On January 13, 2020 Pear Therapeutics, Inc. the leader in Prescription Digital Therapeutics (PDTs), reported that it has entered into an agreement with Apricity Health, LLC to develop up to two product candidates for precision management of patients undergoing cancer treatment (Press release, Pear Therapeutics, JAN 13, 2020, View Source [SID1234553104]). Apricity, a pioneer in leveraging technology and analytics to address the expertise gap in real-world medicine, is developing its first product candidate, ApricityRx, to enable intelligent monitoring and precision management of patients receiving immune checkpoint therapies. As part of the agreement, Pear will have the option to license two oncology PDTs arising out of this combined effort.

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IO is transforming cancer care, but there remains a major unmet need in maximizing its real-world effectiveness and minimizing associated toxicities. Founded by world renowned physician scientists in cancer and immuno-oncology, with an august advisory board of clinical experts led by Nobel Laureate Dr. James Allison, Apricity’s mission is to deliver clinical expertise with digital technology at the point of care to help practicing oncologists and nurses better manage IO-related toxicities in patients receiving IO therapies.

"Dr. Allison, an inventor of immune checkpoint therapy, has shown us that targeting the immune system can potentially cure cancer patients. Our team of expert advisors has over a decade of experience treating patients on IO therapies and managing their toxicities to help them stay on treatment with better outcomes," said Lynda Chin, M.D., President and CEO of Apricity Health. "We now need to share our expertise with real world practitioners so more patients can benefit from these revolutionary new medicines. We believe our synergistic collaboration with Pear will help us get there faster."

"By combining Pear’s platform and infrastructure with Apricity’s clinical expertise and analytics, we believe we can enhance the effectiveness of cancer treatment for patients," said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. "PDTs like ApricityRx may have the potential to directly improve efficacy when prescribed in combination with IO medications."

On January 13, 2020 Genome & Company (KONEX: 314130) is reported that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with avelumab, a human anti-PD-L1 therapy, in multiple cancer indications (Press release, Genome & Company, JAN 13, 2020, View Source;company-announces-a-clinical-trial-collaboration-and-supply-agreement-with-merck-kgaa-darmstadt-germany-and-pfizer-300985435.html [SID1234553121]).

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Under the terms of this agreement, Genome & Company will be the sponsor of the study, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for the phase 1/1b clinical trial that is expected to be commenced in 2020 in the U.S. Both parties will have access to the clinical data.

The combination trial is designed to be a first-in-human (FIH) study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.

"GEN-001 has been developed as the backbone of Genome & Company’s immuno-oncology pipeline, and we are delighted to collaborate with the global leaders in oncology such as Merck KGaA, Darmstadt, Germany and Pfizer on this phase 1/1b clinical trial for this combination of GEN-001 and avelumab. We are excited to investigate how the preclinical data of this combination will be translated to humans. We look forward to initiating this clinical trial in the coming months," said Dr. Jisoo Pae, CEO of Genome & Company.

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.

For full Prescribing Information and Medication Guide for BAVENCIO, please see www.BAVENCIO.com.

About GEN-001

GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists a single strain bacteria isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models.

On January 13, 2020, Monopar Therapeutics Inc ("Monopar" or the "Company") reported that it has entered into a Capital on DemandTM Sales Agreement (the "Agreement") with JonesTrading Institutional Services LLC, as sales agent ("JonesTrading" or the "Agent"), pursuant to which Monopar may offer and sell, from time to time, through or to JonesTrading shares of Common Stock, par value $0.001 per share, of Monopar having an aggregate offering price of up to $19.7 million (the "Shares") (Filing, 8-K, Monopar Therapeutics, JAN 13, 2020, View Source [SID1234553142]).

