Curaleaf Completes Acquisition of Los Sueños

On October 4, 2021 Curaleaf Holdings, Inc. (CSE: CURA / OTCQX: CURLF) ("Curaleaf" or the "Company"), a leading international provider of consumer products in cannabis, reported that it has successfully completed the acquisition of Los Sueños Farms and its related entities ("Los Sueños"), the largest outdoor grow in Colorado (Press release, Curaleaf Holdings, OCT 4, 2021, View Source [SID1234591159]).

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Boris Jordan, Executive Chairman of Curaleaf, stated, "We’re very excited about the closing of the Los Sueños acquisition. The vertical integration of our business in Colorado significantly strengthens Curaleaf’s market presence in the second largest state cannabis market in the U.S. This deal provides Curaleaf with a high-quality, efficient, and low-cost supply of biomass to support our wholesale and retail customers in Colorado and, once interstate commerce is allowed, on a regional scale. Overall, our newly expanded cultivation capacity will allow us to better serve Colorado’s $2.2 billion annual cannabis market opportunity."

Following the successful completion of the Los Sueños acquisition, Curaleaf gains three Pueblo, Colorado outdoor cannabis grow facilities covering 66 acres of cultivation capacity including land, equipment and licensed operating entities; an 1,800 plant indoor grow; and two retail cannabis dispensary locations serving adult use customers. As the largest cannabis biomass producer in the state, the Los Sueños facilities will help fuel the Company’s Select brand’s already market-leading presence in Colorado with a variety of best-in-class cannabis products distributed to nearly 2,000 locations across 18 states.

Bob DeGabrielle, Los Sueños founder and Colorado cannabis industry expert, will continue to oversee the Los Sueños operation and will take responsibility for Curaleaf’s Colorado wholesale and retail businesses.

Joseph Bayern, CEO of Curaleaf, commented, "The Los Sueños acquisition provides important new cultivation capacity to accelerate our growth and share in the fast-growing Colorado market. By leveraging the outdoor grow expertise of the talented Los Sueños team, we will optimize our new outdoor scale and cultivation technologies to lower our total cost of delivery, with the genetics that we perfect there serving as a center of excellence for all our future U.S. outdoor cultivation capabilities."

PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer

On October 4, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune T-cell activating technology, reported the completion of enrollment for the first stage of the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus (HPV16)-associated head and neck cancer (Press release, PDS Biotechnology, OCT 4, 2021, View Source [SID1234590865]). 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine.

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VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.

"Completion of enrollment among checkpoint inhibitor naïve patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naïve arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial," said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer."

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email [email protected] or visit the website at View Source to learn more.

Mirati Therapeutics to Present New Research From its Innovative Oncology Pipeline at the 2021 AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer

On October 4, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported new clinical and preclinical research will be presented at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 7 – 10, 2021 (Press release, Mirati, OCT 4, 2021, View Source [SID1234590833]).

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The Company will present preclinical data evaluating MRTX1719, the selected clinical candidate from our MTA-cooperative PRMT5 inhibitor program, in MTAP-deleted cancer models.

In addition, the Company will present a summary of the discovery and characterization of initial formulations of MRTX1133, a KRASG12D inhibitor, including in pancreatic cancer models. The presentation will also include preliminary new clinical data from a cohort of the KRYSTAL-1 study evaluating adagrasib in previously-treated patients with KRASG12C-mutated pancreatic cancer.

Learn more about Mirati’s development of therapies that target the genetic and immunological drivers of cancers at Mirati.com/science.

