Immutep’s Chinese Partner EOC Pharma to Start Phase II Metastatic Breast Cancer Study

On December 10, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported that its Chinese partner, EOC Pharma will commence a new Phase II clinical trial in up to 152 metastatic breast cancer patients in China (Press release, EOC Pharma, DEC 10, 2020, View Source [SID1234572640]).

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Similar to Immutep’s AIPAC study, the EOC Pharma trial will be a randomised, double-blind, placebo-controlled phase II clinical study with the study endpoints including progression free survival, overall survival and overall response rate. It is expected take place across 20 clinical trial sites in China over 24 months and will evaluate Immutep’s lead product candidate eftilagimod alpha ("efti", designated EOC202 in China) in combination with paclitaxel in HER2-negative/HR positive metastatic breast cancer patients who have progression after endocrine therapy.

EOC Pharma has received positive scientific advice from the Chinese competent authority, the Chinese National Medical Products Administration, enabling the first patient in to be enrolled and dosed in the trial in Q1 of calendar year 2021.

EOC Pharma CEO, Xiaoming Zou, said: "Breast cancer is now the most common cancer in Chinese women, with more than 1.6 million people being diagnosed and 1.2 million people dying of the disease each year1. It is very important that we find new ways to enhance paclitaxel chemotherapy which continues to be a standard of care for HER2-negative/HR positive metastatic breast cancer patients. Immutep’s recent encouraging interim AIPAC results give us hope we can boost the body’s immune system to deliver better outcomes to patients."

Immutep CEO Marc Voigt said: "EOC Pharma shares our growing excitement about the potential for the combination of efti with paclitaxel chemotherapy in metastatic breast cancer. Our ongoing AIPAC study evaluating the same combination is already reporting very encouraging data, including a statistically significant survival benefit of 7.1 months in patients under 65 years of age and 9.4 months for patients with a low starting monocyte count. EOC Pharma’s new trial in China brings this innovative new treatment much closer to market for metastatic breast cancer patients."

EOC Pharma is the exclusive licensee of efti from Immutep for the Chinese market. Under its agreement with Immutep, it will make further milestone payments to the Company if efti achieves specific development milestones as well as undisclosed royalties on sales and is also required to fund the Chinese development of efti.

Webcast Details
Immutep will discuss the recent AIPAC data in a global webcast for investors. Details are as follows:

Date & Time: Friday 11 December at 8.30 am Australian Eastern Daylight Time (AEDT)
Register: View Source
Questions: Investors are invited to submit questions in advance via [email protected].

A replay of the webcast will also be available at www.immutep.com from the day after the event.

Avid Bioservices Announces Pricing of Public Offering of Common Stock

On December 10, 2020 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported the pricing of an underwritten public offering of 3,333,335 shares of its common stock at a price to the public of $9.00 per share (Press release, Avid Bioservices, DEC 10, 2020, View Source [SID1234572608]). The gross proceeds from this offering are expected to be approximately $30 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Avid Bioservices, Inc. The offering is expected to close on or about December 14, 2020, subject to customary closing conditions. Avid Bioservices, Inc. has also granted the underwriters a 30-day option to purchase from it up to an additional 500,000 shares of common stock at the public offering price, less underwriting discounts and commissions. Avid Bioservices, Inc. intends to use the net proceeds from the offering primarily for the expansion of its manufacturing capabilities and any remainder for general corporate purposes.

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RBC Capital Markets is acting as sole book-running manager for the offering. Craig-Hallum Capital Group and Stephens Inc. are acting as co-managers for the offering.

The shares described above are being offered by Avid Bioservices, Inc. pursuant to a shelf registration statement on Form S-3 previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). A preliminary prospectus supplement relating to the offering has also been filed with the SEC and is available on the SEC’s website at View Source Copies of the preliminary prospectus supplement and accompanying base prospectus relating to this offering may be obtained from RBC Capital Markets, LLC, Attn: Equity Capital Markets, 200 Vesey Street, New York, NY 10281, by telephone at 877-822-4089 or by email at [email protected], Craig-Hallum Capital Group LLC, Attn: Equity Capital Markets, 222 South Ninth Street, Suite 350, Minneapolis, MN 55402, by telephone at (612) 334-6300 or by e-mail at [email protected] or from Stephens Inc., Attn: Equity Syndicate, 111 Center Street, Little Rock, AR 72201, by telephone at (501) 377-2000 or by email at [email protected].

