On June 30, 2021 Alligator Bioscience (Nasdaq Stockholm: ATORX) and Scandion Oncology (Nasdaq Stockholm: SCOL) reported that promising preclinical data from their ongoing collaboration exploring the anti-tumor effects on drug resistant cancer by combining Scandion Oncology’s drug candidate SCO-101 and Alligator Bioscience’s candidate drug mitazalimab.

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The collaboration explores the anti-tumor efficacy of the CD40 antibody mitazalimab in combination with SCO-101 as an addition to chemotherapy (FOLFIRINOX) in chemotherapy-resistant preclinical tumor models. The hypothesis is that SCO-101 will revert chemotherapy resistance and thereby facilitate a strengthening of the anti-tumor effects of mitazalimab.

The combination of mitazalimab and FOLFIRINOX demonstrates a strong anti-tumor response in FOLFIRINOX resistant cancer cells. Importantly, the current data indicate that the anti-tumor effect of SCO-101, mitazalimab and FOLFIRINOX is even more potent than mitazalimab and FOLFIRINOX. The studies are still ongoing and further monitored for anti-tumor effects and survival.

The data further validate the potential of mitazalimab in combination with standard of care chemotherapy such as FOLFIRINOX.

"We are pleased to see that the preliminary results strengthen and expand the preclinical efficacy data for mitazalimab, by demonstrating synergy with FOLFIRINOX even in tumors resistant to chemotherapy. This bodes well for our OPTIMIZE-1 phase II study where we are assessing the efficacy of mitazalimab in combination with FOLFIRINOX in pancreatic cancer. Once we have the full data we will evaluate the possibility of testing of the triple combination in clinical trials," said Søren Bregenholt, CEO of Alligator Bioscience.

The data support the basic concept that SCO-101 in combination with chemotherapy and immuno-oncology is well tolerated and has a very potent anti-tumor effect in vivo on drug resistant cancer cells.

"The very first set of in-vivo data is encouraging. The studies will continue to draw the final conclusions, but this first assessment is supporting our hypothesis and opens for a novel opportunity in our R&D strategy. We are pleased that the collaboration with Alligator Bioscience has enabled us to explore the potential of SCO-101 in the setting of immuno-oncology and are committed to explore the potential of SCO-101 in immuno-oncology further," said Bo Rode Hansen, CEO of Scandion Oncology.

On June 30, 2021 Tweardy reported that it has been studying the signal transducer and activator of transcription 3 (STAT3) gene for 30 years (Press release, Tvardi Therapeutics, JUN 30, 2021, View Source [SID1234584512]). DePinho, who conceived andlaunched MD Anderson’s Cancer Moon Shots Program, successfully founded and raised capital for companies including Aveo Pharmaceuticals Inc. and KaryopharmTherapeutics Inc. Together, they raised $25 million in grants to move molecules targeting STAT3 toward the clinic, followed by $9 million in series A financing at thecompany’s launch in September 2018 to fund early clinical work.

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CEO Imran Alibhai, a long-time biotech investor and University of Texas- and Duke University-educated scientist, was hired to lead the company at the end of 2018. Hewas previously a senior vice president and managing director of Houston-based Dnatrix Inc.

STAT3 is important not only in the tumor itself, but also in the environment around the tumor, Alibhai said. Its activation is observed in about 70% of all cancers and up to95% of hepatocellular carcinomas (the most common type of primary liver cancer), according to research the company presented during a poster session at the 2021American Society of Clinical Oncology meeting.

As an orally bioavailable small molecule, TTI-101 "binds STAT3 and prevents phosphorylation, homodimerization, nuclear translocation, and ultimately, STAT3-mediatedtranscriptional activity," researchers explained.

