On October 20, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported a strategic collaboration and license agreement with Roche to develop HB-700 for KRAS-mutated cancers and a second undisclosed novel arenaviral immunotherapy (Press release, Hookipa Pharma, OCT 20, 2022, View Source [SID1234622211]). This represents HOOKIPA’s first oncology licensing collaboration.

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Through the collaboration, HOOKIPA will conduct research and early clinical development through Phase 1b for HB-700, a novel investigational arenaviral immunotherapy for the treatment of KRAS-mutated cancers. Upon the completion of the Phase 1b trial, Roche has the right to assume development responsibility and to commercialize licensed products across multiple indications upon approval. The agreement also includes an option for Roche to license a second arenaviral cancer immunotherapy.

"Roche is an ideal partner, both in terms of development and reaching patients with novel cancer therapeutics. We look forward to working with them to benefit people with KRAS-mutated cancers," said Joern Aldag, Chief Executive Officer at HOOKIPA. "This collaboration validates the potential of our arenavirus platform and accelerates the development pathway to bring new treatments to people with cancer."

"We are excited to collaborate with HOOKIPA in leveraging their arenaviral technology, which has clinically demonstrated the ability to induce potent antigen specific CD8+ T cell responses and represents a promising approach for new cancer immunotherapies," said James Sabry, Global Head of Pharma Partnering at Roche. "This collaboration further strengthens our leadership in oncology, and we are optimistic about advancing this innovative platform to potentially provide more options for people with KRAS-mutated cancers, as well as other potential cancer types."

Under the terms of the agreement, HOOKIPA will receive an upfront payment of $25 million. Roche will have the option to expand the initial collaboration by adding an additional product candidate, whereafter HOOKIPA will receive an additional $15 million payment at option exercise. Including this option payment, HOOKIPA is eligible for research, development and commercialization milestone-based payments for HB-700 and the additional product candidate totaling up to approximately $930 million. Upon commercialization, HOOKIPA is eligible to receive tiered royalties of a high single-digit to mid-teens percentage on the worldwide net sales of HB-700 and the additional product candidate.

About KRAS-mutated cancers
KRAS is a gene that acts as an on/off switch for cell growth. When there is a mutation, or error, in the gene, cells can grow out of control. KRAS mutations are among the most common mutations that cause cancer. While KRAS-mutated, tumor-specific treatments exist, there remains an opportunity to target a broader range of KRAS-mutations simultaneously to potentially help more people impacted by these cancers.

About HOOKIPA’s Arenaviral Technology
HOOKIPA’s novel, replicating arenaviral technology has demonstrated the ability to induce potent antigen-specific T cell responses and promising anti-tumor activity in a Phase 1 clinical trial which treated patients with advanced Human Papillomavirus 16-positive head and neck cancers. Preclinical studies have also demonstrated the ability of arenaviral immunotherapies to break self-tolerance and induce potent T cell responses to tumor self-antigens and mutated epitopes, or target parts of a mutated, cancer-causing gene. These findings provide scientific rationale for the HB-700 program.

About HB-700
HB-700 is an investigational arenaviral immunotherapy designed to treat KRAS-mutated lung, colorectal, pancreatic and other cancers. HB-700 is a replicating 2-vector therapy that targets the most common KRAS mutations: (G12D, G12V, G12R, G12C and G13D) and thereby benefits more patients than single mutation inhibitors.

On October 20, 2022 Biotec Pharmacon reported that Our collaborators at University College London (UCL) Biochemical Engineering Department have presented a poster on the use of M-SAN HQ for purification of lentivirus vectors for cell therapy applications (Press release, Biotec Pharmacon, OCT 20, 2022, View Source [SID1234622210]). The poster entitled: "Removal of contaminating DNA in downstream processing of lentiviral vectors" was presented at the 29th Annual European Society for Cell and Gene Therapy at the EICC in Edinburgh, Scotland on October 12th, 2022. First co-authors, Roman Labbé and Noor Mujahid showed that M-SAN HQ helps to clarify contaminating dsDNA with enzymatic digestion after an optimal period of 10 minutes incubation at 25 U/ml. The poster findings, in summary:

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Significant differences were observed in the removal of dsDNA after enzymatic digestion compared to undigested samples
Lentivirus (LV) titre loss was observed but was attributed to bioprocessing conditions over the effect of nuclease digestion
Nuclease digestion led to a narrower particle distribution around 150 nm as measured by nanoparticle tracking assay (NTA)
Our M-SAN HQ is a leading nuclease for purification of viral vectors, with hundreds of satisfied customers in Cell and Gene Therapy and other biomanufacturing applications.