Mirati studies at the 2021 AACR (Free AACR Whitepaper)-NCI-EORTC International Conference include:
All times noted are U.S. Eastern Time (ET)

Presentation Title: MRTX1719: A First-in-class MTA-cooperative PRMT5 Inhibitor that Selectively Elicits Antitumor Activity in MTAP/CDKN2A Deleted Cancer Models
Author: Peter Olson, Ph.D., Mirati Therapeutics, Inc.
Session: Poster
Session Date/Time: Thursday, October 7, 9:00 a.m. and on-demand throughout conference

Presentation Title: Discovery and Characterization of MRTX1133, a Selective Non-Covalent Inhibitor of KRASG12D*
Author: James G. Christensen, Ph.D., Mirati Therapeutics, Inc.
Session: Plenary Session 5: Drugging Difficult Targets
Session Date/Time: Saturday, October 9, 12:05 – 1:55 p.m.

*Presentation to include preliminary clinical data from a cohort of the KRYSTAL-1 trial evaluating adagrasib in previously treated patients with KRASG12C-mutated pancreatic cancer.

About Adagrasib (MRTX849)
Adagrasib is an investigational, highly selective, and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24−48 hours. Adagrasib is a being evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer and pancreatic cancer. For more information visit Mirati.com/science.

About MRTX1133
MRTX1133 is an investigational, highly selective and potent small molecule inhibitor of KRASG12D. In preclinical studies, MRTX1133 exhibited a long half-life, an ability to bind the KRASG12D protein in both active and inactive states, and selective inhibition of KRAS G12D mutant cancer cells. In G12D mutant tumor models, MRTX1133 showed dose-dependent selective inhibition of the KRAS pathway and tumor regression. Increased activity was also shown when combined with rational combination therapies. MRTX1133 is in Investigational New Drug-enabling studies and has the potential to be a first-in-class therapeutic. For more information visit Mirati.com/science.

About MRTX1719
Mirati is developing MRTX1719, an internally discovered, synthetic lethal PRMT5 inhibitor for the treatment of methylthioadenosine phosphoylase (MTAP)-deleted cancers. PRMT5 is an enzyme critical to the survival of both healthy and cancer cells and is partially inhibited by methylthioadenosine (MTA), which accumulates in MTAP-deleted cancers. MRTX1719 has shown in preclinical models to selectively target the PRMT5/MTA complex in MTAP-deleted cancer cells while sparing healthy cells. MTAP gene deletion occurs in approximately 9% of all cancers including pancreatic, lung, and bladder cancers, as well as other patient populations that have limited treatment options. MRTX1719 is in Investigational New Drug-enabling studies and has the potential to be a first-in-class therapeutic.

Entry into a Material Definitive Agreement

On October 4, 2021 Inspyr Therapeutics, Inc,. a Delaware corporation ("Inspyr"), reported that it is implementing a holding company reorganization pursuant to an Agreement and Plan of Merger (the "Merger Agreement"), dated as of September 28, 2021, among Inspyr, Rebus Holdings, Inc. a Delaware corporation ("Holding Company"), and Rebus Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Holding Company ("Merger Sub"), which will result in the Holding Company becoming the direct parent company of Inspyr and replacing Inspyr as the public company trading on the OTC Markets ("OTC") (the "Reorganization")(Filing, 8-K, Inspyr Therapeutics, OCT 4, 2021, View Source [SID1234590819]).

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Pursuant to the Merger Agreement, Merger Sub will merge with Inspyr pursuant to the filing of a certificate of merger (the "Certificate of Merger"), with Inspyr surviving as a direct, wholly-owned subsidiary of Holding Company (the "Merger"). At the effective time of the Merger (the "Effective Time"), subject to the approval of the Financial Industry Regulatory Authority or FINRA:

(i) Each outstanding share of Inspyr common stock, par value $0.0001 per share ("Inspyr Common Stock"), will automatically be converted into one share of common stock, par value $0.0001 per share, of Holding Company ("Holding Company Common Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Common Stock immediately prior to the Reorganization;

(ii) Each outstanding share of Inspyr Series A Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series A Stock"), will automatically be converted into one share of Series A Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series A Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series A Stock immediately prior to the Reorganization;

(iii) Each outstanding share of Inspyr Series B Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series B Stock"), will automatically be converted into one share of Series B Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series B Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series B Stock immediately prior to the Reorganization;

