On December 17, 2019 Jounce Therapeutics, Inc., a Delaware corporation (the "Company"), reported that it entered into a Sales Agreement (the "Sales Agreement") with Cowen and Company, LLC ("Cowen") pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, with an aggregate offering price of up to $50,000,000, from time to time, through Cowen as its sales agent (Filing, 8-K, Jounce Therapeutics, DEC 17, 2019, View Source [SID1234552434]).
Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, Cowen may sell the common stock by any method permitted by law deemed to be an "at the market offering" (the "Offering") as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on or through The Nasdaq Global Select Market or on any other existing trading market for the common stock.

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The Company will designate the maximum amount of common stock to be sold through Cowen in any placement under the Offering. Subject to the terms and conditions of the Sales Agreement, Cowen has agreed to use its commercially reasonable efforts to sell on the Company’s behalf all of the shares of common stock requested to be sold by the Company. The Company may instruct Cowen not to sell common stock if the sales cannot be effected at or above a price designated by the Company in a placement notice. The Company or Cowen may suspend the offering of the common stock being made through Cowen under the Sales Agreement upon proper notice to the other party. The Company and Cowen each have the right, by giving written notice as specified in the Sales Agreement, to terminate the sales agreement in each party’s sole discretion at any time.
The Sales Agreement provides that Cowen will be entitled to aggregate compensation for its services equal to 3.0% of the gross sales price per share of all shares sold through Cowen under the Sales Agreement. The Company has no obligation to sell any shares under the Sales Agreement. The Company has agreed in the Sales Agreement to provide indemnification and contribution to Cowen against certain liabilities, including liabilities under the Securities Act. In addition, the Company has agreed to reimburse certain legal expenses and filing fees incurred by Cowen in connection with the Offering up to a maximum of $62,500.

The shares will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-223518). The Company filed a prospectus supplement, dated December 17, 2019, with the Securities and Exchange Commission in connection with the offer and sale of the shares pursuant to the Sales Agreement. This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.
The foregoing description of the material terms of the Sales 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.

On December 17, 2019 INmune Bio, Inc., an immunology company developing therapies that reprogram the patient’s innate immune system to treat diseases, reported that it has successfully completed the Phase I trial of INB03 and the database has been locked (Press release, INmune Bio, DEC 17, 2019, View Source [SID1234552433]). The Phase I trial was an open-label, dose-escalation trial in patients with advanced solid tumors. "This was our first trial of the DN-TNF platform in patients, and we are pleased with the safety and efficacy results," said RJ Tesi, MD, CEO and CMO of INmune Bio. "This milestone now allows us to move the trial to Phase II in cancer and leverage our data into other programs for our DN-TNF platform."

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Key Findings:

●1 mg/kg was selected as the recommended Phase II dose for further studies.

●Across all cancer subsets, INB03 showed no toxicities or serious adverse events and was well tolerated.

●The inflammatory cytokine IL-6, a biomarker of soluble TNF function decreased by more than 50% in half the patients suggesting a pharmacodynamic effect of INB03.

The Phase II program will be targeting trastuzumab resistant HER2+ breast cancer using INB03 as part of combination therapy. The program is based on data presented at the San Antonio Breast Cancer Symposium in 2018 by Professor Roxana Schillaci. The data revealed that women with MUC4 expressing HER2+ breast cancers have worse survival than women who do not express MUC4. Furthermore, the data illustrated treatment with INB03 decreased MUC4 expression to make the HER2 expressing cancer sensitive to trastuzumab.

"Resistance to trastuzumab is common problem in women with HER2+ breast cancer," said RJ Tesi, MD, CEO and CMO of INmune Bio. "Current therapies attempt to treat the breast cancer without eliminating the resistance mechanism. In animal models, INB03, by neutralizing the soluble TNF that drives MUC4 expression, makes the resistant cancer cells sensitive to trastuzumab. We plan to confirm this observation in the Phase II clinical trial in women with metastatic HER2+ breast cancer."

Breast cancer is the most common cancer in women in the US with more than 268,000 new cases in 2019 according to the from the American Cancer Society. Because of the population growth and demographic changes, more than 400,000 new cases of breast cancer are expected in 2030. The breast cancer therapy market is expected to grow at more than 9% CAGR and will be valued in excess of $28 billion USD in 2024.

On December 17, 2019 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "IPA") (TSX VENTURE: IPA) (OTCQB: IPATF) reported that it has released its financial results for the second quarter ended October 31, 2019 (Press release, ImmunoPrecise Antibodies, DEC 17, 2019, View Source [SID1234552432]). The financial statements and related management’s discussion and analysis ("MD&A") can be viewed on SEDAR at www.sedar.com.

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Financial Highlights:

Revenue. During the three months ended October 31, 2019, the company generated revenues of $3,162,365, compared to revenues of $2,716,791 in the 2018 fiscal period. This represents a 16% rise in revenue for the three-month period. The increasing revenue trend is due to growth in both the volume of contracts as well as an increase in the financial value of individual client programs resulting in a larger average value per program. Revenue outlook is positive for third quarter.

