "Our alliance with Harvard University leverages the complementary strengths to accelerate the validation of novel therapeutic targets that would lead to the discovery of new drugs. We will continue to work hard to deliver innovative drugs for patients with unmet medical needs."

"Harvard’s alliance with Ono underscores the university’s commitment to advancing our understanding and treatment of some of today’s most pressing health issues," stated Vivian Berlin, Executive Director, Harvard Medical School in Harvard’s Office of Technology Development. "The alliance will support research projects that pave the way for a future where complex diseases are better understood and more effectively treated."

"Strategic alliances bring together academic discovery with industrial capabilities," stated Isaac Kohlberg, Senior Associate Provost and Chief Technology Development Officer at Harvard University. "Not only accelerating the translation of groundbreaking discoveries into tangible innovations but also enriching academic research with real-world applications."

On March 11, 2024 TiumBio Co., Ltd. (KOSDAQ: 321550), a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapeutics for patients with rare and incurable diseases, reported that it has submitted Investigational New Drug (IND) application to the Korean Ministry of Food and Drug Safe (MFDS) for a Phase 2a study of TU2218, an oral immuno-oncology drug, in late February, 2024 and that preclinical results of TU2218 will be presented at the upcoming 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, TiumBio, MAR 11, 2024, View Source [SID1234641029]).

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TU2218 is a novel oral dual inhibitor targeting transforming growth factor beta receptor 1 (TGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2). TGF-ß and VEGF pathways are known to be factors that interfere with the activity of immuno-oncology drugs, so TU2218 is expected to maximize the efficacy of immuno-oncology drugs by blocking them. TiumBio is currently conducting a Phase 1b clinical trial of TU2218 in combination with Keytruda (pembrolizumab) in advanced solid tumors in the U.S.

For the Phase 2a trial, TiumBio has selected indications in biliary tract cancer (BTC), head and neck squamous cell carcinoma (HNSCC), and colorectal cancer (CRC). The study will enroll up to 116 evaluable participants across three cohorts (up to 40 participants for BTC, up to 36 participants for HNSCC, and up to 40 participants for CRC, respectively) and will evaluate the efficacy and safety of TU2218 administered in combination with pembrolizumab.

BTC, HNSCC, and CRC have historically shown low treatment response rates to existing therapies. TiumBio expects that the combination of TU2218 and Keytruda will improve response rates in these tumors.

Meanwhile, to test the feasibility of various combination options with TU2218, TiumBio conducted in vivo efficacy studies in 4T1, MC39, and CT26 syngeneic tumor models. Results will be presented at the 2024 AACR (Free AACR Whitepaper), taking place from April 5-10 in San Diego, California.

The poster abstract highlights the improved efficacy and safety profile of TU2218 in combination with various immuno-oncology drugs. Specifically, the combination of lenvatinib, anti-PD-1 antibody, and TU2218 demonstrated a significant tumor growth inhibition (TGI) of 99% and a complete response (CR) rate of 67% in the CT 26 model, compared to a TGI of 76% and CR of 17% in the control group receiving only lenvatinib and anti-PD-1 antibody. The statistical difference in anti-tumor activity between the two groups was deemed significant (p<0.001).

"We believe that the results of this TU2218 triple combination regimen show substantial potential in enhancing anticancer efficacy. We will explore the commercial potential of the combination," said Hun-taek Kim, Ph.D., MBA, Founder and CEO, TiumBio. "The three indications we selected are diseases characterized by high expression of the target protein TGF-beta within the microenvironment, coupled with a significant unmet medical need attributed to low response rates to anti-PD-1 therapies. We will develop TU2218 as a safer and more effective novel drug to increase clinical benefits of the immune checkpoint inhibitors in this area," he added.