On October 13, 2020 Boehringer Ingelheim reported new data for Gilotrif (afatinib) which further affirm its activity in squamous cell carcinoma of the lung and, in a separate study, epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) (Press release, Boehringer Ingelheim, OCT 13, 2020, View Source [SID1234568434]). The findings are being presented at the IASLC 2020 North America Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (NACLC 2020).

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Analysis from a retrospective, real-world study of patients with metastatic squamous NSCLC who progressed on first-line pembrolizumab plus platinum-based chemotherapy provides effectiveness and safety data for afatinib following immunotherapy (IO) in this second-line setting. Median overall time on treatment (TOT) for patients who received second-line afatinib was 7.3 months (95% confidence interval [CI]; 5.2-8.1). Incidence of severe immune-related adverse events (irAEs) occurred in six patients (pneumonitis, colitis, hepatitis). This analysis also evaluated chemotherapy in this second-line setting, with median overall TOT of 4.2 months (95% CI; 3.9-4.9). There were no reported irAES in the chemotherapy cohort.

"Given relatively recent advances with immunotherapy, prospective trials have yet to investigate the use of afatinib following first-line immunotherapy and chemotherapy in metastatic squamous non-small cell lung cancer," said Edward S. Kim, M.D., FACP, Levine Cancer Institute. "Findings from this study suggest that second-line afatinib is generally well-tolerated and effective in patients with metastatic squamous cell carcinoma of the lung when pembrolizumab is added to first-line platinum-based chemotherapy."

In a separate data set presented at the meeting, researchers assessed the use of afatinib in Asian and non-Asian patients with EGFRm+ NSCLC whose tumors have G719X/L861Q/S768I non-resistant mutations, pooled from randomized clinical trials and real-world studies. The analysis showed that afatinib is effective in these patients, and is unaffected by ethnicity (overall response rate: 66% Asian/59% non-Asian; median duration of response: 14.7 months/15.9 months; G719X: 62%/65%; L861Q: 60%/50%; S768I: 80%/25%).

Bjoern Rueter, M.D., Therapeutic Area Head Oncology, USA, at Boehringer Ingelheim, said, "These data sets further expand our understanding of afatinib’s therapeutic profile in metastatic squamous non-small cell lung cancer and among those with EGFR mutation-positive disease. As we continue to take cancer on at Boehringer Ingelheim, our ongoing research is aimed at supporting unmet treatment needs for the lung cancer and broader oncology community through leading science."

Gilotrif is indicated for the first-line treatment of patients with metastatic NSCLC whose tumors have non-resistant EGFR mutations as detected by an FDA-approved test. Gilotrif is also approved for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.

Data Presentations Featured at IASLC NACLC 2020:

Real-world Effectiveness and Safety of Afatinib Following Immunotherapy (IO) in the Treatment of Metastatic, Squamous Cell/Mixed Histology Carcinoma of the Lung: A Multi-site Retrospective Chart Review Trial in the US. Friday October 16, 17:00-18:00 CDT.
Afatinib in Asian and Non-Asian Patients (pts) with EGFR Mutation-positive (EGFRm+) NSCLC Harboring Major Uncommon Mutations Friday October 16, 17:00-18:00 CDT.
What Is Gilotrif?
Gilotrif is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:

has certain (non-resistant) abnormal epidermal growth factor receptor (EGFR) gene(s). Your healthcare provider will perform a test to make sure that Gilotrif is right for you.
has spread to other parts of the body (metastatic), and
has not been previously treated for metastatic lung cancer
It is not known if Gilotrif is safe and effective in treating people with lung cancer that has resistant abnormal EGFR genes.

or

is used to treat people with squamous cell lung cancer that:

has spread to other parts of the body, and
has been previously treated with chemotherapy that contains platinum.
It is not known if Gilotrif is safe and effective in children.

