On October 17, 2018 Invenra, an antibody drug discovery and development company with novel multispecific platforms and product candidates, reported the close of a $7M Series B financing round (Press release, Invenra, OCT 17, 2018, View Source [SID1234570587]). The financing will be used to expand the company to meet growing demand for partnerships using its’ B-Body multispecific technology as well as continuing development of its internal pipeline.

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Venture Investors led the round with participation from existing investors including Series A leader Wisconsin Investment Partners. The State of Wisconsin Investment Board (SWIB) also joined as a new investor. Additionally, Paul Weiss, Managing Director at Venture Investors, will join Invenra’s Board of Directors.

"Invenra’s discovery and development platform for bispecific antibodies has the potential to make meaningful contributions to the advancement of immuno-oncology", said Paul Weiss. "We already knew the capability of the team from our experience in backing Roland Green and members of the Board at NimbleGen Systems. We look forward to the opportunity to work together again on the important mission of Invenra."

Roland Green, CEO of Invenra, says "Invenra is excited to have Venture Investors and SWIB as part of our team. We look forward to working with Paul on our board as we develop our pipeline and partnerships. The additional funding will allow us to further leverage the B-Body platform for the high-throughput assessment of multispecific antibodies. This throughput and performance unlocks new and important therapeutic targets and mechanisms of action that were previously impractical through traditional methods. This funding along with milestones from partnerships will allow us to advance the preclinical development of our lead product candidates, namely our Biparatopic OX40 Agonist B-Body program and our tumor-specific Treg depleter SNIPER program."

On October 17, 2018 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, presented the results from its ongoing study utilizing Cchek, its artificial intelligence (AI) driven early cancer detection technology, at the 30th Anniversary AACR (Free AACR Whitepaper) Special Conference – Convergence: Artificial Intelligence, Big Data and Prediction in Cancer (Press release, Anixa Biosciences, OCT 17, 2018, View Source [SID1234530497]). This AACR (Free AACR Whitepaper) special conference covered the state of research in understanding cancer from incident to early diagnosis, prevention, and treatment using big data and machine learning. The meeting was held October 14–17, 2018 in Newport, Rhode Island and was attended by global leaders in the intersection of cancer research and artificial intelligence.

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Anixa, for the first time, presented data demonstrating the ability of Cchek to distinguish, among patients scheduled for biopsy, those who have high risk prostate cancer and those who have benign conditions or low grade cancer, for whom surgery is not required and a biopsy is unnecessary. In addition, Anixa’s Cchek data showed the ability to distinguish healthy males from high risk prostate cancer patients with a sensitivity of 89% and a specificity of 100%. This study further demonstrated the potential for Cchek to reduce the number of unnecessary prostate biopsies by up to 56%, while still retaining 89% sensitivity for detecting prostate cancers.

Dr. Amit Kumar, Anixa President and CEO stated, "We are pleased with the results of our ongoing study presented at the AACR (Free AACR Whitepaper) AI conference, and we are excited about the potential for us to dramatically reduce the number of unnecessary prostate biopsies. The ability to distinguish between high risk prostate cancer patients and those with a benign condition or low grade, non-surgically treated cancer is significant, and is a distinct differentiator between Cchek and many other liquid biopsy tests being developed today."

On October 17, 2018 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported that the United States Patent and Trademark Office issued a new patent protecting the company’s lead product candidate, Rigosertib (Press release, Onconova, OCT 17, 2018, View Source [SID1234529944]). U.S. patent 10,098,862 "Formulations with enhanced stability and bioavailability for administration of (E)-2, 6-Dialkoxystyryl 4-Substituted Benzyl Sulfones" describes novel compositions directed towards improving stability and enhancing bioavailability of Rigosertib. The issued patent claims novel formulations for oral and parenteral administration and oral dosing regimens of Rigosertib for the treatment of cancer and proliferative disorders.

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"Rigosertib is well protected by issued US and foreign patents as well as by Orphan Designation in the U.S., Europe, and Japan. We remain focused on our broader IP strategy that provides additional barriers to entry and expanded geographical coverage for our lead product candidate, which is in advanced clinical trials for unmet medical needs of patients with Myelodysplastic Syndromes," commented, Ramesh Kumar, Chief Executive Officer of Onconova. "Ensuring multi-faceted intellectual property protection around Rigosertib helps enhance the potential value of this innovative program."

U.S. patent 10,098,862 complements and adds to coverage provided by previously issued Composition of Matter patent U.S. 7,598,232 and its international counterpart patents and patent applications, including Rigosertib drug combination patents. While previous patents cover compositions, methods, formulations and other aspects of utility, the new patent provides additional coverage related to an oral dosing regimen of Rigosertib. The novel formulation patent was filed in 2017 as a PCT application globally and as National Phase applications in the U.S. and in Non-PCT countries including Taiwan and various countries in Latin America.

The named inventor of the patented technology is Dr. Manoj Maniar, Senior Vice President of Product Development for Onconova. The patent was filed by and is assigned to the Company.

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On October 16, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that it initiated patient dosing in the dose exploration cohort of its ongoing Phase 1 clinical trial of FPA150 (FPA150-001; NCT03514121), a targeted, first-in-class immuno-oncology antibody that targets B7-H4 (Press release, Five Prime Therapeutics, OCT 16, 2018, View Source [SID1234529927]).

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"We’re excited to be ahead of schedule in opening up our dose exploration basket cohort for FPA150, our first-in-class B7-H4 antibody, in patients whose tumors overexpress B7-H4," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "B7-H4 is generating excitement in investigators because it’s expressed in tumor types that are currently not well served by immunotherapy, including breast and gynecologic cancers. We’re hopeful that a targeted therapy like FPA150 will provide clinical benefit in these patients who have limited treatment options."

B7-H4 is in the same family of checkpoint molecules as PD-L1 and, like PD-L1, appears to inhibit T-cells in preclinical models. FPA150 has a dual mechanism of action: it blocks a T cell checkpoint pathway and delivers antibody-dependent cell-mediated cytotoxicity (ADCC) against B7-H4-expressing tumor cells.

FPA150-001 is an ongoing Phase 1a/1b dose escalation and expansion clinical trial of FPA150 monotherapy in patients with advanced solid tumors. The exploratory basket cohort is a part of that trial and will include up to 10 patients whose tumors overexpress B7-H4, as assessed by an immunohistochemistry (IHC) assay. The objective of this cohort is to evaluate a range of FPA150 doses to gain additional data on safety, pharmacokinetics (PK) and potential preliminary clinical activity. All patients will undergo pre- and on-treatment biopsies to assess the pharmacodynamic effects of FPA150 on the tumor and the tumor microenvironment.

The Phase 1a dose-escalation portion of FPA150-001 in unselected patients with any solid tumor is currently ongoing. The primary objective of this portion of the trial is to identify a maximum tolerated dose (MTD) or recommended dose (RD) for FPA150 monotherapy.

Once the MTD/RTD has been identified, the company will initiate a Phase 1b dose-expansion portion of the trial in B7-H4 positive tumors, including in breast cancer, ovarian cancer and endometrial cancer. The Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.

About FPA150

FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast and gynecologic cancers. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering ADCC against tumor cells expressing B7-H4.