On June 8, 2022 C&Cure (CEO Min Jeong-jun and Park Joong-gon), which develops a bacterial anticancer drug platform and radioactive pharmaceuticals, reported the company has completed Series B bridge investment (Press release, CNCure, JUN 8, 2022, View Source [SID1234649033]).

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It has been one year since it was selected for Series A investment (KRW 6.5 billion) and investment-linked Ministry of Trade, Industry and Energy project (support amount KRW 2.5 billion) in February last year.

According to C&Cure on the 8th, existing institutional investors DT&Investment and ID Ventures made follow-up investments in the Series B bridge investment, and Hana Ventures participated as a new institutional investor.

Including the 2019 seed round (KRW 2.3 billion), the total amount raised up to this stage amounts to KRW 13 billion.

Kang Hoon-mo, an executive director at Hana Ventures who led this investment, said, "The investment point is the high research capabilities of C-level executives with world-class global competitiveness."

The funds raised will be used for the development of a bacterial anticancer drug currently underway in the United States (under contract with a US CDMO) and for the development of a radiopharmaceutical drug (in the first clinical trial underway with the Ministry of Food and Drug Safety).

The company plans to apply for an additional clinical trial of a radiopharmaceutical for the early diagnosis of malignant melanoma in the second half of this year.

C&Cure is a company established in 2019 by professors at Chonnam National University College of Medicine, and is conducting a national research project with a total budget of 8 billion won hosted by the Ministry of Trade, Industry and Energy and the Ministry of Science and ICT.

Professor Min (Department of Nuclear Medicine, photo), Professor Hong Young-jin (Microbiology), and Professor Kim Dong-yeon (College of Pharmacy, Gyeongsang National University) who are co-representatives are leading the research and development.

On June 08, 2022 Anagenex, a pioneering drug discovery company pairing large-scale data generation with machine learning to discover the next generation of small molecule medicines, reported that it has closed a $30 million Series A financing round led by Catalio Capital Management, with participation from existing investors Lux Capital, Khosla Ventures, Obvious Ventures, Air Street Capital, and Menlo Ventures (Press release, Anagenex, JUN 8, 2022, View Source [SID1234648814]). Catalio’s George Petrocheilos and Dr. Matthew Hobson will be joining the company’s Board as a Director and Observer respectively. Anagenex will use its Series A funds to further expand its novel data generating platform and build a robust pipeline of programs addressing historically challenging unmet medical needs.

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"At Lux, we’ve repeatedly seen how merging state-of-the-art computational tools with custom built lab operations transforms drug discovery to bring innovative medicines to patients"

"Traditional small molecule drugs, which account for the majority of FDA approvals, remain the best and most cost-effective medicines for most patients," said Nicolas Tilmans, CEO of Anagenex. "However, they are still very challenging to develop. At Anagenex we’ve built a closed-loop iterative system inspired by evolution that alternates between massive lab experiments and next-generation, machine learning-powered predictions so that we can deliver novel small molecule medicines to patients faster."

The Anagenex platform iteratively assesses up to billions of compounds in parallel to generate extraordinarily high quality data. First, Anagenex experimentally tests billions of compounds in parallel using a mix of technologies such as DNA Encoded Libraries (DELs) and Affinity Selected Mass Spectrometry. Those measurements feed into proprietary machine learning (ML) algorithms that consider not only the results of that experiment, but also hundreds of billions of other datapoints from internal databases. The trained ML models then design the next "evolved" generation of compounds to test, which Anagenex then synthesizes and tests. This creates a virtuous cycle of real data perfecting ML models, in turn, driving better data with each cycle. Armed with these enormous datasets and highly accurate models, Anagenex has the tools to address some of the hardest targets in drug discovery.

"We see a lot of platform technologies, but were blown away by Anagenex’s potential to fundamentally reshape how small molecule drugs are discovered," said George Petrocheilos, General Partner at Catalio. "Going after targets that have frustrated the industry for decades is always a risky business. The power and efficiency of Anagenex’s platform makes that risk tolerable, especially considering the potential payout."

Since beginning operations in the fall of 2020, Anagenex has built a customized parallel biochemistry lab miniaturizing, automating and carefully measuring every step in its parallel processes. This means Anagenex can rapidly generate data of unmatched quality, giving its ML algorithms an unprecedented clear view of chemical space.