Important Safety Information for Gilotrif (afatinib) Tablets

Before you take Gilotrif, tell your doctor if you:

have kidney or liver problems
have lung or breathing problems other than lung cancer
have a history of an ulcer, a tear (perforation) in your stomach or intestine, or diverticular disease (inflammation) in parts of your large intestine
have a history of severe dry eye or any other eye problems. Tell your doctor if you wear contact lenses.
have heart problems
have any other medical conditions
are pregnant or plan to become pregnant. Gilotrif can harm your unborn baby.
Females who are able to become pregnant should use effective birth control during treatment with Gilotrif and for at least 2 weeks after your last dose of GILOTRIF. Talk to your doctor about birth control methods that may be right for you.
Tell your doctor right away if you become pregnant or think you are pregnant during treatment with Gilotrif.
are breastfeeding or plan to breastfeed. It is not known if Gilotrif passes into your breast milk. Do not breastfeed while taking Gilotrif and for 2 weeks after your last dose of Gilotrif. Talk to your doctor about the best way to feed your baby if you take Gilotrif.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Gilotrif may affect the way other medicines work, and other medicines may affect the way Gilotrif works. Taking certain medicines with Gilotrif may increase your risk of developing a tear (perforation) in your stomach or intestine.

What to avoid while taking Gilotrif
Limit your time in the sun. Gilotrif can make your skin sensitive to sunlight. You could get or have worsening rash or acne. You could get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight during treatment with Gilotrif.

Gilotrif may cause serious side effects, including:

Diarrhea. Diarrhea is common with Gilotrif and may sometimes be severe. Severe diarrhea can cause loss of body fluid (dehydration) and kidney problems that can sometimes lead to death. During your treatment with Gilotrif, your doctor should prescribe medicines to treat diarrhea. Take this medicine exactly as your doctor tells you to. Tell your doctor if you have diarrhea. Get medical attention right away if your diarrhea does not go away or becomes severe.
Skin reactions. Gilotrif can cause redness, rash, and acne. It is important to get treatment for skin reactions as soon as you notice them. Take medicines to help skin reactions exactly as your doctor tells you to. Get medical attention right away if you develop severe skin reactions such as peeling or blistering of the skin, or blisters in your mouth.
Lung or breathing problems. Gilotrif may cause inflammation of the lung that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung problems, or any combination of the following symptoms: trouble breathing or shortness of breath, cough, or fever.
Liver problems. Gilotrif can cause liver problems that can sometimes lead to death. Tell your doctor right away if you have any symptoms of a liver problem which may include:
yellowing of your skin or the white part of your eyes (jaundice)
dark or brown (tea-colored) urine
pain on the upper right side of your stomach area (abdomen)
bleeding or bruising more easily than normal
feeling very tired
Your doctor will do blood tests to check your liver function during your treatment with Gilotrif.

Tear (perforation) in your stomach or intestine. Tears in your stomach or intestine can happen with Gilotrif and can sometimes lead to death. Your risk of developing a tear in your stomach or intestine may be increased if you:
take certain medicines with Gilotrif including: corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDS), and certain other medicines.
have a history of stomach or intestinal ulcers, or if you have had diverticular disease (inflammation in parts of the large intestine).
Get medical help right away if you develop severe stomach-area (abdomen) pain during treatment with Gilotrif.
Eye problems. Tell your doctor right away if you have symptoms of eye problems. Symptoms may include:
eye pain, swelling, redness, or tearing
blurred vision
sensitivity to light
other changes in your vision
Heart problems. Tell your doctor right away if you have any symptoms of a heart problem which may include:
new or worsening shortness of breath while at rest or with activity
cough
tiredness
swelling of your ankles, feet, or legs
feeling that your heart is pounding or racing (palpitations)
sudden weight gain
Your doctor may change your dose, temporarily stop or permanently stop treatment with Gilotrif if you have certain side effects.

The most common side effects of Gilotrif include diarrhea, rash, acne, mouth sores, nail inflammation, dry skin, decreased appetite, nausea, vomiting, and itching.

Gilotrif may cause decreased fertility in females and males. This may affect your ability to have a child. Talk to your doctor if this is a concern for you.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Gilotrif. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see Prescribing Information and Patient Information.

GF CONS ISI 10.21.19

About Boehringer Ingelheim in Oncology
Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.

