On October 23, 2020 Allarity Therapeutics A/S ("Allarity" or the "Company") reported several updates related to its planned filing of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for dovitinib, a pan-tyrosine kinase inhibitor (TKI) that is one of Allarity’s priority programs (Press release, Allarity Therapeutics, OCT 23, 2020, View Source,to%20the%20approved%20drug%20sorafenib.&text=Due%20to%20this%20reported%20delay,file%20the%20NDA%20in%202021. [SID1234568928]).

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The Company is announcing an update on timing for its originally planned first NDA filing for dovitinib as a treatment for renal cell carcinoma (RCC). This NDA is based on non-inferiority to the approved drug sorafenib. The Company’s preparation of the application itself is progressing as scheduled, however the third-party contract manufacturer of the registration batch of the drug is experiencing delays, in part as a result of the ongoing coronavirus pandemic. A registration batch is a mandatory component of the NDA filing. Due to this reported delay, Allarity is now expecting to file the NDA in 2021.

Separately, the Company remains on track to file its first pre-market approval (PMA) application with the U.S. FDA for the use of the dovitinib DRP companion diagnostic to select and treat likely responders to the drug. If regulatory authorities provide the expected PMA approval of the Dovitinib DRP and an NDA approval of dovitinib, the Company believes it can make the drug available to DRP-selected RCC patients as an effective new therapy to treat their disease.

Dovitinib, originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of RCC, and is a potential therapeutic alternative to sorafenib. Annual sales of sorafenib, under the trade name Nexavar, were approximately USD $715 million in 2018. The global RCC market is projected to grow to USD $6.3 billon by 2022. In addition to the RCC market, dovitinib has promising potential as a monotherapy in a number of other indications, including estrogen receptor (ER) positive metastatic breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.

Steve Carchedi, CEO of the Company, noted "Although we are disappointed with the unanticipated contract manufacturing delay for our priority dovitinib program, and the resulting setback of our planned first NDA filing for this promising cancer therapeutic, we recognize the delays are a result of the ongoing coronavirus pandemic that is affecting many facets of our industry. We remain fully committed to advancing the near-term filing of our first dovitinib NDA towards hopeful U.S. approval and to bringing this beneficial cancer therapeutic to RCC patients. Moreover, we are enthusiastic about remaining on track with our planned PMA filing for the Dovitinib DRP companion diagnostic this year."

On October 23, 2020 ProMIS Neurosciences Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, reported that it is proceeding with a private placement offering (the "Offering") of special warrants of the Company ("Special Warrants") at a price of $0.12 per Special Warrant, for gross proceeds of up to $3,000,000 (Press release, ProMIS Neurosciences, OCT 23, 2020, View Source [SID1234568917]). The Company has received subscriptions in excess of the minimum threshold of $1.5 million.

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Each Special Warrant shall be exercisable, without payment of any additional consideration by the holder, into one common share of the Company (a "Common Share") and one transferable Common Share purchase warrant (a "Warrant"). Each Warrant will entitle the holder thereof to acquire one Common Share (each, a "Warrant Share") at an exercise price of $0.20 per Warrant Share for a period of 60 months after Closing, subject to acceleration of the expiry date as described below. If at any time after the expiry of the four month hold period applicable to the Warrants, the twenty-day volume-weighted average trading price of the Shares on the TSX, or such other exchange on which the Shares may be listed, is greater than $0.60, the Company may deliver a notice to the holders of Warrants accelerating the Expiry Date to a date that is not less than 30 days following the date of such notice.

The net proceeds raised under the Offering will be used for general corporate purposes.

As soon as reasonably practicable after the closing, the Company will take reasonable commercial steps to prepare and file with each of the securities regulatory authorities in the provinces of Canada in which the Special Warrants are sold and obtain a receipt for, a final short form prospectus (the "Final Prospectus"), qualifying the distribution of the Shares and Warrants issuable upon exercise of the Special Warrants.