"At Lux, we’ve repeatedly seen how merging state-of-the-art computational tools with custom built lab operations transforms drug discovery to bring innovative medicines to patients," said Zavain Dar, founding investor and Venture Partner at Lux Capital. "By controlling its process from start to finish, Anagenex’s expert team can build tailored neural networks and lab methodologies to achieve game-changing results."

Rapid Progress to Date

Prior to this Series A financing, Anagenex raised $7.2 million in a seed round led by Lux Capital in 2020, with participation from Obvious, Air Street Capital, Menlo, and Khosla. Since then, Anagenex’s team has applied their decades of experience in ML, parallel chemistry and biochemistry to build and validate the first generation of the company’s platform. With the Series A funding, Anagenex has now raised a total $37.2 million in financing to date.

To date, the Anagenex platform has processed over 25 targets and identified biochemically active compounds for eight of those with more coming weekly. Anagenex’s directed evolution platform has also identified small molecule compounds for a validated "undruggable" target. These powerful results have enabled Anagenex to develop a strong pipeline, including several early-stage drugs for cardiovascular and oncology indications.

For more information about Anagenex, go to www.anagenex.com.

On June 8, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to ALLO-501A in relapsed/refractory LBCL (Press release, Allogene, JUN 8, 2022, View Source [SID1234616278]). The RMAT designation was based on the potential of ALLO-501A to address the unmet need for patients who have failed other therapies.

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"The designation for ALLO-501A supports the patient need for access to an off-the-shelf CAR T product that can be delivered faster, more reliably, and at greater scale," said Rafael Amado, M.D., Executive Vice President of Research and Development and Chief Medical Officer. "Patients who are eligible for autologous CAR T therapy are often faced with treatment delays and manufacturing failures, placing them at risk for disease progression and disease-related complications. We look forward to initiating our pivotal trial on ALLO-501A and making this innovative product candidate readily available to patients."

Results from the ALPHA2 study were presented at an oral session of the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2021. Data support the potential of ALLO-501A to provide a safe and durable alternative to approved autologous CAR T therapies in CAR T naïve patients.

ALLO-501A was associated with consistent and manageable safety with no dose limiting toxicities (DLTs) or graft-vs-host disease (GvHD) and minimal Grade 3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), or Grade 3 cytokine release syndrome (CRS).
There were no relapses observed in LBCL CAR T naïve patients who were in a complete response (CR) at six months with the longest ongoing CRs with ALLO-501A at 15+ months.
Nearly all enrolled patients were able to receive therapy with the median time from enrollment to initiation of treatment of two days in ALPHA2.
Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising pipeline products, including cell therapies, that includes all the benefits of Fast Track and Breakthrough designation. An investigational cell therapy is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints and potential ways to satisfy post approval requirements.

On June 8, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has granted conditional marketing authorisation for the CD20xCD3 Tcell engaging bispecific antibody Lunsumio (mosunetuzumab), for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies (Press release, Hoffmann-La Roche, JUN 8, 2022, View Source [SID1234616239]). Lunsumio is an off-the-shelf therapy that is readily available, so people do not have to wait to start treatment.

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Each year, more than 28,000 people in Europe are diagnosed with FL, which accounts for approximately one in five non-Hodgkin lymphoma cases.1,2 Despite treatment advances, FL is considered an incurable disease and relapse is common, with outcomes worsening on each consecutive treatment.1

"We are delighted that Lunsumio is the first bispecific antibody approved in Europe for people with relapsed or refractory follicular lymphoma," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Lunsumio’s high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated."

"Having additional treatment options for people with follicular lymphoma, where multiple prior lines of therapy have failed, is critical to help them achieve better outcomes," said Elizabeth Budde, M.D., Ph.D., Haematologic Oncologist and Associate Professor at City of Hope. "It is exciting to have a new class of immunotherapy like Lunsumio, offering a readily available, chemotherapy-free and fixed-duration treatment, with great potential to provide durable remissions without the need to stay on treatment continuously."

