On November 18, 2020 Pionyr Immunotherapeutics, Inc., a company developing first-in-class antibody therapeutics that increase the body’s antitumor immunity by altering the composition and function of immune cells within the tumor microenvironment, reported the initiation of a Phase 1 clinical study investigating PY314 in patients with solid tumors (Press release, Pionyr Immunotherapeutics, NOV 18, 2020, View Source [SID1234571376]).

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PY314 targets TREM2, a protein found on the surface of a subpopulation of immunosuppressive, pro-tumor myeloid cells. PY314 works by depleting TREM2-expressing immune suppressive tumor associated macrophages (TAMs), which leads to activation of productive anti-tumor immunity. In preclinical studies, PY314 treatment not only depleted TAMs, but also promoted infiltration of activated anti-tumor cytotoxic T lymphocytes into the tumor microenvironment.

"Pionyr moving PY314 into clinical development is a major milestone for our company and our scientific platform," said Steven P. James, President and Chief Executive Officer, Pionyr. "This study initiation also comes shortly after receiving the FDA clearance of our Investigational New Drug (IND) Application for our second antibody program, PY159, which ‘turbocharges’ anti-tumor activity by targeting TREM1-expressing myeloid cells in the tumor microenvironment. With the acceptance of two INDs in two months, the start of the PY314 Phase 1 trial and the anticipated initiation of the PY159 trial by year end, we are rapidly advancing our mission of creating the new frontier of immuno-oncology therapies."

The Phase 1 study will enroll patients at multiple academic centers in the US and will evaluate PY314 as both a single agent and in combination with an approved checkpoint inhibitor. Once safety is determined, additional patients will be recruited in predefined tumor types where TREM2 expression is most likely implicated as a driver of resistant metastatic disease.

"PY314 represents a potentially foundational therapeutic opportunity to expand immunotherapy options for patients with advanced solid tumors," said Leonard Reyno, M.D., Senior Vice President and Chief Medical Officer, Pionyr. "We are excited to make this transition into a clinical-stage company and work with the leading clinical sites and investigators who have enthusiastically joined in this effort alongside us."

On November 18, 2020 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology"), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported the pricing of its initial public offering of 11,000,000 shares of its common stock at a price to the public of $19.00 per share (Press release, Olema Oncology, NOV 18, 2020, View Source [SID1234571463]). The gross proceeds to Olema Oncology from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $209.0 million. All of the shares are being offered by Olema Oncology. In addition, Olema Oncology has granted the underwriters a 30-day option to purchase up to an additional 1,650,000 shares of its common stock at the initial public offering price, less the underwriting discounts and commissions.

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The shares are expected to begin trading on the Nasdaq Global Select Market on November 19, 2020, under the ticker symbol "OLMA." The offering is expected to close on November 23, 2020, subject to customary closing conditions.

J.P. Morgan Securities LLC, Jefferies LLC and Cowen and Company, LLC are acting as active joint book-running managers for the offering. Canaccord Genuity LLC is also acting as a book-running manager.

Registration statements relating to these securities were filed with the U.S. Securities and Exchange Commission (SEC) and became effective on November 18, 2020. Copies of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering is being made only by means of a written prospectus, forming a part of the effective registration statement. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (212) 834-4533 or by email at [email protected]; Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at +1 (833) 297-2926 or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On November 18, 2020 IMMUNOPRECISE ANTIBODIES LTD. (the "Company" or "ImmunoPrecise") (TSXV: IPA) (OTCQB: IPATF) (FSE: TQB2), a leader in full-service, therapeutic antibody discovery and development, reported that, further to a news release issued on November 4, 2020, subject to the approval of the TSX Venture Exchange, the consolidation of the Company’s issued and outstanding common shares (the "Common Shares") on the basis of five (5) pre-consolidation Common Shares for one (1) post-consolidation Common Share (the "Consolidation") will be effective as of market open on November 23, 2020 (Press release, ImmunoPrecise Antibodies, NOV 18, 2020, View Source [SID1234571265]). The Company’s stock symbol will remain unchanged. The ISIN and CUSIP numbers for the Common Shares will be CA45257F2008 and 45257F200, respectively.