(iv) Each outstanding share of Inspyr Series C Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series C Stock"), will automatically be converted into one share of Series C Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series C Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series C Stock immediately prior to the Reorganization;

(v) Each outstanding share of Inspyr Series D Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series D Stock"), will automatically be converted into one share of Series D Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series D Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series D Stock immediately prior to the Reorganization;

(vi) Each outstanding share of Inspyr Series E Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series E Stock"), will automatically be converted into one share of Series E Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series E Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series E Stock immediately prior to the Reorganization; and

(vii) Each outstanding share of Inspyr Series F Convertible Preferred Stock, par value $0.0001 per share ("Inspyr Series F Stock"), will automatically be converted into one share of Series F Convertible Preferred Stock par value $0.0001 per share, of Holding Company ("Holding Company Series F Stock"), having the same designation, rights, powers, and preferences, and qualifications, limitations, and restrictions as a share of Inspyr Series F Stock immediately prior to the Reorganization.

Accordingly, upon consummation of the Reorganization (and the Reverse Stock Split as defined below), Inspyr stockholders will automatically became stockholders of Holding Company, on a one-for-one basis, with the same number and approximate ownership percentage of shares of the same class as they held in Inspyr immediately prior to the Effective Time. The Reorganization is intended to be a tax-free transaction for U.S. federal income tax purposes for Inspyr stockholders.

The Reorganization is being conducted pursuant to Section 251(g) of the General Corporation Law of the State of Delaware (the "DGCL"), which provides for the formation of a holding company without a vote of the stockholders of the constituent corporation. The conversion of stock will occur automatically without an exchange of stock certificates. In addition, at the Effective Time:

● Each outstanding and unexpired option to purchase Inspyr Common Stock will automatically be converted into one share of Holding Company Common Stock;

● Each outstanding warrant to purchase Inspyr Common Stock ("Inspyr Warrant"), whether or not vested, will automatically be converted into and become a warrant to purchase Holding Company Common Stock ("Holding Company Warrant") and Holding Company will assume each Inspyr Warrant in accordance with the terms of each Inspyr Warrant, and such Holding Company Warrant will have the same number of shares, the same exercise price (subject to adjustments), the same restrictions on exercise, and any other provisions contained in the Inspyr Warrants; and

● Each outstanding convertible debt instrument of Inspyr, including but not limited to, promissory notes or debentures that are convertible into Inspyr Common Stock ("Inspyr Convertible Notes") will automatically be converted into, assumed, and become the convertible debt instruments of the Holding Company ("Holding Company Convertible Notes").

As a result of the Reorganization, the Holding Company will become the successor issuer to Inspyr pursuant to Rule 12g-3(a) of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and as a result, shares of Holding Company Common Stock are deemed registered under Section 12(g) of the Exchange Act as the common stock of the successor issuer.

Reverse Stock Split

As previously disclosed in the Definitive Proxy Statement filed by Inspyr on September 3, 2021, pursuant to a written consent, Inspyr’s shareholders approved a proposal authorizing the board of directors of Inspyr ("Board") to effect a reverse stock split of the Company’s common stock, par value $0.0001 (the "Common Stock").

On September 1, 2021, the Board approved a one-for-seventy-five (1-for-75) reverse stock split of the Inspyr Common Stock ("Reverse Stock Split"). In furtherance of the Reverse Stock Split, Inspyr has filed an amended and restated certificate of incorporation ("Amended and Restated Certificate of Incorporation") with the Secretary of State of Delaware to effect the Reverse Stock Split effective as of 4:59 p.m. Eastern Time on October 5, 2021, but the trading post Reverse Stock Split will not occur until FINRA approval is received ("Reverse Split Effective Time").