On October 13, 2020 Iksuda Therapeutics (Iksuda), the developer of enhanced, new-generation of Antibody Drug Conjugates (ADCs), reported it has executed its option to secure exclusive, worldwide rights to develop a novel class of tumour-activated prodrug payloads from the University of Goettingen, following a successful collaboration exemplifying the series in ADC formats (Press release, Iksuda Therapeutics, OCT 13, 2020, View Source [SID1234568431]). The highly potent and selective payload series represents a powerful new class within ADC development with novel protein alkylating cytotoxicity. Iksuda will drive onward development and commercialisation, incorporating the tuneable payload series in its ADC pipeline and payload armoury, to create best in class ADC therapeutics for nominated targets associated with haematological and solid tumours with high unmet need.

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The partnership with the University of Goettingen was founded on Iksuda’s commitment to expand its payload armoury and optimise ADC design according to target antigen. The programme confirmed the value of tumour-selective activation of these powerful cytotoxic agents, conjugated with Iksuda’s stable conjugation technology (PermaLink), in widening the therapeutic index of ADCs. The novel protein-alkylating mode-of-action of the payload series differs from the field’s primary focus of intra- or DNA inter-strand cross-linking, conferring benefits against drug resistance mechanisms. Through the combination of PermaLink technology and the protein alkylating prodrugs, the Company aims to enable the differentiated development of more powerful ADCs with improved tumour killing, aligned with improved safety index and an ability to overcome potential tumour resistance.

Iksuda has demonstrated the potential value of prodrug approaches for targeted cancer therapeutics through its recent license of a CD19-targeting ADC from LegoChem Biosciences ("LCB") for hard-to-treat B-cell cancers, including diffuse large B-cell lymphoma and Burkitt lymphoma. The ADC contains LCB’s prodrug DNA-cross-linking payload, with preclinical data confirming an impressive increase in therapeutic index over comparators. Under a broader agreement, the Company has gained access to LCB’s prodrug payload platform for use in nominated Iksuda targets.

Dr Dave Simpson, PhD, Chief Executive Officer, Iksuda Therapeutics, said: "Iksuda’s successful partnership with the University of Goettingen, led by Professor Lutz Tietze, and subsequent licensing agreement demonstrates our continued work in building and refining approaches to ADC development. We are successfully responding to the industry-wide challenge of being able to treat all patients with cancer. Iksuda remains focussed on building a pipeline of next-generation ADCs with improved therapeutic index through our internal and external pipeline, harnessing our deep understanding in the field and accepting the challenge of targeting areas of high unmet clinical need."

Dr Jens-Peter Horst, PhD, Chief Executive Officer, MBM ScienceBridge, the technology transfer organisation of the University of Goettingen, said: "This agreement is exemplary for the successful transfer of many years of academic research and development work into a very promising and innovative cancer therapy."

On October 13, 2020 Lassogen, a company dedicated to developing lasso peptides as an entirely new therapeutic modality, reported that it has raised $4.5 million in an oversubscribed seed round of funding led by Playground Global with participation from Better Ventures, First In Ventures, Tsingyuan Ventures, and additional investors (Press release, Lassogen, OCT 13, 2020, View Source [SID1234568430]). Combined with pre-seed funding in 2019, Lassogen has raised investment capital totaling $5.1 million to date. The seed investment proceeds will enable the company to achieve key results that demonstrate the utility and promise of lasso peptides for treating serious human diseases such as cancer, autoimmunity, pain, and inflammation.

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Lassogen is developing a new class of peptide therapeutics that combine the strengths of antibodies and small molecule drugs while overcoming many of their limitations. Lasso peptides are folded into a unique lariat structure which renders them extraordinarily stable to degradation by proteases, low pH, or high temperatures and provides a three-dimensional array of amino acid side chains to engage targets with high affinity and selectivity. Naturally occurring lasso peptides are diverse in terms of size, shape, and composition, thus offering highly tunable and modular scaffolds for designing novel therapeutics with optimized properties.

