On November 27, 2020 Advaxis, Inc. (Nasdaq: ADXS) (the "Company"), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported the closing of an underwritten public offering of 26,666,666 shares of common stock and warrants to purchase up to 13,333,333 shares of common stock, along with an additional 3,999,999 shares of common stock and 1,999,999 warrants pursuant to the full exercise of the underwriters’ option (Press release, Advaxis, NOV 27, 2020, View Source [SID1234571842]). The shares of common stock and warrants were sold together at a combined public offering price of $0.30 per share for total gross proceeds of approximately $9.2 million, before underwriting commissions and estimated expenses.

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The Company plans to use the net proceeds from the offering to fund its continued research and development initiatives in connection with expanding its product pipeline including, but not limited to, investment in its ADXS-HOT program and for general corporate purposes. The Company may also use a portion of the net proceeds to acquire or invest in other businesses, products and technologies.

A.G.P./Alliance Global Partners acted as sole book-running manager for the offering.

This offering was made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-226988) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), which became effective upon filing on August 30, 2018. A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: [email protected].

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and shall not constitute an offer to sell or the 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 26, 2020 ImmuPharma PLC (LSE:IMM | Euronext Growth: ALIMM), the specialist drug discovery and development company, reported the approval of the grant of options over a total of 9,625,000 ordinary shares of 10p each in the Company ("Ordinary Shares") to Directors, employees and consultants representing 3.8% of ImmuPharma’s Ordinary Shares and total voting rights (the "Options") (Press release, ImmuPharma, NOV 26, 2020, View Source [SID1234571783]). ImmuPharma currently has 250,221,297 Ordinary Shares in issue.

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Upon the recommendation of the Company’s remuneration committee, the Company has granted the Options pursuant to the Company’s Share Option Plan which was adopted on 30 March 2017 (the "2017 Plan").

The exercise price for the Options is 20p being a 54% premium to the closing middle market share price of 13p on 25 November 2020. The Options will vest after three years and are exercisable between three and ten years from the date of grant.

On November 26, 2020 Merck, a leading science and technology company, reported that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) exon 14 (METex14) skipping alterations (Press release, Merck & Co, NOV 26, 2020, View Source [SID1234571845]). With this validation, the application is complete, and the EMA will now begin the review procedure.

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Tepotinib is a highly selective oral MET inhibitor that is administered once daily.1 The application to the EMA is based on results from the pivotal Phase II VISION study (NCT02864992) evaluating tepotinib as monotherapy in patients with advanced NSCLC with METex14 skipping alterations, prospectively assessed by liquid biopsy or tissue biopsy. In the ongoing study, the patient population is generally characterized as elderly, with a median age of 74.0 years, and as having poor clinical prognosis typical of NSCLC with METex14 skipping alterations. Data from the primary analysis of the VISION study were published in The New England Journal of Medicine (NEJM) on May 29, 2020.2

Lung cancer is estimated to be the second most common cancer in Europe, and the leading cause of cancer-related mortality, responsible for 388,000 deaths in 2018.3 METex14 skipping occurs in approximately 3–4% of NSCLC cases and correlates with aggressive tumor behavior and poor clinical prognosis.4 Currently, there are no treatments available in Europe for patients with advanced NSCLC harboring METex14 skipping alterations.

Tepotinib became the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval globally, with its approval in Japan in March 2020 through the SAKIGAKE program. Recently, the FDA granted Orphan Drug Designation (ODD) to tepotinib and the FDA is reviewing the application under Priority Review and through the Real-Time Oncology Review pilot program.

About Tepotinib

Tepotinib is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck, it has a highly selective mechanism of action, with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.1

Additional Clinical Investigations: Tepotinib is also being investigated in the Phase II INSIGHT 2 study in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib, and in the Phase II PERSPECTIVE study in combination with cetuximab in RAS/BRAF wild-type left-sided metastatic colorectal cancer patients having acquired resistance to anti-EGFR antibody targeting therapy due to MET amplification.

References

Bladt F, et al. Clin Cancer Res. 2013;19:2941-2951.
Paik PK et al. Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med 2020 May 29; [e-pub]. (View Source)
Ferlay J, et al. Eur J Cancer. 2018;103:356–387.
Reungwetwattana T, et al. Lung Cancer. 2017;103:27–37.
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On November 26, 2020 Sentinel Oncology Limited reported that it has entered into a collaboration and license agreement with Taiwan based pharmaceutical company PharmaEngine, Inc. (TWO: 4162) to advance the development of SOL-578 , their checkpoint kinase 1 (Chk1) inhibitor (Press release, Sentinel Oncology, NOV 26, 2020, View Source [SID1234571836]). Under the terms of the agreement, PharmaEngine will fund IND enabling studies for SOL-578.

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Sentinel Oncology Limited is a drug discovery company passionate about the development of novel therapeutics to treat cancer patients for whom there is currently an unmet medical need. The company’s mission is to increase survival and improve outcomes for cancer patients with CNS tumors. SOL-578 is a best-in-class checkpoint kinase 1 (Chk1) inhibitor featuring high kinase selectivity and oral bioavailability which targets the DNA Damage Response (DDR) network.

Under the terms of the Agreement, Sentinel Oncology will receive an exclusivity payment and PharmaEngine will obtain an option to receive the exclusive rights to develop and commercialize SOL-578 worldwide. In the event that PharmaEngine completes the IND enabling studies and exercise its option, Sentinel Oncology will be eligible to receive an upfront and development milestone payments in addition to tiered royalties based on future worldwide net sales of SOL-578.

Robert Boyle, CEO of Sentinel Oncology commented: "We are very excited about the prospects for this programme and the collaboration with PharmaEngine will enable SOL-578 to reach clinical trials and provide a real benefit for patients for whom there is currently a poor prognosis".

On November 26, 2020 Sanofi reported that Patients with a difficult to treat form of multiple myeloma will now gain access to a new treatment on the NHS in England and Wales, after cost regulators issued final guidance on the use of Sarclisa (isatuximab) (Press release, Sanofi, NOV 26, 2020, View Source [SID1234571827]).

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Sarclisa, administered as an intravenous infusion, plus pomalidomide and dexamethasone, is recommended for use within the Cancer Drugs Fund (CDF) as an option for treating relapsed and refractory multiple myeloma in adults.

Routine NHS funding was not approved at this stage "because the cost-effectiveness estimates are uncertain as there are limitations in the clinical data" the Institute said.

However, its green light via the CDF will allow doctors to offer the treatment as an option for people who have had lenalidomide and a proteasome inhibitor, and whose disease has progressed from their last treatment if they have had three previous forms of treatment, while more data is collated.

"Our independent appraisal committee has recognised more treatment options are needed for those with difficult-to-treat multiple myeloma," said Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE.

"Some of the data our committee has already seen shows promise that isatuximab plus pomalidomide and dexamethasone delays the disease from progressing and increases how long people live compared with current treatment options.

"Its use via the Cancer Drugs Fund will add a fourth line treatment option while data from an on-going clinical trial and from NHS use is collected to establish whether it is cost effective."

The guidance is dependent on conditions laid out in a confidential managed access agreement for the treatment combination.

Around 500 people a year could benefit from treatment with the combination.