On October 20, 2022 Bayer reported that it has received a grant from the Bill & Melinda Gates Foundation (Press release, Bayer, OCT 20, 2022, View Source [SID1234622209]). As part of the grant, Bayer and the Bill & Melinda Gates Foundation have each committed more than US$ 12 million over four years to co-fund pre-clinical research activities with the goal of providing women globally with an option for non-hormonal contraception. In addition to research co-funding over a four-year period, Bayer will leverage its experience in women’s healthcare as well as research and development expertise in order to identify a pre-clinical development candidate. Bayer has also committed to make such a product available in low- and lower-middle-income countries at an affordable price once it would have been approved by health authorities.

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"The collaboration brings together Bayer’s research expertise, with the Bill & Melinda Gates Foundation’s purpose, to reduce inequalities around the world by facilitating access to health in low- and lower-middle-income countries," said Marianne De Backer, Executive Vice President, Head of Strategy, Business Development & Licensing/Open Innovation and Member of the Executive Committee of Bayer’s Pharmaceutical Division. "Together, we aim to further advance our vision to provide highly desired innovative non-hormonal contraceptive options to millions of girls and women around the globe in a sustainable manner."

"Sustainability is an integral part of our business," said Jeanne Kehren, Senior Vice President Digital & Commercial Innovation, Chief Information Officer, as well as responsible for Sustainability and a Member of the Executive Committee of Bayer’s Pharmaceutical Division. "With our strong heritage and deeply rooted expertise in women’s healthcare, Bayer has been supporting initiatives that contribute to providing girls and women in low- and lower-middle-income countries with access to family planning for more than 50 years. We are proud to work together with the Bill & Melinda Gates Foundation and join efforts to expand access to contraceptive options that address the unmet needs of women worldwide."

This new partnership adds to Bayer’s commitment focusing on providing innovative science and sustainable solutions to support the individual health needs of women worldwide and to help provide women and girls in low- and lower-middle-income countries (LMICs) with access to modern contraception. It’s the second joint activity involving both parties in the area of family planning, along with the collaboration on The Challenge Initiative (TCI).

Today, gender inequality remains an ongoing problem and teenage pregnancy and maternal death continue to be a serious health concern, especially in LMICs. Increased choice in modern contraceptive methods that better meet user needs and preferences will enable more women and girls to pursue educational and employment opportunities. Family planning is not only central to women’s health but also gives them greater autonomy over their lives, which can have a positive ripple effect on families and communities. With more than 200 million women worldwide having an unmet need for modern contraception, and 130 million women entering reproductive age until 2030 in LMICs, the need to provide reproductive supplies and services will further increase.

As a leader in women’s healthcare, Bayer has been supporting rights-based family planning programs in more than 130 countries. In partnership with international organizations, such as the United Nations Population Fund and the United States Agency for International Development, Bayer aims to make modern contraception more accessible to women worldwide. These efforts are in line with the Sustainable Development Goals of the United Nations.

About Women’s Healthcare at Bayer

Bayer is a recognized leader in the area of women’s healthcare, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative medicines. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide. Today, Bayer’s research and development efforts focus on finding new treatment options for symptoms associated with menopause as well as gynecological diseases and include several compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated. Additionally, Bayer intends to provide 100 million women in low- and lower-middle-income countries by 2030 with access to family planning by funding multi-stakeholder aid programs and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

On October 20, 2022 Alligator Bioscience AB (Nasdaq Stockholm: ATORX) (Press release, Alligator Bioscience, OCT 20, 2022, View Source [SID1234622208])

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Alligator Continues Progress in Key Clinical Programs

"The Alligator team has worked with dedication through the last months to continue to deliver on our commitment to develop meaningful therapies for patients with hard-to-treat cancer, while creating value for our stakeholders and shareholders. We have announced promising clinical results and achieved clear progress across our development programs. Our OPTIMIZE-1 Phase 2 study with our lead asset mitazalimab has seen a significant acceleration in patient recruitment allowing us to bring the top-line read-out forward by nine months. We announced the successful conclusion of the Phase 1 study in our second candidate ATOR-1017, confirming previously announced signs of clinical benefit. We are now looking for a partner to embark on the next phase of its development. Moreover, we are moving towards a new Phase 1 study in the US having received IND approval by the FDA for ALG.APV-527, which we are co-developing with Aptevo Therapeutics. This positive momentum puts us in a strong position to achieve our next milestones in the months ahead."
Søren Bregenholt, CEO Alligator Bioscience AB