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

Bayer and Tempus Initiate Collaboration to Advance Patient Access to Genomic Testing and Precision Medicine

On December 10, 2020 Bayer and Tempus, leaders in precision medicine and artificial intelligence (AI), reported a new collaboration designed to provide broader access to genomic testing and tailored treatment approaches for the oncology community (Press release, Bayer, DEC 10, 2020, View Source [SID1234572624]). The collaboration will include an initiative to help facilitate patient identification for precision oncology by providing testing, via the Tempus xT broad-panel genomic sequencing assay, for a subset of patients with metastatic colorectal cancer (mCRC), as well as those with radioactive iodine refractory differentiated metastatic thyroid carcinoma (RAIR thyroid cancers). Looking ahead, Bayer and Tempus will continue to implement data-enriched initiatives dedicated to supporting patients.

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Bayer’s commitment to precision oncology is currently supported by its approach to research that prioritizes targets and pathways that impact the way cancer is treated. The Tempus xT broad-panel genomic sequencing assay is designed to detect actionable driver alterations, including BRAF, KRAS, RET, and NTRK gene fusions.1 NTRK gene fusions are genomic alterations that drive tumor growth regardless of where they originate in the body.2-4 These genomic alterations typically occur following DNA damage, which results in structural changes to the DNA either through biological changes or from environmental factors (e.g. ultraviolet light damage).2-4 During the DNA damage repair mechanism, the NTRK gene can fuse with an unrelated gene resulting in an altered TRK fusion protein, which causes a constant signaling cascade, driving tumor growth and its metastasis (progression).2-4 Studies suggest NTRK gene fusions are present in approximately 3% of patients with mCRC with prior high microsatellite instability (MSI-H) status and 2.4%-12% of patients with RAIR thyroid cancers.5-7

Testing early and utilizing comprehensive genomic profiling is critical, as it helps physicians understand the underlying driver of DNA alterations for tumor progression (growth).8,9 When actionable alterations are detected, they aid physicians in the treatment decisions appropriate for their patients.10 The Tempus xT broad-panel genomic sequencing assay detects these alterations by sequencing tumor samples with matched normal saliva or blood samples, when available, covering 648 genes.1 The test is used by many oncologists across a diverse set of clinical settings, including leading academic centers, NCI designated cancer centers, hospital networks and community hospitals.

"Bayer’s strong focus in precision medicine combined with Tempus’ unique testing offering has culminated in this collaboration to bring genomic testing to cancer patients," said Bhavesh Ashar, Senior Vice President, Head of U.S. Oncology at Bayer. "We are excited for the potential of this initiative to identify patients who may benefit from tailored treatment options."

"This strategic collaboration aims to provide eligible colorectal and thyroid cancer patients with broad based access to our genomic test to help their physicians make treatment decisions," said Ryan Fukushima, Chief Operating Officer of Tempus.

Healthcare professionals with eligible patients from the above tumor types can receive additional information by learning more at Tempus.com/bayerprogram and contacting Tempus at [email protected].

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now expands to six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

Forma Therapeutics Announces Pricing of Public Offering

On December 10, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the pricing of an underwritten public offering of 5,300,000 shares of its common stock at a public offering price of $45.25 per share (Press release, Forma Therapeutics, DEC 10, 2020, View Source [SID1234572641]). All of the shares of common stock in the offering will be offered by Forma. In addition, Forma has granted the underwriters a 30-day option to purchase up to an additional 795,000 shares of common stock. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $239.8 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about December 15, 2020, subject to customary closing conditions.

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Jefferies, SVB Leerink and Credit Suisse are acting as joint book-running managers for the offering. Oppenheimer & Co is acting as lead manager for the offering.

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

Registration statements relating to these securities became effective on December 10, 2020. The offering will be made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY, 10004, by telephone at (212) 667-8055, or by email at [email protected].

Bristol Myers Squibb Announces Dividend Increase

On December 10, 2020 Bristol Myers Squibb (NYSE:BMY) reported that its Board of Directors has declared a quarterly dividend of forty-nine cents ($.49) per share on the $.10 par value common stock of the company (Press release, Bristol-Myers Squibb, DEC 10, 2020, View Source [SID1234573349]). The dividend is payable on February 1, 2021 to stockholders of record at the close of business on January 4, 2021.

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This amount represents an 8.9% increase in the quarterly dividend over last year’s quarterly rate of forty-five cents ($.45) per share. At this quarterly dividend rate, subject to the normal quarterly review by the Board of Directors, the annual dividend rate for the fiscal year 2021 is $1.96 per share. This marks the twelfth consecutive fiscal year that Bristol Myers Squibb increased its dividend payouts.

In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable March 1, 2021 to stockholders of record at the close of business on February 2, 2021.