The approval is based on positive results from the phase I/II GO29781 study where Lunsumio demonstrated high complete response rates, with the majority of complete responders maintaining responses for at least 18 months, and favourable tolerability in people with heavily pre-treated FL. After a median follow-up of 18.3 months, the median duration of response among responders was 22.8 months (95% CI: 9.7-not estimable), the complete response rate was 60% (n=54/90), the objective response rate was 80% (n=72/90). The most common adverse event was cytokine release syndrome (39%), which was generally low grade (grade 2: 14%), and resolved by the end of treatment. Other common (≥20%) AEs were neutropenia, pyrexia, hypophosphatemia and headache. The initial dose was administered without mandatory hospitalisation. Results were presented for the first time in December 2021 at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition.3

Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required.

A robust development programme for Lunsumio is ongoing including two phase III studies: CELESTIMO, investigating Lunsumio plus lenalidomide in second line plus (2L+) FL, and SUNMO, investigating Lunsumio plus Polivy (polatuzumab vedotin) in 2L+ diffuse large B-cell lymphoma (DLBCL).

This is Roche’s second EU approval in lymphoma in 2022, following the approval of Polivy in combination with MabThera (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated DLBCL.4 With a broad portfolio and pipeline, Roche is committed to providing treatment solutions for different stages of blood disorders, that are tailored to the disease, patient, physician, and healthcare system, as monotherapies or in combination with established and/or novel agents.

About Lunsumio (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other blood cancers.

About the GO29781 study
The GO29781 study [NCT02500407] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio (mosunetuzumab) in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints).

About follicular lymphoma
Follicular lymphoma (FL) is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL.1 It is considered incurable and relapse is common. It is estimated that more than 100,000 people are diagnosed with FL each year worldwide, including over 28,000 people in Europe.1,2

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera (rituximab), Gazyvaro (obinutuzumab), Polivy (polatuzumab vedotin), Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and Lunsumio (mosunetuzumab), targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On June 8, 2022 Evgen Pharma plc (AIM: EVG), the clinical stage drug development company developing sulforaphane-based medicines for the treatment of multiple diseases, reported its audited results for the year ended 31 March 2022 (Press release, Evgen, JUN 8, 2022, View Source;newsid=1592002 [SID1234616036]).

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Operational highlights

· In vitro pre-clinical work supports SFX-01 use in metastatic breast cancer patients who have become resistant to the widely used class of CDK4/6 inhibitor drugs

· Malignant glioma Orphan Drug Designation for SFX-01 granted by FDA

· Publication of positive preclinical in vitro and in vivo data in glioblastoma from two independent groups of collaborators, in Italy and New Zealand

· Encouraging early in vitro data for SFX-01 in Juvenile Myelomonocytic Leukaemia ("JMML") at the MRC Weatherall Institute, University of Oxford

· Scale-up of the active ingredient in SFX-01 to commercial scale achieved with a number of process improvements

· JuvLife partnership around the application of the Sulforadex technology continues to progress well; US market launch of a JuvLife nutritional health product is anticipated around end- 2023

· New formulation of SFX-01 generated in tablet form enabling scale-up to supply late-stage clinical trials and commercial use

· r Helen Kuhlman and Dr Glen Clack appointed as Chief Business Officer and Chief Medical Officer respectively, completing the senior management team

· utlook:

o Intention to start healthy volunteer trial in Q4 2022 with new SFX-01 formulation

o Final preclinical work in GBM completed and now in late-stage preparation for a Phase Ib/IIa trial due to start in Q4 2022

o New academic collaborations with La Sapienza University, Rome in SFX-01 radiosensitisation and Michigan University in colon cancer

Financial highlights

· Financial performance in-line with expectations:

o Cash and short-term deposits at 31 March 2022 of £9.0m (31 March 2021: £11.6m); Group funded to Q4/2023

o Post-tax loss of £2.7m (2021: loss of £2.7m)

o Cash outflow from operations of £2.6m (2021 outflow of £2.9m)

Dr Huw Jones, CEO of Evgen Pharma, said:

"Our focus during the year has been on achieving the objectives set at our 2021 fundraise, particularly around manufacturing, formulation and clinical trials preparation. With this groundwork now complete, we are pleased to have achieved very visible progress in each of our development programmes and we are anticipating another busy year which will include clinical data from both the Phase I/Ib volunteer and Phase Ib/IIa glioblastoma trials."