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The Consolidation will result in the number of issued and outstanding Common Shares being reduced from 83,809,015 to 16,761,803, and each shareholder will hold the same percentage of Common Shares outstanding immediately after the Consolidation as such shareholder held immediately prior to the Consolidation.

Registered shareholders that hold physical share certificates will receive a letter of transmittal from Computershare Trust Company of Canada, the transfer agent for the Common Shares, describing the process by which such shareholders may obtain new share certificates representing their post-Consolidation Common Shares.

On November 18, 2020 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the final results from its PLX9486 + sunitinib Phase 1/2 study in patients with advanced gastrointestinal stromal tumors (GIST) (Press release, Cogent Biosciences, NOV 18, 2020, View Source [SID1234571323]). The data will be presented, summarized and discussed in a live oral session on Friday, November 20th from 11:30 a.m. to 12:30 p.m. ET at the Connective Tissue Oncology Society (CTOS) 2020 virtual meeting.

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PLX9486 is a selective tyrosine kinase inhibitor designed to potently inhibit KIT exon 17 mutations, including D816V. Most patients with imatinib-resistant GIST have both primary and secondary KIT mutations, often including secondary mutations on exon 17 and exon 13, making it difficult to achieve broad therapeutic KIT inhibition. These data suggest that treatment with a combination of PLX9486, a type 1 KIT inhibitor with activity against exon 17 mutations, and sunitinib, a type 2 KIT inhibitor with activity against exon 13 mutations, may provide substantial clinical benefit over treatment with type I or type II inhibitors alone.

"We are pleased to share final results from our Phase 1/2 trial of PLX9486 + sunitinib and are excited to advance this combination into a Phase 3 GIST trial in the second half of 2021," said Andrew Robbins, President and CEO of Cogent Biosciences. "With a median progression free survival (PFS) of 12 months in a heavily pre-treated population of advanced GIST patients, this combination holds significant promise for these patients with unmet medical need."

Oral Presentation:

Abstract: 3458521

Title: The potent and selective kit inhibitor PLX9486 dosed in combination with sunitinib demonstrates promising progression free survival (PFS) in patients with advanced gastrointestinal stromal tumor (GIST): final results of a phase 1/2 study.

Date: November 20, 2020

Time: Session 8: 11:30 a.m. – 12:30 p.m. ET

"The final results from this Phase 1/2 trial are highly encouraging for GIST patients who have limited treatment options due to secondary resistance KIT mutations," said Jonathan Trent, M.D., Ph.D., Associate Director for Clinical Research, Sylvester Comprehensive Cancer Center, University of Miami Health System. "I look forward to participating in the upcoming trial of this promising combination for imatinib-resistant GIST patients."

Results:

Out of the 18 patients with advanced GIST enrolled in the trial, all patients had received prior treatment, including 67% of patients with at least three prior lines of therapy. Doses for this study included 3 levels:

Level 1: PLX9486 500mg + sunitinib 25mg (3 patients)
Level 2: PLX9486 1000mg + sunitinib 25mg (5 patients)
Level 3: PLX9486 1000mg + sunitinib 37.5mg (10 patients)
Among the 15 patients who had not previously received PLX9486 as a single agent, the median progression free survival (PFS) was 12 months, the confirmed ORR was 20% and the clinical benefit rate (CR+PR+SD) was 80%, with 27% of patients remaining on therapy out 27-34 months. Importantly, there were no dose limiting toxicities in the three dose levels tested, and the most common adverse events were anemia, hypophosphatemia, diarrhea, and lymphopenia.

On November 18, 2020 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conference and invited investors to participate via webcast (Press release, Illumina, NOV 18, 2020, View Source [SID1234571356]).

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Piper Sandler Annual Healthcare Conference
Thursday, December 3, 2020 at 1:30pm Eastern Time

The live webcast can be accessed in the Investor Info section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentation will be posted on Illumina’s website as soon as possible after the event and will be available for at least 30 days following.