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Terumo Blood and Cell Technologies and PhotonPharma Inc. announce collaboration to develop a novel cancer immunotherapy

On August 11, 2021 Terumo Blood and Cell Technologies (Terumo), a medical device company specializing in a portfolio of technology, software and services for blood component collection, therapeutic apheresis and cellular technologies, and PhotonPharma Inc., a cancer immunotherapy developer, reported they have established a memorandum of understanding (MOU) for collaboration to develop Innocell, a novel tumor specific immunotherapy (a therapeutic vaccine) for solid tumors (Press release, PhotonPharma, AUG 11, 2021, View Source [SID1234586670]). The benefit to patients is that collaborations like this can help improve the speed to market for valuable treatments.

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T-cell attaching to cancer cell, illustration T lymphocyte (orange) attached to a cancer cell (blue), illustration. T lymphocytes are a type of white blood cell which matures in the thymus. Certain kinds of T lymphocytes can recognise specific sites (antigens) on the surface of cancer cells or pathogens and bind to them. They can then destroy the cancer cells, or signal for other immune system cells to eliminate them. The genetic changes that cause a cell to become cancerous lead to the present
T-cell attaching to cancer cell, illustration T lymphocyte (orange) attached to a cancer cell (blue), illustration. T lymphocytes are a type of white blood cell which matures in the thymus. Certain kinds of T lymphocytes can recognise specific sites (antigens) on the surface of cancer cells or pathogens and bind to them. They can then destroy the cancer cells, or signal for other immune system cells to eliminate them. The genetic changes that cause a cell to become cancerous lead to the present
To help in the caner immunotherapy development process, PhotonPharma is using Terumo’s Mirasol Pathogen Reduction Technology (PRT) in the manufacturing process. The initial agreement authorizes PhotonPharma to reference the Device Master File (DMF) on record with the FDA for the Mirasol system. This DMF will then support the PhotonPharma regulatory submission for its Innocell therapeutic vaccine technology. Additionally, Terumo Blood and Cell Technologies will supply Mirasol illuminators and single-use sets for the immunotherapy preparation process used in the clinical trial.

Mirasol has been used in select markets outside the United States since 2007. Terumo designed Mirasol to reduce pathogen load and inactivate residual white blood cells in whole blood and blood components. PhotonPharma’s specific use of Mirasol is a further example of how Terumo’s products are being used to develop treatments across the life-sciences sector to help patients gain access to medical therapies.

Another potential therapy in the War Against Cancer
The American Cancer Society’s 2021 forecast projects 1.9 million new cancer diagnoses and more than 600,000 cancer deaths. Each day, that’s approximately 5,200 newly diagnosed cancer cases and 1,670 cancer deaths. Ninety percent of the cases diagnosed are expected to be from solid tumors2.

Therapeutic cancer vaccines are developed to stimulate a patient’s immune system to fight an established cancer. They are different from prophylactic vaccines, which are given to healthy individuals to prevent an infection and related disease.

PhotonPharma developed its technology to be differentiated from other therapeutic cancer vaccines in its potential to preserve solid tumor antigens, cell metabolism and protein translation while also potentially achieving inactivation of cellular replication.

This MOU is the first part of a longer-term collaboration to advance PhotonPharma’s Innocell. The collaboration focuses on the development, regulatory approval and future commercialization of PhotonPharma’s Innocell vaccine. PhotonPharma is currently preparing an Investigational New Drug (IND) submission related to a phase I clinical trial targeting triple-negative breast cancer.

"This agreement to work together with Terumo increases the potential to advance a new therapy for patients suffering from a variety of solid tumor malignancies including breast cancer," said Dr. Gary Gordon, M.D., Ph.D., former Divisional Vice President of Abbvie Oncology and PhotonPharma board member. "Working together will benefit patients in need of new therapeutic approaches to treat their underlying disease."

Antoinette Gawin, President and Chief Executive Officer, Terumo Blood and Cell Technologies, says: "For Terumo, strategic collaborations increase the potential speed to market and decrease development costs of therapies. This will enable patients to benefit from therapies earlier. Contributing toward the development and commercialization of Innocell enables Terumo to contribute toward the next potential major medical breakthrough."

1American Cancer Society. (2021). Retrieved 4 August 2021 from Cancer.org.