As a result, at the Reverse Split Effective Time (and just prior to the completion of the Reorganization, subject to FINRA approval of each), each of the holders of Inspyr Common Stock will receive one (1) new share of Inspyr Common Stock for every seventy-five (75) shares such shareholder held immediately prior to the Reverse Split Effective Time. The Reverse Stock Split will also affect the Company’s outstanding stock options, warrants and other exercisable or convertible instruments and will result in the shares underlying such instruments being reduced and the exercise price being increased proportionately to the Reverse Stock Split ratio. No fractional shares will be issued as a result of the Reverse Stock Split. Any fractional shares that would have otherwise resulted from the Reverse Stock Split will be rounded up to the next whole number of shares.

As a result of the Reverse Stock Split, the number of issued and outstanding shares of Common Stock will be adjusted from 718,202,289 (assuming no change in issued and outstanding until such date) shares to approximately 9,576,030 shares. Additionally, pursuant to the terms of their Certificates of Designation, each Series of Inspyr preferred stock will have the conversion price at which shares of such applicable preferred stock may be converted into shares of Inspyr Common Stock proportionately adjusted to reflect the Reverse Stock Split. Additionally, all outstanding options, warrants and convertible debt of Inspyr will be adjusted proportionately pursuant to the Reverse Stock Split.

Upon the completion of the Reorganization immediately after, each shareholder will have such number of shares of Holding Company Common Stock and Holding Company Preferred Stock as the shareholder would have held of Inspyr immediately following the Reverse Stock Split.

Post Reverse Stock Split and Reorganization Information

Following the completion of the (i) Reverse Stock Split and (ii) the Reorganization, the Holding Company Common Stock will begin trading on post Reverse Stock Split and post Reorganization basis on Pink Sheets of the OTC Markets Group upon completion and approval of the FINRA review and confirmation of a new trading symbol, which we expect to receive soon after the filing of this Current Report. We will announce the new trading symbol and CUSIP via press release prior to the date when such trading begins on a post Reverse Stock Split and Reorganization basis.

At the Effective Time, the officers and members of the Board of Inspyr will become the officers and members of the board of directors of the Holding Company.

Immediately after the consummation of the Reorganization, the Holding Company will have, on a consolidated basis, the same assets, businesses, and operations as Inspyr will have had immediately prior to the consummation of the Reorganization.

The foregoing does not purport to be a complete description of the Reverse Stock Split and the subsequent Reorganization and each are qualified in their entirety by reference to (i) the Amended and Restated Certificate of Incorporation effecting the Reverse Stock Split, (ii) the Merger Agreement, and (iii) the Certificate of Merger, a copy of each of which is filed as Exhibit 3.01(i), 2.01, and 3.02(i), respectively, to this Current Report on Form 8-K and each are incorporated by reference herein.

Item 3.03 Material Modification of Rights of Security Holders.

At the Effective Time of the Merger, each share of capital stock of Inspyr issued and outstanding immediately prior to the Effective Time will automatically convert into a share of the same class or series designation of the Holding Company, having the same designations, rights, powers, and preferences and the qualifications, limitations, and restrictions as such applicable share of Inspyr capital stock immediately prior to the Effective Time.

The information set forth in Item 1.01 under the heading "Adoption of Agreement and Plan of Merger and Consummation of Reorganization" and in Item 5.03 is hereby incorporated by reference in this Item 3.03.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

The information set forth in Item 1.01 under the heading "Post Reverse Stock Split and Reorganization Information" is hereby incorporated by reference in this Item 5.02.

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.

As described in Item 1.01 above under the heading "Reverse Stock Split", Inspyr filed the Amended and Restated Certificate of Incorporation effecting the Reverse Stock Split.

Upon consummation of the Reorganization, the Amended and Restated Certificate of Incorporation of Inspyr will be amended and restated through the Certificate of Merger to (i) decrease the authorized number of shares of Inspyr Common Stock from one billion thirty million (1,030,000,000) shares to one thousand (1,000) shares; (ii) remove the authorized number of shares of Preferred Stock; (iii) add a provision, which is required by Section 251(g) of the DGCL, that provides that any act or transaction by or involving Inspyr, other than the election or removal of directors, that requires for its adoption under the DGCL or the Amended and Restated Certificate of Incorporation, the approval of the stockholders of Inspyr shall require the approval of the stockholders of the Holding Company by the same vote as is required by the DGCL and/or the Amended and Restated Certificate of Incorporation; and (iv) add and remove provisions as appropriate for a wholly-owned subsidiary.