BUSINESS UPDATE

Clinical Pipeline:
Mitazalimab

On September 14, Alligator announced the presentation of additional data from the Phase 1b dose escalation of the OPTIMIZE-1 study, which confirmed the pharmacological activity of mitazalimab in combination with mFOLFIRINOX and was found to be safe and well tolerated.
Patient enrolment for Phase 2 is ongoing at sites in Europe and has experienced a significant acceleration. Top-line data is now due in Q1 2024, nine months sooner than originally anticipated with the primary endpoint to show efficacy in patients with pancreatic cancer as per Response Evaluation Criteria in Solid Tumors (RECIST)-defined overall response rate (ORR).
Interim efficacy read-out expected in Q4 2022, which will be used to optimize the design of the upcoming OPTIMIZE-2 clinical trial.
ATOR-1017

On September 30, Alligator announced positive safety data from the 900 mg dose cohort in the ATOR-1017 Phase 1 dose escalation study in patients with advanced solid malignancies. Stable disease as best tumor response reconfirms previously reported signs of clinical benefit. This Phase 1 study is fully enrolled and has successfully fulfilled its purpose. Alligator will now seek a partner to support the continued clinical development of ATOR-1017.
ALG.APV-527

On September 19, Alligator and Aptevo Therapeutics announced that the US Food and Drug Administration (FDA) had issued a "may proceed" notification for the ALG.APV-527 investigational new drug application (IND), and the companies are now moving towards initiating a multi-center Phase 1 trial in the US.

Corporate:

As a testament to Alligator’s CD40 expertise, senior staff from the company were invited to present at various prestige medical and scientific conferences, including the World Bispecific Summit in Boston and Immuno UK in London.
The full report is attached as a PDF, and is also available on the company’s website: View Source

Alligator will host a conference call today at 3:00 p.m. CET for investors, analysts and media, where CEO Søren Bregenholt and CFO Marie Svensson will present and comment on the Q3 interim report, which will be followed by a Q&A session. The call will be held in English. All necessary information to listen-in is available on the following link: View Source

The information was submitted for publication, through the agency of the contact person set out below, at 08:00 a.m. CET on October 20, 2022.

On October 20, 2022 MonTa Biosciences, a clinical-stage biotechnology company focused on stimulating the immune system of cancer patients to induce immune cell-based tumor cell killing and to generate an immune memory response, reported that it has raised investment capital to complete two clinical studies (Press release, MonTa Biosciences, OCT 20, 2022, View Source [SID1234622170]).

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MonTa Biosciences is currently evaluating the drug candidate MBS8, which is a TLR7 agonist micelle formulation, in a phase I clinical trial. The monotherapy trial is divided into a dose-escalation and a dose-expansion part. So far 17 patients have been treated with MBS8 and have shown good tolerability and several interesting biomarker findings. The study is expected to be completed in Q4, 2023, with an established, Recommended Phase 2 Dose (RP2D). The investment will secure MonTa Biosciences to complete this phase I trial with enrollment of up to 24 patients for the expansion part.

The investment will in addition, secure the completion of a planned phase IB/IIA trial with MBS8 in combination with an oncology drug currently approved in several indications, and where MonTa Biosciences has demonstrated a strong synergistic effect in preclinical models with MBS8. Data from the ongoing phase 1 study support support these findings.The combination study is expected to be initiated during 2023, with the first patient treated by Q4 2023.

Simon S Jensen, CEO of MonTa Biosciences, said: "We are extremely happy to secure investment to further develop MBS8 in clinical trials aiming towards better treatment for cancer patients. We expectthe current studies will enable MonTa Biosciences to continue the clinical development towards an Accelerated Approval strategy". The investment of 11 mEUR is raised from existing investors in MonTa Biosciences and will allow continued development to the end of 2025.

Simon S Jensen further stated, "We have met our deadlines and reached our milestones timely during the last years, and through this process built strong and trusted relations with our investors. The investment provides us the time and resources to pursue a focused clinical development of MBS8 and demonstrate its true value as a potential novel oncology drug".