The offer and sale of the Shares will be made pursuant to a shelf registration statement on Form S-3 and the related prospectus (File No. 333-235791) filed by the Company with the Securities and Exchange Commission (the "SEC") on January 3, 2020 and declared effective by the SEC on January 13, 2020, as supplemented by a prospectus supplement dated January 13, 2020 and filed with the SEC pursuant to Rule 424(b) under the Securities Act of 1933, as amended (the "Securities Act"). This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Company’s Common Stock discussed herein, nor shall there be any offer, solicitation, or sale of the Company’s Common Stock in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Monopar is not obligated to sell any Shares under the Agreement.

Upon delivery of a placement notice by Monopar and subject to the terms and conditions of the Agreement and such placement notice, JonesTrading may sell the Shares by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act and will use commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq Capital Market, to sell the Shares from time to time.

The offering of Shares pursuant to the Agreement will terminate upon the earlier of (a) the sale of all of the Shares subject to the Sales Agreement or (b) the termination of the Sales Agreement by JonesTrading or the Company, as permitted therein.

The Company has agreed to pay JonesTrading commissions for its services in acting as agent in the sale of the Shares in the amount of up to 3.0% of gross proceeds from the sale of the Shares pursuant to the Agreement. The Company has also agreed to provide JonesTrading with customary indemnification and contribution rights, in connection with entering into the Agreement.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed herewith as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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On January 13, 2020 Geron Corporation presented the corporate presentation (Presentation, Geron, JAN 13, 2020, View Source [SID1234553054]).

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On January 13, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the U.S. Food and Drug Administration (FDA) has allowed its second Investigational New Drug (IND) application for FT516, the Company’s off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel CD16 Fc receptor (Press release, Fate Therapeutics, JAN 13, 2020, View Source [SID1234553072]). This is the Company’s fourth IND from its proprietary iPSC product platform cleared by the FDA, and enables the clinical investigation of FT516 in combination with monoclonal antibody (mAb) therapy across a broad range of solid tumors.

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"While monoclonal antibodies are proven therapeutic agents that are often used early in the treatment of many cancers, the functional status of the patient’s NK cells has been shown to play an important role in mediating clinical activity and prolonging survival," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "In particular, stable expression of the NK cell activating receptor CD16, and its binding affinity to therapeutic antibodies, are critical to promoting antibody-dependent cellular cytotoxicity. Our first-of-kind, off-the-shelf approach with FT516 enables administration of multiple doses of CD16-engineered NK cells, and we are excited to investigate the potential of FT516 to augment the clinical efficacy of monoclonal antibody therapy in the setting of solid tumors."

FT516 expresses a novel high-affinity, non-cleavable variant of CD16 (hnCD16) that enhances its binding to therapeutic antibodies and prevents its down-regulation, which can significantly inhibit anti-tumor activity. A publication by scientists from the Company, the University of Minnesota, and the University of California, San Diego in the journal Blood (View Source), entitled "Pluripotent stem cell-derived NK cells with high-affinity non-cleavable CD16a mediate improved anti-tumor activity," highlights preclinical proof-of-concept data for FT516.

In the published studies, iPSC-derived NK cells expressing hnCD16 were shown to have superior therapeutic properties in vitro, including maintenance of CD16 expression and increased levels of cytokine production upon activation, compared to peripheral blood NK cells sourced from healthy donors. In an in vivo systemic tumor model of human lymphoma, treatment with iPSC-derived hnCD16 NK cells plus anti-CD20 mAb resulted in a significant improvement in survival (median survival exceeding 100 days) compared to treatment with anti-CD20 mAb alone or in combination with peripheral blood NK cells sourced from healthy donors (each of which showed median survival of 35 days). Additionally, iPSC-derived hnCD16 NK cells plus anti-HER2 mAb also conveyed a survival benefit in a xenograft model of SKOV-3 ovarian carcinoma.

FT516 is the first-ever cell therapy in the world derived from a genetically engineered pluripotent stem cell cleared for clinical testing. The Company intends to initiate clinical investigation of FT516 in combination with tumor-target antibody therapy in solid tumors later this year. The Company is currently conducting an open-label, multi-dose Phase 1 clinical trial of FT516 as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-directed mAbs for the treatment of advanced B-cell lymphoma.