Each Special Warrant will be automatically exercised, without the payment of any additional consideration, into a Share and a Warrant on the date (the "Qualification Date") that is the earlier of (i) four (4) months and a day following Closing, and (ii) the 3rd business day after a receipt is issued for the Final Prospectus qualifying the distribution of the Shares and Warrants issuable upon the exercise of the Special Warrants. For greater certainty, except with the consent of the Company (such consent not to be unreasonably withheld), no Special Warrants may be exercised by the holder thereof prior to the Qualification Date.

The Company may pay to eligible finders cash finder’s fees equal to 7% of the gross proceeds of the Offering and issue compensation warrants (the "Compensation Warrants") equal to 7% of the number of Special Warrants issued under the Offering. The Compensation Warrants will have the same terms as the Warrants.

The Offering is subject to certain conditions including, but not limited to, the Company receiving minimum subscriptions of $1.5 million (which the Company has received), the receipt of all necessary regulatory and stock exchange approvals, including the approval of the TSX.

Certain insiders of the Company will be participating in the Offering. Such participation will be considered to be a "related party transaction" as defined under Multilateral Instrument 61-101 ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101, as neither the fair market value of any securities issued to nor the consideration paid by such persons exceeded 25% of the Company’s market capitalization.

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

On October 23, 2020 Invitae Corporation (NYSE: NVTA), a leading medical genetics company, reported that it will report its third quarter 2020 financial results on Thursday, November 5, 2020 and will host a conference call and webcast that day at 4:30 p.m. Eastern / 1:30 p.m. Pacific to discuss its financial results and recent highlights (Press release, Invitae, OCT 23, 2020, View Source [SID1234568916]).

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

To register for the conference call and webcast, please use one of the methods below. Upon registering, each participant will be provided with call details and a registrant ID. Reminders will also be sent to registered participants via email.

Online registration: View Source

Phone registration: (888) 869-1189 or (706) 643-5902

The live webcast of the call and slide deck may be accessed here or by visiting the investors section of the company’s website at ir.invitae.com. A replay of the webcast and conference call will be available shortly after the conclusion of the call and will be archived on the company’s website.

Following prepared remarks, management will respond to questions from analysts, subject to time limitations. We encourage our shareholders and those representing them to send in questions to ir.invitae.com.

On October 23, 2020 Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) ("Innate" or the "Company") reported that AstraZeneca (LSE/STO/Nasdaq: AZN) has dosed the first patient in its Phase 3 clinical trial, INTERLINK-1, evaluating monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors ("IO-pretreated") (Press release, Innate Pharma, OCT 23, 2020, View Source [SID1234568899]). Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

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Dosing of the first patient in this trial has triggered a $50 million milestone payment from AstraZeneca to Innate.

"We are very pleased that our key late-stage asset, monalizumab, has progressed into Phase 3 with our partner, AstraZeneca. The launch of INTERLINK-1 represents an important financial milestone for Innate, as it triggers a $50 million milestone payment that fortifies our cash position through the end of 2022," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "The steady and rapid progress of this program is a testament to our strong collaboration with AstraZeneca, and we are hopeful that together we will bring a novel treatment option to this patient population with high unmet medical need."

"Patients with head and neck cancer previously treated with a checkpoint inhibitor are a newly-defined patient population that is currently underserved. We look forward to evaluating the novel combination of monalizumab and cetuximab in the Phase 3 INTERLINK-1 study," said Cristian Massacesi, Senior Vice President, Head of Late Development Oncology R&D, AstraZeneca.

Presented at the ESMO (Free ESMO Whitepaper) 2019 Congress, the combination of monalizumab and cetuximab demonstrated a manageable safety profile and a response rate of 27.5% (36% and 17% in IO-naïve, n=22, and IO-pretreated patients, n=18, respectively). Based on these Phase 1b/2 results and the unmet need in the IO-pretreated population, AstraZeneca and Innate elected to advance this program directly to a Phase 3 study.