To date, the drug has been "incredibly well tolerated," Alibhai told BioWorld, distinguishing it from other STAT3 inhibitor programs, such as Otsuka Pharmaceutical Co.Ltd.’s tablet-formulated OPB-31121, which the company quit developing following phase I results that reflected grade 3 adverse events (AEs) including lactic acidosis,diarrhea and vomiting. Another STAT3 gene inhibitor co-developed by Ionis Pharmaceuticals Inc. and Astrazeneca plc, danvatirsen, has also run into drug-related AEs insome patients, though the current status of the I.V.-administered candidate was unclear.
Selective targeting is the "secret sauce" of TTI-101, Alibhai said. "If you perturb STAT3 in general, you could potentially cause issues in all cells. So you have to be veryspecific about how you’re targeting it and only potentially disrupt the nuclear function," he said.

In Tvardi’s ongoing phase I study so far, TTI-101 has not only side-stepped dose-limiting toxicities, but also shown early signs of clinical benefit, Alibhai said. Multipleparticipants in the study also saw durable partial responses. The trial enrolled patients with both unresectable hepatocellular carcinoma and locally advanced, inoperable,metastatic and/or treatment-refractory solid tumors without other therapeutic options.

With dose escalation wrapped up in multiple arms of the study, it’s now moving on to dose-expansion cohorts which pave the way for phase II testing in liver cancer next.While the specific design of the phase II trial hasn’t been disclosed yet, Alibhai said investigators will enroll several cohorts of liver cancer patients which could generatesignals that could transition very quickly into confirmatory trials.

An expedited trial of TTI-101 in fibrosis could follow. So far, Tvardi has preclinical data demonstrating efficacy in liver fibrosis, idiopathic pulmonary fibrosis and sclerosis,Alibhai said. By the end of next year, the company could also move a second-generation STAT3 inhibitor it is developing, TTI-102, to the clinic. The ‘101 and ‘102 programsshare a similar scaffold, but the latter has shown early-on potency three to eight times greater than what has been seen with ‘101.

New investors Slate Path Capital, Palkon Capital, Arrowmark Partners and 683 Capital, led Tvardi’s series B round, with continued funding from existing investors,including Sporos Bioventures. In conjunction with the financing, Jamie McNab, partner at Slate Path Capital, will join Tvardi’s board. The company was Sporos’ firstinvestment. Along the way, it has attracted a number of high-profile scientific advisors, including MD Anderson Department of Immunology Chairman Jim Allison andKeith Flaherty, a professor of medicine at Harvard Medical School who co-founded Loxo Oncology and Scorpion Therapeutics Inc.

"As a physician, I am eager to see the potential of Tvardi’s molecules in diseases of high unmet medical need where STAT3 is a key driver," Flaherty said.

On June 30, 2021 Bioasis Technologies Inc. and Oxyrane UK are repored to announce the initiation of a research collaboration (Press release, Oxyrane, JUN 30, 2021, View Source [SID1234625993]).

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Bioasis is a pre-clinical, research-stage biopharmaceutical company developing a proprietary xB3 TM platform technology for the delivery of therapeutics across the blood-brain barrier (BBB) and the treatment of CNS disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases.

Oxyrane is developing enhanced enzyme replacement therapies (ERT) for lysosomal storage diseases (LSDs) using a proprietary, glyco-engineered yeast expression system for efficient targeting of enzymes to the lysosome. The research collaboration will focus on combining xB3 TM technology and Oxyrane’s OxyCAT platform to deliver an undisclosed enhanced enzyme replacement therapy into the brain.

Dr. Deborah Rathjen, Bioasis’ Executive Chair said, "We are excited to be collaborating with Oxyrane on this initiative to evaluate the combination of both our technologies to meet an unmet need for patients with LSDs for enzyme replacement therapies with greater efficacy. Bioasis’ technology has demonstrated preclinical success in delivering enzyme replacement therapy into the brain and the aim of this collaboration is to fast track the development of a next generation approach to enzyme replacement therapy with the potential for improved peripheral activity combined with brain penetrance to address neurological symptoms".