In addition, the Amended and Restated Bylaws of Inspyr, dated January 6, 2010, were amended and restated (as amended and restated, the "Inspyr Bylaws") to add and remove provisions as appropriate for a wholly-owned subsidiary.

The foregoing descriptions of the (i) Amended and Restated Certificate of Incorporation, (ii) amendment to the Amended and Restated Certificate of Incorporation as contained in the Certificate of Merger, and (iii) Inspyr Bylaws do not purport to be complete and are qualified in their entirety by reference to the Certificate of Merger and the Bylaws, copies of which are filed as Exhibit 3.01(i), Exhibit 3.02(i), and Exhibit 3.03(ii) respectively, to this Current Report on Form 8-K and incorporated by reference herein.

ERYTECH Announces Maximum Tolerated Dose Declared in a Phase 1 Investigator Sponsored Trial of Eryaspase in First-Line Pancreatic Cancer

ERYTECH Pharma, a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that the MTD has been declared in a Phase I investigator sponsored clinical trial (IST), named rESPECT, of its lead product candidate eryaspase for the first-line treatment of pancreatic cancer, defining the recommended dose for future clinical trials in this indication at 100 U/kg (Press release, ERYtech Pharma, OCT 4, 2021, View Source [SID1234590814]).

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After review of the safety data, the dose escalation committee concluded that the novel combination of mFOLFIRINOX plus eryaspase was well tolerated with no DLT. Consequently, the MTD has been declared at a dose of 100 U/kg eryaspase. Interestingly, all six patients evaluated for response achieved disease control, four patients with objective response and two with stable disease.
The trial will continue to enroll additional patients at the 100 U/kg dose level to further assesss the safety and clinical activity. The declared MTD of 100 U/kg eryaspase corresponds with the dose currently being used in clinical trial in second-line patients and it can now be taken forward into future late-stage clinical studies in first-line pancreatic patients.
Full disclosure of both safety and efficacy information will be made at a future medical congress. Dr Marcus Noel, Associate Professor of Medicine at Georgetown University, Washington DC, USA, commented: "As an oncologist, one of my biggest challenges is the ability to add treatments to existing backbone chemotherapies, such as mFOLFIRINOX, which are already difficult for patients to tolerate. It is highly encouraging that this study has demonstrated the possibility to add a novel treatment, eryaspase, to mFOLFIRINOX without observing DLT. Furthermore, whilst the trial is not designed to answer if eryaspase is efficacious, partial responses in four out of the six patients with imaging are clearly encouraging."
Dr Iman El-Hariry, ERYTECH’s Chief Medical Officer, added: "We are delighted to be working alongside Dr Noel at the University of Georgetown and reaching the important milestone of declaring the MTD of eryaspase in first-line pancreatic patients. We look forward to discussing future study designs with Dr Noel and other Key Opinion Leaders so that we can bring this potentially valuable therapy to first-line pancreatic patients at the earliest opportunity. In the fourth quarter of this year , we also expect top-line results from the TRYbeCA-1 Phase 3 clinical trial in second-line pancreatic cancer. If that trial confirms the survival benefit we observed in the earlier Phase 2 trial, we will plan to launch a pivotal trial in first-line pancreatic cancer and potentially other settings such as locally advanced pancreatic cancer."
About Pancreatic Cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. It is currently the fourth leading cause of cancer death in the United States and is projected to rise to the second leading cause by 2030. Every year, there are approximately 185,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Approximately half of patients are diagnosed with metastatic disease and approximately 30% of patients are diagnosed with locally advanced disease. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate below 10%. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug
combinations with the aim of improving overall patient outcomes and quality of life.