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Alligator Bioscience AB reports financial results for the first 9 months of the year and for Q3 2022 and provides a business update

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.

MonTa Biosciences Announces Investment to Complete the Ongoing Phase I Monotherapy Trial on MBS8, and a Combination Phase IB/IIA Trial with MBS8 and a Currently Approved Oncology Drug.

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]).

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".

Ginkgo Bioworks Completes Acquisition of Zymergen

On October 19, 2022 Ginkgo Bioworks, the leading horizontal platform for cell programming, and Zymergen (Nasdaq: ZY) reported that Ginkgo has completed its previously announced acquisition of Zymergen (Press release, Ginkgo Bioworks, OCT 19, 2022, View Source [SID1234635829]). The acquisition is expected to significantly enhance Ginkgo’s platform by integrating strong automation and software capabilities as well as a wealth of experience across diverse biological engineering approaches.

"Today marks an important step in our long-term growth as we complete the Zymergen acquisition and welcome their world-class team to Ginkgo," said Jason Kelly, CEO and co-founder of Ginkgo Bioworks. "We are excited to integrate Zymergen’s capabilities into our platform and explore new and expanded partnerships and opportunities for their diverse array of product concepts currently under development."

Under the terms of the merger agreement entered into on July 24, 2022, Zymergen stockholders received, for each share of Zymergen common stock, 0.9179 shares of Ginkgo Class A common stock. Zymergen shares will no longer be traded on Nasdaq. Ginkgo Class A common stock will continue to trade on NYSE under the ticker symbol DNA.

Domain Therapeutics to progress into clinical trials with its EP4R antagonist DT-9081 in solid tumors

On October 19, 2022 Domain Therapeutics ("Domain" or "the Company"), a drug discovery and development company focused on G Protein-Coupled Receptors (GPCRs) in immuno-oncology (IO), reported that its proprietary IO candidate, DT-9081, has cleared its clinical trial applications (CTA) by the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) in France and the AFMPS (Agence Fédérale des Médicaments et des Produits de Santé) in Belgium, enabling Domain to start its Phase I clinical trial (Press release, Domain Therapeutics, OCT 19, 2022, View Source [SID1234622445]). The first-in-human clinical trial is on track to initiate by the end of the year .

DT-9081 is an oral small molecule drug candidate, which is able to reverse the prostaglandin E2 (PGE2)-mediated immunosuppression triggered by some tumors to bypass the immune system, by blocking the EP4 receptor present on immune cells. Given the high concentrations of PGE2 exhibited by a range of different solid tumors, Domain Therapeutics develops an extensive biomarker strategy, enabling optimal selection of tumor types and patient subpopulations and monitoring the target engagement in future clinical trials. Furthermore, this approach will help in finalizing the design of future clinical trials, in combination with standard of care including immune checkpoint inhibitors (such as anti-PD1).

Dr. Pascal Neuville, CEO of Domain Therapeutics, commented: "Today’s news marks a pivotal moment for Domain as we progress our first fully-owned immuno-oncology drug candidate towards the clinic. Our proprietary assets in immuno-oncology are selected through a rigorous approach that utilizes our unrivalled expertise of GPCRs. We believe that DT-9081 has the potential to be a best-in-class therapeutic with multi-tumor applications. We look forward to dosing our first patient by the end of this year."

Dr. Asmaa Boudribila, Medical Director at Domain Therapeutics, commented: "DT-9081 is a promising new candidate with the potential to treat a wide range of cancers. The signals and strong synergies with immune checkpoint inhibitors observed in preclinical studies strengthen our belief that DT-9081 could potentially be a game-changer in immuno-oncology therapies for cancer patients and we now look forward to progressing our first clinical milestone."

Hrain Biotech Plans $352 Million Shanghai STAR IPO for Novel CAR Candidates

On October 19, 2022 Shanghai Hrain Biotechnology reported that it will stage an IPO on Shanghai’s STAR board that is expected to raise $352 million for its cell therapy programs (Press release, ChinaBio, OCT 19, 2022, View Source [SID1234622252]). The company used CAR-T, CAR-NK and TCR-T technology to develop a portfolio of 11 candidates. Three of Hrain’s self-developed CAR-T candidates have started clinical trials, while its BCMA T-cell injection HR003 was granted China breakthrough therapy. The company expects to file an NDA for its lead product, a CD19-targeted CAR-T HR001, in 2023, which will be reviewed under priority rules.