"We have been impressed by Bioasis’ technology for BBB delivery of enzyme replacement therapy and our technologies are very complementary so this collaboration is a natural fit. Oxyrane’s technology produces ERTs with enhanced cellular uptake and superior pharmacodynamics in a cost-efficient manner which we believe will be an overall benefit to patients", commented Dr. Wouter Vervecken the CEO of Oxyrane.

On behalf of the Board of Directors of Bioasis Technologies Inc.
Deborah Rathjen

On June 30, 2021 Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, reported that the results from a Phase I open-label study (NCT02903771) of the investigational drug candidate Cantrixil (TRX-E-002-1) have been published in Cancers, a peer-reviewed, open access journal of oncology (Press release, Oasmia, JUN 30, 2021, View Source [SID1234584496]).

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The paper entitled ‘Maximum Tolerated Dose and Anti-Tumor Activity of Intraperitoneal Cantrixil (TRX-E-002-1) in Patients with Persistent or Recurrent Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer: Phase I Study Results’ can be accessed online at the following link: View Source

Oasmia acquired the exclusive global development rights for the Cantrixil ovarian cancer program from Kazia Therapeutics Ltd earlier this year. Top-line data from the Phase I study previously reported by Kazia Therapeutics Ltd in December 2020 and presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2021 confirmed that the Phase I study met its primary endpoints, establishing clinical proof of concept.

The study was conducted at sites in the USA and Australia under the leadership of clinical trial’s Principal Investigator, Jermaine Coward, Associate Professor, ICON Cancer Centre, located in Brisbane, Australia. The study aimed to define the maximum tolerated dose, tolerability, and antitumor activity of Cantrixil when administered via an intraperitoneal (IP) port. Cantrixil was well tolerated even in patients with heavily pre-treated disease.

The study demonstrates the potential for prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cancer cells to standard chemotherapy with IP-administered Cantrixil.

Dr. Heidi B. Ramstad, CMO of Oasmia, commented: "These data are encouraging and has demonstrated the potential for prolonged survival in some patients with advanced ovarian cancer. By inducing ovarian cancer stem cell death and sensitizing cancer cells to standard chemotherapy, Cantrixil may improve survival outcomes in this patient population. Ovarian cancer remains one of the most aggressive cancers and are proven difficult to treat in advanced stages. We look forward to the forthcoming Phase 2 trial investigating Cantrixil in combination with first-line chemotherapy with an aim to improve survival rates in ovarian cancer."

On June 30, 2021 XBiotech (NASDAQ: XBIT) reported it received $75 million from funds escrowed as part of its December 2019 sale of bermekimab (Press release, XBiotech, JUN 30, 2021, View Source [SID1234584513]). The True Human antibody developed by the company to treat inflammatory disorders, including skin diseases, was sold in a uniquely structured Pharma deal that allowed XBiotech to continue to develop new anti-inflammatory antibodies against the same target. With the receipt of $75 million, XBiotech has now received a total of $750 million pursuant to the deal.

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XBiotech developed technology to clone monoclonal antibodies from the peripheral blood of humans with natural immunity against diseases. Bermekimab is a naturally occurring antibody capable of neutralizing one of the body’s most potent, and potentially destructive, inflammatory substances. In the sale agreement, XBiotech maintained the right to discover and develop new True Human antibody molecules with similar activity as bermekimab. According to the purchase agreement, XBiotech can develop these new True Human antibodies for all indications in medicine with the exception of dermatological indications. XBiotech could potentially receive up to $600 million more in cash from the deal by agreeing to provide exclusivity for certain additional indications with bermekimab.

As part of the sale agreement for bermekimab, XBiotech agreed to continue under contract to manufacture the antibody and supply finished product. As well, XBiotech engaged in a services agreement to provide its clinical operations to support clinical trial activities with the antibody therapy. These services have been ongoing and have been a significant source of revenue.

Since the sale, XBiotech has focused on research and development of other True Human antibodies that target the same inflammatory pathway as bermekimab. XBiotech has recently commenced a clinical program with just such a new antibody, XB2001, in pancreatic cancer.

About True Human Therapeutic Antibodies
XBiotech’s True Human antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.