Turning Point Therapeutics Granted Sixth Regulatory Designation for Repotrectinib

On August 11, 2021 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the U.S. Food and Drug Administration (FDA) granted a sixth regulatory designation to lead drug candidate, repotrectinib (Press release, Turning Point Therapeutics, AUG 11, 2021, View Source [SID1234586469]).

The Fast-Track designation was granted for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC) who have been previously treated with one prior ROS1 tyrosine kinase inhibitor (TKI) and who have not received prior platinum-based chemotherapy.

"We are pleased to receive our fourth Fast-Track designation and sixth overall regulatory designation for repotrectinib as we continue to work toward our goal of getting this ROS1 targeted therapy to patients quickly," said Athena Countouriotis, M.D., president and chief executive officer. "We continue to believe repotrectinib has the potential to be a best-in-class treatment for patients with ROS1-positive advanced non-small cell lung cancer or NTRK-positive advanced solid tumors and now have multiple regulatory designations in both the TKI-naïve and TKI-pretreated ROS1 patient populations."

Repotrectinib was previously granted Breakthrough Therapy designation in ROS1- positive metastatic NSCLC patients who have not been treated with a ROS1 tyrosine kinase inhibitor, as well as three Fast-Track designations in ROS1-positive advanced NSCLC patients who are ROS1 TKI naïve, ROS1-positive advanced NSCLC patients who have been previously treated with one prior line of platinum-based chemotherapy and one prior ROS1 TKI, and NTRK-positive patients with advanced solid tumors who have progressed following treatment with at least one prior line of chemotherapy and one or two prior TRK TKIs and have no satisfactory alternative treatments.

About Fast-Track Designation
Fast-Track is an FDA program intended to facilitate the development and expedite the review of drug candidates to treat serious conditions and fill an unmet medical need.

A drug candidate that receives Fast-Track designation may be eligible for:

More frequent meetings with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval;
More frequent written communication with the FDA;
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and
Rolling submission of a New Drug Application (NDA) for review by FDA.

Entry into a Material Definitive Agreement.

On August 11, 2021, ImmunoGen, Inc. (the "Company") reported that entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with RA Capital Healthcare Fund, L.P. (the "Investor"), pursuant to which the Company agreed to sell to the Investor a pre-funded warrant (the "Pre-Funded Warrant") to purchase up to an aggregate of 5,434,782 shares of the Company’s common stock, par value $0.01 per share ("Common Stock"), for aggregate consideration of $29,945,648.82, or $5.51 per share of Common Stock underlying the Pre-Funded Warrant, which, together with the per share exercise price, is equal to $5.52, the closing price of our Common Stock as reported on the Nasdaq Global Select Market on August 4, 2021, the date the Company and the Investor first discussed a potential investment (Filing, 8-K, ImmunoGen, AUG 11, 2021, View Source [SID1234586420]).

The issuance and sale of the Pre-Funded Warrant under the Securities Purchase Agreement (and the shares of Common Stock issuable upon exercise of the Pre-Funded Warrant) are registered pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-251502).

The Securities Purchase Agreement contains certain representations, warranties, and covenants for the benefit of the parties to the Securities Purchase Agreement and should not be relied upon by any of our investors who are not parties to Securities Purchase Agreement, nor should any such investor rely upon any descriptions thereof as characterizations of the actual state of facts or condition. Such investors are not third-party beneficiaries under the Securities Purchase Agreement.

Pre-Funded Warrant

Pursuant to the Securities Purchase Agreement, the Company will issue the Pre-Funded Warrant to the Investor. The Pre-Funded Warrant entitles the Investor to purchase shares of Common Stock at an exercise price equal to $0.01 per share. The Pre-Funded Warrant will be exercisable at any time beginning on the date of issuance. The number of shares of the Company’s Common Stock issuable upon exercise of the Pre-Funded Warrant is subject to adjustment upon certain corporate events, including certain stock dividends and splits, combinations, reclassifications, and certain other events.

The Investor may exercise the Pre-Funded Warrant by delivering an exercise notice, completed and duly signed, and payment in cash of the exercise price for the number of shares of the Company’s Common Stock for which the Pre-Funded Warrant is being exercised. The Investor may also satisfy its obligation to pay the exercise price through a "cashless exercise," in which the Investor receives the net value of the Pre-Funded Warrant in shares of Common Stock determined according to the formula set forth in the Pre-Funded Warrant.