Gross Margin. During the three months ended October 31, 2019, the Company achieved a gross profit of $2,490,015 compared to $1,401,725 in the 2018 fiscal period. Gross profit increased by 78% over the same period last year. In percentage terms, the Company’s gross profit increased to 79% from 52% in 2018. The higher gross profit in 2019 was mostly attributable to the Company investing heavily in research and development initiatives, broadening the breadth and value of its intellectual property in both therapeutic oncology assets as well as advanced technologies in the discovery and analysis of human antibody sequences. Gross profit was positivity affected by an increase in the average value per program.

Net Loss. During the three months ended October 31, 2019, the Company recorded a net loss of $1,363,545 compared to net loss of $1,485,732 for the three months ended October 31, 2018. The net loss decreased in 2019 due to $1,088,290 higher gross profit and lower advertising and consulting expense, offset by higher non-cash expenses including amortization of acquired companies’ intangible assets, depreciation of leased assets as a result of implementing IFRS 16, Leases, and higher office expenses.

Non-IFRS Measures*. Non-IFRS Adjusted EBITDA was ($63,418) in the second quarter of 2019 compared to ($744,054) in the second quarter of 2018. The reduction in loss is due primarily to non-cash expenses reconciling IFRS Net Loss to Adjusted EBITDA. The reduction in EBITDA Loss for the quarter is due to higher gross profit ($1,088,290) offset by higher Adjusted Operating Expenses ($407,654) primarily due to the Company’s investment in research and development and information technology.

Reflecting on the calendar year of 2019, Dr. Jennifer Bath, CEO and President, added, "During 2019 we won an increased number of large pharma clients requiring more comprehensive therapeutic discovery and development outsourcing. These wins have been a core priority for ImmunoPrecise as we grow, which required substantive, strategic investments in our global infrastructure to attract, win and retain large pharma. Onboarding of these programs differs from our pipeline to date in terms of timing and workflow management. While it is a significant positive that we are winning larger programs, we have been cognizant that short-term revenue recognition can be affected by the timing of project activity. We have worked diligently to ensure that these are coupled with renewing, smaller projects to attain business continuity, thoughtful space and equipment utilization and therefore greater profitability going into 2020."

On December 17, 2019 ImmunoGen Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab soravtansine (Press release, ImmunoGen, DEC 17, 2019, View Source [SID1234552431]). Based on this guidance, the company will initiate SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with folate receptor alpha (FRhigh platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab).

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"We have engaged in constructive discussions with FDA and evaluated all avenues to bring mirvetuximab to patients more quickly," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Having aligned with the agency that women with FRα-high platinum-resistant ovarian cancer that has progressed after prior treatment with bevacizumab require better therapeutic options, we are pleased to advance mirvetuximab in this patient population with SORAYA, which, if successful, would enable us to submit an application for accelerated approval during the second half of 2021. We anticipate enrolling the first patient in SORAYA next quarter and expect top-line data from the study in mid-2021."

ImmunoGen’s mirvetuximab program now includes two new trials, SORAYA and MIRASOL, which will enroll concurrently.

SORAYA: Pivotal Trial

SORAYA is a single-arm trial with mirvetuximab that will enroll approximately 100 patients. Eligibility criteria include patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα using the PS2+ scoring method, and who have been treated with up to three prior regimens – at least one of which included bevacizumab. The primary endpoint of this study is overall response rate by investigator assessment and the key secondary endpoint is duration of response.

MIRASOL: Confirmatory Trial

MIRASOL is a randomized Phase 3 trial in which 430 patients will be randomized 1:1 to receive either mirvetuximab or investigator’s choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα using the PS2+ scoring method, and who have been treated with up to three prior regimens. The primary endpoint of this study is progression free survival by investigator assessment. The key secondary endpoints include: overall response rate, overall survival, and patient-reported outcomes.

"We have reviewed the data generated from our Phase 1 and FORWARD I studies using the PS2+ scoring method and have identified 70 patients who would meet the key eligibility criteria for SORAYA. The overall response rate in these patients was 31.4% with 95% CI (20.9%, 43.6%) and a median duration of response of 7.8 months with 95% CI (3.98, -)," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "These data compare quite favorably to the response rate seen with single agent chemotherapy in platinum resistant disease, which was 12% in the AURELIA and CORAIL trials, and included patients naïve to and previously treated with bevacizumab."

Berkenblit continued, "Replicating these data in SORAYA would support an application for accelerated approval in advance of the completion of MIRASOL, which would thereafter provide the randomized data needed for conversion to full approval. We are delighted to advance both studies as soon as possible."

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 7190603. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On December 17, 2019 KeChow Pharma, a novel drug developer located in Shanghai Zhangjiang High-Tech Park, reported that it completed a $45 million Series C round of financing (Press release, Kechow Pharma, DEC 17, 2019, View Source [SID1234552429]). The company discovers targeted small molecule drugs for cancer that have competitive advantages over existing therapies and co-develops them with partners. KeChow will use the proceeds to support development of HL-085, a novel MAP kinase 1 inhibitor already in trials for malignant melanoma and solid tumors. The round was led by Decheng Capital, with participation from Qiming Venture Partners, Sherpa Capital and Grains Valley Venture Capital

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