During the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, Innate presented preliminary data from its Phase 2 expansion cohort evaluating monalizumab and cetuximab in IO-pretreated patients (cohort 2), which confirmed an overall response rate (ORR) of 20% across 40 patients enrolled. Overall, the combination therapy data to date supports the expedited development of monalizumab and cetuximab in this indication. Innate intends to provide an update on this data at an upcoming scientific meeting.

About INTERLINK-1:
INTERLINK-1 is a global, multi-center, randomized, double-blind Phase 3 study of monalizumab and cetuximab vs. placebo and cetuximab that will enroll approximately 600 patients with recurrent or metastatic head and neck squamous cell carcinoma of the head and neck (R/M SCCHN) who have been previously treated with platinum-based chemotherapy and PD-(L)1 inhibitors ("IO-pretreated").

The primary endpoint is overall survival (OS) with secondary endpoints including progression-free survival (PFS), ORR, duration of response (DoR), safety and quality of life. Additional details on the INTERLINK-1 clinical trial can be found here.

About the Innate-AstraZeneca monalizumab agreement:
On April 24, 2015, the Company signed a co development and commercialization agreement with AstraZeneca to accelerate and broaden the development of monalizumab.

The financial terms of the agreement include potential cash payments up to $1.275 billion to Innate Pharma. Including the $50 million payment triggered by dosing the first patient in the Phase 3 INTERLINK-1 clinical trial, Innate Pharma has received $400 million to date.

AstraZeneca will book all sales revenue and will pay Innate low double-digit to mid-teen percentage royalties on net sales worldwide except in Europe where Innate Pharma will receive 50% share of the profits and losses in the territory. Innate will co-fund 30% of the costs of the Phase 3 development program of monalizumab with a pre-agreed limitation of Innate’s financial commitment.

On October 22, 2020 Araris Biotech AG, a company pioneering antibody-drug conjugate (ADC)-linker technology, reported it has received an additional CHF 12.7 million in seed financing, bringing the total amount raised to CHF 15.2 million (Press release, Araris Biotech, OCT 22, 2020, View Source [SID1234651278]).

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The investment round was led by Pureos Bioventures with participation from new investors 4BIO Capital, btov Partners and existing investors Redalpine, VI Partners and Schroder Adveq. The proceeds will be used to nominate a clinical candidate and advance Araris’ lead program into preclinical and clinical development. The new funds will also support the development of a broad proprietary pipeline of ADC compounds.

Philipp Spycher, Ph.D., CEO and co-founder of Araris, said, "We see this funding as strong validation of our company, lead programs and the Araris ADC-linker platform. We’re focused on using our unique linker technology, that allows development of ADCs without engineering the native antibody, to design better medicines for cancer. This capital will allow us to advance our lead program to the next stage of development and progress our preclinical pipeline towards the clinic. We are also pleased to further strengthen our investor base with such a distinguished group of investors, all of whom have a proven track record of supporting successful emerging companies."

Dragan Grabulovski, Ph.D. co-founder and founding chairman of Araris added, "The quality of the investors reflectsthe quality of the science, the product candidates and the entire team at Araris Biotech. I would like to welcome Dominik Escher, Dmitry Kuzmin, Michael Sidler and Arnd Kaltofen to the board of directors. Their experience and knowledge of the sector will be key to ensuring Araris’ continued success."

Dominik Escher, Ph.D., managing partner at Pureos, commented, "With this significant seed round, Araris is in an excellent position to advance its antibody-drug conjugates towards the clinic. Today, there are nine antibody-drug conjugates approved by the FDA but many of them cannot be dosed high enough to elicit efficacy due to systemic toxicity often caused by linker instability or heterogenous distributions of the payload. The Araris technology addresses these limitations and offers a novel and innovative approach to bring better therapies to patients in need."

Dmitry Kuzmin, Ph.D., managing partner at 4BIO Capital, said, "We are excited to be investing at this early stage of what we expect to be an extraordinary future for Araris. Its pioneering technology, enabling fast and precise production of ADCs, is highly innovative and we believe has huge potential to bring enhanced therapies to patients across the globe."