The Investor will not be entitled to exercise any portion of the Pre-Funded Warrant that, upon giving effect to such exercise, would cause the aggregate number of shares of Common Stock beneficially owned by the Investor (together with its affiliates and any other persons whose beneficial ownership of Common Stock would be aggregated with the Investor for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended) to exceed 9.99% of the total number of then issued and outstanding shares of Common Stock, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrant. This threshold is subject to the Investor’s rights under the Pre-Funded Warrant to increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from the Investor to the Company.

TRACON Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Corporate Update

On August 11, 2021 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported financial results for the second quarter ended June 30, 2021 (Press release, Tracon Pharmaceuticals, AUG 11, 2021, View Source [SID1234586371]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

"We remain on track to announce interim efficacy data from the pivotal ENVASARC trial by the end of this year and final data in 2022," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Last week the IDMC recommended the study proceed as planned following review of interim safety data and we will continue to focus our efforts on enrolling this pivotal trial. Following our recent public offering, our balance sheet provides us with cash runway into 2023."

Recent Corporate Highlights

Envafolimab

In June, we received orphan drug designation for envafolimab in soft tissue sarcoma based on clinical data demonstrating confirmed objective partial responses by RECIST with duration of response in excess of six months, in two of five patients with refractory metastatic alveolar soft part sarcoma (ASPS) who received single agent envafolimab in Phase 1 clinical trials conducted by our partners, 3D Medicines and Alphamab Oncology.

On August 6, the Independent Data Monitoring Committee (IDMC) recommended the ENVASARC trial proceed as planned following the review of more than three months of safety data from more than 20 patients enrolled in the trial as of May.

In June, we presented the study design of the pivotal Phase 2 ENVASARC trial of single agent envafolimab and envafolimab given with Yervoy (ipilimumab) at the 2021 ASCO (Free ASCO Whitepaper) virtual annual meeting.
Corporate

In July, we announced an underwritten public offering for gross proceeds of approximately $15.0 million. We estimate that the proceeds will extend our cash runway into 2023, past expected final top-line data for ENVASARC.

In the second quarter we enhanced our senior management team with multiple new hires, including a Head of Regulatory and Head of Biometrics, both of whom have BLA filing experience.

In July, the book Unnecessary Expense: An Antidote to the Billion Dollar Drug Problem, authored by TRACON senior management to be published by ForbesBooks became available for preorder on Amazon. Publication is expected in September.
Other

In June, we presented preliminary Phase 1 data for the CD73 antibody uliledlimab (TJ4309) at the 2021 ASCO (Free ASCO Whitepaper) virtual annual meeting.
Expected Key Upcoming Milestones

Interim ENVASARC efficacy data by end of 2021.

Request FDA breakthrough therapy designation or fast track designation for envafolimab by end of 2021, assuming positive interim efficacy data.

Decision on the envafolimab New Drug Application in MSI-H/dMMR cancer that is under priority review by the Chinese National Medical Products Administration.
Second Quarter 2021 Financial Results

Cash, cash equivalents and short-term investments were $25.6 million at June 30, 2021, compared to $36.1 million at December 31, 2020. The cash balance at June 30, 2021, does not include the proceeds from the $15 million underwritten public offering in July, which extends the Company’s cash runway into 2023.

Research and development expenses for the second quarter of 2021 were $3.1 million, compared to $2.2 million for the second quarter of 2020.

General and administrative expenses for the second quarter of 2021 were $6.1 million, compared to $2.1 million for the second quarter of 2020. The increase was primarily attributable to legal expenses incurred with the now stayed lawsuit filed by I-Mab in the Delaware Court of Chancery and ongoing arbitration on the TJ4309 and bispecific agreements. We expect the second quarter of 2021 to be the high point for general and administrative expenses this year.

Net loss for the second quarter of 2021 was $8.9 million, compared to $4.5 million for the second quarter of 2020.
Conference Call Details

Wednesday, August 11, at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Domestic: 855-779-9066
International: 631-485-4859
Conference ID: 3067769
A live webcast of the conference call will be available online from the Investor/Events and Presentations page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by 3D Medicines. TRACON’s partners Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of the KEYNOTE-164 clinical trial.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled into cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the U.S. FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

Panbela Provides Business Update and Reports Q2 2021 Financial Results

On August 11, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported financial results for the quarter ended June 30, 2021 (Press release, Panbela Therapeutics, AUG 11, 2021, View Source [SID1234586369]). Management is hosting an earnings call today at 4:30 p.m. ET.

