Global Roundup: Ryvu Secures $22.4M Investment, Tessa and Enlivex Start New Trials

Ryvu and Opthea have new funding to work with, Tessa Therapeutics and Enlivex kick off new trials and Revive Therapeutics amends the Phase III protocol for its COVID-19 hopeful.

Poland’s Ryvu Therapeutics and Australia’s Opthea have new funding to work with, Tessa Therapeutics and Enlivex kick off new trials and Revive Therapeutics amends the Phase III protocol for its COVID-19 hopeful. For that and more, read on.

Poland’s Ryvu secured €22 million (about $22.4 million) from the European Investment Bank. Funds will be used to accelerate the development of new therapies to treat severe blood cancers and solid tumors.

The investment will help Ryvu finance its development pipeline of new cancer treatments from discovery through to clinical trials. Ryvu’s pipeline includes candidates with differentiated therapeutic mechanisms, including programs directed at kinase, synthetic lethality and immuno-oncology pathways. The company’s lead program is aimed at acute myeloid leukemia. Phase II data is expected later this year.

“We are very pleased to receive funding from the European Investment Bank, which plays such an instrumental role in providing financial support to innovation-driven companies like Ryvu that seek to develop new and potentially life-saving medicines,” Pawel Przewiezlikowski, chief executive officer of Ryvu Therapeutics said in a statement.

In addition to supporting its developmental pipeline, the funding will allow Ryvu to scale operations.

The money is being provided under the EIB’s venture debt instrument, which is tailored to the specific financing needs of high-growth innovative companies. EIB provided more than €20.7 billion across the continent, with about €1.5 billion going to Poland-based companies and organizations, an increase from €1.2 billion in 2020.

Elsewhere around the globe:

Tessa Therapeutics: Singapore’s Tessa Therapeutics, a cell therapy company focused on developing next-generation treatments for cancer, dosed the first patient in a Phase Ib trial assessing TT11, the company’s autologous CD30 chimeric antigen receptor T-cell therapy. TT11 is being paired with Bristol Myers Squibb’s Opdivo as a potential second-line treatment for patients with relapsed or refractory CD30-positive classical Hodgkin’s lymphoma. The trial will enroll up to 14 patients with CD30+ cHL with relapsed or refractory disease. This is after front-line therapy combining PD-1 antibody and CAR-T therapy in a “sandwich” study design that includes two cycles of Opdivo followed by treatment with TT11 and then two more cycles of treatment with Opdivo.

Opthea Limited: Australia’s Opthea Limited received commitments for a two-tranche placement of ordinary shares that will bring about $90 million. Opthea has entered into a non-dilutive financing arrangement for up to US$170 million with Carlyle and Abingworth, in collaboration with their recently formed development company, Launch Therapeutics.

SciSparc: Israel-based SciSparc Ltd. signed a non-binding letter of intent with Merhavit M.R.M Holding and Management Ltd to acquire from “a top-seller account,” as well as an American food supplements and cosmetics brand and trademark. This will provide dozens of GMP-manufactured hemp-based products. The company also announced it was granted an Israeli patent for its core technology that treats central nervous systems disorders. The invention relates to “Pharmaceutical compositions comprising cannabinoids and N-acylethanolamines, and methods for their use in preventing and treating a variety of cannabinoid-treatable conditions.”

Enlivex Therapeutics: Also based in Israel, Enlivex announced it received clearance from the Israeli Ministry of Health to conduct a Phase I/II study assessing Allocetra alone and in combination with a PD1 checkpoint inhibitor in patients with advanced solid tumors. Allocetra is an off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. The planned Phase I/II trial is a dose escalation trial and is expected to enroll up to 48 patients with advanced solid tumors across two trial stages. The planned study population will be adult patients with advanced, unresectable or metastatic solid tumors that have relapsed or have been refractory to available approved therapies or patients not eligible for or have declined additional standard-of-care systemic therapy.

Evonetix Ltd.: Based in the United Kingdom, Evonetix announced the opening of its early access program for semiconductor synthesized DNA. In its announcement, the company said its DNA synthesis capability “brings together patented semiconductor chip design and proprietary, thermally controlled synthesis chemistry” that will be integral for future gene synthesis platforms.

Revive Therapeutics: Toronto-based Revive Therapeutics announced that it intends to amend the study protocol for its Phase III study of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19. The amendment follows a conversation with the FDA following analysis and review of research supporting pre-dose selection data. The proposed new primary efficacy endpoints may include the time to resolution from COVID-19 via PCR test and the rate of sustained clinical resolution of certain symptoms of COVID-19. The company noted that these proposed endpoints address the shift in COVID-19 clinical outcomes observed throughout the pandemic and have more meaningful study endpoints for the FDA to consider for regulatory approval.

ProBio Gen: Based in Germany, ProBioGen closed a Master Service Agreement with NextPoint to initiate the development and GMP manufacturing of the company’s lead antibody candidate. NextPoint will harness the capabilities of ProBioGen’s CHO.RiGHT cell line to support the development of its drug candidate. The integrated services ensure that NextPoint can bring its molecule to the clinic on time.