Lassogen was founded by CEO Mark Burk, Ph.D., who was previously CEO and founder of Snap Bio, along with co-founder Kent Boles, Ph.D., and academic co-founders and advisors Douglas Mitchell, Ph.D., Professor of Chemistry at University of Illinois Urbana-Champaign, and Tracy Handel, Ph.D., Professor of Pharmaceutical Science at University of California San Diego.

"Lasso peptides represent a rare and powerful new therapeutic modality that could enable breakthrough treatments for challenging diseases by modulation of disease targets that are difficult for antibodies and small molecules. We are benefitting from a confluence of technology advances and insights that revealed the unexpected high prevalence and extreme diversity of lasso peptides produced by bacteria," says co-founder and CEO Mark Burk. "By taking cues from nature, we are now in a position to leverage the modern tools of in silico modeling and synthetic biology, including molecular evolution, to design and rapidly advance optimized lasso peptides into development against a range of high value targets."

"We see an opportunity for Lassogen to create an entirely new class of programmable medicines to treat challenging disease targets," said Peter Barrett, General Partner at Playground Global. "We are delighted to be a part of their journey toward a healthier future."

Phyllis Whiteley, Ph.D., Venture Partner at Playground Global, will join Lassogen’s board of directors. "The majority of therapeutics are dominated by antibodies and small molecules, yet many important diseases are resistant to those treatments," said Whiteley. "The Lassogen team, including serial entrepreneur and operator Mark Burk as well as highly respected academics and technologists, is uniquely positioned to produce and program lasso peptides to treat challenging diseases."

"We’re thrilled to be supporting the important and innovative work that Lassogen is doing, which has the potential to usher in a new era of success against debilitating diseases such as cancer," says Wes Selke, Managing Director at Better Ventures. "Mark and his team have the right backgrounds to make this happen and are exactly the kind of mission-driven founders we seek to back."

On October 13, 2020 Codiak BioSciences, Inc. ("Codiak"), a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, reported the pricing of its initial public offering of 5,500,000 shares of its common stock at a public offering price of $15.00 per share, for gross proceeds of approximately $82.5 million, before deducting underwriting discounts and commissions and offering expenses (Press release, Codiak Biosciences, OCT 13, 2020, View Source [SID1234568425]). All of the shares are being offered by Codiak. In addition, Codiak has granted the underwriters a 30-day option to purchase up to 825,000 additional shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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The shares are scheduled to begin trading on the Nasdaq Global Market on October 14, 2020 under the ticker symbol "CDAK," and the offering is expected to close on October 16, 2020, subject to customary closing conditions.

Goldman Sachs & Co. LLC, Evercore ISI and William Blair are acting as joint book-running managers for the offering and as representatives of the underwriters. Wedbush PacGrow is acting as lead manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on October 13, 2020. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 1-866-471-2526, or email: [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, telephone: (888) 474-0200, or email: [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or email: [email protected].

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

On October 13, 2020 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company utilizing a proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics, with a focus on oncology and infectious diseases, including COVID-19, reported the full exercise of the underwriters’ option to purchase an additional 487,500 shares of common stock at the public offering price of $12.00 per share, resulting in additional gross proceeds of approximately $5.9 million, in connection with the Company’s previously announced initial public offering of common stock (Press release, Immunome, OCT 13, 2020, View Source [SID1234568424]). After giving effect to the full exercise of the over-allotment option, the total number of shares sold by Immunome in the initial public offering was 3,737,500 shares and the gross proceeds were approximately $44.9 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. All of the shares were sold by Immunome. Immunome’s common stock began trading on the Nasdaq Capital Market on October 2, 2020, under the ticker symbol "IMNM".

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Ladenburg Thalmann & Co. Inc. and Chardan acted as book-running managers for the offering.

A registration statement relating to the offering of these securities has been declared effective by the Securities and Exchange Commission on October 1, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained by vising www.sec.gov or from Ladenburg Thalmann & Co. Inc., 277 Park Avenue, 26th Floor, New York, NY 10172, or by calling (212) 409-2000, or by emailing [email protected] or Chardan Capital Markets, LLC, 17 State Street, 21st floor, New York, New York 10004, or by calling (646) 465-9001.

This press release 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.