The second quarter 2021 was marked by meaningful clinical progress.

Recent Highlights

Issue Notification for patent US 11,098,005 titled "METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL". A novel process for the production of our lead investigational product SBP-101, reduces the number of synthetic steps for its production from seventeen to six, and provides patent coverage to 2039.
$10.0 million bought offering of common stock closed July 2021
Added to the Russel Microcap index effective June 25, 2021
Presented data on Phase 1b clinical trial of SBP-101 in combination with gemcitabine and nab-paclitaxel in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDA) at 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Conversion of a patient to a complete response (CR), coupled with a second patient who was a non-CR/no-evidence of disease post ASCO (Free ASCO Whitepaper) poster presentation.
Dr. Michael T. Cullen transitioned to non-executive chairman of the Board of Directors
Partial clinical hold lifted from the company’s Phase 1b first-line study of SBP-101.
"We had a great second quarter and year to date," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. "Highlights included transitioning Dr. Cullen to Chairman of the Board, being added to the Russel Microcap index, and bolstering our balance sheet. Additionally, during the quarter the partial clinical hold was lifted, and with the data presented at ASCO (Free ASCO Whitepaper) and the subsequent conversion of a patient to a complete response (CR), coupled with a second patient who was a non-CR/no-evidence of disease, we are advancing our lead asset SBP-101 in its first indication, pancreatic cancer. We also progressed with research at Johns Hopkins to explore SBP-101’s development outside of pancreatic cancer as well as potentially in combination with a checkpoint inhibitor by year-end. Subsequent to quarter end, we closed a $10.0 million offering of common stock which will help us further develop and expand the application of SBP-101 and drive shareholder value."

As previously announced, in April the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the company’s Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treatment of patients with metastatic pancreatic ductal adenocarcinoma. The company has agreed to include in the design of future studies the exclusion of patients with a history of retinopathy or at risk of retinal detachment and scheduled periodic ophthalmologic monitoring for all patients, and in future dose-finding studies screening for retinal toxicity will be included.

Based on interim data from our Phase I trial, SBP-101 demonstrated a 48% objective response rate in combination with gemcitabine & abraxane (G&A), more than double the historical standard of care for metastatic pancreatic cancer with G&A. After our ASCO (Free ASCO Whitepaper) presentation, a patient converted from a partial response to a complete response. An additional patient was a non-complete response/no evidence of disease. These results support continued development of the pancreatic program.

We believe SBP-101 has the potential to expand into other cancers with known elevated levels of polyamine metabolism.

Upcoming Milestones

Initiation of randomized trial by year-end
Initiation of a neoadjuvant study in pancreatic cancer by year-end
Pre-clinical data which may support new development programs outside of pancreatic cancer in 2H’21
Second Quarter ended June 30, 2021 Financial Results

General and administrative expenses were $1.2 million in the second quarter of 2021, compared to $0.7 million in the second quarter of 2020. The increase in the quarter is primarily associated with increased employee compensation and other increased costs associated with maintaining the listing of our common stock on the Nasdaq Capital Market.

Research and development expenses were $1.0 million in the second quarter of 2021, compared to $0.4 million in the second quarter of 2020. The increase in the quarter is due primarily to higher manufacturing costs in preparation for future clinical trials.

Net loss was $2.2 million, or $0.22 per diluted share, compared to a net loss of $0.4 million, or $0.06 per diluted share, in the second quarter of 2020.

Total cash and cash equivalents was $6.4 million as of June 30, 2021. Total current assets were $7.2 million and current liabilities were $1.4 million as of the same date. Total cash on June 30, 2021 does not include net proceeds of approximately $9.0 million from the sale of 3,333,334 shares of its common stock at a price to the public of $3.00 per share, before underwriting discounts and commissions, which closed on July 2, 2021.

The company had no debt as of June 30, 2021.

Conference Call Information

To participate in Management’s conference call, dial approximately 5 to 10 minutes before the beginning of the call.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse events are being evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source